Evidence Tables for Individual Studies Supporting Guideline Statements
Appendix DStudy characteristics and main results of psychoeducation compared with WL control
Study characteristics and main results of IPT compared with WL plus clinical management
Study characteristics and main results of IPT plus fluoxetine compared with clinical management plus fluoxetine
Study characteristics and main results of ACT compared with TAU
Study characteristics and main results of MACT compared with TAU
Study characteristics and main results of CBT compared with TAU
Study characteristics and main results of DBT compared with WL or TAU
Study characteristics and main results of DBT compared with MBT
Study characteristics and main results of DBT compared with GPM for BPD
Study characteristics and main results of DBT compared with STEPPS behavior therapy
Study characteristics and main results of DBT compared with DDP
Study characteristics and main results of DBT compared with TFP and supportive therapy
Study characteristics and main results of components of DBT compared with other components of DBT for BPD
Study characteristics and main results of component of DBT skills training compared with another component of DBT skills training for BPD
Study characteristics and main results of DBT compared with CT
Study characteristics and main results of DBT compared with community therapy by experts
Study characteristics and main results of DBT plus REMS treatments compared with REMS treatments alone
Study characteristics and main results of DBT compared with conversational model
Study characteristics and main results of DBT compared with standard group therapy
Study characteristics and main results of DDP compared with TAU
Study characteristics and main results of MBT compared with other active comparators
Study characteristics and main results of MBT compared with supportive therapy
Study characteristics and main results of MBT compared with psychodynamic treatment program
Study characteristics and main results of day-hospital MBT compared with specialized psychotherapy
Study characteristics and main results of STEPPS compared with TAU
Study characteristics and main results of TFP compared with TAU
Study characteristics and main results of TFP compared with SFT
Study characteristics and main results of CVT+12S compared with DBT in patients with BPD and SUD
Study characteristics and main results of SUD treatment compared with MBT plus SUD treatment in patients with BPD and SUD
Study characteristics and main results of DDP compared with TAU in the community in patients with BPD and AUD
Study characteristics and main results of CBT compared with DBT in patients with BPD and eating disorder
Study characteristics and main results of SSCM compared with modified MBT in patients with BPD and eating disorder
Study characteristics and main results of CT plus fluoxetine compared with IPT plus fluoxetine in patients with BPD and MDD
Study characteristics and main results of IPT plus fluoxetine compared with clinical management plus fluoxetine in patients with BPD and MDD
Study characteristics and main results of DBT alone compared with DBT plus DBT-PE in patients with BPD and PTSD
Study characteristics and main results of manualized good clinical care compared with CAT in adolescents with BPD
Study characteristics and main results of individual drug counseling compared with I-BAFT in adolescents with BPD and SUD
Study characteristics and main results of SGAs compared with placebo
Study characteristics and main results of SGAs compared with antidepressants
Study characteristics and main results of SGAs compared with SGAs
Study characteristics and main results of anticonvulsants compared with placebo
Study characteristics and main results of antidepressants compared with placebo
Psychoeducation
Psychoeducation vs. Wait-list
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Zanarini and Frankenburg (2008) | Design: RCT Setting: NR Country: United States Funding: Eli Lilly | N = 50 G1 (20): Delayed psychoeducation G2 (30): Psychoeducation Duration: 12 weeks | Inclusion: Females; ages 18–30 years; met DIB-R and DSM-IV criteria for BPD Exclusion: Currently in any type of psychiatric treatment; schizophrenia, schizoaffective disorder, bipolar I disorder, or SUD | Mean age, years (SD): 19 (1.4) Female: 100% Race/ethnicity: White: 86% | Primary outcome: NR No significant difference between G1 and G2 on ZAN-BPD Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 0 Differential attrition: < 10 percentage points | Moderate |
Zanarini et al. (2018) | Design: RCT Setting: NR Country: United States Funding: NIMH, government funding | N = 80 G1 (40): No Psychoeducation G2 (40): Internet-based psychoeducation Duration: 12 weeks Follow-up: 12 months | Inclusion: Met DIB-R and DSM-IV criteria for BPD Exclusion: Schizophrenia, schizoaffective disorder, or intellectual disability; acutely suicidal or fully manic at time of assessment; current physical condition that can cause serious psychiatric symptoms (e.g., lupus, MS); serious substance abuse | Mean age, years (SD): G1: 21 (3.1) G2: 22 (3.7) Female: 100% Race/ethnicity: White: 69% Black: 11% Hispanic: 10% Asian: 8% Other: 3% | Primary outcome: NR G2 significantly more effective than G1 on SAS (0.5 vs. 0.09, P = 0.049) after 12 weeks G2 significantly more effective than G1 on ZAN-BPD scale after 12 months (4.46 vs. 0.0, P = 0.035); no significant differences on any other outcome measures after 12 months Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 4% Differential attrition: < 10 percentage points | Moderate |
AE = adverse event; BPD = borderline personality disorder; DIB-R = Diagnostic Interview for Borderlines–Revised; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; MS = multiple sclerosis; N = sample size; NIMH = National Institute of Mental Health; NR = not reported; RCT = randomized controlled trial; SAS = Social Adjustment Scale; SD = standard deviation; SUD = substance use disorder; WL = wait-list; ZAN-BPD = Zanarini Rating Scale for Borderline Personality Disorder.
Psychosocial Interventions
Interpersonal Psychotherapy vs. Wait-List Plus Clinical Management
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Bozzatello and Bellino (2020) | Design: RCT Setting: Outpatient, single center Country: Italy Funding: Government | N = 43 G1 (21): WL plus clinical management G2 (22): IPT adapted for treating BPD: 50-minute sessions over 40 weeks; 22 sessions in first 20 weeks and 20 sessions in last 20 weeks Duration: 10 months | Inclusion: Ages 18–60 years; attended Center for Personality Disorders and met DSM-5 criteria for BPD Exclusion: Dementia or other cognitive disorders, schizophrenia or other psychotic disorders, or bipolar disorders; co-occurring MDE and/or substance abuse; taken psychotropic medications and/or psychotherapy 3 months previously; females of childbearing age not using birth control | Median age: 35 Female: 67% Race/ethnicity: NR | Primary outcome: NR G2 significantly lower severity of BPD on BPDSI (36.1 vs. 44.6, P = 0.01), symptom scores on BIS-11 (64.8 vs. 77.4, P = 0.03), and functioning scores on CGI-S (3.1 vs. 4.1, P = 0.009) and SOFAS (68.2 vs. 57.1, P = 0.02) than G1 after 10 months, but not on SHI Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 14% Differential attrition: ≤1 0 percentage points | Moderate |
AE = adverse event; BIS-11 = Barratt Impulsiveness Scale–version 11; BPD = borderline personality disorder; BPDSI = Borderline Personality Disorder Severity Index; CGI-S = Clinical Global Impression-Severity; DSM-5 = Diagnostic and Statistical Manual of Mental Disorders, 5th Edition; G1 = Group 1; G2 = Group 2; IPT = interpersonal psychotherapy; MDE = major depressive episode; N = sample size; NR = not reported; RCT = randomized controlled trial; SHI = Self-Harm Inventory; SOFAS = Social Occupational Functioning Assessment Scale; WL = wait-list.
Interpersonal Psychotherapy Plus Fluoxetine vs. Clinical Management Plus Fluoxetine
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Bellino et al. (2006) | Design: RCT Setting: Outpatient, single center Country: Italy Funding: None | N = 39 G1 (19): Clinical management plus fluoxetine 20–40 mg/day; initial fixed 20 mg/day with opportunity to increase to 40 mg/day beginning week 2 G2 (20): IPT in weekly 1-hour sessions plus fluoxetine 20–40 mg/day; initial fixed 20 mg/day with opportunity to increase to 40 mg/day beginning week 2 Duration: 24 weeks | Inclusion: DSM-IV BPD diagnosis; met criteria for MDE Exclusion: Lifetime diagnosis of delirium, dementia, amnestic or other cognitive disorders, or schizophrenia or other psychotic disorders; MDE as expression of bipolar disorder; current SUD; treatment with psychotropic medication or psychotherapy during 2 months prior to study; females not using adequate birth control | Mean age, years (SD): 26 (3.7) Female: 60% (reported as ratio of men:women = 3:5) Race/ethnicity: NR | Primary outcome: NR G2 significantly more effective than G1 for improving symptoms of depression (measured by Ham-D [9.1 vs. 12, P = 0.005]) No significant differences between G2 and G1 for anxiety for clinical global impressions (measured by CGI-S) or anxiety (measured by Ham-A) Attrition: 17.9% (7/39) G1: 20.0% (4/20) G2: 15.8% (3/19) | Moderate |
Bellino et al. (2010) | Design: RCT Setting: Outpatient, single center Country: Italy Funding: None | N = 55 G1 (28): Clinical management plus fluoxetine 20–40 mg/day; initial fixed 20 mg/day with ability to increase to maximum of 40 mg/day beginning in week 2, plus 15–20 minutes of clinical management every 2 weeks dealing with clinical issues G2 (27): IPT plus fluoxetine 20–40 mg/day; initial fixed 20 mg/day with ability to increase to maximum of 40 mg/day beginning in week 2, plus IPT adapted to BPD according to Markowitz’s model (IPT-BPD) Duration: 32 weeks | Inclusion: DSM-IV-TR BPD diagnosis Exclusion: Lifetime diagnosis of delirium, amnestic disorder, other cognitive disorders, schizophrenia or other psychotic disorders, bipolar disorder, or Axis I or II disorders; those receiving psychotropic medication in past 2 months and/or psychotherapy in past 6 months; females of childbearing age not using adequate birth control | Mean age, years (SD): G1: 26 (7.2) G2: 26 (6.4) Female: 67% Race/ethnicity: NR | Primary outcome: NR No significant differences between G2 and G1 on BPDSI, Ham-A, Ham-D, CGI-S, and SOFAS Attrition: 20% (11/55) G1: 21.4% (6/28) G2: 18.5% (5/27) | Moderate |
BPD = borderline personality disorder; BPDSI = Borderline Personality Disorder Severity Index; CGI-S = Clinical Global Impression-Severity; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; DSM-IV-TR = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision; G1 = Group 1; G2 = Group 2; Ham-A = Hamilton Rating Scale for Anxiety; Ham-D = Hamilton Rating Scale for Depression; IPT = interpersonal psychotherapy; MDE = major depressive episode; N = sample size; NR = not reported; RCT = randomized controlled trial; SD = standard deviation; SOFAS = Social Occupational Functioning Assessment Scale; SUD = substance use disorder.
Acceptance and Commitment Therapy vs. Treatment as Usual
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Morton et al. (2012) | Design: RCT Setting: Outpatient, multicenter Country: Australia Funding: NR | N = 41 G1 (20): TAU; case management provided mostly by public mental health services G2 (21): ACT; 12 group sessions in psychoeducational format (2 hours/week) Duration: 13 weeks | Inclusion: Met four or more criteria for BPD (DSM-IV Axis I and Axis II diagnoses using SCID-I and SCID-II, respectively); registered client of public sector adult MHS Exclusion: Current positive or negative psychotic symptoms other than reactive psychotic symptoms associated with BPD; significant risk of violent and/or threatening behavior toward other participants; intellectual disability, cognitive impairment, or difficulty speaking English, severe enough to interfere with participation | Mean age, years (SD): G1: 34 (9.0) G2: 36 (9.3) Female: 93% Race/ethnicity: NR | Primary outcome: BEST at 13 weeks G2 significantly more effective than G1 on BEST (- 11.8 vs. - 2.4, P = 0.028), BHS (- 4.7 vs. + 0.7a, P = 0.006), and DERS (- 18.7 vs. + 5.6a, P = 0.008) Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 22% Differential attrition: G1: 30% (6/20) G2: 14% (3/21) | Moderate |
ACT = acceptance and commitment therapy; AE = adverse event; BEST = Borderline Evaluation of Severity Over Time; BHS = Beck Hopelessness Scale; BPD = borderline personality disorder; DERS = Difficulty in Emotion Regulation Scale; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; MHS = mental health service; N = sample size; NR = not reported; RCT = randomized controlled trial; SCID-I = Structured Clinical Interview for DSM-IV Axis I Disorders; SCID-II = Structured Clinical Interview for DSM-IV Axis II Disorders; SD = standard deviation; TAU = treatment as usual.
aControl group worsened over time, hence the positive change on the scale.
Manual-Assisted Cognitive Therapy vs. Treatment as Usual
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Weinberg et al. (2006) | Design: RCT Setting: Outpatient, single center Country: United States Funding: Other, foundation | N = 30 G1 (15): TAU G2 (15): MACT: Six sessions adjunctive to ongoing TAU, modified to focus on deliberate self-harm in BPD patients Six sessions (duration NR) | Inclusion: Females; ages 18–40 years; met DSM-IV and DIB-R criteria for BPD; history of repetitive deliberate self-harm with at least one episode during month before enrollment Exclusions: Comorbid psychotic disorders, bipolar I disorder, or SUD; elevated suicide risk (scoring ≥ 9 on BHS); describing concrete immediate suicide plan | Mean age, years (SD): G1: 26 (7.7) G2: 30 (8.6) Female: 100% Race/ethnicity: White: 93% Nonwhite: 7% | Primary outcome: NR G2 significantly more effective than G1 in reducing frequency (1.98 vs. 6.69, P < 0.001) and severity (0.51 vs. 1.01, P < 0.001) of deliberate self-harm 6 months posttreatment Attrition: 0% (0/30) G1: 0% (0/15) G2: 0% (0/15) | Moderate |
BHS = Beck Hopelessness Scale; BPD = borderline personality disorder; DIB-R = Diagnostic Interview for Borderlines-Revised; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; MACT = manual-assisted cognitive therapy; N = sample size; NR = not reported; RCT = randomized controlled trial; SD = standard deviation; SUD = substance use disorder; TAU = treatment as usual.
Cognitive-Behavioral Therapy vs. Treatment as Usual
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Davidson et al. (2006); BOSCOT | Design: RCT Setting: Outpatient, multicenter Country: United Kingdom Funding: Other, foundation | N = 106 G1 (52): TAU; inpatient and outpatient hospital services, community-based services, and primary and community care services G2 (54): CBT; up to 30 sessions over 1 year (1 hour/session) with weekly supervision from CBT experts at each site Duration: 24 months | Inclusion: Age 18–65 years; met criteria for at least five BPD items using DSM-IV Axis II Personality Disorders; received either inpatient psychiatric services or assessment at accident and emergency services Exclusion: Currently receiving in-patient treatment for a mental state disorder or systematic psychological therapy or specialist service; evidence of organic illness, mental impairment, substance dependence, schizophrenia, or bipolar disorder | Mean age, years (SD): 32 (9.1) G1: 31 (9.4) G2: 32 (9.0) Female: 84% Race/ethnicity: White: 100% | Primary outcome: Suicidal acts, psychiatric hospitalization, accident, and emergency attendance at 24 months G2 significantly lower number of suicidal acts per person (0.87 vs. 1.73, P = 0.02) and greater improvements on STAI (5.4 vs. 0.5, P = 0.01) than G1 after 24 months No significant differences in suicidal acts; on STAI, BDI-II, EQ-5D, or SFQ; or in number of hospitalizations after 12 months Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 15% Differential attrition: ≤ 10 percentage points | Moderate |
AE = adverse event; BDI-II = Beck Depression Inventory; BOSCOT = Borderline Personality Disorder Study of Cognitive Therapy; BPD = borderline personality disorder; CBT = cognitive-behavioral therapy; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; EQ-5D = European Quality of Life–5 Dimension; G1 = Group 1; G2 = Group 2; N = sample size; NR = not reported; RCT = randomized controlled trial; SD = standard deviation; SFQ = Social Functioning Questionnaire; STAI = State-Trait Anxiety Inventory; TAU = treatment as usual.
Dialectical Behavior Therapy vs. Wait-List/Treatment as Usual
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Bohus et al. (2004) | Design: Nonrandomized clinical trial Setting: Inpatient, single center Country: Germany Funding: Government, DFG other, BPDRF | N = 60 G1 (20): WL (TAU) G2 (40): DBT; individual therapy (2 hours/week), group skills training (2 hours/week), group psychoeducation (1 hour/week), peer group meetings (2 hours/week), mindfulness group (1 hour/week), individual body-oriented therapy (1.5 hours/week), and therapist team consultations meetings (2 hours/week) Duration: 3 months | Inclusion: Met DSM-IV criteria for BPD using SCID-II and DIB-R; one suicide attempt or minimum of two NSSI acts within the past 2 years Exclusion: Comorbid schizophrenia, bipolar I disorder, substance abuse, or intellectual disability; living > 250 miles from inpatient center; ongoing outpatient DBT or DBT post-discharge | Mean age, years (SD): G1: 30 (5.4) G2: 29 (7.2) Female: 100% Race/ethnicity: NR | Primary outcome: NR G2 significantly more effective than G1 on GSI (0.56 vs. 0.07, P = 0.005), GAF (11.4 vs. 1.3, P = 0.003), BDI (NR vs. 10.4, P = 0.002), STAI (- 8.2 vs. + 1.2, P < 0.001), and Ham-A (0.6 vs. NR, P = 0.01) and on self-mutilation (62% vs. 31%, P = 0.039) No significant differences on DES and STAXI Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 17% Differential attrition: G1: 5% (1/20) G2: 22% (9/40) | High |
Carter et al. (2010) | Design: RCT Setting: Outpatient, single center Country: Australia Funding: NR | N = 76 G1 (35): 6 months WL while receiving TAU G2 (38): DBT; team-based approach including individual therapy, weekly group-based skills training, and telephone access to an individual therapist and therapist supervision groups Duration: 12 months | Inclusion: Females; ages 18–65 years; met DSM-IV criteria for BPD; history of multiple episodes of deliberate self-harm with at least three self-reported episodes in preceding 12 months Exclusion: Presence of disabling organic condition, schizophrenia, bipolar disorder, psychotic depression, florid antisocial behavior, or developmental disability | Mean age, years (SD): 25 (6.1) Female: 100% Race/ethnicity: NR Sample demographics and outcome results reported among subset analyzed | Primary outcome: Deliberate self-harm and hospitalizations because of self-harm at 6 months No significant differences on number of self-harm episodes, proportion of participants with self-harm, or hospitalizations Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 30% Differential attrition: G1: 11% (4/35) G2: 47% (18/38) | Low |
Feigenbaum et al. (2012) | Design: RCT Setting: Outpatient, single center Country: United Kingdom Funding: Government, C&IHA, NTRHA | N = 42 G1 (16): TAU; standard care of a range of individualized service provisions according to patients’ needs through local crisis services G2 (26): DBT; goal setting and commitment building (3–6 weeks), individual therapy (1 hour/week), group skills training (2.5 hours/week), and out-of-hours telephone consultation Duration: 12 months | Inclusion: Males and females; ages 18–65 years; DSM-IV criteria for Cluster B personality disorder Exclusion: Forensic history with evidence of current high and immediate risk to others; in long-term psychotherapeutic treatment for schizophrenia or bipolar disorder; substance abuse; severe cognitive impairment | Mean age, years (SD): G1: 35 (7.4) G2: 35 (7.8) Female: 73% Race/ethnicity: NR | Primary outcome: CORE-OM at 12 months No significant differences on CORE-OM, DSH, DES, BDI, STAXI, and OAS-M Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 29% Differential attrition: G1: 13% (2/16) G2: 39% (10/26) | High |
Gregory and Sachdeva (2016)a | Design: Retrospective cohort Setting: Outpatient, single center Country: United States Funding: APsaA | N = 41 G1 (16): TAU; unstructured psychotherapy G2 (25): DBT; skill group sessions including learning mindfulness, emotion regulation, and distress tolerance, followed by individual sessions Duration: 12 months | Inclusion: Age > 18 years; SCID-II; Individual Assessment Profile Exclusion: Schizophrenia, intellectual disabilities, or dementia | Mean age, years (SD): G1: 29 (11.5) G2: 37 (10.2) Female: 81% Race/ethnicity: Caucasian: 88% Other: 12% | Primary outcome: BEST at 12 months G2 significantly more effective than G1 on BDI (- 5.5 vs. - 0.6, P < 0.001) No significant differences on BEST and SDS, or in number of suicide attempts and self-injuries Incidence of AEs: NR Withdrawal due to AEs: G1: 0% (0/16) G2: 0% (0/25) Attrition: 53% Differential attrition: < 10 percentage points | High |
McMain et al. (2017) | Design: RCT Setting: Outpatient, single center Country: Canada Funding: Ontario Mental Health Foundation | N = 84 G1 (42): WL G2 (42): Brief DBT; skills training only 20 weeks Follow up: 32 weeks | Inclusion: Ages 18–60 years; met DSM-IV criteria for BPD; two suicidal and/or NSSI episodes in past 5 years, with one occurring within 10 weeks prior to enrollment Exclusion: Met DSM-IV criteria for psychotic disorder, bipolar I disorder, or dementia; evidence of intellectual disability; participation in DBT program within past year | Mean age, years (SD): 30 (8.6) Female: 79% Race/ethnicity: NR | Primary outcome: Frequency of suicidal or NSSI episodes at 32 weeks G2 significantly more effective than G1 to reduce suicidal and self-injurious episodes on LSASI (7.65 vs. 5.77, P = 0.04) and to improve symptoms on STAXI (8.44 vs. 4.79, P < 0.001) and DERS (20.80 vs. 4.74, P < 0.01) G2 significantly more clinically relevant improvements on SCL-90-R than G1 (43.8% vs. 18.4%, P = 0.024) No significant differences on DSHI, BSL-23, BDI, and BIS-11 Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 16% Differential attrition: < 10 percentage points | Moderate |
Verheul et al. (2003); van den Bosch et al. (2005) | Design: RCT Setting: Outpatient, with various settings Country: The Netherlands Funding: Dutch health insurance company | N = 64 G1 (33): TAU; clinical management from original referral source; generally no more than two sessions per month with a psychologist, psychiatrist, or social worker G2 (31): Weekly DBT; individual CBT sessions with the primary therapist, skills-training groups (2–2.5 hours/session), and supervision and consultation meetings for therapists Duration: 52 weeks | Inclusions: Female; ages 18–70 years; BPD; residing near Amsterdam; referred by psychologist or psychiatrist willing to sign agreement committing to deliver 12 months of TAU Exclusions: DSM-IV diagnosis of bipolar disorder or (chronic) psychotic disorder; insufficient command of Dutch language; severe cognitive impairments | Mean age, years (SD): 35 (7.7) Female: 100% Race/ethnicity: NR | Primary outcome: NR G2 more effective than G1 to reduce self-mutilating behavior (35% vs. 57%, P = 0.003); numerically lower frequency of suicidal attempts (7% vs. 26%, P = 0.06) for G2 than G1 Incidence of AEs: NR Withdrawal due AEs: NR Attrition: 19% | Moderate |
AE = adverse event; APsaA = American Psychoanalytic Association; BDI: Beck Depression Inventory; BEST = Borderline Evaluation of Severity Over Time; BIS-11 = Barrett Impulsiveness Scale–11; BPD = borderline personality disorder; BPDRF = Borderline Personality Disorder Research Foundation; BSL-23 = Borderline Symptom List–23; C&IHA = Camden and Islington Health Authority; CBT = cognitive-behavioral therapy; CORE-OM = Clinical Outcomes in Routine Evaluation–Outcome Measure; DBT = dialectical behavior therapy; DERS = Difficulties in Emotion Regulation Scale; DES = Dissociations Experiences Scale; DFG = German Research Foundation; DIB-R = Diagnostic Interview for Borderlines-Revised; DSH = deliberate self-harm; DSHI = Deliberate Self-Harm Inventory; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; GAF = Global Assessment of Functioning; GSI = Global Severity Index; Ham-A = Hamilton Rating Scale for Anxiety; LSASI = Lifetime Suicide Attempt Self-Injury Interview; N = sample size; NR = not reported; NSSI = nonsuicidal self-injury; NTRHA = North Thames Regional Health Authority; OAS-M = Overt Aggression Scale-Modified; RCT = randomized controlled trial; SCID-II = Structured Clinical Interview for DSM-IV Axis II Disorders; SCL-90-R = Symptom Checklist–90–Revised; SD = standard deviation; SDS = Sheehan Disability Scale; STAI = State-Trait Anxiety Inventory; STAXI = State-Trait Anger Expression Inventor; TAU = treatment as usual; WL = wait-list.
aGregory and Sachdeva (2016) is a three-arm trial. The two relevant arms to DBT vs. TAU are reported in this table; other eligible comparisons are reported in Tables D–11 and D–20.
Dialectical Behavior Therapy vs. Mentalization-Based Treatment
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Barnicot and Crawford (2019) | Design: Nonrandomized clinical trial Setting: Outpatient, multicenter Country: United Kingdom Funding: Government, NIH | N = 90 G1 (58): DBT G2 (32): MBT Duration: 12 months | Inclusion: Met DSM-IV criteria for BPD; was about to begin either outpatient DBT or MBT Exclusion: Intellectual disability; difficulty communicating in English; insufficient capacity to provide informed consent | Mean age, years (SD): 31 (13.0) Female: 72% Race/ethnicity: White: 64% Black and minority: 36% | Primary outcome: NR No significant differences between G1 and G2 on BEST, DERS, and DES and in number of self-harm incidents at 12 months Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 13% Differential attrition: < 10 percentage points | High |
AE = adverse event; BEST = Borderline Evaluation of Severity Over Time; BPD = borderline personality disorder; DBT = dialectical behavior therapy; DERS = Difficulties in Emotion Regulation Scale; DES = Dissociative Experiences Scale; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; MBT = mentalization-based therapy; N = sample size; NIH = National Institutes of Health; NR = not reported; SD = standard deviation.
Dialectical Behavior Therapy vs. General Psychiatric Management
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
McMain et al. (2009) | Design: RCT Setting: Both inpatient and outpatient Country: Canada Funding: Government | N = 180 G1(90): Weekly individual therapy and medication management G2 (90): DBT; weekly individual therapy, skills group sessions, and phone coaching with explicit focus on self-harm and suicidal behavior 1 year Follow up: 36 months | Inclusion: Met DSM-IV criteria for BPD; ages 18–60 years; Two or more episodes of suicidal or NSSI episodes in past 5 years, at least one of which occurred in 3 months preceding enrollment Exclusion: DSM-IV psychotic disorder, bipolar I disorder, delirium, dementia, or SUD in preceding 30 days; medical condition that precluded psychiatric medications; any serious medical condition likely to require hospitalization within next year (e.g., cancer) | Mean age, years (SD): 30 (9.9) Female: 86% Race/ethnicity: NR | Primary outcome: Suicidal episodes, NSSI at 12 months No significant differences between G1 and G2 for number of suicidal events and NSSI, or on SCL-90-R, ZAN-BPD, BDI, and IIP after 12 months G1 significantly greater improvements on BDI (17.4 vs. 12.7, P = 0.004) than G2 at 36-month follow-up; no significant differences at 36 months for any other outcomes Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 38% Differential attrition: < 10 percentage points | High |
AE = adverse event; BDI = Beck Depression Inventory; BPD = borderline personality disorder; DBT = dialectical behavior therapy; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; GPM = general psychiatric management; IIP = Inventory of Interpersonal Problems; N = sample size; NR = not reported; NSSI = nonsuicidal self-injury; RCT = randomized controlled trial; SCL-90-R = Symptom Checklist–90–Revised; SD = standard deviation; SUD = substance use disorder; ZAN-BPD = Zanarini Rating Scale for Borderline Personality Disorder.
Dialectical Behavior Therapy vs. Systems Training for Emotional Predictability and Problem-Solving Behavior Therapy
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Guillén Botella et al. (2021) | Design: Nonrandomized clinical trial Setting: Outpatient, multicenter Country: Spain Funding: NR | N = 72 G1 (45): Weekly individual and group DBT G2 (27): Weekly STEPPS group therapy plus weekly individual therapy Duration: 6 months | Inclusion: Met DSM-5 criteria for BPD Exclusion: Moderate or severe intellectual disability, schizophrenia, or bipolar disorder | Mean age, years (SD): 32 (8.8) Female: 94% Race/ethnicity: Caucasian: 100% | Primary outcome: BSL-23 at 6 months G1 significantly more effective than G2 on sum of BSL-23 (23.56 vs. 29.29, P = 0.03) after 6 months No significant differences for any other measure Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 32% Differential attrition: < 10 percentage points | High |
AE = adverse event; BPD = borderline personality disorder; BSL-23 = Borderline Symptom List–23; DBT = dialectical behavior therapy; DSM-5 = Diagnostic and Statistical Manual of Mental Disorders, 5th Edition; G1 = Group 1; G2 = Group 2; N = sample size; NR = not reported; SD = standard deviation; STEPPS = systems training for emotional predictability and problem-solving.
Dialectical Behavior Therapy vs. Dynamic Deconstructive Psychotherapy
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Gregory and Sachdeva (2016)a; Sachdeva et al. (2013) | Design: Retrospective cohort Setting: Outpatient, single center Country: United States Funding: APsaA | N = 52 G1 (25): DBT; weekly 1-hour individual and 2-hour group sessions and telephone skills coaching G2 (27): DDP; combined elements of translational neuroscience, object relations theory, and deconstructionist philosophy; weekly 1-hour individual sessions Duration: 12 months | Inclusion: Age > 18 years; BPD by SCID-II and Individual Assessment Profile Exclusion: Schizophrenia, intellectual disabilities, or dementia | Mean age, years (SD): G1: 29 (11.5) G2: 37 (10.2) Female: 81% Race/ethnicity: Caucasian: 88% Other: 12% | Primary outcome: BEST scores at 12 months G2 significantly greater improvement than G1 on severity (BEST: 33.0 vs. 41.8, P = 0.04), self-injuries (SBQ: 1.3 vs. 2.4, P = 0.02), depression (BDI: 17.1 vs. 27.6, P = 0.009), and disability (SDS: 3.8 vs. 6.1, P = 0.049) No differences between G1 and G2 in suicide attempts Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 53% Differential attrition: G1: 64% (16/25) G2: 33% (9/27) | High |
AE = adverse event; APsaA = American Psychoanalytic Association; BDI = Beck Depression Inventory; BEST = Borderline Evaluation of Severity Over Time; BPD = borderline personality disorder; DBT = dialectical behavior therapy; DDP = dynamic deconstructive psychotherapy; G1 = Group 1; G2 = Group 2; N = sample size; NR = not reported; RCT = randomized controlled trial; SBQ = Suicidal Behaviors Questionnaire; SCID-II = Structured Clinical Interview for DSM-IV Axis II Personality Disorders; SD = standard deviation; SDS = Sheehan Disability Scale.
aGregory and Sachdeva (2016) is a three-arm trial. The two relevant arms to DBT vs. DDT are reported in this table; other eligible comparisons are reported in Tables D–7 and D–20.
Dialectical Behavior Therapy vs. Transference-Focused Psychotherapy vs. Supportive Therapy
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Clarkin et al. (2007) | Design: RCT Setting: Outpatient, multicenter Country: United States Funding: Other, foundation | N = 90 G1 (22): Weekly supportive treatment sessions G2 (23): TFP; twice weekly individual sessions G3 (17): DBT; weekly individual and group sessions and available telephone consultation Duration: 12 months | Inclusion: Ages 18–50 years; met DSM-IV criteria for BPD Exclusion: Comorbid psychotic disorders, bipolar I disorder, delusional disorder, delirium, dementia, and/or amnestic, other cognitive disorders, or SUD | Mean age, years (SD): 31 (7.9) Female: 92% Race/ethnicity: White: 68% Black: 10% Hispanic: 9% Asian: 6% Other: 8% | Primary outcome: Suicidal behavior at 12 months No significant differences among G1, G2, and G3 in suicidal behavior or on BDI, BSI, or GAF at 12 months Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 31% Differential attrition: G1: 27% (8/30) G2: 23% (7/30) G3: 43% (13/30) | High |
AE = adverse event; BDI = Beck Depression Inventory; BPD = borderline personality disorder; BSI = Brief Symptom Inventory; DBT = dialectical behavior therapy; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; G3 = Group 3; GAF = Global Assessment of Functioning; N = sample size; NR = not reported; RCT = randomized controlled trial; SD = standard deviation; SUD = substance use disorder; TFP = transference-focused psychotherapy.
Components of Dialectical Behavior Therapy vs. Other Components of Dialectical Behavior Therapy
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Andión et al. (2012) | Design: Nonrandomized clinical trial Setting: Outpatient, single center Country: Spain Funding: Government, health department, La Caixa | N = 51 G1 (37): Weekly individual DBT therapy G2 (14): Combined weekly individual and group DBT sessions Duration: 12 months intervention, followed through 18 months | Inclusion: Ages 18–50 years; one or more suicide attempts and/or self-harm behaviors during previous month; met criteria for DSM-IV Axis II and Axis I Disorders Exclusion: Intellectual disability, schizophrenia, or bipolar I disorder; previous DBT treatment | Mean age, years (SD): 26 (6.5) Female: 100% Race/ethnicity: NR | Primary outcome: Suicide attempts and self-harm at 12 and 18 months No significant differences between groups on any outcome Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 10% Differential attrition: < 10 percentage points | High |
Linehan et al. (2015) | Design: RCT Setting: Outpatient, multicenter Country: United States Funding: Government, NIMH | N = 99 G1 (33): Weekly standard DBT: skills training, individual therapy, telephone coaching, and a therapist consultation team G2 (33): DBT individual therapy with no group skills training G3 (33): Weekly DBT group skills training with no individual therapy Duration: 1-year treatment followed through 2 years | Inclusion: Females; ages 18–60 years; met DSM-IV criteria for BPD; two or more suicide attempts and/or NSSI episodes in past 5 years, one or more suicide attempts or NSSI acts in 8 weeks prior to entering study, and one or more suicide attempts in past year Exclusion: IQ < 70; DSM-IV criteria for current psychotic or bipolar disorders; seizure disorder requiring medication; required primary treatment for another life-threatening condition | Mean age, years (SD): 30 (8.9) Female: 100% Race/ethnicity: White: 71% Asian American: 5% Biracial: 22% Other: 2% | Primary outcome: Frequency and severity of suicide attempts and NSSI episodes at 12 and 24 months No significant difference between groups in suicide attempts, NSSI acts, or suicide ideation During the treatment year, G1 and G3 significantly greater improvement in depression than G2 (12.3 and 10.4 vs. 18.2, P = 0.02 on Ham-D) with no differences between groups in anxiety (Ham-A) Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 26% Differential attrition: G1: 18% (6/33) G2: 33% (11/33) G3: 27% (9/33) | High |
Lyng et al. (2020) | Design: Prospective cohort Setting: Outpatient, multicenter Country: Ireland Funding: NR | N = 88 G1 (54): Weekly standard DBT; individual therapy, group skills training, phone consultation (as needed), and therapist consultation team meeting G2 (34): Weekly DBT group skills training Duration: 6 months | Inclusion: DSM-IV-TR BPD or equivalent diagnosis of emotionally unstable personality disorder by community psychiatrist Exclusion: Enduring psychotic disorder or primary (i.e., main reason for seeking treatment) alcohol or substance abuse disorder; suicide attempt in previous 6 months and/or ongoing medically serious self-harm; other weekly counseling | Mean age, years (SD): 33 (range 18–59) Female: 83% Race/ethnicity: NR | Primary outcome: Borderline symptoms, general psychopathology, suicidal ideation at 6 months No significant differences between groups in BPD symptomatology, suicide ideation, and symptom severity index G2 significantly greater improvement on BHS (8.0 vs. 11.91, P = 0.02) and DERS (96.24 vs. 115.12, P = 0.02) Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 25% Differential attrition: G1: 17% (9/54) G2: 38% (13/34) | High |
AE = adverse event; BHS = Beck Hopelessness Scale; BPD = borderline personality disorder; DBT = dialectical behavior therapy; DERS = Difficulties in Emotion Regulation Scale; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; DSM-IV-TR = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision; G1 = Group 1; G2 = Group 2; G3 = Group 3; Ham-A = Hamilton Rating Scale for Anxiety; Ham-D = Hamilton Rating Scale for Depression; IQ = intelligence quotient; N = sample size; NIMH = National Institute of Mental Health; NR = not reported; NSSI = nonsuicidal self-injury; RCT = randomized controlled trial; SD = standard deviation.
Component of Dialectical Behavior Therapy Skills Training vs. Another Component of Dialectical Behavior Therapy Skills Training
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Carmona i Farrés et al. (2019a) | Design: RCT Setting: Outpatient, single center Country: Spain Funding: Other, mixed | N = 70 G1 (35): Weekly group DBT interpersonal effectiveness skills training for 10 sessions G2 (35): Weekly group DBT mindfulness skills training for 10 sessions Duration: 10 weeks | Inclusion: Ages 18–50 years; DSM-IV BPD diagnosis; no comorbidities with schizophrenia, drug-induced psychosis, organic brain syndrome, SUD, bipolar disorder, intellectual disability, or MDE in course; no concurrent psychotherapy at study enrollment; no previous training in mindfulness, other meditation-contemplative practices, or any other mind-body practices Exclusion: NR | Mean age, years (SD): G1: 33.29 (8.54) G2: 30.51 (6.9) Female: 90% Race/ethnicity: NR | Primary outcome: Emotional dysregulation (DERS) and impulsivity (BIS-11) at 10 weeks No significant differences between G1 and G2 on DERS at 10 weeks G2 significantly greater improvement on the BIS-11 (75.3 vs. 79.3, P = 0.03) at 10 weeks Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 28% G1: 20% G2: 37% | High |
Carmona I Farrés et al. (2019b) | Design: RCT Setting: Outpatient, single center Country: Spain Funding: Other, mixed | N = 65 G1 (32): Weekly group DBT interpersonal effectiveness skills training for 10 sessions G2 (33): Weekly group DBT mindfulness skills training for 10 sessions Duration: 10 weeks | Inclusion: Ages 18–50 years; DSM-IV BPD diagnosis; no comorbidities with schizophrenia, drug-induced psychosis, organic brain syndrome, SUD, bipolar disorder, intellectual disability, or major depressive episode in course; no concurrent psychotherapy at study enrollment; right-handed; IQ within normal range Exclusion: NR | Mean age, years (SD): G1: 33.75 (8.78) G2: 31.03 (6.76) Female: 89.2% Race/ethnicity: NR | Primary outcome: DMN activation and deactivation during an executive task No significant differences between G1 and G2 on BSL-23, BDI, STAI-T, or STAI-S at 10 weeks (decreases on outcome measures in both groups) No between‐group differences in DMN activation or deactivation Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 23% Differential attrition: ≤ 10 percentage points | High |
Elices et al. (2016) | Design: RCT Setting: Outpatient, single center Country: Spain Funding: Government | N = 64 G1 (32): Weekly group DBT interpersonal effectiveness skills training G2 (32): Weekly group DBT mindfulness training Duration: 10 weeks | Inclusion: Ages 18–45 years; met BPD criteria according to SCID-II and DIB-R Exclusion: Lifetime diagnosis of schizophrenia, drug-induced psychosis, organic brain syndrome, or bipolar disorder; participation in any psychotherapy during study or having previously received DBT; having meditation/yoga experience | Mean age, years (SD): 32 (6.9) G1: 32 (6.82) G2: 32 (7.25) Female: 86% Race/ethnicity: NR | Primary outcome: Borderline severity at 10 weeks G2 significantly reduced BPD symptoms on BSL-23 than G1 at 10 weeks (33.5 vs. 52.5, P = 0.001) Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 31% Differential attrition: G1: 22% (7/32) G2: 41% (13/32) | High |
Schmidt et al. (2021) | Design: RCT Setting: Outpatient, single center Country: Spain Funding: Other, mixed | N = 102 G1 (52): Weekly group DBT interpersonal effectiveness skills training for 10 sessions G2 (50): Weekly group DBT mindfulness skills training for 10 sessions Duration: 10 weeks | Inclusion: Ages 18–50 years; DSM-IV BPD diagnosis; no comorbidities with schizophrenia, drug-induced psychosis, organic brain syndrome, SUD, bipolar disorder, intellectual disability, or MDE in course; no concurrent psychotherapy at study enrollment; no previous experience in mindfulness meditation and DBT skills training Exclusion: NR | Mean age, years (SD): G1: 33 (8.0) G2: 32 (8.0) Female: 93% Race/ethnicity: NR | Primary outcome: Borderline severity (BSL-23) at 10 weeks G2 significantly greater improvements on BSL-23 at 10 weeks (37.38 vs. 48.90, P = 0.000) and on EQ at 10 weeks (31.28 vs. 27.48, P = 0.001) No differences between groups on DERS Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: NR Differential attrition: NR | High |
AE = adverse event; BDI = Beck Depression Inventory; BIS-11 = Barrett Impulsiveness Scale-11; BPD = borderline personality disorder; BSL-23 = Borderline Symptom List–23; DBT = dialectical behavior therapy; DERS = Difficulties in Emotion Regulation Scale; DIB-R = Diagnostic Interview for Borderlines-Revised; DMN = default mode network; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; EQ = European Quality of Life; G1 = Group 1; G2 = Group 2; IQ = intelligence quotient; MDE = major depressive episode; N = sample size; NR = not reported; RCT = randomized controlled trial; SCID-II = Structured Clinical Interview for DSM-IV Axis II Personality Disorders; SD = standard deviation; STAI‐S = State‐Trait Anxiety Inventory–State; STAI‐T = State‐Trait Anxiety Inventory–Trait; SUD = substance use disorder.
Dialectical Behavior Therapy vs. Cognitive Therapy
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Lin et al. (2019) | Design: RCT Setting: Other: university counseling centers Country: Taiwan Funding: Government | N = 82 G1 (40): Weekly CT group sessions, phone consultations as needed, and closed social media community for group members G2 (42): Weekly DBT group skills training, phone consultation as needed, and closed social media community for group members Duration: 8 weeks | Inclusion: College students; met criteria for BPD per BPDFS; score ≥ 21 on Ko’s Depression Inventory; one or more suicide attempts in past 6 months Exclusions: Lifetime diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or psychotic disorder; current severe depression and suicide risk indicating need for inpatient care and crisis intervention; current neurological signs and substance abuse during past 6 months | Mean age, years (SD): G1: 20.47 (0.71) G2: 20.40 (0.76) Female: 87.8% Race/ethnicity: NR | Primary outcome: Suicide attempt at 32 weeks No significant difference between G1 and G2 on suicide reattempt (CMSADS-L Short form) and Ko’s Depression Inventory at 32 weeks Compared with G1, G2 significant improvements on BPDFS (5.87 vs. 4.91, P <0.01) and in suicide ideation (ASIQ-S; 42.96 vs. 40.27, P <0.01) at 32 weeks Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 1% Differential attrition: < 10 percentage points | Moderate |
AE = adverse event; ASIQ-S = Adult Suicidal Ideation Questionnaire-Shortened Version; BPD = borderline personality disorder; BPDFS = Borderline Personality Disorder Features Scale; CMSADS-L = Chinese Version of the Modified Schedule of Affective Disorders and Schizophrenia–Lifetime; CT =cognitive therapy; DBT = dialectical behavior therapy; G1 = Group 1; G2 = Group 2; N = sample size; NR = not reported; RCT = randomized controlled trial; SD = standard deviation.
Dialectical Behavior Therapy vs. Community Therapy by Experts
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Linehan et al. (2006) | Design: RCT Setting: Outpatient, single center Country: United States Funding: Government, NIMH | N = 111 G1 (49): Community treatment by experts; developed specifically for this study to control for factors previously uncontrolled for in DBT studies G2 (52): DBT Duration: 1 year | Inclusion: Females; ages 18–45 years; BPD; two suicide attempts or self-injuries in past 5 years, with at least one occurring in past 8 weeks Exclusion: Comorbid schizophrenia, schizoaffective disorder, bipolar, psychotic disorder, or intellectual disability; seizure disorder requiring medication; mandate to treatment; need for primary treatment for another debilitating condition | Mean age, years (SD): 29 (7.5) Female: 100% Race/ethnicity: White: 87.0% Black: 4.0% Asian American: 2.0% Native American or Alaskan Native: 1.0% Other: 5.0% | Primary outcome: NR G2 more effective than G1 in preventing suicide attempts (23% vs. 46%, P = 0.01), ED visits for suicide ideation (10.6% vs. 18.4%, P = 0.02), and hospital admissions for suicide ideation (14.9% vs. 18.4%, P = 0.004) No significant differences between groups on NSSI, Ham-D, and RLI Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: Overall: 18% G1: 27.5% (14/51) G2: 10.0% (6/60) | High |
AE = adverse event; BPD = borderline personality disorder; DBT = dialectical behavior therapy; ED = emergency department; G1 = Group 1; G2 = Group 2; Ham-D = Hamilton Rating Scale for Depression; N = sample size; NIMH = National Institute of Mental Health; NR = not reported; NSSI = nonsuicidal self-injury; RCT = randomized controlled trial; RLI = Reasons for Living Inventory; SD = standard deviation.
Dialectical Behavior Therapy Plus REMS Treatments vs. REMS Treatments
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Bianchini et al. (2019) | Design: RCT Setting: Inpatient, single center Country: Italy Funding: NR | N = 21 G1 (11): REMS (Residenze per l’Esecuzione delle Misure di Sicurezza, a small‐scale intensive therapeutic unit) G2 (10): DBT plus REMS treatments Duration: 12 months | Inclusion: Met criteria for BPD as measured by PAI; history of violence toward others Exclusion: Cognitive deficit (IQ < 70) and/or comorbid neurological diseases | Mean age, years (SD): 42 (8.14) Female: 0% Race/ethnicity: NR | Primary outcome: NR No between-group comparisons at end of treatment Significant change on only two outcomes, DERS and BIS-11, within intervention group Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: NR | Moderate |
AE = adverse event; BIS-11 = Barrett Impulsiveness Scale-11; BPD = borderline personality disorder; DBT = dialectical behavior therapy; DERS = Difficulties in Emotion Regulation Scale; G1 = Group 1; G2 = Group 2; IQ = intelligence quotient; N = sample size; NR = not reported; PAI = Personality Assessment Inventory; RCT = randomized controlled trial; REMS = Residenze per l’Esecuzione delle Misure di Sicurezza; SD = standard deviation.
Dialectical Behavior Therapy vs. Conversational Model
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Walton et al. (2020) | Design: RCT Setting: Outpatient, single center Country: Australia Funding: None | N = 166 G1 (83): Conversational model involving twice-weekly individual therapy G2 (83): Weekly DBT; individual therapy, group training, and access to after-hours coaching Duration: 14 months | Inclusion: Ages 18–65 years; DSM-IV BPD; three or more suicidal and/or NSSI episodes in past 12 months Exclusion: Disabling organic conditions, current acute psychotic illness, antisocial behavior that posed significant threat to staff and fellow patients, or developmental disability; substance dependence; living > 1-hour’s drive from treatment facility; inability to speak or read English; prior treatment with DBT or conversational model | Mean age, years (SD): 27 (7.8) Female: 77% Race/ethnicity: White: 86% Aboriginal: 6% Other: 8% | Primary outcome: Suicide attempts and NSSI at 14 months and depression severity (BDI-II) at 14 months No differences between groups in suicide attempts, NSSI, BPD severity (BPDSI-IV), interpersonal problems (IIP), dissociation (DES), and mindfulness at 14 months G2 significantly greater reductions in BDI-II scores at 14 months (15.94 vs. 22.13, P = 0.005) and greater improvements in emotion regulation (DERS; 87.08 vs. 105.16, P = 0.008) Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 29% G1: 24% (20/83) G2: 34% (28/83) | Moderate |
AE = adverse event; BDI-II = Beck Depression Inventory-II; BPD = borderline personality disorder; BPDSI-IV = Borderline Personality Disorder Severity Index-IV; DBT = dialectical behavior therapy; DERS = Difficulties in Emotion Regulation Scale; DES = Dissociative Experiences Scale; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; IIP = Inventory of Interpersonal Problems; N = sample size; NR = not reported; NSSI = nonsuicidal self-injury; RCT = randomized controlled trial; SD = standard deviation.
Dialectical Behavior Therapy Skills Training vs. Standard Group Therapy
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Soler et al. (2009) | Design: RCT Setting: Outpatient, single center Country: Spain Funding: Government | N = 60 G1 (30): Weekly standard group therapy G2 (29): Weekly group DBT skills training Duration: 12 weeks | Inclusion: Age s 18–45 years; met DSM-IV criteria for BPD as assessed by SCID-II and DIB-R; CGI-S score of ≥ 4 Exclusion: Comorbid schizophrenia, drug-induced psychosis, organic brain syndrome, alcohol or other psychoactive SUD, bipolar disorder, intellectual disability, or MDE in course; current psychotherapy | Mean age, years (SD): G1: 29.97 (5.63) G2: 28.45 (6.55) Female: 83.0% Race/ethnicity: NR | Primary outcome: NR No significant differences between G1 and G2 on CGI-BPD and SCL-90-R at 12 weeks G2 significantly greater improvement on the Ham-D (11.1 vs. 16.0, P = 0.001) and Ham-A (16.6 vs. 13.0, P = 0.03) at 12 weeks Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 49% Differential attrition: G1: 35% (10/29) G2: 63% (19/30) | High |
AE = adverse event; BPD = borderline personality disorder; CGI-BPD = Clinical Global Impression Scale for Borderline Personality Disorder; CGI-S = Clinical Global Impression-Severity; DBT = dialectical behavior therapy; DIB-R = Diagnostic Interview for Borderlines–Revised; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; Ham-A = Hamilton Rating Scale for Anxiety; Ham-D = Hamilton Rating Scale for Depression; MDE = major depressive episode; N = sample size; NR = not reported; RCT = randomized controlled trial; SCID-II = Structured Clinical Interview for DSM-IV Axis II Disorders; SCL-90-R = Symptom Checklist–90–Revised; SD = standard deviation; SUD = substance use disorder.
Dynamic Deconstructive Psychotherapy vs. Treatment as Usual
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Gregory and Sachdeva (2016)a | Design: Retrospective cohort Setting: Outpatient, single center Country: United States Funding: APsaA | N = 44 G1 (16): TAU: Unstructured psychotherapy G2 (28): DDP: combined elements of translational neuroscience, object relations theory, and deconstructionist philosophy in weekly 1-hour individual sessions Duration: 12 months | Inclusion: Age >18 years; BPD by SCID-II and Individual Assessment Profile Exclusion: Schizophrenia, intellectual disabilities, or dementia | Mean age, years (SD): G1: 29 (11.5) G2: 28 (11.7) Female: 81% Race/ethnicity: Caucasian: 88% Other: 12% | Primary outcome: BEST at 12 months G2 significantly more effective than G1 on change from baseline in BEST (14.1 vs. - 2.6, P = 0.006), BDI (- 12.6 vs. - 0.6, P < 0.001), and SDS (- 2.5 vs. 0.6, P <0.001) No significant differences in the number of suicide attempts and self-injuries Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 53% Differential attrition: G1: 69% (11/16) G2: 33% (9/27) | High |
AE = adverse event; APsaA = American Psychoanalytic Association; BDI = Beck Depression Inventory; BEST = Borderline Evaluation of Severity Over Time; BPD = borderline personality disorder; DDP = dynamic deconstructive psychotherapy; G1 = Group 1; G2 = Group 2; N = sample size; NR = not reported; SCID-II = Structured Clinical Interview for DSM-IV Axis II Disorders; SD = standard deviation; SDS = Sheehan Disability Scale; TAU = treatment as usual.
aGregory and Sachdeva (2016) is a three-arm trial. The two relevant arms to DDP vs. TAU are reported in this table; other eligible comparisons are reported in Tables D–7 and D–11.
Mentalization-Based Treatment vs. Other Active Comparators
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Beck et al. (2020); M-GAB | Design: double-blinded RCT Setting: Outpatient, multicenter Country: Denmark Funding: Government, region Zealand other, TrygFonden | N = 112 G1 (56): Standardized to at least 12 individual monthly sessions, and additional contact varied across clinics and therapists and according to patient need; therapists were nurses, psychologists, social workers, or psychiatrists not trained in or practicing MBT; treatment was not manualized G2 (56): MBT delivered as a 1-year program with three components: 1) MBT introduction, 2) MBT group, and 3) MBT parents (90-minute sessions) Duration: 12 months | Inclusion: Ages 14–17 years; met four or more DSM-5 BPD criteria and total score above clinical cutoff (> 67) on BPFS-C Exclusion: Comorbid PDD, learning disability (IQ < 75), anorexia, psychosis, schizophrenia or schizotypal personality disorder, ASPD, or any mental disorder other than BPD considered primary diagnosis; current SUD (past 2 months; not substance abuse); current psychiatric inpatient treatment | Mean age, years (SD): G1: 16 (1.0) G2: 16 (1.1) Female: 99% (111/112) Race/ethnicity: NR | Primary outcome: BPFS-C No significant differences between G2 and G1 on BPFS-C, BPFS for Parent, ZAN-BPD, Risk-Taking and Self-Harm Inventory for Adolescents, BDI for Youth, internalizing or externalizing symptoms on Youth Self-Report, Child Behavior Checklist, or Children’s GAS Report of any AEs: 0 Attrition: 25.0% (28/112) G1: 19.6% (11/56) G2: 30.3% (17/56) | High |
AE = adverse event; ASPD = antisocial personality disorder; BDI = Beck Depression Inventory; BPD = borderline personality disorder; BPFS = Borderline Personality Features Scale; BPFS-C = Borderline Personality Features Scale for Children; DSM-5 = Diagnostic and Statistical Manual of Mental Disorders, 5th Edition; G1 = Group 1; G2 = Group 2; GAS = Global Assessment Scale; IQ = intelligence quotient; MBT = mentalization-based treatment; M-GAB = Mentalization-Based Treatment in Groups for Adolescents with Borderline Personality Disorder; N = sample size; NR = not reported; RCT = randomized controlled trial; SD = standard deviation; SUD = substance use disorder; ZAN-BPD = Zanarini Rating Scale for Borderline Personality Disorder.
Mentalization-Based Treatment vs. Supportive Therapy
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Bateman and Fonagy (2009); Bateman et al. (2021) | Design: RCT Setting: Outpatient, single center Country: United Kingdom Funding: Other, foundation | N = 134 G1 (63): SCM individual and group sessions plus medication; therapy based on supportive approach with case management, advocacy support, and problem-oriented psychotherapeutic interventions G2 (71): MBT plus medication; 18-month manualized weekly combined individual and group psychotherapy Duration: 18 months Follow-up: 6 years | Inclusion: Ages 18–65 years; DSM-IV BPD diagnosis; suicide attempt or episode of life-threatening self-harm within past 6 months Exclusion: Current long-term psychotherapeutic treatment; met DSM-IV criteria for psychotic disorder or bipolar I disorder; opiate dependence requiring specialist treatment; mental impairment or evidence of organic brain disorder | Mean age, years (SD): G1: 31 (7.9) G2: 31 (7.6) Female: 80% Race/ethnicity: White: 72% Black: 18% Other: 10% | Primary outcome: Suicide, self-injury, and hospitalizations at 18 months At 18 months, G2 significantly more effective than G1 in reducing life-threatening suicide attempts in prior 6-month period on SCL-90-R (0.03 vs. 0.32, P < 0.001), reducing severe self-harm incidents on SCL-90-R (0.38 vs. 1.66, P < 0.001), and reducing hospitalizations (0.03 vs. 0.19, P < 0.001) (composite of all three measures, 0.5 vs. 2.2, P < 0.001) At 18 months, G2 greater improvement in 6-month periods free of suicidal behavior, severe self-harm, and hospitalizations (OR 0.28, 95% CI 0.13–0.61, P <0.002) G2 significantly greater than G1 in number of participants who achieved primary recovery criteria (free of self-harm, suicide attempts, or inpatient hospital stays) and who remained well over 6-year follow-up period (75% vs. 51%, P = 0.02) At 18 months, G2 significantly greater improvements in BDI (14.80 vs. 18.68, P <0.01), IIP (1.28 vs. 1.65, P <0.001), SCL-90-GSI (1.12 vs. 1.55, P <0.001), and GAF (60.9 vs. 53.2, P <0.001) Incidence of AEs: NR at 18 months Withdrawal due to AEs: NR Attrition: 26% at 18 months; 39% at 6 years post-treatment Differential attrition: < 10 percentage points | Moderate |
Carlyle et al. (2020) | Design: RCT Setting: Outpatient, single center Country: New Zealand Funding: NR | N = 72 G1 (34): Enhanced therapeutic case management with case managers using published manual of SCM G2 (38): MBT: manualized weekly 1-hour individual sessions and weekly 1.5-hour group sessions Duration: 18 months | Inclusion: BPD diagnosis using SCID-II Exclusion: Patients diagnosed with psychoses or primary substance dependence; insufficient proficiency in English; concurrent engagement in structured psychological treatment for personality disorder | Mean age, years (SD): G1: 32 (11.7) G2: 32 (9.8) Female: 99% Race/ethnicity: NZ European: 79% Maori: 6% European other: 12.5% Other: 3% | Primary outcome: NSSI and suicide attempts at 18 months At 18 months, no significant differences between groups on incidents of NSSI, suicide attempts, or hospitalizations Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 14% Differential attrition: < 10 percentage points | Moderate |
Jørgensen et al. (2013) | Design: RCT Setting: Outpatient, single center Country: Denmark Funding: NR | N = 111 randomized; n = 85 treated G1 (27): Biweekly group therapy and monthly group psychoeducational program for 6 months G2 (58): Weekly individual and group MBT therapy and monthly group MBT psychoeducational program for 6 months Duration: 24 months | Inclusion: Age ≥ 21 years; met DSM-IV BPD criteria as assessed by SCID-II; GAF score > 34 Exclusion: Met diagnostic criteria for antisocial or paranoid personality disorder at time of assessment; severe substance abuse (daily) requiring specialist treatment | Mean age, years (SD): G1: 30 (6.8) G2: 30 (6.5) Female: 96% Race/ethnicity: NR | Primary outcome: GAF at 24 months At 24 months, G2 significantly greater improvement than G1 on therapist-rated GAF-F (56.7 vs. 51.3, P = 0.007) and GAF-S (58.5 vs. 54.0, P <0.001) Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 32% Differential attrition: < 10 percentage points | High |
AE = adverse event; BDI = Beck Depression Inventory; BPD = borderline personality disorder; CI = confidence interval; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; GAF = Global Assessment of Functioning; GAF-F = Global Assessment of Functioning-Functioning; GAF-S = Global Assessment of Functioning-Symptoms; IIP = Inventory of Interpersonal Problems; MBT = mentalization-based treatment; N = sample size; NR = not reported; OR = odds ratio; RCT = randomized controlled trial; SCID-II = Structured Clinical Interview for DSM-IV Axis II Personality Disorders; SCL-90-R = Symptom Checklist–90–Revised; SCL-90-GSI = Symptom Checklist-90-Global Severity Index; SCM = structured clinical management; SD = standard deviation.
Mentalization-Based Treatment vs. Psychodynamic Treatment Program
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Kvarstein et al. (2015) | Design: Prospective cohort Setting: Outpatient, single center Country: Norway Funding: NR | N = 345 G1 (281): 18 weeks of weekly inpatient group therapies followed by weekly outpatient group therapy G2 (64): Weekly individual and group MBT therapy and monthly group MBT psychoeducational program Duration: 36 months | Inclusion: NR; assessed baseline diagnostic status with the M.I.N.I. version 4.4 for DSM Axis-I diagnosis and SCID-II at baseline Exclusion: Treated in transition period between G1 and G2; included in RCT during 2004–2006 | Mean age, years (SD): G1: 30 (7.0) G2: 26 (6.0) Female: 83.2% Race/ethnicity: NR | Primary outcome: GAF, CIP, BSI-18 at 36 months G2 significantly greater improvements on CIP (0.9 vs. 1.4, P <0.001), BSI-18 (0.8 vs. 0.9, P < 0.001), and GAF (63.0 vs. 56.0, P < 0.001) No difference between G1 and G2 in self-harm and suicide attempts at 36 months Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 16% Differential attrition: G1: 8% (22/281) G2: 50% (32/64) | High |
AE = adverse event; BPD = borderline personality disorder; BSI-18 = Brief Symptom Inventory-18; CIP = Circumplex of Interpersonal Problems; DSM = Diagnostic and Statistical Manual of Mental Disorders; G1 = Group 1; G2 = Group 2; GAF = Global Assessment of Functioning; MBT = mentalization-based treatment; M.I.N.I. = Mini International Neuropsychiatric Interview; N = sample size; NR = not reported; RCT = randomized controlled trial; SCID-II = Structured Clinical Interview for DSM-IV Axis II Disorders; SD = standard deviation.
Day-Hospital Mentalization-Based Treatment vs. Specialized Psychotherapy
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Bales et al. (2015) | Design: Nonconcurrent cohort Setting: Other day-hospital Country: The Netherlands Funding: NR | N = 204 G1 (175): Variety of psychotherapeutic treatments in inpatient, outpatient, and day-hospital settings G2 (29): MBT in a day-hospital setting; daily group therapy, weekly individual therapy, individual crisis planning and art therapy twice a week, mentalizing cognitive group therapy, and writing therapy; medication consultation when indicated Duration: 18-month treatment phase; actual treatment was mean of 15.5 months (3.8) | Inclusion: Age ≥ 18 years; met DSM-IV criteria for BPD Exclusion: Schizophrenia, ADHD, bipolar disorder, psychotic disorders, or SUDs; intellectual impairment; organic brain disorder | Mean age, years (SD): G1: 30 (7.9) G2: 30 (6.2) Female: G1: 86% G2: 69% Race/ethnicity: NR | Primary outcome: Psychiatric symptoms, personality functioning at 18 months G2 significantly greater improvements than G1 on GSI at 18 months (1.04 vs. 1.21, P = 0.01) and 36 months (0.73 vs. 1.04, P = 0.02) G2 favored on SIPP-118 changes in (mal)adaptive personality functioning (results NR) Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: NR (could assume none) | High |
Laurenssen et al. (2018) | Design: RCT Setting: Other inpatient and outpatient therapies, multicenter Country: The Netherlands Funding: Other, organization | N = 95 G1 (41): Manualized psychiatric treatment and system-oriented tailored care G2 (54): Day-hospital MBT consisting of daily group psychotherapy, weekly individual psychotherapy, individual crisis planning, art therapy twice a week, mentalizing cognitive group therapy, and writing therapy Duration: 18 months | Inclusion: Met DSM-IV criteria for BPD; score of ≥ 20 on BPDSI Exclusion: Schizophrenia or bipolar disorder; substance abuse requiring specialist treatment; organic brain disorder | Mean age, years (SD): G1: 34 (10.6) G2: 34 (9.4) Female: 79% Race/ethnicity: NR | Primary outcome: BPDSI total score at 18 months At 18 months, no significant differences between groups on any outcome Incidence of AEs (among completers): G1: 0% (0/15) G2: 0% (0/33) Withdrawal due to AEs: NR Attrition: 50% Differential attrition: < 10 percentage points | Moderate |
ADHD = attention-deficit/hyperactivity disorder; AE = adverse event; BPD = borderline personality disorder; BPDSI = Borderline Personality Disorder Severity Index; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; GSI = Global Severity Index; MBT = mentalization-based treatment; N = sample size; NR = not reported; RCT = randomized controlled trial; SD = standard deviation; SIPP-118 = Severity Indices of Personality Problems; SUD = substance use disorder.
Systems Training for Emotional Predictability and Problem Solving vs. Treatment as Usual
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Blum et al. (2008); STEPPS | Design: RCT Setting: Other outpatient, inpatient, and community Country: United States Funding: Government, NIMH | N = 165 G1 (72 [data analysis based on 65]): TAU; 20 weeks of continued usual care, including individual psychotherapy, medication, and case management G2 (93 [data analysis based on 59]): STEPPS plus individual therapy; 20 sessions (2 hours/week) of manual-based STEPPS group treatment that combines cognitive-behavioral elements with skills training; components included psychoeducation about BPD, emotion management skills training, and behavior management skills training Duration: 20 weeks | Inclusion: Subjects with DSM-IV BPD who could designate a mental health professional and friend or relative to serve as system members Exclusion: Non-English speaker; psychotic or primary neurological disorder; prior participation in STEPPS | Among 124 who received allocated intervention: Mean age, years (SD): 32 (9.5) Female: 83% Race/ethnicity: White: 95% Black: 2% Other: 3% | Primary outcome: BPD-specific psychiatric symptoms (ZAN-BPD) measured at 20 weeks Significantly improved symptoms of BPD with G2 than G1 at 20 weeks on ZAN-BPD (9.8 vs. 13.4, P = 0.001) Significantly improved impulsivity of BPD with G2 than G1 on BIS (72.7 vs. 76.8, P = 0.004) Significantly improved depression on BDI (22.0 vs. 25.8, P = 0.03) Significantly improved global impressions and functioning with G2 than G1 on SCL-90 (12.5 vs. 14.1, P = 0.03), CGI-S (4.4 vs. 4.7, P < 0.001), CGI-I (2.7 vs. 3.8, P < 0.001), and GAS (50.5 vs. 43.5, P < 0.001) No significant differences between groups on suicide attempts and self-harm acts (BEST); on SCL-90, BDI, CGI, and GAS between 20 weeks and 1 year; or SAS at 20 weeks or 20 weeks to 1 year Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 42% Differential attrition: G1: 29% (21/72) G2: 52% (48/93) | High |
Bos et al. (2010) | Design: RCT Setting: Outpatient, multicenter Country: The Netherlands Funding: Other | N = 79 G1 (37): TAU G2 (42): STEPPS plus individual therapy: 18 weekly sessions of STEPPS and follow-up session 3–6 months after intervention; components included psychoeducation about BPD, emotion management skills training, and behavior management skills training Duration: 24 weeks | Inclusion: Met DSM-IV criteria for BPD by administering BPD modules and SCID-II; BDSI-IV with scores exceeding established cutoff on one or both subscales Exclusion: Did not speak Dutch; cognitively impaired (IQ < 70); age < 18 years; treated involuntarily; presented imminent danger to self or others | Mean age, years (SD): G1: 32 (9.2) G2: 32 (5.6) Female: 86% Race/ethnicity: NR | Primary outcome: BPD-specific (BPD-40) and general psychiatric symptoms (SCL-90) at 1 year Significantly improved BPD-specific symptoms (BPD-40: 78.2 vs. 88.6, P = 0.001), general psychiatric symptoms (SCL-90: 199.2 vs. 222.7, P = 0.001), and quality of life (WHOQOL-Bref: 12.6 vs. 11.3, P = 0.006) for G2 than G1 Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 17% Differential attrition: G1: 21% (9/42) G2: 11% (4/37) | Moderate |
González-González et al. (2021) | Design: Prospective cohort Setting: Outpatient, single center Country: Spain Funding: None | N = 118 G1 (98 [data analysis based on 28]): TAU G2 (20 [data analysis based on 9]): STEPPS: 20 weekly sessions of group STEPPS psychotherapy, 5 sessions of group psychotherapy for companions, monthly sessions of individual and family psychotherapy, and possibility of therapy in case of emergency; combined with usual medication and/or psychiatric consultations Duration: 18 months | Inclusion: DSM-5 BPD diagnosis, including self-harm or aggressive impulsive behaviors for past 2 years Exclusion: Acute patients or those with comorbid pathology; cognitive, intellectual, or psychopathological impairment for daily life activities requiring care in rehabilitation center; receiving another psychotherapy treatment | Mean age, years (range): 34 (18–58) Female: 85% Race/ethnicity: NR | Primary outcome: NR Significantly improved BPD-specific symptoms (BEST: 47.3 [14.1] vs. 28.8 [10.9], P < 0.01) Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 59% Differential attrition: G1: 55% (11/20) G2: 71% (70/98) | High |
AE = adverse event; BDI = Beck Depression Inventory; BDSI-IV = Borderline Syndrome Index IV; BEST = Borderline Evaluation of Severity Over Time; BIS = Barratt Impulsivity Scale; BPD = borderline personality disorder; BPD-40 = Borderline Personality Disorder checklist-40; CGI = Clinical Global Impressions; CGI-I = Clinical Global Impression-Improvement; CGI-S = Clinical Global Impression-Severity; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; DSM-5 = Diagnostic and Statistical Manual of Mental Disorders, 5th Edition; G1 = Group 1; G2 = Group 2; GAS = Global Assessment Scale; IQ = intelligence quotient; N = sample size; NIMH = National Institute of Mental Health; NR = not reported; RCT = randomized controlled trial; SAS = Social Adjustment Scale; SCID-II = Structured Clinical Interview for DSM-IV Axis II Disorders; SCL-90 = Symptom Checklist-90; SD = standard deviation; STEPPS = systems training for emotional predictability and problem-solving; TAU = treatment as usual; WHOQOL-Bref = World Health Organization Quality of Life Bref; ZAN-BPD = Zanarini Rating Scale for Borderline Personality Disorder.
Transference-Focused Psychotherapy vs. Treatment as Usual
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Doering et al. (2010) | Design: RCT Setting: Outpatient, multicenter Countries: Austria and Germany Funding: Other, Austrian bank | N = 104 G1 (52): TAU: treatment by community psychotherapists and medication treatments as needed G2 (52): TFP: Two 50-minute sessions every week from experienced clinical psychologists or medical doctors; medications as needed Duration: 12 months | Inclusion: Female; ages 18–45 years; DSM-IV BPD diagnosis; sufficient knowledge of German language Exclusions: ASPD, schizophrenia, or bipolar I and II disorder with a major depressive, manic, or hypomanic episode during the previous 6 months; SUD during the previous 6 months; organic pathology or intellectual disability | Mean age, years (SD): G1: 27 (7.5) G2: 28 (6.8) Female: 100% Race/ethnicity: NR | Primary outcome: Suicide attempts, dropout from therapy at 12 months Significantly fewer suicide attempts with G2 than G1 (13.7% vs. 21.2%, P = 0.009) for LOCF analysis but not for completers analysis (P ≥ 0.025) G2 significantly more effective than G1 for achieving fewer than five DSM-IV criteria for BPD (42.3% vs. 15.4%, P = 0.002) and on GAF (58.62 vs. 56.06, P = 0.002) No significant differences for self-harm acts, severity of symptoms, depression (BDI), and anxiety (STAI) Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 34% Differential attrition: G1: 42.3% (22/52) G2: 25% (13/52) | High |
AE = adverse event; ASPD = antisocial personality disorder; BDI = Beck Depression Inventory; BPD = borderline personality disorder; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; GAF = Global Assessment of Functioning; LOCF = last observation carried forward; N = sample size; NR = not reported; RCT = randomized controlled trial; SD = standard deviation; STAI = State-Trait Anxiety Inventory; SUD = substance use disorder; TAU = treatment as usual; TFP = transference-focused psychotherapy.
Transference-Focused Psychotherapy vs. Schema-Focused Therapy
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Giesen-Bloo et al. (2006); Spinhoven et al. (2007) | Design: RCT Setting: Outpatient, multicenter Country: The Netherlands Funding: Government, Dutch Health Care Insurance Board | N = 88 G1 (43): TFP: 50-minute sessions twice a week from therapists G2 (45): SFT: 50-minute sessions twice a week from trained therapists Duration: 3 years | Inclusion: Ages 18–60 years; DSM-IV BPD diagnosis; BPDSI-IV score > 20 Exclusion: Psychotic disorders, bipolar disorder, DID, ASPD, or ADHD; addiction requiring clinical detoxification; psychiatric disorders secondary to medical conditions | Mean age, years (SD): G1: 29.5 (6.5) G2: 31.7 (8.9) Female: 93% Race/ethnicity: NR | Primary outcome: BPDSI-IV at 36 months G2 significantly more effective than G1 to improve BPDSI-IV at 36 months (16.24 vs. 21.87, P = 0.005, RR = 2.33, 95% CI 1.24–4.37) Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 39% Differential attrition: G1: 51% (22/43) G2: 27% (12/45) | High |
ADHD = attention-deficit/hyperactivity disorder; AE = adverse event; ASPD = antisocial personality disorder; BPD = borderline personality disorder; BPDSI-IV = Borderline Personality Disorder Severity Index-IV; CI = confidence interval; DID = dissociative identity disorder; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; N = sample size; NR = not reported; RCT = randomized controlled trial; RR = risk ratio; SD = standard deviation; SFT = schema-focused therapy; TFP = transference-focused psychotherapy.
Special Populations
Borderline Personality Disorder and Substance Use Disorder: Comprehensive Validation Therapy Plus 12-Step vs. Dialectical Behavior Therapy
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Linehan et al. (2002) | Design: RCT Setting: Outpatient, single center Country: United States Funding: Government, NIDA, NIH | N = 24 G1 (12): Weekly individual CVT+12S; weekly “12-and-12” NA group, case management, and phone consultation as needed and opiate agonist therapy G2 (12): Weekly DBT individual and group skills training, case management, and phone consultation as needed and opiate agonist therapy Duration: 12 months | Inclusion: Female; ages 18–45 years; BPD diagnosis according to PDE and SCID-II; current opiate dependence according to SCID-I; no indication of treatment coercion (e.g., court-ordered/agency-ordered to retain housing) Exclusion: Did not meet criteria for BPD; met criteria for bipolar mood disorder; currently pregnant; did not complete pretreatment and/or medical evaluation | Mean age, years (SD): 36 (7.3) Female: 100% Race/ethnicity: Caucasian: 66% African American: 26% Other (Asian and Hispanic American): 4% | Primary outcome: Percentage of opiate-positive urine specimens At end of 12-month treatment, G2 significantly lower percentage of opiate-positive urine specimens than G1 (t = 2.32, P < 0.02); no significant differences at 12 months for any other outcomes No significant differences between G1 and G2 for percentage of opiate-positive urine specimens or parasuicidal behavior and on BSI or GAS at 16 months Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 21% Differential attrition: G1: 0% (0/12) G2: 42% (5/12) | Moderate |
AE = adverse event; BPD = borderline personality disorder; BSI = Brief Symptom Inventory; CVT+12S = comprehensive validation therapy plus 12-step; DBT = dialectical behavior therapy; G1 = Group 1; G2 = Group 2; GAS = Global Assessment Scale; N = sample size; NA = Narcotics Anonymous; NIDA = National Institute on Drug Abuse; NIH = National Institute of Health; NR = not reported; PDE = Personality Disorders Exam; RCT = randomized controlled trial; SCID-I = Structured Clinical Interview for DSM-IV Axis I Disorders; SCID-II = Structured Clinical Interview for DSM-IV Axis II Disorders; SD = standard deviation; SUD = substance use disorder.
Borderline Personality Disorder and Substance Use Disorder: Substance Use Disorder Treatment vs. Mentalization-Based Treatment Plus Substance Use Disorder Treatment
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Philips et al. (2018) | Design: RCT Setting: Outpatient, multicenter Country: Sweden Funding: Multiple | N = 46 G1 (22): Standard SUD treatment G2 (24): Standard SUD treatment plus combined individual and group MBT Duration: 18 months | Inclusion: Males and females; ages 18–65 years; DSM-IV BPD and SUD diagnoses; currently undergoing treatment at SUD treatment clinic Exclusion: Schizophrenia, schizoaffective disorder, bipolar disorder type I, cognitive impairment, ASD, or psychopathy; participation in psychotherapy outside of study; inability to communicate in Swedish | Mean age, years (SD): 36.7 (9.6) Female: 80.4% Race/ethnicity: NR | Primary outcome: BPDSI-IV, deliberate self-harm, suicide attempts, IIP, reflective functioning scale, GSI, at 18 months No significant difference between groups on any outcome measure at 18 months Attrition: 48% Differential attrition: < 10 percentage points | High |
ASD = autism spectrum disorder; BPD = borderline personality disorder; BPDSI-IV = Borderline Personality Disorder Severity Index-IV; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; GSI = Global Severity Index; IIP = Inventory of Interpersonal Problems; MBT = mentalization-based treatment; N = sample size; NR = not reported; RCT = randomized clinical trial; SD = standard deviation; SUD = substance use disorder.
Borderline Personality Disorder and Alcohol Use Disorder: Dynamic Deconstructive Psychotherapy vs. Treatment as Usual in the Community
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Gregory et al. (2008, 2009, 2010) | Design: RCT Setting: Outpatient, single center Country: United States Funding: Other, university | N = 30 G1 (15): TAU: combination of individual psychotherapy, medication management, alcohol and drug counseling, professional and self-help groups, and/or case management G2 (15): DDP: weekly, 1-hour sessions administered by the PI or by one of five psychiatry residents Duration: 12 months | Inclusion: Ages 18–45 years; DSM-IV BPD diagnosis; active alcohol abuse or dependence Exclusion: Schizophrenia or schizoaffective disorder, intellectual disability, or neurological condition that may produce secondary psychiatric symptoms (e.g., stroke, MS, partial complex seizures, TBI) | Mean age, years (SD): 29 (7.7) Female: 80% Race/ethnicity: White: 90% Black: 3.3% Hispanic or Latino: 3.3% American Indian or Alaska Native: 3.3% | Primary outcome: Parasuicide behavior, alcohol misuse, and institutional care at 12 months No significant difference between G2 and G1 for parasuicide behavior, alcohol misuse, and dissociation at 12 months G2 significant improvements in depression (21.0 vs. 25.9, P < 0.05) and in core symptoms of BPD (BEST) (33.6 vs. 38.4, P < 0.05) at 12 months Attrition at 12 months: 37% Differential attrition: < 10 percentage points | High |
AUD = alcohol use disorder; BEST = Borderline Evaluation of Severity Over Time; BPD = borderline personality disorder; DDP = dynamic deconstructive psychotherapy; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; MS = multiple sclerosis; N = sample size; PI = principal investigator; RCT = randomized clinical trial; SD = standard deviation; TAU = treatment as usual; TBI = traumatic brain injury.
Borderline Personality Disorder and Eating Disorder: Cognitive-Behavioral Therapy vs. Dialectical Behavior Therapy
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Navarro-Haro et al. (2018) | Design: Nonrandomized controlled trial Setting: Outpatient, multicenter Country: Spain Funding: Government, national agency | N = 118 G1 (47): Weekly individual CBT, weekly group session, and pharmacological treatment G2 (71): Weekly individual DBT, weekly DBT group skills training, and pharmacological treatment Duration: 6 months | Inclusion: Age ≥ 18 years; DSM-IV BPD and eating disorder diagnoses Exclusion: Psychotic disorder and/or bipolar I disorder; alcohol or other SUD; organic disease that could interfere with psychological treatment | Mean age, years (SD): 27 (8.8) Female: 100% Race/ethnicity: NR | Primary outcome: Suicide attempt frequency, NSSI at 6 months G2 significantly more improved on BDI than G1 (23.9 vs. 29.8, P = 0.02) at 6 months No significant differences between groups for suicide attempts, NSSI, or on GAF after 6 months; no significant differences between groups for depression, emotional regulation, or resilience at 6 years Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 8% at 6 months and 41.5% at 6 years Differential attrition: ≤ 10 percentage points | Moderate |
AE = adverse event; BDI = Beck Depression Inventory; BPD = borderline personality disorder; CBT = cognitive-behavioral therapy; DBT = dialectical behavioral therapy; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; GAF = Global Assessment of Functioning; N = sample size; NR = not reported; NSSI = nonsuicidal self-injury; SD = standard deviation; SUD = substance use disorder.
Borderline Personality Disorder and Eating Disorder: Specialist Supportive Clinical Management vs. Modified Mentalization-Based Treatment
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Robinson et al. (2016); NOURISHED | Design: RCT Setting: Outpatient, multicenter Country: United Kingdom Funding: Government, NIHR | N = 68 G1 (34): SSCM: one session every 1–4 weeks for 20–26 sessions over 1 year G2 (34): MBT: one individual and one group session per week for 1 year Duration: 12 months | Inclusion: Age ≥ 18 years; DSM-IV eating disorder and BPD diagnoses or “BPD symptoms” from DSM-IV (impulsivity in two or more potentially self-damaging areas, recurrent suicidal or self-mutilating behavior) Exclusion: Current psychosis; current inpatient or day-patient (3+ days/week); currently in individual or group psychological therapy; received MBT < 6 months prior to randomization; organic brain disease leading to significant cognitive impairment; BMI < 15 | Mean age, years (SD): 31 (9.9) Female: 93% Race/ethnicity: White: 84% | Primary outcome: EDE global score at 18 months No significant differences between G1 and G2 on ZAN-BPD at 18 months Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 78% Differential attrition: G1: 85% (29/34) G2: 71% (24/34) | High |
AE = adverse event; BMI = body mass index; BPD = borderline personality disorder; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; EDE = Eating Disorder Examination; G1 = Group 1; G2 = Group 2; MBT = mentalization-based treatment; N = sample size; NIHR = National Institute for Health Research; NOURISHED = Nice OUtcomes for Referrals with Impulsivity, Self Harm and Eating Disorders; NR = not reported; RCT = randomized clinical trial; SD = standard deviation; SSCM = specialist supportive clinical management; ZAN-BPD = Zanarini Rating Scale for Borderline Personality Disorder.
Borderline Personality Disorder and Major Depressive Disorder: Cognitive Therapy Plus Fluoxetine vs. Interpersonal Therapy Plus Fluoxetine
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Bellino et al. (2007) | Design: RCT Setting: Outpatient, single center Country: Italy Funding: None | N = 32 G1 (16): Weekly CT plus fluoxetine G2 (16): Weekly IPT plus fluoxetine Duration: 24 weeks | Inclusion: Met DSM-IV-TR criteria for BPD and an MDE Exclusion: Lifetime diagnosis of delirium, dementia, amnestic or other cognitive disorders, schizophrenia or other psychotic disorders, or bipolar disorder; current SUD; treated with psychotropic medication or psychotherapy during 2 months prior to study | Based on report among completers: Mean age, years (SD): 31 (5.8) Female: 73% Race/ethnicity: NR | Primary outcome: Ham-D at 24 weeks No significant differences between G1 and G2 on Ham-D, Ham-A, BDI-II, CGI-S, SOFAS, or SAT-P at 24 weeks Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 19% Differential attrition: G1: 25% (4/16) G2: 13% (2/16) | Moderate |
AE = adverse event; BDI-II = Beck Depression Inventory–II; BPD = borderline personality disorder; CGI-S = Clinical Global Impression-Severity; CT = cognitive therapy; DSM-IV-TR = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision; G1 = Group 1; G2 = Group 2; Ham-A = Hamilton Rating Scale for Anxiety; Ham-D = Hamilton Rating Scale for Depression; IPT = interpersonal psychotherapy; MDD = major depressive disorder; MDE = major depressive episode; N = sample size; NR = not reported; RCT = randomized clinical trial; SAT-P = Satisfaction Profile; SD = standard deviation; SOFAS = Social Occupational Functioning Assessment Scale; SUD = substance use disorder.
Borderline Personality Disorder and Major Depressive Disorder: Interpersonal Psychotherapy Plus Fluoxetine vs. Clinical Management Plus Fluoxetine
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Bellino et al. (2006) | Design: RCT Setting: Outpatient, single center Country: Italy Funding: None | N = 39 G1 (19): Clinical management plus fluoxetine 20–40 mg/day; initial fixed 20 mg/day with opportunity to increase to 40 mg/day beginning week 2 G2 (20): IPT in weekly 1-hour sessions plus fluoxetine 20–40 mg/day; initial fixed 20 mg/day with opportunity to increase to 40 mg/day beginning week 2 Duration: 24 weeks | Inclusion: DSM-IV BPD diagnosis; met criteria for MDE Exclusion: Lifetime diagnosis of delirium, dementia, amnestic or other cognitive disorders, or schizophrenia or other psychotic disorders; MDE as an expression of bipolar disorder; current SUD; treatment with psychotropic medication or psychotherapy during 2 months prior to study; females not using adequate birth control | Mean age, years (SD): 26 (3.7) Female: 60% (reported as ratio of males:females = 3:5) Race/ethnicity: NR | Primary outcome: NR G2 significantly more effective than G1 for improving symptoms of depression (measured by Ham-D [9.1 vs. 12, P = 0.005]) No significant differences between G2 and G1 in anxiety on clinical global impressions (measured by CGI-S) or anxiety (measured by Ham-A) Attrition: 17.9% (7/39) G1: 20.0% (4/20) G2: 15.8% (3/19) | Moderate |
BPD = borderline personality disorder; CGI-S = Clinical Global Impression-Severity; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; Ham-A = Hamilton Rating Scale for Anxiety; Ham-D = Hamilton Rating Scale for Depression; IPT = interpersonal psychotherapy; MDD = major depressive disorder; MDE = major depressive episode; N = sample size; NR = not reported; RCT = randomized clinical trial; SD = standard deviation; SUD = substance use disorder.
Borderline Personality Disorder and Posttraumatic Stress Disorder: Dialectical Behavior Therapy Alone vs. Dialectical Behavior Therapy Plus Dialectical Behavior Therapy-Prolonged Exposure
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Harned et al. (2014, 2018) | Design: RCT Setting: Outpatient, single center Country: United States Funding: Government, NIMH | N = 26 G1 (9): DBT: weekly individual therapy, group training, and therapist consultation team meeting and as-needed phone consultation G2 (17): DBT-PE: weekly PE protocol and DBT as well as group DBT skills training and as-needed phone consultation Duration: 1 year | Inclusion: Female; ages 18–60 years; DSM-IV BPD and PTSD diagnoses; can remember at least some part of index trauma; recent and recurrent intentional self-injury; lives within commuting distance of clinic Exclusion: Met criteria for psychotic disorder, bipolar disorder, or intellectual disability; legally mandated to treatment; required primary treatment for another debilitating condition (i.e., life-threatening anorexia nervosa) | Mean age, years (SD): 33 (12) Female: 100% Race/ethnicity: White: 81% Biracial: 15% Asian-American: 4% | Primary outcome: PTSD (PSS-I), intentional self-injury (SASII) at 15 months Numerically greater improvements in suicide attempts and on NSSI, PSS-I, SASII, Ham-A, Ham-D, and GSI across both groups; no statistical tests performed Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 42% Differential attrition: ≤ 10 percentage points | High |
AE = adverse event; BPD = borderline personality disorder; DBT = dialectical behavior therapy; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; GSI = Global Severity Index; Ham-A = Hamilton Rating Scale for Anxiety; Ham-D = Hamilton Rating Scale for Depression; N = sample size; NIMH = National Institute of Mental Health; NR = not reported; NSSI = nonsuicidal self-injury; PE = prolonged exposure; PSS-I = PTSD Symptom Scale–Interview; PTSD = posttraumatic stress disorder; RCT = randomized clinical trial; SASII = Suicide Attempt Self-Injury Interview; SD = standard deviation.
Adolescents With Borderline Personality Disorder: Manualized Good Clinical Care vs. Cognitive Analytic Therapy
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Chanen et al. (2008) | Design: RCT Setting: Outpatient, single center Country: Australia Funding: Government, NHMRC other, VicHealth, Colonial | N = 86 G1 (42): Weekly group standardized good clinical care G2 (44): Weekly CAT Duration: 24 months | Inclusion: Ages 15–18 years; met two to nine DSM-IV criteria for BPD; any personality disorder or disruptive behavior disorder symptom; low socioeconomic status; depressive symptoms; history of abuse or neglect Exclusion: Learning disability, psychiatric disorder, pervasive developmental disorder, or severe primary Axis I disorder; more than nine sessions of specialist mental health treatment in previous 12 months; sustained psychosis and met criteria for Early Psychosis Prevention and Intervention Centre | Mean age: NR Female: NR Race/ethnicity: NR | Primary outcome: Psychopathology, parasuicidal behavior, global functioning at 24 months No significant differences between G1 and G2 for parasuicidal behavior or on BPD Total Score and SOFAS at 24 months Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 9% Differential attrition: ≤ 10 percentage points | Moderate |
AE = adverse event; BPD = borderline personality disorder; CAT = cognitive analytic therapy; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; N = sample size; NHMRC = National Health and Medical Research Council; NR = not reported; RCT = randomized clinical trial; SOFAS = Social Occupational Functioning Assessment Scale.
Adolescents with Borderline Personality Disorder and Substance Use Disorder: Individual Drug Counseling vs. Integrative Borderline Personality Disorder-Oriented Adolescent Family Therapy
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Santisteban et al. (2015) | Design: RCT Setting: Outpatient, single center Country: United States Funding: Government | N = 40 G1 (20): Twice-weekly individual drug counseling and monthly family meeting with caregivers G2 (20): Twice-weekly I-BAFT, including family and individual therapy and skills-building interventions Duration: 7 months | Inclusion: Ages 14–17 years; DSM-IV BPD and substance use diagnoses Exclusion: NR | Mean age, years (SD): G1: 16 (0.8) G2: 16 (0.8) Female: 38% Race/ethnicity: Hispanic: 85% | Primary outcome: Substance use, BPD behaviors at 12 months No significant differences between G1 and G2 in substance use or BPD behavior at 12 months Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 33% Differential attrition: G1: 40% (8/20) G2: 25% (5/20) | High |
AE = adverse event; BPD = borderline personality disorder; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; I-BAFT = integrative borderline personality disorder–oriented adolescent family therapy; N = sample size; NR = not reported; RCT = randomized clinical trial; SD = standard deviation; SUD = substance use disorder.
Pharmacotherapy
Second-Generation Antipsychotics vs. Placebo
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Black et al. (2014) | Design: Double-blinded RCT Setting: Outpatient, multicenter Country: United States Funding: AstraZeneca | N = 95 G1 (29): Placebo G2 (33): Quetiapine ER (150 mg/day) G3 (33): Quetiapine ER (300 mg/day) Duration: 8 weeks | Inclusion: Males and females; ages 18–45 years; DSM-IV criteria for personality disorders; score ≥ 9 on ZAN-BPD Exclusion: History of psychotic disorder, neurological condition, or cognitive impairment; current SUD or abuse; medically unstable; history of lack of response to SGA; pregnant or lactating; acutely suicidal | Mean age, years (SD): G1: 30 (8.8) G2: 28 (8.0) G3: 30 (8.1) Female: 30% Race/ethnicity: European-Caucasian: 78% Other: 21% | Primary outcome: ZAN-BPD at 8 weeks G2 (but not G3) significantly more effective than G1 on ZAN-BPD (P = 0.03) G3 (but not G2) significantly more effective on SCL-90 than G1 (P = 0.03) G2 and G3 significantly more effective on MOAS (P = 0.01) No significant differences on BIS, MADRS, and SDS Incidence of AEs: G1: 86% (25/29) G2: 88% (29/33) G3: 91% (30/33) Withdrawal due to AEs: NR Attrition: 33% Differential attrition: G1: 21% (6/29) G2: 33% (11/33) G3: 42% (14/33) | Moderate |
Bogenschutz and Nurnberg (2004) | Design: Double-blinded RCT Setting: Outpatient, single center Country: United States Funding: Eli Lilly | N = 40 G1 (20): Placebo G2 (20): Olanzapine (2.5–20 mg/day) Duration: 12 weeks | Inclusion: Ages 18–60 years; DSM-IV BPD diagnosis; medically stable Exclusion: Other psychiatric disorders, SUD, or actively suicidal | Mean age, years (SD): 32 (10.3) Female: 63% Race/ethnicity: White: 58% Hispanic: 25% Asian/Pacific Islander: 8% Other: 10% | Primary outcome: CGI-BPD at 12 weeks Significantly greater improvement of G2 than G1 on CGI-BPD (P = 0.03) No significant differences on SCL-90, Ham-A, Ham-D, MOAS, and GAF Incidence of AEs: NR Withdrawal due to AEs: G1: 0% (0/20) G2: 20% (4/20) Attrition: 43% Differential attrition: G1: 35% (7/20) G2: 50% (10/20) | High |
Linehan et al. (2008) | Design: Double-blinded RCT Setting: University hospital Country: United States Funding: Eli Lilly | N = 24 G1 (12): Placebo G2 (12): Olanzapine (5 mg/day) Duration: 6 months | Inclusion: Females; ages 18–60 years; met SCID-II and Borderline Personality Disorder Examination criteria for BPD; MOAS irritability subscale score ≥ 6 Exclusion: Schizophrenia, bipolar I disorder, schizoaffective disorder, MDD with psychotic features or other psychotic disorder, intellectual disability, seizure disorder, or SUD | Mean age, years (SD): 37 (9.0) Female: 100% Race/ethnicity: White: 79% Black: 4% Native American: 4% Latino: 4% Other: 8% | Primary outcome: NR No significant differences between G1 and G2 on MOAS and Ham-D and for self-inflicted injury Incidence of AEs: NR Withdrawal due to AEs: G1: 0% (0/12) G2: 8% (1/12) Attrition: 33% Differential attrition: ≤ 10 percentage points | High |
Nickel et al. (2006, 2007) | Design: Double-blinded RCT Setting: University hospitals Country: Austria, Germany Funding: None | N = 52 G1 (26): Placebo G2 (26): Aripiprazole (15 mg/day) Duration: 8 weeks Follow up: 18 months | Inclusion: Males and females; age ≥ 16 years; DSM-IV BPD diagnosis Exclusion: Schizophrenia; current use of other psychotropic medication; past termination of aripiprazole; current psychotherapy; pregnancy; suicidal ideation; severe somatic illness; alcohol or drug abuse | Mean age, years (SD): G1: 21 (4.6) G2: 22 (3.4) Female: 83% Race/ethnicity: NR | Primary outcome: SCL-90-R, Ham-D, Ham-A, STAXI at 8 weeks G2 significantly greater improvements than G1 on SCL-90-R (15.0 vs. 4.9, P < 0.001), Ham-D (6.4 vs. 2.1, P = 0.002), Ham-A (7.0 vs. 3.3, P = 0.007), and STAXI (13.6 vs. 5.7, P < 0.001) 18-month follow-up for SCL-90-R: 17.9 vs. 1.4, P < 0.01 Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 25% Differential attrition: ≤ 10 percentage points | Moderate |
Pascual et al. (2008) | Design: Double-blinded RCT Setting: Outpatient, single center Country: Spain Funding: Pfizer, government funding | N = 60 G1 (30): Placebo G2 (30): Ziprasidone (40–200 mg/day) Duration: 12 weeks | Inclusion: Males and females; ages 18–45 years; DSM-IV BPD diagnosis; current use of medically accepted contraception for females Exclusion: Schizophrenia, drug-induced psychosis, organic brain syndrome, alcohol or other SUD, bipolar disorder, intellectual disability, or MDE in course; CGI-S score ≥ 4 | Mean age, years (SD): G1: 29 (6.3) G2: 29 (6.0) Female: 82% Race/ethnicity: NR | Primary outcome: CGI-BPD at 12 weeks No significant differences on CGI-BPD, SCL-90, Ham-A, Ham-D, and in clinical psychotic symptoms Incidence of AEs: G1: 13% (4/30) G2: 37% (11/30) Withdrawal due to AEs: G1: 0% (0/30) G2: 30% (9/30) Attrition: 52% Differential attrition: ≤ 10 percentage points | High |
Schulz et al. (2008) | Design: Double-blinded RCT Setting: Outpatient, multicenter Country: Multicountry Funding: Eli Lilly | N = 314 G1 (159): Placebo G2 (155): Olanzapine (2.5–20 mg/day) Duration: 12 weeks | Inclusion: Males and females; ages 18–65 years; DSM-IV BPD diagnosis; ZAN-BPD total score of 9 Exclusion: Schizophrenia, bipolar I disorder, bipolar II disorder, delusional disorder, MDD, SUD, PTSD, panic disorder, or OCD; BMI < 17; use of antidepressants, mood stabilizer, or antipsychotic medication within 1 week of randomization; new psychotherapy treatment | Mean age, years (SD): G1: 32 (9.6) G2: 32 (9.5) Female: 71% Race/ethnicity: White: 87% | Primary outcome: ZAN-BPD at 12 weeks No significant differences on ZAN-BPD, SCL-90-R, and MADRS SDS, GAF, MOAS: data NR Incidence of AEs: G1: 57% (90/159) G2: 66% (102/155) Withdrawal due to AEs: G1: 11% (18/159) G2: 11% (17/155) Attrition: 43% Differential attrition: ≤ 10 percentage points | High |
Soler et al. (2005) | Design: Double-blinded RCT Setting: Outpatient, single center Country: Spain Funding: Eli Lilly | N = 60 G1 (30): DBT plus placebo G2 (30): DBT plus olanzapine (5–20 mg/day) Duration: 12 weeks | Inclusion: Females; ages 18–45 years; DSM-IV BPD diagnosis without comorbid, unstable Axis I disorder; CGI-S score ≥ 4; not receiving psychotherapy Exclusion: NR | Mean age, years (SD): G1: 26 (5.4) G2: 28 (6.3) Female: 87% Race/ethnicity: NR | Primary outcome: NR Significantly greater improvements for G2 than G1 on Ham-D (8.79 vs. 4.87, P = 0.004) and frequency of aggressive behavior (data NR, P = 0.03) No significant differences on Ham-A, CGI-S, and episodes of suicide attempts and self-injury Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 30% Differential attrition: ≤ 10 percentage points | High |
Zanarini and Frankenburg (2001) | Design: Double-blinded RCT Setting: Outpatients, single center Country: United States Funding: Eli Lilly | N = 28 G1 (9): Placebo G2 (19): Olanzapine (2.5 mg/day) Duration: 6 months | Inclusion: Females; ages 18–40 years; DSM-IV BPD diagnosis Exclusion: MDD; previous treatment with olanzapine; currently taking psychotropic medications; actively abusing alcohol or drugs | Mean age, years (SD): G1: 26 (4.5) G2: 28 (7.7) Female: 100% Race/ethnicity: White: 71% Nonwhite: 29% | Primary outcome: SCL-90 at 6 months G2 significantly greater improvements than G1 on four domains of SCL-90 (interpersonal sensitivity, anxiety, anger/hostility, paranoia); overall SCL-90 score NR Incidence of AEs: NR Withdrawal due to AEs: G1: 0% (0/9) G2: 16% (3/19) Attrition: 68% Differential attrition: G1: 89% (8/9) G2: 58% (11/19) | High |
Zanarini et al. (2011b) | Design: Double-blinded RCT Setting: Outpatient, multicenter Country: Multicountry Funding: Eli Lilly | N = 451 G1 (153): Placebo G2 (150): Olanzapine (2.5 mg/day) G3 (148): Olanzapine (5–10 mg/day) Duration: 12 weeks | Inclusion: Males and females; ages 18–65 years; DSM-IV BPD diagnosis; ZAN-BPD total score ≥ 9 Exclusion: Schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, bipolar II disorder, delusional disorder, MDD, SUD within past 3 months, PTSD, panic disorder, or OCD; actively suicidal; BMI < 17; Cluster A personality disorder; new psychotherapy within 3 months prior to visit 1; use of anticholinergic medication as prophylaxis for extrapyramidal symptoms | Mean age, years (SD): G1: 34 (11.3) G2: 33 (11.2) G3: 33 (10.0) Female: 74% Race/ethnicity: White: 65% African descent: 7% East/Southeast Asian: 2% Western Asian: 0.2% Hispanic: 24.6% Other origin: 11.1% | Primary outcome: ZAN-BPD at 12 weeks G3 significantly more effective than G1 on ZAN-BPD (- 8.5 vs. - 6.8, P = 0.01; response: 74% vs. 60%, P = 0.018) and SCL-90-R (- 0.7 vs. - 0.6, P < 0.05) No significant differences between G1 and G3 on MADRS, GAF, and MOAS No significant differences between G1 and G2 on most outcome measures Incidence of AEs: G1: 61% (93/153) G2: 65% (98/150) G3: 67% (99/148) Withdrawal due to AEs: G1: 3% (5/153) G2: 3% (5/150) G3: 6% (9/148) Attrition: 35% Differential attrition: ≤ 10 percentage points | Moderate |
AE = adverse event; BIS = Barratt Impulsiveness Scale; BMI = body mass index; BPD = borderline personality disorder; CGI = Clinical Global Impression Scale; CGI-BPD = Clinical Global Impression Scale for Borderline Personality Disorder; CGI-S = Clinical Global Impression-Severity; DBT = dialectical behavior therapy; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; ER = extended release; G1 = Group 1; G2 = Group 2; G3 = Group 3; GAF = Global Assessment of Functioning; Ham-A = Hamilton Rating Scale for Anxiety; Ham-D = Hamilton Rating Scale for Depression; MADRS = Montgomery-Åsberg Depression Rating Scale; MDD = major depressive disorder; MDE = major depressive episode; MOAS = Modified Overt Aggression Scale; N = sample size; NR = not reported; OCD = obsessive compulsive disorder; PTSD = posttraumatic stress disorder; RCT = randomized controlled trial; SCID-II = Structured Clinical Interview for DSM-IV Axis II Disorders; SCL-90 = Symptom Checklist-90; SCL-90-R = Symptom Checklist–90–Revised; SD = standard deviation; SDS = Sheehan Disability Scale; SGA = second-generation antipsychotic; STAXI = State-Trait Anger Expression Inventory; SUD = substance use disorder; ZAN-BPD = Zanarini Rating Scale for Borderline Personality Disorder.
Second-Generation Antipsychotics vs. Antidepressants
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Zanarini et al. (2004c) | Design: double-blinded RCT Setting: Outpatient, single center Country: United States Funding: Eli Lilly | N = 45 G1 (14): Fluoxetine (10–30 mg/day) G2 (16): Olanzapine (2.5–7.5 mg/day) G3 (15): Fluoxetine (10–30 mg/day) and olanzapine (2.5–7.5 mg/day) Duration: 8 weeks | Inclusion: Females; ages 18–40 years; DSM-IV BPD diagnosis; does not meet criteria for current MDD Exclusion: Current MDD, current or lifetime schizophrenia, schizoaffective disorder, or bipolar disorder; current use of psychotropic medications; medical illness; seizure disorder; substance abuse; acutely suicidal | Mean age, years (SD): 23 (5.7) Female: 100% Race/ethnicity: White: 80% | Primary outcome: NR G2 and G3 significantly more effective than G1 on MOAS (19.7 vs. 20.2 vs. 15.4, P = 0.003 for G2 vs. G1, P < 0.001 for G3 vs. G1) at 8 weeks G2 and G3 significantly more effective than G1 on MADRS (13.6 vs. 11.9 vs. 8.2, P < 0.001 for G2 vs. G1, P = 0.02 for G3 vs. G1) at 8 weeks Incidence of AEs: NR Withdrawal due to AEs: G1: 7% (1/14) G2: 0% (0/16) G3: 7% (1/15) Attrition: 7% Differential attrition: ≤ 10 percentage points | Moderate |
AE = adverse event; BPD = borderline personality disorder; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; G3 = Group 3; MADRS = Montgomery-Åsberg Depression Scale; MDD = major depressive disorder; MOAS = Modified Overt Aggression Scale; N = sample size; NR = not reported; RCT = randomized controlled trial; SD = standard deviation; SGA = second-generation antipsychotic.
Second-Generation Antipsychotics vs. Second-Generation Antipsychotics
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Bozzatello et al. (2017) | Design: Double-blinded RCT Setting: Outpatient, single center Country: Italy Funding: None | N = 51 G1 (26): Olanzapine (5–10 mg/day) G2 (25): Asenapine (5–10 mg/day) Duration: 12 weeks | Inclusion: Ages 18–50 years; DSM-5 BPD diagnosis Exclusion: Dementia, schizophrenia or other psychotic disorders, bipolar disorders, co-occurring MDE, or substance abuse; past use of psychotropic medications and/or psychotherapy | Mean age, years (SD): 25 (5.3) Female: 63% Race/ethnicity: NR | Primary outcome: NR No significant differences between G1 and G2 on BPDSI, CGI-S, BIS, MOAS, Ham-D, and SHI at 12 weeks Incidence of AEs (among completers): G1: 26% (5/19) G2: 19% (4/21) Withdrawal due to AEs: G1: 11% (2/19) G2: 10% (2/21) Attrition: 22% Differential attrition: ≤ 10 percentage points | High |
García-Carmona et al. (2021) | Design: Retrospective cohort study Setting: Outpatient; multicenter Country: Spain Funding: None | N = 116 G1 (66): Oral antipsychotics G2 (50): LAI antipsychotics Duration: 1–3 months | Inclusion: Age ≥ 18 years; DSM-5 BPD diagnosis; treated with an oral or an LAI SGA continuously for > 12 months Exclusion: institutionalized; intellectual disability or other psychiatric disorder; concomitant use of two LAI antipsychotics, or missing clinical records | Mean age, years (SD): G1: 42.4 (1.4) G2: 39.4 (1.7) Female: 46% Race/ethnicity: NR | Primary outcome: NR G1 significantly more ED visits than G2 (7.9 vs. 6.2, P = 0.041) No significant differences in suicidal behavior and hospital admissions Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: NR Differential attrition: NR | High |
AE = adverse event; BIS = Barratt Impulsiveness Scale; BPD = borderline personality disorder; BPDSI = Borderline Personality Disorder Severity Index; CGI-S = Clinical Global Impression-Severity; DSM-5 = Diagnostic and Statistical Manual of Mental Disorders, 5th Edition; ED = emergency department; G1 = Group 1; G2 = Group 2; Ham-D = Hamilton Rating Scale for Depression; LAI = long-acting injectable; MDE = major depressive episode; MOAS = Modified Overt Aggression Scale; N = sample size; NR = not reported; SD = standard deviation; SE = standard error; SGA = second-generation antipsychotic; SHI = Self-Harm Inventory.
Anticonvulsants vs. Placebo
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Crawford et al. (2018); LABILE | Design: Double-blinded RCT Setting: Outpatient, multicenter Country: United Kingdom Funding: NIHR | N = 276 G1 (139): Placebo G2 (137): Lamotrigine (200 mg/day) Duration: 52 weeks | Inclusion: DSM-IV BPD diagnosis Exclusion: Met diagnostic criteria for bipolar disorder (type I or II) or psychotic disorder; history of liver or kidney impairment | Mean age, years (SD): G1: 36 (11.0) G2: 36 (11.0) Female: 75% Race/ethnicity: White: 89% Black: 4% Asian: 1% Other: 6% | Primary outcome: ZAN-BPD at 52 weeks No significant differences on ZAN-BPD, SHI, SFQ, and EQ-5D-3L Incidence of AEs: G1: 67% (93/139) G2: 56% (77/137) Withdrawal due to AEs: G1: 1% (1/139) G2: 4% (4/137) Attrition: 29% Differential attrition: < 10 percentage points | Moderate |
Frankenburg and Zanarini (2002) | Design: Double-blinded RCT Setting: Community recruitment with advertisements Country: United States Funding: Abbott Laboratories | N = 30 G1 (10): Placebo G2 (20): Divalproex sodium (250 mg/day) Duration: 24 weeks | Inclusion: Females; ages 18–40 years; DIB-R and DSM-IV BPD and bipolar II disorder diagnoses Exclusion: Formerly treated with divalproex sodium; medically ill; seizure disorder; current substance abuse; current criteria for an MDE or hypomanic episode; current or lifetime criteria for schizophrenia, schizoaffective disorder, psychotic disorder, or bipolar I disorder | Mean age, years (SD): G1: 26 (7.3) G2: 27 (7.4) Female: 100% Race/ethnicity: White: 67% Black: 10% Hispanic: 13% Biracial: 7% | Primary outcome: MOAS, SCL-90-R (subscales on anger, interpersonal hostility, depression) at 24 weeks G2 significantly more effective than G1 on MOAS (3.0 vs. 1.9, P = 0.03) and SCL-90-R subscales on anger/hostility (0.8 vs. 0.6, P = 0.01) and interpersonal sensitivity (0.8 vs. 0.4, P = 0.04) Incidence of AEs: NR Withdrawal due to AEs: G1: 30% (3/10) G2: 5% (1/20) Attrition: 63% Differential attrition: < 10 percentage points | High |
Hollander et al. (2001) | Design: Double-blinded RCT Setting: Outpatient, single center Country: United States Funding: Abbott Laboratories, NIMH | N = 16 G1 (4): Placebo G2 (12): Divalproex sodium (250 mg/day) Duration: 10 weeks | Inclusion: DSM-IV BPD diagnosis Exclusion: Medical or neurological illness; psychotic disorders, substance abuse, bipolar disorder I or II, or MDD; suicidal ideation | Mean age, years (SD): NR Female: 52% Race/ethnicity: White: 67% Black: 14% Hispanic: 19% | Primary outcome: NR No significant differences on CGI-I, GAS, MOAS, and AQ Incidence of AEs: NR Withdrawal due to AEs: G1: 0% (0/4) G2: 0% (0/12) Attrition: 63% Differential attrition: G1: 100% (4/4) G2: 50% (6/12) | High |
Loew et al. (2006) | Design: Double-blinded RCT Setting: Single center or multicenter Country: Germany and Austria Funding: None | N = 56 G1 (28): Placebo G2 (28): Topiramate (200 mg/day) Duration: 10 weeks | Inclusion: Females; ages 18–35 years; DSM-IV BPD diagnosis Exclusion: Schizophrenia; current use of psychotropic medication or psychotherapy; suicidal; substance abuse; severe somatic illness | Mean age, years (SD): G1: 26 (5.7) G2: 25 (5.3) Female: 100% Race/ethnicity: NR | Primary outcome: SCL-90-R, SF-36, and IIP at 10 weeks G2 significantly more effective than G1 on SCL-90-R (7.4 vs. 1.8, P < 0.001), SF-36 (data NR, P < 0.01), and IIP (data NR) Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 7% Differential attrition: < 10 percentage points | Low |
Moen et al. (2012) | Design: Double-blinded RCT Setting: Outpatient, single center Country: United States Funding: Abbott | N = 15 G1 (5): Placebo G2 (10): Divalproex sodium (NR) Duration: 12 weeks | Inclusion: Ages 21–55 years; DSM-IV BPD diagnosis; score ≥ 150 on SCL-90; score ≥ 5 on SCID-II Exclusion: Current or past history of bipolar disorder, schizophrenia, or MDD with psychotic features; current psychotropic medication; acutely suicidal; SUD; seizure disorder and/or anticonvulsant medications | Mean age, years (range) G1: 37 (22–51) G2: 34 (23–45) Female: 80% Race/ethnicity: White: 80% Black: 7% Hispanic: 7% Mixed: 7% | Primary outcome: NR No significant differences on SCL-90, BIS, and BEST Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 40% Differential attrition: < 10 percentage points | High |
Nickel et al. (2004) | Design: Double-blinded RCT Setting: Community recruitment Country: Germany Funding: None | N = 31 G1 (10): Placebo (50 mg/day) G2 (21): Topiramate (250 mg/day) Duration: 8 weeks | Inclusion: Females; ages 20–35 years; DSM-IV BPD diagnosis Exclusion: Current schizophrenia, MDD, or bipolar disorder; current use of psychotropic medication or psychotherapy; somatically ill; actively suicidal; substance abuse | Mean age, years (SD): G1: 27 (NR) G2: 26 (NR) Female: 100% Race/ethnicity: NR | Primary outcome: STAXI at 8 weeks G2 significantly more effective than G1 on four out of five subscales on STAXI (P values from 0.05 to 0.01); no significant improvement on subscale assessing tendency to repress anger Incidence of AEs: NR Withdrawal due to AEs: G1: 0% (0/10) G2: 0% (0/21) Attrition: 6% Differential attrition: < 10 percentage points | Moderate |
Nickel et al. (2005) | Design: Double-blinded RCT Setting: Outpatient recruitment and community advertisement Country: Germany Funding: None | N = 44 G1 (22): Placebo G2 (22): Topiramate (250 mg/day) Duration: 8 weeks | Inclusion: Males; age > 18 years; DSM-IV BPD diagnosis Exclusion: Acute psychosis, severe MDD or bipolar disorder; current use of psychotropic medication or psychotherapy; somatically ill; actively suicidal; SUD | Mean age, years (SD): G1: 29 (NR) G2: 30 (NR) Female: 0% Race/ethnicity: NR | Primary outcome: STAXI at 8 weeks G2 significantly more effective than G1 on four out of five subscales on STAXI (P values from 0.05 to 0.01); no significant improvement on subscale assessing tendency to repress anger Incidence of AEs: NR Withdrawal due to AEs: G1: 0% (0/22) G2: 0% (0/22) Attrition: 5% Differential attrition: < 10 percentage points | Moderate |
Reich et al. (2009) | Design: Double-blinded RCT Setting: Outpatient, single center Country: United States Funding: GlaxoSmithKline | N = 28 G1 (13): Placebo G2 (15): Lamotrigine (50–275 mg/day) Duration: 12 weeks | Inclusion: DSM-IV BPD diagnosis; score ≥ 8 on DIB-R; “serious” score on affective instability item of ZAN-BPD; score ≥ 14 on ALS Exclusion: Dementia, psychiatric disorder, bipolar disorder, psychotic disorder, or SUD; currently hospitalized; previous treatment with lamotrigine or psychotherapy; active suicidal or homicidal ideation | Mean age, years (SD): G1: 35 (9.7) G2: 28 (9.5) Female: 89% Race/ethnicity: White: 89% | Primary outcome: ALS, affective instability item of ZAN-BPD at 12 weeks G2 significantly greater improvements than G1 on ALS (0.71 vs. 0.40, P = 0.012) and affective lability of ZAN-BPD (1.5 vs. 1.1, P = 0.043) No significant difference on ZAN-BPD Incidence of AEs: G1: 31% (4/13) G2: 40% (6/15) Withdrawal due to AEs: G1: 0% (0/13) G2: 0% (3/15) Attrition: 39% Differential attrition: < 10 percentage points | High |
Tritt et al. (2005) | Design: Double-blinded RCT Setting: single center or multicenter Country: Germany and Austria Funding: None | N = 27 G1 (9): Placebo G2 (18): Lamotrigine (200 mg/day) Duration: 8 weeks | Inclusion: Females; ages 20–40 years; DSM-IV BPD diagnosis Exclusion: Schizophrenia, MDD, or bipolar disorder; current use of psychotropic medication or psychotherapy; somatically ill; actively suicidal; substance abuse | Mean age, years (SD): G1: 29 (NR) G2: 29 (NR) Female: 100% Race/ethnicity: NR | Primary outcome: STAXI at 8 weeks G2 significantly more effective than G1 on all five subscales of STAXI (P values from < 0.05 to < 0.01; overall STAXI score NR) G2 improved more than G1 with respect to all STAXI scales on assessments after 8 weeks of treatment Incidence of AEs: NR Withdrawal due to AEs: G1: 11% (1/9) G2: 6% (1/18) Attrition: 11% Differential attrition: ≤ 10 percentage points | Low |
AE = adverse event; ALS = Affective Liability Scale; AQ = Aggression Questionnaire; BEST = Borderline Evaluation of Severity Over Time; BIS = Barratt Impulsiveness Scale; BPD = borderline personality disorder; CGI-I = Clinical Global Impression-Improvement; DIB-R = Diagnostic Interview for Borderlines-Revised; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; EQ-5D-3L = European Quality of Life–5 Dimension-3 level version; G1 = Group 1; G2 = Group 2; GAS = Global Assessment Scale; IIP = Inventory of Interpersonal Problems; LABILE = Lamotrigine and Borderline Personality Disorder: Investigating Long-Term Effects; MDD = major depressive disorder; MDE = major depressive disorder; MOAS = Modified Overt Aggression Scale; NIHR = National Institute for Health Research; NIMH = National Institute of Mental Health; N = sample size; NR = not reported; RCT = randomized controlled trial; SCID-II = Structured Clinical Interview for DSM-IV Axis II Disorders; SCL-90 = Symptom Checklist-90; SCL-90-R = Symptom Checklist–90–Revised; SD = standard deviation; SF-36 = Short Form Survey; SFQ = Social Functioning Questionnaire; SHI = Self-Harm Inventory; STAXI = State-Trait Anger Expression Inventory; SUD = substance use disorder; ZAN-BPD = Zanarini Rating Scale for Borderline Personality Disorder.
Antidepressants vs. Placebo
| Author (year) and/or trial name | Study characteristics | Participants, N; interventions; duration | Study population, including main inclusion and exclusion criteria | Sample demographics | Primary outcome; main results; attrition | Risk of bias |
|---|---|---|---|---|---|---|
Simpson et al. (2004) | Design: Double-blinded RCT Setting: Outpatient, single center Country: United States Funding: Eli Lilly | N = 25 G1 (13): Placebo G2 (12): Fluoxetine (40 mg/day) Duration: 12 weeks | Inclusion: Admission to Women’s Partial Program; DSM-IV BPD diagnosis Exclusion: SUD; seizure disorder; unstable medical conditions; history of schizophrenia or bipolar disorder; previous adequate trial of fluoxetine | Mean age, years (SD): 35 (10.1) Female: 100% Race/ethnicity: White: 72% Black: 20% Native American: 8% | Primary outcome: NR When corrected for multiple testing, no significant differences between G1 and G2 on STAXI, MOAS, or GAF at mean of 10 weeks Incidence of AEs: NR Withdrawal due to AEs: NR Attrition: 20% Differential attrition: ≤ 10 percentage points | High |
AE = adverse event; BPD = borderline personality disorder; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; G1 = Group 1; G2 = Group 2; GAF = Global Assessment of Functioning; MOAS = Modified Overt Aggression Scale; N = sample size; NR = not reported; RCT = randomized controlled trial; SD = standard deviation; STAXI = State-Trait Anger Expression Inventory; SUD = substance use disorder.
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The American Psychiatric Association Practice Guideline for the Treatment of Patients With Borderline Personality Disorder
November 2024
©American Psychiatric Association Publishing
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