Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT): A Randomized Clinical Trial
Abstract
Objective:
Methods:
Results:
Conclusions:
Methods
Participants
Randomized Assignment and Masking
Clinical Measurements
Secondary Outcome Variables
Sleep metrics.
Depression severity.
Hopelessness.
Health-related quality of life.
Overall status and treatment response.
Antidepressant treatment resistance.
Adverse events.
Actigraphy.
Statistical Analyses
Results
Baseline
Characteristic | Controlled-Release Zolpidem (N=51) | Placebo (N=52) | Overall (N=103) | |||
---|---|---|---|---|---|---|
Mean | SD | Mean | SD | Mean | SD | |
Age (years) | 39.7 | 14.5 | 41.2 | 12.0 | 40.5 | 13.2 |
Body mass index | 28.3 | 6.4 | 28.2 | 5.6 | 28.2 | 6.0 |
N | % | N | % | N | % | |
Female | 32 | 63 | 32 | 62 | 64 | 62 |
Clinic | ||||||
1 | 23 | 45 | 27 | 52 | 50 | 49 |
2 | 15 | 29 | 15 | 29 | 30 | 29 |
3 | 13 | 25 | 10 | 19 | 23 | 22 |
Race or ethnicity | ||||||
Caucasian | 30 | 59 | 33 | 63 | 63 | 61 |
African American | 12 | 24 | 16 | 31 | 28 | 27 |
Hispanic | 4 | 8 | 1 | 2 | 5 | 5 |
Other | 5 | 10 | 2 | 4 | 7 | 7 |
Antidepressant trials in current episode | ||||||
Zero | 29 | 57 | 30 | 58 | 59 | 57 |
One | 14 | 27 | 12 | 23 | 26 | 25 |
Two or more | 8 | 16 | 10 | 19 | 18 | 17 |
Lifetime suicide attempt(s) | 15 | 29 | 16 | 31 | 31 | 30 |
Posttraumatic stress disorder | 13 | 25 | 16 | 31 | 29 | 28 |
Obsessive-compulsive disorder | 2 | 4 | 3 | 6 | 5 | 5 |
Generalized anxiety disorder | 20 | 39 | 21 | 41 | 41 | 40 |
Panic disorder with agoraphobia | 9 | 18 | 8 | 15 | 17 | 17 |
Panic disorder without agoraphobia | 10 | 20 | 7 | 14 | 17 | 17 |
Mean | SD | Mean | SD | Mean | SD | |
Scale for Suicide Ideation: suicide ideation score | 12.2 | 5.3 | 11.8 | 5.3 | 12.0 | 5.3 |
N | % | N | % | N | % | |
Scale for Suicide Ideation: suicide attempts | ||||||
Never | 36 | 71 | 36 | 69 | 72 | 70 |
Once | 8 | 16 | 8 | 15 | 16 | 16 |
Two or more times | 7 | 14 | 8 | 15 | 15 | 15 |
Scale for Suicide Ideation: death wish | ||||||
No suicide attempt | 36 | 71 | 36 | 69 | 72 | 70 |
Low | 3 | 6 | 3 | 6 | 6 | 6 |
Moderate | 6 | 12 | 4 | 8 | 10 | 10 |
High | 6 | 12 | 9 | 17 | 15 | 15 |
Mean | SD | Mean | SD | Mean | SD | |
Columbia–Suicide Severity Rating Scale (C-SSRS) past-week ideation intensity | 1.71 | 1.03 | 1.58 | 1.02 | 1.64 | 1.02 |
N | % | N | % | N | % | |
C-SSRS: a lot of difficulty or inability to control thoughts | 6 | 12 | 12 | 23 | 18 | 18 |
C-SSRS: deterrents probably or definitely stopped suicide attempt | 43 | 86 | 35 | 67 | 78 | 76 |
Clinical Global Impressions Scale, severity scale | ||||||
Mildly ill | 3 | 6 | 0 | 0 | 3 | 3 |
Moderately ill | 33 | 65 | 32 | 62 | 65 | 63 |
Markedly ill | 13 | 25 | 18 | 35 | 31 | 30 |
Severely ill | 2 | 4 | 2 | 4 | 4 | 4 |
Mean | SD | Mean | SD | Mean | SD | |
Hamilton Depression Rating Scale score | 28.7 | 4.7 | 29.6 | 7.0 | 29.1 | 5.9 |
Insomnia Severity Index score | 20.7 | 4.0 | 21.0 | 4.3 | 20.9 | 4.1 |
Beck Hopelessness Scale score | 13.4 | 4.8 | 12.7 | 4.6 | 13.1 | 4.7 |
Disturbing Dream and Nightmare Severity Index score | 10.5 | 8.8 | 10.2 | 7.7 | 10.3 | 8.2 |
Dysfunctional Beliefs and Attitudes About Sleep Scale score | 6.7 | 1.6 | 6.7 | 1.5 | 6.7 | 1.6 |
Behavior and Symptom Identification Scale 32, daily living and role functioning score | 2.4 | 0.6 | 2.2 | 0.7 | 2.3 | 0.6 |
Behavior and Symptom Identification Scale 32, relationship to self and others score | 2.5 | 0.6 | 2.2 | 0.7 | 2.3 | 0.7 |
Mini-Mental State Examination score | 29.6 | 0.8 | 29.3 | 1.0 | 29.4 | 0.9 |
Epworth Sleepiness Scale score | 7.9 | 5.0 | 8.5 | 4.7 | 8.2 | 4.9 |
Randomized Treatment
Outcomes
Follow-Up
Adverse Events
Discussion
Conclusions
Acknowledgments
Footnote
Supplementary Material
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