N/A
N=54
Adjunctive Brief Behavioral Treatment of Insomnia (BBTI) for Sleep Intervention (SI)
Insomnia · Depression · Posttraumatic Stress Disorder · Suicidal Ideation
Bottom Line
View on ClinicalTrials.gov: NCT02248675 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Columbia Suicide Severity Rating Scale (C-SSRS) — 5.4; 8.4 units on a scale — p=.153
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CBT-I (Behavioral); TAU (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Columbia Suicide Severity Rating Scale (C-SSRS) |
5.4; 8.4 | .153 |
| SECONDARY Perceived Treatment Beliefs (PTS) |
135.7; 133.04 | .627 |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
6.4; 12.3 | <.001 sig |
| SECONDARY Insomnia Severity Index (ISI) |
7.9; 17.8 | <.001 sig |
Summary
There is a strong association between sleep disturbance and suicidal thoughts and behaviors. Sleep disturbance is also highly comorbid with other common conditions associated with suicide such as depression and posttraumatic stress disorder. Accordingly, this application focuses on improving sleep as a novel suicide prevention strategy that can be delivered to a broad range of Veterans. This pilot proposal specifically examines how Cognitive Behavioral Therapy for Insomnia, an efficacious treatment for insomnia, may reduce suicidal ideation in Veterans who also suffer from additional conditions. The proposal further suggests that adding this sleep intervention to usual care may further enhance overall care by increasing the utilization of recommended treatments for depression and posttraumatic stress disorder.
Eligibility Criteria
Inclusion Criteria
- English speaking male and female Veterans ages 18-70;
- demonstrate an understanding of the informed consent;
- seeking or receiving services at the Canandaigua VA Medical Center (VAMC) or Rochester Outpatient Clinic;
- endorse death/suicidal ideation on the Columbia Suicide Severity Rating Scale
- either (i) a current diagnosis in their medical record of Major Depressive Disorder, Depression not otherwise specified, PTSD,or (ii) evidence of current depression as indicated by a score of > 10 on the Patient Health Questionnaire (PHQ-9) or current PTSD as indicated by a score of > 38 on the PTSD Symptom Checklist (PCL-5)();
- have an Insomnia Severity Index score > 10 indicating clinically meaningful insomnia with at least 1 insomnia-related daytime consequence (score of 1 on item #3) and trouble sleeping 3 months
Exclusion Criteria
- history of serious mental illness such as schizophrenia, Bipolar I or II disorder, or current psychiatric conditions such as psychosis, mania, dementia, cognitive impairment, OR suicidal ideation with plan and intent, a report of a suicide attempt in the past 6 months in the Computerized Patient Record System (CPRS) or via self-report, or a score of 4 on the Columbia-Suicide Severity Rating Scale
- currently engaged in inpatient or partial hospitalization programs or ongoing/pending medical procedures that could inhibit sleep
- recent substance dependence disorder with < 3 months in remission or abstinence;
- suspicion of or evidence of untreated sleep apnea.
- Diagnosis of a circadian rhythm disorder
- Diagnosis of Narcolepsy
- History of Seizures
Data sourced from ClinicalTrials.gov (NCT02248675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.