Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder
Part of paid clinical trials in San Francisco, California.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT05780177
- Status
- Recruiting
Conditions
- Insomnia Disorder
- Posttraumatic Stress Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Accepted
Interventions
- Brief Behavioral Treatment for Insomnia (BBTI) — BEHAVIORALParticipants in this arm will receive 4 sessions (30-60 minutes) of a brief behavioral treatment for insomnia called BBTI. Relaxation techniques are not a component of BBTI.
- Progressive Muscle Relaxation Training (PMRT) — BEHAVIORALParticipants in this arm will receive 4 sessions (30-60 minutes) of progressive muscle relaxation training called PMRT.
Study Details
This study will investigate treatments for insomnia in Veterans who have posttraumatic stress disorder (PTSD). The purpose of this study is to compare a brief behavioral treatment for insomnia (BBTI) to a treatment that helps promote relaxation (progressive muscle relaxation training or PMRT). The investigators will examine improvements in psychosocial functioning and insomnia severity. The investigators will also examine whether treatment gains last over time and whether suicidal ideation decreases following insomnia treatment.
Key Dates
- Start date
- May 1, 2023
- Status verified
- Apr 2026
- Primary completion
- Apr 30, 2027
- Completion
- Apr 30, 2027
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: BBTIParticipants in this arm will receive 4 sessions (30-60 minutes) of a brief behavioral treatment for insomnia (BBTI). Relaxation techniques are not a component of BBTI.
- Active Comparator: PMRTParticipants in this arm will receive 4 sessions (30-60 minutes) of progressive muscle relaxation training (PMRT).
Primary Outcome Measure
Work and Social Adjustment Scale (WSAS) Change [ Time Frame: Change from baseline (Week 1) to posttreatment (Week 5) ]
Central Contacts
- Shira Maguen, PhD(415) 221-4810
- Joy Huggins, MA(415) 221-4810
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| San Francisco VA Medical Center, San Francisco, CA | San Francisco | California | 94121-1563 | Shira Maguen, PhD (PRINCIPAL_INVESTIGATOR) |
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