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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Brief Behavioral Treatment for Insomnia (BBTI) — BEHAVIORAL
    Participants 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) — BEHAVIORAL
    Participants 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: BBTI
    Participants 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: PMRT
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco VA Medical Center, San Francisco, CASan FranciscoCalifornia94121-1563
Shira Maguen, PhD
(415) 221-4810
Shira Maguen, PhD (PRINCIPAL_INVESTIGATOR)

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