A Transdiagnostic Sleep Health Intervention for Veterans With PTSD

Part of paid clinical trials in San Francisco, California.

Sponsor
VA Office of Research and Development
Study ID
NCT06549049
Status
Not Yet Recruiting

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Conditions

  • Sleep Initiation and Maintenance Disorders
  • Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TranS-C for PTSD — BEHAVIORAL
    The Transdiagnostic sleep and circadian intervention (TranS-C), developed by Allison Harvey, Ph.D. and Daniel Buysse, M.D., involves a patient-centered, module-based, flexibly structured approach that tackles numerous sleep disturbances using evidence-based strategies with the goal of improving sleep and related impairments in daytime functioning. It is thus well-suited for tackling sleep disturbances and the associated impairments in social, occupational and overall functioning in veterans with PTSD. The proposed study is a randomized, controlled clinical trial examining the effectiveness of a modified TranS-C intervention for veterans with PTSD. The modified approach, TranS-C for PTSD (TSC-PTSD), elevates the importance of nightmare-focused, apnea-focused, and insomnia-focused modules relative to the standard intervention, incorporates an evidence-based relaxation module, and modifies the nightmare and apnea modules based on strategies used for veterans in the VA healthcare system.
  • Sleep Psychoeducation Control — BEHAVIORAL
    Participants will receive psychoeducation about sleep.

Study Details

Sleep disturbance is a major problem in Veterans with posttraumatic stress disorder (PTSD). This study will test a version of a sleep treatment that's been shown to be effective in the general population, with some changes to tailor it to the needs of Veterans with PTSD and sleep disturbance.

Key Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
182 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Experimental
    Participants receiving experimental TSC-PTSD treatment.
  • Active Comparator: Arm 2: Active Control
    Participants receiving sleep psychoeducation control.

Primary Outcome Measure

World Health Organization Disability Assessment Schedule (WHODAS) [ Time Frame: Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco VA Medical Center, San Francisco, CASan FranciscoCalifornia94121-1563
Emily J Berg
[email protected]
(415) 900-6016
Anne Richards, MD MPH (PRINCIPAL_INVESTIGATOR)

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By research site
San Francisco VA Medical Center, San Francisco, CA· San Francisco, CA

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