A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
A Randomized, Controlled Trial of a Modified Sleep and Circadian Intervention for Veterans With PTSD: Advancing Psychosocial Rehabilitation Through Sleep Health
1 other identifier
interventional
182
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2024
CompletedFirst Posted
Study publicly available on registry
August 12, 2024
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2029
Study Completion
Last participant's last visit for all outcomes
January 31, 2029
January 20, 2026
January 1, 2026
2.7 years
August 8, 2024
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
World Health Organization Disability Assessment Schedule (WHODAS)
The WHODAS is a validated, comprehensive measure of health-related disability.
Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
Secondary Outcomes (3)
Insomnia Severity Index (ISI)
Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
Clinician-Administered PTSD Scale for DSM-4 Distressing Dream Score (CAPS-4 Nightmare Item)
Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Week 0, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
Study Arms (2)
Arm 1: Experimental
EXPERIMENTALParticipants receiving experimental TSC-PTSD treatment.
Arm 2: Active Control
ACTIVE COMPARATORParticipants receiving sleep psychoeducation control.
Interventions
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.
Participants will receive psychoeducation about sleep.
Eligibility Criteria
You may qualify if:
- U.S. Military Veteran aged 18 and above engaged in VA primary and/or mental health care
- CAPS 5 PTSD diagnosis; or CAPS 5 score \>=25 in the absence of full criteria
- SCID Insomnia Disorder diagnosis, supported by ISI score \>=10
- CAPS-IV nightmare score \>=4
- Sleep-related functional impairment based on a WHODAS score \>=32
- Willingness to engage in 8-12 sessions of treatment to address their sleep disturbance
You may not qualify if:
- Current cognitive problems, active psychosis or mania, or other mental/cognitive conditions such as moderate to severe neurodegenerative disease that would render the participant unable to connect to videoconferencing platform, engage in remote psychotherapy, or communicate using the required VA secure email platform
- No access to reliable internet service connected to a computer, iPad or similar device (telephone not adequate)
- Inability or unwillingness to use a VA-approved videoconferencing platform and VA secure email;
- Current engagement in a sleep-focused psychotherapy, or plan to start a sleep-focused psychotherapy in the next 3 months. Sleep-focused psychotherapies include, but are not limited to, CBT-I, BBT-I, and IRT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Richards, MD MPH
San Francisco VA Medical Center, San Francisco, CA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- This is a single-blind study. Participants will not know to which group they are assigned.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2024
First Posted
August 12, 2024
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
January 31, 2029
Study Completion (Estimated)
January 31, 2029
Last Updated
January 20, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share