A Transdiagnostic Sleep Health Intervention for Veterans With PTSD

January 15, 2026 updated by: VA Office of Research and Development

A Randomized, Controlled Trial of a Modified Sleep and Circadian Intervention for Veterans With PTSD: Advancing Psychosocial Rehabilitation Through Sleep Health

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Sleep disturbance in military Veterans with PTSD is a complex condition, typically characterized by insomnia and nightmares, and frequently accompanied by comorbid obstructive sleep apnea. Each of these problems are shown to influence the others, contributing to a complex sleep disturbance with profound impacts on daytime functioning and quality of life. A vicious cycle in which nighttime disturbances impact daytime functioning, and vice versa, often ensues. Addressing sleep disturbance in Veterans with PTSD therefore requires a multipronged approach that is tailored to each Veterans' constellation of symptoms and each Veterans' goals for sleep health. The Transdiagnostic sleep and circadian intervention (TranS-C), developed by sleep researchers 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 overall goal of improving sleep and improving sleep-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, referred to as 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. The study will administer TSC-PTSD remotely to Veterans in their homes using a VA-approved video-conferencing platform. The study will recruit male and female U.S. military Veterans aged 18 and above throughout California and compare change in a comprehensive measure of daytime functioning and change in insomnia, nightmare and overall PTSD symptoms in participants randomized to the active intervention TSC-PTSD vs. participants randomized to a sleep psychoeducation control (SPC) intervention. The widely used and validated World Health Organization Disability Assessment Schedule (WHODAS) will serve as the primary outcome measure. The Insomnia Severity Index (ISI) and the Clinician-Administered PTSD Scale (CAPS) will be used to measure secondary outcomes. Eligible participants will have an insomnia diagnosis, a PTSD diagnosis (or moderate symptoms of PTSD in the absence of a full diagnosis), and clinically significant nightmares based on gold-standard clinician-administered interviews. All participants will complete baseline surveys related to daytime functioning and sleep-related symptoms prior to treatment initiation, and will complete these surveys again in week 5, and at the end of treatment. For additional high-resolution data on sleep patterns, all participants will record sleep-related information, including nightmare occurrence and severity, in the morning and at bedtime using a Veteran-tested and user-friendly sleep diary mobile app. Participants will also complete the clinical interview and self-report surveys at 3-month and 6-month follow-up, to assess the durability of treatment effects. The duration of TSC-PTSD may vary between a minimum of 8 and a maximum of 12 sessions and the psychoeducation control protocol will involve 10 sessions. The hypotheses are: 1) subjects randomized to TSC-PTSD will demonstrate greater improvement in WHODAS score relative to SPC from baseline to post-treatment; 2) subjects randomized to TSC-PTSD will demonstrate greater improvements in insomnia, nightmares and PTSD symptoms as demonstrated by improvements in the ISI, CAPS distressing dreams score, and CAPS total score relative to SPC from baseline to post-treatment; and 3) subjects randomized to TSC-PTSD will demonstrate greater sustained improvement in functional and clinical outcomes at 3-month and 6-month follow-up relative to SPC, and improvements in WHODAS score will be mediated by improvements in ISI, nightmares and TranS-C indicators of sleep health in both study groups. Findings in support of the investigators' hypotheses will provide a vital new tool for advancing rehabilitation in U.S. military Veterans with PTSD.

Study Type

Interventional

Enrollment (Estimated)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121-1563
        • San Francisco VA Medical Center, San Francisco, CA
        • Contact:
        • Principal Investigator:
          • Anne Richards, MD MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Experimental
Participants receiving experimental TSC-PTSD treatment.
Behavioral: TranS-C for PTSD
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.
Other Names:
  • TSC-PTSD
Active Comparator: Arm 2: Active Control
Participants receiving sleep psychoeducation control.
Behavioral: Sleep Psychoeducation Control
Participants will receive psychoeducation about sleep.
Other Names:
  • SPC

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index (ISI)
Time Frame: Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
The ISI will be used to measure change in severity of insomnia symptoms.
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)
Time Frame: Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
The CAPS-IV Nightmare Item will be used to measure change in nightmare symptoms.
Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time Frame: Week 0, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
The CAPS-5 will be used to measure change in overall PTSD symptoms.
Week 0, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Anne Richards, MD MPH, San Francisco VA Medical Center, San Francisco, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4796-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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