A Transdiagnostic Sleep Health Intervention for Veterans With PTSD

June 4, 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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
182

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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