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A Transdiagnostic Sleep Health Intervention for Veterans With PTSD

ConditionsStress Disorders, Post-TraumaticSleep Initiation and Maintenance Disorders
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

U.S. Military Veteran aged 18 and above engaged in VA primary and/or mental health care

Clinician-Administered PTSD Scale (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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

182 Participants
are divided into 2 treatment groups
Group A: Arm 1: ExperimentalExperimental treatment 1 intervention
Group B: Arm 2: Active ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

World Health Organization Disability Assessment Schedule (WHODAS)

The WHODAS is a validated, comprehensive measure of health-related disability.

Time frame
Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up

Secondary outcomes

1

Insomnia Severity Index (ISI)

The ISI will be used to measure change in severity of insomnia symptoms.

Time frame
Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
2

Clinician-Administered PTSD Scale for DSM-4 Distressing Dream Score (CAPS-4 Nightmare Item)

The CAPS-IV Nightmare Item will be used to measure change in nightmare symptoms.

Time frame
Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
3

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

The CAPS-5 will be used to measure change in overall PTSD symptoms.

Time frame
Week 0, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: