Status:
NOT_YET_RECRUITING
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Lead Sponsor:
VA Office of Research and Development
Conditions:
Stress Disorders, Post-Traumatic
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
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 populat...
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 the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 5 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2029
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT06549049
Start Date
January 5 2026
End Date
January 31 2029
Last Update
October 21 2025
Active Locations (1)
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1
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121-1563