A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Aug 8, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a special sleep treatment designed for U.S. military veterans who have post-traumatic stress disorder (PTSD) and trouble sleeping. Many veterans with PTSD experience sleep problems, and this study aims to see if a proven sleep therapy can help them sleep better. The treatment will be adjusted specifically for veterans to meet their unique needs.
To participate in the trial, veterans must be at least 18 years old and currently receiving care from the VA. Participants should have a diagnosis of PTSD and insomnia, along with some level of sleep-related difficulties in their daily lives. They will need to commit to attending 8 to 12 sessions of treatment, which will be conducted online. It's important to know that individuals with certain severe mental health issues or those who are currently receiving other sleep-focused therapies won't be eligible to join.
Gender
ALL
Eligibility criteria
- 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
About Va Office Of Research And Development
The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Francisco, California, United States
Patients applied
Trial Officials
Anne Richards, MD MPH
Principal Investigator
San Francisco VA Medical Center, San Francisco, CA
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported