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NCT06549049
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Conditions: Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 182
Sponsor: VA Office of Research and Development
Location: San Francisco VA Medical Center, San Francisco, CA San Francisco California
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 population, with some changes to tailor it to the needs of Veterans with PTSD and sleep disturbance.
Eligibility Criteria
Inclusion Criteria:
* 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
* Sleep-related functional impairment based on a World Health Organization Disability Assessment Schedule (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
Source: ClinicalTrials.gov (NCT06549049). StuddyBuddy aggregates publicly available trial information.