A Transdiagnostic Sleep Health Intervention for Veterans With PTSD

Not Applicable

Not yet recruiting

• Conditions: Stress Disorders, Post-Traumatic; Sleep Initiation and Maintenance Disorders

• Registration Number: NCT06549049
• Lead Sponsor: VA Office of Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

Inclusion Criteria:<br><br> - U.S. Military Veteran aged 18 and above engaged in VA primary and/or mental health<br> care<br><br> - CAPS 5 PTSD diagnosis; or CAPS 5 score >=25 in the absence of full criteria<br><br> - SCID Insomnia Disorder diagnosis, supported by ISI score >=10<br><br> - CAPS-IV nightmare score >=4<br><br> - Sleep-related functional impairment based on a WHODAS score >=32<br><br> - Willingness to engage in 8-12 sessions of treatment to address their sleep<br> disturbance<br><br>Exclusion Criteria:<br><br> - Current cognitive problems, active psychosis or mania, or other mental/cognitive<br> conditions such as moderate to severe neurodegenerative disease that would render<br> the participant unable to connect to videoconferencing platform, engage in remote<br> psychotherapy, or communicate using the required VA secure email platform<br><br> - No access to reliable internet service connected to a computer, iPad or similar<br> device (telephone not adequate)<br><br> - Inability or unwillingness to use a VA-approved videoconferencing platform and VA<br> secure email;<br><br> - Current engagement in a sleep-focused psychotherapy, or plan to start a<br> sleep-focused psychotherapy in the next 3 months. Sleep-focused psychotherapies<br> include, but are not limited to, CBT-I, BBT-I, and IRT

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
World Health Organization Disability Assessment Schedule (WHODAS)

Secondary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI);Clinician-Administered PTSD Scale for DSM-4 Distressing Dream Score (CAPS-4 Nightmare Item);Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)