Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD (NCT07069517) | Clinical Trial Compass
RecruitingNot Applicable
Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD
United States160 participantsStarted 2025-12-02
Plain-language summary
This study is a two-arm individually randomized group treatment clinical trial evaluating behavioral therapies for insomnia, nightmares, and PTSD. The study will compare cognitive-behavioral therapy for insomnia and nightmares to sleep hygiene (Control), both integrated with Written Exposure Therapy for PTSD and delivered in an accelerated (i.e., 5-day) group treatment format, preceded and followed by individual treatment sessions. 160 participants will be randomized into one of two study conditions.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Defense Enrollment Eligibility Reporting System (DEERS) eligible active-duty military personnel or veteran, 18-65 years old.
✓. Ability to speak and read English.
✓. Clinically significant PTSD symptoms (CAPS-5 \> 25 with at least one Intrusion symptom and at least one Avoidance symptom).
✓. Clinically significant symptoms of insomnia disorder (Structured Clinical Interview for Sleep Disturbance DSM-5 (SCISD) Insomnia Criteria are met and Insomnia Severity Index (ISI) \> 11).
✓. Nightmares \> 1 monthly (as reported on the SCISD).
✓. Willing to refrain from new behavioral health or medication treatment for issues pertaining to PTSD, sleep, and nightmares during study participation.
Exclusion criteria
✕. Current suicide or homicide risk meriting crisis intervention.
✕. Inability to comprehend the baseline screening questionnaires.
✕. Unwilling to remain abstinent from alcohol during therapy sessions.
✕. Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate clinical attention based on interviewer assessment and clinical judgement.
✕. Currently engaged in evidence-based psychotherapy for PTSD (e.g., Prolonged Exposure Therapy, Cognitive Processing Therapy, Written Exposure Therapy) or insomnia or nightmares (e.g., Cognitive Behavioral Therapy for Insomnia or Nightmares).
What they're measuring
1
Posttraumatic Stress Disorder Checklist (PCL-5)
Timeframe: Change from baseline through 3 and 6 month follow-up assessment
2
Insomnia Severity Index (ISI)
Timeframe: Change from baseline through 3 and 6 month follow up
3
Nightmare Disorders Index
Timeframe: Change from baseline through 3 and 6 month assessments