Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD
Part of paid clinical trials in Kileen, Texas.
- Sponsor
- Palo Alto Veterans Institute for Research
- Study ID
- NCT07069517
- Status
- Recruiting
Conditions
- Insomnia
- Nightmares
- PTSD - Post Traumatic Stress Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Cognitive-Behavioral Therapy for Insomnia (CBTi) — BEHAVIORALCBTi focuses on stimulus control, eliminating maladaptive coping habits, reducing arousal, and challenging maladaptive thoughts about sleep in an effort to reduce time to fall asleep and time awake during the night.
- Cognitive Behavioral Therapy for Nightmares (CBTn) — BEHAVIORALCBTn involves writing about a distressing or frequent nightmare, rewriting the narrative of the nightmare to target trauma-related themes, and reading the rescripted nightmare narrative.
- Written Exposure Therapy (WET) — BEHAVIORALWET is a trauma-focused intervention in which individuals write about their worst traumatic experience following scripted instruction from the therapist.
- Sleep Hygiene — BEHAVIORALInvolves reviewing sleep diary data, sleep education, and reviewing and discussing sleep hygiene practices.
Study Details
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.
Key Dates
- Start date
- Dec 2, 2025
- Status verified
- Dec 2025
- Primary completion
- Dec 1, 2028
- Completion
- Dec 1, 2028
Study Design
- Enrollment
- 160 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Written exposure therapy and sleep hygiene for insomnia and nightmares
- Experimental: Written exposure therapy and CBT for insomnia and nightmares
Primary Outcome Measure
Posttraumatic Stress Disorder Checklist (PCL-5) [ Time Frame: Change from baseline through 3 and 6 month follow-up assessment ]
Central Contacts
- Carmen McLean, PhD650-614-9997
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fort Hood | Kileen | Texas | 76544 |
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