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) — BEHAVIORAL
    CBTi 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) — BEHAVIORAL
    CBTn 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) — BEHAVIORAL
    WET is a trauma-focused intervention in which individuals write about their worst traumatic experience following scripted instruction from the therapist.
  • Sleep Hygiene — BEHAVIORAL
    Involves 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

Locations (1)

FacilityCityStateZIPSite coordinators
Fort HoodKileenTexas76544
Bryce Williams
210-562-6700

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