Actively Recruiting
Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD: A Randomized Controlled Trial
Led by Palo Alto Veterans Institute for Research · Updated on 2025-12-03
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Palo Alto Veterans Institute for Research
Lead Sponsor
T
The University of Texas Health Science Center at San Antonio
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating accelerated behavioral therapies for military personnel and veterans experiencing insomnia, nightmares, and PTSD. This randomized clinical trial compares cognitive-behavioral therapy for insomnia and nightmares combined with Written Exposure Therapy to a control group receiving sleep hygiene practices integrated with Written Exposure Therapy. The study aims to determine the effectiveness of these treatments in improving symptoms of insomnia, nightmares, and PTSD in this population. Participants are assigned to one of two groups: one receiving cognitive-behavioral therapy for insomnia and nightmares (CBTi+n) integrated with Written Exposure Therapy (WET), and the other receiving sleep hygiene education combined with WET. Both treatments are delivered in an accelerated group format over five days, with individual therapy sessions before and after the group treatment. The study involves 160 participants who will undergo these interventions. During the study, participants will be assessed using various tools including the Posttraumatic Stress Disorder Checklist (PCL-5), Insomnia Severity Index (ISI), and Nightmare Disorders Index at baseline and through 3- and 6-month follow-ups. Additional evaluations include clinician interviews, anxiety and depression screenings, and psychosocial functioning assessments. The trial monitors changes in symptoms and treatment effects over time, with safety and adherence tracked throughout the study period, which extends through follow-up visits up to six months post-treatment.
CONDITIONS
Brief Title
Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Active-duty military personnel or veteran eligible under Defense Enrollment Eligibility Reporting System (DEERS), aged 18 to 65 years
- Ability to speak and read English
- Clinically significant PTSD symptoms (CAPS-5 > 25 with intrusion and avoidance symptoms)
- Clinically significant insomnia disorder symptoms (SCISD DSM-5 criteria met and ISI > 11)
- At least one nightmare per month
- Willing to avoid new behavioral or medication treatments for PTSD, sleep, or nightmares during study participation
You will not qualify if you...
- Current suicide or homicide risk requiring crisis intervention
- Inability to understand baseline screening questionnaires
- Unwillingness to abstain from alcohol during therapy sessions
- Serious mental health symptoms such as mania, psychosis, or substance use disorders needing urgent care
- Currently receiving evidence-based psychotherapy for PTSD, insomnia, or nightmares
- Pregnancy
- Working duty shifts ending after 9:00 PM or starting before 5:30 AM more than twice per month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of active therapy sessions as per protocol
Participants receive accelerated cognitive behavioral therapies including CBT for insomnia, nightmares, and written exposure therapy for PTSD.
Multiple therapy visits during treatment period
Duration - Up to 6 months after treatment
Participants are followed up to assess changes in PTSD, insomnia, and nightmare symptoms after treatment completion.
Follow-up visits at 1, 3, and 6 months post-treatment
Trial Site Locations
Total: 1 location
1
Fort Hood
Kileen, Texas, United States, 76544
Actively Recruiting
Research Team
C
Carmen McLean, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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