Actively Recruiting
Treatments in Women Veterans With Insomnia and PTSD
Led by VA Office of Research and Development · Updated on 2026-04-21
100
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This pilot trial will compare trauma-informed Cognitive Behavioral Therapy for Insomnia (CBT-I) to a psychoeducational intervention in women Veterans with comorbid insomnia and posttraumatic stress disorder (PTSD). The CBT-I intervention includes trauma-informed adaptations to an insomnia treatment and the psychoeducational intervention is modeled after usual care in a VA Women's Mental Health Clinic. The study objectives are to: 1) Iteratively refine the structure and materials of trauma-informed CBT-I in preparation for a pilot trial, 2) Pilot test the effects of trauma-informed CBT-I on PTSD treatment readiness and engagement in a sample of women Veterans, and 3) Examine potential mechanisms underlying variations in PTSD treatment readiness and engagement over time among women Veterans. Women Veterans with insomnia and comorbid PTSD who receive care at Sepulveda and West Los Angeles facilities will be recruited for the study. Those who pass an initial eligibility screen will be enrolled and written informed consent will be obtained. A baseline assessment will be completed that includes measures of PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms. Then Veterans who meet all eligibility criteria will be randomly assigned to trauma-informed CBT-I (n=25) or the psychoeducational intervention (n=25). Both treatments will be provided in 5 one-on-one sessions by a trained instructor who is supervised by a behavioral sleep medicine specialist. All randomized participants (n=50) will have 2 follow-up assessments (post-treatment and 3-months). The follow-up assessments will collect information on PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms. Chart reviews will be conducted 6-months post-treatment to assess number of PTSD treatment appointments attended (treatment engagement measure). Qualitative interviews will be conducted to identify mechanisms underlying PTSD treatment engagement.
CONDITIONS
Official Title
Treatments in Women Veterans With Insomnia and PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Community-dwelling women Veterans aged 18 years and older
- Received care from VA Greater Los Angeles Healthcare System
- Have symptoms of PTSD
- Have symptoms of insomnia
You will not qualify if you...
- Health or emotional problems, or drug or alcohol use that make participation difficult
- Too ill to participate in study procedures
- Unable to provide informed consent
- Previously attended more than one session of Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Previously attended more than one session of PTSD psychoeducational group at VA Women's Health Clinic
- Previously completed more than three sessions of PTSD treatment (e.g., Cognitive Processing Therapy, Prolonged Exposure, Eye Movement Desensitization and Reprocessing)
- Pregnant or pregnant within 6 months of study
- Untreated moderate to severe obstructive sleep apnea
- Unstable housing
- Unable to read, write, and communicate in English
- Unstable medical or psychiatric conditions contraindicating behavioral insomnia treatment
- Remission of PTSD or insomnia symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073-1003
Actively Recruiting
Research Team
G
Gwendolyn C Carlson, PhD
CONTACT
M
Michael K Ong, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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