Treatments in Women Veterans With Insomnia and PTSD

Recruiting now · Not applicable

Conditions studied: Insomnia, PTSD, Women Veterans

In brief

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.

Key facts

Study ID

NCT05683132

Run by

VA Office of Research and Development

People needed

100

Starts

2023-06-01

Expected to finish

2028-12-31

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Community-dwelling women Veterans aged 18 years and older
• Received care from VAGLAHS
• Have symptoms of PTSD
• Have symptoms of insomnia

You may not qualify if…

• Reported health or emotional problems, or use of drugs or alcohol that would make it difficult for them to participate in this study
• Too ill to engage in the study procedures
• Unable to self-consent to participate
• Previously engaged in >1 session of Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment
• Previously engaged in >1 session of PTSD psychoeducational group offered in VAGLAHS Women's Health Clinic
• Previously completed >3 sessions of PTSD treatment (e.g., Cognitive Processing Therapy, Prolonged Exposure, and/or Eye Movement Desensitization and Reprocessing )
• Pregnant or pregnant within 6 months of study
• Untreated moderate to severe obstructive sleep apnea diagnosis as evidenced by Apnea Hypopnea Index (AHI) in chart and/or screens that indicate high risk
• Unstable housing
• Inability to read, write, and communicate in English
• Unstable medical or psychiatric disorders (which is a contraindication for behavioral treatment of insomnia)
• Remission of PTSD or insomnia symptoms

Where it is running

• VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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