Increasing PTSD Treatment Engagement in Women Veterans: Role of CBT for Insomnia (CDA 20-227)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Community-dwelling women Veterans aged 18 years and older

• Received care from VAGLAHS

• Have symptoms of PTSD

• Have symptoms of insomnia

Locations
United States
California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
RECRUITING
West Los Angeles
Contact Information
Primary
Michael K Ong, MD PhD
Michael.Ong2@va.gov
(310) 478-3711
Backup
Scott E Krahl, PhD MA BA
scott.krahl@va.gov
(818) 895-5861
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Trauma-Informed CBT-I
This intervention includes trauma-informed adaptations to standard treatment for insomnia, CBT-I
Active_comparator: PTSD Psychoeducation
This intervention includes psychoeducation about PTSD symptoms modeled after usual care in a VA Women's Health Clinic.
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov