Treatments in Women Veterans With Insomnia and PTSD

Part of paid clinical trials in West Los Angeles, California.

Sponsor
VA Office of Research and Development
Study ID
NCT05683132
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trauma-Informed CBT-I — BEHAVIORAL
    5 individual sessions incorporating behavioral and cognitive therapy components and trauma-informed adaptations with a trained instructor.
  • PTSD Psychoeducation — BEHAVIORAL
    5 individual sessions incorporating psychoeducation about PTSD symptoms with a trained instructor.

Study Details

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 Dates

Start date
Jun 1, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

University of Rhode Island Change Assessment Scale (URICA) [ Time Frame: Post-Treatment (approximately 1 week after last intervention session) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los AngelesCalifornia90073-1003
Gwendolyn C Carlson, PhD
[email protected]
818-891-7711
Irma Gvilia, PhD MS
[email protected]
(818) 891-7711
Gwendolyn C Carlson, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in West Los Angeles, CA

By condition
InsomniaPTSD (post-traumatic stress disorder)
By specialty
Mental healthSleep medicinePsychiatryBehavioral health
By research site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA· West Los Angeles, CA

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