RecruitingNot ApplicableNCT05683132

Treatments in Women Veterans With Insomnia and PTSD

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


Sponsor

VA Office of Research and Development

Enrollment

100 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing treatments for women veterans who struggle with both PTSD and insomnia (difficulty sleeping). Researchers want to find better ways to help women veterans manage these two conditions at the same time. **You may be eligible if...** - You are a woman veteran aged 18 or older - You receive care at the VA Greater Los Angeles Healthcare System (VAGLAHS) - You have symptoms of PTSD - You have symptoms of insomnia (trouble sleeping) **You may NOT be eligible if...** - You have already completed Cognitive Behavioral Therapy for Insomnia (CBT-I) - You have already completed a PTSD education group at the VAGLAHS Women's Health Clinic - You have had more than 3 sessions of PTSD therapy (such as CPT or Prolonged Exposure) - You are currently pregnant or were pregnant within the last 6 months - You have untreated moderate to severe sleep apnea - You are currently unstably housed - You cannot read, write, or communicate in English - Your PTSD or insomnia symptoms are already in remission Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALTrauma-Informed CBT-I

5 individual sessions incorporating behavioral and cognitive therapy components and trauma-informed adaptations with a trained instructor.

BEHAVIORALPTSD Psychoeducation

5 individual sessions incorporating psychoeducation about PTSD symptoms with a trained instructor.


Locations(1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States

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NCT05683132


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