Treatments for Insomnia in Veterans With PTSD (NCT05194930)
A Novel Acceptance-based Treatment for Insomnia in Veterans With Post-Traumatic Stress Disorder
๐ฉบ Plain-English Summary (8th-Grade Level)
This randomized trial will compare a novel treatment, Acceptance of the Behavioral Changes to Treat Insomnia (ABC-I) to Cognitive Behavioral Therapy for Insomnia (CBT-I) among Veterans with comorbid Post-Traumatic Stress Disorder (PTSD) and insomnia disorder. ABC-I combines the behavioral components of CBT-I with components of another behavioral therapy (Acceptance and Commitment Therapy) and has been shown to improve treatment adherence. The study objectives are: 1) to evaluate the benefits of ABC-I in reducing post-traumatic stress disorder (PTSD) symptoms among Veterans with comorbid PTSD and insomnia disorder compared to CBT-I, and 2) to evaluate the effectiveness of ABC-I in improving insomnia symptoms and sleep quality among Veterans with comorbid PTSD and insomnia disorder as compared to CBT-I. 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 sleep, PTSD, and quality of life. Veterans who meet all eligibility criteria will be randomly assigned to the ABC-I (n=100) or CBT-I (n=100) treatment. 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=200) will have 3 follow-up assessments (post-treatment, 3-months, and 6-months after randomization). The follow-up assessments will collect information on PTSD symptoms, insomnia symptoms and sleep quality.
Who can join: Review the eligibility criteria below.
Location: VA Greater Los Angeles Healthcare System, Sepulveda, CA โ Sepulveda, California
Age range: 18 Years
๐งช Interventions in This Study
- The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia) (BEHAVIORAL)
- Cognitive-Behavioral Therapy for Insomnia (BEHAVIORAL)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (2 Sites)
- VA Greater Los Angeles Healthcare System, Sepulveda, CA โ Sepulveda, California
- Miami VA Healthcare System, Miami, FL โ Miami, Florida
๐ Contact the Study Coordinator
Phone: (305) 575-7000
Email: jennifer.martin@va.gov
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Wearable Transcranial Electrical Stimulation (tES) for Insomnia โ Bethesda, Maryland
- Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial โ New York, New York
- Remote STATE Training for Insomnia in Older Adults โ San Francisco, California
Explore by condition: All Insomnia clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.