RecruitingNot ApplicableNCT05194930

Treatments for Insomnia in Veterans With PTSD

A Novel Acceptance-based Treatment for Insomnia in Veterans With Post-Traumatic Stress Disorder


Sponsor

VA Office of Research and Development

Enrollment

400 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing treatments for sleep problems (insomnia) in Veterans who also have PTSD. Researchers are looking at whether behavioral and other therapies can improve both sleep and PTSD symptoms. **You may be eligible if...** - You are a Veteran aged 18 or older - You received VA care at the Los Angeles VA (VAGLAHS) in the past year - You live within 50 miles of the VA Sepulveda Ambulatory Care Center - You have symptoms of PTSD - You have trouble sleeping (insomnia) **You may NOT be eligible if...** - You are currently pregnant or have a baby under 6 months old - You are actively using substances or have been sober for less than 90 days - You are too unwell to participate - You have unstable housing - You have severe untreated sleep apnea - You have restless legs syndrome or a circadian rhythm disorder causing your sleep problems - You are currently in prolonged exposure therapy for PTSD 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

BEHAVIORALThe ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia)

5 individual sessions incorporating behavioral treatment components plus acceptance and commitment therapy (ACT) provided by a trained instructor.

BEHAVIORALCognitive-Behavioral Therapy for Insomnia

5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor.


Locations(1)

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, United States

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NCT05194930


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