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RECRUITING
NCT05194930
NA

Treatments for Insomnia in Veterans With PTSD

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2022-09-01

Completion Date

2026-06-30

Last Updated

2025-08-14

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

The 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.

BEHAVIORAL

Cognitive-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