Status:
RECRUITING
Treatments for Insomnia in Veterans With PTSD
Lead Sponsor:
VA Office of Research and Development
Conditions:
Insomnia
PTSD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 P...
Detailed Description
Poor sleep is a nearly universal experience after trauma and in the context of PTSD non-pharmacological therapies are considered first-line treatments, yet VA/DoD clinical practice guidelines acknowle...
Eligibility Criteria
Inclusion
- community-dwelling Veterans aged 18 years and older,
- received care from VAGLAHS in the prior year,
- live within a 50-mile radius of the research offices at the VA Sepulveda Ambulatory Care Center,
- have symptoms of PTSD,
- have symptoms of insomnia.
Exclusion
- current pregnancy or has a child less than 6 months of age (men and women),
- active substance users or in recovery with less than 90 days of sobriety,
- too ill to engage in the study procedures,
- unable to self-consent to participate,
- unstable housing (since we may not be able to retrieve costly and difficult to replace monitoring equipment),
- severe, untreated sleep disordered breathing (AHI\>15 with excessive daytime sleepiness, or AHI\>30),
- restless legs syndrome that accounts for the sleep disturbances reported,
- a circadian rhythm sleep disorder that accounts for the sleep disturbances reported (including shift work sleep disorder),
- unstable medical or psychiatric disorders (which is a contraindication for behavioral treatment of insomnia);
- remission of insomnia symptoms prior to randomization;
- current participation in prolonged exposure therapy for PTSD.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05194930
Start Date
September 1 2022
End Date
June 30 2026
Last Update
August 14 2025
Active Locations (1)
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1
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, United States, 91343