Comparing two treatments for insomnia in veterans with PTSD
Official title: A Novel Acceptance-based Treatment for Insomnia in Veterans With Post-Traumatic Stress Disorder
Run by VA Office of Research and Development · NCT05194930 · Data updated 2026-11-12
This study is trying out a new treatment for insomnia that combines different therapy techniques to see if it helps veterans with PTSD sleep better and feel less anxious compared to standard therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (Sepulveda, California and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2022 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT05194930 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are community-dwelling veterans aged 18 and older who have received care from the VA Greater Los Angeles Healthcare System and live within a 50-mile radius.
✕Probably not a fit
Patients who are currently pregnant, have severe untreated sleep disorders, or unstable medical or psychiatric conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial evaluates the effectiveness of a novel treatment called Acceptance of the Behavioral Changes to Treat Insomnia (ABC-I) against the standard Cognitive Behavioral Therapy for Insomnia (CBT-I) in veterans suffering from both insomnia and Post-Traumatic Stress Disorder (PTSD). ABC-I integrates behavioral components from CBT-I with elements of Acceptance and Commitment Therapy to enhance treatment adherence. The study aims to assess the impact of ABC-I on reducing PTSD symptoms and improving sleep quality compared to CBT-I. Veterans receiving care at Sepulveda and West Los Angeles facilities will be recruited for participation.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for veterans struggling with insomnia and PTSD.
How similar studies have gone: While there is evidence supporting CBT-I for insomnia in individuals with psychiatric comorbidities, this specific comparison of ABC-I to CBT-I is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where it's running
-
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, United States Recruiting -
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States Active not recruiting
Study contacts
- Principal investigator: Jennifer L Martin, PhD — Miami VA Healthcare System, Miami, FL
- Study coordinator: Jennifer L Martin, PhD
- Email: jennifer.martin@va.gov
- Phone: (305) 575-7000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.