Comparing two treatments for insomnia in veterans with PTSD

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: VA Office of Research and Development (fed)
• Locations: 1 site (Sepulveda, California)
• Trial ID: NCT05194930 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Sepulveda, California

• VA Greater Los Angeles Healthcare System, Sepulveda, CA — Sepulveda, California, United States (RECRUITING)

Study contacts

• Principal investigator: Jennifer L Martin, PhD — VA Greater Los Angeles Healthcare System, Sepulveda, CA
• Study coordinator: Jennifer L Martin, PhD

Conditions: Insomnia, PTSD, Insomnia disorder, Chronic Post-Traumatic Stress Disorder