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Search / Trial NCT05194930

Treatments for Insomnia in Veterans With PTSD

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jan 5, 2022

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Insomnia Disorder Chronic Post Traumatic Stress Disorder

ClinConnect Summary

This clinical trial is studying two treatments for insomnia in veterans who also have symptoms of Post-Traumatic Stress Disorder (PTSD). The trial will compare a new treatment called Acceptance of the Behavioral Changes to Treat Insomnia (ABC-I) with the well-known Cognitive Behavioral Therapy for Insomnia (CBT-I). ABC-I combines techniques from CBT-I with another form of therapy that helps people accept their thoughts and feelings, which may improve the way veterans cope with their insomnia and PTSD symptoms. The main goals are to see which treatment helps reduce PTSD symptoms and improve sleep quality better.

To participate in this study, veterans must be at least 18 years old, have received care from a specific VA hospital in the last year, and live within 50 miles of the research location. They should have symptoms of both PTSD and insomnia but must not have certain medical conditions that could interfere with the study. If eligible, participants will be randomly assigned to either the ABC-I or CBT-I group and will attend five one-on-one sessions with a trained instructor. They will also have follow-up assessments to see how well the treatments worked for their sleep and PTSD symptoms. This trial is actively recruiting participants and aims to provide helpful insights into treating insomnia in veterans.

Gender

ALL

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.

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Sepulveda, California, United States

Patients applied

0 patients applied

Trial Officials

Jennifer L Martin, PhD

Principal Investigator

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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