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Search / Trial NCT05683132

Treatments in Women Veterans With Insomnia and PTSD

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jan 5, 2023

Trial Information

Current as of September 10, 2025

Recruiting

Keywords

Insomnia Disorder Posttraumatic Stress Disorder Women's Health

ClinConnect Summary

This clinical trial is studying a new type of therapy called trauma-informed Cognitive Behavioral Therapy for Insomnia (CBT-I) to help women Veterans who are struggling with both insomnia (trouble sleeping) and PTSD (post-traumatic stress disorder). The goal is to see how effective this therapy is compared to a standard educational approach that is usually provided in VA Women’s Mental Health Clinics. The study will involve 50 women Veterans who have been diagnosed with PTSD and insomnia, and they will be randomly assigned to either receive the trauma-informed CBT-I or the educational intervention. Both groups will have five one-on-one sessions with a trained instructor and will be followed up to assess their progress.

To be eligible for the study, participants must be community-dwelling women Veterans aged 18 and older who are receiving care at specific VA facilities and experiencing symptoms of PTSD and insomnia. However, the study excludes individuals with certain health issues, those who have previously received specific treatments for insomnia or PTSD, and those who are pregnant or have unstable housing. Participants can expect to complete some assessments at the beginning and after treatment to measure their readiness for PTSD treatment and any challenges they face, as well as their sleep and mental health symptoms. This trial aims to improve treatment options for women Veterans facing these challenges and understand how to better support their engagement in PTSD treatment.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Community-dwelling women Veterans aged 18 years and older
  • Received care from VAGLAHS
  • Have symptoms of PTSD
  • Have symptoms of insomnia
  • Exclusion Criteria:
  • Reported health or emotional problems, or use of drugs or alcohol that would make it difficult for them to participate in this study
  • Too ill to engage in the study procedures
  • Unable to self-consent to participate
  • Previously engaged in Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment
  • Previously engaged in PTSD psychoeducational group offered in VAGLAHS Women's Health Clinic
  • Previously completed \>3 sessions of PTSD treatment (Cognitive Processing Therapy and/or Prolonged Exposure)
  • Pregnant or pregnant within 6 months of study
  • Untreated moderate to severe obstructive sleep apnea diagnosis as evidenced by Apnea Hypopnea Index (AHI) in chart and/or screens that indicate high risk
  • Unstable housing
  • Inability to read, write, and communicate in English
  • Unstable medical or psychiatric disorders (which is a contraindication for behavioral treatment of insomnia)
  • Remission of PTSD or insomnia symptoms

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

West Los Angeles, California, United States

West Los Angeles, California, United States

Patients applied

0 patients applied

Trial Officials

Gwendolyn C Carlson, PhD

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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