Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05194930

Treatments for Insomnia in Veterans With PTSD

Led by VA Office of Research and Development · Updated on 2025-08-14

400

Participants Needed

1

Research Sites

199 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 Post-Traumatic Stress Disorder (PTSD) and insomnia disorder. ABC-I combines the behavioral components of CBT-I with components of another behavioral therapy (Acceptance and Commitment Therapy) and has been shown to improve treatment adherence. The study objectives are: 1) to evaluate the benefits of ABC-I in reducing post-traumatic stress disorder (PTSD) symptoms among Veterans with comorbid PTSD and insomnia disorder compared to CBT-I, and 2) to evaluate the effectiveness of ABC-I in improving insomnia symptoms and sleep quality among Veterans with comorbid PTSD and insomnia disorder as compared to CBT-I. Veterans with insomnia and comorbid PTSD who receive care at Sepulveda and West Los Angeles facilities will be recruited for the study. Those who pass an initial eligibility screen will be enrolled and written informed consent will be obtained. A baseline assessment will be completed that includes measures of sleep, PTSD, and quality of life. Veterans who meet all eligibility criteria will be randomly assigned to the ABC-I (n=100) or CBT-I (n=100) treatment. Both treatments will be provided in 5 one-on-one sessions by a trained instructor who is supervised by a behavioral sleep medicine specialist. All randomized participants (n=200) will have 3 follow-up assessments (post-treatment, 3-months, and 6-months after randomization). The follow-up assessments will collect information on PTSD symptoms, insomnia symptoms and sleep quality.

CONDITIONS

Official Title

Treatments for Insomnia in Veterans With PTSD

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Community-dwelling Veterans aged 18 years and older
  • Received care from VA Greater Los Angeles Healthcare System in the prior year
  • Live within a 50-mile radius of the VA Sepulveda Ambulatory Care Center research offices
  • Have symptoms of PTSD
  • Have symptoms of insomnia
Not Eligible

You will not qualify if you...

  • Currently pregnant or have a child less than 6 months old (men and women)
  • Active substance users or in recovery with less than 90 days of sobriety
  • Too ill to engage in study procedures
  • Unable to self-consent to participate
  • Unstable housing
  • Severe, untreated sleep disordered breathing (AHI >15 with excessive daytime sleepiness, or AHI >30)
  • Restless legs syndrome causing sleep disturbances
  • Circadian rhythm sleep disorder causing sleep disturbances (including shift work sleep disorder)
  • Unstable medical or psychiatric disorders contraindicating behavioral treatment of insomnia
  • Remission of insomnia symptoms before randomization
  • Currently participating in prolonged exposure therapy for PTSD

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, United States, 91343

Actively Recruiting

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Research Team

J

Jennifer L Martin, PhD

CONTACT

D

Diane I Lee, MSW

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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