Treatments for Insomnia in Veterans With PTSD

This study is comparing two behavioral therapies for Veterans who experience both Post-Traumatic Stress Disorder (PTSD) and insomnia. The treatments are called The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia) and Cognitive-Behavioral Therapy for Insomnia (CBT-I). Both involve 5 individual sessions. Researchers want to see if ABC-I is better than CBT-I at reducing PTSD symptoms, improving insomnia, and enhancing sleep quality. You might be able to join if you are a Veteran aged 18 or older, have PTSD and insomnia symptoms, and live near the VA Sepulveda Ambulatory Care Center. The study aims to enroll 400 participants.

Study design
This is a randomized study comparing two behavioral therapies. It plans to enroll 400 participants.
What's involved
Participants will attend 5 individual sessions for their assigned behavioral therapy. The primary outcomes are measured at 6 months follow-up.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after treatment to measure outcomes.

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NCT05194930

Treatments for Insomnia in Veterans With PTSD

Recruiting
NAAges 18+InterventionalTreatment
VA Office of Research and Development
~400 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia)Cognitive-Behavioral Therapy for Insomnia

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PTSD Check List for DSM-5 (PCL-5)
Measured over 6-months follow-up
+3 more outcomes measured
Insomnia
PTSD
2 sites across 2 states
California1
Florida1
  • Jennifer L Martin, PhD · PRINCIPAL_INVESTIGATOR · Miami VA Healthcare System, Miami, FL

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Eligibility criteria

Inclusion

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

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.
  • PTSD Check List for DSM-5 (PCL-5)6-months follow-up

    The PCL-5 total score will be the main outcome measure for PTSD symptom severity. The PCL-5 is a standardized assessment for PTSD, based on DSM-5. The 20-item scale assesses the presence and severity PTSD symptoms on a 0-4 Likert scale, with a total symptom severity score range from 0-80. A score greater than or equal to 33 is indicative of probable PTSD.

  • Insomnia Severity Index (ISI)6-months follow-up

    Mean score on Insomnia Severity Index (ISI). This 7-item scale measures self-reported severity of insomnia symptoms. Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.

  • Pittsburgh Sleep Quality Index (PSQI)6-months follow-up

    Mean PSQI score will be used as a measure of sleep quality. Scores range from 0 to 21. Higher scores indicate worse sleep quality.

  • Sleep efficiency from 7-day sleep diary6-months follow-up

    Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary. Scores range from 0 to 100 percent. Higher scores indicate better outcome.