Treatments for Insomnia in Veterans With PTSD

Part of paid clinical trials in Sepulveda, California.

Sponsor
VA Office of Research and Development
Study ID
NCT05194930
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia) — BEHAVIORAL
    5 individual sessions incorporating behavioral treatment components plus acceptance and commitment therapy (ACT) provided by a trained instructor.
  • Cognitive-Behavioral Therapy for Insomnia — BEHAVIORAL
    5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor.

Study Details

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.

Key Dates

Start date
Sep 1, 2022
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: The ABC of Insomnia (Acceptance and the Behavioral Changes to
    This is the new treatment arm that is being compared to CBT-I, standard treatment for insomnia.
  • Active Comparator: Cognitive-Behavioral Therapy for Insomnia
    This is the standard treatment for insomnia that is being compared to the new treatment (ABCI).

Primary Outcome Measure

PTSD Check List for DSM-5 (PCL-5) [ Time Frame: 6-months follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Greater Los Angeles Healthcare System, Sepulveda, CASepulvedaCalifornia91343
Scott E Krahl, PhD MA BA
[email protected]
818-895-5861
Cathy A Alessi, MD MPH (SUB_INVESTIGATOR)
Jennifer L Martin, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sepulveda, CA

By condition
InsomniaPTSD (post-traumatic stress disorder)
By specialty
Mental healthSleep medicinePsychiatryBehavioral health
By research site
VA Greater Los Angeles Healthcare System, Sepulveda, CA· Sepulveda, CA

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