Treatments for Insomnia in Veterans With PTSD

  • STATUS
    Recruiting
  • End date
    Jan 31, 2026
  • participants needed
    400
  • sponsor
    VA Office of Research and Development
Updated on 7 October 2022
behavior therapy
insomnia
cognitive therapy
post-traumatic stress disorder
cognitive behavioral therapy for insomnia

Summary

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.

Description

Poor sleep is a nearly universal experience after trauma and in the context of PTSD non-pharmacological therapies are considered first-line treatments, yet VA/DoD clinical practice guidelines acknowledged the paucity of available evidence on the treatment of insomnia disorder in the context of PTSD. There is evidence of sleep-related benefits with CBT-I for individuals with insomnia and psychiatric comorbidities, but challenges remain. Insomnia treatments studied among Veterans with PTSD have typically been combined treatments to address both conditions. While promising, these treatments are difficult to implement because of their length and complexity. Furthermore, studies generally have not compared novel sleep-focused treatments to CBT-I (i.e., standard care for insomnia), making it difficult to support a change in the allocation of clinical resources to train providers in new sleep-focused interventions.

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 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. The analytic plan will simultaneously address superiority of ABC-I over CBT-I for improving PTSD symptoms and non-inferiority of ABC-I compared to CBT-I for improving insomnia symptoms.

Details
Condition Insomnia, PTSD
Treatment Cognitive-Behavioral Therapy for Insomnia, The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia)
Clinical Study IdentifierNCT05194930
SponsorVA Office of Research and Development
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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