Treatments for Insomnia in Veterans With PTSD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Insomnia PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Outcome assessors will be blinded from group assignment and the treatment content. Participants will be blinded to the content of the treatment arm to which they are not assigned.

Study Groups

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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.

Group Type EXPERIMENTAL

The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia)

Intervention Type BEHAVIORAL

5 individual sessions incorporating behavioral treatment components plus acceptance and commitment therapy (ACT) provided by a trained instructor.

Cognitive-Behavioral Therapy for Insomnia

This is the standard treatment for insomnia that is being compared to the new treatment (ABCI).

Group Type ACTIVE_COMPARATOR

Cognitive-Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor.

Interventions

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The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia)

5 individual sessions incorporating behavioral treatment components plus acceptance and commitment therapy (ACT) provided by a trained instructor.

Intervention Type BEHAVIORAL

Cognitive-Behavioral Therapy for Insomnia

5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor.

Intervention Type BEHAVIORAL

Other Intervention Names

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ABC-I CBT-I

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No