Treatments for Insomnia in Veterans With PTSD

August 3, 2023 updated by: VA Office of Research and Development

A Novel Acceptance-based Treatment for Insomnia in Veterans With Post-Traumatic Stress Disorder

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Diane I Lee, MSW
  • Phone Number: 36087 (818) 891-7711
  • Email: Diane.Lee@va.gov

Study Locations

  • United States
    • California
      • Sepulveda, California, United States, 91343
        • Recruiting
        • VA Greater Los Angeles Healthcare System, Sepulveda, CA
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jennifer L Martin, PhD
        • Sub-Investigator:
          • Cathy A Alessi, MD MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
Other Names:
  • ABC-I
Active Comparator: Cognitive-Behavioral Therapy for Insomnia
This is the standard treatment for insomnia that is being compared to the new treatment (ABCI).
Behavioral: Cognitive-Behavioral Therapy for Insomnia
5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor.
Other Names:
  • CBT-I

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Check List for DSM-5 (PCL-5)
Time Frame: 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.
6-months follow-up
Insomnia Severity Index (ISI)
Time Frame: 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.
6-months follow-up
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 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.
6-months follow-up
Sleep efficiency from 7-day sleep diary
Time Frame: 6-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.
6-months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Jennifer L Martin, PhD, VA Greater Los Angeles Healthcare System, Sepulveda, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 20-283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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