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Treatments for Insomnia in Veterans With PTSD

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ClinicalTrials.gov Identifier: NCT05194930
Recruitment Status : Recruiting
First Posted : January 18, 2022
Last Update Posted : August 8, 2023
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Insomnia PTSD Behavioral: The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia) Behavioral: Cognitive-Behavioral Therapy for Insomnia Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Novel Acceptance-based Treatment for Insomnia in Veterans With Post-Traumatic Stress Disorder
Actual Study Start Date : September 1, 2022
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : January 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: CBT-I


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.

  4. 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.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05194930


Contacts
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Contact: Jennifer L Martin, PhD (818) 891-7711 ext 36080 jennifer.martin@va.gov
Contact: Diane I Lee, MSW (818) 891-7711 ext 36087 Diane.Lee@va.gov

Locations
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United States, California
VA Greater Los Angeles Healthcare System, Sepulveda, CA Recruiting
Sepulveda, California, United States, 91343
Contact: Scott E Krahl, PhD MA BA    818-895-5861    scott.krahl@va.gov   
Contact: Taigy T Gooding, DrPH    (310) 478-3711 ext 36025    Taigy.Gooding@va.gov   
Sub-Investigator: Cathy A Alessi, MD MPH         
Principal Investigator: Jennifer L Martin, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Jennifer L Martin, PhD VA Greater Los Angeles Healthcare System, Sepulveda, CA
More Information
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Publications of Results:

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT05194930    
Other Study ID Numbers: IIR 20-283
First Posted: January 18, 2022    Key Record Dates
Last Update Posted: August 8, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Insomnia disorder
Chronic Post-Traumatic Stress Disorder
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders