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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

Tracking Information
First Submitted Date  ICMJE January 5, 2022
First Posted Date  ICMJE January 18, 2022
Last Update Posted Date August 8, 2023
Actual Study Start Date  ICMJE September 1, 2022
Estimated Primary Completion Date July 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatments for Insomnia in Veterans With PTSD
Official Title  ICMJE A Novel Acceptance-based Treatment for Insomnia in Veterans With Post-Traumatic Stress Disorder
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Insomnia
  • PTSD
Intervention  ICMJE
  • 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
  • Behavioral: Cognitive-Behavioral Therapy for Insomnia
    5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor.
    Other Name: CBT-I
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia)
  • Active Comparator: Cognitive-Behavioral Therapy for Insomnia
    This is the standard treatment for insomnia that is being compared to the new treatment (ABCI).
    Intervention: Behavioral: Cognitive-Behavioral Therapy for Insomnia
Publications * Carlson GC, Kelly MR, Mitchell M, Josephson KR, McGowan SK, Culver NC, Kay M, Alessi CA, Fung CH, Washington DL, Hamilton A, Yano EM, Martin JL. Benefits of Cognitive Behavioral Therapy for Insomnia for Women Veterans with and without Probable Post-Traumatic Stress Disorder. Womens Health Issues. 2022 Mar-Apr;32(2):194-202. doi: 10.1016/j.whi.2021.10.007. Epub 2021 Nov 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 5, 2022)		 400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2026
Estimated Primary Completion Date July 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05194930
Other Study ID Numbers  ICMJE IIR 20-283
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party VA Office of Research and Development
Original Responsible Party Same as current
Current Study Sponsor  ICMJE VA Office of Research and Development
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jennifer L Martin, PhD VA Greater Los Angeles Healthcare System, Sepulveda, CA
PRS Account VA Office of Research and Development
Verification Date August 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP