Treatments for Insomnia in Veterans With PTSD
A Novel Acceptance-based Treatment for Insomnia in Veterans With Post-Traumatic Stress Disorder
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2022
CompletedFirst Posted
Study publicly available on registry
January 18, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
August 14, 2025
August 1, 2025
3.8 years
January 5, 2022
August 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
PTSD Check List for DSM-5 (PCL-5)
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)
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)
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
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
Study Arms (2)
The ABC of Insomnia (Acceptance and the Behavioral Changes to
EXPERIMENTALThis is the new treatment arm that is being compared to CBT-I, standard treatment for insomnia.
Cognitive-Behavioral Therapy for Insomnia
ACTIVE COMPARATORThis is the standard treatment for insomnia that is being compared to the new treatment (ABCI).
Interventions
5 individual sessions incorporating behavioral treatment components plus acceptance and commitment therapy (ACT) provided by a trained instructor.
5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343, United States
Related Publications (2)
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.
PMID: 34815139BACKGROUNDMartin JL, Carlson GC, Kelly MR, Song Y, Mitchell MN, Josephson KR, McGowan SK, Culver NC, Kay MA, Erickson AJ, Saldana KS, May KJ, Fiorentino L, Alessi CA, Washington DL, Yano EM. Novel treatment based on acceptance and commitment therapy versus cognitive behavioral therapy for insomnia: A randomized comparative effectiveness trial in women veterans. J Consult Clin Psychol. 2023 Nov;91(11):626-639. doi: 10.1037/ccp0000836. Epub 2023 Aug 3.
PMID: 37535521BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer L Martin, PhD
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2022
First Posted
January 18, 2022
Study Start
September 1, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
August 14, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share