RecruitingNot Applicable

Treatments for Insomnia in Veterans With PTSD

United States400 participantsStarted 2022-09-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PTSD Check List for DSM-5 (PCL-5)

Timeframe: 6-months follow-up

Insomnia Severity Index (ISI)

Timeframe: 6-months follow-up

Pittsburgh Sleep Quality Index (PSQI)

Timeframe: 6-months follow-up

Sleep efficiency from 7-day sleep diary

Timeframe: 6-months follow-up

Trial details

NCT IDNCT05194930

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Jennifer L Martin, PhD

(305) 575-7000 jennifer.martin@va.gov

View on ClinicalTrials.gov More Insomnia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.