Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD (NCT07069517) | Clinical Trial Compass
RecruitingNot Applicable
Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD
United States160 participantsStarted 2025-12-02
Plain-language summary
This study is a two-arm individually randomized group treatment clinical trial evaluating behavioral therapies for insomnia, nightmares, and PTSD. The study will compare cognitive-behavioral therapy for insomnia and nightmares to sleep hygiene (Control), both integrated with Written Exposure Therapy for PTSD and delivered in an accelerated (i.e., 5-day) group treatment format, preceded and followed by individual treatment sessions. 160 participants will be randomized into one of two study conditions.
Who can participate
Age range
18 Years – 65 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
. Defense Enrollment Eligibility Reporting System (DEERS) eligible active-duty military personnel or veteran, 18-65 years old.
. Ability to speak and read English.
. Clinically significant PTSD symptoms (CAPS-5 \> 25 with at least one Intrusion symptom and at least one Avoidance symptom).
. Clinically significant symptoms of insomnia disorder (Structured Clinical Interview for Sleep Disturbance DSM-5 (SCISD) Insomnia Criteria are met and Insomnia Severity Index (ISI) \> 11).
. Nightmares \> 1 monthly (as reported on the SCISD).
. Willing to refrain from new behavioral health or medication treatment for issues pertaining to PTSD, sleep, and nightmares during study participation.
Exclusion criteria
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
1
Posttraumatic Stress Disorder Checklist (PCL-5)
Timeframe: Change from baseline through 3 and 6 month follow-up assessment
2
Insomnia Severity Index (ISI)
Timeframe: Change from baseline through 3 and 6 month follow up
3
Nightmare Disorders Index
Timeframe: Change from baseline through 3 and 6 month assessments
. Current suicide or homicide risk meriting crisis intervention.
. Inability to comprehend the baseline screening questionnaires.
. Unwilling to remain abstinent from alcohol during therapy sessions.
. Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate clinical attention based on interviewer assessment and clinical judgement.
. Currently engaged in evidence-based psychotherapy for PTSD (e.g., Prolonged Exposure Therapy, Cognitive Processing Therapy, Written Exposure Therapy) or insomnia or nightmares (e.g., Cognitive Behavioral Therapy for Insomnia or Nightmares).
. Pregnancy, as determined by self-report, because pregnancy can adversely affect sleep outside of PTSD, insomnia, and nightmares.
. Working duty shifts ending later than 21:00 or starting before 05:30 more than 2 times per month.