Mantram Repetition Versus Health Education for Veterans With PTSD and Chronic Pain (NCT07725588) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mantram Repetition Versus Health Education for Veterans With PTSD and Chronic Pain
United States170 participantsStarted 2027-04-01
Plain-language summary
Approximately 450,000 Veterans Health Administration service users have both posttraumatic stress disorder (PTSD) and chronic pain (CP); treatments that efficiently target both PTSD and CP are limited, and new interventions should address the unique needs of Veterans with PTSD/CP. Mantram Repetition Program (MRP), a meditation-based program, appears well-suited to address these high-priority VA needs. MRP has established effectiveness for treatment of PTSD, is broadly acceptable, can be learned quickly and applied flexibly. However, rigorous testing is needed for pain-related outcomes among a PTSD/CP population. The proposed study will include a randomized controlled trial comparing the efficacy of MRP for PTSD/CP to Health Education while Living with Pain among a sample of 170 Veterans with comorbid PTSD/CP. The primary outcomes will be PTSD symptoms and pain interference. Results from this study will directly inform patient care among the nearly 4% of Veterans with PTSD/CP.
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:
* U.S. Veteran
* Diagnosis of PTSD
* Chronic, non-malignant pain:
* (a) pain most days (\> 3 days/week) for at least 6 months
* (b) average pain severity and interference with enjoyment of life and/or general
* Willing/able to engage in study activities
Exclusion Criteria:
* Significant current risk of suicide or homicide
* Untreated severe alcohol or substance use disorder
* Untreated/unstable serious mental health disorders, such as psychotic disorders, bipolar disorder, or serious dissociative symptoms
* Impaired mental status
* Concurrent interventions specifically targeting PTSD or CP or social functioning (e.g., couples therapy) or any meditative or mind-body intervention
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
The Revised Clinician-Administered PTSD scale for DSM-5 (CAPS-5-R)
Timeframe: 0, 5, 10, 20 weeks
2
Patient Reported Outcome Short Form Pain Interference (PROMIS-PI short form v1.1)