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Not Yet Recruiting
NCT07725588
RCT of Mantram Repetition Versus Health Education for Veterans With PTSD and Chronic Pain
Conditions: Stress Disorders, Post-Traumatic, Pain, Chronic
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 170
Sponsor: VA Office of Research and Development
Location: VA San Diego Healthcare System, San Diego, CA San Diego California
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07725588). StuddyBuddy aggregates publicly available trial information.