Mantram Repetition Versus Health Education for Veterans With PTSD and Chronic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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
Qualifiers
U.S. Veteran
Diagnosis of PTSD
(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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Mantram Repetition Program for PTSD + Pain
- Health Education while Living with Pain
Treatment groups
170 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov