[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07725588":3,"trial-entities:NCT07725588":106,"trial-summary:NCT07725588":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":46,"secondary_outcomes":54,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":79,"locations":82,"central_contacts":100,"overall_officials":102,"references":104,"see_also_links":105},"NCT07725588","NURP-008-25F","Mantram Repetition Versus Health Education for Veterans With PTSD and Chronic Pain","Randomized Controlled Trial of Mantram Repetition Program Versus Health and Wellness Psychoeducation for Veterans With Comorbid Posttraumatic Stress Disorder and Chronic Pain","NOT_YET_RECRUITING","2030-09-30","2026-07","2026-07-27","2027-04-01","VA Office of Research and Development","FED",false,"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\u002FCP. 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\u002FCP population. The proposed study will include a randomized controlled trial comparing the efficacy of MRP for PTSD\u002FCP to Health Education while Living with Pain among a sample of 170 Veterans with comorbid PTSD\u002FCP. 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\u002FCP.","Posttraumatic stress disorder (PTSD) and chronic, non-malignant pain (CP) are prevalent and costly public health problems, especially among Veterans. Veterans with PTSD\u002FCP utilize more healthcare, have higher rates of insomnia and other psychiatric conditions, increased risk of suicide, worse pain interference, and poorer psychological and social functioning than those with one or neither condition. Mantram Repetition Program (MRP) is a meditation-based treatment that involves silent repetition of a spiritual word combined with one-pointed attention and slowing down. Multiple trials demonstrate that MRP is broadly acceptable, and several randomized controlled trials (RCTs) have supported its efficacy for PTSD in Veterans, primarily via reduced physiological arousal. MRP has not been well-tested among Veterans with CP.\n\nComorbid PTSD\u002FCP affects approximately 3.8% of US military Veterans (450,000+ VHA service users). Integrative interventions for PTSD\u002FCP are limited, current practices are often disorder-specific and do not confer benefits for all, and innovative treatments are needed to address the unique needs of Veterans with PTSD\u002FCP. Thus, the target population of this study, Veterans with PTSD\u002FCP, is a high priority VA population, and this project is well-aligned with numerous VHA initiatives, including VHA's Whole Health Initiative, Pain Directive, and Pain Management Strategy. Further, MRP is a VA developed product and is readily accessible.\n\nTo our knowledge, this is the first RCT of MRP to evaluate CP-related outcomes. In addition, there are currently few evidence-based psychosocial interventions, including complementary and integrative health (CIH) approaches, that efficiently target both PTSD symptoms and CP interference in Veterans. Though the VA has emphasized the relevance of a Whole Health approach to Veteran's health care, there is only one recommended CIH approach for the treatment of both PTSD and CP. Furthermore, much of the current mantra meditation literature is limited by small sample sizes and methodological weaknesses, which are addressed here through randomization, use of adequate control conditions, and other procedures to reduce potential bias (e.g., blinded evaluators).\n\nSpecific Aims: (1) To evaluate the efficacy of Mantram Repetition Program for Veterans with comorbid PTSD and CP (MRPPP) compared to Health Education while Living with Pain (H.E.L.P.; health and wellness psychoeducation control) in decreasing PTSD symptom severity and pain interference across study period; (2) to examine hyperarousal and insomnia severity as treatment mechanisms that underpin observed changes in PTSD symptoms and pain interference; (3) evaluate the efficacy of MRPPP vs. H.E.L.P. on exploratory clinical outcomes of interest and potential moderators.\n\nThe proposed study is a randomized, controlled phase II trial with longitudinal assessments over a 26-week period at VA San Diego. MRPPP and H.E.L.P. will be delivered via telehealth in eight, 90- minute group intervention sessions among Veterans with PTSD\u002FCP (n = 170). The primary outcomes are PTSD symptom severity and pain interference, assessed at 0, 5, 10, and 20 weeks. Secondary outcomes include mechanisms of treatment effect, including hyperarousal and insomnia severity. Exploratory aims will include additional potential outcomes of interest and moderators of treatment effects.\n\nFindings from the proposed RCT will inform clinical practice and policy by investigating whether Mantram Repetition Program for PTSD + Pain (MRPPP) will improve treatment outcomes for Veterans. MRP is already being applied in multiple other settings, and dissemination and implementation of the adapted product would be straightforward. This work could ultimately lead to better care for Veterans, greater stakeholder satisfaction, and lower costs to VA.",[19,20],"Stress Disorders, Post-Traumatic","Pain, Chronic",[22],"Meditation","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},170,"ESTIMATED",[31,39],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"BEHAVIORAL","Mantram Repetition Program for PTSD + Pain","manualized Mantram Repetition Program adapted for Veterans with PTSD and chronic pain",[36],"mantram repetition program",[38],"MRP",{"type":32,"name":40,"description":41,"armGroupLabels":42,"otherNames":44},"Health Education while Living with Pain","manualized health and wellness psychoeducation and discussion group",[43],"health education",[45],"H.E.L.P.",[47,51],{"measure":48,"description":49,"timeFrame":50},"The Revised Clinician-Administered PTSD scale for DSM-5 (CAPS-5-R)","The CAPS-5-R is a widely-used, well-validated clinician interview that diagnoses PTSD and assesses the severity of PTSD symptoms. Total severity scores range from 0-200, with higher scores indicated greater severity.","0, 5, 10, 20 weeks",{"measure":52,"description":53,"timeFrame":50},"Patient Reported Outcome Short Form Pain Interference (PROMIS-PI short form v1.1)","The PROMIS-PI short form is a self-report measure of pain-related functional interference. PROMIS-PI items are self-rated from 1 to 5; responses range from 1 (\"not at all\") to 5 (\"very much\"). The PROMIS-PI is psychometrically sound and provides meaningful estimates of change in pain interference in clinical samples.",[55,58],{"measure":56,"description":57,"timeFrame":50},"Insomnia Severity Index (ISI)","The ISI is a 7-item self-report measure of the severity and impact of insomnia over the past two weeks. Items are rated from 0 (\"no problem\") to 4 (\"very severe problem\"); total ISI scores of 0-7 indicate the absence of clinically significant insomnia, scores from 8-14 indicate subthreshold insomnia, and scores of 15-28 indicate moderate-to-severe insomnia. The ISI has good psychometric properties and is sensitive to changes in perceived sleep difficulties.",{"measure":59,"description":60,"timeFrame":50},"Pre-Sleep Arousal Scale (PSAS)","The PSAS is a 16-item self-report measure of cognitive and somatic (hyper)arousal occurring before sleep; cognitive arousal symptoms including worrying about sleep, having racing thoughts, and sleep effort, while somatic arousal symptoms include bodily tension\u002Fgeneral restlessness and difficulty breathing. PSAS items are rated from 1 (\"not at all\") to 5 (\"extremely\"), which are summed to yield two subscale scores ranging from 8 to 40, with higher scores indicated increased arousal before sleep. The PSAS has adequate psychometric properties.","ALL","18 Years",null,{"inclusion":65,"exclusion":72,"raw_text":78},[66,67,68,69,70,71],"U.S. Veteran","Diagnosis of PTSD","Chronic, non-malignant pain:","(a) pain most days (\\> 3 days\u002Fweek) for at least 6 months","(b) average pain severity and interference with enjoyment of life and\u002For general","Willing\u002Fable to engage in study activities",[73,74,75,76,77],"Significant current risk of suicide or homicide","Untreated severe alcohol or substance use disorder","Untreated\u002Funstable 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","Inclusion Criteria:\n\n* U.S. Veteran\n* Diagnosis of PTSD\n* Chronic, non-malignant pain:\n\n  * (a) pain most days (\\> 3 days\u002Fweek) for at least 6 months\n  * (b) average pain severity and interference with enjoyment of life and\u002For general\n* Willing\u002Fable to engage in study activities\n\nExclusion Criteria:\n\n* Significant current risk of suicide or homicide\n* Untreated severe alcohol or substance use disorder\n* Untreated\u002Funstable serious mental health disorders, such as psychotic disorders, bipolar disorder, or serious dissociative symptoms\n* Impaired mental status\n* Concurrent interventions specifically targeting PTSD or CP or social functioning (e.g., couples therapy) or any meditative or mind-body intervention",[80,81],"ADULT","OLDER_ADULT",[83],{"facility":84,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":97},"VA San Diego Healthcare System, San Diego, CA","San Diego","California","92161-0002","United States",[90,95],{"name":91,"role":92,"phone":93,"email":94},"Anne L Malaktaris","CONTACT","(858) 642-3794","anne.malaktaris@va.gov",{"name":91,"role":96},"PRINCIPAL_INVESTIGATOR",{"lat":98,"lon":99},32.71571,-117.16472,[101],{"name":91,"role":92,"phone":93,"email":94},[103],{"name":91,"affiliation":84,"role":96},[],[],{"nct_id":4,"conditions":107,"biomarkers":110},[108,109],"Chronic Pain","Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":112,"summary":113,"prompt_version":123},true,{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This study is an interventional study planning to enroll 170 participants. It compares two different behavioral programs.","completed","Mantram Repetition for Veterans with PTSD and Chronic Pain","This study is looking at two behavioral programs for U.S. Veterans who have both post-traumatic stress disorder (PTSD) and chronic pain. One program is called Mantram Repetition, which is a meditation-based practice. The other is a health education and discussion group. Researchers want to see if Mantram Repetition can help reduce PTSD symptoms and pain interference (how much pain affects your daily life) compared to health education. You might be able to join if you are a U.S. Veteran, have a diagnosis of PTSD, and have chronic pain that has lasted at least 6 months. The study is currently unclear about its recruitment status.","Participants will be followed for 20 weeks after starting the study.",104,"Participants will be measured at 0, 5, 10, and 20 weeks to track changes in PTSD symptoms and pain interference.","Not stated in the trial record.",[],"v2"]