[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634585":3},{"organization":4,"outcomesModule":7,"designInfo":63,"detailedDescription":71,"studyPopulation":62,"armGroups":72,"interventions":81,"overallOfficials":87,"centralContacts":97,"locations":106,"responsibleParty":124,"collaborators":62,"id":127,"slug":62,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":128,"sex":134,"minAge":135,"maxAge":62,"enrollmentInfo":136,"targetDuration":62,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":109,"whyStopped":62,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Minneapolis Veterans Affairs Medical Center","FED",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":62},[9],{"measure":10,"description":11,"timeFrame":12},"Pain interference","Measured using the Brief Pain Inventory (BPI) interference score. Minimum value: 0. Maximum value: 10. Higher scores indicate worse functioning.","Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.",[14,17,20,23,25,28,31,34,37,40,43,46,49,53,56,59],{"measure":15,"description":16,"timeFrame":12},"Pain intensity","Measured using the Brief Pain Inventory (BPI) intensity score. Minimum value: 0. Maximum value: 10. Higher scores indicate more severe pain.",{"measure":18,"description":19,"timeFrame":12},"Pain impact","Measured using the Graded Chronic Pain Scale-Revised (GCPS-R), a six item scale developed to differentiate mild, bothersome, and high-impact chronic pain. Two questions to identify chronic pain and high impact chronic pain; frequency of pain during the prior 3 months and frequency of limitation in activities in the prior 3 months.",{"measure":21,"description":22,"timeFrame":12},"Quality of life","Measured using the World Health Organization (WHO) 2-item measure which measures quality of life and satisfaction with health on a 1 to 5 scale.",{"measure":21,"description":24,"timeFrame":12},"Measured using the Euro Quality of Life scale, a 5 section questionnaire to assess mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression.",{"measure":26,"description":27,"timeFrame":12},"Physical functioning","Using the PROMIS Physical functioning 6-item short form v2.0 which measures difficulty doing household activities and agreement with statements on health limitations in physical activities on a 1 to 5 scale.",{"measure":29,"description":30,"timeFrame":12},"Sleep disturbance","Measured using PROMIS 6-item short form v1.0 which measures sleep quality on a 1 to 5 scale from very poor to very good in addition to agreement with statements on sleep quality on a 1 to 5 scale.",{"measure":32,"description":33,"timeFrame":12},"Sleep duration","Participants self-report their hours of sleep per night in the past month.",{"measure":35,"description":36,"timeFrame":12},"Fatigue","The PROMIS fatigue 4-item short form v1.0, which measures fatigue over the past 7 days.",{"measure":38,"description":39,"timeFrame":12},"Participation in Social Roles and Activities","Measured using the PROMIS 4-item short form v2.0 which measures frequency of trouble doing activities for leisure, work, or with family or friends on a 1 to 5 scale.",{"measure":41,"description":42,"timeFrame":12},"Anxiety","Anxiety will be measured using the Generalized Anxiety Disorder-2 survey (GAD-2) which includes 2 questions that are summed for a total score that can range from 0 to 6.",{"measure":44,"description":45,"timeFrame":12},"Depression","Depression will be measured using the Patient Health Questionnaire-2 (PHQ-2) which includes 2 questions that are summed for a total score that can range from 0 to 6.",{"measure":47,"description":48,"timeFrame":12},"Post Traumatic Stress Disorder (PTSD)","Measured using the Primary Care PTSD Screen for DSM-5, which asks whether the participant has had exposure to a traumatic event, and if yes, asks 5 follow-up yes\u002Fno question regarding experiences in the past month.",{"measure":50,"description":51,"timeFrame":52},"Overall improvement","Overall improvement will be assessed with the Patient Global Impression of Change (PGIC) which has participants rate their overall change from very much worse to very much improved on a 7-point scale.","Average over 6 months of follow-up, with assessments at 10 weeks and 6 months.",{"measure":54,"description":55,"timeFrame":12},"Percentage of participants self-reporting opioid medication use","Participant self report of opioid medication use.",{"measure":57,"description":58,"timeFrame":12},"Substance use","Measured using the Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) survey. The TAPS is comprised of a 4-item screen for substance use.",{"measure":60,"description":61,"timeFrame":52},"Adverse events","Participant self-report of any new or worsening health issue while participating in the study. Participants will also be asked to report potential side effects by choosing from a list of known potential risks of exercise and mindfulness interventions.",null,{"allocation":64,"interventionModel":65,"interventionModelDescription":62,"primaryPurpose":66,"observationalModel":62,"timePerspective":62,"maskingInfo":67},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":68,"maskingDescription":62,"whoMasked":69},"SINGLE",[70],"OUTCOMES_ASSESSOR","Our long-term objective is to improve pain management and reduce opioid use among rural patients in the VA. To accomplish this, we will conduct a randomized clinical trial (RCT) to test the effectiveness of an innovative multi-component complementary and integrative intervention, Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (RAMP) delivered via group telehealth, for improving rural Veterans' pain management, function, and wellbeing, within the VA healthcare system. This project addresses the significant challenge of implementing effective, non-opioid interventions for chronic pain management among rural Veterans, who experience a disproportionate share of the national pain burden, with more chronicity, opioid harms, comorbid mental health conditions and substance abuse, and are prescribed more opioids and have less access to evidence-based, chronic pain care that addresses their \"whole-person\" or biopsychosocial needs. The RAMP program strategically coalesces multiple evidence based CIH self-management strategies to address rural Veterans' biopsychosocial needs and overcome existing barriers to implementation. Comprised of pain education, mindfulness, pain specific exercises, and cognitive behavioral strategies, the program is cohesive and scalable.",[73,78],{"label":74,"type":75,"description":62,"interventionNames":76},"Intervention","EXPERIMENTAL",[77],"Behavioral: RAMP Program",{"label":79,"type":80,"description":62,"interventionNames":62},"Usual Care","NO_INTERVENTION",[82],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":62},"BEHAVIORAL","RAMP Program","RAMP is a 9-week program comprised of weekly online group sessions (90 minutes each) with pre-recorded expert-led education videos, mind-body skill training and practice, and facilitated discussions.",[74],[88,92,95],{"name":89,"affiliation":90,"role":91},"Roni Evans, DC, PhD, MS","University of Minnesota","PRINCIPAL_INVESTIGATOR",{"name":93,"affiliation":94,"role":91},"Katherine Hadlandsmyth, PhD","University of Iowa",{"name":96,"affiliation":5,"role":91},"Diana Burgess, PhD",[98,102],{"name":96,"role":99,"phone":100,"phoneExt":62,"email":101},"CONTACT","612-467-1591","diana.burgess@va.gov",{"name":103,"role":99,"phone":104,"phoneExt":62,"email":105},"Lee Cross, MPH","612-629-7568","lee.cross@va.gov",[107],{"facility":108,"status":109,"city":110,"state":111,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":120,"contacts":121},"Minneapolis VAMC","RECRUITING","Minneapolis","Minnesota","55417","United States","US",{"type":116,"coordinates":117},"Point",[118,119],-93.26384,44.97997,{"lat":119,"lon":118},[122,123],{"name":96,"role":99,"phone":100,"phoneExt":62,"email":101},{"name":103,"role":99,"phone":104,"phoneExt":62,"email":105},{"type":91,"investigatorFullName":125,"investigatorTitle":126,"investigatorAffiliation":5,"oldNameTitle":62,"oldOrganization":62},"Diana J. Burgess","Principal Investigator","100634585",false,"NCT07541599","Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention - UH3","Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention","RAMP","Inclusion Criteria:\n\n* 18 years of age or older\n* rural-dwelling based on U.S. Health Services Research Administration Criteria\n* chronic pain based on two qualifying pain diagnoses in their electronic health record (EHR) within the same diagnostic category, at least 90 days apart, during the previous 2 years\n* self-reported pain on at least most days in the past 3 months\n* Brief Pain Inventory Interference subscale score ≥ 4\u002F10\n* access to a device with internet\n* willingness to engage in intervention-specific procedures (e.g., meet remotely online for sessions)\n* an email address listed in the EHR.\n\nExclusion Criteria:\n\n* severe, poorly controlled psychiatric or substance use disorder (identified by chart review)\n* active member of advisory panel for the study\n* enrollment in another research study for pain\n* enrollment in a similar study\n* enrollment in a similar facilitated, multi-week, multi-modal complementary and integrative health program.","ALL","18 Years",{"count":137,"type":138},500,"ESTIMATED","INTERVENTIONAL",[141],"NA","The goal of the RAMP mind-body program is to provide Veterans with information and tools that can help them manage their pain. The program explores the important connection between our bodies and minds, and how to use this special connection to manage pain more effectively.",[144],"Chronic Pain",[146,147,148,149,150],"chronic pain","complementary therapies","models, biopsychosocial","rural","Veteran","2026-05-11",{"date":153,"type":154},"2026-05-15","ACTUAL",{"date":156,"type":154},"2026-04-01",{"date":158,"type":138},"2028-12",{"name":5,"class":6},1]