[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592267":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":87,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Web-TIRELESS","EXPERIMENTAL","A 4-session, asynchronous, web-based mind-body pain and substance use management intervention.",[13],"Behavioral: Web-TIRELESS",{"label":15,"type":16,"description":17,"interventionNames":18},"Web-MEUC","ACTIVE_COMPARATOR","Open access to a web-based pamphlet containing brief, educational information and coping techniques.",[19],"Other: Web-MEUC",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","This is a self-administered web-based intervention that consists of 4 on-demand sessions, each \\~30 minutes long, that teach mind-body skills, cognitive-behavioral strategies (e.g., reframing, pain and substance use urge surfing), activity pacing, acceptance and commitment skills, and psychoeducation on the association between substance use and pain. The program aims to increase patients' physical and emotional functioning and decrease pain intensity and maladaptive substance use behaviors.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"An educational information web-based pamphlet, containing brief, summarized information tailored for the respective patient population that follows topics including the trajectory of pain and adaptation after non-traumatic painful upper extremity conditions, the role of relaxation strategies to manage pain, and the importance of returning to engagement in activities of daily living.",[15],[30],{"name":31,"affiliation":5,"role":32},"Jafar Bakhshaie, MD, PhD","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","617-643-7641","jbakhshaie@mgh.harvard.edu",{"name":39,"role":35,"phone":40,"phoneExt":25,"email":41},"Kozbi B Cliff, BS","617-643-8678","klbayne@mgh.harvard.edu",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-71.05977,42.35843,{"lat":54,"lon":53},[57],{"name":58,"role":35,"phone":36,"phoneExt":25,"email":37},"Principal Investigator",{"type":60,"investigatorFullName":61,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Jafar Bakhshaie",[63],{"name":64,"class":65},"National Center for Complementary and Integrative Health (NCCIH)","NIH","100592267","web-based-mind-body-program-to-improve-resilience-among-risky-substance-users-with-persistent-upper-extremity-pain-100592267",false,"NCT06991205","Web-based Mind-body Program to Improve Resilience Among Risky Substance Users With Persistent Upper Extremity Pain","Feasibility RCT of Web-based Mind-body Treatment to Enhance Resilience Among Patients With Painful Nontraumatic Upper-extremity Conditions and Commorbid Risky Substance Use","Inclusion Criteria:\n\n1. Outpatient adults seeking care in the Hand and Arm Center\n2. Diagnosed with a non-traumatic painful upper-extremity condition (NPUC)\n3. Pain score \\> 4 on the Numerical Rating Scale (NRS)\n4. Risky substance use (scores \\>10 and \\\u003C27 for alcohol, and \\>3 and \\\u003C27 for cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, opioids, tobacco products, and e-cigarette on The World Health Organization's - Alcohol, Smoking and Substance Involvement Screening Test \\[WHO-ASSIST\\])\n5. Owns a smartphone, laptop, or computer with internet access\n6. Age ≥18yr\n7. English fluency\n8. Ability and willingness to participate in a live video focus group and the following asynchronous Web-based intervention\n\nExclusion Criteria:\n\n1. Participation in mind-body or specialized substance abuse treatment in the past 3 months\n2. Practice of mindfulness \\>45 minutes\u002Fweek in the past 3 months\n3. Psychotropic medications (e.g. antidepressants) changed in the past 3 months\n4. Serious untreated mental illness (e.g., Schizophrenia)\n5. Suicidal ideation with intent or plan\n6. Pregnancy\n7. Secondary gains that may bias motivation (e.g., pending disability claim),\n8. Moderate to severe cognitive impairment (score ≥4 on the Short Portable Mental Status Questionnaire (SPMSQ))\n9. History of surgery for the presented NPUC within the past 6 months OR future plans for surgery.","ALL","18 Years",{"count":76,"type":77},50,"ESTIMATED","INTERVENTIONAL",[80],"NA","The investigator aims to conduct a feasibility randomized controlled trial (RCT) (N=50) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) versus web-based minimally enhanced usual care (Web-MEUC) among adult patients with a painful non-traumatic upper-extremity condition(s) (PNUC) and commorbid risky substance use.\n\nDeliverables: \\[1\\] Adapt and refine open pilot protocol, patient recruitment, and other study materials. \\[2\\] Assess the feasibility, acceptability, and credibility of Web-TIRELESS and Web-MEUC in preparation for future research.",[83,84,85,86],"Orthopedic Disorder","Nontraumatic Injury","Upper Extremity Pain","Risky Substance Use",[88,89,90,91,92,93,94,95],"Upper Extremity Problem","Risky substance use","Randomized Controlled Trial (RCT)","Mindfulness","Nontraumatic conditions","Chronic pain","Psychiatry","Feasibility","2026-03-11",{"date":98,"type":99},"2026-03-13","ACTUAL",{"date":101,"type":99},"2025-09-15",{"date":103,"type":77},"2027-03-01",{"name":61,"class":6},1]