protocolSection identificationModule nctId: NCT06366633, orgStudyIdInfo id: 2024P000713, secondaryIdInfos id: 1K23AT012364-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1K23AT012364-01, briefTitle: Web-based Mind-body Program for Comorbid Nontraumatic Upper-extremity Condition and Risky Substance Use, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Jafar Bakhshaie, class: OTHER, collaborators name: National Center for Complementary and Integrative Health (NCCIH), descriptionModule briefSummary: The investigator aims to conduct an open pilot study (N=12; 10 completers) 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) for adult patients with a comorbidity of non-traumatic painful upper-extremity condition(s) (NPUC) and risky substance use.Deliverables: 1) Adapt and refine open pilot protocol, patient recruitment, and other study materials. 2) Assess the feasibility, acceptability, and credibility of Web- TIRELESS in preparation for a future feasibility RCT.Participants will complete 4 on-demand video sessions at their own pace (approximate pace of 1 session per week) and complete baseline and post-test assessments. participants may also partake in an exit interview to provide feedback on Web-TIRELESS to further refine the program and study protocol for future iterations., conditionsModule conditions: Orthopedic Disorder, conditions: Nontraumatic Injury, conditions: Substance Use, conditions: Upper Extremity Problem, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Web-TIRELESS, outcomesModule primaryOutcomes measure: Credibility and Expectancy Questionnaire (CEQ), primaryOutcomes measure: Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment, primaryOutcomes measure: The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery, primaryOutcomes measure: The percent of patients that agree to participate to assess feasibility of recruitment, primaryOutcomes measure: Rate at which program was accepted, measured by attendance to assess acceptability of treatment, primaryOutcomes measure: Adherence to homework, primaryOutcomes measure: Rate of participant's completion of self-report measures to assess feasibility of assessments, primaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Graded Chronic Pain Scale (GCPS), secondaryOutcomes measure: Disabilities of the Arm, Shoulder and Hand (DASH), secondaryOutcomes measure: Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression-Short Form 8b v1.0, secondaryOutcomes measure: PROMIS Emotional Distress - Anxiety-Short Form 8b v1.0, secondaryOutcomes measure: Pain Catastrophizing Scale (PCS), secondaryOutcomes measure: Pain Anxiety Symptoms Scale - Short Form (PASS-20), secondaryOutcomes measure: Pain Vigilance and Awareness Questionnaire (PVAQ), secondaryOutcomes measure: Brief Experiential Avoidance Questionnaire (BEAQ), secondaryOutcomes measure: Current Opioid Misuse Measure (COMM), secondaryOutcomes measure: The Timeline Follow Back (TLFB), secondaryOutcomes measure: Numerical Rating Scale (NRS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02129, country: United States, contacts name: Jafar Bakhshaie, MD, PhD, role: CONTACT, phone: 617-643-7641, email: jbakhshaie@mgh.harvard.edu, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False