Web-based Mind-body Program for Comorbid Nontraumatic Upper-extremity Condition and Risky Substance Use
CompletedNot applicableNCT06366633
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The investigator aims to conduct an open pilot study (N=6; 5 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.
Study details
- Official title
- Feasibility Open Pilot of Web-based Mind-body Treatment to Enhance Resilience Among Patients With Nontraumatic Painful Upper Extremity Conditions and Comorbid Risky Substance Use
- Conditions
- Orthopedic Disorder
- Nontraumatic Injury
- Substance Use
- Upper Extremity Problem
- Interventions
- Behavioral: Web-TIRELESS
- Sponsor
- Jafar Bakhshaie
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Organization
- Massachusetts General Hospital
- Start date
- 2024-10-29
- Primary completion
- 2025-05-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Outpatient adults seeking care in the Hand and Arm Center 2. Diagnosed with a non-traumatic painful upper-extremity condition (NPUC) 3. Pain score \> 4 on the Numerical Rating Scale (NRS) 4. Risky substance use (scores \>10 and \<27 for alcohol, and \>3 and \<27 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 \[WHO-ASSIST\]) 5. Owns a smartphone, laptop, or computer with internet access 6. Age ≥18yr 7. English fluency 8. Ability and willingness to participate in a live video focus group and the following asynchronous Web-based intervention Exclusion Criteria: 1. Participation in mind-body or specialized substance abuse treatment in the past 3 months 2. Practice of mindfulness \>45 minutes/week in the past 3 months 3. Psychotropic medications (e.g. antidepressants) changed in the past 3 months 4. Serious untreated mental illness (e.g., Schizophrenia) 5. Suicidal ideation with intent or plan 6. Pregnancy 7. Secondary gains that may bias motivation (e.g., pending disability claim), 8. Moderate to severe cognitive impairment (score ≥4 on the Short Portable Mental Status Questionnaire (SPMSQ)) 9. History of surgery for the presented NPUC within the past 6 months
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06366633