Web-based mind-body program to build resilience for adults with non‑traumatic upper‑extremity pain and risky substance use
Feasibility RCT of Web-based Mind-body Treatment to Enhance Resilience Among Patients With Painful Nontraumatic Upper-extremity Conditions and Commorbid Risky Substance Use
This trial will try an online mind‑body program to help adults with non‑traumatic upper‑extremity pain who also engage in risky substance use build resilience and better cope with pain and substance urges.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06991205 on ClinicalTrials.gov |
What this trial studies
This is a feasibility randomized controlled trial (N=50) comparing an asynchronous web-based mind-body program (Web-TIRELESS) to a minimally enhanced web-based usual care program (Web-MEUC) for adults with painful non‑traumatic upper‑extremity conditions and comorbid risky substance use. Participants are randomized and given access to their assigned program for about five weeks, with self-report assessments at baseline, post-program, and six months. Primary goals are to test recruitment and data-collection procedures and to measure feasibility, credibility, acceptability (adherence, retention, fidelity, satisfaction) using mixed methods. Findings will be used to refine the intervention content, study materials, and trial methods for future research.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) receiving outpatient care at the Hand and Arm Center with a non‑traumatic painful upper‑extremity condition, pain >4/10, risky substance use on the WHO‑ASSIST within the specified ranges, English fluency, internet access, and willingness to join an online program and a live video focus group.
Not a fit: Patients already engaged in recent mind‑body or specialized substance treatment, those practicing mindfulness >45 minutes/week, individuals with recent changes to psychotropic medications, or those with substance use severity outside the inclusion ranges are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could provide a scalable, low‑burden way to improve coping, reduce pain‑related distress, and lower substance‑use urges among affected patients.
How similar studies have performed: Web‑delivered mindfulness and mind‑body programs have shown benefits for chronic pain and for reducing substance‑use risk in some trials, but combining a targeted web mind‑body program specifically for non‑traumatic upper‑extremity pain with risky substance use is novel and relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 OR future plans for surgery.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Jafar Bakhshaie, MD, PhD — Massachusetts General Hospital
- Study coordinator: Jafar Bakhshaie, MD, PhD
- Email: jbakhshaie@mgh.harvard.edu
- Phone: 617-643-7641
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.