Web-based mind-body program to build resilience for adults with non‑traumatic upper‑extremity pain and risky substance use

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.