Web-based Mind-body Program to Improve Resilience Among Risky Substance Users With Persistent Upper Extremity Pain
Recruiting now · Not applicable
Conditions studied: Orthopedic Disorder, Nontraumatic Injury, Upper Extremity Pain, Risky Substance Use
In brief
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. Deliverables: \[1\] 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.
Key facts
- Study ID
- NCT06991205
- Run by
- Jafar Bakhshaie
- People needed
- 50
- Starts
- 2025-09-15
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Outpatient adults seeking care in the Hand and Arm Center
- Diagnosed with a non-traumatic painful upper-extremity condition (NPUC)
- Pain score > 4 on the Numerical Rating Scale (NRS)
- 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])
- Owns a smartphone, laptop, or computer with internet access
- Age ≥18yr
- English fluency
- Ability and willingness to participate in a live video focus group and the following asynchronous Web-based intervention
You may not qualify if…
- Participation in mind-body or specialized substance abuse treatment in the past 3 months
- Practice of mindfulness >45 minutes/week in the past 3 months
- Psychotropic medications (e.g. antidepressants) changed in the past 3 months
- Serious untreated mental illness (e.g., Schizophrenia)
- Suicidal ideation with intent or plan
- Pregnancy
- Secondary gains that may bias motivation (e.g., pending disability claim),
- Moderate to severe cognitive impairment (score ≥4 on the Short Portable Mental Status Questionnaire (SPMSQ))
- History of surgery for the presented NPUC within the past 6 months OR future plans for surgery.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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