Web-based Mind-body Program to Improve Resilience Among Risky Substance Users With Persistent Upper Extremity Pain
RecruitingNot applicableNCT06991205
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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 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.
Study details
- Official title
- Feasibility RCT of Web-based Mind-body Treatment to Enhance Resilience Among Patients With Painful Nontraumatic Upper-extremity Conditions and Commorbid Risky Substance Use
- Conditions
- Orthopedic Disorder
- Nontraumatic Injury
- Upper Extremity Pain
- Risky Substance Use
- Interventions
- Behavioral: Web-TIRELESS
- Other: Web-MEUC
- Sponsor
- Jafar Bakhshaie
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Organization
- Massachusetts General Hospital
- Start date
- 2025-09-15
- Primary completion
- 2027-03-01
- 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 OR future plans for surgery.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06991205