Status:
RECRUITING
Web-based Mind-body Program to Improve Resilience Among Risky Substance Users With Persistent Upper Extremity Pain
Lead Sponsor:
Jafar Bakhshaie
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Orthopedic Disorder
Nontraumatic Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 (Too...
Detailed Description
Aim: Conduct a feasibility randomized controlled trial (RCT) (N=50) of Web-TIRELESS versus Minimally Enhanced Usual Care (Web-MEUC)-both of which are web-based-among patients with painful nontraumatic...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06991205
Start Date
September 15 2025
End Date
March 1 2027
Last Update
October 31 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114