NCT06991205 Web-based Mind-body Program to Improve Resilience Among Risky Substance Users With Persistent Upper Extremity Pain
| NCT ID | NCT06991205 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jafar Bakhshaie |
| Condition | Orthopedic Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-09-15 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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.
Eligibility 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.
Contact & Investigator
Jafar Bakhshaie, MD, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT06991205 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Orthopedic Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06991205 currently recruiting?
Yes, NCT06991205 is actively recruiting participants. Contact the research team at jbakhshaie@mgh.harvard.edu for enrollment information.
Where is the NCT06991205 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06991205 clinical trial?
NCT06991205 is sponsored by Jafar Bakhshaie. The principal investigator is Jafar Bakhshaie, MD, PhD at Massachusetts General Hospital. The trial plans to enroll 50 participants.