Web-based Mind-body Program for Comorbid Nontraumatic Upper-extremity Condition and Risky Substance Use
Completed · Not applicable
Conditions studied: Orthopedic Disorder, Nontraumatic Injury, Substance Use, Upper Extremity Problem
In brief
The investigator aims to conduct an open pilot study (N=6; 5 completers) 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) for adult patients with a comorbidity of non-traumatic painful upper-extremity condition(s) (NPUC) and 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 in preparation for a future feasibility RCT. Participants will complete 4 on-demand video sessions at their own pace (approximate pace of 1 session per week) and complete baseline and post-test assessments. participants may also partake in an exit interview to provide feedback on Web-TIRELESS to further refine the program and study protocol for future iterations.
Key facts
- Study ID
- NCT06366633
- Run by
- Jafar Bakhshaie
- People needed
- 5
- Starts
- 2024-10-29
- Expected to finish
- 2025-07-31
- Last updated by the study team
- 2026-02-18
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
Where it is running
- Massachusetts General Hospital (MGH) — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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