Web-based Mind-body Program to Improve Resilience Among Risky Substance Users With Persistent Upp… (NCT06991205) | Clinical Trial Compass
RecruitingNot Applicable
Web-based Mind-body Program to Improve Resilience Among Risky Substance Users With Persistent Upper Extremity Pain
United States50 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Participation in mind-body or specialized substance abuse treatment in the past 3 months
What they're measuring
1
Credibility and Expectancy Questionnaire (CEQ)
Timeframe: Baseline (0 Weeks)
2
Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment
Timeframe: Post-Test (5 Weeks)
3
The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery
Timeframe: Post-Test (5 Weeks)
4
The percent of patients that agree to participate to assess feasibility of recruitment
Timeframe: Baseline (0 Weeks)
5
Rate at which program was accepted, measured by attendance to assess acceptability of treatment
Timeframe: Post-Test (5 Weeks)
6
Adherence to homework
Timeframe: Throughout intervention completion, an average of 1 month
7
Rate of participant's completion of self-report measures to assess feasibility of assessments