Web-based Mind-body Program for Comorbid Nontraumatic Upper-extremity Condition and Risky Substan… (NCT06366633) | Clinical Trial Compass
CompletedNot Applicable
Web-based Mind-body Program for Comorbid Nontraumatic Upper-extremity Condition and Risky Substance Use
United States5 participantsStarted 2024-10-29
Plain-language summary
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.
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 (4 Weeks)
3
The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery
Timeframe: Post-Test (4 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 (4 Weeks)
6
Adherence to homework
Timeframe: Through intervention completion, an average of 1 month
7
Rate of participant's completion of self-report measures to assess feasibility of assessments