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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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