NCT06991205 · Jafar Bakhshaie
Web-based Mind-body Program to Improve Resilience Among Risky Substance Users With Persistent Upper Extremity Pain
What this study is about
The investigator aims to conduct a feasibility randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Web-TIRELESS
This is a self-administered web-based intervention that consists of 4 on-demand sessions, each \~30 minutes long, that teach mind-body skills, cognitive-behavioral strategies (e.g., reframing, pain and substance use urge surfing), activity pacing, acceptance and commitment skills, and psychoeducation on the association between substance use and pain. The program aims to increase patients' physical and emotional functioning and decrease pain intensity and maladaptive substance use behaviors.
OTHER
Web-MEUC
An educational information web-based pamphlet, containing brief, summarized information tailored for the respective patient population that follows topics including the trajectory of pain and adaptation after non-traumatic painful upper extremity conditions, the role of relaxation strategies to manage pain, and the importance of returning to engagement in activities of daily living.
Primary outcome measures
Credibility and Expectancy Questionnaire (CEQ)
Time frame: Baseline (0 Weeks)
Assesses the degree to which one believes the intervention will effectively manage their condition, substance use, and related worry. Possible scores range from 3 to 27 for both the credibility and the expectancy subscales. Higher scores represent higher credibility and expectancy.
Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment
Time frame: Post-Test (5 Weeks)
Participants' satisfaction with treatment received after completion. The score range is 0-12. Higher scores indicate greater satisfaction.
The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery
Time frame: Post-Test (5 Weeks)
This measure will assess how well patients like the Wed-based program content and delivery. Total raw scores range from 22 to 110 with higher scores indicating greater satisfaction with the platform.
The percent of patients that agree to participate to assess feasibility of recruitment
Time frame: Baseline (0 Weeks)
The percent of eligible patients approached that agree to participate.
Rate at which program was accepted, measured by attendance to assess acceptability of treatment
Time frame: Post-Test (5 Weeks)
The proportion of Web-TIRELESS participants who complete \> or = 3 of 4 sessions.
Adherence to homework
Time frame: Throughout intervention completion, an average of 1 month
Rate of Web-TIRELESS participant's completion of homework assigned throughout the study.
Rate of participant's completion of self-report measures to assess feasibility of assessments
Time frame: Baseline (0 Weeks), Post-Test (5 Weeks)
Investigators will report number of patients who complete assessments at each time-point.
Adverse Events
Time frame: Throughout intervention completion, an average of 1 month
Any self-reported or observed negative events related to participation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- 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
- 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 OR future plans for surgery.
Where
- Boston, Massachusetts
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2026 · Source of record for eligibility and locations