Clinical trial NCT06991205: Web-based Mind-body Program to Improve Resilience Among Risky Substance Users With Persistent Upper Extremity Pain
Official title: Feasibility RCT of Web-based Mind-body Treatment to Enhance Resilience Among Patients With Painful Nontraumatic Upper-extremity Conditions and Commorbid Risky Substance Use
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Orthopedic Disorder
Nontraumatic Injury
Upper Extremity Pain
Risky Substance Use
Keywords: Upper Extremity Problem
Risky substance use
Randomized Controlled Trial (RCT)
Mindfulness
Nontraumatic conditions
Chronic pain
Psychiatry
Feasibility
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2025-05-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Aim: Conduct a feasibility randomized controlled trial (RCT) (N=50) of Web-TIRELESS versus Minimally Enhanced Usual Care (Web-MEUC)-both of which are web-based-among patients with painful nontraumatic upper extremity conditions and comorbid risky substance use (N=50), to demonstrate the feasibility of recruitment procedures and data collection; and the feasibility, credibility, and acceptability (adherence, retention, fidelity, and satisfaction) of Web-TIRELESS and Web-MEUC. We will use this mixed-methods information to assess the primary outcomes and optimize both programs and study methodology in preparation for research.

Participants are randomized to either Web-TIRELESS or Web-MEUC and given access to the respective program for approximately 5 weeks to review and complete the assigned material. Both groups are given education material to help improve pain and substance use urge coping. There are 3 assessment points consisting of self-report surveys: baseline, post-program, and 6-month follow-up.

Eligibility criteria: Inclusion Criteria:

1. Outpatient adults seeking care in the Hand and Arm Center
2. Diagnosed with a non-traumatic painful upper-extremity condition (NPUC)
3. Pain score \> 4 on the Numerical Rating Scale (NRS)
4. 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 \[WHO-ASSIST\])
5. Owns a smartphone, laptop, or computer with internet access
6. Age ≥18yr
7. English fluency
8. Ability and willingness to participate in a live video focus group and the following asynchronous Web-based intervention

Exclusion Criteria:

1. Participation in mind-body or specialized substance abuse treatment in the past 3 months
2. Practice of mindfulness \>45 minutes/week in the past 3 months
3. Psychotropic medications (e.g. antidepressants) changed in the past 3 months
4. Serious untreated mental illness (e.g., Schizophrenia)
5. Suicidal ideation with intent or plan
6. Pregnancy
7. Secondary gains that may bias motivation (e.g., pending disability claim),
8. Moderate to severe cognitive impairment (score ≥4 on the Short Portable Mental Status Questionnaire (SPMSQ))
9. History of surgery for the presented NPUC within the past 6 months OR future plans for surgery.

Primary outcomes:
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Baseline (0 Weeks)
measure: Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment
timeFrame: Post-Test (5 Weeks)
measure: The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery
timeFrame: Post-Test (5 Weeks)
measure: The percent of patients that agree to participate to assess feasibility of recruitment
timeFrame: Baseline (0 Weeks)
measure: Rate at which program was accepted, measured by attendance to assess acceptability of treatment
timeFrame: Post-Test (5 Weeks)
measure: Adherence to homework
timeFrame: Throughout intervention completion, an average of 1 month
measure: Rate of participant's completion of self-report measures to assess feasibility of assessments
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks)
measure: Adverse Events
timeFrame: Throughout intervention completion, an average of 1 month
Secondary outcomes:
measure: Graded Chronic Pain Scale (GCPS)
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression-Short Form 8a v1.0
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
measure: PROMIS Emotional Distress - Anxiety-Short Form 8a v1.0
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
measure: Pain Anxiety Symptoms Scale - Short Form (PASS-20)
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
measure: Pain Vigilance and Awareness Questionnaire (PVAQ)
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
measure: Brief Experiential Avoidance Questionnaire (BEAQ)
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
measure: Current Opioid Misuse Measure (COMM)
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
measure: The Timeline Follow Back (TLFB)
timeFrame: Throughout intervention completion, an average of 1 month
measure: Numerical Rating Scale (NRS)
timeFrame: Eligibility Screening (-1 Weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jafar Bakhshaie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: