Web-based Mind-body Program to Improve Resilience Among Risky Substance Users With Persistent Upper Extremity Pain

NCT06991205 | Recruiting DMC

• 2 other identifiers: 2025P0013355K23AT012364-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• Credibility and Expectancy Questionnaire (CEQ)

  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.

  Baseline (0 Weeks)

• Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment

  Participants' satisfaction with treatment received after completion. The score range is 0-12. Higher scores indicate greater satisfaction.

  Post-Test (5 Weeks)

• The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery

  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.

  Post-Test (5 Weeks)

• The percent of patients that agree to participate to assess feasibility of recruitment

  The percent of eligible patients approached that agree to participate.

  Baseline (0 Weeks)

• Rate at which program was accepted, measured by attendance to assess acceptability of treatment

  The proportion of Web-TIRELESS participants who complete \> or = 3 of 4 sessions.

  Post-Test (5 Weeks)

• Adherence to homework

  Rate of Web-TIRELESS participant's completion of homework assigned throughout the study.

  Throughout intervention completion, an average of 1 month

• Rate of participant's completion of self-report measures to assess feasibility of assessments

  Investigators will report number of patients who complete assessments at each time-point.

  Baseline (0 Weeks), Post-Test (5 Weeks)

• Adverse Events

  Any self-reported or observed negative events related to participation.

  Throughout intervention completion, an average of 1 month

Secondary Outcomes (11)

• Graded Chronic Pain Scale (GCPS)

  Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)

• Disabilities of the Arm, Shoulder and Hand (DASH)

  Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)

• Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression-Short Form 8a v1.0

  Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)

• PROMIS Emotional Distress - Anxiety-Short Form 8a v1.0

  Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)

• Pain Catastrophizing Scale (PCS)

  Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)

Study Arms (2)

Web-TIRELESS

EXPERIMENTAL

A 4-session, asynchronous, web-based mind-body pain and substance use management intervention.

Behavioral: Web-TIRELESS

Web-MEUC

ACTIVE COMPARATOR

Open access to a web-based pamphlet containing brief, educational information and coping techniques.

Other: Web-MEUC

Interventions

Web-MEUC OTHER

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.

Web-MEUC

Web-TIRELESS BEHAVIORAL

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.

Web-TIRELESS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnancy
• 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.

Sponsors & Collaborators

• Jafar Bakhshaie: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jafar Bakhshaie, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jafar Bakhshaie, MD, PhD

CONTACT

617-643-7641; jbakhshaie@mgh.harvard.edu

Kozbi B Cliff, BS

CONTACT

617-643-8678; klbayne@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 27, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)