Web-based Mind-body Program for Comorbid Nontraumatic Upper-extremity Condition and Risky Substance Use

NCT06366633 | Completed DMC

• 2 other identifiers: 2024P0007131K23AT012364-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthopedic Disorder; Nontraumatic Injury; Substance Use; Upper Extremity Problem

Keywords

Upper Extremity Condition; Risky substance Use; Mindfulness; Nontraumatic conditions; Chronic pain

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

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

  Post-Test (4 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 (4 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 participants who complete \> or = 3 of 4 sessions.

  Post-Test (4 Weeks)

• Adherence to homework

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

  Through 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 (4 Weeks)

• Adverse Events

  Any self-reported or observed negative events related to participation

  Through study completion, an average of 1 month

Secondary Outcomes (11)

• Graded Chronic Pain Scale (GCPS)

  Baseline (0 Weeks), Post-Test (4 Weeks)

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

  Baseline (0 Weeks), Post-Test (4 Weeks)

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

  Baseline (0 Weeks), Post-Test (4 Weeks)

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

  Baseline (0 Weeks), Post-Test (4 Weeks)

• Pain Catastrophizing Scale (PCS)

  Baseline (0 Weeks), Post-Test (4 Weeks)

Study Arms (1)

Web-TIRELESS

EXPERIMENTAL

An asynchronous web-based mind-body intervention focused on decreasing disability, pain, risky substance use, and related distress in patients with nontraumatic upper-extremity conditions and comorbid risky substance use.

Behavioral: Web-TIRELESS

Interventions

Web-TIRELESS BEHAVIORAL

This is a self-administered web-based intervention that consists of 4 30-45-minute video sessions 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

Sponsors & Collaborators

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

Study Sites (1)

Massachusetts General Hospital (MGH)

Boston, Massachusetts, 02129, United States

Location

Related Publications (1)

• Levey N, Chen N, Ditre J, Sylvia L, Mudgal C, Bhashyam A, Garg R, Ring D, Vranceanu AM, Bakhshaie J. A Web-Based Mind-Body Intervention to Improve Resilience Among Patients With Nontraumatic Painful Upper-Extremity Conditions and Comorbid Risky Substance Use: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2024 Dec 9;13:e64547. doi: 10.2196/64547.

  PMID: 39652859 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases; Substance-Related Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jafar Bakhshaie, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 16, 2024
• Study Start: October 29, 2024
• Primary Completion: May 31, 2025
• Study Completion: July 31, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)