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

NCT06991205 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Jafar Bakhshaie

    lead OTHER

Principal Investigators

  • Jafar Bakhshaie, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-03-01
Completion
2027-03-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06991205 on ClinicalTrials.gov