Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06991205

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

Led by Jafar Bakhshaie · Updated on 2026-03-13

50

Participants Needed

1

Research Sites

76 weeks

Total Duration

On this page

Sponsors

J

Jafar Bakhshaie

Lead Sponsor

N

National Center for Complementary and Integrative Health (NCCIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older seeking outpatient care at the Hand and Arm Center
  • Diagnosed with a non-traumatic painful upper-extremity condition
  • Pain score greater than 4 on the Numerical Rating Scale
  • Risky substance use with screening scores above thresholds for alcohol or other substances
  • Own a smartphone, laptop, or computer with internet access
  • Fluent in English
  • Able and willing to participate in a live video focus group and asynchronous web-based intervention
Not Eligible

You will not qualify if you...

  • Participation in mind-body or specialized substance abuse treatment in the past 3 months
  • Practicing mindfulness more than 45 minutes per week in the past 3 months
  • Changed psychotropic medications in the past 3 months
  • Serious untreated mental illness such as schizophrenia
  • Suicidal thoughts with intent or plan
  • Pregnancy
  • Secondary gains that may bias motivation (e.g., pending disability claim)
  • Moderate to severe cognitive impairment (score 4 or less on SPMSQ)
  • History of surgery for the current upper-extremity condition within the past 6 months or plans for surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

J

Jafar Bakhshaie, MD, PhD

CONTACT

K

Kozbi B Cliff, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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