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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

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.

Study details
    Orthopedic Disorder
    Nontraumatic Injury
    Upper Extremity Pain
    Risky Substance Use

NCT06991205

Jafar Bakhshaie

1 November 2025

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