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Search / Trial NCT06991205

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

Launched by JAFAR BAKHSHAIE · May 19, 2025

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

Upper Extremity Problem Risky Substance Use Randomized Controlled Trial (Rct) Mindfulness Nontraumatic Conditions Chronic Pain Psychiatry Feasibility

ClinConnect Summary

This clinical trial is looking at a new online program called Web-TIRELESS, designed to help adults who experience ongoing pain in their arms or hands and also struggle with risky substance use. The main goal is to see if this web-based mind-body program can help these individuals feel more resilient and better manage their pain and substance use. Participants will be compared to those receiving standard online care, which is a simpler approach without the added mind-body techniques.

To be eligible for the trial, participants must be adults aged 18 or older who are seeking treatment for painful conditions in their upper body and have a certain level of risky substance use. They should also have a pain score of over 4 on a scale of 0 to 10. Participants will need to have access to the internet and be fluent in English. If chosen, they can expect to engage in an online focus group and participate in the web-based program at their convenience. It's important to know that those who have recently participated in similar treatments or have certain mental health conditions may not qualify for this trial.

Gender

ALL

Eligibility criteria

  • 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.

About Jafar Bakhshaie

Jafar Bakhshaie is a dedicated clinical trial sponsor with a commitment to advancing medical research and improving patient outcomes. With a focus on innovative therapies and evidence-based practices, he collaborates with a diverse network of healthcare professionals and research institutions to design and conduct rigorous clinical trials. His expertise encompasses various therapeutic areas, ensuring compliance with regulatory standards while prioritizing participant safety and ethical considerations. Through strategic partnerships and a patient-centered approach, Jafar Bakhshaie aims to contribute significantly to the development of effective treatments and enhance the overall landscape of clinical research.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Jafar Bakhshaie, MD, PhD

Principal Investigator

Massachusetts General Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported