ClinConnect ClinConnect Logo
Search / Trial NCT06366633

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

Launched by JAFAR BAKHSHAIE · Apr 14, 2024

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Upper Extremity Condition Risky Substance Use Mindfulness Nontraumatic Conditions Chronic Pain

ClinConnect Summary

This clinical trial is studying a new online program called Web-TIRELESS, which aims to help adults who have painful upper body conditions and are at risk for substance use problems. The researchers want to see if this program is easy to use, accepted by participants, and credible for those who join. The trial will involve 12 participants, who will watch four video sessions at their own pace—about one session each week. They will also share their thoughts through interviews and fill out surveys before and after the program to help improve it for future studies.

To be eligible for this trial, participants need to be adults over 18 years old who have a painful upper body condition and are using substances in a way that may be risky. They should also have internet access and be comfortable participating in online sessions. However, people who have recently been involved in similar programs or have certain mental health issues may not be able to join. This study is currently looking for participants and could provide valuable insights into how to support those facing these challenges.

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

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

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