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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Patients applied
Trial Officials
Jafar Bakhshaie, MD, PhD
Principal Investigator
Massachusetts General Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported