Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

Outpatient adults seeking care in the Hand and Arm Center

Diagnosed with a non-traumatic painful upper-extremity condition (NPUC)

Pain score > 4 on the Numerical Rating Scale (NRS)

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])

Disqualifiers

Participation in mind-body or specialized substance abuse treatment in the past 3 months

Practice of mindfulness >45 minutes/week in the past 3 months

Psychotropic medications (e.g. antidepressants) changed in the past 3 months

Serious untreated mental illness (e.g., Schizophrenia)

Trial design

Treatments tested in this trial

  • Web-TIRELESS
  • Web-MEUC

Treatment groups

50 Participants
are divided into 2 treatment groups

Locations

1
Massachusetts General Hospital02114, BostonMassachusetts, United States

Sponsors and collaborators

Jafar Bakhshaie

Lead sponsor

Massachusetts General Hospital

Sponsor institution

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov