Recruiting

Web-TIRELESS vs. Web-MEUC

Sponsor:

Jafar Bakhshaie

Code:

NCT06991205

Conditions

Orthopedic Disorder

Nontraumatic Injury

Upper Extremity Pain

Risky Substance Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Web-TIRELESS

Web-MEUC

Study Details

Brief summary:

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.

Conditions

Orthopedic Disorder

Nontraumatic Injury

Upper Extremity Pain

Risky Substance Use

Study ID

NCT06991205

Start date

Sep 15, 2025

Status verified date

Mar, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Web-TIRELESS

A 4-session, asynchronous, web-based mind-body pain and substance use management intervention.

active comparator: Web-MEUC

Open access to a web-based pamphlet containing brief, educational information and coping techniques.

Interventions

Web-TIRELESS

This is a self-administered web-based intervention that consists of 4 on-demand sessions, each \~30 minutes long, that teach mind-body skills, cognitive-behavioral strategies (e.g., reframing, pain and substance use urge surfing), activity pacing, acceptance and commitment skills, and psychoeducation on the association between substance use and pain. The program aims to increase patients' physical and emotional functioning and decrease pain intensity and maladaptive substance use behaviors.

Web-MEUC

An educational information web-based pamphlet, containing brief, summarized information tailored for the respective patient population that follows topics including the trajectory of pain and adaptation after non-traumatic painful upper extremity conditions, the role of relaxation strategies to manage pain, and the importance of returning to engagement in activities of daily living.

Primary outcome measure

  • Credibility and Expectancy Questionnaire (CEQ) [ Time Frame: Baseline (0 Weeks) ]
  • Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment [ Time Frame: Post-Test (5 Weeks) ]
  • The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery [ Time Frame: Post-Test (5 Weeks) ]
  • The percent of patients that agree to participate to assess feasibility of recruitment [ Time Frame: Baseline (0 Weeks) ]
  • Rate at which program was accepted, measured by attendance to assess acceptability of treatment [ Time Frame: Post-Test (5 Weeks) ]
  • Adherence to homework [ Time Frame: Throughout intervention completion, an average of 1 month ]
  • Rate of participant's completion of self-report measures to assess feasibility of assessments [ Time Frame: Baseline (0 Weeks), Post-Test (5 Weeks) ]
  • Adverse Events [ Time Frame: Throughout intervention completion, an average of 1 month ]

Central Contacts and Locations

Central contacts

Jafar Bakhshaie, MD, PhD

617-643-7641jbakhshaie@mgh.harvard.edu

Kozbi B Cliff, BS

617-643-8678klbayne@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator

617-643-7641jbakhshaie@mgh.harvard.edu

More Information

Sponsor

Jafar Bakhshaie

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

  • Upper Extremity Problem
  • Risky substance use
  • Randomized Controlled Trial (RCT)
  • Mindfulness
  • Nontraumatic conditions
  • Chronic pain
  • Psychiatry
  • Feasibility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jafar Bakhshaie on 2026-03-13.