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

NCT ID: NCT06991205

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2027-03-01

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.

Detailed Description

Aim: Conduct a feasibility randomized controlled trial (RCT) (N=50) of Web-TIRELESS versus Minimally Enhanced Usual Care (Web-MEUC)-both of which are web-based-among patients with painful nontraumatic upper extremity conditions and comorbid risky substance use (N=50), to demonstrate the feasibility of recruitment procedures and data collection; and the feasibility, credibility, and acceptability (adherence, retention, fidelity, and satisfaction) of Web-TIRELESS and Web-MEUC. We will use this mixed-methods information to assess the primary outcomes and optimize both programs and study methodology in preparation for research.

Participants are randomized to either Web-TIRELESS or Web-MEUC and given access to the respective program for approximately 5 weeks to review and complete the assigned material. Both groups are given education material to help improve pain and substance use urge coping. There are 3 assessment points consisting of self-report surveys: baseline, post-program, and 6-month follow-up.

Conditions

Orthopedic Disorder; Nontraumatic Injury; Upper Extremity Pain; Risky Substance Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Web-TIRELESS

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

Group Type: EXPERIMENTAL

Web-TIRELESS

Intervention Type: BEHAVIORAL

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

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

Group Type: ACTIVE_COMPARATOR

Web-MEUC

Intervention Type: OTHER

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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Jafar Bakhshaie

OTHER

Sponsor Role: lead

Responsible Party

Jafar Bakhshaie

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jafar Bakhshaie, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jafar Bakhshaie, MD, PhD

Role: CONTACT

jbakhshaie@mgh.harvard.edu

617-643-7641

Kozbi B Cliff, BS

Role: CONTACT

klbayne@mgh.harvard.edu

617-643-8678

Facility Contacts

Principal Investigator

Role: primary

jbakhshaie@mgh.harvard.edu

617-643-7641

Other Identifiers

5K23AT012364-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P001335

Identifier Type: -

Identifier Source: org_study_id