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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Jafar Bakhshaie
Study ID
NCT06991205
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Web-TIRELESS — 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 — 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.

Study Details

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.

Key Dates

Start date
Sep 15, 2025
Status verified
Mar 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Credibility and Expectancy Questionnaire (CEQ) [ Time Frame: Baseline (0 Weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Principal Investigator
[email protected]
617-643-7641

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

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