Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 25, 2024
Date Accepted: Sep 28, 2024
A Web-Based Mind-Body Intervention to Improve Resilience among Patients with Nontraumatic Upper Extremity Conditions and Comorbid Risky Substance Use: Protocol for a Mixed Methods Study
ABSTRACT
Background:
Non-traumatic upper-extremity conditions (NPUCs) are largely age-related degenerations that affect the majority of adults. Most patients with NPUCs do not seek medical care and adjust on their own. Among those who do seek care, approximately 20% report risky substance use, defined as a consumption pattern that increases the risk of harm to physical or psychosocial health. In the context of NPUC, risky substance use is associated with more intense pain, emotional distress, disability, and opioid or other substance misuse (i.e., cross-tolerance). Consequently, risky substance use is a significant modifiable risk factor for the progression and maintenance of chronic pain-related disability and comorbid psychopathology among patients with NPUCs.
Objective:
This study aims to develop, adapt, and test the feasibility of the Toolkit for Resilient Life bEyond pain and SubStance use (Web-TIRELESS), a novel asynchronous web-based mind-body intervention aimed at modifying maladaptive pain-coping behaviors in patients with comorbid NPUC and risky substance use. The present manuscript illustrates the proposed study design, methodology, and intervention content.
Methods:
In Aim I, we will conduct live video qualitative interviews (N=up to 20) with care-seeking adult NPUC patients with comorbid risky substance use to inform the development and refinement of Web-TIRELESS and study procedures. In Aim II, we propose an open pilot study (N=up to 12) of Web-TIRELESS with exit interviews and pre- and post-intervention assessments to evaluate the feasibility, credibility, and acceptability of Web-TIRELESS and refine study procedures. Aim III consists of a pilot feasibility randomized controlled trial (RCT) of Web-TIRELESS versus Minimally Enhanced Usual Care (Web-MEUC) (N=50), both of which follow a web-based modality, to demonstrate the feasibility of recruitment procedures and data collection; and the feasibility, credibility, and acceptability of Web-TIRELESS and the control condition (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks.
Results:
Patient interviews (Aim I) have concluded and results are pending qualitative analysis. The overall completion of the study is anticipated by mid-2027.
Conclusions:
We will develop and test Web-TIRELESS, the first asynchronous mind-body intervention specifically adapted to enhance resilience in response to chronic pain among individuals with NPUCs and comorbid risky substance use. Results from this three-aim study (feasibility, acceptability, and satisfaction of Web-TIRELESS) will be leveraged to inform a future efficacy RCT of Web-TIRELESS versus the Web-MEUC control. Clinical Trial: ClinicalTrials.gov NCT06366633
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