Feasibility of a Virtual Mindfulness-Based Stress Reduction Intervention for Individuals With Chronic Pain: Pilot Randomized Controlled Trial.

Abstract

Background: Chronic pain (CP) is a complex and prevalent public health condition that significantly impacts physical functioning, psychological well-being, and quality of life. Traditional biomedical treatments often provide limited relief, highlighting the need for integrative approaches. Biopsychosocial interventions, such as mindfulness-based stress reduction (MBSR), have shown promise in improving pain-related outcomes by targeting cognitive, emotional, and behavioral processes associated with CP.

Objective: This pilot randomized controlled trial (RCT) evaluated the feasibility and preliminary effects of a virtual MBSR intervention for individuals with CP.

Methods: We conducted a single-blinded, randomized, pilot trial of 61 participants with CP randomly assigned to either an 8-week virtual MBSR program or a no-intervention control group. Participants were aware of their allocation; the data analyst remained blinded throughout the study; and the outcome assessor was blinded at baseline, although blinding could not be reliably maintained at subsequent assessments. The primary outcome was feasibility, assessed through recruitment, retention, and adherence rates. Secondary outcomes, examined on an exploratory basis, included pain disability, CP acceptance, pain catastrophizing, pain self-efficacy, health-related quality of life (HRQoL; PROMIS-29 [Patient-Reported Outcomes Measurement Information System-29] and PROMIS-10 [Patient-Reported Outcomes Measurement Information System-10]), and global rating of change.

Results: Recruitment (23.5%), retention (60.7%), and adherence (63.3%) rates were below the prespecified thresholds of 30%, 80%, and 80%, respectively, indicating that modifications to the current design are required before proceeding to a definitive trial. As this pilot trial was not powered to test intervention effectiveness, the following clinical outcomes are reported as exploratory and hypothesis-generating. A significant group-by-assessment period interaction was observed for pain disability, PROMIS-10 (physical health and global health), and PROMIS-29 (participation in social activities). No significant interactions were observed for pain catastrophizing, pain self-efficacy, or CP acceptance. On the Global Rating of Change scale, MBSR participants reported greater improvement in pain self-efficacy than the no-intervention control group.

Conclusions: This pilot study did not meet its feasibility targets, highlighting the need to refine recruitment, retention, and intervention delivery procedures before conducting a future trial. Preliminary exploratory analyses suggested improvements in pain disability and several HRQoL subdomains in the MBSR group compared with the control group, but these findings should be interpreted cautiously given the underpowered sample and the exploratory nature of these analyses. These results provide guidance for optimizing study design and implementation of a future, adequately powered RCT evaluating virtual MBSR for adults with CP.