Effects of a mobile APP-based mindfulness intervention in persons with spinal cord injury and chronic pain: a randomized controlled trial

The National Institutes of Health National Center for Complementary and Integrative Health awarded Mayo Clinic Jacksonville $780,208 on September 1, 2026, under the Research and Training in Complementary and Integrative Health program (CFDA 93.213) to conduct a randomized controlled trial evaluating the efficacy of a mobile app-based mindfulness intervention for managing chronic pain in persons with spinal cord injury.

The study addresses a clinical gap: chronic pain affects 65–85% of people with spinal cord injury, contributes to depression and anxiety, and limits participation in activities of daily living, yet standard pharmacological agents such as opioids are ineffective and carry significant side effects. Mindfulness meditation training has demonstrated benefit for chronic pain in non-spinal-cord-injury populations, but traditional in-person interventions are lengthy, expensive, and inaccessible to many patients. The recipient's prior NIH-funded feasibility study showed that a free, publicly available mobile app-based mindfulness intervention was feasible and acceptable in this population and showed promise in improving pain and mental health outcomes. This project grant will conduct a full-powered efficacy trial to establish whether the app-based intervention meaningfully improves pain and quality of life compared to standard care, with the ultimate goal of identifying and disseminating accessible tools for a population facing barriers to conventional healthcare services.

Performance occurs in Jacksonville, Florida, with a period of performance through August 31, 2031.

Abstract

The prevalence of debilitating chronic pain in people with spinal cord injury (PWSCI) ranges from 65-85%. Chronic pain after SCI contributes to depression and anxiety, limits participation in activities of daily living, and diminishes health-related quality of life (QOL). Pharmacological agents, such as opioids, are the primary therapeutic options to manage chronic pain after SCI, but they are ineffective in relieving pain and are associated with significant side effects.1-5 mindfulness meditation (MM) training has been shown to improve mental and physical symptoms, including pain, in many studies of people without SCI who have chronic pain. However, these interventions are typically lengthy, expensive, and require in-person visits with a therapist, making them inaccessible to many PWSCI. Mounting evidence suggests that mobile apps may provide an effective and low-cost way to provide MM interventions. Only one feasibility study has explored an APP-based MM intervention in PWSCI, and IT was conducted by this research team. The results of this study suggest that the mobile APP-based MM intervention is feasible and acceptable to PWSCI and shows promise in improving pain and mental health. However, research powered to examine the efficacy of an easily accessible mobile APP-based mindfulness intervention among PWSCI with chronic pain (PWSCI-CP) has not yet been conducted. Determining the efficacy of an existing, free, publicly available MM mobile APP to manage chronic pain is the next essential step in identifying and disseminating tools to improve QOL among PWSCI-CP, a population facing profound barriers to accessing healthcare services. The present study will build on the promising results of an NIH/nccih R34-funded feasibility/acceptability pilot RCT of mobile APP-based MM intervention in PWSCI-CP that our multidisciplinary, interinstitutional team recently completed. Specifically, the present study will test the efficacy of a mobile APP-guided MM intervention (mindfulness coach APP ≥ 10 minutes daily for 6 weeks) compared to a health education active control condition (TED talk APP ≥ 10 minutes daily for 6 weeks) on pain intensity in PWSCI-CP. The secondary aim is to evaluate the intervention's efficacy on pain interference, depression, and anxiety, and the tertiary aim is to explore the maintenance of intervention effects over a 6-month follow-up period. This study will facilitate the team's long-term goal to improve pain management and QOL of PWSCI-CP by identifying affordable and accessible interventions which can be used as an adjuvant tool in conjunction with other treatments. With the emerging use of digital health technologies, this study is both timely and innovative.