Mindfulness-based intervention for adults with spinal cord injury: study protocol for a multicenter randomized controlled trial

Spinal cord injury (SCI) is associated with high rates of depression and anxiety, yet evidence-based psychological interventions tailored to this population are lacking. Mindfulness-based interventions (MBIs) hold promise but have not been evaluated in large-scale trials. This is a multi-center, assessor-blind, parallel, two-arm randomized controlled trial with an initial 6-month internal pilot phase. Following a successful pilot, 216 adults with chronic SCI will be randomized to an 8-week videoconferencing-delivered, tailored MBI plus usual care, or usual care alone. The primary outcome is quality of life measured by the SF-36 at 8 weeks post-intervention. Secondary outcomes include anxiety, depression, pain, post-traumatic growth and functional independence. Analyses will follow the intention-to-treat principle using mixed-effects regression models. In the feasibility study, the MBI was highly acceptable (100% willing to recommend). Significant large improvements were observed in mental health (Cohen’s d = 0.83), maintained at 3-month follow-up. Attrition was 38.5%, with dropouts having significantly poorer baseline mental health. These findings informed key trial adaptations: enhanced retention strategies, a 6-month primary endpoint, and refined statistical handling of non-random missing data. This trial will provide robust evidence on the clinical and cost-effectiveness of a tailored MBI for improving psychological health in people with SCI, potentially guiding integration of mindfulness-based approaches into standard SCI rehabilitation. Chinese Clinical Trial Registry, ChiCTR2500111437.