Randomised controlled trial of the Caring Connections intervention to reduce loneliness and perceived social isolation in persons with spinal cord injuries and disorders: study protocol

INTRODUCTION: Perceived social isolation and loneliness are understudied in individuals with spinal cord injuries and disorders (SCI/D). The few existing studies reported that they are common, yet poorly treated, in persons with SCI/D. We developed an intervention called Caring Connections (CC) aimed at reducing loneliness and perceived social isolation in persons with SCI/D. CC is a peer-based, recurrent letter writing programme designed to provide moments of positivity. We will conduct and evaluate a randomised controlled trial (RCT) to assess changes in loneliness and social isolation outcomes between the CC intervention and control conditions in community-dwelling individuals with SCI/D. METHODS AND ANALYSIS: RCT to compare outcomes of community-dwelling individuals with SCI/D undergoing the CC intervention to an attention control group (receiving informational materials on life domains important to a good quality of life). Eligible participants include adults with chronic SCI/D who have been injured for >1 year. The primary outcome is loneliness, measured using the UCLA (University of California, Los Angeles) 3-item Loneliness Scale. Other outcomes include perceived social isolation and social support. A post-trial process evaluation will assess perceived benefits, negative impacts and satisfaction with the intervention, and areas for improvement. We will test the hypotheses of reduced loneliness and perceived social isolation in the CC intervention arm from baseline to 6 months and will also measure the magnitude of effect (difference between CC arm and attention control arm). We will use generalised linear models for repeated measures. We will assume a one-tailed, α=0.05 level of significance for comparisons. Process outcomes will be analysed using mixed methods, including frequencies for the rating items and thematic analysis for open-ended item responses. ETHICS AND DISSEMINATION: This study has received Hines Veterans Affairs Institutional Review Board approval (#1673654). Findings will be disseminated widely through healthcare organisations, peer-reviewed publications and conferences. TRIAL REGISTRATION NUMBER: NCT05295108