A Study Protocol for a Multisite Randomized Controlled Trial of an Intervention to Improve Outcomes After Spinal Cord Injury

Abstract

Background The consequences of spinal cord injury (SCI) can place significant demands on an individual’s coping mechanisms. Interventions to promote psychological adjustment and coping are often included in inpatient rehabilitation programs; however, following discharge, many individuals with SCI do not receive ongoing counseling or education about psychological adjustment to disability. Effective postacute treatment models are needed to help individuals with SCI build skills that help them adapt to the stresses associated with a chronic physical disability, alleviate the consequences of anxiety and depression, and enhance subjective well-being. Objectives To describe the protocol for a randomized clinical trial (RCT) of a 6-week intervention designed to improve psychosocial outcomes after SCI. Methods To test efficacy and replicability of the intervention, we designed a three-arm, multisite RCT with assessments conducted at six time points. Our primary hypothesis is that participants in the Group arm will report greater improvements in psychosocial outcomes than participants who complete the intervention individually via video (Individual arm) or those who do not receive the intervention (Control arm). We also hypothesize that participants in the Group arm will maintain greater improvements in psychosocial outcomes longer than those in the individual or control arms. Conclusion Results of the RCT will be presented and published to professionals and consumers, and intervention training and materials will be made available upon request.