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

Top Spinal Cord Inj Rehabil. 2022 Fall;28(4):44-55. doi: 10.46292/sci22-00013. Epub 2022 Nov 15.

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.

Keywords: intervention; outcomes; positive psychology; self-efficacy; spinal cord injury.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adaptation, Psychological
  • Humans
  • Patient Discharge
  • Randomized Controlled Trials as Topic
  • Spinal Cord Injuries*

Grants and funding

Financial Support This project was funded by a grant from the National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR grant no. 90DPHF0002). NIDILRR is a Center within the Administration for Community Living (ACL), Department of Health and Human Services (HHS). The contents of this article do not necessarily represent the policy of NIDILRR, ACL, and HHS, and you should not assume endorsement by the Federal Government.