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 · DOI: 10.46292/sci22-00013 · Published: December 1, 2022

Spinal Cord Injury Mental Health Rehabilitation

Simple Explanation

Spinal cord injuries (SCI) present significant challenges to individuals' coping abilities, often leading to depression, anxiety, and reduced participation in activities. Many individuals with SCI do not receive adequate counseling or education post-discharge from inpatient rehabilitation regarding psychological adjustment to their disability. This study describes the protocol for a randomized clinical trial (RCT) of a 6-week intervention designed to improve psychosocial outcomes after SCI. The intervention, called ReInventing Yourself after SCI, delivers positive psychological concepts within a cognitive behavioral therapy–based model to individuals with SCI living in the community. The goals of this intervention are to increase SCI-specific and general self-efficacy, enhance emotional well-being, and improve community participation. The RCT was conducted at three specialty rehabilitation facilities in the United States, with modifications made to the protocol due to the COVID-19 pandemic.

Study Duration

4.5 Years

Participants

281 community-dwelling people with SCI

Evidence Level

Level 1: Multisite Randomized Controlled Trial (RCT)

Key Findings

1
The 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).
2
A secondary hypothesis is that participants in the Group arm will maintain greater improvements in psychosocial outcomes longer than those in the individual or control arms.
3
Preliminary results indicated that despite COVID-19 related modifications, participants expressed satisfaction with virtual sessions and described benefits of online delivery, suggesting increased feasibility and external validity.

Research Summary

This study protocol outlines a multisite randomized controlled trial (RCT) designed to evaluate the efficacy of a 6-week group therapy intervention, "ReInventing Yourself after SCI," aimed at improving psychosocial outcomes for individuals with spinal cord injury (SCI) living in the community. The RCT compares a group-based intervention to an individual self-study approach via YouTube and a control group, assessing outcomes such as SCI-specific self-efficacy, general self-efficacy, societal participation, life satisfaction, depressive symptoms, anxiety symptoms, and resilience. The study adapted its protocol due to the COVID-19 pandemic, transitioning to a fully remote format using HIPAA-compliant technologies, which unexpectedly increased feasibility and participant satisfaction. Results will be disseminated to professionals and consumers, with intervention training and materials made available upon request.

Practical Implications

Improved Psychological Outcomes

The intervention aims to improve psychological adjustment and coping mechanisms for individuals with SCI, addressing issues like depression and anxiety.

Enhanced Self-Efficacy

By increasing self-efficacy, the intervention seeks to empower individuals with SCI to better manage challenges and improve their quality of life.

Increased Community Participation

The study intends to facilitate greater community participation among individuals with SCI, fostering a sense of inclusion and well-being.

Study Limitations

1
Modifications to the protocol due to the COVID-19 pandemic impacted the internal validity of the study.
2
The study may be underpowered to find detectable differences in self-efficacy between the study arms due to COVID-19 related modifications.
3
The sample size and power calculations were based on preliminary data from a single-site two-arm RCT, which may not fully represent the multisite three-arm RCT.

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