Initial Evaluation of an eHealth Self-Management System to Reduce Depression and Increase Resilience after SCI (iManage-SCI SCIRP Pilot Clinical Trial)
Abstract
The sudden, devastating nature of Spinal Cord Injury (SCI) and the potential for lifelong physical limitations and medical complications pose significant mental health challenges for affected individuals. High prevalence rates for depressive disorders and anxiety disorders have been found in both Veterans and civilians with SCI. Resilience is associated with decreased risk for psychological distress following SCI. Unfortunately, it can be challenging to identify and address symptoms of emotional distress and promote resilience in individuals who are learning to function with a new disability. Developing easily accessible interventions to reduce mental health symptoms and increase psychological resilience after SCI is therefore critical to improving quality of life. The goal of this project is to further build, refine, and conduct a pilot clinical trial to fully prepare an existing eHealth intervention for large-scale clinical trial evaluation. This tool, called iManage-SCI, is a symptom-monitoring and self-management tool specifically designed to provide a low-cost and empirically based method of reducing mental health symptoms and increasing resilience among individuals with SCI. During Project Year 1, the team encountered multiple COVID-related and regulatory obstacles. We have now obtained conditional IRB approval at Kessler, a formal exemption from the Single IRB requirement of the Common Rule for the East Orange VA, and the East Orange VA IRB approval is currently pending. HRPO documents have been prepared and will be submitted as soon as all IRB approvals are in place.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2021
- Accession Number
- AD1161740
Entities
People
- David S. Tulsky
- Jerry Slotkin
- Pamela Kisala
Organizations
- University of Delaware