ReInventing Yourself After SCI: an Intervention to Improve Outcomes After Spinal Cord Injury

NCT03390140 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2022-06-03

No results posted yet for this study

Summary

The primary goal of this study is to conduct a multi-site RCT to evaluate the replicability and efficacy of the ReInventing Yourself after SCI intervention in improving health and function outcomes for persons with spinal cord injury (SCI). A total of 252 participants will be randomized to one of three research arms: 1) Group treatment plus workbook (Group), 2) individual self-study through YouTube video plus workbook (Indiv), and 3) no treatment, no workbook (Control). Participants randomized to the Group arm will attend 6 virtual weekly group sessions led by a pair of group facilitators and will utilize the study workbook. Indiv arm participants will receive the workbook and will be instructed to independently access YouTube videos of the group session content. Control arm participants will not receive any intervention during the 6 week period. Participants in all three arms will be assessed at identical time points throughout the study: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks, and 46 weeks.

It is hypothesized that individuals in the Group intervention arm will show greater improvements after the six week intervention in SCI-specific and general self-efficacy, emotional well-being, increased societal participation, less depressive and anxiety symptomatology, and improved resilience than participants in the Indiv and Control arms.

Conditions

  • Spinal Cord Injuries

Interventions

BEHAVIORAL

ReInventing Yourself after SCI structured group CBT

ReInventing Yourself after SCI intervention integrates positive psychotherapy concepts into structured group cognitive behavioral therapy (CBT) to develop optimistic self-efficacy beliefs, thereby strengthening resilience to emotional distress, enhancing a sense of well-being and promoting a more active lifestyle. The intervention consists of six weekly two-hour facilitator-led sessions that include didactic presentations of eight core skills and related experiential exercises with extensive group discussion.

BEHAVIORAL

ReInventing Yourself after SCI study-specific workbook

A study-specific workbook that incorporates positive psychotherapy concepts to develop optimistic self-efficacy beliefs, thereby strengthening resilience to emotional distress, enhancing a sense of well-being and promoting a more active lifestyle.

BEHAVIORAL

ReInventing Yourself after SCI YouTube videos

YouTube videos containing the content of the ReInventing Yourself after SCI structured group CBT sessions

Sponsors & Collaborators

Principal Investigators

  • Susan Charlifue, PhD · Craig Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-22
Primary Completion
2023-03-01
Completion
2023-03-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03390140 on ClinicalTrials.gov