NCT03390140

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

ReInventing Yourself After SCI: A Multi-site Randomized Controlled Trial of an Intervention to Improve Outcomes After Spinal Cord Injury

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: Craig Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to conduct a multi-site randomized controlled trial (RCT) to evaluate the replicability and efficacy of a structured six-week, manualized, group therapy intervention, ReInventing Yourself after SCI that delivers positive psychology concepts within a cognitive behavioral therapy (CBT)-based model. The goals of this RCT are to increase SCI-specific and general self-efficacy, enhance emotional well-being, and improve participation in society for people with SCI living in the community. Craig Hospital is the lead site for this study, collaborating with the University of Michigan, Ann Arbor, and Kessler Institute for Rehabilitation in New Jersey. The intervention is delivered through six sessions, each lasting approximately 2 hours. Eight skills are presented over the course of the intervention to address reframing a person's method of looking at events, building confidence by focusing on personal strengths, developing methods of recognizing and appreciating the good in one's life and expressing gratitude for positive attributes. These skills are presented in a specific sequence through a workbook so that participants can gain mastery of introductory concepts before undertaking those that are both more difficult and complex. The RCT will have three research arms: 1) Group treatment plus workbook (Group), 2) individual self-study through YouTube video plus workbook (Indiv), and 3) no group or individual sessions, no workbook (Control). It is hypothesized that presenting the positive psychotherapy topics in an interactive structured CBT group format while restructuring maladaptive thought processes and providing experiential opportunities to reinforce behavioral change will result in increased self-efficacy, enhanced well-being and improved societal participation. Three specific hypotheses will be tested: Hypothesis 1 (Primary): Individuals in the Group 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. Hypothesis 2 (Secondary): Individuals in the Group arm will maintain greater improvements through 46 weeks post-intervention in SCI-specific self-efficacy than participants in the Indiv and Control arms. Hypothesis 3 (Secondary): Individuals in the Group arm will show greater improvements after six weeks of treatment and through 46 weeks post-intervention in general self-efficacy, life satisfaction, community participation, resilience, and less depressive and anxiety symptomatology than participants in the Indiv and Control groups. The Moorong Self-Efficacy Scale (MSES) will serve as the primary outcome measure for this study. Secondary outcome measures include the General Self-Efficacy Scale, Diener Satisfaction with Life Scale, and measures of participation, resilience, anxiety and depression. Each collaborating site will enroll 84 individuals to be randomized into one of the three study arms in waves of 21 people per wave (up to 6 waves per site). Training of site facilitators will take place at Craig Hospital.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-07-22
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2018-01-04
• Last updated: 2022-06-03

Locations

3 sites across 1 country: United States