ReInventing Yourself After SCI: an Intervention to Improve Outcomes After Spinal Cord Injury
1 other identifier
interventional
281
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2017
CompletedFirst Posted
Study publicly available on registry
January 4, 2018
CompletedStudy Start
First participant enrolled
July 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedJune 3, 2022
June 1, 2022
4.6 years
December 27, 2017
June 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Moorong Self-Efficacy Scale (MSES) - assessing change over time
The MSES is a 16 item self-report measure of self-efficacy related to everyday life activities, designed specifically for persons with SCI. Individuals use a 7-point Likert scale ranging from 1 (very uncertain) to 7 (very certain) to rate their ability to perform 16 everyday tasks, with higher scores representing greater perceived self-efficacy. A Total Score, ranging from 16 to 112 is calculated by summing all item responses
The MSES will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
Secondary Outcomes (6)
Generalized Self-Efficacy Scale (GSES)- assessing change over time
The GSES will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
Diener Satisfaction with Life Scale (SWLS)- assessing change over time
The SWLS will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
Participation Assessment with Recombined Tools - Objective (PART-O)- assessing change over time
The PART-O will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
Patient Health Questionnaire - 9 (PHQ-9)- assessing change over time
The PHQ-9 will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
General Anxiety Disorder 7-item (GAD-7)- assessing change over time
The GAD-7 will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks)
- +1 more secondary outcomes
Study Arms (3)
Group
EXPERIMENTALReInventing Yourself after SCI structured group CBT and ReInventing Yourself after SCI study-specific workbook
Indiv
ACTIVE COMPARATORReInventing Yourself after SCI study-specific workbook and ReInventing Yourself after SCI YouTube videos
Control
NO INTERVENTIONNo group sessions, no YouTube videos, no workbook
Interventions
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.
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.
YouTube videos containing the content of the ReInventing Yourself after SCI structured group CBT sessions
Eligibility Criteria
You may qualify if:
- History of spinal cord injury/disorder (SCI/D) at any neurological level
- At least 4 weeks post-discharge from initial inpatient rehabilitation
- English speaking in order to complete study measures and participate in group interactions
- Access to the internet and a laptop/desktop computer/smartphone with webcam and the ability and willingness to download Zoom software to join a video conference
- Able to provide informed consent to participate.
You may not qualify if:
- Diagnosed with MS, Lupus, ALS, or Spina Bifida
- History of moderate or severe traumatic brain injury
- Current participation in another RCT
- Unable to verbally communicate
- Unable to attend group sessions
- Active participation in another formal clinical group or psychological therapy
- Currently experiencing moderately severe or greater levels of depressive symptoms which would require more intense treatment than is provided in this intervention, as evidenced by a score of 15 or higher on the PHQ-9
- Has any medical or psychological condition that, in the judgment of the investigators, precludes successful participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Craig Hospitallead
- University of Michigancollaborator
- Kessler Foundationcollaborator
Study Sites (3)
Craig Hospital
Englewood, Colorado, 80113, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Kessler Foundation
West Orange, New Jersey, 07052, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Charlifue, PhD
Craig Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2017
First Posted
January 4, 2018
Study Start
July 22, 2018
Primary Completion
March 1, 2023
Study Completion
March 1, 2023
Last Updated
June 3, 2022
Record last verified: 2022-06