ReInventing Yourself After SCI: an Intervention to Improve Outcomes After Spinal Cord Injury
NCT ID: NCT03390140
Last Updated: 2022-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
281 participants
INTERVENTIONAL
2018-07-22
2023-03-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group
ReInventing Yourself after SCI structured group CBT and ReInventing Yourself after SCI study-specific workbook
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.
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.
Indiv
ReInventing Yourself after SCI study-specific workbook and ReInventing Yourself after SCI YouTube videos
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.
ReInventing Yourself after SCI YouTube videos
YouTube videos containing the content of the ReInventing Yourself after SCI structured group CBT sessions
Control
No group sessions, no YouTube videos, no workbook
No interventions assigned to this group
Interventions
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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.
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.
ReInventing Yourself after SCI YouTube videos
YouTube videos containing the content of the ReInventing Yourself after SCI structured group CBT sessions
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Kessler Foundation
OTHER
Craig Hospital
OTHER
Responsible Party
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Principal Investigators
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Susan Charlifue, PhD
Role: PRINCIPAL_INVESTIGATOR
Craig Hospital
Locations
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Craig Hospital
Englewood, Colorado, United States
University of Michigan
Ann Arbor, Michigan, United States
Kessler Foundation
West Orange, New Jersey, United States
Countries
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Other Identifiers
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90DPHF0002-01-00
Identifier Type: -
Identifier Source: org_study_id
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