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Clinical Trials/NCT03554733
NCT03554733
Completed
N/A

A Bridge From Rehabilitation to Real-World: Re-Inventing Yourself After SCI

Craig Hospital1 site in 1 country46 target enrollmentApril 1, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
Craig Hospital
Enrollment
46
Locations
1
Primary Endpoint
Change in Moorong Self-Efficacy Scale (MSES)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The goal of this randomized controlled trial is to determine the efficacy of a treatment to improve resilience to stress for individuals with SCI who are transitioning from inpatient rehabilitation to home. The overarching hypothesis is that individuals who participate in an intervention that presents positive psychotherapy topics in an interactive, structured, cognitive-behaviorally-based group intervention that stresses restructuring maladaptive thought processes and provides experiential opportunities to reinforce behavioral change will demonstrate increased self-efficacy.

Detailed Description

The goal of this randomized controlled trial is to determine the efficacy of a treatment to improve resilience to stress for individuals with SCI who are transitioning from inpatient rehabilitation to home. The overarching hypothesis is that individuals who participate in an intervention that presents positive psychotherapy topics in an interactive, structured, cognitive-behaviorally-based group intervention that stresses restructuring maladaptive thought processes and provides experiential opportunities to reinforce behavioral change will demonstrate increased self-efficacy. There were three aims of this study: AIM 1: Self-Efficacy - To examine the ability of a six-week, manualized, cognitive-behaviorally based group educational intervention (Re-Inventing Yourself after SCI-Bridge) to improve both SCI-specific and general self-efficacy for people who are early in the process of community reintegration; AIM 2: Psychosocial Adjustment - To assess the ability of the Re-Inventing Yourself after SCI-Bridge intervention to improve psychosocial adjustment of people with SCI who are early in the community reintegration process; and, Aim 3: Participation - To determine the ability of the Re-Inventing Yourself after SCI-Bridge intervention to improve societal participation for people with SCI who are early in the community reintegration process.

Registry
clinicaltrials.gov
Start Date
April 1, 2014
End Date
April 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Coker

Research Associate

Craig Hospital

Eligibility Criteria

Inclusion Criteria

  • History of SCI at any level;
  • completed initial inpatient rehabilitation but are no more than 6 months post-discharge;
  • 18 years of age or older at the time of study enrollment;
  • English speaking in order to complete study measures and participate in group interactions; and
  • able to provide informed consent to participate.

Exclusion Criteria

  • History of moderate or severe traumatic brain injury;
  • current participation in another RCT;
  • live beyond a reasonable commuting distance from Craig Hospital;
  • unable to verbally communicate;
  • unable to attend group sessions;
  • active participation in another formal clinical group or psychological therapy;
  • are currently experiencing severe depression which would require more intense treatment than is provided in this intervention, as evidenced by a score of 20 or higher on the Personal Health Questionnaire-9;
  • report any current suicidal ideation on the Personal Health Questionnaire-9; or
  • have any condition that, in the judgment of the investigators, precludes successful participation in the study.

Outcomes

Primary Outcomes

Change in Moorong Self-Efficacy Scale (MSES)

Time Frame: Baseline, 6 weeks, 12 weeks, 18 weeks

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 has been used in previous studies of SCI, and demonstrates excellent internal consistency (alpha = 0.91 - 0.93), high reliability, and good convergent, concurrent and divergent validity. Time to administer: 5 to 10 minutes.

Secondary Outcomes

  • Change in Generalized Self-Efficacy Scale (GSES)(Baseline, 6 weeks, 12 weeks, 18 weeks)
  • Change in Participation Assessment with Recombined Tools - Objective (PART-O)(Baseline, 6 weeks, 12 weeks, 18 weeks)
  • Patient Health Questionnaire - 9 (PHQ-9)(Baseline, 6 weeks, 12 weeks, 18 weeks)
  • Change in General Anxiety Disorder 7-item (GAD-7)(Baseline, 6 weeks, 12 weeks, 18 weeks)
  • Change in Satisfaction with Life Scale (SWLS)(Baseline, 6 weeks, 12 weeks, 18 weeks)

Study Sites (1)

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