Back to resultsRe-Inventing Yourself After Spinal Cord Injury
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SCI Reinvention Protocol Participants
Waitlist Group
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal Cord Injury, Self-Efficacy, Life Satisfaction, Community Participation
Eligibility Criteria
Inclusion Criteria:
- History of traumatic SCI at any level;
- at least 4 weeks post-discharge from initial inpatient rehabilitation;
- 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 moderately severe or greater levels of depression which would require more intense treatment than is provided in this intervention, as evidenced by a score of 15 or higher on the Personal Health Questionnaire-9;37
- are currently of high self efficacy, as determined by a score of 90 or higher on the MSES,32 which has a range of 16 to 112, with higher scores representing higher SCI-specific self-efficacy; or
- have any condition that, in the judgment of the investigators, precludes successful participation in the study.
Sites / Locations
- Craig Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
SCI Reinvention Protocol Participants
Waitlist Group
Arm Description
This group will receive 6 instructor-led 2 hour long didactic presentations regarding 8 key principles of self-efficacy and experiential exercises, including goal setting and problem solving with extensive group discussion. At the end of each session, tasks are assigned to participants to be completed outside the group during the week between sessions. Experiences from these activities and practice implementing the intervention principles will be shared and discussed each week, providing additional opportunities for problem solving and positive feedback.
This group will include individuals randomized to receive no treatment for the 30 weeks during which the interventional group will receive the active treatment and have their progress tracked.
Outcomes
Primary Outcome Measures
Change in Moorong Self-Efficacy Scale (MSES) score over a 30 week time period
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.
Secondary Outcome Measures
Change in General Self-Efficacy Scale scores over a 30 week time period
The General Self-Efficacy Scale (GSES) is a questionnaire designed to assess a person's ability to cope with a variety of difficult demands in life, with ten items scored using a Likert rating scale, ranging from 1 (not at all true) to 4 (exactly true).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01633164
Brief Title
Re-Inventing Yourself After Spinal Cord Injury
Official Title
Re-Inventing Yourself After SCI: A Site-Specific Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Craig Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of a replicable, psychologically-based group education intervention, Re-Inventing Yourself after Spinal Cord Injury (SCI), which aims to enhance personal self-efficacy. A structured six-week, manualized, group therapy intervention that delivers positive psychology concepts within a cognitive-behavioral therapy-based model has been created for the purpose of developing a resilient and optimistic sense of efficacy for people with SCI. Concepts covered within this intervention include: reframing and restructuring 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. The goals of this intervention are to increase personal self-efficacy, enhance emotional well-being and improve participation in society for people with SCI living in the community. The investigators hypothesize that persons receiving the intervention will demonstrate improved SCI-specific and overall self-efficacy as compared to waitlist controls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal Cord Injury, Self-Efficacy, Life Satisfaction, Community Participation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SCI Reinvention Protocol Participants
Arm Type
Experimental
Arm Description
This group will receive 6 instructor-led 2 hour long didactic presentations regarding 8 key principles of self-efficacy and experiential exercises, including goal setting and problem solving with extensive group discussion. At the end of each session, tasks are assigned to participants to be completed outside the group during the week between sessions. Experiences from these activities and practice implementing the intervention principles will be shared and discussed each week, providing additional opportunities for problem solving and positive feedback.
Arm Title
Waitlist Group
Arm Type
Other
Arm Description
This group will include individuals randomized to receive no treatment for the 30 weeks during which the interventional group will receive the active treatment and have their progress tracked.
Intervention Type
Behavioral
Intervention Name(s)
SCI Reinvention Protocol Participants
Intervention Description
The intervention involves participation in a six week psychologically-based educational intervention. During the course, 8 specific skills are reviewed in order to specifically address reframing a person's method of looking at events, build confidence by focusing on personal strengths, develop methods of recognizing and appreciating the good in one's life and express gratitude for positive attributes. These skills are presented in a specific sequence so that participants can gain mastery of introductory concepts before undertaking those that are both more difficult and complex.
Intervention Type
Other
Intervention Name(s)
Waitlist Group
Intervention Description
Wait list arm will begin study intervention after 4 1/2 months.
Primary Outcome Measure Information:
Title
Change in Moorong Self-Efficacy Scale (MSES) score over a 30 week time period
Description
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.
Time Frame
Baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Secondary Outcome Measure Information:
Title
Change in General Self-Efficacy Scale scores over a 30 week time period
Description
The General Self-Efficacy Scale (GSES) is a questionnaire designed to assess a person's ability to cope with a variety of difficult demands in life, with ten items scored using a Likert rating scale, ranging from 1 (not at all true) to 4 (exactly true).
Time Frame
Baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
History of traumatic SCI at any level;
at least 4 weeks post-discharge from initial inpatient rehabilitation;
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 moderately severe or greater levels of depression which would require more intense treatment than is provided in this intervention, as evidenced by a score of 15 or higher on the Personal Health Questionnaire-9;37
are currently of high self efficacy, as determined by a score of 90 or higher on the MSES,32 which has a range of 16 to 112, with higher scores representing higher SCI-specific self-efficacy; or
have any condition that, in the judgment of the investigators, precludes successful participation in the study.
Facility Information:
Facility Name
Craig Hospital
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
12. IPD Sharing Statement
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Re-Inventing Yourself After Spinal Cord Injury
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