Re-Inventing Yourself After Spinal Cord Injury

This study is currently recruiting participants.

Verified June 2012 by Craig Hospital

Sponsor:

Information provided by (Responsible Party):

Craig Hospital

ClinicalTrials.gov Identifier:

NCT01633164

First received: June 26, 2012

Last updated: June 29, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 26, 2012
Last Updated Date	June 29, 2012
Start Date ^ICMJE	April 2012
Estimated Primary Completion Date	December 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 29, 2012)	Change in Moorong Self-Efficacy Scale (MSES) score over a 30 week time period [ Time Frame: Baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01633164 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 29, 2012)	Change in General Self-Efficacy Scale scores over a 30 week time period [ Time Frame: Baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks ] [ Designated as safety issue: No ] 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).
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Re-Inventing Yourself After Spinal Cord Injury
Official Title ^ICMJE	Re-Inventing Yourself After SCI: A Site-Specific Randomized Clinical Trial
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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Spinal Cord Injury
Intervention ^ICMJE	Behavioral: Re-Inventing Yourself after SCI protocol 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.
Study Arm (s)	Experimental: SCI Reinvention Protocol Participants 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. Intervention: Behavioral: Re-Inventing Yourself after SCI protocol No Intervention: SCI Reinvention Protocol Waitlist Group 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: Behavioral: Re-Inventing Yourself after SCI protocol
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	85
Estimated Completion Date	December 2014
Estimated Primary Completion Date	December 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01633164
Other Study ID Numbers ^ICMJE	H133N110006
Has Data Monitoring Committee	No
Responsible Party	Craig Hospital
Study Sponsor ^ICMJE	Craig Hospital
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Craig Hospital
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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