Re-Inventing Yourself After Spinal Cord Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Craig Hospital
Sponsor:
Information provided by (Responsible Party):
Craig Hospital
ClinicalTrials.gov Identifier:
NCT01633164
First received: June 26, 2012
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Spinal Cord Injury
Behavioral: SCI Reinvention Protocol Participants
Other: Waitlist Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Re-Inventing Yourself After SCI: A Site-Specific Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Craig Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 85
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: SCI Reinvention Protocol Participants
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.
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.
Other: Waitlist Group
Wait list arm will begin study intervention after 4 1/2 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. History of traumatic SCI at any level;
  2. at least 4 weeks post-discharge from initial inpatient rehabilitation;
  3. 18 years of age or older at the time of study enrollment;
  4. English speaking in order to complete study measures and participate in group interactions; and
  5. able to provide informed consent to participate

Exclusion Criteria:

  1. History of moderate or severe traumatic brain injury;
  2. current participation in another RCT;
  3. live beyond a reasonable commuting distance from Craig Hospital;
  4. unable to verbally communicate;
  5. unable to attend group sessions;
  6. active participation in another formal clinical group or psychological therapy;
  7. 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
  8. 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
  9. have any condition that, in the judgment of the investigators, precludes successful participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633164

Locations
United States, Colorado
Craig Hospital Recruiting
Englewood, Colorado, United States, 80113
Contact: Susie Charlifue, PhD    303-789-8306    Susie@Craig-Hospital.org   
Contact: Jeff Cuthbert, MPH MS    303-789-8028    JCuthbert@Craighospital.org   
Sponsors and Collaborators
Craig Hospital
  More Information

No publications provided

Responsible Party: Craig Hospital
ClinicalTrials.gov Identifier: NCT01633164     History of Changes
Other Study ID Numbers: H133N110006
Study First Received: June 26, 2012
Last Updated: August 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Craig Hospital:
Spinal Cord Injury
Self-Efficacy
Life Satisfaction
Community Participation

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 22, 2014