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Re-Inventing Yourself After Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01633164
Recruitment Status : Active, not recruiting
First Posted : July 4, 2012
Last Update Posted : January 31, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Spinal Cord Injury Behavioral: SCI Reinvention Protocol Participants Other: Waitlist Group

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Re-Inventing Yourself After SCI: A Site-Specific Randomized Clinical Trial
Study Start Date : April 2012
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Change in General Self-Efficacy Scale scores over a 30 week time period [ Time Frame: Baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks ]
    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).

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633164

United States, Colorado
Craig Hospital
Englewood, Colorado, United States, 80113
Sponsors and Collaborators
Craig Hospital
More Information

Responsible Party: Craig Hospital
ClinicalTrials.gov Identifier: NCT01633164     History of Changes
Other Study ID Numbers: H133N110006
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

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

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