Re-Inventing Yourself After Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Re-Inventing Yourself After SCI: A Site-Specific Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633164
• Other study ID #: H133N110006
• Status: Completed
• Phase: N/A
• First received: June 26, 2012
• Last updated: January 30, 2018
• Start date: April 2012
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: Craig Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

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.

Other:
• Waitlist Group
Wait list arm will begin study intervention after 4 1/2 months.

Locations

Country	Name	City	State
United States	Craig Hospital	Englewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Craig Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Secondary	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).	Baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks