Re-Inventing Yourself After Spinal Cord Injury

NCT ID: NCT01633164

Last Updated: 2018-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2017-09-30

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

SCI Reinvention Protocol Participants

Intervention Type: BEHAVIORAL

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.

Group Type: OTHER

Waitlist Group

Intervention Type: OTHER

Wait list arm will begin study intervention after 4 1/2 months.

Interventions

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.

Intervention Type: BEHAVIORAL

Waitlist Group

Wait list arm will begin study intervention after 4 1/2 months.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Craig Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Craig Hospital

Englewood, Colorado, United States

Countries

United States

Other Identifiers

H133N110006

Identifier Type: -

Identifier Source: org_study_id