This trial is active, not recruiting.

Condition spinal cord injury
Treatments sci reinvention protocol participants, waitlist group
Sponsor Craig Hospital
Start date April 2012
End date September 2016
Trial size 81 participants
Trial identifier NCT01633164, H133N110006


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
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.
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.
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.
waitlist group
Wait list arm will begin study intervention after 4 1/2 months.

Primary Outcomes

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

Secondary Outcomes

Change in General Self-Efficacy Scale scores over a 30 week time period
time frame: Baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

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.

Additional Information

Official title Re-Inventing Yourself After SCI: A Site-Specific Randomized Clinical Trial
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Craig Hospital.