Re-Inventing Yourself After Spinal Cord Injury

NCT01633164 | Completed

• 1 other identifier: H133N110006
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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

Keywords

Spinal Cord Injury; Self-Efficacy; Life Satisfaction; Community Participation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in General Self-Efficacy Scale scores over a 30 week time period

  Baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks

Study Arms (2)

SCI Reinvention Protocol Participants

EXPERIMENTAL

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

Waitlist Group

OTHER

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

Interventions

SCI Reinvention Protocol Participants 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.

SCI Reinvention Protocol Participants

Waitlist Group OTHER

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

Waitlist Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of moderate or severe traumatic brain injury;
• current participation in another RCT;
• live beyond a reasonable commuting distance from Craig Hospital;
• unable to verbally communicate;
• unable to attend group sessions;
• active participation in another formal clinical group or psychological therapy;
• 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
• 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
• have any condition that, in the judgment of the investigators, precludes successful participation in the study.

Sponsors & Collaborators

• Craig Hospital: lead

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Personal Satisfaction

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: July 4, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

US (1)