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Completed

NCT Number: NCT01633164

Re-Inventing Yourself After Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injury Behavior Central Nervous System Diseases Nervous System Diseases Personal Satisfaction Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Craig Hospital

Englewood, Colorado, 80113, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of traumatic SCI at any level;
  • at least 4 weeks post-discharge from initial inpatient rehabilitation;
  • 18 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Waitlist Group

Other

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Craig Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jul 4, 2012
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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