Clinical trial NCT01633164: Re-Inventing Yourself After Spinal Cord Injury
Official title: Re-Inventing Yourself After SCI: A Site-Specific Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
Self-Efficacy
Life Satisfaction
Community Participation
Lead sponsor: Craig Hospital
Sponsor class: OTHER
First posted: 2012-07-04
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Moorong Self-Efficacy Scale (MSES) score over a 30 week time period
timeFrame: Baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Secondary outcomes:
measure: Change in General Self-Efficacy Scale scores over a 30 week time period
timeFrame: Baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
Study officials:
References: