Re-Inventing Yourself After Spinal Cord Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01633164|
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : February 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Behavioral: SCI Reinvention Protocol Participants Other: Waitlist Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Re-Inventing Yourself After SCI: A Site-Specific Randomized Clinical Trial|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
Experimental: 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.
Behavioral: 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.
Other: Waitlist Group
Wait list arm will begin study intervention after 4 1/2 months.
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633164
|United States, Colorado|
|Englewood, Colorado, United States, 80113|