ReInventing Yourself After SCI: an Intervention to Improve Outcomes After Spinal Cord Injury

Tracking Information
First Submitted Date ICMJE	December 27, 2017
First Posted Date ICMJE	January 4, 2018
Last Update Posted Date	September 25, 2018
Actual Study Start Date ICMJE	July 22, 2018
Estimated Primary Completion Date	March 2022 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 2, 2018)	Moorong Self-Efficacy Scale (MSES) - assessing change over time [ Time Frame: The MSES will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 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. A Total Score, ranging from 16 to 112 is calculated by summing all item responses
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT03390140 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 2, 2018)	Generalized Self-Efficacy Scale (GSES)- assessing change over time [ Time Frame: The GSES will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks) ]The 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).; Diener Satisfaction with Life Scale (SWLS)- assessing change over time [ Time Frame: The SWLS will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks) ]The SWLS will be used to measure global life satisfaction. This is a five item measure on which respondents rate their life satisfaction using a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). A Total Score is calculated by summing each of the items, and has a range of 5 to 35, with higher scores representing greater perceived QoL.; Participation Assessment with Recombined Tools - Objective (PART-O)- assessing change over time [ Time Frame: The PART-O will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks) ]The PART-O is a 24-item assessment of participation and has demonstrated good psychometric properties in measuring participation for people living with disabilities. An Averaged Total Score is computed by taking the mean of 17 items, with scores ranging from 0 (never participate in these types of activities) to 5 (almost always participate in these types of activities), with higher scores representing greater participation. This assessment will be utilized to measure overall participation.; Patient Health Questionnaire - 9 (PHQ-9)- assessing change over time [ Time Frame: The PHQ-9 will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks) ]The PHQ-9 is a 9 item scale that will be used to assess depression. Respondents rate the frequency at which specific problems have been bothersome during the past two weeks, using a four point scale ranging from 0 (not at all) to 3 (nearly every day). A Total Score is calculated by summing all items, with higher scores indicating an increasing severity of depression.; General Anxiety Disorder 7-item (GAD-7)- assessing change over time [ Time Frame: The GAD-7 will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks) ]The GAD-7 is a brief 7 item measure that will be used to assess the severity of general anxiety. Using a four point Likert scale ranging from 0 (not at all sure) to 3 (nearly every day), respondents rate how often they have been bothered by specific symptoms during the past two weeks. A Total Severity Score, ranging from 0 to 21, is calculated by summing all items.; The Connor-Davidson Resilience Scale (CD-RISC 10) short form- assessing change over time [ Time Frame: The CD-RISC 10 will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks) ]The CD-RISC 10 will be used to measure resilience. The measure consists of 10 items using a 5-point Likert scale ranging from 0 (not true at all) to 4 (true nearly all of the time). The scale measures how the participant felt over the past month. The questionnaire produces an overall resilience score that ranges from 0-40, with higher scores representing greater resilience.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	ReInventing Yourself After SCI: an Intervention to Improve Outcomes After Spinal Cord Injury
Official Title ICMJE	ReInventing Yourself After SCI: A Multi-site Randomized Controlled Trial of an Intervention to Improve Outcomes After Spinal Cord Injury
Brief Summary	The primary goal of this study is to conduct a multi-site RCT to evaluate the replicability and efficacy of the ReInventing Yourself after SCI intervention in improving health and function outcomes for persons with spinal cord injury (SCI). A total of 252 participants will be randomized to one of three research arms: 1) Group treatment plus workbook (Group), 2) individual self-study through YouTube video plus workbook (Indiv), and 3) no treatment, no workbook (Control). Participants randomized to the Group arm will attend 6 weekly group sessions led by a pair of group facilitators and will utilize the study workbook. Indiv arm participants will receive the workbook and will be instructed to independently access YouTube videos of the group session content. Control arm participants will not receive any intervention during the 6 week period. Participants in all three arms will be assessed at identical time points throughout the study: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks, and 46 weeks. It is hypothesized that individuals in the Group intervention arm will show greater improvements after the six week intervention in SCI-specific and general self-efficacy, emotional well-being, increased societal participation, less depressive and anxiety symptomatology, and improved resilience than participants in the Indiv and Control arms.
Detailed Description	The purpose of this study is to conduct a multi-site randomized controlled trial (RCT) to evaluate the replicability and efficacy of a structured six-week, manualized, group therapy intervention, ReInventing Yourself after SCI that delivers positive psychology concepts within a cognitive behavioral therapy (CBT)-based model. The goals of this RCT are to increase SCI-specific and general self-efficacy, enhance emotional well-being, and improve participation in society for people with SCI living in the community. Craig Hospital is the lead site for this study, collaborating with the University of Michigan, Ann Arbor, and Kessler Institute for Rehabilitation in New Jersey. The intervention is delivered through six sessions, each lasting approximately 2 hours. Eight skills are presented over the course of the intervention to address reframing 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. These skills are presented in a specific sequence through a workbook so that participants can gain mastery of introductory concepts before undertaking those that are both more difficult and complex. The RCT will have three research arms: 1) Group treatment plus workbook (Group), 2) individual self-study through YouTube video plus workbook (Indiv), and 3) no group or individual sessions, no workbook (Control). It is hypothesized that presenting the positive psychotherapy topics in an interactive structured CBT group format while restructuring maladaptive thought processes and providing experiential opportunities to reinforce behavioral change will result in increased self-efficacy, enhanced well-being and improved societal participation. Three specific hypotheses will be tested: Hypothesis 1 (Primary): Individuals in the Group arm will show greater improvements after the six week intervention in SCI-specific and general self-efficacy, emotional well-being, increased societal participation, less depressive and anxiety symptomatology, and improved resilience than participants in the Indiv and Control arms. Hypothesis 2 (Secondary): Individuals in the Group arm will maintain greater improvements through 46 weeks post-intervention in SCI-specific self-efficacy than participants in the Indiv and Control arms. Hypothesis 3 (Secondary): Individuals in the Group arm will show greater improvements after six weeks of treatment and through 46 weeks post-intervention in general self-efficacy, life satisfaction, community participation, resilience, and less depressive and anxiety symptomatology than participants in the Indiv and Control groups. The Moorong Self-Efficacy Scale (MSES) will serve as the primary outcome measure for this study. Secondary outcome measures include the General Self-Efficacy Scale, Diener Satisfaction with Life Scale, and measures of participation, resilience, anxiety and depression. Each collaborating site will enroll 84 individuals to be randomized into one of the three study arms in waves of 21 people per wave (4 waves per site). Training of site facilitators will take place at Craig Hospital.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Spinal Cord Injuries
Intervention ICMJE	Behavioral: ReInventing Yourself after SCI structured group CBT ReInventing Yourself after SCI intervention integrates positive psychotherapy concepts into structured group cognitive behavioral therapy (CBT) to develop optimistic self-efficacy beliefs, thereby strengthening resilience to emotional distress, enhancing a sense of well-being and promoting a more active lifestyle. The intervention consists of six weekly two-hour facilitator-led sessions that include didactic presentations of eight core skills and related experiential exercises with extensive group discussion.; Behavioral: ReInventing Yourself after SCI study-specific workbook A study-specific workbook that incorporates positive psychotherapy concepts to develop optimistic self-efficacy beliefs, thereby strengthening resilience to emotional distress, enhancing a sense of well-being and promoting a more active lifestyle.; Behavioral: ReInventing Yourself after SCI YouTube videos YouTube videos containing the content of the ReInventing Yourself after SCI structured group CBT sessions
Study Arms	Experimental: Group ReInventing Yourself after SCI structured group CBT and ReInventing Yourself after SCI study-specific workbook Interventions: Behavioral: ReInventing Yourself after SCI structured group CBT Behavioral: ReInventing Yourself after SCI study-specific workbook; Active Comparator: Indiv ReInventing Yourself after SCI study-specific workbook and ReInventing Yourself after SCI YouTube videos Interventions: Behavioral: ReInventing Yourself after SCI study-specific workbook Behavioral: ReInventing Yourself after SCI YouTube videos; No Intervention: Control No group sessions, no YouTube videos, no workbook
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: January 2, 2018)	252
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	March 2022
Estimated Primary Completion Date	March 2022 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: History of spinal cord injury/disorder (SCI/D) at any neurological level; At least 4 weeks post-discharge from initial inpatient rehabilitation; English speaking in order to complete study measures and participate in group interactions; Access to the internet and/or a DVD player; Able to provide informed consent to participate. Exclusion Criteria: Diagnosed with MS, Lupus, ALS, or Spina Bifida; History of moderate or severe traumatic brain injury; Current participation in another RCT; Lives beyond a reasonable commuting distance from one of the collaborating sites; Unable to verbally communicate; Unable to attend group sessions; Active participation in another formal clinical group or psychological therapy; Currently experiencing moderately severe or greater levels of depressive symptoms which would require more intense treatment than is provided in this intervention, as evidenced by a score of 15 or higher on the PHQ-9; Has any medical or psychological condition that, in the judgment of the investigators, precludes successful participation in the study.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Kimberley Monden, PhD 303.789.8562 kmonden@craighospital.org Contact: Jennifer Coker, MPH 303.789.8229 jcoker@craighospital.org
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT03390140
Other Study ID Numbers ICMJE	90DPHF0002-01-00
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Plan to Share IPD: Undecided
Responsible Party	Craig Hospital
Study Sponsor ICMJE	Craig Hospital
Collaborators ICMJE	University of Michigan; Kessler Foundation
Investigators ICMJE	Principal Investigator: Susan Charlifue, PhD Craig Hospital
PRS Account	Craig Hospital
Verification Date	September 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP