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

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ClinicalTrials.gov Identifier: NCT03390140
Recruitment Status : Not yet recruiting
First Posted : January 4, 2018
Last Update Posted : January 4, 2018
Sponsor:
Collaborators:
University of Michigan
Kessler Foundation
Information provided by (Responsible Party):
Craig Hospital

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: ReInventing Yourself after SCI structured group CBT Behavioral: ReInventing Yourself after SCI study-specific workbook Behavioral: ReInventing Yourself after SCI YouTube videos Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ReInventing Yourself After SCI: A Multi-site Randomized Controlled Trial of an Intervention to Improve Outcomes After Spinal Cord Injury
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group
ReInventing Yourself after SCI structured group CBT and ReInventing Yourself after SCI study-specific workbook
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.
Active Comparator: Indiv
ReInventing Yourself after SCI study-specific workbook and ReInventing Yourself after SCI YouTube videos
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
No Intervention: Control
No group sessions, no YouTube videos, no workbook



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of traumatic SCI 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
  • Able to provide informed consent to participate.

Exclusion Criteria:

  • 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
  • Currently of high general self-efficacy, as determined by a score of 30 or higher on the GSES, which has a range of scores from 10-40
  • Has any medical or psychological condition that, in the judgment of the investigators, precludes successful participation in the study.

Information from the National Library of Medicine

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): NCT03390140


Contacts
Contact: Kimberley Monden, PhD 303.789.8562 kmonden@craighospital.org
Contact: Jennifer Coker, MPH 303.789.8229 jcoker@craighospital.org

Locations
United States, Colorado
Craig Hospital Not yet recruiting
Englewood, Colorado, United States, 80113
Contact: Angela Philippus, BA    303-789-8030    aphilippus@craighospital.org   
Contact: Jennifer Coker, MPH    303.789.8229    jcoker@craighospital.org   
Principal Investigator: Susan Charlifue, PhD         
Sub-Investigator: Kimberley Monden, PhD         
Sub-Investigator: Jennifer Coker, MPH         
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Denise Tate, PhD       dgtate@med.umich.edu   
Principal Investigator: Denise Tate, PhD         
United States, New Jersey
Kessler Foundation Not yet recruiting
West Orange, New Jersey, United States, 07052
Contact: Amanda Boticello, PhD       abotticello@kesslerfoundation.org   
Principal Investigator: Amanda Botticello, PhD         
Sponsors and Collaborators
Craig Hospital
University of Michigan
Kessler Foundation
Investigators
Principal Investigator: Susan Charlifue, PhD Craig Hospital

Responsible Party: Craig Hospital
ClinicalTrials.gov Identifier: NCT03390140     History of Changes
Other Study ID Numbers: 90DPHF0002-01-00
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Craig Hospital:
Spinal Cord Injuries
Group Intervention
Self Efficacy

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System