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



Status:Recruiting
Conditions:Hospital, Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - Any
Updated:9/27/2018
Start Date:July 22, 2018
End Date:March 2022
Contact:Kimberley Monden, PhD
Email:kmonden@craighospital.org
Phone:303.789.8562

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ReInventing Yourself After SCI: A Multi-site Randomized Controlled Trial of an Intervention to Improve Outcomes After Spinal Cord Injury

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.

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.

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.
We found this trial at
3
sites
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Denise Tate, PhD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Englewood, Colorado 80113
Principal Investigator: Susan Charlifue, PhD
Phone: 303-789-8030
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Englewood, CO
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West Orange, New Jersey 07052
Principal Investigator: Amanda Botticello, PhD
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West Orange, NJ
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