ReInventing Yourself After SCI: an Intervention to Improve Outcomes After Spinal Cord Injury
Status unconfirmed · Not applicable
Conditions studied: Spinal Cord Injuries
In brief
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 virtual 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.
Key facts
- Study ID
- NCT03390140
- Run by
- Craig Hospital
- People needed
- 281
- Starts
- 2018-07-22
- Expected to finish
- 2023-03-01
- Last updated by the study team
- 2022-06-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 a laptop/desktop computer/smartphone with webcam and the ability and willingness to download Zoom software to join a video conference
- Able to provide informed consent to participate.
You may not qualify if…
- Diagnosed with MS, Lupus, ALS, or Spina Bifida
- History of moderate or severe traumatic brain injury
- Current participation in another RCT
- 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.
Where it is running
- Craig Hospital — Englewood, Colorado, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Kessler Foundation — West Orange, New Jersey, United States
Full record on ClinicalTrials.gov
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