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NCT03390140
ReInventing Yourself After SCI: an Intervention to Improve Outcomes After Spinal Cord Injury
NA trial testing ReInventing Yourself after SCI structured group CBT in Spinal Cord Injuries in 281 participants. Status unknown.
1 March 2023
Quick facts
| Lead sponsor | Craig Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 281 |
| Start date | 22 July 2018 |
| Primary completion | 1 March 2023 |
| Estimated completion | 1 March 2023 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- ReInventing Yourself after SCI structured group CBT
- ReInventing Yourself after SCI study-specific workbook
- ReInventing Yourself after SCI YouTube videos
Conditions studied
- Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
Sponsor
Craig Hospital
Who can join
18 and older, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03390140
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Spinal Cord Injuries
Currently open trials in the same condition.
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- NCT07472985 — Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial · NA · recruiting
- NCT07210411 — Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury · NA · recruiting
- NCT07488793 — Remote Ischemic Conditioning for PwSCI · NA · recruiting
- NCT07536386 — Self-balancing Personal Exoskeleton for SCI (WIP) · NA · recruiting
Other Craig Hospital trials
Trials by the same sponsor.
- NCT07227727 — Endothelial Dysfunction After SCI · recruiting
- NCT07227740 — Testosterone Deficiency and Endothelial Dysfunction After Spinal Cord Injury · recruiting
- NCT06780280 — Walking With Overground Robotic Exoskeletons to Improve Arrousal in Individuals With Disorders of Consciousness · Phase 2, PHASE3 · not yet recruiting
- NCT06443151 — Role of Endothelial Function in SCI CVD Risk · recruiting
- NCT06276894 — Functional Near-Infrared Spectroscopy (fNIRS) Assessing Neural Activity During Virtual Reality Walking Intervention · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03390140 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Craig Hospital
- Last refreshed: 3 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03390140.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing