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NCT05933629 · ClinicalTrials.gov registry record · NA
Community-based Implementation of Online EmReg
A NA study of Traumatic Brain Injury and Emotion Regulation, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05933629: Recruiting NA study of Traumatic Brain Injury and Emotion Regulation, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05933629 is a NA study of Traumatic Brain Injury and Emotion Regulation that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 50 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05933629, a NA study of Traumatic Brain Injury and Emotion Regulation, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a hybrid type III implementation-effectiveness trial; this study design blends elements of implementation and clinical effectiveness research, with the primary aim of determining the utility of an implementation strategy and a secondary aim of assessing clinical outcomes associated with the implementation trial. Consistent with best practices for this type of design, the study team will conduct a randomized test of the effect of implementation strategy on effective delivery of the Online EmReg intervention in clinical practice. Specifically, the study team will compare Standard Training (a 3-hour on-demand training workshop) to Extended Training, (a 3-hour on-demand training workshop with 3 months of bi-weekly consultation). The research team's primary aim is to determine the optimal strategy to train clinicians in effectively delivering Online EmReg, and secondary aim is to assess patient improvement per clinician-administered DERS. Outcome measures will be assessed via self-report surveys, performance evaluations (via role-plays), and tracked clinician participation and fidelity. Study participation is expected to last up to 18 months.
Primary Outcome
A 7-item Likert Scale (not at all confident (1) to fully confident (7)) adapted for use with EmReg to assess provider confidence in delivering core components of the Online EmReg intervention. Total scores range from 26 to 182. Higher values indicate a higher level of self-efficacy. Used in the literature to reliably predict implementation of evidence-based interventions.
Conditions Studied
Interventions
- BEHAVIORAL Online EmReg
- BEHAVIORAL Consultation Sessions
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-07-18 |
| Est. Completion | 2027-05-31 |
| Phase | NA |
What NCT05933629 shows while recruiting
NCT05933629 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which Online EmReg is the first listed.
NCT05933629 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05933629 about?
NCT05933629 is a clinical study titled "Community-based Implementation of Online EmReg". This is a hybrid type III implementation-effectiveness trial; this study design blends elements of implementation and clinical effectiveness research, with the primary aim of determining the utility of an implementation strategy and a secondary aim of assessing clinical outcomes associated with the ...
What is the current status of trial NCT05933629?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2023-07-18. Estimated completion is 2027-05-31.
What conditions does trial NCT05933629 study?
This clinical trial studies the following conditions: Traumatic Brain Injury, Emotion Regulation.
What interventions are being tested in trial NCT05933629?
The interventions under investigation include: Online EmReg (BEHAVIORAL), Consultation Sessions (BEHAVIORAL).
Who is sponsoring clinical trial NCT05933629?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05933629 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05933629's enrollment target sits among peer trials
50 116th of 171 higher than 51 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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