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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05933629
The ClinicalTrials.gov registry entry for NCT05933629 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (82% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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