RecruitingNot ApplicableNCT05933629

Community-based Implementation of Online EmReg

Community-based Implementation of an Emotion Regulation Intervention for Individuals With Traumatic Brain Injury


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

50 participants

Start Date

Jul 18, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Consultation Sessions and a behavioral approach called Online EmReg for people with emotion regulation and traumatic brain injury. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALOnline EmReg

A Web-based group intervention to improve emotion regulation in individuals with traumatic brain injury (TBI). Online EmReg is a 3-hour on-demand training workshop

BEHAVIORALConsultation Sessions

3 months of bi-weekly consultation sessions


Locations(1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

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NCT05933629


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