NCT05933629

Community-based Implementation of Online EmReg

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

• Traumatic Brain Injury
• Emotion Regulation

Interventions

Type	Name	Description
BEHAVIORAL	Online 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
BEHAVIORAL	Consultation Sessions	3 months of bi-weekly consultation sessions

Timeline

• Start date: 2023-07-18
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2023-07-06
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States