Community-based Implementation of Online EmReg

Recruiting now · Not applicable

Conditions studied: Traumatic Brain Injury, Emotion Regulation

In brief

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.

Key facts

Study ID

NCT05933629

Run by

Icahn School of Medicine at Mount Sinai

People needed

50

Starts

2023-07-18

Expected to finish

2027-08-31

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Licensed psychologist, social worker, or mental health counselor.
• Training and experience in CBT, the framework for EmReg.
• Experience working with people with TBI.
• Experience providing group treatment.
• A computer and internet to conduct group treatment via telehealth.
• Actively treating ≥3 patients with TBI who are appropriate for EmReg (have emotion regulation difficulties based on clinician assessment).
• Amenable to study tasks (e.g., completion of training, consultation, performance based role-play, data collection).
• Not previously trained in EmReg.
• Proficient in English.

You may not qualify if…

• Not willing to conduct group treatment via telehealth.
• Non-English speaking.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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