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Community-based Implementation of Online EmReg

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

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Inclusion Criteria:

* 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.

Exclusion Criteria:

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

About the study

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.

What is being tested

• Online EmReg (behavioral)
• Consultation Sessions (behavioral)

Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 50 · Started: Jul 18, 2023

Contact the study team

• Emily Blunt, BA · Phone: 212-241-0818
• Annell Ovalles, MPH · Phone: 212-241-4706

Official record on ClinicalTrials.gov — NCT05933629

Locations in the U.S.

Conditions

• Traumatic Brain Injury

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.