Community-based Implementation of Online EmReg

Mount Sinai Health System

Status: Enrolling

Conditions: Traumatic Brain Injury; Emotion Regulation

Treatments: Behavioral: Consultation Sessions; Behavioral: Online EmReg

Study type: Interventional

Funder types: Other

Identifiers

NCT05933629

90DPTB0028-01-00 (Other Grant/Funding Number)

STUDY-22-01380

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Standard Training

Active Comparator group

Description:

Participants assigned to this arm will complete a 3-hour training workshop on the intervention. After completing the training, participants will be asked to implement the intervention into their routine clinical practice.

Treatment:

Behavioral: Online EmReg

Extended Training

Experimental group

Description:

Participants assigned to this arm will complete the same 3-hour training workshop on the intervention as Arm #1. After completing the training, participants will also be asked to implement the intervention into their routine clinical practice. However, participants in this group will be asked to attend bi-weekly consultation sessions with members of the study team for 3 months following training.

Treatment:

Behavioral: Online EmReg

Behavioral: Consultation Sessions