Community-based Implementation of Online EmReg

NCT05933629 | Recruiting DMC

• 2 other identifiers: STUDY-22-0138090DPTB0028-01-00
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Provider Self-Efficacy Scale Score

  A 7-item Likert Scale (not at all confident (1) to fully confident (7)) adapted for use with EmReg to assess provider confidence in delivering core components of the Online EmReg intervention. Total scores range from 26 to 182. Higher values indicate a higher level of self-efficacy. Used in the literature to reliably predict implementation of evidence-based interventions.

  Up to 18 months

• Performance Evaluation (via Role Plays)

  Assessed using a structured role play of EmReg groups in a simulated clinical setting. These role plays will be recorded and rated by a blinded evaluator. The evaluator will indicate the degrees to which the session goals were accomplished using a 15-item checklist. Each item will be rated a 0 (not introduced or covered), 1 (attempted/partially achieved), 2 (fully covered/achieved), or N/A (not applicable/relevant to session #). Participants can receive a total score of 0 to 30 on their performance-based role play. Higher values indicate higher achievement.

  Post-3 hour EmReg training workshop

Secondary Outcomes (9)

• Training Satisfaction Rating Scale

  Up to 18 months

• Acceptability of Intervention Measure (AIM)

  Up to 18 months

• Feasibility of Intervention Measure (FIM) Scale

  Up to 18 months

• Intervention Appropriateness Measure (IAM) Scale

  Up to 18 months

• Number of EmReg groups scheduled and completed

  Up to 18 months

Study Arms (2)

Standard Training

ACTIVE COMPARATOR

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.

Behavioral: Online EmReg

Extended Training

EXPERIMENTAL

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.

Behavioral: Online EmReg; Behavioral: Consultation Sessions

Interventions

Online EmReg BEHAVIORAL

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

Extended Training; Standard Training

Consultation Sessions BEHAVIORAL

3 months of bi-weekly consultation sessions

Extended Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Emotional Regulation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Self-Control; Social Behavior; Behavior

Study Officials

• Maria Kajankova, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Blunt, BA

CONTACT

212-241-0818; emily.blunt@mountsinai.org

Annell Ovalles, MPH

CONTACT

212-241-4706; annell.ovalles@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 6, 2023
• Study Start: July 18, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)