Community-based Implementation of Online EmReg

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

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury; Emotion Regulation
• Intervention / Treatment: Behavioral: Online EmReg; Behavioral: Consultation Sessions

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annell Ovalles, MPH; Phone Number: 212-241-4706; Email: annell.ovalles@mountsinai.org
• Study Contact Backup: Name: Emily Blunt, BA; Phone Number: 212-241-0818; Email: emily.blunt@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • ICAHN School of Medicine at Mount Sinai
      • Contact: Maria Kajankova, PhD; Phone Number: 212-241-3379; Email: maria.kajankova@mountsinai.org
      • Contact: Maria Kajankova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Training; 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; 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
Experimental: Extended Training; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Training Satisfaction Rating Scale	Satisfaction with training will be assessed using the Training Satisfaction Rating Scale, a 12-item, 5-point Likert scale (higher scores = higher satisfaction). Total scores range from 12 to 60. Training engagement and consultation engagement (extended group only) will be tracked by study team.	Up to 18 months
Acceptability of Intervention Measure (AIM)	Provider's satisfaction with the intervention will be assessed using the Acceptability of Intervention Measure (AIM), a 4-item, 5-point Likert scale. Total scores can range from 4 to 20 with higher scores indicating greater acceptability.	Up to 18 months
Feasibility of Intervention Measure (FIM) Scale	Feasibility of the intervention will be assessed using the Feasibility of Intervention Measure (FIM), a 4-item, 5-point Likert scale. Total scores can range from 4 to 20 with higher scores indicating greater feasibility.	Up to 18 months
Intervention Appropriateness Measure (IAM) Scale	Appropriateness of the intervention will be assessed using the Intervention Appropriateness Measure (IAM), a 4-item, 5-point Likert scale. Total scores can range from 4 to 20 with higher scores indicating greater intervention appropriateness.	Up to 18 months
Number of EmReg groups scheduled and completed	The number of EmReg groups scheduled and completed by the clinician participants	Up to 18 months
Time between initial uptake and completion	The time between completion of training and initial uptake will be tracked.	Up to 18 months
Skills Acquisition Quiz for Providers (SAQ-P)	Clinician participants will be given a 25-item multiple-choice test of knowledge of Online EmReg training content. Correct answers are coded as 1 and incorrect answers are coded as 0. Scores range from 0-25 with higher scores indicating greater knowledge of the intervention.	Up to 18 months
Number of participants who receive treatment	Clinician participants will be asked to track the number of patients who receive treatment out of those who appear eligible.	Up to 18 months
Difficulties in Emotion Regulation Scale (DERS)	A 36-item questionnaire assessing capacity for emotion regulation. Each item is scored on a 5-point scale. Total scores range from 80 to 136. Out of the 36 items, 11 are reverse scored. Higher scores suggest greater problems with emotion regulation.	Up to 18 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Maria Kajankova, PhD, ICAHN School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Brain Injuries
• Other Study ID Numbers: STUDY-22-01380; 90DPTB0028-01-00 (Other Grant/Funding Number: National Institute On Disability & Rehabilitation Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Currently, there is no plan to share individual participant data. Results will be published by the investigators in academic journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No