Recruiting

Observational Study

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05933629

Conditions

Traumatic Brain Injury

Emotion Regulation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Online EmReg

Consultation Sessions

Study Details

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

Study ID

NCT05933629

Start date

Jul 18, 2023

Status verified date

Jul, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

Consultation Sessions

3 months of bi-weekly consultation sessions

Primary outcome measure

  • Provider Self-Efficacy Scale Score [ Time Frame: Up to 18 months ]
  • Performance Evaluation (via Role Plays) [ Time Frame: Post-3 hour EmReg training workshop ]

Central Contacts and Locations

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Maria Kajankova

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-07-16.