Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05933629

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

Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-04-06

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the best way to train clinicians to deliver the Online EmReg intervention, a web-based group therapy designed to improve emotion regulation in individuals with traumatic brain injury (TBI). This hybrid type III implementation-effectiveness trial aims to determine which training strategy helps clinicians deliver Online EmReg most effectively, while also assessing patient improvements related to emotion regulation. The study is sponsored by the Icahn School of Medicine at Mount Sinai and involves a randomized comparison of training approaches. The trial compares two training methods for clinicians: Standard Training, which is a 3-hour on-demand workshop, and Extended Training, which includes the same 3-hour workshop plus three months of bi-weekly consultation sessions. After training, clinicians are expected to implement the Online EmReg intervention into their routine clinical practice. The Extended Training arm adds ongoing support to help clinicians during the first three months of applying the intervention. Participants in the study will be assessed through self-report surveys, performance evaluations using role plays, and tracking of clinician participation and fidelity to the intervention. The primary outcomes include clinician self-efficacy and performance evaluation scores, measured up to 18 months. Secondary outcomes include training satisfaction, intervention acceptability, feasibility, appropriateness, and patient emotion regulation improvements. The total participation may last up to 18 months, during which clinicians will complete training, consultations if assigned, and implementation activities.

CONDITIONS

Brief Title

Community-based Implementation of Online EmReg

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Licensed psychologist, social worker, or mental health counselor
  • Training and experience in cognitive behavioral therapy (CBT)
  • Experience working with individuals with traumatic brain injury
  • Experience providing group treatment
  • Access to a computer and internet to conduct group treatment via telehealth
  • Actively treating at least 3 patients with traumatic brain injury who have emotion regulation difficulties
  • Willing and able to complete study tasks including training, consultation, role-play, and data collection
  • Not previously trained in Online EmReg
  • Proficient in English
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 3 months

Participants complete a 3-hour online training workshop on emotion regulation. Depending on the group, participants may also attend bi-weekly consultation sessions for 3 months following the training to support implementation of the intervention into their routine clinical practice.

3 months of bi-weekly consultation sessions for Extended Training arm; 1 online training workshop for Standard Training arm

Trial Site Locations

Total: 1 location

1

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

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Research Team

E

Emily Blunt, BA

A

Annell Ovalles, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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