Community-based Implementation of Online EmReg

  • STATUS
    Recruiting
  • End date
    May 31, 2027
  • participants needed
    50
  • sponsor
    Icahn School of Medicine at Mount Sinai
Updated on 11 July 2023
Accepts healthy volunteers

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 15 months.

Details
Condition Traumatic Brain Injury, Emotion Regulation
Age 18years or above
Treatment Online EmReg, Consultation Sessions
Clinical Study IdentifierNCT05933629
SponsorIcahn School of Medicine at Mount Sinai
Last Modified on11 July 2023

Eligibility

Yes No Not Sure

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
Exclusion Criteria
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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