← Back to all trials
Recruiting
NCT05933629
Community-based Implementation of Online EmReg
Conditions: Traumatic Brain Injury, Emotion Regulation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 50
Sponsor: Icahn School of Medicine at Mount Sinai
Location: Icahn School of Medicine at Mount Sinai New York New York
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05933629). StuddyBuddy aggregates publicly available trial information.