Condition: Traumatic Brain Injury · Emotion Regulation · Sponsor: Icahn School of Medicine at Mount Sinai
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.
This description comes directly from the study's public registry record.
Emily Blunt, BA · 212-241-0818 · emily.blunt@mountsinai.org
Annell Ovalles, MPH · 212-241-4706 · annell.ovalles@mountsinai.org
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| Icahn School of Medicine at Mount Sinai | New York, New York, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05933629