NCT05933629 Community-based Implementation of Online EmReg
| NCT ID | NCT05933629 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-07-18 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-07-18 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Maria Kajankova, PhD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT05933629 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05933629 currently recruiting?
Yes, NCT05933629 is actively recruiting participants. Contact the research team at emily.blunt@mountsinai.org for enrollment information.
Where is the NCT05933629 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05933629 clinical trial?
NCT05933629 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Maria Kajankova, PhD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 50 participants.