Community-based Implementation of Online EmReg (NCT05933629)
Community-based Implementation of an Emotion Regulation Intervention for Individuals With Traumatic Brain Injury
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Icahn School of Medicine at Mount Sinai — New York, New York
Age range: 18 Years
🧪 Interventions in This Study
- Online EmReg (BEHAVIORAL)
- Consultation Sessions (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Icahn School of Medicine at Mount Sinai — New York, New York
📞 Contact the Study Coordinator
Phone: (212) 241-0818
Email: emily.blunt@mountsinai.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Traumatic Brain Injury
- Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI) — San Francisco, California
- Improving Time-Based Prospective Memory in TBI — East Hanover, New Jersey
- Re-entry Continuum for Brain Injury — Greencastle, Indiana
- Transcranial Direct Current Stimulation (TDCS) as an Intervention for Patients With Traumatic Brain Injury — Minneapolis, Minnesota
- TRACK-TBI Longitudinal Biomarker Study — San Francisco, California
- Narrative Discourse Treatment Development — West Haven, Connecticut
Explore by condition: All Traumatic Brain Injury clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.