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NCT04127292 · ClinicalTrials.gov registry record · NA
Impact of Clinician Virtual Human Interaction Training in Emotional Self-Awareness on Patients Suicidal Ideation and Suicide Crisis Syndrome
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 213
- Enrollment target
NCT04127292 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 213 participants.
The verdict
NCT04127292, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 213 participants
- Enrollment target
Study Summary
Working with patients at risk for suicide is highly stressful for clinicians and often elicits powerful negative emotional responses that may adversely affect suicidal outcomes. A proposed explanation has been that negative emotional responses may result in less empathic communication and unwitting rejection of the patient, which is liable to damage therapeutic alliance. Thus, there is a need for clinician training in effective management of negative emotions towards suicidal patients, which can result in tangible improvement in suicidal outcomes. The training must be web-based, scalable and easy to disseminate, making it available to clinicians everywhere. In this project, the study team will address this critical need by using Virtual Human Interaction (VHI) to train outpatient clinicians in emotional self-awareness (ESA), which includes both recognition of one's own negative emotional responses, and ability to engage in verbal empathic communication with acutely suicidal patients. The study team will conduct a prospective multisite, blinded, randomized trial comparing VHI ESA training with a Control condition, which will assess both clinician-level and patient-level outcomes in 80 outpatient clinician participants (CPs) and 400 of their participating patients (PPs). Using the same VHI scenarios, the ESA group will receive clinician-focused, comprehensive feedback in ESA, while the Control group will assess the VH's suicide risk without receiving the ESA feedback. The study team will measure efficacy of the VHI ESA training on clinicians by comparing ESA feedback and Control CPs' post-training (T2) ESA towards virtual humans, adjusting for pre-training (T1) ESA. The study team will measure the impact of the VHI ESA training on patients' suicidal outcomes by assessing the primary and secondary outcome variables in both CPs and PPs three times: at baseline (T0), after the first post-training treatment session (T3) and one-month post-training (T4). The study team wi
Interventions
- BEHAVIORAL Emotional Self Awareness (ESA) Individual Feedback
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 213 participants |
| Start Date | 2019-09-09 |
| Est. Completion | 2022-06-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04127292
The ClinicalTrials.gov registry entry for NCT04127292 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 213 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Emotional Self Awareness (ESA) Individual Feedback is the first listed.
NCT04127292 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04127292 about?
NCT04127292 is a clinical study titled "Impact of Clinician Virtual Human Interaction Training in Emotional Self-Awareness on Patients Suicidal Ideation and Suicide Crisis Syndrome". Working with patients at risk for suicide is highly stressful for clinicians and often elicits powerful negative emotional responses that may adversely affect suicidal outcomes. A proposed explanation has been that negative emotional responses may result in less empathic communication and unwitting ...
What is the current status of trial NCT04127292?
This trial is currently completed. It is a NA study. The enrollment target is 213 participants. The study started on 2019-09-09. Estimated completion is 2022-06-05.
What interventions are being tested in trial NCT04127292?
The interventions under investigation include: Emotional Self Awareness (ESA) Individual Feedback (BEHAVIORAL).
Who is sponsoring clinical trial NCT04127292?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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