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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: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT04127292 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 213 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
A 49-item self-report instrument for the assessment of the severity of the Suicidal Crisis Syndrome (SCS), an acute state shown to correlate with a near-term suicide attempt. Items are rated by self-report on a five-point scale ranging from 0=not at all to 4=extremely. Full scale from 0-196, with higher score indicating increased suicide risk.
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 |
What the finished NCT04127292 record still lists
NCT04127292 is an interventional study that assigns participants to a tested intervention. The registered 213 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Emotional Self Awareness (ESA) Individual Feedback is the first listed.
NCT04127292 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04127292's enrollment target sits among peer trials
213 488th of 2000 higher than 1,512 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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