Impact of Clinician Virtual Human Interaction Training in Emotional Self-Awareness on Patients Suicidal Ideation and Suicide Crisis Syndrome

Completed · Not applicable

Conditions studied: Suicide

In brief

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 will examine the role of therapeutic alliance as a possible mediator of the relationship between clinicians' ESA and their patients' Suicidal Ideation (SI) and Suicide Crisis Syndrome (SCS). To accomplish this goal, the study team will use the novel validated suicide risk assessment instruments developed in preliminary studies: the Therapist Response Questionnaire - Suicide Form (TRQ-SF), which assesses negative emotional responses to suicidal patients, and the Suicide Crisis inventory (SCI), which assesses the SCS severity and predicts near-term suicidal behavior. For web-based VHI training the study team will use the already tested and disseminated web-based empathy-teaching platform, coupled with an assessment of verbal empathy measured by the Empathic Communication Coding System (ECCS).

Key facts

Study ID: NCT04127292
Run by: Icahn School of Medicine at Mount Sinai
People needed: 213
Starts: 2019-09-09
Expected to finish: 2022-06-05
Last updated by the study team: 2022-11-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

a staff clinician or trainee in one of the Psychiatry outpatient clinics of the MSHS or Florida International University/Citrus Health Network outpatient clinics
have a caseload of 5 - 10 patients meeting PP inclusion and exclusion criteria.

You may not qualify if…

non-approval for study participation by department chairman, training director or clinical supervisor.
Patient Participant
Inclusion Criteria:
currently in ongoing outpatient treatment at one of the recruitment clinics
have SI in the past month as defined by the CSSRS, have a lifetime history of actual SA as defined by the CSSRS or to have a confirmed psychiatric emergency room visit or hospitalization within the past two weeks.
Exclusion Criteria:
a need for hospitalization at the time of study enrollment
acute medical illness, cognitive impairment, linguistic limitation precluding understanding of the consent or research questions
and lack of contact information needed for follow up assessment.

Where it is running

University of Florida — Gainesville, Florida, United States
Florida International University — Miami, Florida, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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