Impact of Clinician Virtual Human Interaction Training in Emotional Self-Awareness on Patients Suicidal Ideation and Suicide Crisis Syndrome
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Suicide
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Two experimental groups will complete the same Virtual Human Interaction (VHI) scenarios. Only the Emotional Self-Awareness (ESA) group will also 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 the VHI ESA training effectiveness by comparing clinician participants' (CPs) ESA towards virtual humans at post-training (T2), adjusting for pre-training (T1) levels. The study team will measure the impact of the VHI ESA on patient participants' (PPs) 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 after the final treatment session, 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' SI and SCS.Masking: Double (Participant, Care Provider)Masking Description: The study will follow a double-blind procedure to minimize the effects of expectation bias. Prior to the start of the study, the Co-Investigators will assign different letters to the ESA training and control group; they will not reveal which letter corresponds to which condition to the coordinators and research assistants until the completion of the study. The Co-Investigators at each site will carry out the randomization procedure and record this information in a password-protected file. Following the baseline T0 assessments but prior to the T1 VHI, the Co-Investigators will inform the coordinators which condition each CP has been assigned to. Although the CPs will be aware that they are receiving feedback on their ESA ratings, they will not know that this is the active component of the training. To ensure PP blinding, CPs will be asked not to discuss the VHI experience with their colleagues or patients to minimize the potential that they will figure out which condition they are in.Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
The study has three interconnected Specific Aims. In Aim 1 the study team will determine if, VHI ESA clinician training improves ESA when interacting with virtual humans. The study team hypothesizes that clinicians in the ESA group will report less negative emotional responses and greater empathic c...
The study has three interconnected Specific Aims. In Aim 1 the study team will determine if, VHI ESA clinician training improves ESA when interacting with virtual humans. The study team hypothesizes that clinicians in the ESA group will report less negative emotional responses and greater empathic communication at the post-training (T2) assessment than clinicians in the Control group, adjusting for pre-treatment (T1) scores. In Aim 2 the study team will establish if, VHI ESA clinician training results in sustained improvement in patients' suicidal ideation and SCS. The study team's primary patient level outcomes will be SI as measured by the Beck Suicide Scale, and SCS severity as measured by the SCI. The study team's secondary outcomes will be treatment retention, patients' perception of the therapeutic alliance as measured by the Working Alliance Inventory, patients' perception of clinician empathy as measured by the Consultational and Relational Empathy scale, treatment adherence as measured by the Morisky Medication Adherence Scale, and suicidal behaviors as measured by the Columbia Suicide Severity Rating Scale. The study team hypothesizes that patient participants in the ESA group will report less severe SI and SCS at the first post-training clinical encounter with their clinician (T3) than the Control group, adjusting for baseline (T0) levels of SI and SCS, and that these differences will extend to the final post-training follow-up (T4). In Aim 3 the study team will assess the role of therapeutic alliance in improving SI and SCS. The study team hypothesizes that patients' therapeutic alliance at post-training assessments T3 and T4 will mediate the relationship between post-training ESA indices and post-training patient suicidal outcomes, adjusting for baseline (T0) levels of the outcome. If successful, the proposed work may have a broad impact on clinician training and practice by adding an ESA dimension to evidence-based suicide risk assessment. Suicide is preventable and the ultimate goal is to create an industry-standard platform to train clinicians in ESA, thereby improving their skills in interacting with suicidal patients, and, ultimately, saving lives.
Tracking Information
- NCT #
- NCT04127292
- Collaborators
- Florida International University
- Citrus Health Network, Inc.
- University of Florida
- Investigators
- Principal Investigator: Igor Galynker, MD, PhD Icahn School of Medicine at Mount Sinai Principal Investigator: Adriana Foster, MD Florida International Univerisity Principal Investigator: Benjamin Lok, PhD University of Florida
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