Clinical trial NCT04127292: Impact of Clinician Virtual Human Interaction Training in Emotional Self-Awareness on Patients Suicidal Ideation and Suicide Crisis Syndrome
Official title: Impact of Clinician Virtual Human Interaction Training in Emotional Self-Awareness on Patients Suicidal Ideation and Suicide Crisis Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: Suicide
Empathy
Emotional Self-Awareness
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Florida International University
name: Citrus Health Network, Inc.
name: University of Florida
First posted: 2019-10-15
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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).

Detailed 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 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.

Eligibility criteria: Clinician Participant

Inclusion Criteria:

* 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.

Exclusion Criteria:

- 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.

Primary outcomes:
measure: Suicide Crisis Inventory (SCI)
timeFrame: Baseline (T0)
measure: Suicide Crisis Inventory (SCI)
timeFrame: 6 weeks (T3 = One month after T2)
measure: Suicide Crisis Inventory (SCI)
timeFrame: 10 weeks (T4 = One month after T3)
measure: Beck Scale for Suicide Ideation (BSS)
timeFrame: Baseline (T0)
measure: Beck Scale for Suicide Ideation (BSS)
timeFrame: 6 weeks (T3 = One month post T2)
measure: Beck Scale for Suicide Ideation (BSS)
timeFrame: 10 weeks (T4 = One month after T3)
Secondary outcomes:
measure: TRQ-SF (Therapist Response Questionnaire Short Form)
timeFrame: Baseline (T0)
measure: TRQ-SF (Therapist Response Questionnaire Short Form)
timeFrame: 1 week (T1)
measure: TRQ-SF (Therapist Response Questionnaire Short Form)
timeFrame: 2 weeks (T2)
measure: TRQ-SF (Therapist Response Questionnaire Short Form)
timeFrame: 6 weeks (T3 = One month post T2)
measure: TRQ-SF (Therapist Response Questionnaire Short Form)
timeFrame: 10 weeks (T4 = One month after T3)
measure: Empathic Communication Coding System (ECCS)
timeFrame: 1 week (T1)
measure: Empathic Communication Coding System (ECCS)
timeFrame: 2 weeks (T2)
measure: Columbia Suicide-Severity Rating Scale (CSSRS)
timeFrame: Baseline (T0)
measure: Columbia Suicide-Severity Rating Scale (CSSRS)
timeFrame: 10 weeks (T4 = One month after T3)
measure: Working Alliance Inventory Short Form (WAI)
timeFrame: Baseline (T0)
measure: Working Alliance Inventory Short Form (WAI)
timeFrame: 6 weeks (T3 = One month post T2)
measure: Working Alliance Inventory Short Form (WAI)
timeFrame: 10 weeks (T4 = One month after T3)
measure: Clinician Prediction Scale (CPS)
timeFrame: 1 week (T1)
measure: Clinician Prediction Scale (CPS)
timeFrame: 2 weeks (T2)
measure: VHI training utility survey
timeFrame: 2 weeks (T2)
measure: Consultation and Relational Empathy (CARE)
timeFrame: Baseline (T0)
measure: Consultation and Relational Empathy (CARE)
timeFrame: 6 weeks (T3 = One month post T2)
measure: Consultation and Relational Empathy (CARE)
timeFrame: 10 weeks (T4 = One month after T3)
measure: Medication Adherence Rating Scale (MARS)
timeFrame: Baseline (T0)
measure: Medication Adherence Rating Scale (MARS)
timeFrame: 6 weeks (T3 = One month post T2)
measure: Medication Adherence Rating Scale (MARS)
timeFrame: 10 weeks (T4 = one month after T3)
measure: Facial Affective Coding System (FACS)
timeFrame: 1 week (T1)
measure: Facial Affective Coding System (FACS)
timeFrame: 2 weeks (T2)
measure: Proportion of Nonsensical VH Responses
timeFrame: 1 week (T1)
measure: Proportion of Nonsensical VH Responses
timeFrame: 2 weeks (T2)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: Florida International University
state: Florida
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Igor Galynker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida International Univerisity
name: Adriana Foster, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Benjamin Lok, PhD
role: PRINCIPAL_INVESTIGATOR
References: