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

NCT04127292 | Completed DMC

• 1 other identifier: GCO 18-1346
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 3

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).

Conditions

Suicide

Keywords

Suicide; Empathy; Emotional Self-Awareness

Outcome Measures

Primary Outcomes (6)

• Suicide Crisis Inventory (SCI)

  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.

  Baseline (T0)

• Suicide Crisis Inventory (SCI)

  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.

  6 weeks (T3 = One month after T2)

• Suicide Crisis Inventory (SCI)

  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.

  10 weeks (T4 = One month after T3)

• Beck Scale for Suicide Ideation (BSS)

  A well validated 21-item self-report measure of active and passive suicidal desires will be used to assess severity of patient SI pre- and post-training. Scores on each item range from 0 to 2, full scale from 0-42, with higher scores indicating greater severity of SI.

  Baseline (T0)

• Beck Scale for Suicide Ideation (BSS)

  A well validated 21-item self-report measure of active and passive suicidal desires will be used to assess severity of patient SI pre- and post-training. Scores on each item range from 0 to 2, full scale from 0-42, with higher scores indicating greater severity of SI.

  6 weeks (T3 = One month post T2)

• Beck Scale for Suicide Ideation (BSS)

  A well validated 21-item self-report measure of active and passive suicidal desires will be used to assess severity of patient SI pre- and post-training. Scores on each item range from 0 to 2, full scale from 0-42, with higher scores indicating greater severity of SI.

  10 weeks (T4 = One month after T3)

Secondary Outcomes (25)

• TRQ-SF (Therapist Response Questionnaire Short Form)

  Baseline (T0)

• TRQ-SF (Therapist Response Questionnaire Short Form)

  1 week (T1)

• TRQ-SF (Therapist Response Questionnaire Short Form)

  2 weeks (T2)

• TRQ-SF (Therapist Response Questionnaire Short Form)

  6 weeks (T3 = One month post T2)

• TRQ-SF (Therapist Response Questionnaire Short Form)

  10 weeks (T4 = One month after T3)

Study Arms (4)

Emotional Self Awareness Group (Clinician participants)

EXPERIMENTAL

Virtual Human Interaction (VHI) to train outpatient clinicians in emotional self-awareness (ESA) and receive clinician-focused, comprehensive feedback in ESA

Behavioral: Emotional Self Awareness (ESA) Individual Feedback

Emotional Self Awareness Group (Patient participants)

NO INTERVENTION

Patients provided care by clinicians trained in ESA

Control Group (Clinician participants)

SHAM COMPARATOR

The Control group CPs will engage in the same two VHI scenarios and will complete the TRQ-SF in response to each scenario without receiving the ESA feedback

Behavioral: Emotional Self Awareness (ESA) Individual Feedback

Control Group (Patient participants)

NO INTERVENTION

Patients provided care by clinicians not receiving ESA feedback

Interventions

Emotional Self Awareness (ESA) Individual Feedback BEHAVIORAL

Virtual Human Interaction (VHI) to train outpatient clinicians in emotional self-awareness (ESA) and receive clinician-focused, comprehensive feedback in ESA

Control Group (Clinician participants); Emotional Self Awareness Group (Clinician participants)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• \- non-approval for study participation by department chairman, training director or clinical supervisor.
• Patient Participant
• 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.
• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Florida International University: collaborator
• Citrus Health Network, Inc.: collaborator
• University of Florida: collaborator

Study Sites (3)

University of Florida

Gainesville, Florida, 32611, United States

Location

Florida International University

Miami, Florida, 33199, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 15, 2019
• Study Start: September 9, 2019
• Primary Completion: May 31, 2022
• Study Completion: June 5, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)