Impact of Clinician Virtual Human Interaction Training in Emotional Self-Awareness on Patients Suicidal Ideation and Suicide Crisis Syndrome
Condition: Suicide
MeSH terms: Suicide; Suicidal Ideation
Study type: Interventional

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.
    

Intervention name(s): Emotional Self Awareness (ESA) Individual Feedback
Intervention type(s): Behavioral
Intervention description(s): Virtual Human Interaction (VHI) to train outpatient clinicians in emotional self-awareness (ESA) and receive clinician-focused, comprehensive feedback in ESA
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
Keywords: Suicide; Empathy; Emotional Self-Awareness