SuicideNCT04127292
Impact of Clinician Virtual Human Interaction Training in Emotional Self-Awareness on Patients Suicidal Ideation and Suicide Crisis Syndrome
A study testing Emotional Self Awareness (ESA) Individual Feedback in people with Suicide, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicide
- What is being tested?
- Emotional Self Awareness (ESA) Individual Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Sep 2019to 5 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- non-approval for study participation by department chairman, training director or clinical supervisor.
- Patient Participant
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Florida
Gainesville, Florida, 32611
Florida International University
Miami, Florida, 33199
Icahn School of Medicine at Mount Sinai
New York, New York, 10003
About this study
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
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).
Read the 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.
- Conditions
- Suicide
- Being tested
- Emotional Self Awareness (ESA) Individual Feedback
- Keywords
- Suicide, Empathy, Emotional Self-Awareness
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Self Awareness (ESA) Individual FeedbackBehavioural
Virtual Human Interaction (VHI) to train outpatient clinicians in emotional self-awareness (ESA) and receive clinician-focused, comprehensive feedback in ESA
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Emotional Self Awareness (ESA) Individual Feedback |
| Control Group (Patient participants) | No intervention | Patients provided care by clinicians not receiving ESA feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 weeks (T4 = One month after T3)
Secondary outcomes (25)
TRQ-SF (Therapist Response Questionnaire Short Form)
10-item, Likert-type scale designed to capture clinicians' emotional responses to acutely suicidal patients. TRQ-SF individual item scores range from 0 (Not at all) to 4 (Extremely). The scale probes suicide-related negative emotional response to patients with three sub-scales: Affiliation (5 items), Distress (3 items), and Hopefulness (2 items). The potential range for TRQ total scores is 0-40. Higher score indicate higher risk of suicide.
Measured: Baseline (T0)
TRQ-SF (Therapist Response Questionnaire Short Form)
10-item, Likert-type scale designed to capture clinicians' emotional responses to acutely suicidal patients. TRQ-SF individual item scores range from 0 (Not at all) to 4 (Extremely). The scale probes suicide-related negative emotional response to patients with three sub-scales: Affiliation (5 items), Distress (3 items), and Hopefulness (2 items). The potential range for TRQ total scores is 0-40. Higher score indicate higher risk of suicide.
Measured: 1 week (T1)
TRQ-SF (Therapist Response Questionnaire Short Form)
10-item, Likert-type scale designed to capture clinicians' emotional responses to acutely suicidal patients. TRQ-SF individual item scores range from 0 (Not at all) to 4 (Extremely). The scale probes suicide-related negative emotional response to patients with three sub-scales: Affiliation (5 items), Distress (3 items), and Hopefulness (2 items). The potential range for TRQ total scores is 0-40. Higher score indicate higher risk of suicide.
Measured: 2 weeks (T2)
TRQ-SF (Therapist Response Questionnaire Short Form)
10-item, Likert-type scale designed to capture clinicians' emotional responses to acutely suicidal patients. TRQ-SF individual item scores range from 0 (Not at all) to 4 (Extremely). The scale probes suicide-related negative emotional response to patients with three sub-scales: Affiliation (5 items), Distress (3 items), and Hopefulness (2 items). The potential range for TRQ total scores is 0-40. Higher score indicate higher risk of suicide.
Measured: 6 weeks (T3 = One month post T2)
TRQ-SF (Therapist Response Questionnaire Short Form)
10-item, Likert-type scale designed to capture clinicians' emotional responses to acutely suicidal patients. TRQ-SF individual item scores range from 0 (Not at all) to 4 (Extremely). The scale probes suicide-related negative emotional response to patients with three sub-scales: Affiliation (5 items), Distress (3 items), and Hopefulness (2 items). The potential range for TRQ total scores is 0-40. Higher score indicate higher risk of suicide.
Measured: 10 weeks (T4 = One month after T3)
Empathic Communication Coding System (ECCS)
An expert-rated scale developed to code empathetic opportunities, defined as an explicit, clear, and direct statement of emotion, progress, or challenge by the patient. The ECCS also codes healthcare providers' verbal responses to these opportunities ranging from level 6 to level 0, denial of patient's perspective. The CPs' responses to the empathetic opportunities presented by the VHI will be coded with this scale. Full scale from 0-6, with higher score indicating more shared feeling or experience.
Measured: 1 week (T1)
Empathic Communication Coding System (ECCS)
An expert-rated scale developed to code empathetic opportunities, defined as an explicit, clear, and direct statement of emotion, progress, or challenge by the patient. The ECCS also codes healthcare providers' verbal responses to these opportunities ranging from level 6 to level 0, denial of patient's perspective. The CPs' responses to the empathetic opportunities presented by the VHI will be coded with this scale. Full scale from 0-6, with higher score indicating more shared feeling or experience.
Measured: 2 weeks (T2)
Columbia Suicide-Severity Rating Scale (CSSRS)
A semi-structured interview of current and past suicidal thoughts and behaviors. Full range from 0 to 9, with higher score indicating higher intensity suicidal ideation.
Measured: Baseline (T0)
Columbia Suicide-Severity Rating Scale (CSSRS)
A semi-structured interview of current and past suicidal thoughts and behaviors. Full range from 0 to 9, with higher score indicating higher intensity suicidal ideation.
Measured: 10 weeks (T4 = One month after T3)
Working Alliance Inventory Short Form (WAI)
Well-validated 12 item, 7-point Likert scale, self-report patient and clinician questionnaire with demonstrated predictive value for psychotherapeutic treatment adherence and outcomes. Full scale from 12-84, with higher scores indicating better alliance.
The WAI-SR is a patient-rated questionnaire. Patients rate items on a 5-point Likert scale anchored at each end with 'rarely or never' (1) and 'always' (5). The full score range from 5 to 20. Higher scores indicate a better therapeutic alliance.
Measured: Baseline (T0)
Working Alliance Inventory Short Form (WAI)
Well-validated 12 item, 7-point Likert scale, self-report patient and clinician questionnaire with demonstrated predictive value for psychotherapeutic treatment adherence and outcomes. Full scale from 12-84, with higher scores indicating better alliance.
The WAI-SR is a patient-rated questionnaire. Patients rate items on a 5-point Likert scale anchored at each end with 'rarely or never' (1) and 'always' (5). The full score range from 5 to 20. Higher scores indicate a better therapeutic alliance.
Measured: 6 weeks (T3 = One month post T2)
Working Alliance Inventory Short Form (WAI)
Well-validated 12 item, 7-point Likert scale, self-report patient and clinician questionnaire with demonstrated predictive value for psychotherapeutic treatment adherence and outcomes. Full scale from 12-84, with higher scores indicating better alliance.
The WAI-SR is a patient-rated questionnaire. Patients rate items on a 5-point Likert scale anchored at each end with 'rarely or never' (1) and 'always' (5). The full score range from 5 to 20. Higher scores indicate a better therapeutic alliance.
Measured: 10 weeks (T4 = One month after T3)
Clinician Prediction Scale (CPS)
A one-item 10-point Likert Scale will be used to assess clinicians' judgement of patient suicide risk. Full score from 0-10, with higher score indicating higher risk of making a suicide attempt in the next 6 months if untreated.
Measured: 1 week (T1)
Clinician Prediction Scale (CPS)
A one-item 10-point Likert Scale will be used to assess clinicians' judgement of patient suicide risk. Full score from 0-10, with higher score indicating higher risk of making a suicide attempt in the next 6 months if untreated.
Measured: 2 weeks (T2)
VHI training utility survey
CPs ratings of satisfaction with the VHI through a satisfaction survey completed online at the 2nd VHI interaction. The survey has six items adapted from the Maastricht Assessment of Simulated Patients. Total score from 0-36 with higher score indicating higher satisfaction with virtual human interaction.
Measured: 2 weeks (T2)
Consultation and Relational Empathy (CARE)
A well-validated 10-item questionnaire that measures patient's perception of healthcare provider's empathy, with each item measured on a 5-point scale: Poor =1, Fair=2, Good=3, Very Good=4, Excellent=5. Full score from 10-50, with higher score indicating better healthcare provider's empathy perceived by the patient.
Measured: Baseline (T0)
Consultation and Relational Empathy (CARE)
A well-validated 10-item questionnaire that measures patient's perception of healthcare provider's empathy, with each item measured on a 5-point scale: Poor =1, Fair=2, Good=3, Very Good=4, Excellent=5. Full score from 10-50, with higher score indicating better healthcare provider's empathy perceived by the patient.
Measured: 6 weeks (T3 = One month post T2)
Consultation and Relational Empathy (CARE)
A well-validated 10-item questionnaire that measures patient's perception of healthcare provider's empathy, with each item measured on a 5-point scale: Poor =1, Fair=2, Good=3, Very Good=4, Excellent=5. Full score from 10-50, with higher score indicating better healthcare provider's empathy perceived by the patient.
Measured: 10 weeks (T4 = One month after T3)
Medication Adherence Rating Scale (MARS)
Well-validated 8-item self-report instrument measuring patient's medication adherence and barriers to it. Full scale is from 0-10, with higher score indicating better adherence.
Measured: Baseline (T0)
Medication Adherence Rating Scale (MARS)
Well-validated 8-item self-report instrument measuring patient's medication adherence and barriers to it. Full scale is from 0-10, with higher score indicating better adherence.
Measured: 6 weeks (T3 = One month post T2)
Medication Adherence Rating Scale (MARS)
Well-validated 8-item self-report instrument measuring patient's medication adherence and barriers to it. Full scale is from 0-10, with higher score indicating better adherence.
Measured: 10 weeks (T4 = one month after T3)
Facial Affective Coding System (FACS)
The Facial Action Coding System (FACS) is a comprehensive, anatomically based system for describing all visually discernible facial movement, breaking down facial expressions into individual components of muscle movement. FACS, using Noldus FaceReader Software, will be applied to video recordings of clinicians interacting with the VHs. The system will evaluate clinicians' facial affective behavior to detect the presence of basic emotions, including sadness, happiness, anger, disgust, surprise, and fear. Duration of analyzed video segments in minutes and seconds, as well as computerized character values of emotions detected by the software, will be provided for analysis.
Measured: 1 week (T1)
Facial Affective Coding System (FACS)
The Facial Action Coding System (FACS) is a comprehensive, anatomically based system for describing all visually discernible facial movement, breaking down facial expressions into individual components of muscle movement. FACS, using Noldus FaceReader Software, will be applied to video recordings of clinicians interacting with the VHs. The system will evaluate clinicians' facial affective behavior to detect the presence of basic emotions, including sadness, happiness, anger, disgust, surprise, and fear. Duration of analyzed video segments in minutes and seconds, as well as computerized character values of emotions detected by the software, will be provided for analysis.
Measured: 2 weeks (T2)
Proportion of Nonsensical VH Responses
The number of nonsensical and sensical VH responses will be manually coded. Members of the research team will code nonsensical and sensical VH responses through assessment clinician transcripts with the VH, which are generated automatically after each VH interaction. The proportion of nonsensical to sensical counts per transcript will be calculated, and items are rated nominally as 0 = nonsensical and 1 = sensical.
Measured: 1 week (T1)
Proportion of Nonsensical VH Responses
The number of nonsensical and sensical VH responses will be manually coded. Members of the research team will code nonsensical and sensical VH responses through assessment clinician transcripts with the VH, which are generated automatically after each VH interaction. The proportion of nonsensical to sensical counts per transcript will be calculated, and items are rated nominally as 0 = nonsensical and 1 = sensical.
Measured: 2 weeks (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start9 Sep 2019
- Primary completion31 May 2022
- Study completion5 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Florida International University, Citrus Health Network, Inc., University of Florida
- Responsible party
- Principal investigator, Igor Galynker, Icahn School of Medicine at Mount Sinai
- Investigators
- Igor Galynker, MD, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiAdriana Foster, MD, Principal investigator, Florida International UniverisityBenjamin Lok, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127292
- Sponsor's protocol ID
- GCO 18-1346
- Status last verified
- Nov 2022
- First submitted
- 30 Sep 2019
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04127292
- Acronym / sponsor ID
- GCO 18-1346
- Conditions
- Suicide
- Keywords
- Suicide, Empathy, Emotional Self-Awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Florida International University, Citrus Health Network, Inc., University of Florida
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 5 Jun 2022 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Emotional Self Awareness Group (Clinician participants) | Experimental | Behavioral: Emotional Self Awareness (ESA) Individual FeedbackVirtual Human Interaction (VHI) to train outpatient clinicians in emotional self-awareness (ESA) and receive clinician-focused, comprehensive feedback in ESA |
| Emotional Self Awareness Group (Patient participants) | No intervention | –Patients provided care by clinicians trained in ESA |
| Control Group (Clinician participants) | Sham comparator | Behavioral: Emotional Self Awareness (ESA) Individual FeedbackThe 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 |
| Control Group (Patient participants) | No intervention | –Patients provided care by clinicians not receiving ESA feedback |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- 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.
Key exclusion criteria (5 listed)
- non-approval for study participation by department chairman, training director or clinical supervisor.
- Patient Participant
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Self Awareness (ESA) Individual FeedbackVirtual Human Interaction (VHI) to train outpatient clinicians in emotional self-awareness (ESA) and receive clinician-focused, comprehensive feedback in ESA | Behavioural | Control Group (Clinician participants), Emotional Self Awareness Group (Clinician participants) |
Primary outcome
Suicide Crisis Inventory (SCI)
Time frame: Baseline (T0)
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.
Suicide Crisis Inventory (SCI)
Time frame: 6 weeks (T3 = One month after T2)
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.
Suicide Crisis Inventory (SCI)
Time frame: 10 weeks (T4 = One month after T3)
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.
Beck Scale for Suicide Ideation (BSS)
Time frame: Baseline (T0)
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.
Beck Scale for Suicide Ideation (BSS)
Time frame: 6 weeks (T3 = One month post T2)
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.
Beck Scale for Suicide Ideation (BSS)
Time frame: 10 weeks (T4 = One month after T3)
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.
25 secondary outcomes
TRQ-SF (Therapist Response Questionnaire Short Form)
Time frame: Baseline (T0)
TRQ-SF (Therapist Response Questionnaire Short Form)
Time frame: 1 week (T1)
TRQ-SF (Therapist Response Questionnaire Short Form)
Time frame: 2 weeks (T2)
TRQ-SF (Therapist Response Questionnaire Short Form)
Time frame: 6 weeks (T3 = One month post T2)
TRQ-SF (Therapist Response Questionnaire Short Form)
Time frame: 10 weeks (T4 = One month after T3)
Empathic Communication Coding System (ECCS)
Time frame: 1 week (T1)
Empathic Communication Coding System (ECCS)
Time frame: 2 weeks (T2)
Columbia Suicide-Severity Rating Scale (CSSRS)
Time frame: Baseline (T0)
Columbia Suicide-Severity Rating Scale (CSSRS)
Time frame: 10 weeks (T4 = One month after T3)
Working Alliance Inventory Short Form (WAI)
Time frame: Baseline (T0)
Working Alliance Inventory Short Form (WAI)
Time frame: 6 weeks (T3 = One month post T2)
Working Alliance Inventory Short Form (WAI)
Time frame: 10 weeks (T4 = One month after T3)
Clinician Prediction Scale (CPS)
Time frame: 1 week (T1)
Clinician Prediction Scale (CPS)
Time frame: 2 weeks (T2)
VHI training utility survey
Time frame: 2 weeks (T2)
Consultation and Relational Empathy (CARE)
Time frame: Baseline (T0)
Consultation and Relational Empathy (CARE)
Time frame: 6 weeks (T3 = One month post T2)
Consultation and Relational Empathy (CARE)
Time frame: 10 weeks (T4 = One month after T3)
Medication Adherence Rating Scale (MARS)
Time frame: Baseline (T0)
Medication Adherence Rating Scale (MARS)
Time frame: 6 weeks (T3 = One month post T2)
Medication Adherence Rating Scale (MARS)
Time frame: 10 weeks (T4 = one month after T3)
Facial Affective Coding System (FACS)
Time frame: 1 week (T1)
Facial Affective Coding System (FACS)
Time frame: 2 weeks (T2)
Proportion of Nonsensical VH Responses
Time frame: 1 week (T1)
Proportion of Nonsensical VH Responses
Time frame: 2 weeks (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor Galynker, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Adriana Foster, MD principal investigator
Florida International Univerisity
Benjamin Lok, PhD principal investigator
University of Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Self Awareness (ESA) Individual Feedback in people with Suicide, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide Crisis Inventory (SCI) (time frame: Baseline (T0)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.