Clairity in a University Mental Health Clinic (FECU)
Primary Purpose
Depression, Anxiety, Suicide
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clairity
Sponsored by
About this trial
This is an interventional screening trial for Depression
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old
- Currently a client receiving services from XUPS
- Able to provide informed consent
- Speaks and understands English fluently
- Willing to abide by all research procedures
Exclusion Criteria:
- Participants with communication disorders (linguistic or articulation) or who cannot articulate clearly in English.
- Participants with an intellectual and/or neurocognitive disability that the study staff deems a barrier to participation.
- History of any other serious medical or psychiatric condition that would interfere with the ability of the patient to complete the study or would make it ethically unfeasible to enroll.
- Any participant, who at the discretion of the study staff, should not be enrolled.
Sites / Locations
- Xavier University Psychological Services Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Participants will complete a Clairity session between their regular therapy visits. The Clairity interview is between 4-11 minutes where a clinical research coordinator will ask participants questions about hope, secrets, anger, fear, and emotional pain.
Participants will submit demographics and medical records and will only complete standard of care.
Outcomes
Primary Outcome Measures
Clairity Dashboard
A clinical dashboard (Clairity) where consolidated results of standardized instruments and language-based machine learning models can more fully inform and expedite the clinical decision-making process. This type of dashboard can provide the clinician a time-based snapshot of the current mental state of the client and can inform the clinician of whether treatment methods are making an impact. The addition of an unbiased, innovative measure derived from vocal biomarkers may bring objectivity to the current methods. Multiple data points for a client's session displayed in the Clairity dashboard will support the clinician's ability to reliably monitor clients' progress and make more informed and reliable clinical decisions.
Identify Mental States with Area Under the AUC metric
The area under the receiver operating characteristic (AUC) metric is popular when evaluating machine learning models because it does not impose arbitrary thresholds for classification, as is required for other metrics, such as sensitivity and specificity. An AUC of 0.5 is a model that predicts as well as random chance, and an AUC of 1.0 is a perfect model. In the social sciences, an AUC ≥ 0.8 is considered excellent. An AUC ≥ 0.8 for suicidal risk and depression will be the target. To meet this target with tolerances for type I (α) and type II (β) errors at 0.01 and 0.95 respectively, and an allocation ratio of 1 (number of controls/number of cases), a sample size analysis determines 25 cases and 25 controls for each condition. While many of the conditions of interest exist as comorbidities, historical data at the XUPS clinic supports a sample of 50 clients measured over four interactions will meet the required case-control numbers for each condition.
Outcome Measure Comparison
To measure the potential impact of the Clairity process, clients will complete their treatment as usual, which includes the Outcome Questionnaire-45 (OQ-45) prior to therapy sessions. The OQ-45 is a quantitative self-report inventory used to assess therapy progress. A repeated measures ANOVA will be used to compare scores on the OQ-45 for control and treatment participants enrolled in the study over an eight-week treatment period. Additionally, changes to treatment plans and therapy attendance between the two groups will be examined.
Clinical Utility Treatment Outcomes
Additional mental health data collected through Clairity, delivered via a dashboard, will provide value to clinicians that may influence therapy, such as altering treatment plans or creating safety plans. Qualitative survey data will be collected to understand how clinicians use and value this information. An evaluation of the change in clients' scores over time on the Outcome Questionnaire-45 for those in the control and treatment groups will also occur. This will allow the investigators to estimate the effect, if any, the Clairity process has on clients' mental health.
Secondary Outcome Measures
Full Information
NCT ID
NCT05513963
First Posted
March 7, 2022
Last Updated
August 23, 2022
Sponsor
Clarigent Health
Collaborators
Xavier University of Louisiana.
1. Study Identification
Unique Protocol Identification Number
NCT05513963
Brief Title
Clairity in a University Mental Health Clinic
Acronym
FECU
Official Title
Feasibility and Effectiveness of the Clairity Tool in a University Mental Health Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 4, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 3, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clarigent Health
Collaborators
Xavier University of Louisiana.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a clinical trial to evaluate the effectiveness of the Clairity tool within the university setting for students who are being seen by a mental health provider.
Detailed Description
In this study, the investigators plan to evaluate the effect of the Clairity process in a university setting. The Clairity process will be implemented as a 15-20 minute "between-the-visit" mental health check-in between a patient and clinical staff. Clairity will record and analyze patient speech using artificial intelligence algorithms developed for early detection and monitoring of mental health and suicidal risk. This study will be the first to return Clairity results real time to the clinician. The study employs a mixed-methods design, using rolling recruitment of clients of the Xavier University Psychological services clinic (XUPS) during the 2022-2023 school year. Study-trained clinical research coordinators will begin enrolling participants after completing the online protocol training and brief human subject's protection training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Suicide, Mental Health Issue
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized-Control Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Participants will complete a Clairity session between their regular therapy visits. The Clairity interview is between 4-11 minutes where a clinical research coordinator will ask participants questions about hope, secrets, anger, fear, and emotional pain.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will submit demographics and medical records and will only complete standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Clairity
Other Intervention Name(s)
MHSAFE Interview
Intervention Description
Treatment group participants will complete study session using the Clairity tool in between regularly scheduled therapy visits.
Primary Outcome Measure Information:
Title
Clairity Dashboard
Description
A clinical dashboard (Clairity) where consolidated results of standardized instruments and language-based machine learning models can more fully inform and expedite the clinical decision-making process. This type of dashboard can provide the clinician a time-based snapshot of the current mental state of the client and can inform the clinician of whether treatment methods are making an impact. The addition of an unbiased, innovative measure derived from vocal biomarkers may bring objectivity to the current methods. Multiple data points for a client's session displayed in the Clairity dashboard will support the clinician's ability to reliably monitor clients' progress and make more informed and reliable clinical decisions.
Time Frame
12 month
Title
Identify Mental States with Area Under the AUC metric
Description
The area under the receiver operating characteristic (AUC) metric is popular when evaluating machine learning models because it does not impose arbitrary thresholds for classification, as is required for other metrics, such as sensitivity and specificity. An AUC of 0.5 is a model that predicts as well as random chance, and an AUC of 1.0 is a perfect model. In the social sciences, an AUC ≥ 0.8 is considered excellent. An AUC ≥ 0.8 for suicidal risk and depression will be the target. To meet this target with tolerances for type I (α) and type II (β) errors at 0.01 and 0.95 respectively, and an allocation ratio of 1 (number of controls/number of cases), a sample size analysis determines 25 cases and 25 controls for each condition. While many of the conditions of interest exist as comorbidities, historical data at the XUPS clinic supports a sample of 50 clients measured over four interactions will meet the required case-control numbers for each condition.
Time Frame
12 month
Title
Outcome Measure Comparison
Description
To measure the potential impact of the Clairity process, clients will complete their treatment as usual, which includes the Outcome Questionnaire-45 (OQ-45) prior to therapy sessions. The OQ-45 is a quantitative self-report inventory used to assess therapy progress. A repeated measures ANOVA will be used to compare scores on the OQ-45 for control and treatment participants enrolled in the study over an eight-week treatment period. Additionally, changes to treatment plans and therapy attendance between the two groups will be examined.
Time Frame
12 month
Title
Clinical Utility Treatment Outcomes
Description
Additional mental health data collected through Clairity, delivered via a dashboard, will provide value to clinicians that may influence therapy, such as altering treatment plans or creating safety plans. Qualitative survey data will be collected to understand how clinicians use and value this information. An evaluation of the change in clients' scores over time on the Outcome Questionnaire-45 for those in the control and treatment groups will also occur. This will allow the investigators to estimate the effect, if any, the Clairity process has on clients' mental health.
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old
Currently a client receiving services from XUPS
Able to provide informed consent
Speaks and understands English fluently
Willing to abide by all research procedures
Exclusion Criteria:
Participants with communication disorders (linguistic or articulation) or who cannot articulate clearly in English.
Participants with an intellectual and/or neurocognitive disability that the study staff deems a barrier to participation.
History of any other serious medical or psychiatric condition that would interfere with the ability of the patient to complete the study or would make it ethically unfeasible to enroll.
Any participant, who at the discretion of the study staff, should not be enrolled.
Facility Information:
Facility Name
Xavier University Psychological Services Clinic
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Clairity in a University Mental Health Clinic
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