Clairity in a University Mental Health Clinic (FECU)

Feasibility and Effectiveness of the Clairity Tool in a University Mental Health Clinic

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Depression; Anxiety; Suicide; Mental Health Issue
• Intervention / Treatment: Behavioral: Clairity

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45202
      • Xavier University Psychological Services Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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.	Behavioral: Clairity; Treatment group participants will complete study session using the Clairity tool in between regularly scheduled therapy visits.; Other Names: MHSAFE Interview
No Intervention: Control; Participants will submit demographics and medical records and will only complete standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 month
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.	12 month
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.	12 month
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.	12 month

Collaborators and Investigators

• Sponsor: Clarigent Health
• Collaborators: Xavier University

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): November 3, 2023

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide
• Other Study ID Numbers: 105-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No