FECU: Clairity in a University Mental Health Clinic

Clarigent Health (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
Xavier University (Other)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Anticipated Enrollment :
100 participants
Intervention Model:
Single Group Assignment
Intervention Model Description:
Randomized-Control TrialRandomized-Control Trial
None (Open Label)
Primary Purpose:
Official Title:
Feasibility and Effectiveness of the Clairity Tool in a University Mental Health Clinic
Actual Study Start Date :
Nov 4, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Nov 3, 2023

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Clairity Dashboard [12 month]

      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.

    2. Identify Mental States with Area Under the AUC metric [12 month]

      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. We will target an AUC ≥ 0.8 for suicidal risk and depression. 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 we will require 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.

    3. Outcome Measure Comparison [12 month]

      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. We will use a repeated measures ANOVA to compare scores on the OQ-45 for control and treatment participants enrolled in the study over an eight-week treatment period. Additionally, we will examine changes to treatment plans and therapy attendance between the two groups.

    4. Clinical Utility Treatment Outcomes [12 month]

      We anticipate 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. We will collect qualitative survey data to understand how clinicians use and value this information. We will also evaluate how clients' scores on the Outcome Questionnaire-45 change over time for those in the control and treatment groups. This will allow us to estimate the effect, if any, the Clairity process has on clients' mental health.

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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.

    Contacts and Locations


    Site City State Country Postal Code
    1 Xavier University Psychological Services Clinic Cincinnati Ohio United States 45202

    Sponsors and Collaborators

    • Clarigent Health
    • Xavier University


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Clarigent Health
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • 105-2021
    First Posted:
    Aug 24, 2022
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 24, 2022