Clairity in a University Mental Health Clinic

NCT05513963 | Unknown

• 1 other identifier: 105-2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Suicide; Mental Health Issue

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Treatment

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants will submit demographics and medical records and will only complete standard of care.

Interventions

Clairity BEHAVIORAL

Treatment group participants will complete study session using the Clairity tool in between regularly scheduled therapy visits.

Also known as: MHSAFE Interview

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clarigent Health: lead
• Xavier University of Louisiana.: collaborator

Study Sites (1)

Xavier University Psychological Services Clinic

Cincinnati, Ohio, 45202, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Suicide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Self-Injurious Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized-Control Trial

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: August 24, 2022
• Study Start: November 4, 2021
• Primary Completion: September 1, 2023
• Study Completion: November 3, 2023
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

US (1)