Clairity in a University Mental Health Clinic (FECU)

Clarigent Health

Status: Invitation-only

Conditions: Mental Health Issue; Depression; Anxiety; Suicide

Treatments: Behavioral: Clairity

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05513963

105-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Treatment

Experimental group

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.

Treatment:

Behavioral: Clairity

Control

No Intervention group

Description:

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