Clairity in a University Mental Health Clinic

NCT ID: NCT05513963

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-04
• Study Completion Date: 2023-11-03

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.

Conditions

Depression; Anxiety; Suicide; Mental Health Issue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Clairity

Intervention Type: BEHAVIORAL

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Clairity

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

Intervention Type: BEHAVIORAL

Other Intervention Names

MHSAFE Interview

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xavier University of Louisiana.

OTHER

Sponsor Role: collaborator

Clarigent Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xavier University Psychological Services Clinic

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

105-2021

Identifier Type: -

Identifier Source: org_study_id