DepressionFECUNCT05513963
Clairity in a University Mental Health Clinic
A study testing Clairity in people with Depression and Anxiety, run by Clarigent Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Suicide
- What is being tested?
- Clairity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2021to 3 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Xavier University Psychological Services Clinic
Cincinnati, Ohio, 45202
About this study
Official title: 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.
Read the 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
- Being tested
- Clairity
- Medical subject headings
- Depression, Anxiety Disorders, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClairityBehavioural
Also called MHSAFE Interview
Treatment group participants will complete study session using the Clairity tool in between regularly scheduled therapy visits.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Clairity |
| Control | No intervention | Participants will submit demographics and medical records and will only complete standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start4 Nov 2021
- Primary completionSep 2023 (estimated)
- Study completion3 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized-Control Trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clarigent Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xavier University of Louisiana.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513963
- Sponsor's protocol ID
- 105-2021
- Acronym
- FECU
- Status last verified
- Aug 2022
- First submitted
- 7 Mar 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of the Clairity Tool in a University Mental Health Clinic
- ClinicalTrials.gov ID
- NCT05513963
- Acronym / sponsor ID
- FECU / 105-2021
- Conditions
- Depression, Anxiety, Suicide, Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Clarigent HealthIndustry (pharma, biotech, devices)
- Collaborators
- Xavier University of Louisiana.
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- 3 Nov 2023 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized-Control Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: ClairityParticipants 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. |
| Control | No intervention | –Participants will submit demographics and medical records and will only complete standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClairityAlso: MHSAFE InterviewTreatment group participants will complete study session using the Clairity tool in between regularly scheduled therapy visits. | Behavioural | Treatment |
Primary outcome
Clairity Dashboard
Time frame: 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.
Identify Mental States with Area Under the AUC metric
Time frame: 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. 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.
Outcome Measure Comparison
Time frame: 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. 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.
Clinical Utility Treatment Outcomes
Time frame: 12 month
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clairity in people with Depression and Anxiety, run by Clarigent Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clairity Dashboard (time frame: 12 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.