Evaluating Conversational Artificial Intelligence for Depression Management

Recruiting · NCT07105397 · Interventional (participants receive a specific treatment) · Lead sponsor: George Mason University

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Depression

Interventions studied

Conversational AI system vs Usual Care

What this trial is about

The goal of this clinical trial is to evaluate how a conversational method of collecting medical history affects patients' perceptions and experiences compared to clinical care as usual. This conversational AI intake system collects medical history information, can be completed by participants at home, and do not disrupt routine clinical care. The primary questions this study aims to answer are: 1\) Does conversational intake affect patients' perceptions of empathy during their clinical interactions? This will be a prospective study that follows a cohort of participants for four (4) months after engaging with the AI intake system. Because each participant serves as his/her own control, both comparators will be administered within-subject, and the order of exposure (AI intake vs. usual care) will be randomized to minimize sequence effects. After completing the AI intake method, participants will rate their experience, particularly in terms of empathy and compare it to their usual interactions with their own clinicians.

Who can take part

Age range

18 Years to 85 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Eligibility criteria (as published)

1. Participant is between 18 to 85 years old. 2. Participant has been, or are likely to be, diagnosed with moderate to severe Major Depressive Disorder without signs of bipolar depression. 3. Participant is not in active suicidal crisis and do not face imminent risk of suicide within the next 3 hours. 4. Participant is not pregnant or seeking to be pregnant. 5. Participant able to communicate in English on the Internet. 6. Participant must reside in the United States. 7. Participant has access to a mental health clinician, or the participant is willing to see study clinicians to help review the advice and medication adjustments recommended by the AI Intake System to the participant. 8. If the participant is seeing study clinicians, the participant must reside in a state where study clinicians are licensed. 9. Participant must be using a device (phone or computer) that is located in the United States.

Where it is running

1 location listed across 1 US state.

George Mason University - Fairfax, Virginia, United States

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →