NCT07105397 Evaluating Conversational Artificial Intelligence for Depression Management
| NCT ID | NCT07105397 |
| Status | Recruiting |
| Phase | — |
| Sponsor | George Mason University |
| Condition | Major Depressive Disorder (MDD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2026-07-22 |
| Primary Completion | 2028-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2026-07-22 with a primary completion date of 2028-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07105397 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Major Depressive Disorder (MDD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07105397 currently recruiting?
Yes, NCT07105397 is actively recruiting participants. Contact the research team at rapidai@gmu.edu for enrollment information.
Where is the NCT07105397 trial being conducted?
This trial is being conducted at Fairfax, United States.
Who is sponsoring the NCT07105397 clinical trial?
NCT07105397 is sponsored by George Mason University. The trial plans to enroll 130 participants.