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Evaluating Conversational Artificial Intelligence for Depression Management

NCT07105397 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

  • Major Depressive Disorder (MDD)

Interventions

OTHER

Conversational AI system vs Usual Care

Participants complete medical history intake through an interactive conversational AI designed to support patient-centered, empathetic dialogue. Using large language models (LLM), the system interprets patient input, maintains context, and generates natural-language responses. A dialogue manager prioritizes medically relevant topics to support efficient data collection and reduce off-topic discussion. For safety, trained human monitors oversee conversations in real time and can intervene if risks such as self-harm arise. The AI intake is compared with patients' experiences with their clinicians through monthly follow-up questionnaires over four months. The study evaluates patients' ratings of empathy, communication quality, and engagement, not conversation content. Each participant serves as their own control, with AI intake and usual care compared within-subject and randomized by order of exposure.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • George Mason University

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2028-04-15
Completion
2028-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07105397 on ClinicalTrials.gov