NCT07105397 · George Mason University
Evaluating Conversational Artificial Intelligence for Depression Management
What this study 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.
View original scientific description
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.
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.
Primary outcome measures
Perceptions of empathy
Time frame: From enrollment up to 4 months after participation
The primary outcome assesses the impact of intake methods (conversational AI vs. structured survey) on patients' perceptions of empathy. Patient empathy perceptions will be measured using the Jefferson Scale of Empathy (JSE), a validated instrument. A higher JSE score means higher perceptions of empathy. We hypothesize that patients interacting with the conversational AI will report higher perceived empathy scores compared to those using the structured survey. For evaluation of impact of comparators, the primary analysis will focus on impact of LLM and clinician encounters on patient perceived empathy. These data will be analyzed using paired comparisons (ANOVA), with randomized order of exposure accounted for in the design. At the power of 0.80, a small-to medium effect size (d = 0.3), and significance level of 0.05, a sample size of 90 participants is needed, with 112 participants needed with attrition. In order to support higher power, a total of 130 participants will be recruited.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participant is between 18 to 85 years old.
- Participant has been, or are likely to be, diagnosed with moderate to severe Major Depressive Disorder without signs of bipolar depression.
- Participant is not in active suicidal crisis and do not face imminent risk of suicide within the next 3 hours.
- Participant is not pregnant or seeking to be pregnant.
- Participant able to communicate in English on the Internet.
- Participant must reside in the United States.
- 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.
- If the participant is seeing study clinicians, the participant must reside in a state where study clinicians are licensed.
- Participant must be using a device (phone or computer) that is located in the United States.
Where
- Fairfax, Virginia
Collaborators
Patient-Centered Outcomes Research Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 28, 2026 · Source of record for eligibility and locations