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Depression - Major Depressive DisorderGPT4-RAG-PHQNCT06801925

Evaluating the Effectiveness and Acceptability of a GPT-4o and RAG-Based Voice Chatbot for Depression Screening Using PHQ-9

An observational study of Depression - Major Depressive Disorder and Depression Anxiety Disorder, run by University College, London at 1 site in United Kingdom.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record

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Trial summary

This study aims to assess the feasibility and acceptability of a voice-based chatbot, powered by GPT-4o and Retrieval-Augmented Generation (RAG), for conducting depression screening using the Patient Health Questionnaire-9 (PHQ-9). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
GPT-4o and RAG Voice Chatbot for PHQ-9 Screening
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteUnited Kingdom
Study dates
1 Feb 2025to 31 May 2025
Phase
Observational

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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population consists of healthy individuals aged 18 to 65 years who do not have severe mental illnesses. We welcome participants who have an interest in artificial intelligence technologies. Recruitment will be conducted both online and offline. Participants will engage with a sophisticated AI chatbot designed to simulate a consultation with a mental health professional. This interaction enables them to complete a psychometric evaluation, such as the PHQ-9 test, in a structured yet conversational manner. Unlike conventional online versions of the PHQ-9 test, the chatbot offers enhanced interactivity. For individuals who may experience difficulties in articulating or summarizing their responses, the chatbot provides clarifications and assistance using a comprehensive language model. After the assessment, participants will receive an interpretation of their test results along with tailored advice, delivered in accordance with established mental health guidelines.

Who may be able to join

  • Adults aged 18-65 years.
  • Fluent in English.
  • Access to a device capable of voice interaction and stable internet connection.
  • Willing to participate in chatbot interaction and a follow-up interview.

Who cannot join

  • Current severe psychiatric diagnoses (e.g., psychosis, bipolar disorder).
  • Participants undergoing active treatment for depression with a psychiatrist.
  • Discomfort with voice-based technology or inability to provide informed consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site
  • UCL Institute of Health Informatics

    London, NW1 2DA

Other trials in United Kingdom

About this study

This study aims to assess the feasibility and acceptability of a voice-based chatbot, powered by GPT-4o and Retrieval-Augmented Generation (RAG), for conducting depression screening using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a validated self-report instrument widely used to screen, diagnose, and monitor the severity of depression. It consists of nine questions that correspond to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder. Respondents rate the frequency of symptoms experienced over the past two weeks on a scale from 0 ("not at all") to 3 ("nearly every day"). The total score (ranging from 0 to 27) indicates the severity of depressive symptoms, categorized into minimal, mild, moderate, moderately severe, or severe depression. The PHQ-9 is also used to assess functional impairment and guide treatment decisions in clinical and research settings.

The voice-based chatbot integrates GPT-4o, with RAG to enhance its ability to provide informed and contextualized responses during interactions. GPT-4o serves as the conversational engine, capable of generating human-like, empathetic, and contextually appropriate dialogue. RAG, on the other hand, enables the chatbot to retrieve and incorporate external, up-to-date knowledge from a curated database or knowledge repository, ensuring the accuracy and reliability of its responses.

Read the detailed description

Depression is a prevalent mental health challenge with significant personal, social, and economic costs. Traditional mental health resources face barriers such as stigma, limited availability, and long wait times. Technology, particularly AI-powered tools, provides an opportunity to bridge these gaps. This study utilizes GPT-4o and RAG to create a voice-interactive chatbot capable of conversational engagement, administering the PHQ-9 questionnaire, and delivering personalized feedback.

Participants will fill in the PHQ-9 for self-testing before interacting with the chatbot (the results will not be disclosed to the public and will only be used for accuracy comparisons), and the results of their self-tests will be compared with the results given by the chatbot in terms of accuracy.

The chatbot interaction comprises three phases:

  1. Warm-up conversations for rapport-building and general support.
  • The chatbot initiates casual, empathetic dialogues to build rapport with users, helping them feel comfortable and at ease before transitioning to the PHQ-9 screening.
  • Users can ask general questions related to mental health, and the chatbot provides informed and supportive responses.
  1. Administration of the PHQ-9 questionnaire for depression screening.
  • The chatbot introduces the PHQ-9 questionnaire, explaining its purpose and how the results will help assess the user's mental health.
  • Through voice interaction, users respond to the nine PHQ-9 questions, and the chatbot records their responses. The chatbot can clarify questions or provide additional context if users have difficulty understanding specific items.
  1. Analysis of results and delivery of tailored recommendations.
  • After the user completes the PHQ-9, the chatbot analyzes the responses, calculates the total score, and categorizes the results into severity levels (e.g., mild, moderate).
  • Based on the score, the chatbot provides personalized recommendations, such as self-help strategies for mild symptoms or suggesting professional mental health services for more severe cases.

Participants will interact with the chatbot and then participate in a 1-hour semi-structured interview to provide feedback on their experience. The study focuses on evaluating the acceptability and feasibility of using such LLM-based chatbots in mental health screening and identifying potential improvements and risks.

Study Objectives Primary Objectives

  1. To evaluate the acceptability, feasibility, and accuracy of a GPT-4o and RAG-based voice chatbot (HopeBot) for depression screening using PHQ-9. Hypothesis: Participants showed high acceptance of HopeBot (higher than 65%) and high willingness to use such LLM-based chatbot for mental health screening in the future (higher than 65%), indicating recognition of the credibility of LLM as a supportive tool in mental health screening (higher than 65%). Participants use of the HopeBot for depression screening matched their self-test PHQ-9 results by 100%
  2. To analyze the chatbot's effectiveness in identifying depressive symptoms and delivering actionable recommendations.

Hypothesis: HopeBot can help users take the PHQ-9 test in a friendly way, help users categorize the answers accurately, and give accurate test results, the advice they provide is based on the official PHQ-9 guidelines, and more than 70% of the users say that their responses are very effective and helpful.

Secondary Objectives

  1. To assess the feasibility and performance of integrating RAG with LLM in creating a voice-interactive chatbot for mental health. Hypothesis: Over 65% of participants recognized that responses using RAG were more helpful and effective.
  2. To explore the strengths, limitations, and risks of deploying LLMs in the mental health domain.

Hypothesis: More than 65% of users say that HopeBot is very convenient, more accessible, and cost-free to provide non-judgmental advice. However, 50% still expressed concerns about its privacy and data security.

Being tested
GPT-4o and RAG Voice Chatbot for PHQ-9 Screening
Keywords
mental health, depression, chatbot, GPT, PHQ-9, RAG
Medical subject headings
Psychological Well-Being, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GPT-4o and RAG Voice Chatbot for PHQ-9 ScreeningProcedure or surgery

    This study involves the use of a voice-based chatbot powered by GPT-4o and Retrieval-Augmented Generation (RAG) to conduct depression screening using the Patient Health Questionnaire-9 (PHQ-9).

    The chatbot aims to evaluate the feasibility and acceptability of using AI-powered conversational tools for mental health screening.

    Participants interact with the chatbot in a single session, answering PHQ-9 questions and receiving responses generated using GPT-4o and RAG technologies.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility and Acceptability of the GPT-4o and RAG Voice Chatbot

    Participants' perceptions of the chatbot's feasibility, acceptability, and effectiveness are assessed through semi-structured interviews conducted after the interaction session. These interviews explore themes such as the chatbot's empathy, usability, and the overall user experience.

    Measured: Interviews are conducted immediately following the chatbot interaction.

Secondary outcomes (1)
  1. Accuracy of PHQ-9 Scoring by the Chatbot

    The accuracy of the PHQ-9 scores generated by the chatbot is measured by comparing the chatbot's results to participants' self-reported PHQ-9 scores collected prior to the interaction. Agreement will be assessed using statistical methods such as Cohen's kappa or intraclass correlation coefficient (ICC).

    Measured: Measured immediately after the interaction session, once the chatbot has generated PHQ-9 scores

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2025
  2. Study start1 Feb 2025 (estimated)
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion31 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06801925
Sponsor's protocol ID
26133.001
Other IDs
26133.001
Acronym
GPT4-RAG-PHQ
Status last verified
Jan 2025
First submitted
24 Jan 2025
Last updated
30 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared to ensure participant confidentiality and comply with ethical guidelines related to mental health research. Additionally, participants did not provide explicit consent for data sharing with external researchers.

Publications

  • Guo Z, Lai A, Ive J, Petcu A, Wang Y, Qi L, Thygesen JH, Li K. Feasibility and user evaluation of HopeBot: An LLM-powered conversational chatbot for depression screening. PLOS Digit Health. 2026 Jun 25;5(6):e0001446. doi: 10.1371/journal.pdig.0001446. eCollection 2026 Jun.

    PubMed 42348542

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