- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06965439
- Original Trial
Effectiveness of AI Chatbots in Improving Students' General Wellbeing
Evaluating the Effectiveness of AI Chatbots in Improving Students' General Wellbeing
The goal of this randomised controlled trial is to evaluate the effectiveness of an AI mental health chatbot in promoting emotional wellbeing and perceived empathy among university students in Singapore with mild or subclinical symptoms of anxiety and depression. The main questions it aims to answer are:
Can the chatbot provide emotional validation and be perceived as empathic?
Does the chatbot reduce symptoms of anxiety and depression and improve wellbeing more than an inactive control condition?
Researchers will compare students who engage in four sessions with the chatbot to students who complete four neutral writing tasks to assess differences in emotional wellbeing, empathy, and resilience.
Participants will:
Complete baseline wellbeing assessments
Be randomised to:
Four 20-minute chatbot sessions providing personalised support using cognitive-behavioural and compassion-focused techniques (intervention group), or
Four 20-minute neutral writing sessions unrelated to mental health (control group)
Complete post-session and follow-up wellbeing questionnaires
All sessions are conducted virtually over Zoom. Participants are full-time students at the National University of Singapore, aged 21 and above. The study aims to inform future development of AI tools for emotional support in non-clinical settings.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomised controlled trial evaluates the effectiveness of an AI-based mental health chatbot in promoting emotional wellbeing among university students in Singapore. The chatbot, part of the existing Intellect app used by the National University of Singapore (NUS), delivers supportive conversations grounded in cognitive-behavioural and compassion-focused techniques.
A total of 172 NUS students (aged 21+) will be screened for eligibility. Those with moderate to severe anxiety or depression (GAD-7 or PHQ-9 ≥10), current mental health treatment, or history of self-harm will be excluded and provided with mental health resources. Eligible participants will be randomly assigned to either:
Intervention group: Four 20-minute chatbot sessions over four weeks, delivered via Zoom. The chatbot explores participants' challenges, promotes emotional insight, identifies unhelpful thinking patterns and behaviours, and offers weekly reflection homework.
Control group: Four 20-minute neutral writing tasks (non-mental-health topics) over four weeks, matched in format and timing.
All participants complete self-report wellbeing questionnaires before and after each session, and a one-month follow-up. Primary outcomes include changes in anxiety (GAD-7), depression (PHQ-9), wellbeing (WHO-5), affect (PANAS), resilience (BRS), and perceived empathy (PEQ). The chatbot's perceived empathy will be assessed after session 1 and session 4 in the intervention group.
Sessions are not audio- or video-recorded, and participant anonymity is preserved. Researchers monitor sessions via video to ensure safety. At follow-up, control participants will be offered access to the chatbot if it proves effective.
This study aims to assess feasibility, empathy, and clinical impact of chatbot-delivered support, contributing to the development of scalable digital tools for emotional wellbeing in non-clinical university settings.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Singapore, Singapore, 119077
- NUS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Current undergraduate student at the National University of Singapore (NUS)
Aged 21 years and above
Proficient in English
Not currently undergoing psychological treatment or taking psychiatric medication
No history of self-harm or suicide
Scores below 10 on both the GAD-7 and PHQ-9 (i.e., subclinical levels of anxiety and depression)
Exclusion Criteria:
Currently undergoing psychological treatment or counselling
Currently taking psychiatric medication
History of self-harm or suicidal ideation
Scores ≥10 on the GAD-7 and/or PHQ-9, indicating moderate to severe anxiety or depression
Inability to provide informed consent or comply with study procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: AI-delivered emotional wellbeing support
Participants in this arm will complete four sessions with an AI-powered mental health chatbot over four weeks.
Each session will last approximately 20 minutes and take place via Zoom.
The chatbot provides structured emotional support informed by CBT principles, including identifying unhelpful thinking patterns and coping behaviours, delivering thought restructuring and compassion-focused techniques, and assigning weekly reflection-based homework.
The intervention is designed to promote emotional wellbeing and alleviate mild anxiety and depressive symptoms.
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Participants in this arm will complete four 20-minute sessions with an AI-powered chatbot designed to deliver CBT-based emotional wellbeing support.
The chatbot provides conversational guidance using techniques such as cognitive restructuring, behavioural activation, and emotion validation.
Sessions are delivered via Zoom, and participants receive structured homework after each session to reinforce learning.
The chatbot was not custom-built for this study but is an existing tool provided to NUS students as part of their digital mental health benefits.
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Placebo Comparator: Inactive control (neutral writing tasks)
Participants in this arm will complete four 20-minute sessions over four weeks involving neutral writing tasks unrelated to mental health.
Writing prompts cover non-emotive topics (e.g., daily routines, neutral observations) and do not include emotional support, feedback, or guidance.
This arm serves as an inactive control condition to isolate the effect of the chatbot intervention on emotional wellbeing and perceived empathy.
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Participants in this arm will complete four 20-minute sessions of neutral writing tasks unrelated to mental health.
Prompts include writing factually about daily routines or describing an object in detail.
The content is emotionally neutral to act as a comparison for the chatbot intervention.
Sessions are conducted online via Zoom.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived empathy (Robot's Perceived Empathy Scale - RoPE)
Time Frame: Immediately after Session 1 and Session 4 (baseline and post-intervention for chatbot group only).
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Assesses participants' perception of the AI chatbot's empathy (cognitive and affective components), using the validated Robot's Perceived Empathy (RoPE) scale. The RoPE consists of 20 items rated on a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree). Score range: 20-100. Higher scores indicate: Greater perceived empathy. |
Immediately after Session 1 and Session 4 (baseline and post-intervention for chatbot group only).
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Change in emotional wellbeing (WHO-5 Wellbeing Index)
Time Frame: Day 1 (Baseline), Week 4 (End of Session 4), and Week 8 (1-month follow-up after last session).
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Assesses overall emotional wellbeing and life satisfaction using the WHO-5 Wellbeing Index, a 5-item self-report scale. Each item is rated on a 6-point Likert scale (0 = At no time to 5 = All of the time). Score range: 0-25. Higher scores indicate: Greater wellbeing. |
Day 1 (Baseline), Week 4 (End of Session 4), and Week 8 (1-month follow-up after last session).
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Change in anxiety symptoms (Generalised Anxiety Disorder 7-item - GAD-7)
Time Frame: Day 1 (Baseline), Week 4 (End of Session 4), and Week 8 (1-month follow-up after last session).
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Assesses anxiety symptoms using the GAD-7, a 7-item self-report scale. Each item is scored from 0 ("Not at all") to 3 ("Nearly every day"). Score range: 0-21. Higher scores indicate: Greater severity of anxiety symptoms. |
Day 1 (Baseline), Week 4 (End of Session 4), and Week 8 (1-month follow-up after last session).
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Change in depressive symptoms (Patient Health Questionnaire-9 - PHQ-9)
Time Frame: Day 1 (Baseline), Week 4 (End of Session 4), and Week 8 (1-month follow-up after last session).
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Assesses depressive symptoms using the PHQ-9, a 9-item self-report scale. Each item is scored from 0 ("Not at all") to 3 ("Nearly every day"). Score range: 0-27. Higher scores indicate: Greater severity of depressive symptoms. |
Day 1 (Baseline), Week 4 (End of Session 4), and Week 8 (1-month follow-up after last session).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in resilience (Brief Resilience Scale - BRS)
Time Frame: Day 1 (Baseline) , Week 2 (Post-Session 2), Week 4 (Post-Session 4) , Week 8 (1-month follow-up after last session)
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Assesses participants' ability to bounce back or recover from stress. The BRS includes 6 items scored on a 5-point Likert scale (1 = "Strongly disagree" to 5 = "Strongly agree"). Score range: Average score between 1 and 5. Higher scores indicate: Greater resilience. |
Day 1 (Baseline) , Week 2 (Post-Session 2), Week 4 (Post-Session 4) , Week 8 (1-month follow-up after last session)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NUS-IRB-2024-930
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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