Control ConditionNCT06965439
Effectiveness of AI Chatbots in Improving Students' General Wellbeing
A study testing AI-delivered emotional wellbeing support and Neutral writing tasks in people with Control Condition and Intervention, run by National University of Singapore at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Control Condition, Intervention
- What is being tested?
- AI-delivered emotional wellbeing support and Neutral writing tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Oct 2025to 5 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Control Condition, Intervention
- Being tested
- AI-delivered emotional wellbeing support, Neutral writing tasks
- Keywords
- Writing task, Mental health chatbot, Digital mental health, Emotional wellbeing, Subclinical anxiety, Subclinical depression, University students, AI intervention, Cognitive behavioural therapy (CBT), Resilience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-delivered emotional wellbeing supportBehavioural
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.
Neutral writing tasksOther
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.
| Study group | Role | What they receive |
|---|---|---|
| AI-delivered emotional wellbeing support | Experimental | 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. Receives: Behavioral: AI-delivered emotional wellbeing support |
| Inactive control (neutral writing tasks) | Placebo comparator | 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. Receives: Other: Neutral writing tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived empathy (Robot's Perceived Empathy Scale - RoPE)
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.
Measured: Immediately after Session 1 and Session 4 (baseline and post-intervention for chatbot group only).
Change in emotional wellbeing (WHO-5 Wellbeing Index)
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.
Measured: Day 1 (Baseline), Week 4 (End of Session 4), and Week 8 (1-month follow-up after last session).
Change in anxiety symptoms (Generalised Anxiety Disorder 7-item - GAD-7)
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.
Measured: Day 1 (Baseline), Week 4 (End of Session 4), and Week 8 (1-month follow-up after last session).
Change in depressive symptoms (Patient Health Questionnaire-9 - PHQ-9)
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.
Measured: Day 1 (Baseline), Week 4 (End of Session 4), and Week 8 (1-month follow-up after last session).
Secondary outcomes (1)
Change in resilience (Brief Resilience Scale - BRS)
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.
Measured: Day 1 (Baseline) , Week 2 (Post-Session 2), Week 4 (Post-Session 4) , Week 8 (1-month follow-up after last session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Oct 2025
- Primary completion1 Feb 2026
- Study completion5 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Control ConditionStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study uses a parallel assignment model in which participants are randomly allocated to one of two groups: (1) an experimental group receiving a four-session intervention with a mental health chatbot designed to deliver structured conversational support using CBT and emotional validation techniques, or (2) an inactive control group completing neutral writing tasks unrelated to mental health. Both groups complete sessions over four weeks, with follow-up assessment one month post-intervention to evaluate sustained effects.
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Oliver Suendermann, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965439
- Sponsor's protocol ID
- NUS-IRB-2024-930
- Status last verified
- Oct 2025
- First submitted
- 23 Apr 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study involves personal mental health disclosures, even if anonymised. Sharing individual participant data (IPD), even coded, increases the risk of re-identification and may breach the trust established during consent.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of AI Chatbots in Improving Students' General Wellbeing
- ClinicalTrials.gov ID
- NCT06965439
- Acronym / sponsor ID
- NUS-IRB-2024-930
- Conditions
- Control Condition, Intervention
- Keywords
- Writing task, Mental health chatbot, Digital mental health, Emotional wellbeing, Subclinical anxiety, Subclinical depression, University students, AI intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 5 Apr 2026 (actual)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel assignment model in which participants are randomly allocated to one of two groups: (1) an experimental group receiving a four-session intervention with a mental health chatbot designed to deliver structured conversational support using CBT and emotional validation techniques, or (2) an inactive control group completing neutral writing tasks unrelated to mental health. Both groups complete sessions over four weeks, with follow-up assessment one month post-intervention to evaluate sustained effects.
| Arm | Type | Receives |
|---|---|---|
| AI-delivered emotional wellbeing support | Experimental | Behavioral: AI-delivered emotional wellbeing supportParticipants 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. |
| Inactive control (neutral writing tasks) | Placebo comparator | Other: Neutral writing tasksParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-delivered emotional wellbeing supportParticipants 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. | Behavioural | AI-delivered emotional wellbeing support |
| Neutral writing tasksParticipants 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. | Other | Inactive control (neutral writing tasks) |
Primary outcome
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).
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.
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).
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.
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).
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.
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).
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No. This study involves personal mental health disclosures, even if anonymised. Sharing individual participant data (IPD), even coded, increases the risk of re-identification and may breach the trust established during consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-delivered emotional wellbeing support and Neutral writing tasks in people with Control Condition and Intervention, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.