Clinical trial NCT06965439: Effectiveness of AI Chatbots in Improving Students' General Wellbeing
Official title: Evaluating the Effectiveness of AI Chatbots in Improving Students' General Wellbeing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Control Condition
Intervention
Keywords: Writing task
Mental health chatbot
Digital mental health
Emotional wellbeing
Subclinical anxiety
Subclinical depression
University students
AI intervention
Cognitive behavioural therapy (CBT)
Resilience
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Perceived empathy (Robot's Perceived Empathy Scale - RoPE)
timeFrame: Immediately after Session 1 and Session 4 (baseline and post-intervention for chatbot group only).
measure: Change in emotional wellbeing (WHO-5 Wellbeing Index)
timeFrame: Day 1 (Baseline), Week 4 (End of Session 4), and Week 8 (1-month follow-up after last session).
measure: Change in anxiety symptoms (Generalised Anxiety Disorder 7-item - GAD-7)
timeFrame: Day 1 (Baseline), Week 4 (End of Session 4), and Week 8 (1-month follow-up after last session).
measure: Change in depressive symptoms (Patient Health Questionnaire-9 - PHQ-9)
timeFrame: Day 1 (Baseline), Week 4 (End of Session 4), and Week 8 (1-month follow-up after last session).
Secondary outcomes:
measure: Change in resilience (Brief Resilience Scale - BRS)
timeFrame: Day 1 (Baseline) , Week 2 (Post-Session 2), Week 4 (Post-Session 4) , Week 8 (1-month follow-up after last session)
Other outcomes:
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