Effectiveness of AI Chatbots in Improving Students' General Wellbeing

NCT06965439 | Not Yet Recruiting

• 1 other identifier: NUS-IRB-2024-930
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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)

  Day 1 (Baseline) , Week 2 (Post-Session 2), Week 4 (Post-Session 4) , Week 8 (1-month follow-up after last session)

Study Arms (2)

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.

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.

Other: Neutral writing tasks

Interventions

AI-delivered emotional wellbeing support BEHAVIORAL

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.

AI-delivered emotional wellbeing support

Neutral writing tasks OTHER

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.

Inactive control (neutral writing tasks)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead

Central Study Contacts

Pak (Martin) Hei Ng, Trainee Clinical Psychologist

CONTACT

‪+65 9616 0572‬; e1350419@u.nus.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants are partially masked to the study's purpose. They are not informed of the specific aim to evaluate the chatbot's impact on mental health outcomes, nor are they aware of the control versus intervention group distinctions. This partial masking helps reduce demand characteristics and expectancy effects. No other parties are blinded.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 11, 2025
• Study Start: August 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share