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Набор скоро начнётся NCT06965439

Effectiveness of AI Chatbots in Improving Students' General Wellbeing

Без фазы С лечением Control Condition Intervention

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: AI-delivered emotional wellbeing support, Neutral writing tasks.
Кому может быть актуально
Состояния в реестре: Control Condition, Intervention. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluating the Effectiveness of AI Chatbots in Improving Students' General Wellbeing

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое AI-delivered emotional wellbeing support
    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
  • Другое Neutral writing tasks
    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.

Первичные конечные точки

  • Perceived empathy (Robot's Perceived Empathy Scale - RoPE) [Срок оценки: Immediately after Session 1 and Session 4 (baseline and post-intervention for chatbot group only).]
  • Change in emotional wellbeing (WHO-5 Wellbeing Index) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Day 1 (Baseline), Week 4 (End of Session 4), and Week 8 (1-month follow-up after last session).]
Вторичные конечные точки (1)
  • Change in resilience (Brief Resilience Scale - BRS) [Срок оценки: Day 1 (Baseline) , Week 2 (Post-Session 2), Week 4 (Post-Session 4) , Week 8 (1-month follow-up after last session)]

Критерии участия

Критерии включения

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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Факторный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06965439 · NUS-IRB-2024-930

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗