Chatbot-based Mindfulness-based Stress Reduction Programme for University Students With Depressive Symptoms: Intervention Development and Pilot Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
The goal of this study is to evaluate the feasibility, acceptability, safety and preliminary efficacy of a chatbot-based mindfulness-based stress reduction (MBSR) intervention for university students with depressive symptoms.
A rule-based MBSR chatbot will be developed and evaluated with a single-group pretest-posttest study for university students aged 18 or above in Hong Kong reporting depressive symptoms, followed by the collection of their subjective feedback. The intervention will last eight weeks. The primary clinical outcome is depression levels, with a range of secondary outcomes including stress, anxiety and mindfulness levels.
详细描述
Depression is a growing concern among university students. Chatbots provide flexible, accessible, personalized psychosocial support. Delivering Mindfulness-based Stress Reduction (MBSR) sessions via chatbots may reduce depressive symptoms in university students.
This study consists of two phases. In the first phase, a rule-based automated chatbot will be developed to facilitate MBSR interventions. The second phase will employ a single-group pretest-posttest design to evaluate the feasibility, acceptability, safety and preliminary effectiveness of the chatbot-based MBSR intervention for university students with self-reported depressive symptoms. The study will be guided by the CONSORT 2010 checklist-extension for pilot and feasibility studies of information to include when reporting a pilot or feasibility trial. This study specifically targets university students in Hong Kong.
Phase One: Development of the Chatbot-based MBSR Intervention Phase one focuses on developing a chatbot-based MBSR intervention using an interactive system named Power Virtual Agents, integrated within the Microsoft Teams platform. We will first conduct a comprehensive literature review to inform the integration of chatbot conversational flows with the content of MBSR sessions and craft a comprehensive chatbot-mediated conversational flow structure to guide participants through the MBSR sessions. The sessions will be delivered in audio format (Cantonese) via the chatbot programmed to operate in Traditional Chinese. Subsequently, we will employ a logical algorithm to establish coherent flows for the intervention sessions. Each session will be programmed with specific triggers, keywords, and queries to effectively engage users. The chatbot incorporates natural language understanding capabilities to analyze user input and guide the conversation accordingly. Additionally, a lightweight database will be integrated to track and maintain user progress and facilitate continuity across the MBSR sessions. The usability of the chatbot-based MBSR intervention will be evaluated through backend data analysis from the chatbot system and qualitative feedback from users. All steps will be supervised by the authors to ensure the reliability and accuracy of the development process.
Phase Two: A Feasibility Clinical Trial Participant Recruitment Posters will be displayed across various key locations within our university. These posters include a concise overview of the study and a quick response (QR) code for assessing participant eligibility. Additionally, the study will be promoted on social media platforms such as Facebook and Instagram. Eligible participants who complete the programme will be offered coupons. The recruitment period is expected to extend for four months.
Participate Screening Eligible participants must be students aged over 18 years pursuing a bachelor degree, associate degree, or higher diploma, with self-reported depressive symptoms. The depressive symptoms are assessed pre-intervention using the 9-item Patient Health Questionnaire, with cumulative scores of 5 or higher indicating depressive symptoms. Participants must also be able to provide informed consent, read Chinese, listen to Cantonese, and ensure internet access during the study. Participants will be excluded if they had been diagnosed with a clinical psychotic condition pre-intervention or are currently involved in any mindfulness-based or other psychosocial interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •University students aged over 18 years
- •University students pursuing a bachelor degree, associate degree, or higher diploma in Hong Kong
- •University students with self-reported depressive symptoms (The depressive symptoms are assessed pre-intervention using the 9-item Patient Health Questionnaire, with cumulative scores of 5 or higher indicating at least mild depressive symptoms.)
- •Be able to provide informed consent, read Chinese, listen to Cantonese
- •Ensure internet access during the study
排除标准
- •University students who have been diagnosed with a clinical psychotic condition pre-intervention
- •University students who are currently involved in any mindfulness-based or other psychosocial interventions
研究组 & 干预措施
one arm pre-post test
This study consists of two phases. In the first phase, a rule-based automated chatbot will be developed to facilitate mindfulness-based stress reduction (MBSR) interventions. The second phase will employ a single-group pretest-posttest design to evaluate the feasibility, acceptability, safety and preliminary efficacy of the chatbot-based MBSR intervention for university students with self-reported depressive symptoms. The study will be guided by the 'CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trial'. This study specifically targets university students in Hong Kong and the intervention lasts eight weeks.
干预措施: chatbot-based mindfulness-based stress reduction (Other)
结局指标
主要结局
Patient Health Questionnaire (PHQ-9)
时间窗: The pre-intervention/baseline assessment using this measure will be conducted one week before the start of the intervention. The post-intervention assessment using this measure will be conducted upon the completion of the 8-week intervention.
The depression levels of the participants will be assessed using the Patient Health Questionnaire (PHQ-9) in Chinese. Items are rated on a scale from 0 (not at all) to 3 (nearly every day), with total scores categorizing depression severity: 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and ≥20 (severe). Higher scores mean a worse outcome.
次要结局
- Five-Facet Mindfulness Questionnaire (FFMQ-39)(The pre-intervention/baseline assessment using this measure will be conducted one week before the start of the intervention. The post-intervention assessment using this measure will be conducted upon the completion of the 8-week intervention.)
- Generalized Anxiety Disorder Scale (GAD-7)(The pre-intervention/baseline assessment using this measure will be conducted one week before the start of the intervention. The post-intervention assessment using this measure will be conducted upon the completion of the 8-week intervention.)
- Perceived Stress Scale (PSS-14)(The pre-intervention/baseline assessment using this measure will be conducted one week before the start of the intervention. The post-intervention assessment using this measure will be conducted upon the completion of the 8-week intervention.)