The goal of this randomized controlled trial is to evaluate the effectiveness of a mindfulness-centered stress management AI chatbot in reducing perceived stress and enhancing mental health among Chinese men who have sex with men (MSM).
The main questions it aims to answer are:
1. Does the AI chatbot show a greater reduction in perceived stress compared to standardized psychoeducational materials? 2. Does the AI chatbot improve mental health outcomes, including depressive and anxiety symptoms, subjective well-being, and emotion regulation?
Researchers will compare the AI chatbot to a control group receiving psychoeducational materials to see if the chatbot works to reduce stress and improve mental health.
Participants will:
1. Be randomized to use the AI chatbot (recommended at least 2 sessions per week, 10-15 minutes per session) or read psychoeducational materials (2 times per week) for 4 weeks. 2. Complete online self-report questionnaires at baseline, post-intervention (Week 4), and 4-week follow-up.
Age ≥ 18 years.
Chinese
Self-identify as MSM.
Own a smartphone to ensure compatibility with the intervention platform.
Diagnosed with an acute severe mental disorder, such as psychosis, major depressive disorder, or anxiety disorder;
Currently receiving psychotherapy at enrollment.
Report moderately severe to severe depressive symptoms, defined as a PHQ-9 total score greater than 14.
Unable to provide online informed consent or complete study procedures.
Parallel
Mindfulness-centered stress management AI chatbot
BehavioralAn investigational, web-based conversational AI chatbot providing preventive, low-intensity psychological support for Chinese MSM experiencing mild-to-moderate stress. It has the following functions: (1) Built on a Chinese open-source LLM optimized through RAG to deliver culturally adapted, empathetic responses addressing minority stress, stigma, and identity concealment. (2) Delivers interactive, 10-20 min guided mindfulness-based stress reduction exercises (grounding, self-compassion, sleep-support, etc).
Psychoeducation
BehavioralParticipants receive standardized, text-based psychoeducational readings covering general stress, coping concepts, and mental health awareness. The delivery contains no interactive features, conversational elements, or guided mindfulness coaching.
Score of Perceived Stress
Chinese version of Perceived Stress Scale (PSS-14). Score range: 0-56. The higher the score, the greater the perceived stress. PSS-14 is highly sensitive to both acute and subtle changes in stress levels, making it effective for capturing variations in stress even within short periods of intervention. It can detect moderate fluctuations in perceived stress, even in individuals with low to moderate baseline stress levels.
Score of Difficulties in Emotion Regulation
Chinese version of 16 item Difficulties in Emotion Regulation Scale Short Form (DERS-SF). Score range: 16-80. The higher the score, the lower the individual's level of emotional regulation. DERS-SF is highly sensitive to short-term fluctuations in emotion regulation.
Score of Stress Coping
Chinese version of Brief Coping Orientation to Problems Experienced Inventory (Brief-COPE). Score range: 28-112. The higher score of the subscale demonstrates more likely the coping strategies were used by the respondents. Brief-COPE is highly sensitive to changes in coping strategies and can capture variations in stress responses, especially following interventions aimed at improving coping mechanisms.
Score of Rumination
Chinese version of Ruminative Responses Scale (RRS). Score range:22-88. A higher score indicates a more severe tendency toward ruminative thinking. RRS is sensitive to both moderate and subtle changes in rumination. It can detect shifts in rumination levels, particularly in individuals with depression or stress-related disorders.
Score of Distress Tolerance
Chinese version of distress tolerance scale (DTS). Score range: 15-75. A higher score indicates that an individual has a higher tolerance for emotional distress.
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