Effectiveness of A Mindfulness-centered Stress Management AI Chatbot to Reduce Stress and Enhance Mental Health Among Men Who Have Sex With Men in China

NCT07732621 | Not Yet Recruiting

• 1 other identifier: UW 26-192
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Does the AI chatbot show a greater reduction in perceived stress compared to standardized psychoeducational materials?
2. 2.Does the AI chatbot improve mental health outcomes, including depressive and anxiety symptoms, subjective well-being, and emotion regulation?
3. 3.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.
4. 4.Complete online self-report questionnaires at baseline, post-intervention (Week 4), and 4-week follow-up.

Conditions

Stress (Psychology)

Keywords

stress; sexual minority; mindfulness

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of intervention at week 1, week 4, and week 8.

Secondary Outcomes (10)

• Score of Difficulties in Emotion Regulation

  From enrollment to the end of intervention at week 1, week 4, and week 8.

• Score of Stress Coping

  From enrollment to the end of intervention at week 1, week 4, and week 8.

• Score of Rumination

  From enrollment to the end of intervention at week 1, week 4, and week 8.

• Score of Depressive symptom

  From enrollment to the end of intervention at week 1, week 4, and week 8.

• Score of Anxiety Symptom

  From enrollment to the end of intervention at week 1, week 4, and week 8.

Study Arms (2)

Mindfulness-centered stress management AI chatbot

EXPERIMENTAL

Participants will receive mindfulness-centered stress management AI chatbot.

Behavioral: Mindfulness-centered stress management AI chatbot

Psychoeducation

ACTIVE COMPARATOR

Participants will receive psychoeducation reading materials.

Behavioral: Psychoeducation

Interventions

Mindfulness-centered stress management AI chatbot BEHAVIORAL

An 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).

Mindfulness-centered stress management AI chatbot

Psychoeducation BEHAVIORAL

Participants 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.

Psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Chinese
• Self-identify as MSM.
• Own a smartphone to ensure compatibility with the intervention platform.
• Mild to moderate perceived stress, defined as Chinese Perceived Stress Scale (PSS-14) score \< 43.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 29, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)