Stress (Psychology)MSMNCT07732621
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
A study testing Mindfulness-centered stress management AI chatbot and Psychoeducation in people with Stress (Psychology), run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stress (Psychology)
- What is being tested?
- Mindfulness-centered stress management AI chatbot and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Jul 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
The University of Hong Kong
Hong Kong
Shuochi Wei, 852-68744705, weisc@connect.hku.hk
About this study
Official title: 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: A Randomized Controlled Trial Study
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:
Read more
- Does the AI chatbot show a greater reduction in perceived stress compared to standardized psychoeducational materials?
- 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:
- 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.
- Complete online self-report questionnaires at baseline, post-intervention (Week 4), and 4-week follow-up.
Read the detailed description
Chinese MSM often experience unique social stress factors related to stigma, discrimination, and the pressures of concealing their sexual identity. These ongoing challenges are closely linked to elevated levels of anxiety, depressive symptoms, and general psychological distress. While traditional face-to-face therapy can be effective, common barriers such as waiting lists, costs, and privacy concerns frequently prevent individuals from seeking care. To help bridge this gap, the trial evaluates an accessible, private, and real-time AI tool that delivers safe, low-intensity mental health preventive support directly to a user's smartphone.
The investigational tool is a web-based chatbot built on a open-source Chinese large language model and tailored using Retrieval-Augmented Generation technology. This design ensures that the chatbot's responses are empathetic, culturally sensitive, and tailored to MSM-related stress and mental health topics. During conversations, the chatbot guides users through brief, evidence-based mindfulness practices-such as grounding, cognitive defusion, self-compassion, and sleep support-designed for 10-to-20-minute sessions. The tool focuses strictly on stress management and coping skills; it is not intended to provide clinical diagnosis, formal psychotherapy, or emergency crisis intervention.
The research follows a randomized controlled trial design spanning four weeks of intervention followed by a post-study assessment four weeks later. Adult participants with mild-to-moderate stress are recruited via major social media platforms, including Xiaohongshu, Weibo, and WeChat. After completing online consent and baseline surveys, participants are randomly assigned to either the intervention group or a control group. Those in the intervention group attend a brief online orientation and gain access to the AI chatbot, which they are recommended to use at least twice a week. Participants in the control group receive non-interactive educational readings on general stress management twice weekly. Researchers measure changes in stress levels, anxiety, depression, emotion regulation, rumination, and coping strategies across three key evaluation points.
- Conditions
- Stress (Psychology)
- Being tested
- Mindfulness-centered stress management AI chatbot, Psychoeducation
- Keywords
- stress, sexual minority, mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-centered stress management AI chatbotBehavioural
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).
PsychoeducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-centered stress management AI chatbot | Experimental | Participants will receive mindfulness-centered stress management AI chatbot. Receives: Behavioral: Mindfulness-centered stress management AI chatbot |
| Psychoeducation | Active comparator | Participants will receive psychoeducation reading materials. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of intervention at week 1, week 4, and week 8.
Secondary outcomes (10)
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.
Measured: From enrollment to the end of intervention at week 1, week 4, and week 8.
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.
Measured: From enrollment to the end of intervention at week 1, week 4, and week 8.
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.
Measured: From enrollment to the end of intervention at week 1, week 4, and week 8.
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.
Measured: From enrollment to the end of intervention at week 1, week 4, and week 8.
Score of Depressive symptom
Chinese version of Patient Health Questionnaire-9 (PHQ-9). Score range:0-27. A higher score indicates more severe symptoms of depression.
PHQ-9 is sensitive to both moderate and mild changes in depressive symptoms. It has been shown to detect reductions in depressive symptoms following short-term interventions, even those targeting stress or emotion regulation rather than directly treating depression.
Measured: From enrollment to the end of intervention at week 1, week 4, and week 8.
Score of Anxiety Symptom
Chinese version of Generalized Anxiety Disorder-7 (GAD-7). Score range: 0-21. A higher score indicates more severe symptoms of anxiety.
GAD-7 is particularly sensitive to changes in anxiety, capturing both the intensity and frequency of anxiety symptoms. Even short-term interventions can result in significant reductions in anxiety.
Measured: From enrollment to the end of intervention at week 1, week 4, and week 8.
Score of Subjective Well-Being
Chinese version of WHO Well-Being Index (WHO-5). Score range:0-30. A higher score indicates a higher level of wellbeing.
WHO-5 is sensitive to short-term fluctuations in subjective well-being, making it ideal for measuring the effects of interventions like mindfulness.
Measured: From enrollment to the end of intervention at week 1, week 4, and week 8.
Score of Acceptability of Intervention
Chinese version of Acceptability of Intervention (AIM). Score range: 1-5. Higher scores indicate greater acceptability.
4-item Acceptability of Intervention Measure (AIM) will be used to assess acceptability. It is a 5-point Likert scale, with good readability, reliability, and validity. Higher scores indicate greater acceptability.
Measured: From enrollment to the end of intervention at week 4.
Score of Intervention Appropriateness
Chinese version of Intervention Appropriateness Measure (IAM). Score range: 1-5. Higher scores indicate greater appropriateness.
4-item Intervention Appropriateness Measure (IAM) will be used to assess the appropriateness of the intervention. It is a 5-point Likert scale, with good readability, reliability, and validity. Higher scores indicate greater appropriateness.
Measured: From enrollment to the end of intervention at week 4.
Score of AI Psychological Dialogue Quality
AI Psychological Dialogue Quality Assessment. Score range: 1-5. Higher scores indicate higher quality.
AI Psychological Dialogue Quality Assessment is a 5-point Likert scale for evaluating AI psychological dialogue quality including normativity, professionalism, emotional understanding and empathy, consistency and coherence and potentially harmful information).
Measured: From enrollment to the end of intervention at week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress (Psychology)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WEI Shuochi, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732621
- Sponsor's protocol ID
- UW 26-192
- Acronym
- MSM
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and maintain strict confidentiality, given the sensitive nature of sexual minority status, mental health data, and personal conversational logs.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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: A Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT07732621
- Acronym / sponsor ID
- MSM / UW 26-192
- Conditions
- Stress (Psychology)
- Keywords
- stress, sexual minority, mindfulness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the AI chatbot show a greater reduction in perceived stress compared to standardized psychoeducational materials?
- 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:
- 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.
- Complete online self-report questionnaires at baseline, post-intervention (Week 4), and 4-week follow-up.
Detailed description
Chinese MSM often experience unique social stress factors related to stigma, discrimination, and the pressures of concealing their sexual identity. These ongoing challenges are closely linked to elevated levels of anxiety, depressive symptoms, and general psychological distress. While traditional face-to-face therapy can be effective, common barriers such as waiting lists, costs, and privacy concerns frequently prevent individuals from seeking care. To help bridge this gap, the trial evaluates an accessible, private, and real-time AI tool that delivers safe, low-intensity mental health preventive support directly to a user's smartphone.
The investigational tool is a web-based chatbot built on a open-source Chinese large language model and tailored using Retrieval-Augmented Generation technology. This design ensures that the chatbot's responses are empathetic, culturally sensitive, and tailored to MSM-related stress and mental health topics. During conversations, the chatbot guides users through brief, evidence-based mindfulness practices-such as grounding, cognitive defusion, self-compassion, and sleep support-designed for 10-to-20-minute sessions. The tool focuses strictly on stress management and coping skills; it is not intended to provide clinical diagnosis, formal psychotherapy, or emergency crisis intervention.
The research follows a randomized controlled trial design spanning four weeks of intervention followed by a post-study assessment four weeks later. Adult participants with mild-to-moderate stress are recruited via major social media platforms, including Xiaohongshu, Weibo, and WeChat. After completing online consent and baseline surveys, participants are randomly assigned to either the intervention group or a control group. Those in the intervention group attend a brief online orientation and gain access to the AI chatbot, which they are recommended to use at least twice a week. Participants in the control group receive non-interactive educational readings on general stress management twice weekly. Researchers measure changes in stress levels, anxiety, depression, emotion regulation, rumination, and coping strategies across three key evaluation points.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-centered stress management AI chatbot | Experimental | Behavioral: Mindfulness-centered stress management AI chatbotParticipants will receive mindfulness-centered stress management AI chatbot. |
| Psychoeducation | Active comparator | Behavioral: PsychoeducationParticipants will receive psychoeducation reading materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-centered stress management AI chatbotAn 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). | Behavioural | Mindfulness-centered stress management AI chatbot |
| PsychoeducationParticipants 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. | Behavioural | Psychoeducation |
Primary outcome
Score of Perceived Stress
Time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.
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.
10 secondary outcomes
Score of Difficulties in Emotion Regulation
Time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.
Score of Stress Coping
Time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.
Score of Rumination
Time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.
Score of Distress Tolerance
Time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.
Score of Depressive symptom
Time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.
Score of Anxiety Symptom
Time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.
Score of Subjective Well-Being
Time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.
Score of Acceptability of Intervention
Time frame: From enrollment to the end of intervention at week 4.
Score of Intervention Appropriateness
Time frame: From enrollment to the end of intervention at week 4.
Score of AI Psychological Dialogue Quality
Time frame: From enrollment to the end of intervention at week 4.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and maintain strict confidentiality, given the sensitive nature of sexual minority status, mental health data, and personal conversational logs.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-centered stress management AI chatbot and Psychoeducation in people with Stress (Psychology), run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of Perceived Stress (time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.