An interventional study of Virtual Peer Agent Intervention and Human peer mentor in Youth Mental Health, Psychological Distress in Adolescents and Young Adults and Early Intervention, sponsored by Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 14 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Prevention
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Among 45 studies in Psychological Well-Being with a site in China — 21 open to participants now, 25 under way, none of them phase 3. Psychological Well-Being · China.
Among the 45 studies in Psychological Well-Being with a site in China, this one is the 9th largest by planned enrollment of the 34 interventional ones that give a count, is one of 10 that started in 2026, is one of 34 with no phase, reaches primary completion later than 12 of the 24 other live ones, and was the 42nd registered.
2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
Browse Psychological Well-Being studies →21 of the 45 studies in Psychological Well-Being with a site in China are open now. Recruiting first, the newest first:
Brown University · Sites in China
Ages 11+ · Healthy volunteers
Universiti Sains Malaysia · Sites in China
Healthy volunteers
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 18–65
Hunan University · Sites in China
Ages 18+ · Healthy volunteers
Beijing Sport University · Sites in China
Ages 45–70 · Women only · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 401 Psychological Well-Being studies recruiting now, 218 (54%) set no upper age limit and 157 (39%) stop at 75 or younger; 120 take children under 18; 204 take healthy volunteers.
This study: 14 Years to 25 Years · all sexes · no healthy volunteers.
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45 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 10 started in 2026.
This study's planned enrollment of 234 is above the median of 110 across 1,798 interventional studies indexed under Psychological Well-Being.
Median enrollment 123 across the 34 interventional studies, 1,000 across the 11 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.
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None of the 45 has an industry lead sponsor. The 10 most frequent:
Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 618 are open to participants now.
Sun Yat-sen University has 4 studies filed under Psychological Well-Being — fewer than ten, so there is no comparison to draw.
9 of the studies in Psychological Well-Being with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07778758Sun Yat-sen UniversityVIPeerAgent for Adolescent Mental Health | 2026-11-30 |
| NCT07755995Xu ShuishuiLatin Dance and Psychological Health in Primary School Children | 2026-11-30 |
| NCT07791550Tianjin Medical University Cancer Institute and HospitalBaduanjin for Quality of Life in Pancreatic Cancer Chemotherapy | 2027-01-31 |
| NCT06839417Tsinghua UniversityEffect of Squash Exercise Intervention on Sleep and Mental Health Among Young Adults | 2027-03-01 |
| NCT07647965The Hong Kong Polytechnic UniversityAn Ecological Momentary Intervention for Mental Health in Individuals With Ankylosing Spondylitis | 2027-03-31 |
Add all 9 to your calendar (.ics) → With an account.
Among the 45 studies in Psychological Well-Being with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This three-arm parallel randomized controlled trial aims to evaluate the effectiveness of VIPeerAgent, a virtual peer support agent, in improving mental health outcomes among adolescents and young adults aged 14-25 years experiencing psychological distress without a diagnosed mental disorder. Participants will be randomized to receive support from VIPeerAgent, a human peer mentor, or usual care. The study will assess whether VIPeerAgent is non-inferior to human peer support and superior to usual care in promoting mental health. Outcomes include mental health status, psychological resilience, coping strategies, perceived social support, and emotional intelligence. The findings will provide evidence for the effectiveness and scalability of AI-assisted peer support as an early intervention approach for youth mental health.
This study aims to evaluate the effectiveness of VIPeerAgent, an artificial intelligence-powered virtual peer support agent, in promoting mental health among adolescents and young adults aged 14-25 years who experience psychological distress but do not meet diagnostic criteria for a mental disorder. The study is designed to support the early identification, early intervention, and prevention of mental health problems in youth populations.
The study adopts a three-arm parallel randomized controlled trial with a non-inferiority and superiority testing framework. Eligible participants will be randomly assigned in a 1:1:1 ratio to one of three groups: (1) the VIPeerAgent intervention group, (2) the human peer mentor support group, or (3) the usual-care control group.
Participants in the VIPeerAgent group will engage in multi-turn conversations with the virtual peer agent. The intervention focuses on providing psychological support in three key areas: emotional awareness and regulation, social support enhancement, and coping strategy development. At the end of each interaction, VIPeerAgent will guide participants in developing an individualized and actionable to-do list based on their personal needs and goals. Additional support will be provided through proactive follow-up and personalized content recommendations tailored to participants' psychological needs.
Participants in the human peer mentor group will receive support from trained peer mentors. The intervention components are comparable to those delivered by VIPeerAgent and include peer support consultations, enhanced follow-up, individualized action planning through to-do lists, and personalized supportive messages. Participants in the usual-care control group will receive routine mental health education through weekly mental health promotion materials. The intervention period will last four weeks.
The primary outcome is improvement in mental health status during the follow-up period, assessed using the Brief Symptom Inventory-53 (BSI-53). Secondary outcomes include psychological resilience, coping strategies, perceived social support, and emotional intelligence.
In addition to the randomized controlled trial, an explanatory qualitative study will be conducted following completion of the intervention. Using purposive sampling, participants with diverse experiences and intervention responses will be invited to participate in semi-structured interviews. The qualitative interviews will explore participants' perceptions of the intervention, user experiences, acceptability, engagement, and perceived impact. Findings from the qualitative analysis will be used to complement and help explain the quantitative trial results, providing a deeper understanding of the mechanisms, benefits, and implementation considerations of AI-assisted peer support for youth mental health.
This design will generate comprehensive evidence regarding both the effectiveness and user experience of VIPeerAgent and inform the future development, implementation, and scalability of AI-supported mental health interventions for adolescents and young adults.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Virtual Peer Agent Intervention
Other: Human peer mentor
Participants in the VIPeerAgent group will engage in multi-turn conversations with the virtual peer agent. The intervention focuses on providing psychological support in three key areas: emotional awareness and regulation, social support enhancement, and coping strategy development. At the end of each interaction, VIPeerAgent will guide participants in developing an individualized and actionable to-do list based on their personal needs and goals.
Participants in the human peer mentor group will receive support from trained peer mentors. The intervention components are comparable to those delivered by VIPeerAgent and include peer support consultations, enhanced follow-up, individualized action planning through to-do lists, and personalized supportive messages.
Level of Psychological Symptoms
Level of Psychological Symptoms: Assessed by change in scores on the Brief Symptom Inventory-53 (BSI-53). This 53-item instrument, which encompasses 9 dimensions, is rated on a 5-point Likert scale. A cut-off point of 63 or higher is used to define a positive case.
Time frame: Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.
Social Support
Social Support: Assessed by scores on the Perceived Social Support Scale (PSSS). The Perceived Social Support Scale (PSSS) consists of 12 items, which are divided into three dimensions: family, friend, and other support. Using a 7-point Likert scale, the total score (range: 12-84) is calculated, with a higher score reflecting a higher level of perceived social support.
Time frame: Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.
Stressful life events
The Adolescent Self-Rating Life Events Checklist (ASLEC) assesses the frequency and impact of stressful life events in adolescents. It comprises 27 items covering five domains: punishment, loss, interpersonal stress, academic stress, and adaptation problems. Each item is rated on a 6-point scale from 0 (never occurred) to 5 (extremely severe). Scale range: 0 to 135 Higher scores indicate a worse outcome (greater negative impact of stressful life events).
Time frame: Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.
Coping Strategies
Coping Strategies: Assessed by scores on the Coping Strategy Indicator - Short Form in Chinese (CSIS-SFC). The scale is composed of 21 items divided into four subscales: Task-Oriented Coping, Emotion-Oriented Coping, Distraction Coping, and Social Diversion Coping. It is a 5-point Likert scale.
Time frame: Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.
Psychological Resilience
Psychological Resilience: Assessed by change in scores on the Connor-Davidson Resilience Scale (CD-RISC). The instrument consists of 25 items distributed among three dimensions: hardiness (13 items), strength (8 items), and optimism (4 items). Responses are recorded on a 5-point Likert scale, yielding a total score between 0 and 100, where a higher score denotes a higher level of psychological resilience.
Time frame: Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.
Emotional Intelligence
Emotional Intelligence: Assessed by change in scores on the Wong and Law Emotional Intelligence Scale (WLEIS). The Emotional Intelligence Scale contains 16 items across four subscales: Self-Emotion Appraisal and Expression, Others' Emotion Appraisal, Regulation of Self-Emotion, and Use of Emotion. A 7-point scoring system is used, and the total score for each subscale is used to determine the competency level in that specific dimension.
Time frame: Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.
Plan to share: Yes — Upon reasonable request and after approval of a research proposal, de-identified individual participant data that underlie the results of this study (specifically, the pre- and post-intervention scale scores) will be made available. This does not include any raw transcript data from conversations with the virtual agent, to protect participant privacy.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: After the publication of the study
Access criteria: The researchers can access the data by contacting the PI at xiaw23@mail.sysu.edu.cn with the research purpose described.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Nov 2026, 3 months later.
Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 3 months is below that.
Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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