Depression, AnxietyNCT06992180
Generative Artificial Intelligence Intervention and Individual Psychological Counseling on Emotional Distress in Young Adults
A study testing Generative Artificial Intelligence Intervention and Individual Psychological Counseling in people with Depression, Anxiety, run by Central University of Finance and Economics, China at 1 site in China.
Trial summary
This randomized controlled trial aims to evaluate the effectiveness of an AI-based mental health chatbot, Emohaa, in reducing symptoms of depression, anxiety, insomnia, and academic burnout among young adults experiencing emotional distress. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Generative Artificial Intelligence Intervention and Individual Psychological Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2025to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ranges from 15 to 30
- Suffering from emotional distress (PHQ-9 > 14 or GAD-7 > 12)
- Ability to use the mobile phone to interact with AI
- Consent to participate in the study
Who cannot join
- High risk of self-injury and suicide
- Presence of psychotic symptoms (i.e., delusions)
- Serious substance use problems
- Other mental or physical illnesses requiring urgent medical assistance
- Received other psychological or pharmacological interventions in the last month.
Trial locations and contacts
1 site in 1 country.
China1 site
Mental Health Center, Central University of Finance and Economics
Beijing, Haidian, 100081
About this study
Official title: The Intervention Effect of Generative Artificial Intelligence (Emohaa) and Individual Psychological Counseling on Emotional Distress in Young Adults: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effectiveness of an AI-based mental health chatbot, Emohaa, in reducing symptoms of depression, anxiety, insomnia, and academic burnout among young adults experiencing emotional distress. A total of 222 participants will be randomly assigned to one of three groups: (1) AI chatbot intervention, (2) traditional counseling, or (3) waitlist control. The study spans six time points from baseline through one-month follow-up. Primary and secondary outcomes will be measured via validated self-report questionnaires. The intervention is delivered entirely online through a WeChat-integrated platform, ensuring high accessibility and scalability.
Read the detailed description
This three-arm randomized controlled trial will investigate the efficacy of Emohaa, a generative artificial intelligence (AI)-based chatbot designed to deliver empathetic conversational support to young adults experiencing emotional distress. The study will enroll 222 participants, randomly allocated (1:1:1) into one of the following arms:
AI Chatbot Group: Participants will interact weekly with Emohaa via a WeChat-integrated interface for 30-minute sessions over a 6-week period. The chatbot uses fine-tuned large language models to simulate emotionally supportive conversations and provide personalized, non-directive psychological support.
Traditional Counseling Group: Participants will receive six weekly sessions (face-to-face or remote) with trained counselors using structured, supportive counseling protocols derived from cognitive-behavioral therapy (CBT).
Waitlist Control Group: Participants will not receive any intervention during the study period but will be offered access to Emohaa after study completion.
Assessment Schedule and Outcome Measures
Data will be collected via Wenjuanxing online survey links at six time points:
T1: Baseline (before intervention)
T2: After session 2
T3: After session 4
T4: Post-intervention (after session 6)
T5: 2-week follow-up
T6: 1-month follow-up
All outcome measures are validated self-report instruments with established psychometric properties in Chinese populations.
Primary Outcomes (T1-T6) PHQ-9: Patient Health Questionnaire for depressive symptoms
GAD-7: Generalized Anxiety Disorder Scale
ISI: Insomnia Severity Index (7 items)
Academic Burnout Scale (6 items)
Secondary Outcomes (T1-T6) ERQ: Emotion Regulation Questionnaire (10 items)
Loneliness Scale (3 items)
IUS-12: Intolerance of Uncertainty Scale
PSS-10: Perceived Stress Scale
GESS: General Self-Efficacy Scale (10 items)
Additional Measures (T2-T6) CSQ-8: Client Satisfaction Questionnaire
DWAI: Digital Working Alliance Inventory
Data Quality and Collection Procedures All data will be collected electronically using Wenjuanxing (问卷星), which provides timestamped, secure survey distribution and response logging. Participants will receive automatic reminders prior to each time point. The data collection team will perform regular checks to detect and manage missing or inconsistent entries.
To ensure the reliability and validity of the data collection process:
All measurement instruments are widely used, psychometrically validated scales in Chinese.
Survey completion will be monitored in real time.
Study staff will be trained in participant guidance and data integrity monitoring procedures.
Duplicate entries will be flagged using participant ID and contact verification protocols.
Random audits and outlier checks will be conducted at each time point to ensure data quality.
- Conditions
- Depression, Anxiety
- Being tested
- Generative Artificial Intelligence Intervention, Individual Psychological Counseling
- Keywords
- Depression, anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generative Artificial Intelligence InterventionBehavioural
The intervention is delivered via a generative artificial intelligence platform called Emohaa. Participants will register and gain access to the platform prior to the start of the trial. Emohaa's responses are based on Hill's helping skills theory in psychology and are designed to simulate the basic communication strategies of a human counselor. The system demonstrates strong capabilities in active listening, emotional mirroring, and empathy, supporting users in understanding their own thoughts and feelings, learning to cope with emotional challenges, and achieving a more optimistic and positive mental and emotional state.
Individual Psychological CounselingBehavioural
Participants in the traditional counseling group will receive individual psychological counseling sessions conducted by certified psychotherapists.
| Study group | Role | What they receive |
|---|---|---|
| Generative Artificial Intelligence Intervention Group | Experimental | Participants will interact weekly with Emohaa via a WeChat-integrated interface for 30-minute sessions over a 6-week period. The chatbot uses fine-tuned large language models to simulate emotionally supportive conversations and provide personalized, non-directive psychological support. Receives: Behavioral: Generative Artificial Intelligence Intervention |
| Individual Psychological Counseling Group | Experimental | Participants will receive six weekly sessions (face-to-face or remote) with trained counselors using structured, supportive counseling protocols derived from cognitive-behavioral therapy (CBT). Receives: Behavioral: Individual Psychological Counseling |
| Waiting List Group | No intervention | Participants will not receive any intervention during the study period but will be offered access to Emohaa after study completion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
The Patient Health Questionnaire-9 (PHQ-9) was employed in this study to measure depressive symptoms. This scale consists of 9 items, each rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with scores of 0-4 indicating no depressive symptoms, 5-9 indicating mild symptoms, 10-14 indicating moderate symptoms, and 15 or above indicating severe depressive symptoms. Previous research has demonstrated good reliability and validity for the Chinese version of the PHQ-9.
Measured: From enrollment to the end of treatment at 10 weeks
Anxiety
The Generalized Anxiety Disorder-7 (GAD-7) was used to assess anxiety symptoms in this study. This scale consists of 7 items, each rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21, with scores of 0-4 indicating no anxiety symptoms, 5-9 indicating mild symptoms, 10-14 indicating moderate symptoms, and 15 or above indicating severe anxiety symptoms. Prior studies have shown that the Chinese version of the GAD-7 has good reliability and validity.
Measured: From enrollment to the end of treatment at 10 weeks
Secondary outcomes (1)
Loneliness
The short version of the UCLA Loneliness Scale (ULS-3) was used to assess feelings of loneliness. This scale comprises 3 items, each rated on a 3-point scale ranging from 1 (hardly ever) to 3 (often). The total score ranges from 3 to 9, with higher scores indicating greater loneliness. The short version of the UCLA Loneliness Scale is frequently used in large-scale surveys, and its Chinese version has demonstrated good reliability and validity.
Measured: From enrollment to the end of treatment at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start20 May 2025
- Primary completion30 Aug 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central University of Finance and Economics, China
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Normal University, China Agricultural University, Qinghai University
- Responsible party
- Principal investigator, Yi Feng, Central University of Finance and Economics, China
- Investigators
- Zhihong Qiao, Doctor, Study director, Beijing Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992180
- Sponsor's protocol ID
- CUFE-20260518
- Status last verified
- May 2026
- First submitted
- 18 May 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will release the statistical analysis results based on the research design after anonymizing the personal identification information of the participants. And the raw data of each participant can be obtained through the corresponding author of the research report.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intervention Effect of Generative Artificial Intelligence (Emohaa) and Individual Psychological Counseling on Emotional Distress in Young Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06992180
- Acronym / sponsor ID
- CUFE-20260518
- Conditions
- Depression, Anxiety
- Keywords
- Depression, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Central University of Finance and Economics, ChinaUniversity, hospital or other
- Collaborators
- Beijing Normal University, China Agricultural University, Qinghai University
- Study start
- 20 May 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 28 May 2025 (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.
This randomized controlled trial aims to evaluate the effectiveness of an AI-based mental health chatbot, Emohaa, in reducing symptoms of depression, anxiety, insomnia, and academic burnout among young adults experiencing emotional distress. A total of 222 participants will be randomly assigned to one of three groups: (1) AI chatbot intervention, (2) traditional counseling, or (3) waitlist control. The study spans six time points from baseline through one-month follow-up. Primary and secondary outcomes will be measured via validated self-report questionnaires. The intervention is delivered entirely online through a WeChat-integrated platform, ensuring high accessibility and scalability.
Detailed description
This three-arm randomized controlled trial will investigate the efficacy of Emohaa, a generative artificial intelligence (AI)-based chatbot designed to deliver empathetic conversational support to young adults experiencing emotional distress. The study will enroll 222 participants, randomly allocated (1:1:1) into one of the following arms:
AI Chatbot Group: Participants will interact weekly with Emohaa via a WeChat-integrated interface for 30-minute sessions over a 6-week period. The chatbot uses fine-tuned large language models to simulate emotionally supportive conversations and provide personalized, non-directive psychological support.
Traditional Counseling Group: Participants will receive six weekly sessions (face-to-face or remote) with trained counselors using structured, supportive counseling protocols derived from cognitive-behavioral therapy (CBT).
Waitlist Control Group: Participants will not receive any intervention during the study period but will be offered access to Emohaa after study completion.
Assessment Schedule and Outcome Measures
Data will be collected via Wenjuanxing online survey links at six time points:
T1: Baseline (before intervention)
T2: After session 2
T3: After session 4
T4: Post-intervention (after session 6)
T5: 2-week follow-up
T6: 1-month follow-up
All outcome measures are validated self-report instruments with established psychometric properties in Chinese populations.
Primary Outcomes (T1-T6) PHQ-9: Patient Health Questionnaire for depressive symptoms
GAD-7: Generalized Anxiety Disorder Scale
ISI: Insomnia Severity Index (7 items)
Academic Burnout Scale (6 items)
Secondary Outcomes (T1-T6) ERQ: Emotion Regulation Questionnaire (10 items)
Loneliness Scale (3 items)
IUS-12: Intolerance of Uncertainty Scale
PSS-10: Perceived Stress Scale
GESS: General Self-Efficacy Scale (10 items)
Additional Measures (T2-T6) CSQ-8: Client Satisfaction Questionnaire
DWAI: Digital Working Alliance Inventory
Data Quality and Collection Procedures All data will be collected electronically using Wenjuanxing (问卷星), which provides timestamped, secure survey distribution and response logging. Participants will receive automatic reminders prior to each time point. The data collection team will perform regular checks to detect and manage missing or inconsistent entries.
To ensure the reliability and validity of the data collection process:
All measurement instruments are widely used, psychometrically validated scales in Chinese.
Survey completion will be monitored in real time.
Study staff will be trained in participant guidance and data integrity monitoring procedures.
Duplicate entries will be flagged using participant ID and contact verification protocols.
Random audits and outlier checks will be conducted at each time point to ensure data quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Generative Artificial Intelligence Intervention Group | Experimental | Behavioral: Generative Artificial Intelligence InterventionParticipants will interact weekly with Emohaa via a WeChat-integrated interface for 30-minute sessions over a 6-week period. The chatbot uses fine-tuned large language models to simulate emotionally supportive conversations and provide personalized, non-directive psychological support. |
| Individual Psychological Counseling Group | Experimental | Behavioral: Individual Psychological CounselingParticipants will receive six weekly sessions (face-to-face or remote) with trained counselors using structured, supportive counseling protocols derived from cognitive-behavioral therapy (CBT). |
| Waiting List Group | No intervention | –Participants will not receive any intervention during the study period but will be offered access to Emohaa after study completion. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age ranges from 15 to 30
- Suffering from emotional distress (PHQ-9 > 14 or GAD-7 > 12)
- Ability to use the mobile phone to interact with AI
- Consent to participate in the study
Key exclusion criteria (5 listed)
- High risk of self-injury and suicide
- Presence of psychotic symptoms (i.e., delusions)
- Serious substance use problems
- Other mental or physical illnesses requiring urgent medical assistance
- Received other psychological or pharmacological interventions in the last month.
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 |
|---|---|---|
| Generative Artificial Intelligence InterventionThe intervention is delivered via a generative artificial intelligence platform called Emohaa. Participants will register and gain access to the platform prior to the start of the trial. Emohaa's responses are based on Hill's helping skills theory in psychology and are designed to simulate the basic communication strategies of a human counselor. The system demonstrates strong capabilities in active listening, emotional mirroring, and empathy, supporting users in understanding their own thoughts and feelings, learning to cope with emotional challenges, and achieving a more optimistic and positive mental and emotional state. | Behavioural | Generative Artificial Intelligence Intervention Group |
| Individual Psychological CounselingParticipants in the traditional counseling group will receive individual psychological counseling sessions conducted by certified psychotherapists. | Behavioural | Individual Psychological Counseling Group |
Primary outcome
Depression
Time frame: From enrollment to the end of treatment at 10 weeks
The Patient Health Questionnaire-9 (PHQ-9) was employed in this study to measure depressive symptoms. This scale consists of 9 items, each rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with scores of 0-4 indicating no depressive symptoms, 5-9 indicating mild symptoms, 10-14 indicating moderate symptoms, and 15 or above indicating severe depressive symptoms. Previous research has demonstrated good reliability and validity for the Chinese version of the PHQ-9.
Anxiety
Time frame: From enrollment to the end of treatment at 10 weeks
The Generalized Anxiety Disorder-7 (GAD-7) was used to assess anxiety symptoms in this study. This scale consists of 7 items, each rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21, with scores of 0-4 indicating no anxiety symptoms, 5-9 indicating mild symptoms, 10-14 indicating moderate symptoms, and 15 or above indicating severe anxiety symptoms. Prior studies have shown that the Chinese version of the GAD-7 has good reliability and validity.
1 secondary outcome
Loneliness
Time frame: From enrollment to the end of treatment at 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Yes. We will release the statistical analysis results based on the research design after anonymizing the personal identification information of the participants. And the raw data of each participant can be obtained through the corresponding author of the research report.
Related trials for Depression, Anxiety
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Not yet recruiting
Health-Related Social Needs Food Boxes Delivery Program
Food Insecurity
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. This study is not recruiting at the moment.
Zhihong Qiao, Doctor study director
Beijing Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Generative Artificial Intelligence Intervention and Individual Psychological Counseling in people with Depression, Anxiety, run by Central University of Finance and Economics, China at 1 site in China.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 28 May 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: From enrollment to the end of treatment at 10 weeks). The study lists 2 primary outcomes in all. 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 28 May 2026.