Subclinical DepressionNCT07542561

AI-Assisted Mindfulness Intervention in Emotional Distress

A study testing Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention in people with Subclinical Depression and Subclinical Anxious Adults, run by Xinghua Liu at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The goal of this clinical trial is to learn whether an artificial intelligence-assisted internet-based mindfulness intervention for emotional distress (iMIED) can prevent or reduce anxiety and depressive symptoms in adults with subclinical emotional distress. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Subclinical Depression, Subclinical Anxious Adults, Subclinical Emotional Distress
What is being tested?: Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 550 participants
Where: 1 siteChina
Study dates: 15 Apr 2026to 15 May 2029
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 18 to 65 years PHQ-9 or GAD-7 score ≥5 Able to use a smartphone or other internet-enabled electronic device and possessing sufficient digital literacy to participate in the online intervention and complete follow-up assessments Willing to participate and able to provide informed consent

Who cannot join

Current psychotic disorder or bipolar disorder Current organic mental disorder, pervasive developmental disorder, severe cognitive impairment, or substance use disorder Current suicide risk, defined as a score of ≥2 on Item 9 of the PHQ-9 Previous participation in a structured 8-week mindfulness course or the 49-day self-guided course developed by the Peking University Mindfulness Laboratory

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University
Beijing, Beijing Municipality, 100871

Other trials in China

About this study

Official title: Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention for Emotional Distress: Protocol for a Randomized Controlled Trial on Long-Term Outcomes and Cost-Effectiveness

Can iMIED reduce anxiety symptoms, as measured by the Generalized Anxiety Disorder-7 (GAD-7)? Can iMIED reduce depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9)?

Researchers will compare participants receiving iMIED plus access to usual mental health resources with participants receiving usual mental health resources alone to see whether iMIED leads to greater improvement in emotional distress over time.

Participants will:

complete online screening and baseline assessments; be randomly assigned to either the iMIED intervention group or the control group; if assigned to the intervention group, complete a 49-day AI-assisted online mindfulness self-help program using a WeChat mini-program and AI support tool; complete follow-up online questionnaires during the intervention and at 3, 6, 12, 18, and 24 months after the intervention; report information on mental health symptoms, quality of life, healthcare use, sleep, stress, resilience, and life satisfaction.

Conditions: Subclinical Depression, Subclinical Anxious Adults, Subclinical Emotional Distress
Being tested: Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention
Keywords: artificial intelligence-assisted intervention, internet-based mindfulness intervention, emotional distress, subclinical anxiety and depression
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Artificial Intelligence-Assisted Internet-Based Mindfulness InterventionCombination product
Delivered via the internet, the intervention is grounded in the Psychopathology Diamond Model proposed by Liu Xinghua's team. It integrates four core strategies: increasing engagement in life, enhancing distress tolerance, reducing excessive emotional behavior, and improving cognitive flexibility (Liu, 2024). Based on advanced large language models, including Tencent Hunyuan and DeepSeek R1, and supported by an official MIED knowledge base comprising the "Mindfulness Practice" WeChat public account, supervision Q\&A records, and other official materials produced by Liu Xinghua and colleagues, the team developed an AI assistant called the "MIED Mindfulness Assistant," along with a WeChat self-help mini-program. Together, these tools support participants' learning and practice over a 49-day continuous training period (Liu, 2024).

Study groups in NCT07542561
Study group	Role	What they receive
iMIED	Experimental	Not described Receives: Combination Product: Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention
WL	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 is a 7-item self-report questionnaire used to assess the severity of anxiety symptoms over the past 2 weeks. Each item is rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 21. Higher scores indicate greater anxiety severity. The GAD-7 has demonstrated good reliability and validity in both clinical and general populations (Spitzer et al., 2006).
Measured: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a 9-item self-report questionnaire used to assess the severity of depressive symptoms over the past 2 weeks. Each item is rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 27. Higher scores indicate greater depression severity. The PHQ-9 has demonstrated good reliability and validity in both clinical and general populations (Kroenke et al., 2001).
Measured: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.

Secondary outcomes (9)

Treatment Inventory of Costs in Patients with Psychiatric Disorders (TIC-P)
TIC-P is a widely used health economic instrument in mental health research for assessing psychiatric healthcare use and societal costs, including service utilization, medication use, and productivity losses (Bouwmans et al., 2013). In this study, TIC-P will be used to record healthcare resource consumption during the trial, including outpatient visits, medication costs, and other healthcare-related expenditures. To capture healthcare utilization more comprehensively, a self-developed healthcare utilization questionnaire will also be administered.
Measured: Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
This is one of the most widely used instruments in health economic evaluation for measuring health-related quality of life and includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five response levels (Devlin \& Brooks, 2017; Herdman et al., 2011). The health utility values derived from EQ-5D-5L will be used to calculate Quality-Adjusted Life Years (QALYs) for cost-utility analysis (Drummond et al., 2015; Group, 1990).
Measured: Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Connor-Davidson Resilience Scale (CD-RISC)
Resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC), one of the most widely used instruments for assessing the ability to cope with stress and adversity, with good reliability and validity (Connor \& Davidson, 2003).
Measured: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Perceived Stress Scale (PSS)
Perceived stress will be measured using the Perceived Stress Scale (PSS), a widely used instrument that assesses individuals' subjective appraisal of stress over a recent period (Cohen et al., 1983).
Measured: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Satisfaction With Life Scale (SWLS)
Life satisfaction will be measured using the Satisfaction With Life Scale (SWLS), which assesses individuals' cognitive evaluation of their overall life circumstances and has sound psychometric properties (Diener et al., 1985).
Measured: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Insomnia Severity Index (ISI)
Sleep status will be assessed using the Insomnia Severity Index (ISI), a brief 7-item self-report scale widely used in clinical and digital health research to assess the severity of insomnia symptoms and their impact on daily functioning (Bastien et al., 2001; Morin et al., 2011).
Measured: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
Overall Anxiety Severity and Impairment Scale (OASIS)
The OASIS is a 5-item self-report measure designed to assess the frequency and severity of anxiety symptoms, as well as the extent of anxiety-related functional impairment and avoidance, over the past week. Each item is rated on a 5-point scale from 0 to 4, with total scores ranging from 0 to 20. Higher scores indicate greater overall anxiety severity and impairment. The OASIS has demonstrated good reliability and validity in both clinical and nonclinical samples (Norman et al., 2006).
Measured: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
Overall Depression Severity and Impairment Scale (ODSIS)
The ODSIS is a 5-item self-report measure designed to assess the frequency and severity of depressive symptoms, as well as depression-related functional impairment and avoidance, over the past week. Each item is rated on a 5-point scale from 0 to 4, with total scores ranging from 0 to 20. Higher scores indicate greater overall depression severity and impairment. The ODSIS has demonstrated good reliability and validity in both clinical and nonclinical samples (Bentley et al., 2014).
Measured: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Five Facet Mindfulness Questionnaire (FFMQ)
Mindfulness will be assessed using the Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ measures trait mindfulness across five dimensions: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. It is one of the most widely used instruments in mindfulness research and has demonstrated good reliability and validity (Baer et al., 2006). In this study, the total FFMQ score and its subscale scores will be analyzed as exploratory continuous variables
Measured: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 202615 May 2029

First posted21 Apr 2026
Study start15 Apr 2026
Primary completion15 Apr 2029 (estimated)
Study completion15 May 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Subclinical DepressionStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 550 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07542561
Sponsor's protocol ID: E20260331
Status last verified: Jun 2026
First submitted: 4 Apr 2026
Last updated: 25 Jun 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data (IPD) will not be made publicly available because the study involves sensitive mental health data and participant privacy must be protected. Requests for additional information regarding the study may be directed to the corresponding author.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Subclinical Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention for Emotional Distress: Protocol for a Randomized Controlled Trial on Long-Term Outcomes and Cost-Effectiveness
ClinicalTrials.gov ID: NCT07542561
Acronym / sponsor ID: E20260331
Conditions: Subclinical Depression, Subclinical Anxious Adults, Subclinical Emotional Distress
Keywords: artificial intelligence-assisted intervention, internet-based mindfulness intervention, emotional distress, subclinical anxiety and depression
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 550 participants (estimated)
Lead sponsor: Xinghua LiuUniversity, hospital or other
Study start: 15 Apr 2026 (actual)
Primary completion: 15 Apr 2029 (estimated)
Study completion: 15 May 2029 (estimated)
First posted: 21 Apr 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.

Can iMIED reduce anxiety symptoms, as measured by the Generalized Anxiety Disorder-7 (GAD-7)? Can iMIED reduce depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9)?

Participants will:

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
iMIED	Experimental	Combination Product: Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention
WL	No intervention	–

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Aged 18 to 65 years PHQ-9 or GAD-7 score ≥5 Able to use a smartphone or other internet-enabled electronic device and possessing sufficient digital literacy to participate in the online intervention and complete follow-up assessments Willing to participate and able to provide informed consent

Key exclusion criteria (1 listed)

Current psychotic disorder or bipolar disorder Current organic mental disorder, pervasive developmental disorder, severe cognitive impairment, or substance use disorder Current suicide risk, defined as a score of ≥2 on Item 9 of the PHQ-9 Previous participation in a structured 8-week mindfulness course or the 49-day self-guided course developed by the Peking University Mindfulness Laboratory

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
Artificial Intelligence-Assisted Internet-Based Mindfulness InterventionDelivered via the internet, the intervention is grounded in the Psychopathology Diamond Model proposed by Liu Xinghua's team. It integrates four core strategies: increasing engagement in life, enhancing distress tolerance, reducing excessive emotional behavior, and improving cognitive flexibility (Liu, 2024). Based on advanced large language models, including Tencent Hunyuan and DeepSeek R1, and supported by an official MIED knowledge base comprising the "Mindfulness Practice" WeChat public account, supervision Q\&A records, and other official materials produced by Liu Xinghua and colleagues, the team developed an AI assistant called the "MIED Mindfulness Assistant," along with a WeChat self-help mini-program. Together, these tools support participants' learning and practice over a 49-day continuous training period (Liu, 2024).	Combination product	iMIED

Primary outcome

Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
The GAD-7 is a 7-item self-report questionnaire used to assess the severity of anxiety symptoms over the past 2 weeks. Each item is rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 21. Higher scores indicate greater anxiety severity. The GAD-7 has demonstrated good reliability and validity in both clinical and general populations (Spitzer et al., 2006).
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
The PHQ-9 is a 9-item self-report questionnaire used to assess the severity of depressive symptoms over the past 2 weeks. Each item is rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 27. Higher scores indicate greater depression severity. The PHQ-9 has demonstrated good reliability and validity in both clinical and general populations (Kroenke et al., 2001).

9 secondary outcomes

Treatment Inventory of Costs in Patients with Psychiatric Disorders (TIC-P)
Time frame: Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Perceived Stress Scale (PSS)
Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Satisfaction With Life Scale (SWLS)
Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Insomnia Severity Index (ISI)
Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
Overall Depression Severity and Impairment Scale (ODSIS)
Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.
the Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.

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 25 Jun 2026.
Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made publicly available because the study involves sensitive mental health data and participant privacy must be protected. Requests for additional information regarding the study may be directed to the corresponding author.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention in people with Subclinical Depression and Subclinical Anxious Adults, run by Xinghua Liu 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 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?

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?

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?

Generalized Anxiety Disorder-7 (GAD-7) (time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), 18 months (T7), and 24 months (T8) post-intervention.). 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?

On the ClinicalTrials.gov record for NCT07542561.

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 25 Jun 2026.