Identification and Molecular Characterisation of Urban-environmental Stress Patterns Affecting Mental Illness

NCT07571226 | Not Yet Recruiting

• 1 other identifier: KY2025-1492
• Study Type: observational
• Target: 680
• Locations: 0 countries
• Sites: N/A

Brief Summary

Mental disorders have become a major contributor to the global burden of non-communicable diseases, with disability-adjusted life years (DALYs) attributable to these conditions continuing to rise. Although evidence suggests that environmental factors may account for up to 40% of the attributable risk for mental disorders such as major depressive disorder, anxiety disorders, and alcohol use disorder, the underlying mechanisms remain unclear, particularly regarding how dynamic environmental stress influences disease onset, progression, and relapse. Traditional research has primarily focused on individual-level psychosocial factors, including socioeconomic status and life events, while lacking real-time, multidimensional assessments of objective urban environmental stressors such as air pollution, noise exposure, and reduced green space. This study proposes a prospective longitudinal cohort design based in real-world environments, enrolling both patients with mental disorders and healthy controls. Using wearable devices integrated with the "'StreetMind'" mobile application and wear the visible watch, we will continuously and dynamically collect multimodal data on environmental exposures and physiological responses in urban settings. These include photoplethysmography (PPG)-derived heart rate, oxygen saturation, physical activity, and gait parameters, as well as objective environmental indicators such as temperature, humidity, light intensity, and noise levels. At baseline, all participants will undergo standardized psychiatric assessments to characterize depressive, anxiety, and addictive conditions. Peripheral blood and urine samples will also be collected for subsequent molecular and multi-omics analyses. The study aims to systematically evaluate the associations between urban environmental factors-including air pollution, noise exposure, and green space availability-and the risk of mental disorder relapse. Furthermore, it seeks to elucidate the potential mechanisms by which environmental stress affects mental health through neuroinflammation and alterations in brain circuitry. The findings are expected to provide novel insights for risk prediction, early intervention, and precision management of mental disorders.

Conditions

Major Depressive Disorder (MDD); Anxiety Disorder; Alcohol Use Disorder (AUD)

Outcome Measures

Primary Outcomes (1)

• To characterize fine-grained features of urban environmental stress and evaluate their predictive validity for the development and progression of mental disorders

  4 weeks (participants will wear the device continuously during the study period)

Study Arms (4)

Major depressive disorder (MDD）

Device: wearable monitoring devices

Anxiety disorder (ANX)

Device: wearable monitoring devices

Alcohol use disorde (AUD)

Device: wearable monitoring devices

Healthy individuals (CON)

Device: wearable monitoring devices

Interventions

wearable monitoring devices DEVICE

This study uses a wrist-worn smartwatch to enable continuous, real-time monitoring of physiological parameters, including heart rate, oxygen saturation, and physical activity.

Alcohol use disorde (AUD); Anxiety disorder (ANX); Healthy individuals (CON); Major depressive disorder (MDD）

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from adult individuals aged 18-60 years, including patients diagnosed with depressive disorder, generalized anxiety disorder, or alcohol use disorder according to DSM-IV criteria, as well as healthy control subjects without mental disorders.

You may qualify if:

• Diagnosis: The primary diagnosis meets the DSM-IV criteria for depressive disorder, generalized anxiety disorder, or alcohol use disorder, and comorbid conditions may be present;
• Patients with mental disorders aged 18-60 years, with a balanced gender ratio;
• Normal intelligence and ability to use a smartphone running the Android operating system;
• Willingness to wear a wristband equipped with physiological monitoring functions (such as heart rate and electrodermal activity), download the study application, and upload data during the study period;
• For participants with depression or generalized anxiety disorder who are taking medication, they must be on a single selective serotonin reuptake inhibitor (SSRIs) (especially citalopram or escitalopram) at a stable dose, and this medication status must last for at least 5 days. For patients with alcohol use disorder who are taking medication, there is no specific restriction on the type of medication, but the medication status should also last for at least 5 days. At baseline assessment, patients with depressive and anxiety disorders must have HAMD-17 \>7 or HAMA-14 \>7;
• Voluntary participation in this study and signing of informed consent;
• For patients with alcohol use disorder (AUD): AUD patients must have successfully completed alcohol withdrawal, confirmed by clinical standards or relevant healthcare professionals.
• Healthy subjects aged 18-60 years, with a balanced gender ratio;
• Normal intelligence and ability to use a smartphone running the Android operating system;
• Willingness to wear a wristband equipped with physiological monitoring functions (such as heart rate and electrodermal activity), download the study application, and upload data during the study period;
• Voluntary participation in this study and signing of informed consent.

You may not qualify if:

• Currently taking opioid medications;
• Receiving any form of brain stimulation therapy within the past 1 month (including transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or other similar treatments);
• Skin infection or severe skin damage on the wrist or upper limbs that may affect the normal use of monitoring devices;
• Recent use (within 30 days) of medications that may interfere with drug metabolism, such as strong CYP450 inhibitors/inducers;
• Severe physical diseases (such as brain tumors or injuries) or special conditions (such as current pregnancy or lactation) that may affect the study protocol;
• HAMD-17 item 3 (suicide) \>3 points (severe suicidal behavior);
• Currently using benzodiazepines or opioid medications;
• Currently receiving any form of brain stimulation therapy (including transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or other similar treatments);
• Skin infection or severe skin damage on the wrist or upper limbs that may affect the normal use of monitoring devices;
• Recent use (within 30 days) of medications that may interfere with drug metabolism, such as strong CYP450 inhibitors/inducers, or not reaching steady-state drug concentration before the study;
• Severe physical diseases (such as brain tumors or injuries) or special conditions (such as current pregnancy or lactation) that may affect the study protocol.

Sponsors & Collaborators

• Huashan Hospital: lead

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders; Alcoholism

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Central Study Contacts

Yanqun Zheng Dr

CONTACT

+8613651748730; zhengyanqun@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): May 30, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share