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

31 de mayo de 2026 actualizado por: Chongbo Zhao, Huashan Hospital

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.

Descripción general del estudio

Tipo de estudio

De observación

Inscripción (Estimado)

680

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Beijing, Porcelana
        • Reclutamiento
        • Peking University Sixth Hospital
      • Shanghai, Porcelana
        • Reclutamiento
        • Huashan Hospital Affiliated to Fudan University
        • Contacto:
          • Yanqun Zheng
          • Número de teléfono: 13651748730
      • Shanghai, Porcelana
        • Reclutamiento
        • Shanghai Mental Health Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

Inclusion Criteria:

  1. 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;
  2. Patients with mental disorders aged 18-60 years, with a balanced gender ratio;
  3. Normal intelligence and ability to use a smartphone running the Android operating system;
  4. 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;
  5. Participants with depression or generalized anxiety disorder who are taking medication must be on a single stable dose of a selective serotonin reuptake inhibitor (SSRI), specifically citalopram or escitalopram, and this medication regimen must have been maintained for at least 5 days. Participants with alcohol use disorder who are taking medication have no restriction on the type of drug, but the medication regimen should also have been maintained for at least 5 days. At baseline assessment, patients with depression or anxiety disorders should have a Hamilton Depression Rating Scale (HAMD-17) score >7 or a Hamilton Anxiety Rating Scale (HAMA-14) score >7.;
  6. Voluntary participation in this study and signing of informed consent;
  7. For patients with alcohol use disorder (AUD): AUD patients must have successfully completed alcohol withdrawal, confirmed by clinical standards or relevant healthcare professionals.

Inclusion Criteria for Healthy Control Group

  1. Healthy subjects aged 18-60 years, with a balanced gender ratio;
  2. Normal intelligence and ability to use a smartphone running the Android operating system;
  3. 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;
  4. Voluntary participation in this study and signing of informed consent.

Exclusion Criteria:

  1. Currently taking opioid medications;
  2. Receiving any form of brain stimulation therapy within the past 1 month (including transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or other similar treatments);
  3. Skin infection or severe skin damage on the wrist or upper limbs that may affect the normal use of monitoring devices;
  4. Recent use (within 30 days) of medications that may interfere with drug metabolism, such as strong CYP450 inhibitors/inducers;
  5. Severe physical diseases (such as brain tumors or injuries) or special conditions (such as current pregnancy or lactation) that may affect the study protocol;
  6. HAMD-17 item 3 (suicide) >3 points (severe suicidal behavior);

Exclusion Criteria for Healthy Control Group

  1. Currently using benzodiazepines or opioid medications;
  2. Currently receiving any form of brain stimulation therapy (including transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or other similar treatments);
  3. Skin infection or severe skin damage on the wrist or upper limbs that may affect the normal use of monitoring devices;
  4. 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;
  5. Severe physical diseases (such as brain tumors or injuries) or special conditions (such as current pregnancy or lactation) that may affect the study protocol.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Major depressive disorder (MDD)
This study uses a wrist-worn smartwatch to enable continuous, real-time monitoring of physiological parameters, including heart rate, oxygen saturation, and physical activity.
Anxiety disorder (ANX)
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)
This study uses a wrist-worn smartwatch to enable continuous, real-time monitoring of physiological parameters, including heart rate, oxygen saturation, and physical activity.
Healthy individuals (CON)
This study uses a wrist-worn smartwatch to enable continuous, real-time monitoring of physiological parameters, including heart rate, oxygen saturation, and physical activity.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
To characterize fine-grained features of urban environmental stress and evaluate their predictive validity for the development and progression of mental disorders
Periodo de tiempo: 4 weeks (participants will wear the device continuously during the study period)
4 weeks (participants will wear the device continuously during the study period)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Safety Assessment:
Periodo de tiempo: From baseline to week 4
Since this study does not involve any additional interventions and is limited to the observation of environmental factors, safety will be monitored primarily through routine clinical follow-up to record any potential adverse events, ensuring that patients' treatment regimens are not affected by the study.
From baseline to week 4

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de abril de 2026

Finalización primaria (Estimado)

1 de abril de 2029

Finalización del estudio (Estimado)

30 de mayo de 2029

Fechas de registro del estudio

Enviado por primera vez

29 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de abril de 2026

Publicado por primera vez (Actual)

6 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

31 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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