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

2026年5月31日 更新者: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.

調査の概要

研究の種類

観察的

入学 (推定)

680

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

      • Beijing、中国
        • 募集
        • Peking University Sixth Hospital
      • Shanghai、中国
        • 募集
        • Huashan Hospital Affiliated to Fudan University
        • コンタクト:
          • Yanqun Zheng
          • 電話番号:13651748730
      • Shanghai、中国
        • 募集
        • Shanghai Mental Health Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
To characterize fine-grained features of urban environmental stress and evaluate their predictive validity for the development and progression of mental disorders
時間枠:4 weeks (participants will wear the device continuously during the study period)
4 weeks (participants will wear the device continuously during the study period)

二次結果の測定

結果測定
メジャーの説明
時間枠
Safety Assessment:
時間枠: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

協力者と研究者

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スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年4月10日

一次修了 (推定)

2029年4月1日

研究の完了 (推定)

2029年5月30日

試験登録日

最初に提出

2026年4月29日

QC基準を満たした最初の提出物

2026年4月29日

最初の投稿 (実際)

2026年5月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月3日

QC基準を満たした最後の更新が送信されました

2026年5月31日

最終確認日

2026年5月1日

詳しくは

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