Multimodal Cohort Study of Generalized Anxiety Disorder (MC-GAD)
A Cohort Study of Generalized Anxiety Disorder Based on Multimodal Data
Generalized anxiety disorder (GAD) is a common mental health condition characterized by persistent and excessive worry that is difficult to control. It can affect sleep, daily functioning, work, and quality of life. Some individuals experience long-lasting or recurrent symptoms, but the factors that influence the course and outcome of GAD are still not fully understood.
The main purpose of this study is to establish a long-term cohort of people with GAD and to better understand how their symptoms and health change over time. The study will also explore factors that may help predict symptom improvement, recurrence, and treatment outcomes.
Approximately 400 adults with GAD who receive care at Shanghai Mental Health Center will participate in this study. Participants will undergo regular clinical assessments and follow-up visits.
During the study, researchers will collect information about participants' symptoms, medical and treatment history, blood samples, and brain-related measurements. Participants will be followed at several time points to observe changes in symptoms and health. The information collected will be used to better understand the course of GAD and to support the development of more individualized approaches to diagnosis, treatment, and long-term care.
Study Overview
Status
Conditions
Detailed Description
Generalized anxiety disorder (GAD) is a heterogeneous psychiatric disorder with substantial variation in clinical presentation, treatment response, disease course, and risk of recurrence. Current diagnosis and clinical management are mainly based on clinical interviews and symptom assessments, while objective markers that can assist in diagnosis, assessment of disease severity, and prediction of long-term outcomes remain limited. This prospective cohort study is designed to characterize the longitudinal course of GAD and to integrate clinical and biological information collected over time.
Participants enrolled in the cohort will receive treatment according to routine clinical practice rather than being assigned to a specific intervention by the study protocol. Information on current treatments, including pharmacological, psychological, and physical treatments, will be recorded during follow-up. Changes in anxiety symptoms, associated symptoms, treatment response, adverse events, and other clinical characteristics will be assessed longitudinally. The study will examine patterns of symptom change and identify factors associated with persistence, recurrence, treatment response, and prognosis.
A multimodal data collection framework will be used to characterize GAD from complementary clinical and biological perspectives. In addition to demographic, clinical, medical, treatment, and family-history information, the study will collect blood samples and multiple types of brain-related data. These include electroencephalography, magnetic resonance imaging, magnetoencephalography, and functional near-infrared spectroscopy. Computerized neuropsychological assessments will be used to evaluate cognitive domains such as executive function, decision-making, reward processing, and emotion recognition. Dynamic information such as heart rate variability, sleep patterns, and changes in emotional state will also be collected.
Participants will undergo repeated follow-up assessments after baseline. Follow-up visits are scheduled at weeks 2, 4, 8, 12, 24, 36, and 48, followed by an additional one-year extended follow-up. At these visits, researchers will assess changes in symptoms and current treatment, record adverse events, and collect selected clinical, blood, electrophysiological, neuroimaging, neuropsychological, and real-time health data according to the study schedule.
By integrating longitudinal clinical information with multimodal biological data, this study aims to characterize the clinical course of GAD, explore potential objective biomarkers, identify factors associated with treatment response and prognosis, and develop models for individualized outcome prediction. The resulting longitudinal database is expected to provide a foundation for risk stratification and more individualized approaches to the diagnosis, treatment, and long-term management of GAD.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lanying LIU
- Phone Number: 13516816012
- Email: balindaliu@126.com
Study Locations
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Shanghai, China
- Shanghai Mental Health Center
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Contact:
- Lanying LIU
- Email: balindaliu@126.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Meets the ICD-10 diagnostic criteria for generalized anxiety disorder (GAD). Aged 18 to 65 years. Hamilton Anxiety Rating Scale (HAMA) total score >14. Has at least a junior high school education and is able to complete self-report questionnaires.
Voluntarily agrees to participate in the study and provides written informed consent.
Exclusion Criteria:
Meets ICD-10 diagnostic criteria for any psychiatric disorder other than GAD, as assessed using the Mini International Neuropsychiatric Interview (M.I.N.I.).
Has significant suicidal ideation or is considered to be at high risk of suicide.
Has a clinically significant medical condition or clinically significant laboratory abnormalities.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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GAD Cohort
Participants diagnosed with generalized anxiety disorder (GAD) who receive routine clinical care.
No specific treatment or intervention is assigned by the study protocol.
Participants will be followed longitudinally, and information on clinical symptoms, treatments, blood samples, and multimodal neurophysiological and neuroimaging measures will be collected according to the study schedule.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline
Time Frame: Baseline; Weeks 2, 4, 8, 12, 24, 36, and 48; and 1-year extended follow-up
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The Hamilton Anxiety Rating Scale (HAMA) is a clinician-rated scale used to assess the severity of anxiety symptoms.
The scale consists of 14 items, each rated from 0 to 4, resulting in a total score ranging from 0 to 56.
Higher scores indicate greater severity of anxiety symptoms.
Changes in HAMA total scores from baseline will be assessed during follow-up.
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Baseline; Weeks 2, 4, 8, 12, 24, 36, and 48; and 1-year extended follow-up
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-47
- 2025-CBDL02 (Other Grant/Funding Number: Shanghai Mental Health Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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