Generalized Anxiety Disorder (GAD)
Conditions
Brief summary
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.
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.
Interventions
None listed
Sponsors
Shanghai Mental Health Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline | Baseline; Weeks 2, 4, 8, 12, 24, 36, and 48; and 1-year extended follow-up | 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. |
Countries
China
Contacts
CONTACTLanying LIU
Outcome results
None listed