Multimodal Cohort Study of Generalized Anxiety Disorder

NCT07764211 | Not Yet Recruiting

• 2 other identifiers: 2026-472025-CBDL02
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder (GAD)

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline

  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.

  Baseline; Weeks 2, 4, 8, 12, 24, 36, and 48; and 1-year extended follow-up

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients with generalized anxiety disorder (GAD) receiving outpatient or inpatient care at Shanghai Mental Health Center, including both first-episode and non-first-episode GAD. Potential participants will be identified through clinical screening and assessed for eligibility by trained research personnel. Approximately 400 participants will be enrolled and followed prospectively.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Lanying LIU

CONTACT

13516816012; balindaliu@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)