Multimodal Cohort Study of Generalized Anxiety Disorder

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorShanghai Mental Health Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 1 trial group
Group A: GAD Cohort

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: