About this trial
This randomized, double-blind, sham-controlled clinical trial will evaluate whether individualized alpha-frequency transcranial alternating current stimulation (tACS) can enhance the effects of mindfulness therapy in adults with generalized anxiety disorder. A total of 99 participants will be randomly assigned to one of three groups: synchronous tACS combined with mindfulness therapy, desynchronous tACS combined with mindfulness therapy, or sham tACS combined with mindfulness therapy.
All participants will receive a standardized mindfulness therapy program. The study will compare changes in anxiety symptoms, worry, mindfulness, attention control, cognitive performance, and neurophysiological measures across the three groups. Assessments will be conducted from baseline through follow-up visits to examine both clinical effects and possible neural mechanisms.
Eligibility criteria
Qualifiers
Outpatients or inpatients of The Second Xiangya Hospital of Central South University.
Diagnosis of generalized anxiety disorder as the primary diagnosis according to the International Classification of Diseases 11th Revision (ICD-11) diagnostic criteria, confirmed by two experienced psychiatrists.
Hamilton Anxiety Rating Scale (HAMA) total score of 14 or higher.
Aged 18 to 60 years, inclusive.
Disqualifiers
Presence of psychotic symptoms.
Meeting ICD-11 diagnostic criteria for schizophrenia or other primary psychotic disorders, bipolar or related disorders, current depressive episode, dysthymic disorder, or post-traumatic stress disorder currently or within the past year.
Organic brain disease or severe physical illness, including but not limited to thyroid disease, systemic lupus erythematosus, diabetes, severe pulmonary, hepatic, or renal impairment, infection, or major trauma.
Clinically significant uncorrectable sensory impairment, such as hearing impairment that prevents effective communication.
Trial design
Treatments tested in this trial
- Synchronous Individualized Alpha-Frequency tACS
- Desynchronous Individualized Alpha-Frequency tACS
- Sham tACS
- Mindfulness Therapy