Transcranial Alternating Current Stimulation to Enhance Mindfulness Therapy in Generalized Anxiety Disorder

Starting soon · Not applicable · Has a placebo group

Conditions studied: Generalized Anxiety Disorder (GAD)

In brief

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.

Key facts

Study ID

NCT07648797

Run by

Central South University

People needed

99

Starts

2026-06-01

Expected to finish

2028-06-01

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Right-handed.
• Junior high school education or above, with sufficient ability to understand the study procedures, complete informed consent, clinical scales, and cognitive assessments.
• Currently not using anxiolytic or antidepressant medications, or receiving a stable medication regimen for at least 1 month before enrollment, with no planned changes in the medication regimen during the 2-week treatment period unless clinically necessary.
• Voluntarily agrees to participate in the study, signs the informed consent form, and is able to comply with study visits, treatment procedures, laboratory examinations, and other study requirements.

You may not qualify if…

• 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.
• Pregnancy or lactation.
• Contraindications to transcranial electrical stimulation or related procedures, including metal implants in the body, intracranial hypertension, skull defects, brain tumor, severe heart disease, unstable vital signs due to serious physical illness, acute cerebrovascular disease, or a history of adverse reactions to electrical stimulation.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.

Where it is running

• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China

Full record on ClinicalTrials.gov

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