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

Key facts

Who runs it
Central South University
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
99 people, planned
Started
1 Jun 2026
Expected to end
1 Jun 2028
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Synchronous Individualized Alpha-Frequency tACS
  • Desynchronous Individualized Alpha-Frequency tACS
  • Sham tACS
  • Mindfulness Therapy
Record updated
16 June 2026

Who can take part

Age
18 years to 60 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Presence of psychotic symptoms
  • Pregnancy or lactation

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 60 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 3 groups in the trial

  • Synchronous tACS Plus Mindfulness TherapyTreatment being tested

    Participants in this arm will receive individualized alpha-frequency transcranial alternating current stimulation (tACS) combined with standardized mindfulness therapy. The stimulation electrodes will be placed over F3 and P3, corresponding to the left dorsolateral prefrontal cortex and left inferior parietal lobule, and will deliver in-phase stimulation. Mindfulness therapy will be delivered using the same standardized program as in the other arms.

    Treatment: Synchronous Individualized Alpha-Frequency tACS and Mindfulness Therapy

  • Desynchronous tACS Plus Mindfulness TherapyExisting treatment, for comparison

    Participants in this arm will receive individualized alpha-frequency tACS combined with the same standardized mindfulness therapy program. The stimulation targets, treatment duration, and general stimulation setup will be the same as in the synchronous tACS arm, but the phase difference between the F3 and P3 stimulation electrodes will be set at 180 degrees.

    Treatment: Desynchronous Individualized Alpha-Frequency tACS and Mindfulness Therapy

  • Sham tACS Plus Mindfulness TherapySham treatment, for comparison

    Participants in this arm will receive sham tACS combined with the same standardized mindfulness therapy program. Sham stimulation will include 30-second ramp-up and ramp-down periods at the beginning and end of stimulation to mimic the sensation of active tACS. No active current will be delivered during the main 20-minute stimulation period, while the electrodes will remain in place to maintain blinding.

    Treatment: Sham tACS and Mindfulness Therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effects and Mechanisms of Individualized Alpha-Frequency Transcranial Alternating Current Stimulation as an Augmentation Strategy for Mindfulness Therapy in Patients With Generalized Anxiety Disorder
Fit questions
Built from NCT07648797, who can take part
Record updated
16 June 2026