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Generalized Anxiety Disorder (GAD)NCT07648797

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

A study testing Synchronous Individualized Alpha-Frequency tACS, Desynchronous Individualized Alpha-Frequency tACS and Mindfulness Therapy in people with Generalized Anxiety Disorder (GAD), run by Central South University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Generalized Anxiety Disorder (GAD)
What is being tested?
Synchronous Individualized Alpha-Frequency tACS, Desynchronous Individualized Alpha-Frequency tACS and Mindfulness Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
1 siteChina
Study dates
1 Jun 2026to 1 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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 join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

    Fanqi Zhou, +86-18711022278, 2205228535@qq.com

Other trials in China

About this study

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

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.

Read the detailed description

Generalized anxiety disorder is characterized by excessive and difficult-to-control worry, often accompanied by physical symptoms and impaired daily functioning. Mindfulness-based therapy may help patients observe worry and anxiety-related bodily sensations with greater awareness and acceptance. Transcranial alternating current stimulation (tACS) is a non-invasive brain stimulation technique that may modulate neural oscillations related to cognitive control and emotion regulation.

This study will enroll 99 adults with generalized anxiety disorder. Eligible participants will be randomly assigned in a 1:1:1 ratio to one of three intervention groups: synchronous tACS plus mindfulness therapy, desynchronous tACS plus mindfulness therapy, or sham tACS plus mindfulness therapy. All groups will receive the same standardized mindfulness therapy program. The active tACS conditions will target the frontoparietal network, with stimulation parameters individualized according to each participant's alpha-band neurophysiological characteristics. The sham stimulation condition will mimic the initial and final sensation of stimulation while delivering no active current during the main stimulation period.

Clinical, behavioral, and neurophysiological assessments will be collected at baseline and follow-up visits. Outcome assessments will include anxiety severity, depressive symptoms, worry, mindfulness, attention control, cognitive performance, adverse effects related to tACS, and multimodal measures such as electroencephalography, magnetic resonance imaging, and eye tracking. The study aims to determine whether individualized alpha-frequency tACS can improve the therapeutic effects of mindfulness therapy and to explore potential neural mechanisms underlying treatment response.

Being tested
Synchronous Individualized Alpha-Frequency tACS, Desynchronous Individualized Alpha-Frequency tACS, Sham tACS, Mindfulness Therapy
Keywords
Transcranial Alternating Current Stimulation, tACS, Mindfulness Therapy, Mindfulness Meditation, Individualized Alpha Frequency, Frontoparietal Network, Dorsolateral Prefrontal Cortex, Inferior Parietal Lobule, Worry, Executive Attention
Medical subject headings
Generalized Anxiety Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Synchronous Individualized Alpha-Frequency tACSDevice

    Also called Synchronous tACS, In-Phase tACS, Transcranial Alternating Current Stimulation

    Individualized alpha-frequency transcranial alternating current stimulation (tACS) will be delivered to the frontoparietal network. Stimulation electrodes will be placed over F3 and P3, corresponding to the left dorsolateral prefrontal cortex and left inferior parietal lobule. In the synchronous tACS condition, the F3 and P3 stimulation electrodes will deliver in-phase sinusoidal alternating current. The stimulation frequency will be individualized based on each participant's alpha-band phase locking value peak between F3 and P3.

  • Desynchronous Individualized Alpha-Frequency tACSDevice

    Also called Desynchronous tACS, Anti-Phase tACS, 180-Degree Phase Difference tACS

    Individualized alpha-frequency tACS will be delivered using the same stimulation targets and general setup as the synchronous tACS condition. Stimulation electrodes will be placed over F3 and P3, corresponding to the left dorsolateral prefrontal cortex and left inferior parietal lobule. In the desynchronous tACS condition, the phase difference between the F3 and P3 stimulation electrodes will be set at 180 degrees.

  • Sham tACSDevice

    Also called Sham Transcranial Alternating Current Stimulation

    Sham tACS will be delivered with the electrodes placed in the same positions as in the active tACS conditions. The sham condition will include 30-second ramp-up and ramp-down periods at the beginning and end of stimulation to mimic the sensation of active stimulation. No active current will be delivered during the main 20-minute stimulation period, while the electrodes will remain in place to maintain blinding.

  • Mindfulness TherapyBehavioural

    Also called Mindfulness Meditation Training, Standardized Mindfulness Training

    Participants will receive a standardized mindfulness therapy program for 2 weeks, with 10 sessions in total. Each session will last 40 minutes. The program follows a progressive structure of awareness, acceptance, and application. The first five sessions focus on breath awareness and body scan practices. The last five sessions focus on observing anxiety-related bodily sensations and worry-related thoughts with a nonjudgmental and accepting attitude, and on using breathing space practices to redirect attention to the present moment.

Study groups in NCT07648797
Study groupRoleWhat they receive
Synchronous tACS Plus Mindfulness TherapyExperimentalParticipants 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.
Receives: Device: Synchronous Individualized Alpha-Frequency tACS; Behavioral: Mindfulness Therapy
Desynchronous tACS Plus Mindfulness TherapyActive comparatorParticipants 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.
Receives: Device: Desynchronous Individualized Alpha-Frequency tACS; Behavioral: Mindfulness Therapy
Sham tACS Plus Mindfulness TherapySham comparatorParticipants 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.
Receives: Device: Sham tACS; Behavioral: Mindfulness Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Hamilton Anxiety Rating Scale total score at Week 2 post-randomization

    The Hamilton Anxiety Rating Scale (HAMA) is a clinician-administered scale used to assess the severity of anxiety symptoms. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms. This outcome is defined as the change in HAMA total score from baseline to Week 2 post-randomization, calculated as the Week 2 score minus the baseline score. A greater reduction indicates greater improvement in anxiety symptoms.

    Measured: Baseline and Week 2

Secondary outcomes (6)
  1. Change in Generalized Anxiety Disorder-7 Score From Baseline to Follow-up

    The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report questionnaire used to assess the severity of anxiety symptoms. The total score ranges from 0 to 21, with higher scores indicating greater anxiety severity.

    Measured: Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6

  2. Change in Penn State Worry Questionnaire Score From Baseline to Follow-up

    The Penn State Worry Questionnaire (PSWQ) is a 16-item self-report questionnaire used to assess the tendency to engage in excessive and uncontrollable worry. The total score ranges from 16 to 80, with higher scores indicating greater worry severity.

    Measured: Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6

  3. Change in Five Facet Mindfulness Questionnaire Score From Baseline to Follow-up

    The Five Facet Mindfulness Questionnaire (FFMQ) is a self-report questionnaire used to assess mindfulness-related abilities,including observing, describing, acting with awareness, non-judging, and non-reactivity.. For the standard 39-item version, the total score ranges from 39 to 195, with higher scores indicating a higher level of mindfulness.

    Measured: Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6

  4. Change in Attentional Control Scale Score From Baseline to Follow-up

    The Attentional Control Scale (ACS) is a 20-item self-report questionnaire used to assess perceived ability to focus and shift attention. The total score ranges from 20 to 80, with higher scores indicating better attentional control.

    Measured: Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6

  5. tACS-Related Adverse Effects Assessed by the tACS Adverse Effects Questionnaire

    The Transcranial Alternating Current Stimulation Adverse Effects Questionnaire (tACS-AEQ) will be used to assess stimulation-related adverse effects, including headache, dizziness, fatigue, skin redness, itching, tingling, burning sensation, scalp discomfort, and other adverse sensations. This outcome will report the presence and severity of adverse effects, with higher severity ratings indicating more severe adverse effects.

    Measured: Week 1 and Week 2

  6. Change in Hamilton Depression Rating Scale-17 Score From Baseline to Follow-up

    The Hamilton Depression Rating Scale-17 (HAMD-17) is a 17-item clinician-administered scale used to assess the severity of depressive symptoms. The total score ranges from 0 to 52, with higher scores indicating more severe depressive symptoms.

    Measured: Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: synchronous tACS plus mindfulness therapy, desynchronous tACS plus mindfulness therapy, or sham tACS plus mindfulness therapy. Each participant will receive only the assigned intervention throughout the treatment period. All groups will receive the same standardized mindfulness therapy program, and the groups will differ only in the tACS stimulation condition.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
99 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07648797
Sponsor's protocol ID
KYZZ20260020
Status last verified
Jun 2026
First submitted
10 Jun 2026
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Synchronous Individualized Alpha-Frequency tACS, Desynchronous Individualized Alpha-Frequency tACS and Mindfulness Therapy in people with Generalized Anxiety Disorder (GAD), run by Central South University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yumeng Ju, PhD (+86-18100731091, yumeng.ju@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Hamilton Anxiety Rating Scale total score at Week 2 post-randomization (time frame: Baseline and Week 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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