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

12 июня 2026 г. обновлено: Yumeng Ju, Central South University

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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

99

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Yumeng Ju, PhD
  • Номер телефона: +86-18100731091
  • Электронная почта: yumeng.ju@csu.edu.cn

Учебное резервное копирование контактов

  • Имя: Fanqi Zhou
  • Номер телефона: +86-18711022278
  • Электронная почта: 2205228535@qq.com

Места учебы

  • Китай
    • Hunan
      • Changsha, Hunan, Китай, 410011
        • The second Xiangya Hospital of Central South University
        • Контакт:
          • Fanqi Zhou
          • Номер телефона: +86-18711022278
          • Электронная почта: 2205228535@qq.com

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Synchronous tACS Plus Mindfulness Therapy
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.
Устройство: Synchronous Individualized Alpha-Frequency tACS
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.
Другие имена:
  • Synchronous tACS
  • In-Phase tACS
  • Transcranial Alternating Current Stimulation
Поведенческий: Mindfulness Therapy
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.
Другие имена:
  • Mindfulness Meditation Training
  • Standardized Mindfulness Training
Активный компаратор: Desynchronous tACS Plus Mindfulness Therapy
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.
Поведенческий: Mindfulness Therapy
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.
Другие имена:
  • Mindfulness Meditation Training
  • Standardized Mindfulness Training
Устройство: Desynchronous Individualized Alpha-Frequency 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.
Другие имена:
  • Desynchronous tACS
  • Anti-Phase tACS
  • 180-Degree Phase Difference tACS
Фальшивый компаратор: Sham tACS Plus Mindfulness Therapy
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.
Поведенческий: Mindfulness Therapy
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.
Другие имена:
  • Mindfulness Meditation Training
  • Standardized Mindfulness Training
Устройство: Sham tACS
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.
Другие имена:
  • Sham Transcranial Alternating Current Stimulation

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change from baseline in Hamilton Anxiety Rating Scale total score at Week 2 post-randomization
Временное ограничение: Baseline and Week 2
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.
Baseline and Week 2

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Generalized Anxiety Disorder-7 Score From Baseline to Follow-up
Временное ограничение: Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
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.
Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
Change in Penn State Worry Questionnaire Score From Baseline to Follow-up
Временное ограничение: Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
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.
Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
Change in Attentional Control Scale Score From Baseline to Follow-up
Временное ограничение: Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
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.
Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
Change in Hamilton Depression Rating Scale-17 Score From Baseline to Follow-up
Временное ограничение: Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
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.
Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
Change in Five Facet Mindfulness Questionnaire Score From Baseline to Follow-up
Временное ограничение: Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
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.
Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
tACS-Related Adverse Effects Assessed by the tACS Adverse Effects Questionnaire
Временное ограничение: Week 1 and Week 2
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.
Week 1 and Week 2

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Central South University

Следователи

  • Учебный стул: Yan Zhang, PhD, Second Xiangya Hospital of Central South University
  • Директор по исследованиям: Yumeng Ju, PhD, Second Xiangya Hospital of Central South University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 июня 2026 г.

Первичное завершение (Оцененный)

1 декабря 2027 г.

Завершение исследования (Оцененный)

1 июня 2028 г.

Даты регистрации исследования

Первый отправленный

10 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

10 июня 2026 г.

Первый опубликованный (Действительный)

15 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

16 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

12 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • KYZZ20260020

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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