Transcranial Alternating Current Stimulation to Enhance Mindfulness Therapy in Generalized Anxiety Disorder
2026년 6월 10일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
99
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Yumeng Ju, PhD
- 전화번호: +86-18100731091
- 이메일: yumeng.ju@csu.edu.cn
연구 연락처 백업
- 이름: Fanqi Zhou
- 전화번호: +86-18711022278
- 이메일: 2205228535@qq.com
연구 장소
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Hunan
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Changsha, Hunan, 중국, 410011
- The Second Xiangya Hospital Of Central South University
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연락하다:
- Fanqi Zhou
- 전화번호: +86-18711022278
- 이메일: 2205228535@qq.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
다른 이름들:
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.
다른 이름들:
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활성 비교기: 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.
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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.
다른 이름들:
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.
다른 이름들:
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가짜 비교기: 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.
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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.
다른 이름들:
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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in Hamilton Anxiety Rating Scale total score at Week 2 post-randomization
기간: Baseline and Week 2
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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.
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Baseline and Week 2
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Generalized Anxiety Disorder-7 Score From Baseline to Follow-up
기간: Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
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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.
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Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
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Change in Penn State Worry Questionnaire Score From Baseline to Follow-up
기간: Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
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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.
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Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
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Change in Five Facet Mindfulness Questionnaire Score From Baseline to Follow-up
기간: Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
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The Five Facet Mindfulness Questionnaire (FFMQ) is a self-report questionnaire used to assess mindfulness-related abilities, including observing, describing, acting with awareness, nonjudging, and nonreactivity.
For the standard 39-item version, the total score ranges from 39 to 195, with higher scores indicating a higher level of mindfulness.
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Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
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Change in Attentional Control Scale Score From Baseline to Follow-up
기간: Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
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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.
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Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
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tACS-Related Adverse Effects Assessed by the tACS Adverse Effects Questionnaire
기간: Week 1 and Week 2
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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 item-level severity ratings indicating more severe adverse effects.
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Week 1 and Week 2
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Change in Hamilton Depression Rating Scale-17 Score From Baseline to Follow-up
기간: Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
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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.
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Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Yan Zhang, PhD, Second Xiangya Hospital of Central South University
- 연구 책임자: Yumeng Ju, PhD, Second Xiangya Hospital of Central South University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2027년 6월 1일
연구 완료 (추정된)
2027년 6월 1일
연구 등록 날짜
최초 제출
2026년 6월 10일
QC 기준을 충족하는 최초 제출
2026년 6월 10일
처음 게시됨 (실제)
2026년 6월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 10일
마지막으로 확인됨
2026년 6월 1일
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추가 관련 MeSH 약관
기타 연구 ID 번호
- KYZZ20260020
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Synchronous Individualized Alpha-Frequency tACS에 대한 임상 시험
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