Effects and Mechanisms of Individualized Alpha-Frequency Transcranial Alternating Current Stimulation as an Augmentation Strategy for Mindfulness Therapy in Patients With Generalized Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Change from baseline in Hamilton Anxiety Rating Scale total score at Week 2 post-randomization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be masked to group assignment. 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, while no active current will be delivered during the main 20-minute stimulation period. The psychotherapist, tACS operator, and data collectors will be independent research personnel, and outcome assessors will not be involved in treatment delivery.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Synchronous Individualized Alpha-Frequency tACS (Device)
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.
干预措施: Mindfulness Therapy (Behavioral)
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.
干预措施: Desynchronous Individualized Alpha-Frequency tACS (Device)
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.
干预措施: Mindfulness Therapy (Behavioral)
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.
干预措施: Sham tACS (Device)
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.
干预措施: Mindfulness Therapy (Behavioral)
结局指标
主要结局
Change from baseline in Hamilton Anxiety Rating Scale total score at Week 2 post-randomization
时间窗: 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.
次要结局
- Change in Generalized Anxiety Disorder-7 Score From Baseline to Follow-up(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(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(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(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(Week 1 and Week 2)
- Change in Hamilton Depression Rating Scale-17 Score From Baseline to Follow-up(Baseline, Week 1, Week 2, Month 1, Month 2, Month 4, and Month 6)
研究者
Yumeng Ju
Associate Researcher
Central South University