Mechanisms of Deep Transcranial Magnetic Stimulation Enhances the Efficacy of Cognitive-behavioral Therapy (CBT) by Modulating Anterior Cingulate Cortex in Patients With Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
The goal of this clinical trial is to learn if dTMS targeting the ACC can be used to rapidly and effectively treat AN. A randomized controlled study design is adopted, in which patients with AN are divided into the CBT+dTMS treatment group and CBT+pseudostimulation group by 1:1 randomization, followed by a 6-week intervention and a half-year follow-up to clarify whether CBT combined with dTMS is superior to single CBT treatment for AN.
详细描述
The investigators propose hypothesis that CBT improves AN symptoms by modulating the "AN-ACC pathology network", and that high-frequency stimulation targeting the ACC by dTMS can synergize "AN-ACC pathology network" and enhance the efficacy of CBT. In order to verify this hypothesis, a randomized controlled study design is adopted, in which patients with AN are divided into the CBT+dTMS treatment group and CBT+pseudostimulation group by 1:1 randomization, followed by 6-week intervention and a half-year follow up, to clarify the near-term and long-term efficacy and safety of the dTMS treatment. Patients in both groups undergo fMRI examinations, complete delay discounting task (DDT) and body image task before and after each treatment session. Symptoms, psychometrics and side effect questionnaires are followed up at baseline, week 6 (at the end of treatment), and weeks 4, 8, 12 and 24 (after completion of treatment). This study will provide a theoretical and practical basis for the innovative combined intervention method in patients with AN, and to verify the "AN-ACC pathological network" pathomechanism of AN at multiple levels.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Female, aged 18-35 years, right handedness.
- •Above primary education.
- •Meet the diagnostic criteria of AN in DSM-V, and13.0 kg/m2 ≤ body mass index (BMI)<18.5 kg/m
- •No systemic nutritional therapy, psychiatric medication or any form of psychotherapy have been received within 1 month before enrollment.
- •Able to understand the nature of this study and sign an informed consent form.
排除标准
- •Diagnosed with a DSM-5 disease other than anorexia nervosa, or at high risk of suicide, strong impulsive behavior as well as anti-social behavior.
- •With severe physical or cognitive impairment.
- •Not able to undergo MRI.
- •Considered unsuitable for enrollment in this clinical trial for other reasons.
研究组 & 干预措施
CBT+dTMS treatment group
CBT+dTMS treatment group has 55 patients. Each patient receives 12 individual sessions of CBT for 50 minutes 2 times per week for 6 weeks. dTMS intervention use real coils, targeting ACC, given 5 times per week (Monday to Friday) for 6 consecutive weeks.
干预措施: Deep transcranial magnetic stimulation (Device)
CBT+dTMS treatment group
CBT+dTMS treatment group has 55 patients. Each patient receives 12 individual sessions of CBT for 50 minutes 2 times per week for 6 weeks. dTMS intervention use real coils, targeting ACC, given 5 times per week (Monday to Friday) for 6 consecutive weeks.
干预措施: cognitive behavior therapy (Behavioral)
CBT+dTMS treatment group
CBT+dTMS treatment group has 55 patients. Each patient receives 12 individual sessions of CBT for 50 minutes 2 times per week for 6 weeks. dTMS intervention use real coils, targeting ACC, given 5 times per week (Monday to Friday) for 6 consecutive weeks.
干预措施: Basic treatment (Other)
CBT+pseudo-stimulation group
CBT+Pseudo-stimulation group has 55 patients. Each patient receives 12 individual sessions of CBT for 50 minutes 2 times per week for 6 weeks. dTMS intervention uses sham coils (with the same parameters as real dTMS and generating the same noise as real coils, but without the magnetic field). It is given 5 times per week (Monday to Friday) for 6 consecutive weeks.
干预措施: cognitive behavior therapy (Behavioral)
CBT+pseudo-stimulation group
CBT+Pseudo-stimulation group has 55 patients. Each patient receives 12 individual sessions of CBT for 50 minutes 2 times per week for 6 weeks. dTMS intervention uses sham coils (with the same parameters as real dTMS and generating the same noise as real coils, but without the magnetic field). It is given 5 times per week (Monday to Friday) for 6 consecutive weeks.
干预措施: Sham deep transcranial magnetic stimulation (Device)
CBT+pseudo-stimulation group
CBT+Pseudo-stimulation group has 55 patients. Each patient receives 12 individual sessions of CBT for 50 minutes 2 times per week for 6 weeks. dTMS intervention uses sham coils (with the same parameters as real dTMS and generating the same noise as real coils, but without the magnetic field). It is given 5 times per week (Monday to Friday) for 6 consecutive weeks.
干预措施: Basic treatment (Other)
结局指标
主要结局
Body Mass Index (BMI)
时间窗: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
Calculation: BMI = weight (kg) divided by the square of height (m)
次要结局
- Eating Disorder Examination Questionnaire (EDE-Q6.0)(week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）)
- Eating Disorder Inventory (EDI-II)(week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）)
- Beck Depression Inventory (BDI)(week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）)
- Beck Anxiety Inventory (BAI)(week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）)
- Self-assessed Compulsive Questionnaire for Eating Disorders (SR-YBC-EDS)(week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）)
- Body Image Tasks(week 0（baseline）, ,week 6（post-intervention）)
- Delay Discounting Task (DDT task)(week 0（baseline）, week 6（post-intervention）)
研究者
Jue CHEN
Director of Psychosomatic Department in Shanghai Mental Health Center
Shanghai Mental Health Center