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.
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/m2.
No systemic nutritional therapy, psychiatric medication or any form of psychotherapy have been received within 1 month before enrollment.
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.
Parallel
Deep transcranial magnetic stimulation
DeviceM-100 Ultimate pulsed magnetic field stimulator is used for dTMS treatment. The coil is positioned 4 cm anterior to the scalp point and the foot motor cortex, corresponding to the ACC. A naturally cold HF001A coil is used to obtain a greater depth of stimulation, up to about 6 cm subcortical. The coil is an integrated coil for true and false stimulation loops. The intervention protocol is as follows: 30 treatments are given 5 times per week (Monday to Friday) for 6 consecutive weeks. Intervention mode: stimulation frequency 20Hz, stimulation intensity 100% RMT, number of serial pulses 50, sequence interval 20s, a total of 40 trials, 2000 pulses, stimulating the left and right ACC respectively.
cognitive behavior therapy
BehavioralEach patient receives 12 individual sessions of 50 minutes twice a week for 6 weeks.The CBT therapists are nationally registered psychotherapists with systematic professional training and uniform training in CBT for anorexia nervosa to ensure consistency. They are also supervised by a CBT supervisor at the end of each session.
Sham deep transcranial magnetic stimulation
DeviceM-100 Ultimate pulsed magnetic field stimulator is used for dTMS treatment. The coil is positioned 4 cm anterior to the scalp point and the foot motor cortex, corresponding to the ACC (The sham coil has the same parameters as real dTMS and generating the same noise as real coils, but without the magnetic field). A naturally cold HF001A coil is used to obtain a greater depth of stimulation, up to about 6 cm subcortical. The intervention protocol is as follows: 30 treatments are given 5 times per week (Monday to Friday) for 6 consecutive weeks. Intervention mode: stimulation frequency 20Hz, stimulation intensity 100% RMT, number of serial pulses 50, sequence interval 20s, a total of 40 trials, 2000 pulses, stimulating the left and right ACC respectively.
Basic treatment
Other interventionAccording to national and international guidelines for the treatment of eating disorders, the basic treatment for patients is nutritional therapy, that is, regular and quantitative dietary treatment, with three regular meals followed by a snack meal 2 hours after the regular meal. Both groups received the same nutritional treatment.
Body Mass Index (BMI)
Calculation: BMI = weight (kg) divided by the square of height (m)
Eating Disorder Examination Questionnaire (EDE-Q6.0)
Eating Disorder Examination Questionnaire can assess the core symptoms of eating disorders, including behavioral and psychological characteristics, and rate their frequency and intensity, which can assess the severity of the eating disorder. It consists of 4 subscales, including dietary restriction, eating concerns, body image concerns, and weight concerns.
Eating Disorder Inventory (EDI-II)
It is a commonly used scale for assessing cognitive-behavioral symptoms of eating disorders and is used to assess the severity of eating disorders. The scale contains 91 items divided into 8 subscales and 3 temporary subscales, including the pursuit of thinness, bulimia, body dissatisfaction, feelings of ineffectiveness, perfectionism, mistrust of others, introspection, maturity fears, abstinence, impulsive regulation and social insecurity.
Beck Depression Inventory (BDI)
The BDI consists of 21 items and assesses the patient's accompanying feelings of depression over the past 2 weeks.
Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory (BAI) is a self-rating scale used to assess a patient's anxiety symptoms. The scale consists of 21 items, each evaluating the degree of distress caused by anxiety symptoms. It uses a four-point scale from 1 to 4, with 1 indicating no symptoms and 4 indicating severe symptoms. The total score ranges from a minimum of 21 to a maximum of 84, with higher scores indicating more severe anxiety symptoms.
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