TMS Treatment for Anorexia Nervosa: Effects on Body Image Processing and Clinical Outcome Measures
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Body Attitude Test (BAT)
研究概览
简要总结
To evaluate if TMS together with a body image intervention is an efficacious treatment for anorexia nervosa compared to treatment as usual.
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
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •Being enrolled as a patient at the eating disorder unit of the Child and adolescent psychiatric clinic and Psychiatric clinic in Linköping
- •Having a DSM-5 diagnosis of anorexia nervosa, atypical anorexia (restrictive type)
- •Being at least 18 years of age
- •Having a BMI of 20 or under.
- •Being free of psychotropic medications or on stable (at least three months on the same dose) medication.
排除标准
- •Clinical diagnosis of schizophrenia or psychotic disorder
- •Clinical diagnosis of bipolar disorder
- •Alcohol/drug dependence
- •Ongoing treatment with antipsychotics or tricyclic antidepressants
- •Previous severe head injury
- •Birth before 33 weeks of gestation
- •Hearing impairment
- •Earlier epilepsy or seizures of other causes
- •Having severe claustrophobia
- •Being pregnant
- •Having a cognitive disability
结局指标
主要结局
Body Attitude Test (BAT)
时间窗: Change from baseline at 4 weeks and at 6 months
BAT measures attitudes toward one own body. It contains a total of 20 items that are rated on a Likert scale between 0-5. Total scores range from 0-100. Higher scores indicate more problems with body attitude.
Body Mass Index (BMI)
时间窗: Change from baseline at 4 weeks and at 6 months
Body Mass Index is a person's weight in kilograms divided by the square of height in meters and is an indication of under- or overweight in adults.
Figure Rating Scale
时间窗: Change from baseline at 4 weeks and at 6 months
Figure Rating Scale measures body image and estimation of one's own body size. Each figure presents nine schematic silhouettes, ranging from extreme thinness (1) to extreme obesity (9). For research purposes, participants are asked to self-select the silhouette that best indicates his or her current body size (ranging from 1-9) and the silhouette that reflects his or her ideal body size (ranging from 1-9).
Eating Disorder Examination Questionnaire (EDE-Q)
时间窗: Change from baseline at 4 weeks and at 6 months
EDE-Q measures symptoms of eating disorder. It contains at total of 36 items. 23 of these are rated on a Likert scale between 0-6 and contains 4 subscales: Restraint (ranging from 0-30); Eating concern (ranging from 0-30); shape concern (ranging from 0-48); weight concern (ranging from 0-30). Higher scores indicating more difficulties with eating disorder. In addition, 11 open ended questions concern binge eating and compensating behaviors.
Body Shape Questionnaire (BSQ)
时间窗: Change from baseline at 4 weeks and at 6 months
BSQ measures dissatisfaction with one's own body/figure. It contains a total of 34 items, which are rated on a Likert scale ranging from 1-6. total scores range from 34-204, with higher scores indicating more dissatisfaction.
次要结局
未报告次要终点
研究者
Maria Zetterqvist
Principal Investigator
Region Östergötland