Adolescent Inpatients With Anorexia Nervosa: Changes in Heart Rate Variability, Body Warmth and Eating Disorder Features - a Prospective Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Drive for Thinness
研究概览
简要总结
A study to assess changes in mental and physical symptoms in adolescent inpatients with anorexia nervosa, a severe eating disorder.
详细描述
This is a prospective controlled trial to assess changes in psycho-physiological parameters, including eating disorder features (drive for thinness, body dissatisfaction) and comorbid symptoms such as anxiety, depression and quality of life as well as heart rate variability, body warmth and BMI in adolescent inpatients with anorexia nervosa. Parameters were assessed at admission, six weeks after admission and three months thereafter and compared to reference values of healthy controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 11-18 years
- •Restrictive subtype of adolescent AN
- •Fulfilling the AN diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV and V)
- •Admitted to the Filderklinik for inpatient treatment
排除标准
- •Patients diagnosed with the binge-purge subtype of adolescent AN or with other eating disorders
- •Healthy controls: BMI beyond the defined norm for their age group
- •Healthy controls: acute or chronic disorders including psychiatric disorders, heart defects, cardiac arrhythmia, other disorders requiring medication
结局指标
主要结局
Change in Drive for Thinness
时间窗: At admission (timepoint 1, t1), six weeks after admission (t2), and three months after t2 (t3)
Assessed with the 7-item subscale Drive for Thinness of the self-reporting Eating Disorder Inventory-2 at admission to the hospital (t1), six weeks after admission (t2) and three months after t2 (t3)
Change in Body Dissatisfaction
时间窗: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Assessed with the 9-item subscale Body Dissatisfaction of the self-reporting Eating Disorder Inventory-2 at admission to the hospital (t1), six weeks after admission (t2) and three months after t2 (t3)
次要结局
- Weight gain(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))
- Heart rate variability: SDNN(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))
- SF-12 physical(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))
- Anxiety(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))
- SF-12 global(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))
- Depression(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))
- Body warmth(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))
- SF-12 mental(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))
- Heart rate(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))