Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa: A Randomized Control Trial
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
- 2
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
Anorexia Nervosa inpatient treatment has often a short-term success as weight is restored to a healthy level, but high percentage of patients relapse during the first year following the discharge. The development of strategies to overcome this problem represents a priority for clinicians. Aim of this trial is to evaluate the effects of a relapse prevention program based on cognitive dissonance theory developed for hospitalized patients.
详细描述
Inpatient treatment for anorexia nervosa is often successful in restoring body weight, but a high percentage of patients relapse following discharge. The aim of the study was to assess the effect of a relapse prevention program during the last phase of inpatient treatment. Patients, when they achieve a BMI of 18.5, are randomly allocated to complete the standard cognitive behavior inpatient treatment (CBT-I) or to complete the standard CBT-I plus eight relapse prevention groups based on the cognitive dissonance. The intervention has been derived by the selective and indicated prevention programs using a dissonance-based approach. This intervention showed to be effective in reducing the risk for eating pathology onset. The primary outcome of the study is to assess the number of patients allocated to the two condition with a BMI equal or greater than 18.5 at 12-months after discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index ≥ 18.5
- •Anorexia Nervosa patients admitted to inpatient treatment
- •Written informed consent
排除标准
- •Schizophrenia or other psychiatric disorders
- •Substance abuse
- •Medical complication that may hamper the interpretation of results (medical condition that causes weight changes)
- •Absence of medical treatment (drugs) that may hamper the interpretation of results
- •Pregnancy or plan to get pregnant
结局指标
主要结局
Body Mass Index (BMI)
时间窗: 1 year
The main outcome is to assess the number of patients with good BMI outcome (BMI ≥ 18.5) at 12-month follow-up end in the two arm conditions.
次要结局
- Eating disorder Examination (EDE)(1 year)
研究者
Riccardo Dalle Grave
Head of Department of Eating and Weight Disorders
Villa Garda Hospital