Implementation and Evaluation of a Standardized Protocol for Treatment of Restrictive Eating Disorders With Pronounced Starvation During the First Month in Child Psychiatric Outpatient Care. The ROCKETLAUNCH Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
In the Region Skåne in Sweden, the investigators have developed guidelines for providing intensive and evidence-based treatment during the first month in case of severe restrictive eating disorder with pronounced starvation.
The project is aiming at implementing this treatment program in the general Child Psychiatric clinic, with its main focus on the implementation of evidence based family therapy. The study aims to evaluate the implementation of a standardized treatment model during the first month. The outcome will be compared with the patients and families who have been in treatment before the ROCKETLAUNCH project started.
详细描述
Anorexia nervosa and other restrictive eating disorders with pronounced starvation is one of the most acute and life-threatening conditions in child psychiatry and requires immediate treatment. Anorexia nervosa is the eating disorder which most often causes pronounced starvation, and also has the highest mortality in psychiatry. These conditions are hard to treat, and there are not many successful treatment methods. Family therapy, and more specific family based treatment has so far proved to be the most successful treatment method for the young patient with anorexia nervosa.
For patients presenting with severe underweight, it is critically important to treat starvation and achieve medical stabilization and weight gain as the first priority. Research shows that weight gain during the first month of treatment produces a better outcome. Family-based treatment has the best evidence support to achieve early weight gain for adolescents with anorexia nervosa.
In child and adolescent psychiatry in the Region Skåne in Sweden, a working group have developed guidelines for providing intensive and evidence-based treatment during the first month in case of severe restrictive eating disorder with pronounced starvation.
Whenever a young person diagnosed with an eating disorder is suspected to suffer from starvation, an assessment shall be offered promptly, normally at the latest within fourteen days. If significant cardiac symptoms are reported, assessment must be made within a few days. The treating service should be prepared to offer at least 1-2 visits a week directly at treatment start.
The high-intensity treatment focuses on medical stabilization and weight gain from the first visit. The goal of the treatment during the first month is weight gain of at least 2 kg (exception made for atypical anorexia nervosa with a normal or high weight - where the goal is to achieve medical stabilization). The focus is on helping the patient to conquer starvation. Interventions for normalizing eating will continue after this period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffering from one in three restrictive Eating Disorders according to DSM-5 criteria: Anorexia Nervosa, Atypical Anorexia Nervosa or Avoidant/Restrictive Food Intake Disorder
- •Patient with pronounced starvation
- •Patient aged between 7 and 17
- •Patient and his/her parents who accept to participate to the study
- •Patient comes to treatment for the first time.
排除标准
- •Patient who is diagnosed with: psychosis, mental deficiency, organic cerebral disorder, any pathology that interfere with feeding or its regurgitation
- •Patient who does not speak Swedish
- •Patient who is already in family therapy for an other condition
结局指标
主要结局
Body Mass Index (BMI)
时间窗: 1 month and 12 months
Change from baseline Body Mass Index (weight in kg/height in m²) at 1 month and 12 months
Medical stabilization
时间窗: 1 month
Rate of particapants that have normalized pulse rate and blood pressure.
次要结局
- In-patient treatment(1 month and 12 months)
- Change from baseline nature and seriousness of eating-disorder symptoms at 1 months and 12 months(1 month and 12 months)
- Change from baseline patient's emotional symptoms at 1 month and 12 months(1 month and 12 months)
研究者
Ulf Wallin
MD, PhD Head of Research and Development
Lund University Hospital