跳至主要内容
临床试验/NCT06139770
NCT06139770进行中(未招募)不适用

Treatment of Anorexia Nervosa in Children and Adolescents: An Integrated Family-based and Metacognitive Approach

Norwegian University of Science and Technology2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
48
试验地点
2
主要终点
Body Mass Index

研究概览

简要总结

The goal of this study is to evaluate the treatment effects of an integrated treatment called Family-based and Metacognitive therapy for patients with Anorexia Nervosa. In addition, we will evaluate if an active follow-up of the patients will reduce the number of relapses, which is common during the 1 year after discharge. Fifty patients aged 12-18 years old and their parents will be invited to participate in this study and all will receive the same treatment but be randomly allocated to different follow-up conditions. The active follow-up includes 3 sessions of Metacognitive therapy and the passive follow-up includes ordinary follow-up, with no booster sessions. The patients will be assessed at baseline, pre-treatment, post-treatment, and at 6 and 12 months follow-up.

详细描述

The study is an evaluation of a new approach to treating Anorexia Nervosa (F.50.0 and F 50.1) called Family-based and Metacognitive therapy. The treatment integrates both family-based work approach, where the parents learn to be in control of the meal situation and communicate better with their child. The metacognitive treatment approach, is targeting the child to work with its problems with emotional regulation and self-esteem issues, but also their attitudes to body and weight. Our aim is to both address what the overall effect of the treatment will be, but also to test if an active follow-up after discharge will lead to reduced relapse rates in the 12 months after treatment. We will apply the same approach to all included patients (A-B design), but the patients and their parents will be allocated to one of two different conditions for follow-up. The active follow-up involves receiving 3 sessions of metacognitive therapy, whereas the other group gets ordinary follow-up, with no sessions of MCT. All patients are assessed at baseline, pre-treatment, post-treatment, and by 6 and 12 months follow-up. The purpose of the design is to evaluate if the rate of relapse during the first year after discharge can be reduced

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
None

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Primary diagnosis of F 50.0 and F 50.1

排除标准

  • Psychotic symptoms
  • Severe somatic illness
  • Mental retardation or developmental disorder
  • Bipolar disorder
  • Extreme self-mutilation or acute suicidal risks
  • Does not speak or understand Norwegian

结局指标

主要结局

Body Mass Index

时间窗: 18 months

Body mass index

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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