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临床试验/NCT05140109
NCT05140109已完成不适用

Effectiveness Randomized Controlled Trial on Eating Disorders Group Treatment: a Cognitive Dissonance, a Mindfulness and a Person-centered Based Program

Université Lumière Lyon 22 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Mean change in The Eating Disorders Diagnostic Interview from pretest to 1-year follow-up

研究概览

简要总结

This trial aims at comparing three group treatments designed for eating disorders: a Cognitive-dissonance, a Mindfulness and a Person-centered based programs. Women with eating disorders will be recruited and randomized to one of the three programs. Participants will complete a pretest, a posttest, a 3-months follow-up and a 1-year follow-up. This trial aims to compare the programs to analyze the specific dimensions upon which each program acts. The investigators therefore made hypotheses according to the programs' theory: participants in the Cognitive-dissonance based program should experience a greater decrease in eating disorders symptoms, thin-ideal internalization and body dissatisfaction and a greater improvement in quality of life than other participants. Participants in the Mindfulness-based program should show a greater improvement in negative affect and in equanimity than other participants. Participants in the Person-Centered based program should report a greater increase in congruence than other participants.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • eating disorders (anorexia nervosa, bulimia nervosa or binge eating disorder) or other specified feeding or eating disorder (subthreshold of anorexia, bulimia or binge eating disorder) according to Diagnostic Statistical Manual 5
  • to have no regular treatment (no more than one session per month) during the 8 weeks of the program
  • participants with a Body Mass Index under 17.5 could be include in the study if they had a medical monitoring in another structure

排除标准

  • a psychotic disorder
  • a bipolar disorder
  • a mental retardation
  • to not read or speak French fluently

结局指标

主要结局

Mean change in The Eating Disorders Diagnostic Interview from pretest to 1-year follow-up

时间窗: From pretest to 1-year follow-up

The minimum of the scale is 0 and the maximum is 276. A higher score means a worse outcome.

次要结局

  • Mean change in the subscale "Body dissatisfaction" from the scale Eating disorders inventory-2 from pretest to 1-year follow-up(From pretest to 1-year follow-up)
  • Mean change in the World Health Organization Quality Of Life Scale from pretest to 1-year follow-up(From pretest to 1-year follow-up)
  • Mean change in the Strathclyde Inventory measuring congruence from pretest to 1-year follow-up(From pretest to 1-year follow-up)
  • Mean change in the Equanimity scale from pretest to 1-year follow-up(From pretest to 1-year follow-up)
  • Mean change in the Sociocultural Attitudes Towards Appearance Scale from pretest to 1-year follow-up(From pretest to 1-year follow-up)
  • Mean change in The Hospital Anxiety and Depression Scale from pretest to 1-year follow-up(From pretest to 1-year follow-up)

研究者

发起方
Université Lumière Lyon 2
申办方类型
Other
责任方
Principal Investigator
主要研究者

TURGON Roxane

Principal investigator

Université Lumière Lyon 2

研究点 (2)

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