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临床试验/NCT04405440
NCT04405440Unknown不适用

Excessive Avoidance Behaviors in Anorexia Nervosa: the Role of Reward

Bram Vervliet2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Relief pleasantness ratings (Visual Analog Scale, from neutral [0] to very pleasant [100])

研究概览

简要总结

This study investigates excessive avoidance behaviors in patients with a diagnosis of Anorexia Nervosa (AN) compared to a healthy control group. The study further examines the role of reward (relief) as a putative factor in maintaining excessive avoidance behaviors in AN.

详细描述

Anorexia Nervosa (AN) is a life-threatening mental disease with a disappointing treatment outcome. Fear of weight gain and diet restrictions are considered the core symptoms of AN. Although from a diagnostic perspective AN is conceptualized as an eating-related disorder connected to an extremely low Body Mass Index (BMI) and body image distortion, AN might represent a specific phenotype of anxiety disorders characterized by tenacious avoidance behaviors, especially the restrictive subtype. To date, avoidance in AN is often investigated as a general personality trait (e.g. harm avoidance) but poorly examined in its behavioral form (which is life-threatening, such as food-avoidance). Hence, the investigators will perform a systematic investigation of excessive avoidance behaviors within a laboratory setting. Within a learning perspective, the investigators will investigate excessive avoidance in a group of 30 AN patients and 30 healthy volunteers. To achieve this, a well-validated avoidance paradigm will be used. Most critically, the investigators will examine whether patients with a diagnosis of anorexia nervosa show persistent avoidance behaviors compared to a control group. Additionally, the investigators will examine if, in the anorexia group, higher subjective relief to successful omissions of negative events during avoidance learning predicts persistent (excessive) avoidance behaviors after fear extinction.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •For the AN group, patients need to be physically strong and sufficiently emotionally stable
  • •For the healthy group, the investigators will recruit participants without a previous or current history of psychiatric, cardiovascular, neurological or other relevant disorder

排除标准

  • •For the AN group, the investigators will exclude patients who are insufficiently emotionally stable and/or physically weak to participate in the study as estimated by the treating physicians of the units on which the patients are admitted
  • •Insufficient verbal skills to understand the questionnaires and the computer task
  • •Participants who are pregnant or breastfeeding

结局指标

主要结局

Relief pleasantness ratings (Visual Analog Scale, from neutral [0] to very pleasant [100])

时间窗: through study completion, an average of 1 year

To investigate whether, compared to healthy controls, individuals with a diagnosis of anorexia nervosa show higher relief pleasantness during the omission of the aversive stimuli. The investigators will also test if such responses predict a return in avoidance behaviors (button click) after fear has been extinguished. Repeated measure ANOVA (analysis of variance) and multiple linear regressions will be employed to evaluate differences between groups. If data will violate the assumption of normality mixed or generalize methods will be used.

Button clicks during a red cue will be recorded as a measure of avoidance (binary response)

时间窗: through study completion, an average of 1 year

To investigate whether, compared to healthy controls, individuals with a diagnosis of anorexia nervosa show excessive avoidance behaviors (frequent clicking to prevent the aversive stimulus). Repeated measure ANOVA (analysis of variance) will be employed to evaluate differences between groups. If data will violate the assumption of normality, mixed or generalize methods will be used.

次要结局

  • Distress Tolerance Scale [DTS](through study completion, an average of 1 year)
  • US-Expectancy ratings (Likert scale from 0:no picture to 10:certainly a picture)(through study completion, an average of 1 year)
  • Eating Disorders Inventory [EDI](through study completion, an average of 1 year)

研究者

发起方
Bram Vervliet
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bram Vervliet

Principal Investigator Prof. Dr. Bram Vervliet

KU Leuven

研究点 (2)

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