跳至主要内容
临床试验/NCT05879679
NCT05879679招募中不适用

Pilot Study on the Validity of the Metacognitive Hub Model of Craving in Bulimia Nervosa (BN) and Binge Eating Disorders (BED)

Laval University3 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2024年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
3
主要终点
Live metacognition

研究概览

简要总结

Craving is defined as an irrepressible urge to consume certain products and represents one of the key factors in severe substance use disorders, as illustrated by its recent inclusion as a diagnostic criterion in the most recent fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM 5). However, the pathophysiological models of craving remain debated.

The "metacognitive hub model", a conceptual, experimental and clinical approach to craving, proposes that craving should be considered as the embedded consequence of the interaction between three components (the reflexive, automatic and interoceptive systems), each of which has an implicit and explicit element. This model links the three components by suggesting that metacognitive abilities, the ability to understand one's own cognitive functioning, may be a skill of individuals that allows them to make the three sub-components explicit or not.

To date, the conception of eating disorders is increasingly similar to that of addictive disorders. Indeed, there is growing evidence that the symptomatology of bulimia nervosa and binge eating disorder can be considered in part as an "food addiction" and would fit the diagnostic criteria of an addictive disorder. Bulimia nervosa is an eating disorder (DSM 5) characterized by a cycle of binge eating and compensatory behaviors such as self-induced vomiting that tend to negate or compensate for the effects of the binge eating. Binge eating disorder (DSM 5) is characterized by a cycle of binge eating, but without the compensatory behaviors seen in bulimia nervosa. In addition, there are common neurological aspects as well as similar cognitions between these eating disorders and addictive disorders. Given the importance of craving in addictive pathology, it seems essential to address this issue in bulimia nervosa and binge eating disorder. The cognitive difficulties of patients with bulimia nervosa and binge eating disorder, which are close to the difficulties observed in patients with addictive behaviors, suggest that the "metacognitive hub model" could provide a clear and measurable theoretical framework of the different dimensions of craving.

The overall objective of this project is to explore the relationship between the level of craving induced by food picture exposure and the level of impairment of the reflexive, automatic, interoceptive, and metacognitive systems in women with bulimia nervosa and binge eating disorder and to compare these impairments according to the nature of the eating disorder (i.e., binge eating versus bulimia nervosa).

Our hypotheses are:

  1. the induction of food craving will affect the reflexive, automatic, and interoceptive systems of patients with bulimia nervosa and binge eating disorder.
  2. the magnitude of the effect of food craving induction on implicit craving and explicit craving will be modulated by the participants' metacognitive abilities.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • have been medically diagnosed with binge eating disorder or bulimia nervosa
  • fluent in french
  • able to consent

排除标准

  • co-morbid substance use disorder,
  • pregnancy or breastfeeding

结局指标

主要结局

Live metacognition

时间窗: 1 hour (after food craving induction)

"live" metacognitive assessment will be done by asking the participants to rate their level of confidence on a visual analog scale ranging from 0% (I just guessed) to 100% (completely confident) for each items.

Attention Network Test (ANT)

时间窗: 1 hour (after food craving induction)

The ANT is a task designed to test three attentional networks in children and adults: alerting, orienting, and executive control

Dot Probe Task

时间窗: 1 hour (after food craving induction)

To test and measure selective attention

Water load task

时间窗: 1 hour (after food craving induction)

This task was originally developed to induce gastric distension and assess gastrointestinal symptoms in patients with functional digestive disorders. This task stimulates the stomach using a natural distension stimulus (i.e., water ingestion) and without the complex hormonal response of a caloric meal.

Avoidance/Approach task adapted for food craving

时间窗: 1 hour (after food craving induction)

In this task, participants are asked to move a joystick that simulates the movement of the food represented in the image. The joystick movements are accompanied by a zoom effect that increases the illusion of movement.

次要结局

  • Beck Depression Inventory II (BDI-II)(Baseline)
  • Food Craving Questionnaire Trait (FCQ-T)(Baseline)
  • Difficulties in Emotional Regulation Scale (DERS- 18)(Baseline)
  • State-Trait Anxiety Inventory (STAI)(Baseline)
  • Food Craving Questionnaire State (FCQ-S)(Baseline)
  • Visual Analogic Scale of craving(Baseline, at 1 hour (after craving induction), at 3 hours (end of the session_)
  • Schedule for the Assessment of Insight in Eating Disorders (SAI-ED)(Baseline)
  • Body Awareness Questionnaire (BAQ)(Baseline)
  • Eating Disorder Examination Questionnaire (EDE-Q)(Baseline)
  • Attentional Control Scale (ACS)(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sylvain Iceta

Associate professor

Laval University

研究点 (3)

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