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临床试验/NCT06179992
NCT06179992已完成不适用

A Cross-over Randomized-control Study Evaluating the Efficacy of GGED in Reducing Maladaptive Beliefs Related to Eating Disorders.

University of Valencia2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2022年12月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
2
主要终点
Change in the degree of ascription to dysfunctional beliefs associated with ED.

研究概览

简要总结

The aim of the present study is to evaluate the efficacy of GGTCA to decrease the maladaptive beliefs associated with eating disorders (ED) in non-clinical adult population. Specifically, a randomized controlled trial with crossover assignment design and two groups (experimental and control) will be carried out in adults aged 18-65 years to assess the changes pre and post use the app. It's expected that after the use of the GGTCA app for 15 days are, at the primary level: decrease in the degree of ascription to dysfunctional beliefs associated with ED; and at the secondary level: increase in self-esteem; decrease in eating symptomatology; and no changes in emotional symptomatology, since the pilot study did not find. These results are also expected to be maintained in subsequent follow-ups, at 15 days and a month after to finish the app in experimental group, and 15 days after to finish the app in control group.

详细描述

There is a digital platform called GGtude, which is composed of different modules, each of them aimed at working with different mental health problems. The goal is to provide an easy-to-use tool as a CBT complement to work on the self-dialogue that relates to the core beliefs associated with the psychological problem in particular. To achieve this target, a cognitive training exercise is performed: different sentences appear in the form of beliefs, and the person must identify and accept those beliefs that are functional, adaptive and positive, dragging them to the lower part of the screen; and reject those that are dysfunctional, maladaptive and negative dragging them to the upper part of the screen.

There are different modules, for example, to work self-esteem, depression, body image or obsessive-compulsive disorder, that have proven their effectiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ages between 18 and
  • Have a dispositive with Internet access.

排除标准

  • 未提供

结局指标

主要结局

Change in the degree of ascription to dysfunctional beliefs associated with ED.

时间窗: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later

Score change in the degree of ascription to dysfunctional beliefs associated with ED measured by the Eating Disorder Beliefs Questionnaire (EDBQ). It is composed of 32 items that examines core beliefs about weight, physical appearance and eating that are associated with eating disorders. Items are rated on an analog scale from 0 to 100, being 0 "I do not usually believe this at all" and 100 "I am usually completely convinced that this is true". Higher scores indicate the person has more degree of ascription to dysfunctional beliefs associated with eating disorders.

Change in maladaptive body and eating beliefs.

时间窗: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later

Score change in maladaptive body and eating beliefs associated with ED measured by Obsessive Beliefs about Body Size and Eating Survey (OBBSES). It is composed of 57 items, which involve beliefs associated with food, eating, weight and body shape, divided into 5 factors: 1) appearance perfectionism; 2) vulnerability to weight gain; 3) eating control; 4) magical thinking; and, 5) thought control. People have to indicate in each item their degree of agreement in a Likert scale whit 7 point (1= "desagree very much" and 7 = "agree very much"). Higher scores indicate the person has more maladaptive body and eating beliefs.

次要结局

  • Change in self-esteem.(15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later)
  • Change in body satisfaction.(15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later)
  • Change in eating symptomatology.(15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later)
  • Change in emotional symptomatology.(15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later)

研究者

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

María Roncero

Associate Professor

University of Valencia

研究点 (2)

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