A Cross-over Randomized-control Study Evaluating the Efficacy of GGON in Reducing Maladaptive Beliefs Related to Orthorexia Nervosa.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Change in the degree of ascription to dysfunctional beliefs associated with Orthorexia Nervosa
研究概览
简要总结
The aim of the present study is to evaluate the efficacy of GGON to decrease the maladaptive beliefs associated with orthorexia nervosa (ON) 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 GGON app for 15 days are, at the primary level: decrease in the degree of ascription to dysfunctional beliefs associated with ON; and at the secondary level: decrease in orthorexia nervosa symptomatology, in eating symptomatology and in obsessive beliefs; increase in self-esteem; and no changes in drepessive symptomatology. 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, eating disorders, depression, body image or obsessive-compulsive disorder, that have proven their effectiveness. The GGON app has not efficacy studies. So, it is relevant to evaluate its effectiveness with an RCT study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages between 18 and
- •Have a dispositive with Internet access.
排除标准
- 未提供
研究组 & 干预措施
Experimental group
The experimental group used the GGON module for 15 days after the first assessment.
干预措施: GGON mobile app. (Device)
Control group
The control group used the GGON module for 15 days after the second assessment.
干预措施: GGON mobile app. (Device)
结局指标
主要结局
Change in the degree of ascription to dysfunctional beliefs associated with Orthorexia Nervosa
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 Orthorexia Nervosa measured by Orthorexia Beliefs Scale (OBS). Self-assessment instrument that evaluates the core beliefs of orthorexia nervosa. Its original version is in Spanish. It is composed of 21 items with a 4-point Likert-type scale response (0 = Strongly Disagree to 3 = Strongly Agree). Specifically, it assesses three factors: value, morality and control. These factors present adequate internal consistency in the sample of this study, with Cronbach's α values ranging from .72 to .86.
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 Orthorexia 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)
- Change in obsessive beliefs(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)
研究者
María Roncero
Associate Professor
University of Valencia