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Completed

NCT Number: NCT06179992

Study of the Efficacy of GGED: a Cognitive Training App for Eating Disorders.

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.

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Key information

Conditions

Eating Disorders Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages between 18 and 40.
  • Have a dispositive with Internet access.

Exclusion criteria

  • None.

Treatment and study plan

GGED mobile app

Device

The intervention will be done through an app named GGED, which is used to work on the dysfunctional beliefs that are associated with eating disorders. The app is made up of a series of levels comprising the topics that are normally worked on in CBT in relation to eating disorders. At each level, affirmations in the form of beliefs appear on the screen, and the person must accept them if they are functional, adaptive and positive; or reject them if they are dysfunctional, maladaptive and negative.

Other names: GGED app

Primary outcomes

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

    Time frame: 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.

  2. Change in maladaptive body and eating beliefs.

    Time frame: 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.

Secondary outcomes

  1. Change in eating symptomatology.

    Time frame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later

    Score change in eating symptoms measured by the Eating Disorder Examination Questionnaire (EDE-Q). It is a 36-item self-report questionnaire with 7-point Likert-type scale ranging from 0 (No day/ No time/ Not at all) to 6 (Every day/ Always/ Completely). It's composed of attitudinal and behavioral items, using for the present study only the attitudinal items (22 items). Higher scores indicate the person has greater presence of eating symptomatology.

  2. Change in body satisfaction.

    Time frame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later

    Score change in body satisfaction measured by the Body Appreciation Scale-2 (BAS-2). It is a single-factor questionnaire that evaluates body satisfaction with 10 items on a 5-point Likert scale (1 = Never; 5 = Always). Higher scores indicate the person has more body satisfaction.

  3. Change in self-esteem.

    Time frame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later

    Score change in self-report measures with The Single-Item Self-Esteem Scale (SISE; Robins et al., 2001). The person has to indicate how the statement "I have high self-esteem" describes him/her on a 9-point scale (1 = "Not very true for me" and 9 = "Very true for me"). Higher scores indicate the person has more self-esteem.

  4. Change in emotional symptomatology.

    Time frame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later

    Score change in emotional symptomatology measured by The Depression, Anxiety-Stress Scale (DASS-21). It is composed of 21 items that evaluate emotional negative symptoms: depression, anxiety and stress. It has a Likert scale with 4 points (0 = "Did not apply to me at all" and 3 = "Applied to me very much or most of the time"). In this study only the scale of depression was used, composed of 7 items. Higher scores indicate the person has more emotional symptomatology.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 22, 2023
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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