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Completed

NCT Number: NCT06039514

Mobile App for Eating Disorders in Adolescents

This study aims to evaluate the effectiveness of GGTCA-AD to decrease the maladaptive beliefs associated with eating disorders (ED) in non-clinical adolescent population. Specifically, a randomized controlled trial with parallel design and two groups (experimental and control) will be carried out in adolescents aged 13-15 years to assess the changes pre and post use of the app. It is expected that after the use of the GGTCA-AD app for 14 days, at the primary level, a: decrease in the degree of ascription to dysfunctional beliefs associated with ED; and at the secondary level: increase in body satisfaction and self-esteem; decrease in eating symptomatology; and no changes in emotional symptomatology. These results are also expected to be maintained in subsequent follow-up at 1 month.

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Key information

Conditions

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

Age range

13 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia/ Universitat de València

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.

The GGTCA app is a module of GGtude that was developed to work on dysfunctional beliefs associated with eating disorders. Previous research showed that the app produced a statistically significant decrease of mean scores in maladaptive beliefs associated with ED and a statistically significant increase in self-esteem in adult population.

Furthermore, adolescence is a developmental stage vulnerable to the development of these disorders, so it's relevant to adapt the GGTCA application to the adolescent population (GGTCA-AD) and to evaluate its effectiveness.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(1) ages between 13 and 16; (2) that the parents or guardians of the adolescents and the participants have signed the informed consent form; (3) have a dispositive with Internet access.

Exclusion criteria

(1) have inadequately answered control questions, for example "please check the option every day in this sentence".

Treatment and study plan

GGTCA-AD mobile app

Device

The intervention will be done through an adaptation of the GGTCA app for teenagers: GGTCA-AD. This app 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 cognitive behavior therapy (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.

GGNeutra mobile app

Device

the control group will complete another module belonging to the GGTUDE digital platform. Specifically, this app is called GGNEUTRA, and the statements that compose it are totally independent of the target of the study. The operation is similar, sentences appear in the center of the screen, but in this case, the person must accept those sentences that are true, for example: "Madrid is the capital of Spain", by dragging it to the top of the screen; and reject those that are false, for example: "Tokyo is the capital of Spain", by dragging it to the bottom of the screen.

Primary outcomes

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

    Time frame: 15 days (after using the app) and one month later at follow-up.

    Score change in eating disorders maladaptive beliefs 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 maladaptive beliefs.

Secondary outcomes

  1. Change in eating symptomatology.

    Time frame: 15 days (after using the app) and one month later at follow-up.

    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 (after using the app) and one month later at follow-up.

    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 (after using the app) and one month later at follow-up.

    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 persona has more self-esteem.

  4. Changes in emotional symptoms

    Time frame: 15 days (after using the app) and one month later at follow-up.

    No score change in depression and anxiety symptoms measured by The Patient Health Questionnaire for Depression and Anxiety (PH-4). It consists of 4 items, two for Anxiety and two for Depression, with a 4-point Likert scale (from 0 = "never" to 3 = "almost every day"). Higher scores indicate a greater presence of depression or anxiety symptoms.

  5. Changes in perfectionism ans interpersonal distrust symptoms

    Time frame: 15 days (after using the app) and one month later at follow-up.

    Score change in perfectionism ans interpersonal distrust symptoms measured by the Eating Disorder Inventory (EDI-3), composed of 90 items with a 6-point Likert scale, where 0 = Never and 5 = Always. In this study only the interpersonal distrust and perfectionism factors are used, consisting of 7 and 6 items respectively. Higher scores indicate the person has greater presence of interpersonal distrust and perfectionism.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Ministry of Science and Innovation, Spain

Registry information

Official study title

Promoting Mental Health in Adolescents Through Mobile Apps: the Case of Eating Disorders.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 15, 2023
Registry last updated
Jun 18, 2024

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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