Mobile App for Eating Disorders in Adolescents

Eating Disorders in Adolescence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06039514
• Other study ID #: PID2021-124409OB-I00
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 9, 2024
• Est. completion date: May 23, 2024

Study information

• Verified date: February 2024
• Source: University of Valencia
• Contact: Gemma García Soriano
• Phone: 963983389
• Email: gemma.garcia[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: May 23, 2024
• Est. primary completion date: May 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 15 Years

Eligibility

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".

Related Conditions & MeSH terms

• Eating Disorders in Adolescence
• Feeding and Eating Disorders

Intervention

Device:
• GGTCA-AD mobile app
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
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.

Locations

Country	Name	City	State
Spain	University of Valencia/ Universitat de València	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Ministry of Science and Innovation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the degree of ascription to dysfunctional beliefs associated with ED.	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.	15 days (after using the app) and one month later at follow-up.
Secondary	Change in eating symptomatology.	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.	15 days (after using the app) and one month later at follow-up.
Secondary	Change in body satisfaction.	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.	15 days (after using the app) and one month later at follow-up.
Secondary	Change in self-esteem.	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.	15 days (after using the app) and one month later at follow-up.
Secondary	Changes in emotional symptoms	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.	15 days (after using the app) and one month later at follow-up.
Secondary	Changes in perfectionism ans interpersonal distrust symptoms	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.	15 days (after using the app) and one month later at follow-up.

External Links

•   Link to download the app from Google Play