Mobile App for Eating Disorders in Adolescents

NCT06039514 | Completed

• 1 other identifier: PID2021-124409OB-I00
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eating Disorders in Adolescence

Keywords

Maladaptive beliefs; Cognitive therapy; Eating Disorders; Mobile app; Adolescents; e-health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in eating symptomatology.

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

• Change in body satisfaction.

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

• Change in self-esteem.

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

• Changes in emotional symptoms

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

• Changes in perfectionism ans interpersonal distrust symptoms

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

Study Arms (2)

GGTCA-AD mobile app

EXPERIMENTAL

The experimental group uses the GGTCA-AD module for 14 days after the first assessment.

Device: GGTCA-AD mobile app

GGNeutra mobile app

ACTIVE COMPARATOR

The control group uses GGNeutra for 14 days after the first assessment.

Device: GGNeutra mobile app

Interventions

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.

GGTCA-AD mobile app

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.

GGNeutra mobile app

Eligibility Criteria

• Age: 13 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead
• Ministry of Science and Innovation, Spain: collaborator

Study Sites (1)

University of Valencia/ Universitat de València

Valencia, 46010, Spain

Location

Related Publications (1)

• Corberan M, Arnaez S, Saman Y, Pascual-Vera B, Garcia-Soriano G, Roncero M. Cognitive training via mobile app for addressing eating disorders' cognitions in adolescents: a randomized control trial protocol. BMC Psychol. 2024 May 14;12(1):268. doi: 10.1186/s40359-024-01772-z.

  PMID: 38745260 DERIVED

Related Links

• Link to download the app from Google Play

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Gemma García Soriano

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants that meet the inclusion criteria will complete the web-based baseline assessment (pre), with questionnaires relating to maladaptive beliefs, emotional symptomatology, self-esteem, body satisfaction and eating symptomatology. After, experimental group will use the GGTCA-AD, and control group will use the GGNeutra for 14 days. Then, both groups will complete again the above-mentioned assessment (post use the app). Finally, all participants will complete the follow-up measures at one month.

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 15, 2023
• Study Start: April 9, 2024
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: 3 months after the study is published.
• Access Criteria: The variables analyzed will be included in the manuscript in which the RCT data are presented, and will be published on the institutional page of the applicants' university (https://roderic.uv.es/) up to 3 months after the article is published.

Locations

ES (1)