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

NCT06179992 | Completed

• 1 other identifier: GVA/2021/162
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eating Disorders

Keywords

maladaptive beliefs; cognitive therapy; mobile app; apps; e-health; non-clinical population

Outcome Measures

Primary Outcomes (2)

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

  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.

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

• Change in maladaptive body and eating beliefs.

  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.

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

Secondary Outcomes (4)

• Change in eating symptomatology.

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

• Change in body satisfaction.

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

• 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 emotional symptomatology.

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

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group used the GGED module for 15 days after the first assessment.

Device: GGED mobile app

Control group

ACTIVE COMPARATOR

The control group used the GGED module for 15 days after the second assessment.

Device: GGED mobile app

Interventions

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.

Also known as: GGED app

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Related Links

• Description Information about GGTUDE Mobile App and links to download.

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 Design

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

Model Details: All participants were requested to complete web-based assessment, with questionnaires relating to maladaptive beliefs associated with ED, eating and emotional symptomatology, body satisfaction and self-esteem at baseline (T1). The experimental group started using the app for 15 days, and later completed the following assessment (T2). The control group also completed the T2 in the same date but started to use the app after this second assessment.15 days and one month later, both groups completed T3 and T4.

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: December 9, 2022
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: April 30, 2025

Record last verified: 2024-01

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)