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Eating DisordersNCT06842862

Mobile Application for Relapse Prevention in Eating Disorders Beliefs in Three Patients in Remission.

A study testing GGED in people with Eating Disorders, run by University of Valencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to assess the efficacy of GGED module in preventing relapse in three patients with ED diagnoses in remission. In particular, the objective of the present study is to analyse whether the GGED module diminishes the level of attachment to dysfunctional beliefs related to the maintenance of EDs, which had… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Eating Disorders
What is being tested?
GGED
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteSpain
Study dates
19 Sep 2023to 24 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (1) informed consent signed; (2) a diagnosis of an ED in remission; (3) having received CBT; (4) and access to a mobile device to complete the GGED module.

Who cannot join

  • (1) Not meeting the described inclusion criteria.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University of Valencia

    Valencia, 46010

Other trials in Spain

About this study

Official title: A Mobile Application to Work on Dysfunctional Beliefs Related to Eating Disorders: a Case Series Study in Three Patients in Remission

This study aims to assess the efficacy of GGED module in preventing relapse in three patients with ED diagnoses in remission. In particular, the objective of the present study is to analyse whether the GGED module diminishes the level of attachment to dysfunctional beliefs related to the maintenance of EDs, which had previously been addressed in CBT therapy. Specifically, an uncontrolled case series design was carried out to assess the changes pre and post use the app. It's expected that after the use of the GGED module for 15 days are, the patients show 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 and body satisfaction; decrease in eating symptomatology; and no changes in emotional symptomatology. These results are also expected to be maintained in subsequent follow-ups, at 15 days and a month after to finish the app.

Read the detailed description

There is a mobile platform, called OCD.app (previously GGtude) which is an evidence-based platform comprising of brief game-like exercises targeting a wide range of psychological symptoms. GGED (GG Eating Disorders) is a module within the app that addresses the core beliefs related to the development and maintenance of eating disorders. In this, 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. GGED has shown promising results in reducing maladaptive beliefs in the general adult population and in general adolescent population. In addition, another module that target on obsessive-Compulsive disorder (OCD) has demonstrated its efficacy in preventing relapses in patients diagnosed with OCD in remission. Given that the GGED module has not yet been tested in EDs patients and there is a need for the development of techniques to prevent relapses in these disorders, the objective of the present study is to assess its efficacy in preventing relapse in three patients with ED diagnoses in remission.

Being tested
GGED
Keywords
Maladaptive beliefs, Relapse prevention, Mobile app, Patients, Case series study
Medical subject headings
Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GGEDDevice

    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 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.

Study groups in NCT06842862
Study groupRoleWhat they receive
GGEDExperimentalThe patients used the GGED module for 15 days after the first assessment.
Receives: Device: GGED

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 15 days and 15 days later

  2. 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.

    Measured: 15 days and 15 days later

Secondary outcomes (4)

  1. 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.

    Measured: 15 days and 15 days later

  2. 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.

    Measured: 15 days and 15 days later

  3. Change in self-esteem

    Score change in depression 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.

    Measured: 15 days and 15 days later

  4. Change in depressive and anxious symptomatology

    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.

    Measured: 15 days and 15 days later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2025
  2. Study start19 Sep 2023
  3. Primary completion24 Jun 2024
  4. Study completion24 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06842862
Sponsor's protocol ID
2021/162
Status last verified
Feb 2025
First submitted
18 Feb 2025
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Share all IPD that underlie results in a publication.

Publications

  • Corberan M, Carratala-Ricart L, Segura-Serralta M, Agullo I, Garcia-Soriano G, Roncero M. Cognitive Intervention via Mobile App for Eating Disorders: An Exploratory Case Series in Remission-Phase Patients. J Cogn Psychother. 2026 Feb 14:JCP-2025-0019.R1. doi: 10.1891/JCP-2025-0019. Online ahead of print.

    PubMed 41690793

Questions about this trial

What is this clinical trial studying?

A study testing GGED in people with Eating Disorders, run by University of Valencia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the degree of ascription to dysfunctional beliefs associated with ED (time frame: 15 days and 15 days later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06842862, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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