Eating DisordersNCT06179992
Study of the Efficacy of GGED: a Cognitive Training App for Eating Disorders.
A study testing GGED mobile app in people with Eating Disorders, run by University of Valencia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders
- What is being tested?
- GGED mobile app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteSpain
- Study dates
- 9 Dec 2022to 22 Jun 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages between 18 and 40.
- Have a dispositive with Internet access.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-over Randomized-control Study Evaluating the Efficacy of GGED in Reducing Maladaptive Beliefs Related to Eating Disorders.
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.
Read the detailed 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.
There are different modules, for example, to work self-esteem, depression, body image or obsessive-compulsive disorder, that have proven their effectiveness.
- Conditions
- Eating Disorders
- Being tested
- GGED mobile app
- Keywords
- maladaptive beliefs, cognitive therapy, mobile app, apps, e-health, non-clinical population
- 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.
GGED mobile appDevice
Also called GGED app
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group used the GGED module for 15 days after the first assessment. Receives: Device: GGED mobile app |
| Control group | Active comparator | The control group used the GGED module for 15 days after the second assessment. Receives: Device: GGED mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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 for experimental group 15 and 30 days later; and for the control group 15 days later
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 for experimental group 15 and 30 days later; and for the control group 15 days later
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 person has more self-esteem.
Measured: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
Change in emotional 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 for experimental group 15 and 30 days later; and for the control group 15 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start9 Dec 2022
- Primary completion22 Jun 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Roncero, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179992
- Sponsor's protocol ID
- GVA/2021/162
- Status last verified
- Jan 2024
- First submitted
- 12 Dec 2023
- Last updated
- 30 Apr 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-over Randomized-control Study Evaluating the Efficacy of GGED in Reducing Maladaptive Beliefs Related to Eating Disorders.
- ClinicalTrials.gov ID
- NCT06179992
- Acronym / sponsor ID
- GVA/2021/162
- Conditions
- Eating Disorders
- Keywords
- maladaptive beliefs, cognitive therapy, mobile app, apps, e-health, non-clinical population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
There are different modules, for example, to work self-esteem, depression, body image or obsessive-compulsive disorder, that have proven their effectiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: GGED mobile appThe experimental group used the GGED module for 15 days after the first assessment. |
| Control group | Active comparator | Device: GGED mobile appThe control group used the GGED module for 15 days after the second assessment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ages between 18 and 40.
- Have a dispositive with Internet access.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GGED mobile appAlso: GGED appThe 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. | Device | Control group, Experimental group |
Primary outcome
Change in the degree of ascription to dysfunctional beliefs associated with ED.
Time frame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
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.
Change in maladaptive body and eating beliefs.
Time frame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
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.
4 secondary outcomes
Change in eating symptomatology.
Time frame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
Change in body satisfaction.
Time frame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
Change in self-esteem.
Time frame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
Change in emotional symptomatology.
Time frame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: Yes. Share all IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GGED mobile app 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 2 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 30 Apr 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 for experimental group 15 and 30 days later; and for the control group 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?
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 30 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.