Eating Disorders in AdolescenceNCT06039514
Mobile App for Eating Disorders in Adolescents
A study testing GGTCA-AD mobile app and GGNeutra mobile app in people with Eating Disorders in Adolescence, run by University of Valencia at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 13 to 15 years
- Conditions the study is for
- Eating Disorders in Adolescence
- What is being tested?
- GGTCA-AD mobile app and GGNeutra mobile app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteSpain
- Study dates
- 9 Apr 2024to 23 May 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 13 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- have inadequately answered control questions, for example "please check the option every day in this sentence".
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Mental Health in Adolescents Through Mobile Apps: the Case of Eating Disorders.
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.
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.
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.
- Conditions
- Eating Disorders in Adolescence
- Being tested
- GGTCA-AD mobile app, GGNeutra mobile app
- Keywords
- Maladaptive beliefs, Cognitive therapy, Eating Disorders, Mobile app, Adolescents, e-health
- 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.
GGTCA-AD mobile appDevice
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 appDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| GGTCA-AD mobile app | Experimental | The experimental group uses the GGTCA-AD module for 14 days after the first assessment. Receives: Device: GGTCA-AD mobile app |
| GGNeutra mobile app | Active comparator | The control group uses GGNeutra for 14 days after the first assessment. Receives: Device: GGNeutra 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 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 (after using the app) and one month later at follow-up.
Secondary outcomes (5)
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 (after using the app) and one month later at follow-up.
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 (after using the app) and one month later at follow-up.
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.
Measured: 15 days (after using the app) and one month later at follow-up.
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.
Measured: 15 days (after using the app) and one month later at follow-up.
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.
Measured: 15 days (after using the app) and one month later at follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start9 Apr 2024
- Primary completion23 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating Disorders in AdolescenceStudies 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
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain
- Responsible party
- Principal investigator, Gemma García-Soriano, University of Valencia
- Investigators
- Gemma García Soriano, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039514
- Sponsor's protocol ID
- PID2021-124409OB-I00
- Status last verified
- Jun 2024
- First submitted
- 4 Sep 2023
- Last updated
- 18 Jun 2024
- 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, 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.
PubMed 38745260
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Mental Health in Adolescents Through Mobile Apps: the Case of Eating Disorders.
- ClinicalTrials.gov ID
- NCT06039514
- Acronym / sponsor ID
- PID2021-124409OB-I00
- Conditions
- Eating Disorders in Adolescence
- Keywords
- Maladaptive beliefs, Cognitive therapy, Eating Disorders, Mobile app, Adolescents, e-health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 15 Sep 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.
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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| GGTCA-AD mobile app | Experimental | Device: GGTCA-AD mobile appThe experimental group uses the GGTCA-AD module for 14 days after the first assessment. |
| GGNeutra mobile app | Active comparator | Device: GGNeutra mobile appThe control group uses GGNeutra for 14 days after the first assessment. |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- have inadequately answered control questions, for example "please check the option every day in this sentence".
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 |
|---|---|---|
| GGTCA-AD mobile appThe 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. | Device | GGTCA-AD mobile app |
| GGNeutra mobile appthe 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. | Device | GGNeutra mobile app |
Primary outcome
Change in the degree of ascription to dysfunctional beliefs associated with ED.
Time frame: 15 days (after using the app) and one month later at follow-up.
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.
5 secondary outcomes
Change in eating symptomatology.
Time frame: 15 days (after using the app) and one month later at follow-up.
Change in body satisfaction.
Time frame: 15 days (after using the app) and one month later at follow-up.
Change in self-esteem.
Time frame: 15 days (after using the app) and one month later at follow-up.
Changes in emotional symptoms
Time frame: 15 days (after using the app) and one month later at follow-up.
Changes in perfectionism ans interpersonal distrust symptoms
Time frame: 15 days (after using the app) and one month later at follow-up.
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 18 Jun 2024.
- Derived from this study: PubMed 38745260Corberan 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.
- Link to download the app from Google PlayLink provided by the sponsor.
- 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.
Gemma García Soriano principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GGTCA-AD mobile app and GGNeutra mobile app in people with Eating Disorders in Adolescence, 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 18 Jun 2024. 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 (after using the app) and one month later at follow-up.). 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 NCT06039514, 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 18 Jun 2024.