Orthorexia NervosaNCT06288347
Study of the Efficacy of GGON: a Cognitive Training App for Orthorexia Nervosa.
A study testing GGON mobile app. in people with Orthorexia Nervosa, run by University of Valencia at 1 site in Spain.
Trial summary
The aim of the present study is to evaluate the efficacy of GGON to decrease the maladaptive beliefs associated with orthorexia nervosa (ON) 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 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthorexia Nervosa
- What is being tested?
- GGON mobile app.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSpain
- Study dates
- 2 May 2024to 17 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages between 18 and 65.
- 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 GGON in Reducing Maladaptive Beliefs Related to Orthorexia Nervosa.
The aim of the present study is to evaluate the efficacy of GGON to decrease the maladaptive beliefs associated with orthorexia nervosa (ON) 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 GGON app for 15 days are, at the primary level: decrease in the degree of ascription to dysfunctional beliefs associated with ON; and at the secondary level: decrease in orthorexia nervosa symptomatology, in eating symptomatology and in obsessive beliefs; increase in self-esteem; and no changes in drepessive symptomatology. 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, eating disorders, depression, body image or obsessive-compulsive disorder, that have proven their effectiveness. The GGON app has not efficacy studies. So, it is relevant to evaluate its effectiveness with an RCT study.
- Conditions
- Orthorexia Nervosa
- Being tested
- GGON mobile app.
- Keywords
- maladaptive beliefs, cognitive therapy, mobile app, e-health
- Medical subject headings
- Orthorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GGON mobile app.Device
The intervention will be done through an app named GGON, which is used to work on the dysfunctional beliefs that are associated with orthorexia nervosa. The app is made up of a series of levels comprising the topics based in cognitive-conductual perspective that are related to Orthorexia Nervosa. 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 GGON module for 15 days after the first assessment. Receives: Device: GGON mobile app. |
| Control group | Active comparator | The control group used the GGON module for 15 days after the second assessment. Receives: Device: GGON 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 Orthorexia Nervosa
Score change in the degree of ascription to dysfunctional beliefs associated with Orthorexia Nervosa measured by Orthorexia Beliefs Scale (OBS). Self-assessment instrument that evaluates the core beliefs of orthorexia nervosa. Its original version is in Spanish. It is composed of 21 items with a 4-point Likert-type scale response (0 = Strongly Disagree to 3 = Strongly Agree). Specifically, it assesses three factors: value, morality and control. These factors present adequate internal consistency in the sample of this study, with Cronbach's α values ranging from .72 to .86.
Measured: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
Secondary outcomes (5)
Change in Orthorexia symptomatology
Score change in Orthorexia symptomatology measured by Teruel Orthorexia Scale (TOS). It is an instrument for the assessment of orthorexia. Its original version is in Spanish. It consists of 17 items with a 4-point Likert-type response scale (0 = Strongly disagree to 3 = Strongly agree). It evaluates two factors: Healthy Orthorexia, referring to a healthy interest in diet, not associated with psychopathology; and Orthorexia Nervosa, which is the pathological preoccupation with a healthy diet. In the current study these factors present very good internal consistency, with Cronbach's α values of .84 and .82.
Measured: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
Change in eating symptomatology
Score change in eating symptoms measured by the Eating Disorder Examination Questionnaire (EDE-Q). It is a 36-item questionnaire designed to evaluate the range, frequency and severity of behaviors associated with eating disorders. It is structured into four distinct subscales: restriction, food concern, weight concern, and figure concern, each encompassing attitudinal and behavioral components. In the current study exclusively 22 attitudinal inquiries were used. Responses to these inquiries are assessed on a 7-point Likert scale, spanning from 0 ("No day/ No time/ Not at all") to 6 ("Every day/ Always/ Completely"). Internal consistency values for such factors were very good in this study (Cronbach's αs ranging from .81 to .92).
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). It is a self-esteem questionnaire in which individuals are asked to rate the extent to which the statement "I have high self-esteem" matches their self-perception on a 9-point scale (ranging from 1 = "Not very true for me" to 9 = "Very true for me"). This scale demonstrates strong test-retest reliability and exhibits a criterion validity coefficient comparable to that of the Rosenberg Self-Esteem Scale (Rosenberg, 1965), exceeding .80 Cronbach's alpha value.
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 a self-report that assesses negative emotional symptoms: depression, anxiety and stress. It consists of 21 items that are answered on a Likert-type scale from 0 to 3 (0 = "It does not affect me at all" and 4 = "It affects me a lot or most of the time"). In the present study, only the 7-itmes depression scale was used, which presented a very good internal consistency in this sample, with Cronbach's alpha values of .91.
Measured: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
Change in obsessive beliefs
Score change in obsessive beliefs measured by Inventario de Creencias Obsesivas Revisado (ICO-R). It is a 50-items questionnaire which assesses the dysfunctional beliefs related to development or mantenaince of obsessive-compulssive disorder (OCD), in both clinical and non-clinical samples. Its original version is in Spanish. It has a 7-point Likert-type response scale from 1 "strongly disagree" to 7 "strongly agree". It evaluates 8 scales: excessive responsibility, importance of thought control, perfectionism, overestimation of danger, intolerance to uncertainty, overimportance of thoughts, thought-action probability fusion, and thought-action moral fusion. Only the 33 items corresponding to the factors of excessive responsibility, importance of thought control, perfectionism, overestimation of danger and intolerance to uncertainty were used in this study. These factors present very good internal consistency in this sample, with Cronbach's α values ranging from .79 to .89.
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 posted1 Mar 2024
- Study start2 May 2024
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthorexia NervosaStudies 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 ON, ortorexia, eating and depressive symptomatology, obsessive belifs 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
- 112 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
- NCT06288347
- Sponsor's protocol ID
- 216099
- Status last verified
- Dec 2024
- First submitted
- 22 Feb 2024
- Last updated
- 6 Dec 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. 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 GGON in Reducing Maladaptive Beliefs Related to Orthorexia Nervosa.
- ClinicalTrials.gov ID
- NCT06288347
- Acronym / sponsor ID
- 216099
- Conditions
- Orthorexia Nervosa
- Keywords
- maladaptive beliefs, cognitive therapy, mobile app, e-health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 1 Mar 2024 (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 GGON to decrease the maladaptive beliefs associated with orthorexia nervosa (ON) 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 GGON app for 15 days are, at the primary level: decrease in the degree of ascription to dysfunctional beliefs associated with ON; and at the secondary level: decrease in orthorexia nervosa symptomatology, in eating symptomatology and in obsessive beliefs; increase in self-esteem; and no changes in drepessive symptomatology. 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, eating disorders, depression, body image or obsessive-compulsive disorder, that have proven their effectiveness. The GGON app has not efficacy studies. So, it is relevant to evaluate its effectiveness with an RCT study.
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 ON, ortorexia, eating and depressive symptomatology, obsessive belifs 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: GGON mobile app.The experimental group used the GGON module for 15 days after the first assessment. |
| Control group | Active comparator | Device: GGON mobile app.The control group used the GGON module for 15 days after the second assessment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages between 18 and 65.
- 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 |
|---|---|---|
| GGON mobile app.The intervention will be done through an app named GGON, which is used to work on the dysfunctional beliefs that are associated with orthorexia nervosa. The app is made up of a series of levels comprising the topics based in cognitive-conductual perspective that are related to Orthorexia Nervosa. 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 Orthorexia Nervosa
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 Orthorexia Nervosa measured by Orthorexia Beliefs Scale (OBS). Self-assessment instrument that evaluates the core beliefs of orthorexia nervosa. Its original version is in Spanish. It is composed of 21 items with a 4-point Likert-type scale response (0 = Strongly Disagree to 3 = Strongly Agree). Specifically, it assesses three factors: value, morality and control. These factors present adequate internal consistency in the sample of this study, with Cronbach's α values ranging from .72 to .86.
5 secondary outcomes
Change in Orthorexia symptomatology
Time frame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
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 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
Change in obsessive beliefs
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 6 Dec 2024.
- 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 GGON mobile app. in people with Orthorexia Nervosa, 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 6 Dec 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 Orthorexia Nervosa (time frame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later). 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 6 Dec 2024.