Study of the Efficacy of GGON: a Cognitive Training App for Orthorexia Nervosa.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Orthorexia Nervosa
• Intervention / Treatment: Device: GGON mobile app.

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: María Roncero, PhD; Phone Number: 83364 0034963983364; Email: maria.roncero@uv.es

Study Locations

• Spain
  • Valencia, Spain, 46010
    • University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Ages between 18 and 65.
• Have a dispositive with Internet access.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; The experimental group used the GGON module for 15 days after the first assessment.	Device: 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.
Active Comparator: Control group; The control group used the GGON module for 15 days after the second assessment.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	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.	15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later

Collaborators and Investigators

• Sponsor: University of Valencia

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 2, 2024
• Primary Completion (Estimated): June 17, 2024
• Study Completion (Estimated): June 17, 2024

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: cognitive therapy; e-health; mobile app; maladaptive beliefs
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Orthorexia Nervosa
• Other Study ID Numbers: 216099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Share all IPD that underlie results in a publication.
• IPD Sharing Time Frame: 3 months after the study is published.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No