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

NCT06288347 | Completed

• 1 other identifier: 216099
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Orthorexia Nervosa

Keywords

maladaptive beliefs; cognitive therapy; mobile app; e-health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Orthorexia symptomatology

  15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later

• Change in eating symptomatology

  15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later

• Change in self-esteem.

  15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later

• Change in emotional symptomatology

  15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later

• Change in obsessive beliefs

  15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group used the GGON module for 15 days after the first assessment.

Device: GGON mobile app.

Control group

ACTIVE COMPARATOR

The control group used the GGON module for 15 days after the second assessment.

Device: GGON mobile app.

Interventions

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.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Related Links

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

MeSH Terms

Conditions

Orthorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 1, 2024
• Study Start: May 2, 2024
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: 3 months after the study is published.
• 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.

Locations

ES (1)