Clinical trial NCT06288347: Study of the Efficacy of GGON: a Cognitive Training App for Orthorexia Nervosa.
Official title: A Cross-over Randomized-control Study Evaluating the Efficacy of GGON in Reducing Maladaptive Beliefs Related to Orthorexia Nervosa.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthorexia Nervosa
Keywords: maladaptive beliefs
cognitive therapy
mobile app
e-health
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in the degree of ascription to dysfunctional beliefs associated with Orthorexia Nervosa
timeFrame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
Secondary outcomes:
measure: Change in Orthorexia symptomatology
timeFrame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
measure: Change in eating symptomatology
timeFrame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
measure: Change in self-esteem.
timeFrame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
measure: Change in emotional symptomatology
timeFrame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
measure: Change in obsessive beliefs
timeFrame: 15 days, and for experimental group 15 and 30 days later; and for the control group 15 days later
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
References: