Clinical trial NCT06039514: Mobile App for Eating Disorders in Adolescents
Official title: Promoting Mental Health in Adolescents Through Mobile Apps: the Case of Eating Disorders.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders in Adolescence
Keywords: Maladaptive beliefs
Cognitive therapy
Eating Disorders
Mobile app
Adolescents
e-health
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Innovation, Spain
First posted: 2023-09-15
Enrollment: 93
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

(1) 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.

Exclusion Criteria:

(1) have inadequately answered control questions, for example "please check the option every day in this sentence".

Primary outcomes:
measure: Change in the degree of ascription to dysfunctional beliefs associated with ED.
timeFrame: 15 days (after using the app) and one month later at follow-up.
Secondary outcomes:
measure: Change in eating symptomatology.
timeFrame: 15 days (after using the app) and one month later at follow-up.
measure: Change in body satisfaction.
timeFrame: 15 days (after using the app) and one month later at follow-up.
measure: Change in self-esteem.
timeFrame: 15 days (after using the app) and one month later at follow-up.
measure: Changes in emotional symptoms
timeFrame: 15 days (after using the app) and one month later at follow-up.
measure: Changes in perfectionism ans interpersonal distrust symptoms
timeFrame: 15 days (after using the app) and one month later at follow-up.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia/ Universitat de València
Study officials:
affiliation: University of Valencia
name: Gemma García Soriano
role: PRINCIPAL_INVESTIGATOR
References: