Eating Disorders in Adolescence Clinical Trial
Official title:
Promoting Mental Health in Adolescents Through Mobile Apps: the Case of Eating Disorders.
Verified date | June 2024 |
Source | University of Valencia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 93 |
Est. completion date | May 23, 2024 |
Est. primary completion date | May 23, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 15 Years |
Eligibility | 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". |
Country | Name | City | State |
---|---|---|---|
Spain | University of Valencia/ Universitat de València | Valencia |
Lead Sponsor | Collaborator |
---|---|
University of Valencia | Ministry of Science and Innovation |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the degree of ascription to dysfunctional beliefs associated with ED. | Score change in eating disorders maladaptive beliefs measured by the Eating Disorder Beliefs Questionnaire (EDBQ). It is composed of 32 items that examines core beliefs about weight, physical appearance and eating that are associated with eating disorders. Items are rated on an analog scale from 0 to 100, being 0 "I do not usually believe this at all" and 100 "I am usually completely convinced that this is true". Higher scores indicate the person has more maladaptive beliefs. | 15 days (after using the app) and one month later at follow-up. | |
Secondary | Change in eating symptomatology. | Score change in eating symptoms measured by the Eating Disorder Examination Questionnaire (EDE-Q). It is a 36-item self-report questionnaire with 7-point Likert-type scale ranging from 0 (No day/ No time/ Not at all) to 6 (Every day/ Always/ Completely). It's composed of attitudinal and behavioral items, using for the present study only the attitudinal items (22 items). Higher scores indicate the person has greater presence of eating symptomatology. | 15 days (after using the app) and one month later at follow-up. | |
Secondary | Change in body satisfaction. | Score change in body satisfaction measured by the Body Appreciation Scale-2 (BAS-2). It is a single-factor questionnaire that evaluates body satisfaction with 10 items on a 5-point Likert scale (1 = Never; 5 = Always). Higher scores indicate the person has more body satisfaction. | 15 days (after using the app) and one month later at follow-up. | |
Secondary | Change in self-esteem. | Score change in self-report measures with The Single-Item Self-Esteem Scale (SISE; Robins et al., 2001). The person has to indicate how the statement "I have high self-esteem" describes him/her on a 9-point scale (1 = "Not very true for me" and 9 = "Very true for me"). Higher scores indicate the persona has more self-esteem. | 15 days (after using the app) and one month later at follow-up. | |
Secondary | Changes in emotional symptoms | No score change in depression and anxiety symptoms measured by The Patient Health Questionnaire for Depression and Anxiety (PH-4). It consists of 4 items, two for Anxiety and two for Depression, with a 4-point Likert scale (from 0 = "never" to 3 = "almost every day"). Higher scores indicate a greater presence of depression or anxiety symptoms. | 15 days (after using the app) and one month later at follow-up. | |
Secondary | Changes in perfectionism ans interpersonal distrust symptoms | Score change in perfectionism ans interpersonal distrust symptoms measured by the Eating Disorder Inventory (EDI-3), composed of 90 items with a 6-point Likert scale, where 0 = Never and 5 = Always. In this study only the interpersonal distrust and perfectionism factors are used, consisting of 7 and 6 items respectively. Higher scores indicate the person has greater presence of interpersonal distrust and perfectionism. | 15 days (after using the app) and one month later at follow-up. |
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