Mobile Application for Relapse Prevention in Eating Disorders Beliefs in Three Patients in Remission.

NCT06842862 | Completed

• 1 other identifier: 2021/162
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the efficacy of GGED module in preventing relapse in three patients with ED diagnoses in remission. In particular, the objective of the present study is to analyse whether the GGED module diminishes the level of attachment to dysfunctional beliefs related to the maintenance of EDs, which had previously been addressed in CBT therapy. Specifically, an uncontrolled case series design was carried out to assess the changes pre and post use the app. It's expected that after the use of the GGED module for 15 days are, the patients show at the primary level: decrease in the degree of ascription to dysfunctional beliefs associated with ED; and at the secondary level: increase in self-esteem and body satisfaction; decrease in eating symptomatology; and no changes in emotional symptomatology. These results are also expected to be maintained in subsequent follow-ups, at 15 days and a month after to finish the app.

Conditions

Eating Disorders

Keywords

Maladaptive beliefs; Relapse prevention; Mobile app; Patients; Case series study

Outcome Measures

Primary Outcomes (2)

• 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 and 15 days later

• Change in maladaptive body and eating beliefs

  Score change in maladaptive body and eating beliefs associated with ED measured by Obsessive Beliefs about Body Size and Eating Survey (OBBSES). It is composed of 57 items, which involve beliefs associated with food, eating, weight and body shape, divided into 5 factors: 1) appearance perfectionism; 2) vulnerability to weight gain; 3) eating control; 4) magical thinking; and, 5) thought control. People have to indicate in each item their degree of agreement in a Likert scale whit 7 point (1= "desagree very much" and 7 = "agree very much"). Higher scores indicate the person has more maladaptive body and eating beliefs.

  15 days and 15 days later

Secondary Outcomes (4)

• Change in eating symptomatology

  15 days and 15 days later

• Change in body satisfaction

  15 days and 15 days later

• Change in self-esteem

  15 days and 15 days later

• Change in depressive and anxious symptomatology

  15 days and 15 days later

Study Arms (1)

GGED

EXPERIMENTAL

The patients used the GGED module for 15 days after the first assessment.

Device: GGED

Interventions

GGED DEVICE

This app is used to work on the dysfunctional beliefs that are associated with eating disorders. The app is made up of a series of levels comprising the topics that are normally worked on in CBT in relation to eating disorders. 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.

GGED

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) informed consent signed; (2) a diagnosis of an ED in remission; (3) having received CBT; (4) and access to a mobile device to complete the GGED module.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: September 19, 2023
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

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)