A Randomized Controlled Trials of Self-help Application for Eating Disorder Through Multifaceted Measurement

Gangnam Severance Hospital1 site in 1 country120 target enrollmentJanuary 27, 2023

ConditionsEating Disorder in Adolescents and Young Adults

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Eating Disorder in Adolescents and Young Adults
Sponsor: Gangnam Severance Hospital
Enrollment: 120
Locations: 1
Primary Endpoint: Change in Eating Disorder Cognitions assessed using EDE-Q global scores
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether mobile-based self-help CBT-E treatment for eating disorder can reduce eating disorder symptoms compared to the waitlist group

Registry

clinicaltrials.gov

Start Date

January 27, 2023

End Date

December 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Gangnam Severance Hospital

Responsible Party

Principal Investigator

Eun Joo Kim

Associate professor

Gangnam Severance Hospital

Eligibility Criteria

Inclusion Criteria

•Aged 13-22 years
•Owns a smartphone
•Experienced at least one episode of binge eating over the past 4 weeks

Exclusion Criteria

•diagnosed with anorexia nervosa
•having developmental disabilities, including autism, intellectual disabilities, schizophrenia, or other psychosis

Outcomes

Primary Outcomes

Change in Eating Disorder Cognitions assessed using EDE-Q global scores

Time Frame: Baseline, 8 weeks,16 weeks, 28 weeks

The global score of Eating Disorder Examination Questionnaire (EDE-Q) has the 28-item scale of key attitudinal and behavioral ED symptoms. Higher scores indicate higher eating disorder symptomology.

Secondary Outcomes

Change in assessed the impact an eating disorder has on psychosocial functioning using The Clinical Impairment Assessment Questionnaire (CIA)(Baseline, 8 weeks,16 weeks, 28 weeks)
Change in self-esteem assessed using the Rosenberg self-esteem scale (RSES)(Baseline, 8 weeks,16 weeks, 28 weeks)
Change in the body attitudes associated with desiring a thinner assessed using the Eating Disorder Inventory-2, Drive for Thinness(Baseline, 8 weeks,16 weeks, 28 weeks)
Change in concerns with body weight assessed using EDE-Q weight concern scores(Baseline, 8 weeks,16 weeks, 28 weeks)
Change in concerns with body shape assessed using EDE-Q shape concern scores(Baseline, 8 weeks,16 weeks, 28 weeks)
Change in concerns with eating assessed using EDE-Q eating concern scores(Baseline, 8 weeks,16 weeks, 28 weeks)
Change in restrained eating assessed using EDE-Q dietary restraint scores(Baseline, 8 weeks,16 weeks, 28 weeks)
Change in eating disorder symptoms assessed using the Eating Attitude Test(Baseline, 8 weeks,16 weeks, 28 weeks)
Change in addictive-like eating behaviors assessed using the Yale Food Addiction scale(Baseline, 8 weeks,16 weeks, 28 weeks)
Change in addictive-like eating behaviors assessed using the Yale Food Addiction Scale for Children(Baseline, 8 weeks,16 weeks, 28 weeks)
Change in emotion regulation problems assessed using the Difficulties in Emotion Regulation Scale(Baseline, 8 weeks,16 weeks, 28 weeks)
Change in Depression symptoms assessed using the Beck Depression Inventory(Baseline, 8 weeks,16 weeks, 28 weeks)
Change in anxiety symptoms assessed using the State-Trait Anxiety Inventory(Baseline, 8 weeks,16 weeks, 28 weeks)
Change in eating disorder symptoms assessed using the Korean version of the Eating disorder Diagnostic Scale(Baseline, 8 weeks,16 weeks)
Change in the heart rate variability(Baseline, 8 weeks,16 weeks)
Change in brain activities recorded with functional near-infrared spectroscopy (fNIRS)(Baseline, 8 weeks)