Self-help Application for Eating Disorder

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

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

Study Overview

• Status: Recruiting
• Conditions: Eating Disorder in Adolescents and Young Adults
• Intervention / Treatment: Procedure: Arm I (Prepectoral),; Procedure: Arm II (Subpectoral)

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: EunJoo Kim; Phone Number: 82-2-2019-4601; Email: ejkim96@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • GangnamSeverance Hospital
    • Contact: EunJoo Kim; Phone Number: 82-2-2019-4601; Email: ejkim96@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. diagnosed with anorexia nervosa
2. BMI ≤ 17.5
3. having developmental disabilities, including autism, intellectual disabilities, schizophrenia, or other psychosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I (Prepectoral); Participants received the Self-help app-based CBT-E for eating disorder for 8 weeks	Procedure: Arm I (Prepectoral),; The intervention will be delivered through a smartphone app. The app provides users with ED symptom self-monitoring, psycho-education and relapse prevention in an evidence-based CBT-E.
Other: II (Subpectoral); Waiting list Wait-list control(participants will use the smartphone app after the intervention phase) The waitlist group will receive treatment as usual, Patients from the waitlist group will be offered access to App after a 8-weeks period.	Procedure: Arm II (Subpectoral); The intervention will be delivered through a smartphone app. The app provides users with ED symptom self-monitoring, psycho-education and relapse prevention in an evidence-based CBT-E.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Eating Disorder Cognitions assessed using EDE-Q global scores	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.	Baseline, 8 weeks,16 weeks, 28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in concerns with body weight assessed using EDE-Q weight concern scores	EDE-Q subscales Higher scores indicate higher eating disorder symptomology.	Baseline, 8 weeks,16 weeks, 28 weeks
Change in concerns with body shape assessed using EDE-Q shape concern scores	EDE-Q subscales Higher scores indicate higher eating disorder symptomology.	Baseline, 8 weeks,16 weeks, 28 weeks
Change in restrained eating assessed using EDE-Q dietary restraint scores	EDE-Q subscales Higher scores indicate higher eating disorder symptomology.	Baseline, 8 weeks,16 weeks, 28 weeks
Change in concerns with eating assessed using EDE-Q eating concern scores	EDE-Q subscales Higher scores indicate higher eating disorder symptomology.	Baseline, 8 weeks,16 weeks, 28 weeks
Change in eating disorder symptoms assessed using the Eating Attitude Test	The Eating Attitude Test (EAT) is a 40-item, 6-point, self-report scale that measures dieting behaviors, food preoccupation, anorexia, bulimia, and concerns about being overweight. The total score (between 0 and 78) provides an overall risk score, where higher scores indicating greater risk of an eating disorder.	Baseline, 8 weeks,16 weeks, 28 weeks
Change in addictive-like eating behaviors assessed using the Yale Food Addiction scale	The Yale Food Addiction Scale is a 35-item self-report inventory to identify people most likely to have an addiction to high-fat and/or high-sugar foods. The scale uses a combination of Likert and dichotomous scoring options. The YFAS provides two scoring options, a "symptom" count version that indicates the number of dependence symptoms experienced in the past 12 months and a "diagnostic" threshold that is met when three or more "symptoms" are present during the past 12 months and clinically significant impairment or distress is endorsed(Gearhardt et al., 2012).	Baseline, 8 weeks,16 weeks, 28 weeks
Change in addictive-like eating behaviors assessed using the Yale Food Addiction Scale for Children	The Yale Food Addiction Scale for Children(YFAS-C) is a 25-item, 5-point self-report scale with higher scores indicating more food addiction symptoms in children. Items 1 to 18 are rated on a 5-point Likert scale and Items 19 to 25 are rated on a dichotomous (0 = no; 1 = yes) scale.	Baseline, 8 weeks,16 weeks, 28 weeks
Change in emotion regulation problems assessed using the Difficulties in Emotion Regulation Scale	The Difficulties in Emotion Regulation Scale(DERS) is the 36 items self-report scale to asks respondents how they relate to their emotions. Scores are presented as a total score as well as a score for each of the 6 subscales. Higher scores mean greater problems with emotion regulation.	Baseline, 8 weeks,16 weeks, 28 weeks
Change in Depression symptoms assessed using the Beck Depression Inventory	The Beck Depression Inventory (BDI) is a 21-item self-reporting questionnaire for assessing the severity of depression. The total score range from 0 to 63 and 0-9 indicates minimal depression, 10-18: indicates mild depression, 19-29: indicates moderate depression and 30-63: indicates severe depression.	Baseline, 8 weeks,16 weeks, 28 weeks
Change in anxiety symptoms assessed using the State-Trait Anxiety Inventory	The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale. Higher scores indicate greater anxiety	Baseline, 8 weeks,16 weeks, 28 weeks
Change in assessed the impact an eating disorder has on psychosocial functioning using The Clinical Impairment Assessment Questionnaire (CIA)	The Clinical Impairment Assessment questionnaire (CIA) is a 16-items self-report measure to assess psychosocial impairment resulting from eating disorder features. Possible scores range between 0 - 48, with higher scores indicating more impairment and lower scores indicating less impairment.	Baseline, 8 weeks,16 weeks, 28 weeks
Change in self-esteem assessed using the Rosenberg self-esteem scale (RSES)	The Rosenberg Self-Esteem Scale(RSES) is a A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The total score is from 0 to 30, with higher scores representing higher self-esteem.	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	Drive for thinness (DT), a subscale of the Eating Disorder Inventory (EDI), is a self-report measure of disordered eating attitudes about body image, weight, and shape. The total score is from 0 to 21. Higher scores mean an excessive concern with dieting, preoccupation with weight, and fear of weight gain	Baseline, 8 weeks,16 weeks, 28 weeks
Change in eating disorder symptoms assessed using the Korean version of the Eating disorder Diagnostic Scale	The Eating Disorder Diagnostic Scale (EDDS) is a 22-item self-report questionnaire designed to measure eating disorders symptomatology	Baseline, 8 weeks,16 weeks
Change in the heart rate variability	The heart rate variabilities the physiological recordings of the variation in the time interval between consecutive heartbeats in milliseconds. This measures only those who want it	Baseline, 8 weeks,16 weeks
Change in brain activities recorded with functional near-infrared spectroscopy (fNIRS)	Functional near-infrared spectroscopy (fNIRS) is a tool to measure functional brain activities using the changes of optical absorption in the brain through the intact skull. This tool measures only those who want it, and the target number of participants is 40.	Baseline, 8 weeks

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Publications and helpful links

General Publications

• Gearhardt AN, White MA, Masheb RM, Morgan PT, Crosby RD, Grilo CM. An examination of the food addiction construct in obese patients with binge eating disorder. Int J Eat Disord. 2012 Jul;45(5):657-63. doi: 10.1002/eat.20957. Epub 2011 Aug 30.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: 3-2022-0342

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No