Self-help Application for Eating Disorder

Study Overview
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Brief Summary
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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

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

Conditions
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Eating Disorder in Adolescents and Young Adults

Intervention / Treatment
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* Procedure: Arm I (Prepectoral),
* Procedure: Arm II (Subpectoral)


Participation Criteria
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Eligibility Criteria
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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 BMI ≤ 17.5 having developmental disabilities, including autism, intellectual disabilities, schizophrenia, or other psychosis

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The waitlist group receives usual care for the first 8 weeks. After 8 weeks, the waitlist group begins the intervention and the immediate intervention group begins a maintenance phase
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I (Prepectoral)<br>Participants received the Self-help app-based CBT-E for eating disorder for 8 weeks | Procedure: Arm I (Prepectoral),<br>* 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.<br>|
| Other: II (Subpectoral)<br>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)<br>* 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.<br>|

What is the study measuring?
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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 |