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Eating Disorder in Adolescents and Young AdultsNCT05615090

Self-help Application for Eating Disorder

A study testing Arm I (Prepectoral), and Arm II (Subpectoral) in people with Eating Disorder in Adolescents and Young Adults, run by Gangnam Severance Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 13 to 22 years
What is being tested?
Arm I (Prepectoral), and Arm II (Subpectoral)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSouth Korea
Study dates
27 Jan 2023to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 22 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • diagnosed with anorexia nervosa
  • BMI ≤ 17.5
  • having developmental disabilities, including autism, intellectual disabilities, schizophrenia, or other psychosis

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting
  • GangnamSeverance Hospital

    Seoul

    EunJoo Kim, 82-2-2019-4601, ejkim96@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

Official title: 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

Being tested
Arm I (Prepectoral),, Arm II (Subpectoral)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arm I (Prepectoral),Procedure or surgery

    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.

  • Arm II (Subpectoral)Procedure or surgery

    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.

Study groups in NCT05615090
Study groupRoleWhat they receive
I (Prepectoral)ExperimentalParticipants received the Self-help app-based CBT-E for eating disorder for 8 weeks
Receives: Procedure: Arm I (Prepectoral),
II (Subpectoral)OtherWaiting 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.
Receives: Procedure: Arm II (Subpectoral)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 8 weeks,16 weeks, 28 weeks

Secondary outcomes (16)
  1. Change in concerns with body weight assessed using EDE-Q weight concern scores

    EDE-Q subscales Higher scores indicate higher eating disorder symptomology.

    Measured: Baseline, 8 weeks,16 weeks, 28 weeks

  2. Change in concerns with body shape assessed using EDE-Q shape concern scores

    EDE-Q subscales Higher scores indicate higher eating disorder symptomology.

    Measured: Baseline, 8 weeks,16 weeks, 28 weeks

  3. Change in restrained eating assessed using EDE-Q dietary restraint scores

    EDE-Q subscales Higher scores indicate higher eating disorder symptomology.

    Measured: Baseline, 8 weeks,16 weeks, 28 weeks

  4. Change in concerns with eating assessed using EDE-Q eating concern scores

    EDE-Q subscales Higher scores indicate higher eating disorder symptomology.

    Measured: Baseline, 8 weeks,16 weeks, 28 weeks

  5. 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.

    Measured: Baseline, 8 weeks,16 weeks, 28 weeks

  6. 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).

    Measured: Baseline, 8 weeks,16 weeks, 28 weeks

  7. 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.

    Measured: Baseline, 8 weeks,16 weeks, 28 weeks

  8. 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.

    Measured: Baseline, 8 weeks,16 weeks, 28 weeks

  9. 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.

    Measured: Baseline, 8 weeks,16 weeks, 28 weeks

  10. 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

    Measured: Baseline, 8 weeks,16 weeks, 28 weeks

  11. 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.

    Measured: Baseline, 8 weeks,16 weeks, 28 weeks

  12. 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.

    Measured: Baseline, 8 weeks,16 weeks, 28 weeks

  13. 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

    Measured: Baseline, 8 weeks,16 weeks, 28 weeks

  14. 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

    Measured: Baseline, 8 weeks,16 weeks

  15. 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

    Measured: Baseline, 8 weeks,16 weeks

  16. 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.

    Measured: Baseline, 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2022
  2. Study start27 Jan 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05615090
Sponsor's protocol ID
3-2022-0342
Status last verified
Apr 2024
First submitted
7 Nov 2022
Last updated
16 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 22684991
  • Oh H, Lee U, Shin B, Kim Y, Jung YC, Kim E. Feasibility and clinical outcomes of tailored digital CBT-E guided self-help for youth with binge-eating symptoms: A pilot randomized controlled trial. Internet Interv. 2026 Apr 28;44:100945. doi: 10.1016/j.invent.2026.100945. eCollection 2026 Jun.

    PubMed 42088594

Questions about this trial

What is this clinical trial studying?

A study testing Arm I (Prepectoral), and Arm II (Subpectoral) in people with Eating Disorder in Adolescents and Young Adults, run by Gangnam Severance Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact EunJoo Kim (82-2-2019-4601, ejkim96@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Eating Disorder Cognitions assessed using EDE-Q global scores (time frame: Baseline, 8 weeks,16 weeks, 28 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05615090, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.

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