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.
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
- Conditions the study is for
- Eating Disorder in Adolescents and Young Adults
- 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
- Recruiting
GangnamSeverance Hospital
Seoul
EunJoo Kim, 82-2-2019-4601, ejkim96@yuhs.ac
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 group | Role | What they receive |
|---|---|---|
| I (Prepectoral) | Experimental | Participants received the Self-help app-based CBT-E for eating disorder for 8 weeks Receives: Procedure: Arm I (Prepectoral), |
| II (Subpectoral) | Other | 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. Receives: Procedure: Arm II (Subpectoral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted14 Nov 2022
- Study start27 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eating Disorder in Adolescents and Young AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Joo Kim, Gangnam Severance Hospital
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 22684991Oh 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trials of Self-help Application for Eating Disorder Through Multifaceted Measurement
- ClinicalTrials.gov ID
- NCT05615090
- Acronym / sponsor ID
- 3-2022-0342
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| I (Prepectoral) | Experimental | Procedure: Arm I (Prepectoral),Participants received the Self-help app-based CBT-E for eating disorder for 8 weeks |
| II (Subpectoral) | Other | Procedure: Arm 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. |
Who may qualify
- Ages
- 13 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 13-22 years
- Owns a smartphone
- Experienced at least one episode of binge eating over the past 4 weeks
Key exclusion criteria (3 listed)
- diagnosed with anorexia nervosa
- BMI ≤ 17.5
- having developmental disabilities, including autism, intellectual disabilities, schizophrenia, or other psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | I (Prepectoral) |
| 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. | Procedure or surgery | II (Subpectoral) |
Primary outcome
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.
16 secondary outcomes
Change in concerns with body weight assessed using EDE-Q weight concern scores
Time frame: Baseline, 8 weeks,16 weeks, 28 weeks
Change in concerns with body shape assessed using EDE-Q shape concern scores
Time frame: Baseline, 8 weeks,16 weeks, 28 weeks
Change in restrained eating assessed using EDE-Q dietary restraint scores
Time frame: Baseline, 8 weeks,16 weeks, 28 weeks
Change in concerns with eating assessed using EDE-Q eating concern scores
Time frame: Baseline, 8 weeks,16 weeks, 28 weeks
Change in eating disorder symptoms assessed using the Eating Attitude Test
Time frame: Baseline, 8 weeks,16 weeks, 28 weeks
Change in addictive-like eating behaviors assessed using the Yale Food Addiction scale
Time frame: Baseline, 8 weeks,16 weeks, 28 weeks
Change in addictive-like eating behaviors assessed using the Yale Food Addiction Scale for Children
Time frame: Baseline, 8 weeks,16 weeks, 28 weeks
Change in emotion regulation problems assessed using the Difficulties in Emotion Regulation Scale
Time frame: Baseline, 8 weeks,16 weeks, 28 weeks
Change in Depression symptoms assessed using the Beck Depression Inventory
Time frame: Baseline, 8 weeks,16 weeks, 28 weeks
Change in anxiety symptoms assessed using the State-Trait Anxiety Inventory
Time frame: 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)
Time frame: Baseline, 8 weeks,16 weeks, 28 weeks
Change in self-esteem assessed using the Rosenberg self-esteem scale (RSES)
Time frame: 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
Time frame: Baseline, 8 weeks,16 weeks, 28 weeks
Change in eating disorder symptoms assessed using the Korean version of the Eating disorder Diagnostic Scale
Time frame: Baseline, 8 weeks,16 weeks
Change in the heart rate variability
Time frame: Baseline, 8 weeks,16 weeks
Change in brain activities recorded with functional near-infrared spectroscopy (fNIRS)
Time frame: Baseline, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Background: PubMed 22684991Gearhardt 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.
- Derived from this study: PubMed 42088594Oh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.