Eating DisordersNCT06294353
Study of Efficacy and Safety of WELT-ED for Eating Disorder (WCTP-ED-B-01)
A study testing WELT-ED (CBT based DTx) and Standard Treatment in people with Eating Disorders and Binge Eating, run by WELT corp at 2 sites in South Korea.
Trial summary
The purpose of this clinical trial is to evaluate the safety and efficacy of a digital therapeutic device (WELT-ED) based on Cognitive Behavioral Therapy (CBT) for the treatment of eating disorders. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Eating Disorders, Binge Eating, Binge-Eating Disorder
- What is being tested?
- WELT-ED (CBT based DTx) and Standard Treatment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 29 Mar 2023to 30 Aug 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged between 19 and 65 years
- Diagnosed with an eating disorder according to ICD-10.
- F50.0 Anorexia nervosa F50.1 Atypical anorexia nervosa F50.2 Bulimia nervosa F50.3 Atypical bulimia nervosa F50.4 Overeating associated with other psychological disturbances F50.5 Vomiting associated with other psychological disturbances F50.8 Other eating disorders F50.9 Eating disorder, unspecified)
- Have a binge eating frequency (as per item 14 of the EDE-Q) of 4 or more times over the past 4 weeks (28 days) at the time of screening.
- Able to use a mobile application (app) on a smartphone without difficulty.
- After receiving and understanding sufficient information about this clinical trial, voluntarily decides to participate and provides written consent.
Who cannot join
- Previously received Cognitive Behavioral Therapy for the treatment of an eating disorder.
- Have a history of bariatric surgery (e.g., adjustable gastric band, sleeve gastrectomy, biliopancreatic diversion, Roux-en-Y gastric bypass).
- Have a BMI less than 17 kg/m^2 or more than 40 kg/m^2 at the time of screening.
- Diagnosed with a major psychiatric disorder according to the MINI.
- Have a past or current diagnosis of schizophrenia or bipolar disorder.
- At risk of suicide (C-SSRS score of 4 or higher) or have attempted suicide in the past 2 weeks.
Show all 11Show fewer
- Have active and progressive physical illnesses (e.g., congestive heart failure, chronic obstructive pulmonary disease, acute pain), neurological disorders (e.g., cerebrovascular disease), neurodegenerative diseases (e.g., dementia, multiple sclerosis), unstable medical conditions, or a life expectancy of less than 6 months.
- Pregnant or planning to become pregnant during the trial period.
- Participated in another clinical trial within 4 weeks prior to screening.
- Have a history of alcohol or substance abuse.
- Considered by the investigator to be unsuitable for participation in this clinical trial for any other reason.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
soohee Choi, 0215885700, soohchoi@snu.ac.kr
- Recruiting
Severance Hospital
Seoul, 03722
Young Chul Jung, MD, 82-2-2228-1622, eugenejung@yuhs.ac
About this study
Official title: A Randomized, Multicenter, Treatment-as-usual Controlled Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy for Eating Disorder
The purpose of this clinical trial is to evaluate the safety and efficacy of a digital therapeutic device (WELT-ED) based on Cognitive Behavioral Therapy (CBT) for the treatment of eating disorders.
The main questions it aims to answer are:
Read more
- Is WELT-ED as effective as standard treatment in reducing the symptoms of eating disorders?
- Is the WELT-ED safe for use in the target population without causing adverse effects?
Participants will:
- Undergo assessments to determine their baseline health status and severity of eating disorder symptoms.
- Use WELT-ED or receive standard treatment as directed for the duration of the study period (8 weeks).
- Participate in assessments to monitor changes in their eating disorder symptoms and any potential side effects.
- Conditions
- Eating Disorders, Binge Eating, Binge-Eating Disorder
- Being tested
- WELT-ED (CBT based DTx), Standard Treatment
- Keywords
- Digital Therapeutics, Digital Cognitive Behaviorial Therapy, App Based Intervention
- Medical subject headings
- Feeding and Eating Disorders, Bulimia, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WELT-ED (CBT based DTx)Device
The product delivers Cognitive Behavioral Therapy for Eating Disorders (CBT-ED) through a software interface (iOS and Android), designed to engage patients in a structured and interactive manner. It operates by analyzing patterns in the patient's lifestyle and eating data, identifying problematic behaviors associated with their eating disorder. Based on this analysis, the software sets daily learning objectives aimed at fostering positive cognitive and behavioral habits. By providing tailored guidance and support, the product seeks to assist patients in making sustainable changes, ultimately contributing to the improvement of eating disorder symptoms. This approach combines the principles of CBT-ED with the convenience and accessibility of digital technology, offering a personalized therapeutic experience to support patients in their recovery.
Standard TreatmentBehavioural
In the control group, from screening/baseline (Visit 1) to 8 weeks (Visit 5), counseling and support therapy will be conducted at all visits. Participants can continue taking SSRI medications and other antipsychotic drugs that they were already taking for the treatment of eating disorders during the trial period. However, the intake of any additional antipsychotic drugs, other than those already being taken (including SSRIs), is prohibited during the trial period.
| Study group | Role | What they receive |
|---|---|---|
| WELT-ED (CBT based DTx) | Experimental | Participants in this group will receive a shortened version of the standard treatment plus access to the DTx app for 8 weeks.
The DTx app is designed to provide therapeutic interventions based on CBT principles, aiming to help participants manage and reduce their eating disorder symptoms.
Participants are expected to engage with the app, completing tasks such as self-monitoring food diaries. The app will collect data on adherence, including diary completion rates and app login frequency.
Additional Support: Aside from app usage, participants will receive counseling and support therapy during visits at baseline, the 4-week mark, and the 8-week mark.
They will continue any pre-existing medication for eating disorders. Receives: Device: WELT-ED (CBT based DTx) |
| Standard Treatment | Other | Participants will receive the standard treatment protocol for eating disorders, which includes regular counseling and support therapy at all scheduled visits.
This treatment is comprehensive and follows the conventional approach to managing eating disorders, without the use of the DTx app.
Participants will continue any pre-existing medication for eating disorders. Receives: Behavioral: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge Eating Frequency
Change of Binge Eating Frequency (item 14 of the Eating Disorder Examination Questionnaire, EDE-Q)
Measured: from baseline (pre-use) to the 8-week point.
Secondary outcomes (7)
Eating Disorder Examination Questionnaire (EDE-Q)
28 items divided into four subscales: dietary restraint, concern with eating, concern with body shape, and concern with weight. Excluding frequency questions, it assesses symptoms over the past 4 weeks on a 7-point scale from 0 to 6, where higher scores indicate more problematic eating behaviors and attitudes.
Measured: 8 weeks
Clinical Impairment Assessment (CIA)
Purpose: Evaluates the secondary impairment in three main areas (personal, social, and cognitive) related to eating disorders.
Format: A brief self-report tool consisting of 16 items, scored on a 4-point scale from 0 (no impairment) to 3 (high impairment).
Interpretation: Total score ranges from 0 to 48, higher scores indicate greater personal, social, and cognitive impairment due to eating disorders.
Measured: 8 weeks
Patient health questionnaire-9 (PHQ-9)
Purpose: Assesses symptoms of depression based on the diagnostic criteria for major depressive disorder in DSM-IV, focusing on the past two weeks.
Format: Comprises 9 questions related to mood, sleep changes, fatigue, appetite change, guilt, worthlessness, concentration difficulty, restlessness, and suicidal thoughts, scored from 0 (not at all) to 3 (nearly every day).
Interpretation: Higher scores indicate more severe symptoms of depression.
Measured: 8 weeks
Generalized anxiety disorder 7-item scale (GAD-7)
Purpose: A screening tool developed to identify symptoms of generalized anxiety disorder, evaluating the severity of related anxiety or worry.
Format: Contains 7 items, with responses ranging from 0 (not at all) to 3 (nearly every day).
Interpretation: Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms and greater functional impairment.
Measured: 8 weeks
The EuroQol Visual Analogue Scale (EQ-VAS)
Purpose: Measures the participant's overall health status as part of a quality of life questionnaire.
Format: A visual analogue scale from 0 to 100. Interpretation: Higher scores represent better overall health status.
Measured: 8 weeks
Clinical Global Impression of Improvement (CGI-I)
Purpose: Assesses the degree of improvement or worsening in a participant's overall health status at 4 weeks (Visit 3) and 8 weeks (Visit 5).
Format: Rated on a 7-point scale, with lower scores indicating greater improvement.
Interpretation: Designed to provide a description of change over time, emphasizing the clinician's perspective on patient progress.
Measured: 8 weeks
Clinical Global Impression of Severity (CGI-S)
Purpose: Evaluates the overall severity of the participant's condition at baseline, 4 weeks (Visit 3), and 8 weeks (Visit 5).
Format: A 7-point scale is used, with higher scores indicating greater disease severity.
Interpretation: Aims to quantify the severity of the condition from a clinical standpoint, offering insight into the disorder's impact on the patient's life.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start29 Mar 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WELT corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294353
- Sponsor's protocol ID
- WCTP-ED-B-01
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Treatment-as-usual Controlled Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy for Eating Disorder
- ClinicalTrials.gov ID
- NCT06294353
- Acronym / sponsor ID
- WCTP-ED-B-01
- Conditions
- Eating Disorders, Binge Eating, Binge-Eating Disorder
- Keywords
- Digital Therapeutics, Digital Cognitive Behaviorial Therapy, App Based Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- WELT corpIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 5 Mar 2024 (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 clinical trial is to evaluate the safety and efficacy of a digital therapeutic device (WELT-ED) based on Cognitive Behavioral Therapy (CBT) for the treatment of eating disorders.
The main questions it aims to answer are:
- Is WELT-ED as effective as standard treatment in reducing the symptoms of eating disorders?
- Is the WELT-ED safe for use in the target population without causing adverse effects?
Participants will:
- Undergo assessments to determine their baseline health status and severity of eating disorder symptoms.
- Use WELT-ED or receive standard treatment as directed for the duration of the study period (8 weeks).
- Participate in assessments to monitor changes in their eating disorder symptoms and any potential side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WELT-ED (CBT based DTx) | Experimental | Device: WELT-ED (CBT based DTx)Participants in this group will receive a shortened version of the standard treatment plus access to the DTx app for 8 weeks. The DTx app is designed to provide therapeutic interventions based on CBT principles, aiming to help participants manage and reduce their eating disorder symptoms. Participants are expected to engage with the app, completing tasks such as self-monitoring food diaries. The app will collect data on adherence, including diary completion rates and app login frequency. Additional Support: Aside from app usage, participants will receive counseling and support therapy during visits at baseline, the 4-week mark, and the 8-week mark. They will continue any pre-existing medication for eating disorders. |
| Standard Treatment | Other | Behavioral: Standard TreatmentParticipants will receive the standard treatment protocol for eating disorders, which includes regular counseling and support therapy at all scheduled visits. This treatment is comprehensive and follows the conventional approach to managing eating disorders, without the use of the DTx app. Participants will continue any pre-existing medication for eating disorders. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged between 19 and 65 years
- Diagnosed with an eating disorder according to ICD-10.
- F50.0 Anorexia nervosa F50.1 Atypical anorexia nervosa F50.2 Bulimia nervosa F50.3 Atypical bulimia nervosa F50.4 Overeating associated with other psychological disturbances F50.5 Vomiting associated with other psychological disturbances F50.8 Other eating disorders F50.9 Eating disorder, unspecified)
- Have a binge eating frequency (as per item 14 of the EDE-Q) of 4 or more times over the past 4 weeks (28 days) at the time of screening.
- Able to use a mobile application (app) on a smartphone without difficulty.
Key exclusion criteria (11 listed)
- Previously received Cognitive Behavioral Therapy for the treatment of an eating disorder.
- Have a history of bariatric surgery (e.g., adjustable gastric band, sleeve gastrectomy, biliopancreatic diversion, Roux-en-Y gastric bypass).
- Have a BMI less than 17 kg/m^2 or more than 40 kg/m^2 at the time of screening.
- Diagnosed with a major psychiatric disorder according to the MINI.
- Have a past or current diagnosis of schizophrenia or bipolar disorder.
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 |
|---|---|---|
| WELT-ED (CBT based DTx)The product delivers Cognitive Behavioral Therapy for Eating Disorders (CBT-ED) through a software interface (iOS and Android), designed to engage patients in a structured and interactive manner. It operates by analyzing patterns in the patient's lifestyle and eating data, identifying problematic behaviors associated with their eating disorder. Based on this analysis, the software sets daily learning objectives aimed at fostering positive cognitive and behavioral habits. By providing tailored guidance and support, the product seeks to assist patients in making sustainable changes, ultimately contributing to the improvement of eating disorder symptoms. This approach combines the principles of CBT-ED with the convenience and accessibility of digital technology, offering a personalized therapeutic experience to support patients in their recovery. | Device | WELT-ED (CBT based DTx) |
| Standard TreatmentIn the control group, from screening/baseline (Visit 1) to 8 weeks (Visit 5), counseling and support therapy will be conducted at all visits. Participants can continue taking SSRI medications and other antipsychotic drugs that they were already taking for the treatment of eating disorders during the trial period. However, the intake of any additional antipsychotic drugs, other than those already being taken (including SSRIs), is prohibited during the trial period. | Behavioural | Standard Treatment |
Primary outcome
Binge Eating Frequency
Time frame: from baseline (pre-use) to the 8-week point.
Change of Binge Eating Frequency (item 14 of the Eating Disorder Examination Questionnaire, EDE-Q)
7 secondary outcomes
Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: 8 weeks
Clinical Impairment Assessment (CIA)
Time frame: 8 weeks
Patient health questionnaire-9 (PHQ-9)
Time frame: 8 weeks
Generalized anxiety disorder 7-item scale (GAD-7)
Time frame: 8 weeks
The EuroQol Visual Analogue Scale (EQ-VAS)
Time frame: 8 weeks
Clinical Global Impression of Improvement (CGI-I)
Time frame: 8 weeks
Clinical Global Impression of Severity (CGI-S)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Eating Disorders
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
Binge-Eating Disorder
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WELT-ED (CBT based DTx) and Standard Treatment in people with Eating Disorders and Binge Eating, run by WELT corp at 2 sites 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 6 inclusion and 11 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 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yujin Lee (82-2-6439-0707, info@weltcorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binge Eating Frequency (time frame: from baseline (pre-use) to the 8-week point.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2024.