Clinical trial NCT06294353: Study of Efficacy and Safety of WELT-ED for Eating Disorder (WCTP-ED-B-01)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eating Disorders
Binge Eating
Binge-Eating Disorder
Keywords: Digital Therapeutics
Digital Cognitive Behaviorial Therapy
App Based Intervention
Lead sponsor: WELT corp
Sponsor class: INDUSTRY
First posted: 2024-03-05
Enrollment: 134
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Binge Eating Frequency
timeFrame: from baseline (pre-use) to the 8-week point.
Secondary outcomes:
measure: Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: 8 weeks
measure: Clinical Impairment Assessment (CIA)
timeFrame: 8 weeks
measure: Patient health questionnaire-9 (PHQ-9)
timeFrame: 8 weeks
measure: Generalized anxiety disorder 7-item scale (GAD-7)
timeFrame: 8 weeks
measure: The EuroQol Visual Analogue Scale (EQ-VAS)
timeFrame: 8 weeks
measure: Clinical Global Impression of Improvement (CGI-I)
timeFrame: 8 weeks
measure: Clinical Global Impression of Severity (CGI-S)
timeFrame: 8 weeks
Other outcomes:
measure: Adherence (Compliance) to WELT-ED (applicable only to WELT-ED Group)
timeFrame: 8weeks
measure: BMI (Body Mass Index)
timeFrame: 8weeks
measure: WELT-ED App Usage Satisfaction (applicable only to WELT-ED Group)
timeFrame: 8 weeks
measure: App-Based Lifestyle and Eating Data (applicable only to WELT-ED Group)
timeFrame: 8weeks
measure: Change in Regular Meal Frequency (applicable only to WELT-ED Group)
timeFrame: 8 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: