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Study of Efficacy and Safety of WELT-ED for Eating Disorder (WCTP-ED-B-01)

NCT06294353 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-03-06

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

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.

BEHAVIORAL

Standard Treatment

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.

Sponsors & Collaborators

  • WELT corp

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-29
Primary Completion
2024-06-30
Completion
2024-08-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06294353 on ClinicalTrials.gov