Self-help Application for Eating Disorder

NCT05615090 | Recruiting

• 1 other identifier: 3-2022-0342
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Eating Disorder in Adolescents and Young Adults

Outcome Measures

Primary Outcomes (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.

  Baseline, 8 weeks,16 weeks, 28 weeks

Secondary Outcomes (16)

• Change in concerns with body weight assessed using EDE-Q weight concern scores

  Baseline, 8 weeks,16 weeks, 28 weeks

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

  Baseline, 8 weeks,16 weeks, 28 weeks

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

  Baseline, 8 weeks,16 weeks, 28 weeks

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

  Baseline, 8 weeks,16 weeks, 28 weeks

• Change in eating disorder symptoms assessed using the Eating Attitude Test

  Baseline, 8 weeks,16 weeks, 28 weeks

Study Arms (2)

I (Prepectoral)

EXPERIMENTAL

Participants received the Self-help app-based CBT-E for eating disorder for 8 weeks

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.

Procedure: Arm II (Subpectoral)

Interventions

Arm I (Prepectoral), PROCEDURE

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.

I (Prepectoral)

Arm II (Subpectoral) PROCEDURE

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.

II (Subpectoral)

Eligibility Criteria

• Age: 13 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 22684991 BACKGROUND

Central Study Contacts

EunJoo Kim

CONTACT

82-2-2019-4601; ejkim96@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: January 27, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

KR (1)