Self-help Application for Eating Disorder

Sponsor
Gangnam Severance Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05615090
Collaborator
(none)
120
1
2
23.1
5.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Arm I (Prepectoral),
  • Procedure: Arm II (Subpectoral)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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 phaseThe 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)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trials of Self-help Application for Eating Disorder Through Multifaceted Measurement
Actual Study Start Date :
Jan 27, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: I (Prepectoral)

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

Procedure: 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.

Other: 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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  1. Change in Eating Disorder Cognitions assessed using EDE-Q global scores [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.

Secondary Outcome Measures

  1. Change in concerns with body weight assessed using EDE-Q weight concern scores [Baseline, 8 weeks,16 weeks, 28 weeks]

    EDE-Q subscales Higher scores indicate higher eating disorder symptomology.

  2. Change in concerns with body shape assessed using EDE-Q shape concern scores [Baseline, 8 weeks,16 weeks, 28 weeks]

    EDE-Q subscales Higher scores indicate higher eating disorder symptomology.

  3. Change in restrained eating assessed using EDE-Q dietary restraint scores [Baseline, 8 weeks,16 weeks, 28 weeks]

    EDE-Q subscales Higher scores indicate higher eating disorder symptomology.

  4. Change in concerns with eating assessed using EDE-Q eating concern scores [Baseline, 8 weeks,16 weeks, 28 weeks]

    EDE-Q subscales Higher scores indicate higher eating disorder symptomology.

  5. Change in eating disorder symptoms assessed using the Eating Attitude Test [Baseline, 8 weeks,16 weeks, 28 weeks]

    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.

  6. Change in addictive-like eating behaviors assessed using the Yale Food Addiction scale [Baseline, 8 weeks,16 weeks, 28 weeks]

    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).

  7. Change in addictive-like eating behaviors assessed using the Yale Food Addiction Scale for Children [Baseline, 8 weeks,16 weeks, 28 weeks]

    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.

  8. Change in emotion regulation problems assessed using the Difficulties in Emotion Regulation Scale [Baseline, 8 weeks,16 weeks, 28 weeks]

    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.

  9. Change in Depression symptoms assessed using the Beck Depression Inventory [Baseline, 8 weeks,16 weeks, 28 weeks]

    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.

  10. Change in anxiety symptoms assessed using the State-Trait Anxiety Inventory [Baseline, 8 weeks,16 weeks, 28 weeks]

    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

  11. Change in assessed the impact an eating disorder has on psychosocial functioning using The Clinical Impairment Assessment Questionnaire (CIA) [Baseline, 8 weeks,16 weeks, 28 weeks]

    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.

  12. Change in self-esteem assessed using the Rosenberg self-esteem scale (RSES) [Baseline, 8 weeks,16 weeks, 28 weeks]

    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.

  13. Change in the body attitudes associated with desiring a thinner assessed using the Eating Disorder Inventory-2, Drive for Thinness [Baseline, 8 weeks,16 weeks, 28 weeks]

    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

  14. Change in eating disorder symptoms assessed using the Korean version of the Eating disorder Diagnostic Scale [Baseline, 8 weeks,16 weeks]

    The Eating Disorder Diagnostic Scale (EDDS) is a 22-item self-report questionnaire designed to measure eating disorders symptomatology

  15. Change in the heart rate variability [Baseline, 8 weeks,16 weeks]

    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

  16. Change in brain activities recorded with functional near-infrared spectroscopy (fNIRS) [Baseline, 8 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 22 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Aged 13-22 years

  2. Owns a smartphone

  3. Experienced at least one episode of binge eating over the past 4 weeks

Exclusion Criteria:
  1. diagnosed with anorexia nervosa

  2. BMI ≤ 17.5

  3. having developmental disabilities, including autism, intellectual disabilities, schizophrenia, or other psychosis

Contacts and Locations

Locations

Site City State Country Postal Code
1 GangnamSeverance Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Eun Joo Kim, Associate professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT05615090
Other Study ID Numbers:
  • 3-2022-0342
First Posted:
Nov 14, 2022
Last Update Posted:
Feb 1, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2023