Clinical trial NCT05615090: Self-help Application for Eating Disorder
Official title: A Randomized Controlled Trials of Self-help Application for Eating Disorder Through Multifaceted Measurement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eating Disorder in Adolescents and Young Adults
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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 phase
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in Eating Disorder Cognitions assessed using EDE-Q global scores
timeFrame: Baseline, 8 weeks,16 weeks, 28 weeks
Secondary outcomes:
measure: Change in concerns with body weight assessed using EDE-Q weight concern scores
timeFrame: Baseline, 8 weeks,16 weeks, 28 weeks
measure: Change in concerns with body shape assessed using EDE-Q shape concern scores
timeFrame: Baseline, 8 weeks,16 weeks, 28 weeks
measure: Change in restrained eating assessed using EDE-Q dietary restraint scores
timeFrame: Baseline, 8 weeks,16 weeks, 28 weeks
measure: Change in concerns with eating assessed using EDE-Q eating concern scores
timeFrame: Baseline, 8 weeks,16 weeks, 28 weeks
measure: Change in eating disorder symptoms assessed using the Eating Attitude Test
timeFrame: Baseline, 8 weeks,16 weeks, 28 weeks
measure: Change in addictive-like eating behaviors assessed using the Yale Food Addiction scale
timeFrame: Baseline, 8 weeks,16 weeks, 28 weeks
measure: Change in addictive-like eating behaviors assessed using the Yale Food Addiction Scale for Children
timeFrame: Baseline, 8 weeks,16 weeks, 28 weeks
measure: Change in emotion regulation problems assessed using the Difficulties in Emotion Regulation Scale
timeFrame: Baseline, 8 weeks,16 weeks, 28 weeks
measure: Change in Depression symptoms assessed using the Beck Depression Inventory
timeFrame: Baseline, 8 weeks,16 weeks, 28 weeks
measure: Change in anxiety symptoms assessed using the State-Trait Anxiety Inventory
timeFrame: Baseline, 8 weeks,16 weeks, 28 weeks
measure: Change in assessed the impact an eating disorder has on psychosocial functioning using The Clinical Impairment Assessment Questionnaire (CIA)
timeFrame: Baseline, 8 weeks,16 weeks, 28 weeks
measure: Change in self-esteem assessed using the Rosenberg self-esteem scale (RSES)
timeFrame: Baseline, 8 weeks,16 weeks, 28 weeks
measure: Change in the body attitudes associated with desiring a thinner assessed using the Eating Disorder Inventory-2, Drive for Thinness
timeFrame: Baseline, 8 weeks,16 weeks, 28 weeks
measure: Change in eating disorder symptoms assessed using the Korean version of the Eating disorder Diagnostic Scale
timeFrame: Baseline, 8 weeks,16 weeks
measure: Change in the heart rate variability
timeFrame: Baseline, 8 weeks,16 weeks
measure: Change in brain activities recorded with functional near-infrared spectroscopy (fNIRS)
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References:
citation: 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.