Binge Eating Disorder
Conditions
Keywords
Binge Eating Disorder, Ghrelin, Dialectical Behavioral Therapy
Brief summary
Binge eating disorder (BED) is one of the recently acknowledged eating disorders, with many theories underlying its pathology whether biological or psychological. From the biological perspective, changes in plasma ghrelin were hypothesized to have a major role in developing and maintaining the disorder, while from the psychopathological perspectives, abnormalities in emotion regulation were found in many patients. Since Dialectical Behavioral Therapy (DBT) is known to target emotion dysregulation, the main aim of this study is to assess the efficacy of DBT versus treatment as usual (TAU) in BED patients, and whether plasma ghrelin level will be affected after treatment in both arms.
Detailed description
Binge eating disorder (BED) is one of the recently acknowledged eating disorders, with many theories underlying its pathology whether biological or psychological. From the biological perspective, changes in plasma ghrelin were hypothesized to have a major role in developing and maintaining the disorder, while from the psychopathological perspectives, abnormalities in emotion regulation were found in many patients. Since Dialectical Behavioral Therapy (DBT) is known to target emotion dysregulation, the main aim of this study is to assess the efficacy of DBT versus treatment as usual (TAU) in BED patients, and whether plasma ghrelin level will be affected after treatment in both arms, with patients being randomly allocated in both groups.
Interventions
BEHAVIORALDBT
Applying DBT modules in group format over 20 weeks
DRUGTAU
Giving TAU (usual pharmacotherapy in BED) over 20 weeks
DIAGNOSTIC_TESTPlasma Ghrelin
Measuring fasting plasma ghrelin pre and post treatment in both arms
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age above 18 years. 2. Patients diagnosed as BED according to the Diagnostic and Statistical Manual of Mental Disorders- Fifth Version (DSM-5), after providing a written informed consent 3. Overweight or obese patients (body mass index ≥ 25), or patients with a history of overweight or obesity
Exclusion criteria
1. Patients with known psychotic disorders or substance use disorders 2. Patients diagnosed with current major depressive or anxiety disorders 3. Patients diagnosed with borderline personality disorder 4. Patients who are actively suicidal 5. Patients with medical conditions that can affect or alter the frequency of eating and metabolism (e.g., Thyroid disorders, Diabetes Mellitus, Malignancy) 6. Patients presenting with medical complications of BED 7. The presence of purging or compensatory behaviors 8. Current pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binge Eating Severity | 30 weeks (20 weeks intervention and 10 weeks follow up) | measure the change in BED severity using binge eating scale, with range of scores from 0 to 46. A score of 17 is a cut-off for mild or no binge eating, while 27 or more represents severe binge eating |
| Emotion regulation | 30 weeks (20 weeks intervention and 10 weeks follow up) | measure the change in emotion regulation using Difficulties in Emotion Regulation Scale. Higher scores reflect worse emotional regulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Ghrelin Level | 20 weeks | Measure Plasma Ghrelin levels in ng/mL in both arms pre and post treatment, using enzyme-linked immunosorbent assay technique |
Countries
Egypt
Outcome results
None listed