Dialectical Behavioral Therapy As A Therapeutic Tool In Patients With Binge Eating Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dialectical Behavioral Therapy As A Therapeutic Tool In Patients With Binge Eating Disorder

Conditions
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Binge Eating Disorder

Intervention / Treatment
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* Behavioral: DBT
* Drug: TAU
* Diagnostic Test: Plasma Ghrelin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 18 years. Patients diagnosed as BED according to the Diagnostic and Statistical Manual of Mental Disorders- Fifth Version (DSM-5), after providing a written informed consent Overweight or obese patients (body mass index ≥ 25), or patients with a history of overweight or obesity Exclusion Criteria: Patients with known psychotic disorders or substance use disorders Patients diagnosed with current major depressive or anxiety disorders Patients diagnosed with borderline personality disorder Patients who are actively suicidal Patients with medical conditions that can affect or alter the frequency of eating and metabolism (e.g., Thyroid disorders, Diabetes Mellitus, Malignancy) Patients presenting with medical complications of BED The presence of purging or compensatory behaviors Current pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBT (Group A)<br>DBT to be applied over 20 weeks | Behavioral: DBT<br>* Applying DBT modules in group format over 20 weeks<br>Diagnostic Test: Plasma Ghrelin<br>* Measuring fasting plasma ghrelin pre and post treatment in both arms<br>|
| Active Comparator: TAU (Group B)<br>TAU to be applied over 20 weeks | Drug: TAU<br>* Giving TAU (usual pharmacotherapy in BED) over 20 weeks<br>Diagnostic Test: Plasma Ghrelin<br>* Measuring fasting plasma ghrelin pre and post treatment in both arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binge Eating Severity | 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 | 30 weeks (20 weeks intervention and 10 weeks follow up) | 
| Emotion regulation | measure the change in emotion regulation using Difficulties in Emotion Regulation Scale. Higher scores reflect worse emotional regulation | 30 weeks (20 weeks intervention and 10 weeks follow up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Ghrelin Level | Measure Plasma Ghrelin levels in ng/mL in both arms pre and post treatment, using enzyme-linked immunosorbent assay technique | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Binge Eating Disorder, Ghrelin, Dialectical Behavioral Therapy