Dialectical Behavioral Therapy As a Therapeutic Tool in Patients with Binge Eating Disorder

Phase 4

Completed

• Conditions: Binge Eating Disorder
• Interventions: Drug: TAU; Behavioral: DBT; Diagnostic Test: Plasma Ghrelin

• Registration Number: NCT05560529
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study First Submitted: 2022-09-24
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-09-29
• Study Start: 2023-03-15
• Primary Completion: 2024-06-15
• Study Completion: 2024-09-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU (Group B)	TAU	TAU to be applied over 20 weeks
DBT (Group A)	Plasma Ghrelin	DBT to be applied over 20 weeks
DBT (Group A)	DBT	DBT to be applied over 20 weeks
TAU (Group B)	Plasma Ghrelin	TAU to be applied over 20 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Medicine, Alexandria University; 🇪🇬 Alexandria, Egypt