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

Binge Eating Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05560529
• Other study ID #: 0201665
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: August 2024

Study information

• Verified date: May 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Behavioral:
• DBT
Applying DBT modules in group format over 20 weeks

Drug:
• TAU
Giving TAU (usual pharmacotherapy in BED) over 20 weeks

Diagnostic Test:
• Plasma Ghrelin
Measuring fasting plasma ghrelin pre and post treatment in both arms

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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