Back to resultsDialectical Behavioral Therapy As A Therapeutic Tool In Patients With Binge Eating Disorder
Primary Purpose
Binge Eating Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
DBT
TAU
Plasma Ghrelin
Sponsored by
About this trial
This is an interventional treatment trial for Binge Eating Disorder focused on measuring Binge Eating Disorder, Ghrelin, Dialectical Behavioral Therapy
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine, Alexandria UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DBT (Group A)
TAU (Group B)
Arm Description
DBT to be applied over 20 weeks
TAU to be applied over 20 weeks
Outcomes
Primary Outcome Measures
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
Emotion regulation
measure the change in emotion regulation using Difficulties in Emotion Regulation Scale. Higher scores reflect worse emotional regulation
Secondary Outcome Measures
Plasma Ghrelin Level
Measure Plasma Ghrelin levels in ng/mL in both arms pre and post treatment, using enzyme-linked immunosorbent assay technique
Full Information
NCT ID
NCT05560529
First Posted
September 24, 2022
Last Updated
July 19, 2023
Sponsor
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT05560529
Brief Title
Dialectical Behavioral Therapy As A Therapeutic Tool In Patients With Binge Eating Disorder
Official Title
Dialectical Behavioral Therapy As A Therapeutic Tool In Patients With Binge Eating Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder
Keywords
Binge Eating Disorder, Ghrelin, Dialectical Behavioral Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DBT (Group A)
Arm Type
Experimental
Arm Description
DBT to be applied over 20 weeks
Arm Title
TAU (Group B)
Arm Type
Active Comparator
Arm Description
TAU to be applied over 20 weeks
Intervention Type
Behavioral
Intervention Name(s)
DBT
Intervention Description
Applying DBT modules in group format over 20 weeks
Intervention Type
Drug
Intervention Name(s)
TAU
Intervention Description
Giving TAU (usual pharmacotherapy in BED) over 20 weeks
Intervention Type
Diagnostic Test
Intervention Name(s)
Plasma Ghrelin
Intervention Description
Measuring fasting plasma ghrelin pre and post treatment in both arms
Primary Outcome Measure Information:
Title
Binge Eating Severity
Description
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
Time Frame
30 weeks (20 weeks intervention and 10 weeks follow up)
Title
Emotion regulation
Description
measure the change in emotion regulation using Difficulties in Emotion Regulation Scale. Higher scores reflect worse emotional regulation
Time Frame
30 weeks (20 weeks intervention and 10 weeks follow up)
Secondary Outcome Measure Information:
Title
Plasma Ghrelin Level
Description
Measure Plasma Ghrelin levels in ng/mL in both arms pre and post treatment, using enzyme-linked immunosorbent assay technique
Time Frame
20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Israa Abdelfattah
Phone
+201221553017
Email
israayoussuf@hotmail.com
Facility Information:
Facility Name
Faculty of Medicine, Alexandria University
City
Alexandria
ZIP/Postal Code
21521
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Israa Abdelfattah
Phone
+201221553017
Email
israayoussuf@hotmail.com
First Name & Middle Initial & Last Name & Degree
Tarek Molokhia
Phone
+201223173572
Email
molokhiatark@yahoo.com
First Name & Middle Initial & Last Name & Degree
Israa Abdelfattah
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Dialectical Behavioral Therapy As A Therapeutic Tool In Patients With Binge Eating Disorder
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