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Clinical Trials/NCT05560529
NCT05560529
Completed
Phase 4

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

Alexandria University1 site in 1 country60 target enrollmentMarch 15, 2023

Overview

Phase
Phase 4
Intervention
TAU
Conditions
Binge Eating Disorder
Sponsor
Alexandria University
Enrollment
60
Locations
1
Primary Endpoint
Binge Eating Severity
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2023
End Date
September 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

TAU (Group B)

TAU to be applied over 20 weeks

Intervention: TAU

TAU (Group B)

TAU to be applied over 20 weeks

Intervention: Plasma Ghrelin

DBT (Group A)

DBT to be applied over 20 weeks

Intervention: DBT

DBT (Group A)

DBT to be applied over 20 weeks

Intervention: Plasma Ghrelin

Outcomes

Primary Outcomes

Binge Eating Severity

Time Frame: 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

Time Frame: 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 Outcomes

  • Plasma Ghrelin Level(20 weeks)

Study Sites (1)

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