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

NCT05560529 | Completed Phase 4

• 1 other identifier: 0201665
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge Eating Disorder

Keywords

Binge Eating Disorder; Ghrelin; Dialectical Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Plasma Ghrelin Level

  20 weeks

Study Arms (2)

DBT (Group A)

EXPERIMENTAL

DBT to be applied over 20 weeks

Behavioral: DBT; Diagnostic Test: Plasma Ghrelin

TAU (Group B)

ACTIVE COMPARATOR

TAU to be applied over 20 weeks

Drug: TAU; Diagnostic Test: Plasma Ghrelin

Interventions

DBT BEHAVIORAL

Applying DBT modules in group format over 20 weeks

DBT (Group A)

TAU DRUG

Giving TAU (usual pharmacotherapy in BED) over 20 weeks

TAU (Group B)

Plasma Ghrelin DIAGNOSTIC_TEST

Measuring fasting plasma ghrelin pre and post treatment in both arms

DBT (Group A); TAU (Group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine, Alexandria University

Alexandria, Alexandria Governorate, 21521, Egypt

Location

MeSH Terms

Conditions

Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2022
• First Posted: September 29, 2022
• Study Start: March 15, 2023
• Primary Completion: June 15, 2024
• Study Completion: September 15, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

EG (1)