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Completed

NCT Number: NCT05560529

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Alexandria University

Alexandria, Alexandria Governorate, 21521, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DBT

Behavioral

Applying DBT modules in group format over 20 weeks

TAU

Drug

Giving TAU (usual pharmacotherapy in BED) over 20 weeks

Plasma Ghrelin

Diagnostic Test

Measuring fasting plasma ghrelin pre and post treatment in both arms

Primary outcomes

  1. 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

  2. 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

  1. Plasma Ghrelin Level

    Time frame: 20 weeks

    Measure Plasma Ghrelin levels in ng/mL in both arms pre and post treatment, using enzyme-linked immunosorbent assay technique

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2022
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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