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

• Sponsor: Alexandria University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05560529
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 4.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Binge Eating Disorder	Behavioral: DBT; Drug: TAU; Diagnostic Test: Plasma Ghrelin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Dialectical Behavioral Therapy As A Therapeutic Tool In Patients With Binge Eating Disorder
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DBT (Group A) DBT to be applied over 20 weeks	Behavioral: DBT; Applying DBT modules in group format over 20 weeks; Diagnostic Test: Plasma Ghrelin; Measuring fasting plasma ghrelin pre and post treatment in both arms
Active Comparator: TAU (Group B) TAU to be applied 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

Outcome Measures

Primary Outcome Measures

1. Binge Eating Severity [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 [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 Outcome Measures

1. Plasma Ghrelin Level [20 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Alexandria University	Alexandria		Egypt	21521

Sponsors and Collaborators

• Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexandria University
• ClinicalTrials.gov Identifier: NCT05560529
• Other Study ID Numbers: 0201665
• First Posted: Sep 29, 2022
• Last Update Posted: Oct 4, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alexandria University: Binge Eating Disorder; Ghrelin; Dialectical Behavioral Therapy
• Additional relevant MeSH terms: Disease; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder

Study Results

No Results Posted as of Oct 4, 2022