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

Alexandria University

Status and phase: Completed; Phase 4

Conditions: Binge Eating Disorder

Treatments: Drug: TAU; Diagnostic Test: Plasma Ghrelin; Behavioral: DBT

Study type: Interventional

Funder types: Other

Identifiers

NCT05560529

0201665

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

DBT (Group A)

Experimental group

Description:

DBT to be applied over 20 weeks

Treatment:

Behavioral: DBT

Diagnostic Test: Plasma Ghrelin

TAU (Group B)

Active Comparator group

Description:

TAU to be applied over 20 weeks

Treatment:

Diagnostic Test: Plasma Ghrelin

Drug: TAU