Clinical trial NCT05560529: Dialectical Behavioral Therapy As A Therapeutic Tool In Patients With Binge Eating Disorder
Official title: Dialectical Behavioral Therapy As A Therapeutic Tool In Patients With Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Binge Eating Disorder
Keywords: Binge Eating Disorder
Ghrelin
Dialectical Behavioral Therapy
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Binge Eating Severity
timeFrame: 30 weeks (20 weeks intervention and 10 weeks follow up)
measure: Emotion regulation
timeFrame: 30 weeks (20 weeks intervention and 10 weeks follow up)
Secondary outcomes:
measure: Plasma Ghrelin Level
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Alexandria University
Study officials:
References: