Faculty of Medicine, Alexandria University
Alexandria, Alexandria Governorate, 21521, Egypt
NCT Number: NCT05560529
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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Notify Me18 year and older
All sexes
Interventional
Phase 4
Alexandria, Alexandria Governorate, 21521, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Applying DBT modules in group format over 20 weeks
Giving TAU (usual pharmacotherapy in BED) over 20 weeks
Measuring fasting plasma ghrelin pre and post treatment in both arms
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
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
Time frame: 20 weeks
Measure Plasma Ghrelin levels in ng/mL in both arms pre and post treatment, using enzyme-linked immunosorbent assay technique
Alexandria University
Other
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