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

What Was Tested

In this phase 4 trial, researchers set out to test Ghrelin.

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.

It had two arms (groups): DBT (Group A) (experimental) and TAU (Group B) (active comparator).

DBT to be applied over 20 weeks.

TAU to be applied over 20 weeks.

The registry classes the interventions as behavioral, diagnostic test and drug.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: patients with known psychotic disorders or substance use disorders; patients diagnosed with current major depressive or anxiety disorders; patients diagnosed with borderline personality disorder.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Ghrelin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Ghrelin study did not mask who received what.

It started in 2023-03-15 with completion listed for 2024-06-15.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Binge Eating Severity (time frame: 30 weeks (20 weeks intervention and 10 weeks follow up)). Emotion regulation (time frame: 30 weeks (20 weeks intervention and 10 weeks follow up)).

It also tracked 1 secondary outcome, for example Plasma Ghrelin Level.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Ghrelin in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Ghrelin compound page, all human trials.