Binge Eating DisorderPhase 4NCT05560529
Dialectical Behavioral Therapy As A Therapeutic Tool In Patients With Binge Eating Disorder
A Phase 4 study testing DBT, TAU and Plasma Ghrelin in people with Binge Eating Disorder, run by Alexandria University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- DBT, TAU and Plasma Ghrelin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2023to 15 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
Who cannot join
- Patients with known psychotic disorders or substance use disorders
- Patients diagnosed with current major depressive or anxiety disorders
- Patients diagnosed with borderline personality disorder
- Patients who are actively suicidal
- Patients with medical conditions that can affect or alter the frequency of eating and metabolism (e.g., Thyroid disorders, Diabetes Mellitus, Malignancy)
- Patients presenting with medical complications of BED
- The presence of purging or compensatory behaviors
- Current pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Alexandria University
Alexandria, Alexandria Governorate, 21521
About this study
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.
Read the 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.
- Conditions
- Binge Eating Disorder
- Being tested
- DBT, TAU, Plasma Ghrelin
- Keywords
- Binge Eating Disorder, Ghrelin, Dialectical Behavioral Therapy
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBTBehavioural
Applying DBT modules in group format over 20 weeks
TAUDrug
Giving TAU (usual pharmacotherapy in BED) over 20 weeks
Plasma GhrelinDiagnostic test
Measuring fasting plasma ghrelin pre and post treatment in both arms
| Study group | Role | What they receive |
|---|---|---|
| DBT (Group A) | Experimental | DBT to be applied over 20 weeks Receives: Behavioral: DBT; Diagnostic Test: Plasma Ghrelin |
| TAU (Group B) | Active comparator | TAU to be applied over 20 weeks Receives: Drug: TAU; Diagnostic Test: Plasma Ghrelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge Eating Severity
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
Measured: 30 weeks (20 weeks intervention and 10 weeks follow up)
Emotion regulation
measure the change in emotion regulation using Difficulties in Emotion Regulation Scale. Higher scores reflect worse emotional regulation
Measured: 30 weeks (20 weeks intervention and 10 weeks follow up)
Secondary outcomes (1)
Plasma Ghrelin Level
Measure Plasma Ghrelin levels in ng/mL in both arms pre and post treatment, using enzyme-linked immunosorbent assay technique
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start15 Mar 2023
- Primary completion15 Jun 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560529
- Sponsor's protocol ID
- 0201665
- Status last verified
- Jan 2025
- First submitted
- 24 Sep 2022
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialectical Behavioral Therapy As A Therapeutic Tool In Patients With Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT05560529
- Acronym / sponsor ID
- 0201665
- Conditions
- Binge Eating Disorder
- Keywords
- Binge Eating Disorder, Ghrelin, Dialectical Behavioral Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBT (Group A) | Experimental | Behavioral: DBT, Diagnostic Test: Plasma GhrelinDBT to be applied over 20 weeks |
| TAU (Group B) | Active comparator | Drug: TAU, Diagnostic Test: Plasma GhrelinTAU to be applied over 20 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Patients with known psychotic disorders or substance use disorders
- Patients diagnosed with current major depressive or anxiety disorders
- Patients diagnosed with borderline personality disorder
- Patients who are actively suicidal
- Patients with medical conditions that can affect or alter the frequency of eating and metabolism (e.g., Thyroid disorders, Diabetes Mellitus, Malignancy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBTApplying DBT modules in group format over 20 weeks | Behavioural | DBT (Group A) |
| TAUGiving TAU (usual pharmacotherapy in BED) over 20 weeks | Drug | TAU (Group B) |
| Plasma GhrelinMeasuring fasting plasma ghrelin pre and post treatment in both arms | Diagnostic test | DBT (Group A), TAU (Group B) |
Primary outcome
Binge Eating Severity
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
Emotion regulation
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
1 secondary outcome
Plasma Ghrelin Level
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DBT, TAU and Plasma Ghrelin in people with Binge Eating Disorder, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binge Eating Severity (time frame: 30 weeks (20 weeks intervention and 10 weeks follow up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.