- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06703502
Evaluation of Pilot Online Binge Eating Disorder Group (BEG) in Under 18s.
Investigating the Efficacy of an Online Binge Eating Disorder Group Intervention for Under 18s
Study Overview
Status
Conditions
Detailed Description
Background and study aims: The National Institute for Clinical Excellence recommends a cognitive behavioural therapy (CBT) group intervention for binge eating disorder in under-18s. However, there is limited current research in this population. The present study sought to evaluate a CBT group intervention for binge eating disorder in under-18s.
Who can participate? Participants were recruited from the Coventry Warwickshire Partnership Trust's Children and Young People Eating Disorders Team (n=2).
What does the study involve: Participating in a group intervention and completing questionnaires (Eating Disorder Examination - Questionnaire (EDE-Q), Revised Children's Anxiety and Depression Scale (RCADS) Child and RCADS Parent) before the group, at the end of the group and a follow-up appointment, as well as a feedback form at the end of the group intervention.
What are the possible benefits and risks of participating:
- Benefits: Working towards recovering from binge eating disorder
- Risks: As with all therapy, there is a risk of distress due to the topics discussed. There is no more risk than any other group online therapy.
Where is the study run from: Online intervention for participants who are eligible and who are under the care of the RISE Eating Disorders Team within Coventry and Warwickshire NHS Partnership Trust.
When is the study starting and how long is it expected to run for: The study commenced on on 23rd May 2023. The group intervention ran from 20th June 2023 to 26th September 2023.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
West Midlands
-
Coventry, West Midlands, United Kingdom, CV2 1XA
- Wood End Health Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosed with Binge Eating Disorder
- Under 18 prior to the group commencing
- Spoke English fluently
Exclusion Criteria:
- If they were underweight. This was measured by percentage median body mass index (%mBMI) as recommended by the Medical Emergencies in Eating Disorders guidelines (Royal College of Psychiatrists, 2022) for under 18s. As such, individuals were excluded if %mBMI was less than 95%
- If they had any physical illness serious enough to prevent the participant from engaging fully in the group and completing the in-between session work
- If they were pregnant
- If they had an eating disorder-induced physical health state requiring regular medical intervention by the nursing team
- If they presented a mental health state requiring stabilisation prior to participating in the group intervention according the assessment team
- If they regularly used alcohol and/or drugs
- If they repeatedly self-harmed to the point of requiring additional interventions
- If they had a living situation not conducive to the start of an intervention (ongoing or upcoming changes).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eating Disorder Examination Questionnaire
Time Frame: 23rd May 2023-26th September 2023
|
The questionnaire is designed to assess the range, frequency and severity of behaviours associated with a diagnosis of an eating disorder.
|
23rd May 2023-26th September 2023
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Revised Children's Anxiety and Depression Scale (RCADS) Child
Time Frame: 23rd May 2023-26th September 2023
|
The Revised Children's Anxiety and Depression Scale (RCADS) measures the reported frequency of various symptoms of anxiety and low mood.
|
23rd May 2023-26th September 2023
|
|
Revised Children's Anxiety and Depression Scale (RCADS) Parent/Carer
Time Frame: 23rd May 2023-26th September 2023
|
The Revised Children's Anxiety and Depression Scale (RCADS) measures the reported frequency of various symptoms of anxiety and low mood.
|
23rd May 2023-26th September 2023
|
|
Feedback form
Time Frame: 23rd August 2023
|
Feedback form asking questions about experience of the group and any recommendations for future groups.
|
23rd August 2023
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 320293
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Binge Eating Disorder
-
University of Sao Paulo General HospitalActive, not recruitingBinge Eating DisorderBrazil
-
University of North Carolina, Chapel HillThe Hilda & Preston Davis Foundation; Global Foundation for Eating DisordersCompletedEating Disorder | Binge-eating DisorderUnited States
-
ShireCompleted
-
Lindner Center of HOPEUniversity of CincinnatiCompleted
-
Axsome Therapeutics, Inc.Enrolling by invitationBinge-Eating DisorderUnited States
-
BioprojetCompleted
-
Sao Jose do Rio Preto Medical SchoolFundação de Amparo à Pesquisa do Estado de São PauloCompletedBinge-Eating Disorder | Eating Disorders | Eating Behavior | Eating Disorder | Binge Eating Disorder Associated With ObesityBrazil
-
Axsome Therapeutics, Inc.RecruitingBinge-Eating DisorderUnited States
-
Otsuka Pharmaceutical Development & Commercialization...CompletedBinge-Eating DisorderUnited States
-
Ali RezaiActive, not recruiting