Binge Eating DisorderNCT06703502
Evaluation of Pilot Online Binge Eating Disorder Group (BEG) in Under 18s.
An observational study of Binge Eating Disorder, run by Coventry and Warwickshire Partnership NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Binge Eating Disorder
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Apr 2023to 26 Sep 2023
- Phase
- Observational
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Population for study were young people (under 18) that are receiving support from the RISE Eating Disorder Team in the Coventry and Warwickshire Partnership Trust with a diagnosis of binge eating disorder.
Who may be able to join
- Diagnosed with Binge Eating Disorder
- Under 18 prior to the group commencing
- Spoke English fluently
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wood End Health Centre
Coventry, West Midlands, CV2 1XA
About this study
Official title: Investigating the Efficacy of an Online Binge Eating Disorder Group Intervention for Under 18s
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.
Read the 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.
- Conditions
- Binge Eating Disorder
- Keywords
- group, adolescent
- Medical subject headings
- Binge-Eating Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Examination Questionnaire
The questionnaire is designed to assess the range, frequency and severity of behaviours associated with a diagnosis of an eating disorder.
Measured: 23rd May 2023-26th September 2023
Secondary outcomes (3)
Revised Children's Anxiety and Depression Scale (RCADS) Child
The Revised Children's Anxiety and Depression Scale (RCADS) measures the reported frequency of various symptoms of anxiety and low mood.
Measured: 23rd May 2023-26th September 2023
Revised Children's Anxiety and Depression Scale (RCADS) Parent/Carer
The Revised Children's Anxiety and Depression Scale (RCADS) measures the reported frequency of various symptoms of anxiety and low mood.
Measured: 23rd May 2023-26th September 2023
Feedback form
Feedback form asking questions about experience of the group and any recommendations for future groups.
Measured: 23rd August 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start26 Apr 2023
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coventry and Warwickshire Partnership NHS Trust
- Sponsor type
- Other government
- Collaborators
- Birmingham Newman University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703502
- Sponsor's protocol ID
- 320293
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small population size, it does not feel appropriate to share the data.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of an Online Binge Eating Disorder Group Intervention for Under 18s
- ClinicalTrials.gov ID
- NCT06703502
- Acronym / sponsor ID
- 320293
- Conditions
- Binge Eating Disorder
- Keywords
- group, adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Coventry and Warwickshire Partnership NHS TrustOther government
- Collaborators
- Birmingham Newman University
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 25 Nov 2024 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Population for study were young people (under 18) that are receiving support from the RISE Eating Disorder Team in the Coventry and Warwickshire Partnership Trust with a diagnosis of binge eating disorder.
Key inclusion criteria (3 listed)
- Diagnosed with Binge Eating Disorder
- Under 18 prior to the group commencing
- Spoke English fluently
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Revised Children's Anxiety and Depression Scale (RCADS) Child
Time frame: 23rd May 2023-26th September 2023
Revised Children's Anxiety and Depression Scale (RCADS) Parent/Carer
Time frame: 23rd May 2023-26th September 2023
Feedback form
Time frame: 23rd August 2023
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 25 Nov 2024.
- Individual participant dataSharing planned: No. Due to the small population size, it does not feel appropriate to share the data.
Related trials for Binge Eating Disorder
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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?
An observational study of Binge Eating Disorder, run by Coventry and Warwickshire Partnership NHS Trust at 1 site in United Kingdom.
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 25 Nov 2024. 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 United Kingdom. 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.
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?
Eating Disorder Examination Questionnaire (time frame: 23rd May 2023-26th September 2023). 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 25 Nov 2024.