Bulimia NervosaNCT04364659
Computerised Training for Binge-Subtype Eating Disorders
A study of Bulimia Nervosa and Binge-Eating Disorder, run by King's College London at 1 site in United Kingdom.
Trial summary
This research project aims to explore the feasibility of a computerised training to reduce approach to high energy-dense foods among individuals who binge eat. The computerised intervention used will be an inhibitory control training, particularly, a food-specific go/no-go task. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bulimia Nervosa, Binge-Eating Disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2019to 1 Jan 2021
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A diagnosis of bulimia nervosa or binge eating disorder
- Age 18-60 years old
- 2) BMI ≥ 18.5 3) Fluency in English
Who cannot join
- A diagnosis of psychosis
- A visual impairment that cannot be corrected by glasses or lenses
- Cognitive or neurological impairment
- Drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, SE5 8AF
Janet Treasure, OBE, PhD, FRCP, FRCPsych
About this study
Official title: Targeting Inhibitory Control Using Computerised Training Among Patients With Bulimia Nervosa and Binge Eating Disorder
This research project aims to explore the feasibility of a computerised training to reduce approach to high energy-dense foods among individuals who binge eat. The computerised intervention used will be an inhibitory control training, particularly, a food-specific go/no-go task. Eighty adults with a diagnosis of bulimia nervosa or binge eating disorder who are currently receiving psychological and/or pharmacological treatment for their eating disorder will be recruited and randomised to receive the computerised training in addition to treatment as usual (experimental group: training + TAU) or treatment as usual only (control group: TAU). Participants will complete questionnaires at baseline (T0), post-intervention (T1; 4 weeks), and follow-up (T2; 8 weeks).
Participants will be asked to complete the computerised training for 4 weeks using a mobile app called FoodT. The computerised training consists of completing a food-specific go/no-go task to reduce approach to high energy-dense foods.
The results of this study will build steps for future larger-scale interventions and improve understanding of psychological mechanisms involved in binge eating behaviour.
Read the detailed description
Participants will learn about the study through flyers, e-mail, and social media (i.e. Facebook and twitter), which will describe the main eligibility criteria and the researcher's contact information. Participants will also learn about the study from their eating disorder unit if they are currently outpatients at one of the identification centres. Inpatients will not be recruited.
Interested individuals will be asked to contact the researchers, who will then send an information sheet detailing the study procedure and what participation would involve. After reading the information sheet, interested individuals will be contacted by the researchers in order to confirm all eligibility criteria including diagnostic assessment. If these are met, a PDF of the consent form will be sent to the participants, including information about their rights as participants and their ability to withdraw at any time without having to give a reason. Participants who sign the consent form will respond to the e-mail with the attached document. Next, participants will be randomly allocated to the experimental condition (TAU + training) or control group (TAU only). Researchers will then inform the participant which group they have been allocated to. If they are in the intervention group, the researcher will contact the participant to give details about the training. All participants will be asked to complete a battery of questionnaires on Qualtrics, an online platform.
The questionnaires will collect data regarding: 1) a demographic information, 2) eating disorder symptoms (Eating Disorders Examination Questionnaire; Self-Regulation of Eating Behaviour Questionnaire; Adult Eating Behaviour Questionnaire; Yale Food Addiction Scale; Food Liking Task), 3) impulsivity (Negative Urgency Scale), 4) symptoms of anxiety or depression (GAD-7 anxiety; PHQ-9 Depression) and 5) quality of life (EQ-5D-3L).
Participants in the intervention group will be asked to complete the training and a food diary for four weeks. After the four weeks, all participants will be asked to complete the same battery of questionnaires (except for the demographic questionnaire). One month post-intervention, a follow-up questionnaire will also be sent.
- Conditions
- Bulimia Nervosa, Binge-Eating Disorder
- Being tested
- Food-Specific Inhibitory Control Training (FoodT App)
- Medical subject headings
- Bulimia Nervosa, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food-Specific Inhibitory Control Training (FoodT App)Behavioural
FoodTrainer (FoodT) is a simple game that aims to train individuals to 'stop' to certain unhealthy foods. Repeatedly playing this game is hypothesised to help build associations between certain foods (such as chocolate) and stopping, putting the brakes on unhelpful eating behaviour.
| Study group | Role | What they receive |
|---|---|---|
| Food-specific ICT + TAU | Experimental | Participants in the Food-specific ICT + TAU group will be encouraged to complete the FoodT phone app (a food-specific go/no-go task) and a food diary daily for four weeks. After four weeks, they will be asked to complete a post-intervention questionnaire. After eight weeks, they will be asked to complete a follow-up questionnaire. Receives: Behavioral: Food-Specific Inhibitory Control Training (FoodT App) |
| TAU | No intervention | Participants in the TAU group will not receive the Food-specific ICT. After four weeks, they will be asked to complete a 'post-intervention' questionnaire. After eight weeks, they will be asked to complete a follow-up questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention
Feasibility as defined by: 1) the recruitment of 75% of the target number (N = 80), 2) participants' adherence to the training task, with ≥ 75% of participants completing at least 8 training sessions, and 3) participants' retention in treatment, with ≥ 80% of the sample completing the end of training measures.
Measured: At 4 weeks.
Acceptability of intervention
Feedback forms will be used to assess the acceptability of the training, including participants' view of the helpfulness, practicality, and potential improvements to it.
Measured: Feedback forms will be completed 8 weeks post-randomisation (at follow-up).
Acceptability of intervention
Focus groups will be used to assess the acceptability of the training, including participants' view of the helpfulness, practicality, and potential improvements to it.
Measured: Focus groups will be conduced 2 weeks after recruitment has ended.
Efficacy: Changes in Binge Eating Frequency
The primary outcome aim is to examine the efficacy of app-based food-specific go/no-go training in targeting binge-eating frequency (as measured using item #13 on the Eating Disorder Examination Questionnaire). It is hypothesised that participants would exhibit reductions in binge eating frequency, with stronger effects in the experimental group (training + TAU) compared to the control (TAU) group. Participants are free to enter any numerical value, with a greater value indicating a higher frequency of binge eating.
Measured: Measured at baseline, at 4 weeks, and at 8 weeks (follow-up).
Secondary outcomes (4)
Efficacy: Changes in Eating Disorder Psychopathology
The aim of this secondary outcome is to examine the efficacy of app-based food-specific go/no-go training in targeting eating disorder psychopathology (as measured using the Global Eating Disorder Examination Questionnaire score). It is hypothesised that participants will exhibit reductions in these outcomes, with stronger effects in the experimental group (training + TAU) compared to the control (TAU) group. The mean score can range from 0-6, with higher scores indicating higher eating disorder psychopathology.
Measured: Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Efficacy: Changes in High Energy-Dense Food Valuation
The aim of this secondary outcome is to examine the efficacy of app-based food-specific go/no-go training in targeting high energy-dense food valuation (as measured using the Food Rating Test). It is hypothesised that participants will exhibit reductions in these outcomes, with stronger effects in the experimental group (training + TAU) compared to the control (TAU) group. The mean score can range from 0-100, with higher scores indicating greater high energy-dense food valuation.
Measured: Measured at baseline, at 4 weeks (post-intervention), Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Efficacy: Changes in Food Approach
The aim of this secondary outcome is to examine the efficacy of app-based food-specific go/no-go training in targeting food approach (as measured using the Adult Eating Behaviour Questionnaire, food approach sub scale). It is hypothesised that participants will exhibit reductions in these outcomes, with stronger effects in the experimental group (training + TAU) compared to the control (TAU) group. Participant responses range from 1-5, ranging from strongly disagree to strongly agree. Higher scores indicate greater food approach behaviour.
Measured: Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Efficacy: Changes in Food Addiction
The aim of this secondary outcome is to examine the efficacy of app-based food-specific go/no-go training in targeting food addiction (as measured using the Yale Food Addiction Scale). It is hypothesised that participants will exhibit reductions in these outcomes, with stronger effects in the experimental group (training + TAU) compared to the control (TAU) group. The mean score can range from 0-4, with higher scores indicating greater food addiction.
Measured: Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Jun 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter
- Responsible party
- Sponsor
- Investigators
- Janet Treasure, OBE, PhD, FRCP, FRCPsych, Principal investigator, Institute of Psychiatry, Psychology, & Neuroscience, King's College LondonValentina Cardi, PhD, Study director, Institute of Psychiatry, Psychology, & Neuroscience, King's College LondonNatalia Lawrence, PhD, Study chair, University of ExeterJohanna Keeler, BSc, Study chair, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364659
- Sponsor's protocol ID
- IRAS ID: 252717
- Status last verified
- Oct 2019
- First submitted
- 9 Mar 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Inhibitory Control Using Computerised Training Among Patients With Bulimia Nervosa and Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT04364659
- Acronym / sponsor ID
- IRAS ID: 252717
- Conditions
- Bulimia Nervosa, Binge-Eating Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University of Exeter
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 28 Apr 2020 (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.
This research project aims to explore the feasibility of a computerised training to reduce approach to high energy-dense foods among individuals who binge eat. The computerised intervention used will be an inhibitory control training, particularly, a food-specific go/no-go task. Eighty adults with a diagnosis of bulimia nervosa or binge eating disorder who are currently receiving psychological and/or pharmacological treatment for their eating disorder will be recruited and randomised to receive the computerised training in addition to treatment as usual (experimental group: training + TAU) or treatment as usual only (control group: TAU). Participants will complete questionnaires at baseline (T0), post-intervention (T1; 4 weeks), and follow-up (T2; 8 weeks).
Participants will be asked to complete the computerised training for 4 weeks using a mobile app called FoodT. The computerised training consists of completing a food-specific go/no-go task to reduce approach to high energy-dense foods.
The results of this study will build steps for future larger-scale interventions and improve understanding of psychological mechanisms involved in binge eating behaviour.
Detailed description
Participants will learn about the study through flyers, e-mail, and social media (i.e. Facebook and twitter), which will describe the main eligibility criteria and the researcher's contact information. Participants will also learn about the study from their eating disorder unit if they are currently outpatients at one of the identification centres. Inpatients will not be recruited.
Interested individuals will be asked to contact the researchers, who will then send an information sheet detailing the study procedure and what participation would involve. After reading the information sheet, interested individuals will be contacted by the researchers in order to confirm all eligibility criteria including diagnostic assessment. If these are met, a PDF of the consent form will be sent to the participants, including information about their rights as participants and their ability to withdraw at any time without having to give a reason. Participants who sign the consent form will respond to the e-mail with the attached document. Next, participants will be randomly allocated to the experimental condition (TAU + training) or control group (TAU only). Researchers will then inform the participant which group they have been allocated to. If they are in the intervention group, the researcher will contact the participant to give details about the training. All participants will be asked to complete a battery of questionnaires on Qualtrics, an online platform.
The questionnaires will collect data regarding: 1) a demographic information, 2) eating disorder symptoms (Eating Disorders Examination Questionnaire; Self-Regulation of Eating Behaviour Questionnaire; Adult Eating Behaviour Questionnaire; Yale Food Addiction Scale; Food Liking Task), 3) impulsivity (Negative Urgency Scale), 4) symptoms of anxiety or depression (GAD-7 anxiety; PHQ-9 Depression) and 5) quality of life (EQ-5D-3L).
Participants in the intervention group will be asked to complete the training and a food diary for four weeks. After the four weeks, all participants will be asked to complete the same battery of questionnaires (except for the demographic questionnaire). One month post-intervention, a follow-up questionnaire will also be sent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food-specific ICT + TAU | Experimental | Behavioral: Food-Specific Inhibitory Control Training (FoodT App)Participants in the Food-specific ICT + TAU group will be encouraged to complete the FoodT phone app (a food-specific go/no-go task) and a food diary daily for four weeks. After four weeks, they will be asked to complete a post-intervention questionnaire. After eight weeks, they will be asked to complete a follow-up questionnaire. |
| TAU | No intervention | –Participants in the TAU group will not receive the Food-specific ICT. After four weeks, they will be asked to complete a 'post-intervention' questionnaire. After eight weeks, they will be asked to complete a follow-up questionnaire. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A diagnosis of bulimia nervosa or binge eating disorder
- Age 18-60 years old
- 2) BMI ≥ 18.5 3) Fluency in English
Key exclusion criteria (4 listed)
- A diagnosis of psychosis
- A visual impairment that cannot be corrected by glasses or lenses
- Cognitive or neurological impairment
- Drug or alcohol abuse
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 |
|---|---|---|
| Food-Specific Inhibitory Control Training (FoodT App)FoodTrainer (FoodT) is a simple game that aims to train individuals to 'stop' to certain unhealthy foods. Repeatedly playing this game is hypothesised to help build associations between certain foods (such as chocolate) and stopping, putting the brakes on unhelpful eating behaviour. | Behavioural | Food-specific ICT + TAU |
Primary outcome
Feasibility of intervention
Time frame: At 4 weeks.
Feasibility as defined by: 1) the recruitment of 75% of the target number (N = 80), 2) participants' adherence to the training task, with ≥ 75% of participants completing at least 8 training sessions, and 3) participants' retention in treatment, with ≥ 80% of the sample completing the end of training measures.
Acceptability of intervention
Time frame: Feedback forms will be completed 8 weeks post-randomisation (at follow-up).
Feedback forms will be used to assess the acceptability of the training, including participants' view of the helpfulness, practicality, and potential improvements to it.
Acceptability of intervention
Time frame: Focus groups will be conduced 2 weeks after recruitment has ended.
Focus groups will be used to assess the acceptability of the training, including participants' view of the helpfulness, practicality, and potential improvements to it.
Efficacy: Changes in Binge Eating Frequency
Time frame: Measured at baseline, at 4 weeks, and at 8 weeks (follow-up).
The primary outcome aim is to examine the efficacy of app-based food-specific go/no-go training in targeting binge-eating frequency (as measured using item #13 on the Eating Disorder Examination Questionnaire). It is hypothesised that participants would exhibit reductions in binge eating frequency, with stronger effects in the experimental group (training + TAU) compared to the control (TAU) group. Participants are free to enter any numerical value, with a greater value indicating a higher frequency of binge eating.
4 secondary outcomes
Efficacy: Changes in Eating Disorder Psychopathology
Time frame: Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Efficacy: Changes in High Energy-Dense Food Valuation
Time frame: Measured at baseline, at 4 weeks (post-intervention), Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Efficacy: Changes in Food Approach
Time frame: Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Efficacy: Changes in Food Addiction
Time frame: Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
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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.
Janet Treasure, OBE, PhD, FRCP, FRCPsych principal investigator
Institute of Psychiatry, Psychology, & Neuroscience, King's College London
Valentina Cardi, PhD study director
Institute of Psychiatry, Psychology, & Neuroscience, King's College London
Natalia Lawrence, PhD study chair
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Bulimia Nervosa and Binge-Eating Disorder, run by King's College London 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 4 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: status not confirmed, as of the sponsor's last update on 28 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rayane Chami, MSc (07482036997, rayane.chami@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention (time frame: At 4 weeks.). The study lists 4 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 28 Apr 2020.