Computerised Training for Binge-Subtype Eating Disorders

Bulimia Nervosa Clinical Trial

Official title:

Targeting Inhibitory Control Using Computerised Training Among Patients With Bulimia Nervosa and Binge Eating Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04364659
• Other study ID #: IRAS ID: 252717
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: October 2019
• Source: King's College London
• Contact: Rayane Chami, MSc
• Phone: 07482036997
• Email: rayane.chami[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. A diagnosis of bulimia nervosa or binge eating disorder

2. Age 18-60 years old

2) BMI = 18.5 3) Fluency in English

Exclusion criteria:

1. A diagnosis of psychosis

2. A visual impairment that cannot be corrected by glasses or lenses

3. Cognitive or neurological impairment

4. Drug or alcohol abuse

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Feeding and Eating Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory: Changes in Depression	The aim of this experimental outcome is to explore whether individuals in the experimental group (training + TAU) will show reductions in depression (as measured using the Patient Health Questionnaire- 9), and if so, whether the reduction is greater than that found among participants in the control group (TAU). The total score can range from 0-27, with greater scores indicating greater levels of depression.	Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Other	Exploratory: Changes in Anxiety	The aim of this experimental outcome is to explore whether individuals in the experimental group (training + TAU) will show reductions in anxiety (as measured by the Generalised Anxiety Disorder-7), and if so, whether the reduction is greater than that found among participants in the control group (TAU). The total score can range from 0-21, with higher scores indicating greater levels of anxiety.	Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Primary	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.	At 4 weeks.
Primary	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.	Feedback forms will be completed 8 weeks post-randomisation (at follow-up).
Primary	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.	Focus groups will be conduced 2 weeks after recruitment has ended.
Primary	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 at baseline, at 4 weeks, and at 8 weeks (follow-up).
Secondary	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 at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Secondary	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 at baseline, at 4 weeks (post-intervention), Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Secondary	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 at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Secondary	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 at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).