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Computerised Training for Binge-Subtype Eating Disorders

Primary Purpose

Bulimia Nervosa, Binge-Eating Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Food-Specific Inhibitory Control Training (FoodT App)
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bulimia Nervosa

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King's College LondonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Food-specific ICT + TAU

TAU

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 9, 2020
Last Updated
April 23, 2020
Sponsor
King's College London
Collaborators
University of Exeter
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1. Study Identification

Unique Protocol Identification Number
NCT04364659
Brief Title
Computerised Training for Binge-Subtype Eating Disorders
Official Title
Targeting Inhibitory Control Using Computerised Training Among Patients With Bulimia Nervosa and Binge Eating Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
University of Exeter

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa, Binge-Eating Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Food-specific ICT + TAU
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Food-Specific Inhibitory Control Training (FoodT App)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of intervention
Description
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.
Time Frame
At 4 weeks.
Title
Acceptability of intervention
Description
Feedback forms will be used to assess the acceptability of the training, including participants' view of the helpfulness, practicality, and potential improvements to it.
Time Frame
Feedback forms will be completed 8 weeks post-randomisation (at follow-up).
Title
Acceptability of intervention
Description
Focus groups will be used to assess the acceptability of the training, including participants' view of the helpfulness, practicality, and potential improvements to it.
Time Frame
Focus groups will be conduced 2 weeks after recruitment has ended.
Title
Efficacy: Changes in Binge Eating Frequency
Description
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.
Time Frame
Measured at baseline, at 4 weeks, and at 8 weeks (follow-up).
Secondary Outcome Measure Information:
Title
Efficacy: Changes in Eating Disorder Psychopathology
Description
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.
Time Frame
Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Title
Efficacy: Changes in High Energy-Dense Food Valuation
Description
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.
Time Frame
Measured at baseline, at 4 weeks (post-intervention), Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Title
Efficacy: Changes in Food Approach
Description
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.
Time Frame
Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Title
Efficacy: Changes in Food Addiction
Description
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.
Time Frame
Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Other Pre-specified Outcome Measures:
Title
Exploratory: Changes in Depression
Description
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.
Time Frame
Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Title
Exploratory: Changes in Anxiety
Description
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.
Time Frame
Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A diagnosis of bulimia nervosa or binge eating disorder Age 18-60 years old 2) BMI ≥ 18.5 3) Fluency in English Exclusion criteria: A diagnosis of psychosis A visual impairment that cannot be corrected by glasses or lenses Cognitive or neurological impairment Drug or alcohol abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rayane Chami, MSc
Phone
07482036997
Email
rayane.chami@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Treasure, OBE, PhD, FRCP, FRCPsych
Organizational Affiliation
Institute of Psychiatry, Psychology, & Neuroscience, King's College London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Valentina Cardi, PhD
Organizational Affiliation
Institute of Psychiatry, Psychology, & Neuroscience, King's College London
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Natalia Lawrence, PhD
Organizational Affiliation
University of Exeter
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Johanna Keeler, BSc
Organizational Affiliation
University of Exeter
Official's Role
Study Chair
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Treasure, OBE, PhD, FRCP, FRCPsych

12. IPD Sharing Statement

Learn more about this trial

Computerised Training for Binge-Subtype Eating Disorders

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