Computerised Training for Binge-Subtype Eating Disorders

NCT04364659 | Unknown

• 1 other identifier: IRAS ID: 252717
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Bulimia Nervosa; Binge-Eating Disorder

Outcome Measures

Primary Outcomes (4)

• 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.

• 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).

• 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.

• 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 Outcomes (4)

• Efficacy: Changes in Eating Disorder Psychopathology

  Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).

• Efficacy: Changes in 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).

• Efficacy: Changes in Food Approach

  Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).

• Efficacy: Changes in Food Addiction

  Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).

Other Outcomes (2)

• Exploratory: Changes in Depression

  Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).

• Exploratory: Changes in Anxiety

  Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).

Study Arms (2)

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.

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.

Interventions

Food-Specific Inhibitory Control Training (FoodT App) BEHAVIORAL

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.

Food-specific ICT + TAU

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A diagnosis of bulimia nervosa or binge eating disorder
• Age 18-60 years old
• \) BMI ≥ 18.5 3) Fluency in English

You may not qualify if:

• A diagnosis of psychosis
• A visual impairment that cannot be corrected by glasses or lenses
• Cognitive or neurological impairment
• Drug or alcohol abuse

Sponsors & Collaborators

• King's College London: lead
• University of Exeter: collaborator

Study Sites (1)

King's College London

London, SE5 8AF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Bulimia Nervosa; Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Janet Treasure, OBE, PhD, FRCP, FRCPsych

  Institute of Psychiatry, Psychology, & Neuroscience, King's College London

  PRINCIPAL INVESTIGATOR

• Valentina Cardi, PhD

  Institute of Psychiatry, Psychology, & Neuroscience, King's College London

  STUDY DIRECTOR

• Natalia Lawrence, PhD

  University of Exeter

  STUDY CHAIR

• Johanna Keeler, BSc

  University of Exeter

  STUDY CHAIR

Central Study Contacts

Rayane Chami, MSc

CONTACT

07482036997; rayane.chami@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: April 28, 2020
• Study Start: June 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: January 1, 2021
• Last Updated: April 28, 2020

Record last verified: 2019-10

Locations

GB (1)