Clinical trial NCT04364659: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Bulimia Nervosa
Binge-Eating Disorder
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University of Exeter
First posted: 2020-04-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of intervention
timeFrame: At 4 weeks.
measure: Acceptability of intervention
timeFrame: Feedback forms will be completed 8 weeks post-randomisation (at follow-up).
measure: Acceptability of intervention
timeFrame: Focus groups will be conduced 2 weeks after recruitment has ended.
measure: Efficacy: Changes in Binge Eating Frequency
timeFrame: Measured at baseline, at 4 weeks, and at 8 weeks (follow-up).
Secondary outcomes:
measure: Efficacy: Changes in Eating Disorder Psychopathology
timeFrame: Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
measure: Efficacy: Changes in High Energy-Dense Food Valuation
timeFrame: Measured at baseline, at 4 weeks (post-intervention), Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
measure: Efficacy: Changes in Food Approach
timeFrame: Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
measure: Efficacy: Changes in Food Addiction
timeFrame: Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Other outcomes:
measure: Exploratory: Changes in Depression
timeFrame: Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
measure: Exploratory: Changes in Anxiety
timeFrame: Measured at baseline, at 4 weeks (post-intervention), and at 8 weeks (follow-up).
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: Institute of Psychiatry, Psychology, & Neuroscience, King's College London
name: Janet Treasure, OBE, PhD, FRCP, FRCPsych
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Psychiatry, Psychology, & Neuroscience, King's College London
name: Valentina Cardi, PhD
role: STUDY_DIRECTOR
affiliation: University of Exeter
name: Natalia Lawrence, PhD
role: STUDY_CHAIR
affiliation: University of Exeter
name: Johanna Keeler, BSc
role: STUDY_CHAIR
References: