A Multimodal Outcome Study of Eating Disorders

NCT03126526 | Completed DMC

• 1 other identifier: IRAS Project ID: 209609
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This research project aims to explore the effectiveness of combined go/no-go training and implementation intentions in targeting binge eating frequency among people with binge eating disorder and bulimia nervosa. The full intervention is 4 weeks long and consists of completing the training and food diaries every day and meeting with the researcher twice for EEG recording. Moreover, it involves completing questionnaires at baseline, at intervention completion, and one month after the intervention. Moreover, healthy control participants will be recruitment to complete baseline questionnaires and take part in one EEG recording session in order to assess baseline differences in brain activation in response to computer tasks.

Conditions

Eating Disorder; Healthy

Outcome Measures

Primary Outcomes (1)

• Change in eating disorder symptomatology

  Decrease in binge eating frequency and decrease in compensatory behaviours.

  This will be assessed at baseline, intervention completion, and follow-up (1 month later)

Secondary Outcomes (5)

• Change in weight/BMI

  This will be assessed at baseline (Time 0), intervention completion (4 weeks), and follow-up (8 weeks)

• Change in inhibitory control

  This will be assessed at baseline (Time 0) and intervention completion (4 weeks).

• Change in anxiety and depression symptoms

  This will be assessed at baseline (Time 0), intervention completion (4 weeks), and follow-up (8 weeks)

• Changes in High Calorie Food Valuation

  This will be assessed at baseline (Time 0) and post-intervention (4 weeks).

• Changes in Low Calorie Food Valuation

  This will be assessed at baseline (Time 0) and post-intervention (4 weeks).

Study Arms (3)

Food specific inhibitory control training

EXPERIMENTAL

The stimuli in this task will involve pictures of food.

Behavioral: Food specific Inhibitory control training; Behavioral: Implementation intentions

General inhibitory control training

ACTIVE COMPARATOR

The stimuli in this task will not involve pictures of food, but pictures of stationary and household items.

Behavioral: Implementation intentions; Behavioral: General inhibitory control training

Baseline brain activation assessment (healthy controls)

NO INTERVENTION

This arm is included to assess brain activation using EEG among healthy controls at baseline in order to compare responses to participants with eating disorders.

Interventions

Food specific Inhibitory control training BEHAVIORAL

It involves a go/no-go task in which participants are requested to respond by clicking a particular button when a specific stimulus appears and requested to withhold their response when another particular stimulus appears. Stimuli in this intervention include photos of food and non-food.

Food specific inhibitory control training

Implementation intentions BEHAVIORAL

It involves designing "if-then" strategies of behaviour. Participants will be asked to describe situations in which they feel they are more prone to behave in a way that is not congruent to their long term goals, and then to plan strategies to behave differently when faced with this situation in the future.

Food specific inhibitory control training; General inhibitory control training

General inhibitory control training BEHAVIORAL

It involves a go/no-go task in which participants are requested to respond by clicking a particular button when a specific stimulus appears and requested to withhold their response when another particular stimulus appears. Stimuli in this intervention include only non-food pictures.

General inhibitory control training

Eligibility Criteria

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

You may qualify if:

• \) Diagnosis of an Eating Disorder (Bulimia Nervosa or Binge Eating Disorder); 2) No severe psychiatric comorbidity (e.g. psychosis); 3) Fluency in English; 4) No visual impairment; 5) No cognitive/neurological impairment; 6) No drugs or alcohol abuse; 7) No use of weight-loss medication; 8 No metabolic disorder; 9) Above 18 years old and below 60 years old.

You may not qualify if:

• \) No diagnosis of an eating disorder; 2) Severe psychiatric comorbidity; 3) No English language fluency; 4) Visual impairment (not correctable with eye-wear); 5) Cognitive/neurological impairment; 6) Drug or alcohol abuse; 7) Use of weight-loss medication; 8) A metabolic disorder; 9) Below 18 years old and above 60 years old.

Sponsors & Collaborators

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

Study Sites (1)

Eating Disorders Unit, Institute of Psychiatry, Psychology, and Neuroscience

London, SE5 8AF, United Kingdom

Location

Related Publications (6)

• Lowe MR, Friedman MI, Mattes R, Kopyt D, Gayda C. Comparison of verbal and pictorial measures of hunger during fasting in normal weight and obese subjects. Obes Res. 2000 Nov;8(8):566-74. doi: 10.1038/oby.2000.73.

  PMID: 11156432 BACKGROUND

• Hunot C, Fildes A, Croker H, Llewellyn CH, Wardle J, Beeken RJ. Appetitive traits and relationships with BMI in adults: Development of the Adult Eating Behaviour Questionnaire. Appetite. 2016 Oct 1;105:356-63. doi: 10.1016/j.appet.2016.05.024. Epub 2016 May 20.

  PMID: 27215837 BACKGROUND

• Whiteside, S. P., & Lynam, D. R. (2001). The Five Factor Model and impulsivity: Using a structural model of personality to understand impulsivity. Personality and Individual Differences, 30(4), 669-689. http://dx.doi.org/10.1016/S0191-8869(00)00064-7.

  BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Fairburn, C. G. (2008). Cognitive behavior therapy and eating disorders. Guilford Press

  BACKGROUND

• Kliemann N, Beeken RJ, Wardle J, Johnson F. Development and validation of the Self-Regulation of Eating Behaviour Questionnaire for adults. Int J Behav Nutr Phys Act. 2016 Aug 2;13:87. doi: 10.1186/s12966-016-0414-6.

  PMID: 27484457 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Rayane Chami, MSc/ PhD Student

  King's College London

  PRINCIPAL INVESTIGATOR

• Dr Valentina Cardi, PhD

  King's College London

  STUDY DIRECTOR

• Professor Janet Treasure

  King's College London

  STUDY DIRECTOR

• Dr Grainne McLoughlin

  King's College London

  STUDY DIRECTOR

Study Design

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

Model Details: The model includes two interventions (i.e. inhibitory control training and implementation intentions) that aim to target cognitive processes that have been reported to play a role in the onset and maintenance of eating disorders. Moreover, three arms exist, one for healthy controls including only one EEG assessment, and two interventional arms for participants with eating disorders. Participants in one interventional arm will receive food-specific inhibitory control training, while participants in the other interventional arm will receive general inhibitory control training. These are delivered through a website task (go/no-go training),

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 24, 2017
• Study Start: November 26, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)