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A Multimodal Outcome Study of Eating Disorders

Primary Purpose

Eating Disorder, Healthy

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Food specific Inhibitory control training
Implementation intentions
General inhibitory control training
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorder

Eligibility Criteria

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

Inclusion Criteria:

1) 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.

Exclusion Criteria:

1) 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Food specific inhibitory control training

General inhibitory control training

Baseline brain activation assessment (healthy controls)

Arm Description

The stimuli in this task will involve pictures of food.

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

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.

Outcomes

Primary Outcome Measures

Change in eating disorder symptomatology
Decrease in binge eating frequency and decrease in compensatory behaviours.

Secondary Outcome Measures

Change in weight/BMI
Weight will be measured by the researcher and BMI will be calculated.
Change in inhibitory control
This will be assessed using the self-report measure of disinhibition and using the go/no-go computerized task.
Change in anxiety and depression symptoms
This will be assessed using the GAD and PHQ measures.
Changes in High Calorie Food Valuation
This will be assessed using the food rating task.
Changes in Low Calorie Food Valuation
This will be assessed using the food rating task.

Full Information

First Posted
April 3, 2017
Last Updated
October 22, 2019
Sponsor
King's College London
Collaborators
University of Exeter
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1. Study Identification

Unique Protocol Identification Number
NCT03126526
Brief Title
A Multimodal Outcome Study of Eating Disorders
Official Title
Targeting Top-down and Bottom-up Processing in Eating Disorders Using Computerized Training Approaches: A Multimodal Outcome Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 26, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

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
Yes

5. Study Description

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.
Detailed Description
Participants will learn about the study through flyers, e-mail, and social media (i.e. twitter and Facebook) which will describe the interventional nature of the study, the main eligibility criteria, and the researcher's contact information. 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 email with the attached document. Next, researchers will contact the participant to set an appointment to enter the lab for the first EEG recording. Before entering the lab, participants will be asked to complete a food diary and complete the complete a battery of questionnaires. The questionnaires include: 1) a demographic questionnaire, 2) eating disorders examination questionnaire, 3) food ratings test, 4) self-regulation of eating behaviour questionnaire for adults, 5) The negative urgency scale, 6) the adults eating behaviour questionnaire, 7) GAD-7, and 8) PHQ-9. Upon participants' arrival to the lab, participants will be asked to complete the food rating task. Next, they will learn to complete the training tasks (i.e. food specific go/no-go and general go/no-go) and perform them during EEG recording. They will be offered the opportunity to ask questions relating to the task or the EEG at any time. Their weight will also be measured. Participants will be asked to complete the training and complete food diaries every day for four weeks. The successful/ unsuccessful attempts at implementation intentions will be assessed weekly by a mentor. A researcher/clinician will discuss setting the implementation intention goals with the participant over email. At the end of the training, participants will enter the lab to re-complete the four tasks while researchers record brain activation using the EEG. They will also be asked to complete the food rating task again and their weight will be re-assessed. Before leaving, they will be asked to complete a feedback sheet in which they can express their experience with the training, in terms of facilitators and barriers and visual analogue scales that will ask participants to rate the acceptability, usefulness and level of burden experienced with training. Participants will then be followed up at 1 month post-intervention; they will be asked to complete the battery of questionnaires used at baseline and post-intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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),
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Food specific inhibitory control training
Arm Type
Experimental
Arm Description
The stimuli in this task will involve pictures of food.
Arm Title
General inhibitory control training
Arm Type
Active Comparator
Arm Description
The stimuli in this task will not involve pictures of food, but pictures of stationary and household items.
Arm Title
Baseline brain activation assessment (healthy controls)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Food specific Inhibitory control training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Implementation intentions
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
General inhibitory control training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in eating disorder symptomatology
Description
Decrease in binge eating frequency and decrease in compensatory behaviours.
Time Frame
This will be assessed at baseline, intervention completion, and follow-up (1 month later)
Secondary Outcome Measure Information:
Title
Change in weight/BMI
Description
Weight will be measured by the researcher and BMI will be calculated.
Time Frame
This will be assessed at baseline (Time 0), intervention completion (4 weeks), and follow-up (8 weeks)
Title
Change in inhibitory control
Description
This will be assessed using the self-report measure of disinhibition and using the go/no-go computerized task.
Time Frame
This will be assessed at baseline (Time 0) and intervention completion (4 weeks).
Title
Change in anxiety and depression symptoms
Description
This will be assessed using the GAD and PHQ measures.
Time Frame
This will be assessed at baseline (Time 0), intervention completion (4 weeks), and follow-up (8 weeks)
Title
Changes in High Calorie Food Valuation
Description
This will be assessed using the food rating task.
Time Frame
This will be assessed at baseline (Time 0) and post-intervention (4 weeks).
Title
Changes in Low Calorie Food Valuation
Description
This will be assessed using the food rating task.
Time Frame
This will be assessed at baseline (Time 0) and post-intervention (4 weeks).

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: 1) 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. Exclusion Criteria: 1) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rayane Chami, MSc/ PhD Student
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Valentina Cardi, PhD
Organizational Affiliation
King's College London
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Professor Janet Treasure
Organizational Affiliation
King's College London
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dr Grainne McLoughlin
Organizational Affiliation
King's College London
Official's Role
Study Director
Facility Information:
Facility Name
Eating Disorders Unit, Institute of Psychiatry, Psychology, and Neuroscience
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11156432
Citation
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.
Results Reference
background
PubMed Identifier
27215837
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
11556941
Citation
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.
Results Reference
background
Citation
Fairburn, C. G. (2008). Cognitive behavior therapy and eating disorders. Guilford Press
Results Reference
background
PubMed Identifier
27484457
Citation
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.
Results Reference
background

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A Multimodal Outcome Study of Eating Disorders

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