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A Multimodal Outcome Study of Eating Disorders

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ClinicalTrials.gov Identifier: NCT03126526
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
University of Exeter
Information provided by (Responsible Party):
King's College London

Brief Summary:

This research project aims to explore the effectiveness of a computerised intervention as a treatment for eating disorders, particularly binge eating disorder and bulimia nervosa. Two interventions will be used to target cognitive processes: 1) food-specific inhibitory control training and 2) implementation intentions.

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 and taste tests. 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.


Condition or disease Intervention/treatment Phase
Eating Disorder Healthy Behavioral: Food specific Inhibitory control training Behavioral: Implementation intentions Behavioral: General inhibitory control training Not Applicable

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) verbal hunger questionnaire, 3) eating disorders examination questionnaire, 4) food ratings test, 5) self-regulation of eating behaviour questionnaire for adults, 6) The negative urgency scale , 7) the adults eating behaviour questionnaire, 8) GAD-7 anxiety, and 9) PHQ-9 Depression.

Upon participants' arrival to the lab, they will learn to complete the training tasks (i.e. food specific go/no-go, general go/no-go, emotion task, and arrow flanker task) 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. Next, they will discuss the completed food diary with the researcher, who will encourage them to set small weekly goals and plan behaviour towards food, known as implementation intentions. Their weight will also be measured. Before leaving the lab, participants will take part in a taste test, in which they are asked to rate the taste of particular foods. Researchers will monitor intake accordingly.

Participants will be asked to complete the training and complete food diaries every day for four weeks. The food diaries and the successful/ unsuccessful attempts of implementation intentions to reduce craving, bingeing, and purging will be assessed weekly. A researcher/clinician will discuss setting the implementation intention goals either on the phone, e-mail, or in person, depending on travel requirements. Within the training, visual analogue scales will be used to assess mood and urge to eat. Moreover, participants will be asked to weekly report how often they have completed the training within that week. 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 discuss their food diaries with the researcher. Additionally, their weight will be re-assessed. Moreover, they will take part in another taste test, in which they are asked to rate the taste of particular foods. 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 food diaries and the complete battery of questionnaires used at baseline.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Targeting Top-down and Bottom-up Processing in Eating Disorders Using Computerized Training Approaches: A Multimodal Outcome Study
Actual Study Start Date : November 26, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: Food specific inhibitory control training
The stimuli in this task will involve pictures of food.
Behavioral: Food specific Inhibitory control training
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.

Behavioral: Implementation intentions
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.

Active Comparator: General inhibitory control training
The stimuli in this task will not involve pictures of food, but pictures of stationary and household items.
Behavioral: Implementation intentions
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.

Behavioral: General inhibitory control training
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.

No Intervention: Baseline brain activation assessment (healthy controls)
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.



Primary Outcome Measures :
  1. Change in eating disorder symptomatology [ Time Frame: This will be assessed at baseline, intervention completion, and follow-up (1 month later) ]
    Decrease in binge eating frequency and decrease in compensatory behaviours.


Secondary Outcome Measures :
  1. Change in weight/BMI [ Time Frame: This will be assessed at baseline (Time 0), intervention completion (4 weeks), and follow-up (8 weeks) ]
    Weight will be measured by the researcher and BMI will be calculated.

  2. Change in calories consumed from palatable food [ Time Frame: This will be assessed at baseline (Time 0) and intervention completion (4 weeks). ]
    This will be assessed through a taste test, where we expect lower intake.

  3. Change in calories consumed from healthy foods [ Time Frame: This will be assessed at baseline (Time 0) and intervention completion (4 weeks). ]
    This will be assessed through a taste test, where we expect increased intake.

  4. Change in inhibitory control [ Time Frame: This will be assessed at baseline (Time 0) and intervention completion (4 weeks). ]
    This will be assessed using the self-report measure of disinhibition and using the go/no-go computerized task.

  5. Change in anxiety, depression, and stress symptoms [ Time Frame: This will be assessed at baseline (Time 0), intervention completion (4 weeks), and follow-up (8 weeks) ]
    This will be assessed using the DASS measure, where we expect decrease.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) Diagnosis of an Eating Disorder (Anorexia Nervosa, 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126526


Contacts
Contact: Rayane Chami 07482036997 rayane.chami@kcl.ac.uk

Locations
United Kingdom
Eating Disorders Unit, Institute of Psychiatry, Psychology, and Neuroscience Recruiting
London, United Kingdom, SE5 8AF
Contact: Professor Janet Treasure, MD, PhD, OBE    02074785978    janet.treasure@kcl.ac.uk   
Sponsors and Collaborators
King's College London
University of Exeter
Investigators
Principal Investigator: Rayane Chami, MSc/ PhD Student King's College London
Study Director: 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

Publications:
Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03126526     History of Changes
Other Study ID Numbers: IRAS Project ID: 209609
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders