A Multimodal Outcome Study of Eating Disorders

Healthy Clinical Trial

Official title:

Targeting Top-down and Bottom-up Processing in Eating Disorders Using Computerized Training Approaches: A Multimodal Outcome Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126526
• Other study ID #: IRAS Project ID: 209609
• Status: Completed
• Phase: N/A
• Start date: November 26, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: October 2019
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Eating Disorder
• Feeding and Eating Disorders
• Healthy

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Eating Disorders Unit, Institute of Psychiatry, Psychology, and Neuroscience	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	University of Exeter

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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

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. — View 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. — View 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. — View 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in weight/BMI	Weight will be measured by the researcher and BMI will be calculated.	This will be assessed at baseline (Time 0), intervention completion (4 weeks), and follow-up (8 weeks)
Secondary	Change in inhibitory control	This will be assessed using the self-report measure of disinhibition and using the go/no-go computerized task.	This will be assessed at baseline (Time 0) and intervention completion (4 weeks).
Secondary	Change in anxiety and depression symptoms	This will be assessed using the GAD and PHQ measures.	This will be assessed at baseline (Time 0), intervention completion (4 weeks), and follow-up (8 weeks)
Secondary	Changes in High Calorie Food Valuation	This will be assessed using the food rating task.	This will be assessed at baseline (Time 0) and post-intervention (4 weeks).
Secondary	Changes in Low Calorie Food Valuation	This will be assessed using the food rating task.	This will be assessed at baseline (Time 0) and post-intervention (4 weeks).