- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02484599
Look at Food and Lose Your Fear - Evaluation of a Computerized Attention Training (CAT) for Anorexia Nervosa Patients (CAT)
Evaluation of a Computerized Attention Training (CAT) to Modify Attention Bias for Food Cues in Anorexia Nervosa Patients
Study Overview
Status
Conditions
Detailed Description
Recently, attention bias modification (ABM) has successfully been applied in the field of anxiety disorders and emerging evidence suggests that attention bias modification can ameliorate attention bias for threatening stimuli. ABM is based on the premise that if biased attention maintains disorder symptoms, a modification of the bias should reduce symptoms. The advantage of ABM is that it operates implicitly, thereby offering a more indirect, less deliberate procedure. This requires less cognitive control compared to the effortful and explicit psychotherapeutic treatment of cognitive biases. As food-related fears and avoidance in AN patients have been recognized as important anxiety-related symptoms, ABM seems particularly suitable to treat food-related fears and avoidance, especially because AN patients might be unaware of their avoidance strategy. The aim of this study is to test if food-related fears and food avoidance can be changed by experimentally modifying attention towards food in Anorexia Nervosa patients using an innovative computerized training paradigm (computerized attention training - CAT) and to evaluate related change in symptoms.
The investigators hypothesize that the active CAT will change attentional processing of food cues (research aim 1), transfer to changes in food-related fears and food avoidance, and to improvements in AN symptoms and weight in the short term (research aim 2) and longer term (research aim 3).
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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London, United Kingdom, SE5 8AF
- Recruiting
- Institute of Psychiatry, Psychology and Neuroscience
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Contact:
- Jessica Werthmann, PhD
- Phone Number: 00442078485608
- Email: jessica.werthmann@kcl.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI < 18.5 5 kg/m2
- Current diagnosis of AN-restricting type, AN-Binge/purging type or Eating Disorder Not Otherwise Specified (EDNOS) - Anorexia type
- Fluent in English
Exclusion Criteria:
- Currently taking a dose of any psychoactive medication that has not been stable for at least 14 days prior to participation in the study
- Currently meeting the diagnostic criteria of another major psychiatric disorder (e.g., major depressive disorder, substance dependence, schizophrenia or bipolar disorder) needing treatment in its own right
- Learning and developmental impairments
- If the disorder is currently life threatening
- If patients are currently suicidal
- If patients are currently having extreme physiological complications or co-morbid alcohol and drug-abuse disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: CAT active attention bias modification
Active computerized attention training (CAT).
Attention training via repeated trials of a modified anti-saccade task with concurrent assessment of eye-movements intended to direct attention towards food stimuli using pictorial food and non-food stimuli (see Werthmann, Field, Roefs, Nederkoorn, & Jansen, 2014).
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Three sessions of active computerized attention training.
Other Names:
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Placebo Comparator: CAT sham bias modification
Sham computerized attention training.
Attention training via repeated trials of a modified anti-saccade task with concurrent assessment of eye-movements not intended to change attention processing of food stimuli using pictures of two different non-food stimuli categories (e.g.
household and musical instruments).
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Three sessions of sham computerized attention training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Attention bias
Time Frame: max. 2 weeks (pre and post attention bias modification training)
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The dot-probe task with concurrent assessment of eye-movements will be used for the assessment of attention bias at baseline and post-treatment.
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max. 2 weeks (pre and post attention bias modification training)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Eating Disorder symptoms
Time Frame: max. 2 week (pre and post attention bias modification training) and at 4 weeks follow-up
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The Eating Disorder Examination Questionnaire (EDE-Q, Fairburn & Belgin, 1994) is a commonly used index for AN symptoms and will be assessed at baseline and post-treatment and at 4 weeks follow-up.
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max. 2 week (pre and post attention bias modification training) and at 4 weeks follow-up
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Body Mass Index
Time Frame: max. 2 (pre and post attention bias modification training) and after 4 weeks (follow-up).
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Weight and height will be assessed to calculate BMI and assess whether BMI changes occurred during the study period due to CAT
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max. 2 (pre and post attention bias modification training) and after 4 weeks (follow-up).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Eating Behaviour
Time Frame: max. 2 weeks
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Participants will be instructed to taste from different food options and their willingness to do so and their actual intake will be assessed as measure for behavioural food avoidance at baseline and at post-treatment.
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max. 2 weeks
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Approach and avoidance tendencies
Time Frame: max. 2 weeks
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Approach and avoidance tendencies for food pictures will be assessed with the Affective Simon Task (AST, see Neimeijer, de Jong, & Roefs, 2015) at baseline and at post-training to test changes in food-related approach or avoidance.
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max. 2 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jessica Werthmann, PhD, Institute of Psychiatry, Psychology and Neuroscience, King's College London
Publications and helpful links
General Publications
- Neimeijer RA, de Jong PJ, Roefs A. Automatic approach/avoidance tendencies towards food and the course of anorexia nervosa. Appetite. 2015 Aug;91:28-34. doi: 10.1016/j.appet.2015.03.018. Epub 2015 Mar 24.
- Werthmann J, Field M, Roefs A, Nederkoorn C, Jansen A. Attention bias for chocolate increases chocolate consumption--an attention bias modification study. J Behav Ther Exp Psychiatry. 2014 Mar;45(1):136-43. doi: 10.1016/j.jbtep.2013.09.009. Epub 2013 Sep 29.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRAS ID 160749
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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