Look at Food and Lose Your Fear - Evaluation of a Computerized Attention Training (CAT) for Anorexia Nervosa Patients

Anorexia Nervosa Clinical Trial

— CAT  

Official title:

Evaluation of a Computerized Attention Training (CAT) to Modify Attention Bias for Food Cues in Anorexia Nervosa Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02484599
• Other study ID #: IRAS ID 160749
• Status: Recruiting
• Phase: Phase 1
• First received: June 25, 2015
• Last updated: July 7, 2015
• Start date: June 2015
• Est. completion date: November 2016

Study information

• Verified date: July 2015
• Source: King's College London
• Contact: Jessica Werthmann, PhD
• Phone: 0044/ (0)20 7848 5608
• Email: Jessica.Werthmann[@]kcl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the therapeutic effects of a computerized attention training for patients with Anorexia Nervosa (AN). The primary aim is to determine if a computerized attention training can modify attention towards food and ameliorate eating disorder symptoms and related difficulties, such as anxiety. The secondary aim is to explore underlying mechanisms that contribute to these improvements. The stability of potentially observed effects over a one-month period will also be determined.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Behavioral:
• Computerized attention training (CAT)
Three sessions of active computerized attention training.
• Sham computerized attention training (control condition)
Three sessions of sham computerized attention training.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Netherlands Organisation for Scientific Research

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Eating Behaviour	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.	max. 2 weeks	No
Other	Approach and avoidance tendencies	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.	max. 2 weeks	No
Primary	Attention bias	The dot-probe task with concurrent assessment of eye-movements will be used for the assessment of attention bias at baseline and post-treatment.	max. 2 weeks (pre and post attention bias modification training)	No
Secondary	Eating Disorder symptoms	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.	max. 2 week (pre and post attention bias modification training) and at 4 weeks follow-up	No
Secondary	Body Mass Index	Weight and height will be assessed to calculate BMI and assess whether BMI changes occurred during the study period due to CAT	max. 2 (pre and post attention bias modification training) and after 4 weeks (follow-up).	No