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

Primary Purpose

Anorexia Nervosa

Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Computerized attention training (CAT)
Sham computerized attention training (control condition)
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Eating Disorders, Anorexia Nervosa, Attention bias, Attention bias modification

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Psychiatry, Psychology and NeuroscienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CAT active attention bias modification

CAT sham bias modification

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
June 25, 2015
Last Updated
July 7, 2015
Sponsor
King's College London
Collaborators
Netherlands Organisation for Scientific Research
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1. Study Identification

Unique Protocol Identification Number
NCT02484599
Brief Title
Look at Food and Lose Your Fear - Evaluation of a Computerized Attention Training (CAT) for Anorexia Nervosa Patients
Acronym
CAT
Official Title
Evaluation of a Computerized Attention Training (CAT) to Modify Attention Bias for Food Cues in Anorexia Nervosa Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
Netherlands Organisation for Scientific Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Eating Disorders, Anorexia Nervosa, Attention bias, Attention bias modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAT active attention bias modification
Arm Type
Experimental
Arm Description
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).
Arm Title
CAT sham bias modification
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Computerized attention training (CAT)
Other Intervention Name(s)
Attention bias modification training
Intervention Description
Three sessions of active computerized attention training.
Intervention Type
Behavioral
Intervention Name(s)
Sham computerized attention training (control condition)
Intervention Description
Three sessions of sham computerized attention training.
Primary Outcome Measure Information:
Title
Attention bias
Description
The dot-probe task with concurrent assessment of eye-movements will be used for the assessment of attention bias at baseline and post-treatment.
Time Frame
max. 2 weeks (pre and post attention bias modification training)
Secondary Outcome Measure Information:
Title
Eating Disorder symptoms
Description
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.
Time Frame
max. 2 week (pre and post attention bias modification training) and at 4 weeks follow-up
Title
Body Mass Index
Description
Weight and height will be assessed to calculate BMI and assess whether BMI changes occurred during the study period due to CAT
Time Frame
max. 2 (pre and post attention bias modification training) and after 4 weeks (follow-up).
Other Pre-specified Outcome Measures:
Title
Eating Behaviour
Description
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.
Time Frame
max. 2 weeks
Title
Approach and avoidance tendencies
Description
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.
Time Frame
max. 2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Werthmann, PhD
Phone
0044/ (0)20 7848 5608
Email
Jessica.Werthmann@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrike Schmidt, PhD
Phone
+44 (0)20 7848 0181
Email
Ulrike.Schmidt@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Werthmann, PhD
Organizational Affiliation
Institute of Psychiatry, Psychology and Neuroscience, King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Psychiatry, Psychology and Neuroscience
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Werthmann, PhD
Phone
00442078485608
Email
jessica.werthmann@kcl.ac.uk

12. IPD Sharing Statement

Citations:
PubMed Identifier
25817483
Citation
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.
Results Reference
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PubMed Identifier
24140811
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.
Results Reference
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Look at Food and Lose Your Fear - Evaluation of a Computerized Attention Training (CAT) for Anorexia Nervosa Patients

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