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

July 7, 2015 updated by: King's College London

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 8AF
        • Recruiting
        • Institute of Psychiatry, Psychology and Neuroscience
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Behavioral: Computerized attention training (CAT)
Three sessions of active computerized attention training.
Other Names:
  • Attention bias modification training
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).
Behavioral: Sham computerized attention training (control condition)
Three sessions of sham computerized attention training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Attention bias
Time Frame: max. 2 weeks (pre and post attention bias modification training)
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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Eating Disorder symptoms
Time Frame: max. 2 week (pre and post attention bias modification training) and at 4 weeks follow-up
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
Body Mass Index
Time Frame: max. 2 (pre and post attention bias modification training) and after 4 weeks (follow-up).
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).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Eating Behaviour
Time Frame: max. 2 weeks
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
Approach and avoidance tendencies
Time Frame: max. 2 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Netherlands Organisation for Scientific Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jessica Werthmann, PhD, Institute of Psychiatry, Psychology and Neuroscience, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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