Anorexia NervosaPhase 1CATNCT02484599
Look at Food and Lose Your Fear - Evaluation of a Computerized Attention Training (CAT) for Anorexia Nervosa Patients
A Phase 1 study testing Computerized attention training (CAT) in people with Anorexia Nervosa, run by King's College London at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Computerized attention training (CAT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Nov 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Institute of Psychiatry, Psychology and Neuroscience
London, SE5 8AF
Jessica Werthmann, PhD, 00442078485608, jessica.werthmann@kcl.ac.uk
About this study
Official title: 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.
Read the 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).
- Conditions
- Anorexia Nervosa
- Being tested
- Computerized attention training (CAT), Sham computerized attention training (control condition)
- Keywords
- Eating Disorders, Anorexia Nervosa, Attention bias, Attention bias modification
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized attention training (CAT)Behavioural
Also called Attention bias modification training
Three sessions of active computerized attention training.
Sham computerized attention training (control condition)Behavioural
Three sessions of sham computerized attention training.
| Study group | Role | What they receive |
|---|---|---|
| CAT active attention bias modification | Experimental | 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). Receives: Behavioral: Computerized attention training (CAT) |
| CAT sham bias modification | Placebo comparator | 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). Receives: Behavioral: Sham computerized attention training (control condition) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: max. 2 weeks (pre and post attention bias modification training)
Secondary outcomes (2)
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.
Measured: max. 2 week (pre and post attention bias modification training) 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
Measured: max. 2 (pre and post attention bias modification training) and after 4 weeks (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Responsible party
- Sponsor
- Investigators
- Jessica Werthmann, PhD, Principal investigator, Institute of Psychiatry, Psychology and Neuroscience, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484599
- Sponsor's protocol ID
- IRAS ID 160749
- Acronym
- CAT
- Status last verified
- Jul 2015
- First submitted
- 25 Jun 2015
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25817483Werthmann 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.
PubMed 24140811
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Computerized Attention Training (CAT) to Modify Attention Bias for Food Cues in Anorexia Nervosa Patients
- ClinicalTrials.gov ID
- NCT02484599
- Acronym / sponsor ID
- CAT / IRAS ID 160749
- Conditions
- Anorexia Nervosa
- Keywords
- Eating Disorders, Anorexia Nervosa, Attention bias, Attention bias modification
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Study start
- Jun 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAT active attention bias modification | Experimental | Behavioral: Computerized attention training (CAT)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). |
| CAT sham bias modification | Placebo comparator | Behavioral: Sham computerized attention training (control condition)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized attention training (CAT)Also: Attention bias modification trainingThree sessions of active computerized attention training. | Behavioural | CAT active attention bias modification |
| Sham computerized attention training (control condition)Three sessions of sham computerized attention training. | Behavioural | CAT sham bias modification |
Primary outcome
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.
2 secondary outcomes
Eating Disorder symptoms
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
- Background: PubMed 25817483Neimeijer 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.
- Background: PubMed 24140811Werthmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Werthmann, PhD principal investigator
Institute of Psychiatry, Psychology and Neuroscience, King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computerized attention training (CAT) in people with Anorexia Nervosa, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Werthmann, PhD (0044/ (0)20 7848 5608, Jessica.Werthmann@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention bias (time frame: max. 2 weeks (pre and post attention bias modification training)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484599, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015.