Anorexia Nervosa in RemissionNCT03450291
Eating Concerns and Compulsivity
A study testing Volatility task in people with Anorexia Nervosa in Remission and Eating Disorder, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This study uses a computational task to examine differences in adaptive learning to both rewards and punishments between three groups: those who have recovered from anorexia nervosa, those who score highly on the EAT-26 (Eating Attitudes Test - 26 item version; an eating disorder symptom scale), and healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa in Remission, Eating Disorder
- What is being tested?
- Volatility task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Aug 2017to 1 Jun 2018
- Phase
- Interventional
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Females aged 18 to 45 years.
- BMI over 18.5 and has remained so for the last year.
- Participant is a fluent English speaker. Inclusion: recovered from anorexia
- Past formal diagnosis of AN (defined by DSM-5 criteria).
- Fully recovered: Score must be below 2.767 on the EDE-Q, below 16 on the CIA, and below 20 on the EAT-26 or partially recovered: scores may be above 2.767, 16 and 20 respectively.
- Score above 20 on the EAT-26 questionnaire. Inclusion: healthy control
- Score below 2.767 on the EDE-Q, below 16 on the CIA, and below 20 on the EAT-26.
Who cannot join
- Any current diagnosis of a psychiatric disorder which in the investigator's opinion could impact study results (e.g. significant depression, anxiety or OCD).
- Any current psychotropic medications.
- Current regular cigarette smoking of over 5 cigarettes per day.
- Recent use of illicit drugs.
- Alcohol intake which indicates an element of alcohol abuse; or unwillingness to refrain from drinking the night before the study visit.
- A former formal diagnosis of an eating disorder. Note that in this group a current diagnosis of EDNOS will not be an exclusion criterion.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Psychiatry, University of Oxford
Oxford, Oxfordshire, OX3 7JX
About this study
Official title: Do Individuals in Eating Disorder Risk Groups Learn About the Causal Statistics of the Environment?
This study uses a computational task to examine differences in adaptive learning to both rewards and punishments between three groups: those who have recovered from anorexia nervosa, those who score highly on the EAT-26 (Eating Attitudes Test - 26 item version; an eating disorder symptom scale), and healthy controls. This task also allows the examination of pupil response (thought to reflect norepinephrine activity) in response to expected and unexpected wins and losses.
Read the detailed description
This study involves using a novel computational task (the volatility task, designed by Dr Michael Browning) to examine differences in adaptive learning in terms of sensitivity to environmental change in those who are in eating disorder 'risk' groups (defined as those with a previous diagnosis of AN, and those who score highly in the EAT-26 for eating disorder symptoms. This study allows us to investigate whether or not these individuals are able to pick up key environmental statistics and adapt their behaviour accordingly. We hypothesise that those in eating disorder risk groups will show a deficit in this area, which might begin to explain why the cognitive phenotype of 'cognitive inflexibility' is found so commonly in these patients. Using pupillometry measures will also allow us to putatively form links between this behaviour and the norepinephrine system in these participants, as pupil dilation measures are thought to track environmental statistics of this kind. Additionally, this task allows us to identify whether there is a particular deficit in tracking and learning about positive or negative environmental information. We will be using standard clinical interviews and questionnaires to define the groups and to record key variables (e.g. mood information) within groups. This study will consist of a single visit, including these interviews and questionnaires, the volatility task with pupillometry measures, and the Wisconsin Card Sort Task, which we hope to use to demonstrate a baseline difference between groups on cognitive flexibility.
- Conditions
- Anorexia Nervosa in Remission, Eating Disorder
- Being tested
- Volatility task
- Keywords
- Computational
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volatility taskOther
Participants complete a volatility task, with pupillometry; and a Wisconsin Card Sort Task.
| Study group | Role | What they receive |
|---|---|---|
| Recovered from anorexia nervosa | Experimental | Those who have a past diagnosis of AN (defined by the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria) but are currently recovered, as shown by BMI over 18.5 throughout the last 12 months (self-report and current weight measured). Defined as either 'fully recovered'and: score must be within the 'normal range' of the Eating Disorders Examination Questionnaire (EDE-Q) global mean scores for young women, below 20 on the EAT-26 and below 16 on the Clinical Impairment Assessment for Eating Disorders (CIA); or partially recovered where one or more of these scores may be above the above-mentioned cutoffs. Receives: Other: Volatility task |
| High scoring on the EAT-26 | Experimental | Those who score above 20 on the EAT-26, but who do not declare a former diagnosis of an eating disorder (though they may meet criteria for a current diagnosis during the Structured Clinical Interview for the DSM-5). Receives: Other: Volatility task |
| Healthy controls | Experimental | No history of or current diagnosis of any psychiatric disorder (especially eating disorders) which could impact study results. Receives: Other: Volatility task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between eating disorder risk groups and healthy controls in extent to which learning rate difference between win-volatile and loss-volatile blocks changes.
Difference in relative inverse logit learning rate (alpha) for the volatile versus stable blocks between groups.
Measured: 1 day
Secondary outcomes (4)
Whether there is a difference in the learning rate for different valence environmental information (positive vs. negative) across groups.
To compare changes in learning rate across blocks for reward vs. punishment information across groups.
Measured: 1 day
Differences in pupil dilation after volatility and surprising events between groups
Examine whether post-outcome pupil dilation tracks environmental volatility and outcome surprise to the same extent across groups.
Measured: 1 day
Correlation between relative log learning rate (alpha) change between blocks and eating disorder symptom scores on the Eating Attitudes Questionnaire - 26 item version
The EAT-26 is a questionnaire which measures eating disorder symptoms. The total score will be used (summing of individual items). Lower scores represent lower presence of eating disorder symptoms.
Measured: 1 day
Correlate relative log learning rate and beta size (an inverse temperature parameter) with perseverative errors on the Wisconsin Card Sort task across groups
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start18 Aug 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia Nervosa in RemissionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Three parallel groups: those who have recovered from anorexia nervosa; those who worry a lot about eating, shape and weight; and healthy control participants will be included, and all will complete some questionnaires and two tasks.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip J Cowen, Prof, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450291
- Sponsor's protocol ID
- R51898/RE003
- Status last verified
- Feb 2018
- First submitted
- 15 Feb 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Individuals in Eating Disorder Risk Groups Learn About the Causal Statistics of the Environment?
- ClinicalTrials.gov ID
- NCT03450291
- Acronym / sponsor ID
- R51898/RE003
- Conditions
- Anorexia Nervosa in Remission, Eating Disorder
- Keywords
- Computational
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 1 Mar 2018 (actual)
- 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.
This study uses a computational task to examine differences in adaptive learning to both rewards and punishments between three groups: those who have recovered from anorexia nervosa, those who score highly on the EAT-26 (Eating Attitudes Test - 26 item version; an eating disorder symptom scale), and healthy controls. This task also allows the examination of pupil response (thought to reflect norepinephrine activity) in response to expected and unexpected wins and losses.
Detailed description
This study involves using a novel computational task (the volatility task, designed by Dr Michael Browning) to examine differences in adaptive learning in terms of sensitivity to environmental change in those who are in eating disorder 'risk' groups (defined as those with a previous diagnosis of AN, and those who score highly in the EAT-26 for eating disorder symptoms. This study allows us to investigate whether or not these individuals are able to pick up key environmental statistics and adapt their behaviour accordingly. We hypothesise that those in eating disorder risk groups will show a deficit in this area, which might begin to explain why the cognitive phenotype of 'cognitive inflexibility' is found so commonly in these patients. Using pupillometry measures will also allow us to putatively form links between this behaviour and the norepinephrine system in these participants, as pupil dilation measures are thought to track environmental statistics of this kind. Additionally, this task allows us to identify whether there is a particular deficit in tracking and learning about positive or negative environmental information. We will be using standard clinical interviews and questionnaires to define the groups and to record key variables (e.g. mood information) within groups. This study will consist of a single visit, including these interviews and questionnaires, the volatility task with pupillometry measures, and the Wisconsin Card Sort Task, which we hope to use to demonstrate a baseline difference between groups on cognitive flexibility.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three parallel groups: those who have recovered from anorexia nervosa; those who worry a lot about eating, shape and weight; and healthy control participants will be included, and all will complete some questionnaires and two tasks.
| Arm | Type | Receives |
|---|---|---|
| Recovered from anorexia nervosa | Experimental | Other: Volatility taskThose who have a past diagnosis of AN (defined by the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria) but are currently recovered, as shown by BMI over 18.5 throughout the last 12 months (self-report and current weight measured). Defined as either 'fully recovered'and: score must be within the 'normal range' of the Eating Disorders Examination Questionnaire (EDE-Q) global mean scores for young women, below 20 on the EAT-26 and below 16 on the Clinical Impairment Assessment for Eating Disorders (CIA); or partially recovered where one or more of these scores may be above the above-mentioned cutoffs. |
| High scoring on the EAT-26 | Experimental | Other: Volatility taskThose who score above 20 on the EAT-26, but who do not declare a former diagnosis of an eating disorder (though they may meet criteria for a current diagnosis during the Structured Clinical Interview for the DSM-5). |
| Healthy controls | Experimental | Other: Volatility taskNo history of or current diagnosis of any psychiatric disorder (especially eating disorders) which could impact study results. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Females aged 18 to 45 years.
- BMI over 18.5 and has remained so for the last year.
- Participant is a fluent English speaker. Inclusion: recovered from anorexia
- Past formal diagnosis of AN (defined by DSM-5 criteria).
Key exclusion criteria (6 listed)
- Any current diagnosis of a psychiatric disorder which in the investigator's opinion could impact study results (e.g. significant depression, anxiety or OCD).
- Any current psychotropic medications.
- Current regular cigarette smoking of over 5 cigarettes per day.
- Recent use of illicit drugs.
- Alcohol intake which indicates an element of alcohol abuse; or unwillingness to refrain from drinking the night before the study visit.
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 |
|---|---|---|
| Volatility taskParticipants complete a volatility task, with pupillometry; and a Wisconsin Card Sort Task. | Other | Healthy controls, High scoring on the EAT-26, Recovered from anorexia nervosa |
Primary outcome
Difference between eating disorder risk groups and healthy controls in extent to which learning rate difference between win-volatile and loss-volatile blocks changes.
Time frame: 1 day
Difference in relative inverse logit learning rate (alpha) for the volatile versus stable blocks between groups.
4 secondary outcomes
Whether there is a difference in the learning rate for different valence environmental information (positive vs. negative) across groups.
Time frame: 1 day
Differences in pupil dilation after volatility and surprising events between groups
Time frame: 1 day
Correlation between relative log learning rate (alpha) change between blocks and eating disorder symptom scores on the Eating Attitudes Questionnaire - 26 item version
Time frame: 1 day
Correlate relative log learning rate and beta size (an inverse temperature parameter) with perseverative errors on the Wisconsin Card Sort task across groups
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Anorexia Nervosa in Remission
Recruiting
Therapeutic Ketogenic Diet in Anorexia Nervosa
Anorexia Nervosa in Remission, Bulimia Nervosa
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.
Philip J Cowen, Prof principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volatility task in people with Anorexia Nervosa in Remission and Eating Disorder, run by University of Oxford 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 8 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: finished, as of the sponsor's last update on 6 Jul 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between eating disorder risk groups and healthy controls in extent to which learning rate difference between win-volatile and loss-volatile blocks changes. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2018; AzTrials last refreshed its copy on 27 Oct 2026.