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Eating Concerns and Compulsivity

Primary Purpose

Anorexia Nervosa in Remission, Eating Disorder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Volatility task
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anorexia Nervosa in Remission focused on measuring Computational

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Inclusion: high scoring on EAT-26

  • 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.

Exclusion Criteria:

  • 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.

Exclusion for high scoring EAT-26

• A former formal diagnosis of an eating disorder. Note that in this group a current diagnosis of EDNOS will not be an exclusion criterion.

Sites / Locations

  • Department of Psychiatry, University of Oxford

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Recovered from anorexia nervosa

High scoring on the EAT-26

Healthy controls

Arm Description

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.

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).

No history of or current diagnosis of any psychiatric disorder (especially eating disorders) which could impact study results.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Correlate relative log learning rate and beta size (an inverse temperature parameter) with perseverative errors on the Wisconsin Card Sort task across groups

Full Information

First Posted
February 15, 2018
Last Updated
July 5, 2018
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT03450291
Brief Title
Eating Concerns and Compulsivity
Official Title
Do Individuals in Eating Disorder Risk Groups Learn About the Causal Statistics of the Environment?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 18, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa in Remission, Eating Disorder
Keywords
Computational

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recovered from anorexia nervosa
Arm Type
Experimental
Arm Description
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.
Arm Title
High scoring on the EAT-26
Arm Type
Experimental
Arm Description
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).
Arm Title
Healthy controls
Arm Type
Experimental
Arm Description
No history of or current diagnosis of any psychiatric disorder (especially eating disorders) which could impact study results.
Intervention Type
Other
Intervention Name(s)
Volatility task
Intervention Description
Participants complete a volatility task, with pupillometry; and a Wisconsin Card Sort Task.
Primary Outcome Measure Information:
Title
Difference between eating disorder risk groups and healthy controls in extent to which learning rate difference between win-volatile and loss-volatile blocks changes.
Description
Difference in relative inverse logit learning rate (alpha) for the volatile versus stable blocks between groups.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Whether there is a difference in the learning rate for different valence environmental information (positive vs. negative) across groups.
Description
To compare changes in learning rate across blocks for reward vs. punishment information across groups.
Time Frame
1 day
Title
Differences in pupil dilation after volatility and surprising events between groups
Description
Examine whether post-outcome pupil dilation tracks environmental volatility and outcome surprise to the same extent across groups.
Time Frame
1 day
Title
Correlation between relative log learning rate (alpha) change between blocks and eating disorder symptom scores on the Eating Attitudes Questionnaire - 26 item version
Description
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.
Time Frame
1 day
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Inclusion: high scoring on EAT-26 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. Exclusion Criteria: 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. Exclusion for high scoring EAT-26 • A former formal diagnosis of an eating disorder. Note that in this group a current diagnosis of EDNOS will not be an exclusion criterion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip J Cowen, Prof
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, University of Oxford
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7JX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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