NCT03450291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 18, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 6, 2018

Status Verified

February 1, 2018

Enrollment Period

10 months

First QC Date

February 15, 2018

Last Update Submit

July 5, 2018

Conditions

Keywords

Computational

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (4)

  • Whether there is a difference in the learning rate for different valence environmental information (positive vs. negative) across groups.

    1 day

  • Differences in pupil dilation after volatility and surprising events between groups

    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

    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

    1 day

Study Arms (3)

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.

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).

Other: Volatility task

Healthy controls

EXPERIMENTAL

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

Other: Volatility task

Interventions

Participants complete a volatility task, with pupillometry; and a Wisconsin Card Sort Task.

Healthy controlsHigh scoring on the EAT-26Recovered from anorexia nervosa

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • 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 below 2.767 on the EDE-Q, below 16 on the CIA, and below 20 on the EAT-26.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, University of Oxford

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Philip J Cowen, Prof

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2018

First Posted

March 1, 2018

Study Start

August 18, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

July 6, 2018

Record last verified: 2018-02

Locations