The Embodied Cognition: Exploratory Study of Automatic and Controlled Processes in Anorexia Nervosa.
2 other identifiers
interventional
176
1 country
1
Brief Summary
Anorexia nervosa (AN) is a common psychiatric illness, with severe prognosis (5% mortality) that has changed little over in half a century. One of the forms is the restrictive anorexia nervosa (ANR). It consists of a phobia of weight gain and food with a massive food restriction. This pathology is studied in psychology but not using the theories of embodied cognition in which "perception and action" interact through sensorimotor processes. They are the source of attitudes (unconscious) towards certain stimuli and influence our interpretation (conscious).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2011
Longer than P75 for not_applicable
1 active site
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
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 31, 2015
CompletedFirst Posted
Study publicly available on registry
September 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedMarch 10, 2016
March 1, 2016
4.7 years
August 31, 2015
March 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response time (ms) in the different conditions of the three tasks (composite measure)
Tasks are: * tap a key on the computer keyboard during the presentation of food and non-food words containing an "A" on a computer screen * pull a lever towards you at the presentation of food and non-food words on a computer screen * pull a lever towards you at the presentation of food and non-food words that approach on a computer screen
Day 1
Secondary Outcomes (4)
BMI in kg/m²
Day 1
Rate of wrong answers
Day 1
Score EDI-2
Day 1
Silhouettes test score
Day 1
Study Arms (8)
Patients group 1
EXPERIMENTALTEA + Grober Test + Task 1 + Grober Test
Patients group 2
EXPERIMENTALTEA + Grober Test + Task 2 + Grober Test
Patients group 3
EXPERIMENTALTEA + Grober Test + Implicit Task 3 + Grober Test
Patients group 4
EXPERIMENTALTEA + Grober Test + Explicit Task 3 + Grober Test
Healthy volonteers group 1
ACTIVE COMPARATORTEA + Grober Test + Task 1 + Grober Test
Healthy volonteers group 2
ACTIVE COMPARATORTEA + Grober Test + Task 2 + Grober Test
Healthy volonteers group 3
ACTIVE COMPARATORTEA + Grober Test + Implicit Task 3 + Grober Test
Healthy volonteers group 4
ACTIVE COMPARATORTEA + Grober Test + Explicit Task 3 + Grober Test
Interventions
The Test of Everyday Attention (TEA) measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 1 consists of a stimulus that moves on the screen. The response of the patient is done on the keyboard. It is composed on two conditions: one is fast (without conscious), the other consists in assessing words (conscious). It includes food and non-food words.
The TEA measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 2 consists of a stimulus that is fixed on the screen. The response of the patient is done by pushing or pulling a lever. It is composed on two conditions: one is fast (without conscious), the other consists in assessing words (conscious). It includes food and non-food words.
The TEA measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 3 is a compilation of tasks 1 and 2 to investigate the bidirectional link. The instructions are implicit condition to detect an A in the word ("yes-no" answer).
The TEA measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 3 is a compilation of tasks 1 and 2 to investigate the bidirectional link. The instructions are explicit condition to judge the emotional value of words ("positive-negative" answer).
Eligibility Criteria
You may qualify if:
- Restrictive anorexia nervosa according to Diagnostic and Statistical Manual of Mental Disorders Text Revision (DSM IV-TR)
- BMI\> 16 to avoid the effects of undernutrition
- Start disorders \<10 years
- Right handed
- Having given free and informed consent prior to study participation
- Subject affiliated to the French National Health Insurance
- BMI between 18,5 and 25
- Right handed
- Of school level paired in that of the patients (+/-1 the year)
- Having given free and informed consent prior to study participation
- Subject affiliated to the French National Health Insurance
You may not qualify if:
- Patients with at the beginning or during the study form of purgative anorexia nervosa
- Control with disorders of current or past eating behavior.
- Control making a restrictive diet during the study period
- Participants with depressive table
- Participants with a somatic problem restricted movement or a problem of uncorrected visual acuity annoying reading of the screen.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de SAINT-ETIENNE
Saint-Etienne, 42000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine MASSOUBRE, MD PhD
CHU de SAINT-ETIENNE
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2015
First Posted
September 2, 2015
Study Start
May 1, 2011
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
March 10, 2016
Record last verified: 2016-03