The Embodied Cognition: Exploratory Study of Automatic and Controlled Processes in Anorexia Nervosa.

Anorexia Nervosa Clinical Trial

Official title:

The Embodied Cognition: Exploratory Study of Automatic and Controlled Processes in Anorexia Nervosa. A Monocentric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538796
• Other study ID #: 1001179
• Secondary ID: 2010-A01523-36
• Status: Completed
• Phase: N/A
• First received: August 31, 2015
• Last updated: March 9, 2016
• Start date: May 2011
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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).

Description:

The investigators hypothesis is that food restriction behavior is the result of two processes. One automatic and not conscious, which is an attraction toward food and manifests itself in the motivational attitudes of approach, and the other controlled and conscious, which prevents attraction to this type of stimuli and is manifested by motivational attitudes avoidance. These processes of attraction and avoidance are observed in embodied cognition paradigms because the answers induce movement of approach or avoidance of stimuli. The validation of these assumptions could lead to reconsideration of the respective roles of automatic and controlled processes in food behaviors of anorexics patients and to complete or refocus psychological techniques of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

Inclusion Criteria for patients:

• 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

Inclusion Criteria for control group:

• 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

Exclusion Criteria for patients and control group:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• TEA + Grober Test + Task 1 + Grober Test
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.
• TEA + Grober Test + Task 2 + Grober Test
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.
• TEA + Grober Test + Implicit Task 3 + Grober Test
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).
• TEA + Grober Test + Explicit Task 3 + Grober Test
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).

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	BMI in kg/m²	The Body Mass Index (BMI) is defined as the body mass divided by the square of the body height.	Day 1	No
Secondary	Rate of wrong answers	It is the rate of wrong answers in the different conditions of the three tasks.	Day 1	No
Secondary	Score EDI-2	The Eating Disorder Inventory (EDI) is a self-report questionnaire used to assess the presence of eating disorders.	Day 1	No
Secondary	Silhouettes test score	The patient selects among several silhouettes a silhouette to represent her real body image and her ideal body image.	Day 1	No