EMOTION: Cognition and Emotion in the SII and IBD

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT01095042

Collaborator

French National Society of Gastroenterology (Other), Association François Aupetit (Other)

120

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims at showing that the susceptibility in the stress is more raised at the person affected digestive pathologies (SII or IBD) in forgiveness than healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome Inflammatory Bowel Disease (IBD) Crohn's Disease(CD) Ulcerative Colitis	Behavioral: emotion	N/A

Detailed Description

The objective of the study which we wish to lead consists in looking for, at the patients SII and IBD in forgiveness, the existence of a correlation between the rate of cortisol(Hormone of the stress) and the level of HRV (Heart Rate Variability) to estimate the inhibitive fronto-amygdalien tonus.

So we make the hypothesis that the persons affected by digestive pathologies of type SII or IBD would present an emotional and physiological vulnerability more important than unhurt subjects of pathologies.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Etude de la réactivité émotionnelle Des Patients MICI ou SII

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Control group 30 Asymptomatic Healthy Volunteers Intervention : Observation of emotional behavior in asymptomatic healthy volunteers subjected to stress.	Behavioral: emotion Show that the susceptibility in the stress (recording of Heart Rate Variability;viewing films;...) is more important at the person affected by digestive pathologies (SII or IBD) in forgiveness than to unhurt subjects of pathologies. Other Names: STRESS
Experimental: Experimental group Persons reached by digestive pathologies (SII or IBD). Group SII : 30 patients Group IBD: 60 patients (30 patients RCH and 30 patients CD) Intervention : Observation of emotional behavior in person affected by digestive pathologies subjected to stress.	Behavioral: emotion Show that the susceptibility in the stress (recording of Heart Rate Variability;viewing films;...) is more important at the person affected by digestive pathologies (SII or IBD) in forgiveness than to unhurt subjects of pathologies. Other Names: STRESS

Arm

Intervention/Treatment

Experimental: Control group

30 Asymptomatic Healthy Volunteers Intervention : Observation of emotional behavior in asymptomatic healthy volunteers subjected to stress.

Behavioral: emotion

Show that the susceptibility in the stress (recording of Heart Rate Variability;viewing films;...) is more important at the person affected by digestive pathologies (SII or IBD) in forgiveness than to unhurt subjects of pathologies.

Other Names:

STRESS

Experimental: Experimental group

Persons reached by digestive pathologies (SII or IBD). Group SII : 30 patients Group IBD: 60 patients (30 patients RCH and 30 patients CD) Intervention : Observation of emotional behavior in person affected by digestive pathologies subjected to stress.

Behavioral: emotion

Other Names:

STRESS

Outcome Measures

Primary Outcome Measures

RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY [24 MONTHS]

Secondary Outcome Measures

SCORES OF DEPRESSIVE SYMPTOMATOLOGIE AND ANXIETY, RATE PLASMATIQUES OF CATECHOLAMINES, LEPTINE, ADIPONECTINE AND PRO-INFLAMMATORY CYTOKINES. [24 MONTHS]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients with SII :Membership to the Social Security,SII defined according to the criteria Rome III.
Patients with IBD :Membership to the Social Security,patients with a ulcerative colitis(UC) or a Crohn's disease (CD)ileal and/or colic.

Exclusion Criteria:

Existence of a severe affectation on the general plan (cardiac,respiratory,hematological,renal,hepatic,cancerous),
Subject diabetic,
Pregnant or breast-feeding woman,
Subject included in another clinical and\or therapeutic trial or having been included in a clinical and\or therapeutic trial for less than a month,
Subject presenting a psychiatric pathology evident,
Person under guardianship.