Modification of Cerebral Activity of Obsessive Compulsive Disorder (OCD) Patients During Cognitive and Behavioral Therapy

Study Overview
=================
Brief Summary
-----------------
Obsessive compulsive Disorder (OCD) is a frequent psychiatric disorder. Obsessions and compulsions are the two manifestations of this disease. Obsessions are recurrent anxious ideas, and compulsions repetitive behavior aiming to decrease this anxiety. OCD symptoms have been associated with cortical and sub-cortical dysfunctions and more precisely an hyperactivity of prefrontal cortex / basal ganglia loops. Functional neuro-imagery studies have shown a significant decrease of orbito-frontal cortex, anterior cingulate cortex, caudate nucleus and cerebellum activities after two OCD reference treatments : medication and Cognitive and Behavioral Therapy (CBT). Two groups of 20 patients are included in this study and follow a CBT for 15 sessions. They are randomised in two groups : one proposing a reference CBT, the other associate CBT to a new psychopedagogic task developed by the investigators team. Clinical investigations and neuro-imagery data are collected at the main steps of therapies : before, during (half-therapy), at the end of therapies and 6 month later. Symptoms severity, patients and relatives quality of life are also assessed.

Official Title
-----------------
Evaluation and Comparison of Cerebral Activities Modifications Associated With Two Different Cognitive and Behavioral Therapies for Obsessive Compulsive Disorder Patients

Conditions
-----------------
Obsessive Compulsive Disorder

Intervention / Treatment
-----------------
* Behavioral: Cognitive and behavioral Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 65; Following Obsessive Compulsive Disorder criteria according to DSM IV(300.3 ;MINI 5.0.0); OCD severity range from 20 to 30 on the Y-Brown obsessive compulsive scale; Having checking symptoms; Understanding and accepting the study; Giving his written informed consent to the study. Exclusion Criteria: Claustrophobia; Cerebral abnormality; Chronic absenteism to CBT (more than 5 missed sessions during the whole therapy). In case of exclusion of the study either decided by the patient himself or by the investigator, a debriefing is proposed by a psychologist.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: reference therapy<br>20 OCD patients following 15 sessions of the reference CBT (Bouvard,2006) | Behavioral: Cognitive and behavioral Therapy<br>* 15 CBT sessions with a psychologist expert in OCD treatment<br>|
| Experimental: experimental therapy<br>20 OCD patients following 15 sessions of reference CBT associated with a new psychopedagogic task developed by our team. | Behavioral: Cognitive and behavioral Therapy<br>* 15 CBT sessions with a psychologist expert in OCD treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in brain activity associated with different types of Cognitive Behavioral Therapy Obsessive Compulsive Disorder | Evaluation and comparison of changes in brain activity associated with different types of Cognitive Behavioral Therapy in patients with Obsessive Compulsive Disorder | before CBT, at half CBT (1.5 month), after CBT (3 months) and 6 six months later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive and Behavioral Therapy