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

Obsessive Compulsive Disorder Clinical Trial

— TOC TOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331876
• Other study ID #: C09-02
• Secondary ID: 2009-A00652-55
• Status: Completed
• Phase: N/A
• First received: March 29, 2010
• Last updated: October 1, 2012
• Start date: October 2009
• Est. completion date: July 2012

Study information

• Verified date: October 2012
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Cognitive and behavioral Therapy
15 CBT sessions with a psychologist expert in OCD treatment

Locations

Country	Name	City	State
France	Pitié-Salpêtrière hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

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