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Clinical Trials/NCT01331876
NCT01331876
Completed
Not Applicable

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

Institut National de la Santé Et de la Recherche Médicale, France1 site in 1 country35 target enrollmentOctober 1, 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obsessive Compulsive Disorder
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Enrollment
35
Locations
1
Primary Endpoint
Changes in brain activity associated with different types of Cognitive Behavioral Therapy Obsessive Compulsive Disorder
Status
Completed
Last Updated
8 months ago

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2009
End Date
July 1, 2012
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Changes in brain activity associated with different types of Cognitive Behavioral Therapy Obsessive Compulsive Disorder

Time Frame: before CBT, at half CBT (1.5 month), after CBT (3 months) and 6 six months later

Evaluation and comparison of changes in brain activity associated with different types of Cognitive Behavioral Therapy in patients with Obsessive Compulsive Disorder

Study Sites (1)

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