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

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ClinicalTrials.gov Identifier: NCT01331876
Recruitment Status : Completed
First Posted : April 8, 2011
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Study Description
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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.


Condition or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Behavioral: Cognitive and behavioral Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation and Comparison of Cerebral Activities Modifications Associated With Two Different Cognitive and Behavioral Therapies for Obsessive Compulsive Disorder Patients
Study Start Date : October 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : July 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: reference therapy
20 OCD patients following 15 sessions of the reference CBT (Bouvard,2006)
 Behavioral: Cognitive and behavioral Therapy
15 CBT sessions with a psychologist expert in OCD treatment
Experimental: experimental therapy
20 OCD patients following 15 sessions of reference CBT associated with a new psychopedagogic task developed by our team.
 Behavioral: Cognitive and behavioral Therapy
15 CBT sessions with a psychologist expert in OCD treatment


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331876


Locations
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France
Pitié-Salpêtrière hospital
Paris, France, 75013
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
More Information
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01331876    
Other Study ID Numbers: C09-02
2009-A00652-55 ( Registry Identifier: IDRCB )
First Posted: April 8, 2011    Key Record Dates
Last Update Posted: October 2, 2012
Last Verified: October 2012
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Cognitive and Behavioral Therapy
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders