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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01331876
First received: March 29, 2010
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

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 Intervention
Obsessive Compulsive Disorder
Behavioral: Cognitive and behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Evaluation and comparison of changes in brain activity associated with different types of Cognitive Behavioral Therapy in patients with Obsessive Compulsive Disorder


Enrollment: 35
Study Start Date: October 2009
Study Completion Date: July 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331876

Locations
France
Pitié-Salpêtrière hospital
Paris, France, 75013
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01331876     History of Changes
Other Study ID Numbers: C09-02, 2009-A00652-55
Study First Received: March 29, 2010
Last Updated: October 1, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Cognitive and Behavioral Therapy

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on September 30, 2014