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

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

Tracking Information

• First Submitted Date: March 29, 2010
• First Posted Date: April 8, 2011
• Last Update Posted Date: October 2, 2012
• Study Start Date: October 2009
• Actual Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 7, 2011)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Modification of Cerebral Activity of Obsessive Compulsive Disorder (OCD) Patients During Cognitive and Behavioral Therapy
• Official Title: Evaluation and Comparison of Cerebral Activities Modifications Associated With Two Different Cognitive and Behavioral Therapies for Obsessive Compulsive Disorder Patients

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Obsessive Compulsive Disorder

Intervention

Behavioral: Cognitive and behavioral Therapy

15 CBT sessions with a psychologist expert in OCD treatment

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 1, 2012): 35
• Original Estimated Enrollment (submitted: April 7, 2011): 40
• Actual Study Completion Date: July 2012
• Actual Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01331876
• Other Study ID Numbers: C09-02; 2009-A00652-55 ( Registry Identifier: IDRCB )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
• Original Responsible Party: Luc Mallet, Inserm, Pitié-salpêtrière hospital
• Current Study Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Institut National de la Santé Et de la Recherche Médicale, France
• Verification Date: October 2012