Modification of Cerebral Activity of Obsessive Compulsive Disorder (OCD) Patients During Cognitive and Behavioral Therapy (TOC TOC)
Primary Purpose
Obsessive Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive and behavioral Therapy
Sponsored by
About this trial
This is an interventional diagnostic trial for Obsessive Compulsive Disorder focused on measuring Cognitive and Behavioral Therapy
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.
Sites / Locations
- Pitié-Salpêtrière hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
reference therapy
experimental therapy
Arm Description
20 OCD patients following 15 sessions of the reference CBT (Bouvard,2006)
20 OCD patients following 15 sessions of reference CBT associated with a new psychopedagogic task developed by our team.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01331876
First Posted
March 29, 2010
Last Updated
October 1, 2012
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT01331876
Brief Title
Modification of Cerebral Activity of Obsessive Compulsive Disorder (OCD) Patients During Cognitive and Behavioral Therapy
Acronym
TOC TOC
Official Title
Evaluation and Comparison of Cerebral Activities Modifications Associated With Two Different Cognitive and Behavioral Therapies for Obsessive Compulsive Disorder Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
Cognitive and Behavioral Therapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
reference therapy
Arm Type
Experimental
Arm Description
20 OCD patients following 15 sessions of the reference CBT (Bouvard,2006)
Arm Title
experimental therapy
Arm Type
Experimental
Arm Description
20 OCD patients following 15 sessions of reference CBT associated with a new psychopedagogic task developed by our team.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive and behavioral Therapy
Intervention Description
15 CBT sessions with a psychologist expert in OCD treatment
Primary Outcome Measure Information:
Title
Changes in brain activity associated with different types of Cognitive Behavioral Therapy Obsessive Compulsive Disorder
Description
Evaluation and comparison of changes in brain activity associated with different types of Cognitive Behavioral Therapy in patients with Obsessive Compulsive Disorder
Time Frame
before CBT, at half CBT (1.5 month), after CBT (3 months) and 6 six months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Pitié-Salpêtrière hospital
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Learn more about this trial
Modification of Cerebral Activity of Obsessive Compulsive Disorder (OCD) Patients During Cognitive and Behavioral Therapy
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