- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01331876
Modification of Cerebral Activity of Obsessive Compulsive Disorder (OCD) Patients During Cognitive and Behavioral Therapy (TOC TOC)
Evaluation and Comparison of Cerebral Activities Modifications Associated With Two Different Cognitive and Behavioral Therapies for Obsessive Compulsive Disorder Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75013
- Pitié-Salpêtrière Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: reference therapy
20 OCD patients following 15 sessions of the reference CBT (Bouvard,2006)
|
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.
|
15 CBT sessions with a psychologist expert in OCD treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
before CBT, at half CBT (1.5 month), after CBT (3 months) and 6 six months later
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C09-02
- 2009-A00652-55 (Registry Identifier: IDRCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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