Modification of Cerebral Activity of Obsessive Compulsive Disorder (OCD) Patients During Cognitive and Behavioral Therapy (TOC TOC)
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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 |
- 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 |
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 More Information
Additional 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:
|
Obsessive-Compulsive Disorder Compulsive Personality Disorder Anxiety Disorders Mental Disorders Personality Disorders |
ClinicalTrials.gov processed this record on June 18, 2013