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

NCT ID: NCT01331876

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-07-31

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.

Conditions

Obsessive Compulsive Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

reference therapy

20 OCD patients following 15 sessions of the reference CBT (Bouvard,2006)

Group Type: EXPERIMENTAL

Cognitive and behavioral Therapy

Intervention Type: BEHAVIORAL

15 CBT sessions with a psychologist expert in OCD treatment

experimental therapy

20 OCD patients following 15 sessions of reference CBT associated with a new psychopedagogic task developed by our team.

Group Type: EXPERIMENTAL

Cognitive and behavioral Therapy

Intervention Type: BEHAVIORAL

15 CBT sessions with a psychologist expert in OCD treatment

Interventions

Cognitive and behavioral Therapy

15 CBT sessions with a psychologist expert in OCD treatment

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pitié-Salpêtrière hospital

Paris, , France

Countries

France

References

Haynes WIA, Clair AH, Fernandez-Vidal S, Gholipour B, Morgieve M, Mallet L. Altered anatomical connections of associative and limbic cortico-basal-ganglia circuits in obsessive-compulsive disorder. Eur Psychiatry. 2018 Jun;51:1-8. doi: 10.1016/j.eurpsy.2018.01.005. Epub 2018 Mar 4.

Reference Type: BACKGROUND

PMID: 29514116 (View on PubMed)

Other Identifiers

2009-A00652-55

Identifier Type: REGISTRY

Identifier Source: secondary_id

C09-02

Identifier Type: -

Identifier Source: org_study_id