NCT01331876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2010

Completed
1 year until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

September 4, 2025

Status Verified

October 1, 2012

Enrollment Period

2.5 years

First QC Date

March 29, 2010

Last Update Submit

August 27, 2025

Conditions

Keywords

Cognitive and Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • 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

    before CBT, at half CBT (1.5 month), after CBT (3 months) and 6 six months later

Study Arms (2)

reference therapy

EXPERIMENTAL

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

Behavioral: Cognitive and behavioral Therapy

experimental therapy

EXPERIMENTAL

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

Behavioral: Cognitive and behavioral Therapy

Interventions

15 CBT sessions with a psychologist expert in OCD treatment

experimental therapyreference therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Claustrophobia;
  • Cerebral abnormality;
  • Chronic absenteism to CBT (more than 5 missed sessions during the whole therapy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitié-Salpêtrière hospital

Paris, 75013, France

Location

Related Publications (1)

  • 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.

    PMID: 29514116BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2010

First Posted

April 8, 2011

Study Start

October 1, 2009

Primary Completion

April 1, 2012

Study Completion

July 1, 2012

Last Updated

September 4, 2025

Record last verified: 2012-10

Locations