Obsessive Compulsive DisorderTOC TOCNCT01331876
Modification of Cerebral Activity of Obsessive Compulsive Disorder (OCD) Patients During Cognitive and Behavioral Therapy
A study testing Cognitive and behavioral Therapy in people with Obsessive Compulsive Disorder, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Cognitive and behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Cognitive and behavioral Therapy
- Keywords
- Cognitive and Behavioral Therapy
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive and behavioral TherapyBehavioural
15 CBT sessions with a psychologist expert in OCD treatment
| Study group | Role | What they receive |
|---|---|---|
| reference therapy | Experimental | 20 OCD patients following 15 sessions of the reference CBT (Bouvard,2006) Receives: 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. Receives: Behavioral: Cognitive and behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before CBT, at half CBT (1.5 month), after CBT (3 months) and 6 six months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startOct 2009
- Primary completionApr 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331876
- Sponsor's protocol ID
- C09-02
- Other IDs
- 2009-A00652-55
- Acronym
- TOC TOC
- Status last verified
- Oct 2012
- First submitted
- 29 Mar 2010
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29514116
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Comparison of Cerebral Activities Modifications Associated With Two Different Cognitive and Behavioral Therapies for Obsessive Compulsive Disorder Patients
- ClinicalTrials.gov ID
- NCT01331876
- Acronym / sponsor ID
- TOC TOC / C09-02
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- Cognitive and Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Oct 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reference therapy | Experimental | Behavioral: Cognitive and behavioral Therapy20 OCD patients following 15 sessions of the reference CBT (Bouvard,2006) |
| experimental therapy | Experimental | Behavioral: Cognitive and behavioral Therapy20 OCD patients following 15 sessions of reference CBT associated with a new psychopedagogic task developed by our team. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive and behavioral Therapy15 CBT sessions with a psychologist expert in OCD treatment | Behavioural | experimental therapy, reference therapy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 29514116Haynes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive and behavioral Therapy in people with Obsessive Compulsive Disorder, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01331876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.