Obsessive-Compulsive DisorderM-TOCNCT06494735
Effect of the French Version If the Metagognitive Bibliotherapy Program "MYMCT" on Obsessive-compulsive Symptoms
A study testing MyMCT in people with Obsessive-Compulsive Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Obsessive-compulsive disorder (OCD) is a psychiatric illness characterized by the presence of obsessions and/or compulsions. Without effective treatment, symptoms tend to worsen and become chronic. International guidelines recommend medication and/or psychotherapy as the first-line treatment for OCD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- MyMCT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2024to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With OCD diagnosed by a psychiatrist,
- Unchanged psychiatric medication over the past 3 months,
- Have a good command of the French language,
Who cannot join
- Person with a psychotic or bipolar comorbidity diagnosed by a psychiatric physician
- Person participating simultaneously in another clinical trial interfering with the results of the present study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bruno GIORDANA, Dr contact
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice
Bruno Dr GIORDANA, +334 92 03 70 09, giordana.b@chu-nice.fr
About this study
Obsessive-compulsive disorder (OCD) is a psychiatric illness characterized by the presence of obsessions and/or compulsions. Without effective treatment, symptoms tend to worsen and become chronic. International guidelines recommend medication and/or psychotherapy as the first-line treatment for OCD. However, the majority of sufferers remain undertreated worldwide. This lack of access to care worsened during the Covid-19 pandemic. Much of this suffering could be avoided by facilitating access to evidence-based therapies. As such, many distance therapeutic interventions have recently developed, such as bibliotherapy. These unguided self-help programs are mostly based on approaches derived from cognitive behavioral therapies (CBTs). Specialized metacognition bibliotherapy is more specifically based on the hypothesis of a cognitive meta-level that affects off-line knowledge and on-line self-regulatory behaviors.
Yet, the majority of OCD sufferers are reported to exhibit inadequate metacognitive processing. Although these metacognitive abilities are often neglected in the OCD literature, they appear to play a significant causal role in the onset and maintenance of obsessive-compulsive symptoms. As a result, OCD-specific metacognitive treatments need to be developed to reduce symptomatology and improve quality of life for these patients. To date and to our knowledge, there is only one validated metacognitive bibliotherapeutic program for OCD. This manual is called "MyMCT: My MetaCognitive Training". A recent meta-analysis confirms its effectiveness with 373 participants from Germany, Switzerland and Russia in reducing obsessions and compulsions. Although these results are promising, MyMCT did not exist in a French version until 2021. Our team then translated the manual on a not-for-profit basis, and an independent translator at Nice University Hospital confirmed that it faithfully transcribed the meaning of the English version. This version has been freely available since November 2021 on the website of the Department of Psychiatry and Psychotherapy at Hamburg-Eppendorf University Medical Center (https://clinical-neuropsychology.de/metacognitive-training-for-ocd-mymct/).
The investigator propose to carry out a single-center randomized controlled research protocol concerning the effects of the French version of MyMCT in OCD patients. This clinical trial will be carried out́ in collaboration with Professor Moritz, author of MyMCT and renowned researcher.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- MyMCT
- 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.
MyMCTBehavioural
Using the french version of the metagognitive bibliotherapy MyMCT
| Study group | Role | What they receive |
|---|---|---|
| MyMCT Group | Experimental | Use of the bibliotherapy program Receives: Behavioral: MyMCT |
| Witness Group | No intervention | Not using the bibliotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive Compulsive Scale
the intensity of obsessive-compulsive symptoms will be assessed using Yale Brown Obsessive Compulsive Scale (Y-BOCS). A global evaluation of symptoms (/40) is calculated using two subscores: 1. obsessions (/20); 2. compulsions (/20).
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Sep 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno GIORDANA, Dr, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494735
- Sponsor's protocol ID
- 22-AOI-02
- Acronym
- M-TOC
- Status last verified
- Sep 2024
- First submitted
- 2 Jul 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the French Version If the Metagognitive Bibliotherapy Program "MYMCT" on Obsessive-compulsive Symptoms
- ClinicalTrials.gov ID
- NCT06494735
- Acronym / sponsor ID
- M-TOC / 22-AOI-02
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 10 Jul 2024 (actual)
- 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 psychiatric illness characterized by the presence of obsessions and/or compulsions. Without effective treatment, symptoms tend to worsen and become chronic. International guidelines recommend medication and/or psychotherapy as the first-line treatment for OCD. However, the majority of sufferers remain undertreated worldwide. This lack of access to care worsened during the Covid-19 pandemic. Much of this suffering could be avoided by facilitating access to evidence-based therapies. As such, many distance therapeutic interventions have recently developed, such as bibliotherapy. These unguided self-help programs are mostly based on approaches derived from cognitive behavioral therapies (CBTs). Specialized metacognition bibliotherapy is more specifically based on the hypothesis of a cognitive meta-level that affects off-line knowledge and on-line self-regulatory behaviors.
Yet, the majority of OCD sufferers are reported to exhibit inadequate metacognitive processing. Although these metacognitive abilities are often neglected in the OCD literature, they appear to play a significant causal role in the onset and maintenance of obsessive-compulsive symptoms. As a result, OCD-specific metacognitive treatments need to be developed to reduce symptomatology and improve quality of life for these patients. To date and to our knowledge, there is only one validated metacognitive bibliotherapeutic program for OCD. This manual is called "MyMCT: My MetaCognitive Training". A recent meta-analysis confirms its effectiveness with 373 participants from Germany, Switzerland and Russia in reducing obsessions and compulsions. Although these results are promising, MyMCT did not exist in a French version until 2021. Our team then translated the manual on a not-for-profit basis, and an independent translator at Nice University Hospital confirmed that it faithfully transcribed the meaning of the English version. This version has been freely available since November 2021 on the website of the Department of Psychiatry and Psychotherapy at Hamburg-Eppendorf University Medical Center (https://clinical-neuropsychology.de/metacognitive-training-for-ocd-mymct/).
The investigator propose to carry out a single-center randomized controlled research protocol concerning the effects of the French version of MyMCT in OCD patients. This clinical trial will be carried out́ in collaboration with Professor Moritz, author of MyMCT and renowned researcher.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyMCT Group | Experimental | Behavioral: MyMCTUse of the bibliotherapy program |
| Witness Group | No intervention | –Not using the bibliotherapy program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- With OCD diagnosed by a psychiatrist,
- Unchanged psychiatric medication over the past 3 months,
- Have a good command of the French language,
Key exclusion criteria (2 listed)
- Person with a psychotic or bipolar comorbidity diagnosed by a psychiatric physician
- Person participating simultaneously in another clinical trial interfering with the results of the present study
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 |
|---|---|---|
| MyMCTUsing the french version of the metagognitive bibliotherapy MyMCT | Behavioural | MyMCT Group |
Primary outcome
Yale Brown Obsessive Compulsive Scale
Time frame: 2 month
the intensity of obsessive-compulsive symptoms will be assessed using Yale Brown Obsessive Compulsive Scale (Y-BOCS). A global evaluation of symptoms (/40) is calculated using two subscores: 1. obsessions (/20); 2. compulsions (/20).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Bruno GIORDANA, Dr contact
Bruno GIORDANA, Dr principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyMCT in people with Obsessive-Compulsive Disorder, run by Centre Hospitalier Universitaire de Nice 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno GIORDANA, Dr (giordana.b@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Brown Obsessive Compulsive Scale (time frame: 2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2024.