NCT07834567 Clinical and Biological Correlates of Obsessive-Compulsive Disorder and Online Mindfulness-Based Cognitive Therapy
| NCT ID | NCT07834567 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli |
| Condition | Obsessive - Compulsive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-08-26 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2026-08-26 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study has two main objectives: (1) to evaluate the acceptability and feasibility of a specialized Mindfulness-Based Cognitive Therapy (MBCT) program for Obsessive-Compulsive Disorder (OCD), delivered via videoconference in a synchronous group format; and (2) to explore the associations between selected clinical and biological markers, OCD severity, and treatment response. This is an interventional study involving outpatients with a diagnosis of OCD recruited at two participating centers in Italy: IRCCS Fatebenefratelli in Brescia (Center 1) and Centro Terapia Cognitiva e Mindfulness per il DOC in Vicenza (Center 2). Participants will take part in group-based treatment based on the MBCT program for OCD. Participants recruited at Center 1 will undergo blood and saliva sampling for the molecular analyses planned as part of the study. A healthy control group, matched for age and sex, will also be recruited for comparison in the analyses related to the second objective.
Eligibility Criteria
Patients with OCD. Inclusion Criteria: * Diagnosis of obsessive-compulsive disorder (OCD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) * Age between 18 and 45 years * Stable pharmacological treatment for at least 3 months prior to the start of the experimental intervention * No previous experience with mindfulness meditation, or previous mindfulness meditation experience with no practice during the 12 months prior to study enrollment * Ability and willingness to provide written informed consent. Exclusion Criteria: * Diagnosis of schizophrenia spectrum or other psychotic disorders, including schizoaffective disorder * Diagnosis of bipolar and related disorders * Major depressive disorder in an acute phase * Active substance use disorder or alcohol use disorder as the primary diagnosis * Personality disorders of clinically significant severity * Documented major neurocognitive disorder. Neurological conditions or medical conditions with a clinically significant impact on cognitive or mental functioning * Previous mindfulness meditation practice within the 12 months prior to study enrollment * Inability or unwillingness to provide informed consent Healthy subjects. Inclusion Criteria: * Age between 18 and 45 years, with age matching within a maximum difference of ±3 years from the corresponding index patient. In all cases, control participants must be at least 18 years and no older than 48 years * Voluntary participation in the study. * Ability and willingness to provide written informed consent Exclusion criteria: * Age younger than 18 years * History of psychiatric disorders, as assessed using the Structured Clinical Interview for DSM-5 Disorders - Clinician Version (SCID-CV) * Intellectual developmental disorder. * Current substance use disorder or alcohol use disorder * Neurological disorders, including Parkinson's disease, major neurocognitive disorders, neurodegenerative syndromes, ataxias, multiple sclerosis, cerebrovascular events (stroke or transient ischemic attack \[TIA\]), central nervous system neoplasms, epilepsy, history of seizures, or clinically significant tremor * Systemic medical conditions (e.g., diabetes mellitus, atherosclerosis, chronic arterial hypertension, or malignancies) requiring pharmacological treatment * Current or previous mindfulness meditation practice within the 12 months prior to study enrollment
Contact & Investigator
Mariangela Lanfredi, psychologist
PRINCIPAL INVESTIGATOR
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Frequently Asked Questions
Who can join the NCT07834567 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Obsessive - Compulsive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07834567 currently recruiting?
Yes, NCT07834567 is actively recruiting participants. Contact the research team at mlanfredi@fatebenefratelli.eu for enrollment information.
Where is the NCT07834567 trial being conducted?
This trial is being conducted at Brescia, Italy.
Who is sponsoring the NCT07834567 clinical trial?
NCT07834567 is sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli. The principal investigator is Mariangela Lanfredi, psychologist at IRCCS Centro San Giovanni di Dio Fatebenefratelli. The trial plans to enroll 42 participants.