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RECRUITING

NCT07834567

Clinical and Biological Correlates of Obsessive-Compulsive Disorder and Online Mindfulness-Based Cognitive Therapy

Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli

View on ClinicalTrials.gov

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.

Official title: Clinical and Biological Correlates of Obsessive-Compulsive Disorder and Implementation of an Integrated, Manualized Group Mindfulness-Based Cognitive Therapy Intervention

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08-26

Completion Date

2028-11

Last Updated

2026-09-22

Healthy Volunteers

Conditions

Obsessive - Compulsive Disorder

Interventions

BEHAVIORAL

Mindfulness-based Cognitive Therapy for OCD

The intervention is a manualized Mindfulness-Based Cognitive Therapy (MBCT) program for OCD that integrates cognitive-behavioral therapy, exposure techniques, mindfulness, decentering, acceptance, and self-compassion practices (Didonna, 2022). The program aims to improve participants' ability to relate to internal experiences and reduce reactive patterns such as rituals and compulsions. Groups of 8-10 patients will receive the intervention online via synchronous videoconference. The program consists of 11 weekly sessions, including a 1.5-hour session involving family members and/or partners and a 6-hour intensive practice day.

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

Locations (1)

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, Italy