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.
Study 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
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Change from baseline in the Yale-Brown Obsessive Compulsive Scale 2nd version (Y-BOCS-II) total score. — Baseline, post-treatment (11 weeks), and 3-month follow-up The Y-BOCS-II is a clinician-administered semi-structured interview used to assess the presence and severity of obsessive-compulsive disorder (OCD) symptoms. The scale consists of 10 severity items, each rated from 0 (no symptoms) to 5 (extreme symptoms). The total score ranges from 0 to 50, where higher scores indicate greater symptom severity. A decrease in the score reflects clinical improvement.
Recruitment rate — From study initiation to completion of recruitment. Recruitment rate will be calculated as the percentage of eligible participants who enroll in the study among all participants assessed for eligibility.
Treatment dropout rate — End of Treatment (Week 11). Treatment dropout rate will be calculated as the percentage of participants who discontinue treatment before completing the intervention.End of Treatment (Week 11).
Treatment attendance rate — End of Treatment (Week 11). Treatment attendance rate will be calculated as the percentage of scheduled treatment sessions attended by each participant.
Assessment questionnaire completion rate — Baseline (Week 0), End of Treatment (Week 11), and Post-Treatment Follow-Up (3 months after treatment completion). Assessment questionnaire completion rate will be calculated as the percentage of scheduled assessment questionnaires completed by participants.
Participant Satisfaction with the Group Treatment Program — End of Treatment (Week 11). Participant satisfaction will be assessed using a study-specific 19-item questionnaire developed for this trial. Each item is rated on a 5-point Likert scale (1 = not at all; 5 = very much), yielding a total score ranging from 19 to 95. Higher total scores indicate a more favorable evaluation of the treatment program, including its perceived usefulness and acceptability, group experience, facilitators, and online treatment modality.
Home mindfulness practice time — During treatment (Weeks 1-11) and Post-Treatment Follow-Up (3 months after treatment completion). Home mindfulness practice time will be assessed as the total amount of time spent practicing mindfulness at home during the treatment and follow-up periods.
Quality of home mindfulness practice — At Weeks 4, 8, 12, 20, and 24 from the start of the intervention. The quality of home mindfulness practice will be assessed using the Practice-Quality-Mindfulness (PQ-M) scale at predefined assessment time points. The PQ-M consists of six items rated on a visual analog percentage scale ranging from 0% to 100%. The total score is calculated as the mean of the six items, with higher scores indicating better quality of home mindfulness practice.
Trial sites (1)
Facility
City
Region
Status
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia
Italy
Recruiting
More IRCCS Centro San Giovanni di Dio Fatebenefratelli trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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