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.
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
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
Single group
Mindfulness-based Cognitive Therapy for OCD
BehavioralThe 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.
Change from baseline in the Yale-Brown Obsessive Compulsive Scale 2nd version (Y-BOCS-II) total score.
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
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
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
Treatment attendance rate will be calculated as the percentage of scheduled treatment sessions attended by each participant.
Change from baseline in the Beck Depression Inventory-II (BDI-II) total score.
The Beck Depression Inventory-II (BDI-II) is a self-report questionnaire designed to assess the severity of depressive symptoms. Each item is rated on a 4-point scale ranging from 0 to 3, reflecting increasing severity of the symptom.
Change from baseline in the Beck Anxiety Inventory (BAI) total score.
The Beck Anxiety Inventory (BAI) is a 21-item self-report questionnaire designed to measure the severity of anxiety symptoms over the past week. Each item is rated on a 4-point scale ranging from 0 (not at all) to 3 (severely). The total score ranges from 0 to 63, with higher scores indicating greater anxiety severity.
Change from baseline in the Five Facet Mindfulness Questionnaire-Short Form (FFMQ-SF) total score.
The Five Facet Mindfulness Questionnaire-Short Form (FFMQ-SF) is a 24-item self-report instrument used to assess five facets of mindfulness: Observing, Describing, Acting with Awareness, Non-judging of Inner Experience, and Non-reactivity to Inner Experience. Each item is scored on a 5-point Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true). The total score is calculated by summing all items and ranges from 24 to 120, with higher scores indicating higher levels of mindfulness.
Change from baseline in the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) subscale scores.
The Multidimensional Assessment of Interoceptive Awareness (MAIA-2) is a self-report questionnaire designed to evaluate multiple dimensions of individuals' awareness and perception of internal bodily sensations. The questionnaire assesses different aspects of interoceptive awareness, including noticing bodily sensations, emotional awareness, attention regulation, and the ability to respond to bodily sensations in an adaptive manner. Higher scores indicate greater adaptive interoceptive awareness.
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