An interventional study of Mindfulness-based Cognitive Therapy for OCD in Obsessive - Compulsive Disorder, sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Not applicable, Interventional, and Treatment
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.
Obsessive-Compulsive Disorder (OCD) is a common and potentially disabling psychiatric condition, characterized by intrusive and distressing thoughts (obsessions) and repetitive behaviors or mental acts (compulsions). Cognitive behavioral therapy, particularly exposure and response prevention, is considered a first-line treatment for OCD. However, a proportion of patients continue to experience clinically significant symptoms after treatment, highlighting the need for complementary therapeutic approaches.
Mindfulness-based interventions may help patients develop a less reactive and more accepting relationship with intrusive thoughts, emotions, and bodily sensations, potentially reducing the use of maladaptive strategies such as suppression, neutralization, and compulsions. Preliminary evidence suggests that mindfulness-based approaches may reduce OCD symptoms and may improve the acceptability of exposure-based treatment. However, evidence regarding synchronous, therapist-led online group interventions specifically adapted for OCD remains limited.
This study aims to evaluate the feasibility and acceptability of a specialized Mindfulness-Based Cognitive Therapy (MBCT) program for OCD, delivered online through synchronous videoconferencing. The manualized intervention (Didonna, 2022) integrates mindfulness practices with cognitive behavioral therapy, exposure and response prevention, acceptance, decentering, and self-compassion techniques.
The primary objective is to assess the feasibility and acceptability of the synchronous online intervention. Exploratory objectives are to evaluate changes in OCD symptoms and other clinical variables and to investigate associations between clinical characteristics, treatment response, and selected biological markers.
At least 42 adults aged 18-45 years with a diagnosis of OCD will be recruited at two participating centers in Italy. Participants will attend 11 weekly online group sessions conducted by trained therapists. The intervention may be provided alongside ongoing stable pharmacological treatment and other standard clinical care.
Clinical assessments: patients will undergo diagnostic and clinical assessment using the Structured Clinical Interview for DSM-5 (SCID-5-CV), including the personality disorders section (SCID-PD), and a medical and clinical history.
Clinical assessments will be performed at baseline, immediately after treatment, and at 3-month follow-up. Clinician-administered assessment will include the Yale-Brown Obsessive Compulsive Scale-2nd version (Y-BOCS-II) to assess OCD symptom severity. Self-report measures will assess depressive and anxiety symptoms, mindfulness, interoceptive awareness, dysfunctional obsessive beliefs, self-compassion, mind wandering, and general psychopathology.
Treatment acceptability and feasibility will be assessed through recruitment and dropout rates, treatment adherence, attendance, completion rates of assessment questionnaires, reasons for treatment discontinuation, treatment satisfaction, and home mindfulness practice. Participants will complete an ad hoc treatment satisfaction questionnaire at the end of treatment. Home practice time will be monitored during treatment and follow-up, and practice quality will be assessed using the Practice-Quality-Mindfulness (PQ-M) at predefined time points.
Biological assessments: patients recruited at Center 1 will provide blood and saliva samples before and after the intervention. Blood will be collected for RNA, DNA, plasma, and serum analyses; while saliva samples will be collected during the day to measure cortisol levels.
635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.
This study's planned enrollment of 42 is close to the median of 45 across 520 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →IRCCS Centro San Giovanni di Dio Fatebenefratelli is the lead sponsor of 36 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with OCD.
Inclusion Criteria:
Exclusion Criteria:
Healthy subjects.
Inclusion Criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a manualized Mindfulness-Based Cognitive Therapy (MBCT) program for obsessive-compulsive disorder (OCD), integrating cognitive-behavioral therapy, exposure techniques, mindfulness, decentering, acceptance, and self-compassion practices.
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.
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.
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up
Recruitment rate
Recruitment rate will be calculated as the percentage of eligible participants who enroll in the study among all participants assessed for eligibility.
Time frame: From study initiation to completion of recruitment.
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).
Time frame: 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.
Time frame: End of Treatment (Week 11).
Assessment questionnaire completion rate
Assessment questionnaire completion rate will be calculated as the percentage of scheduled assessment questionnaires completed by participants.
Time frame: Baseline (Week 0), End of Treatment (Week 11), and Post-Treatment Follow-Up (3 months after treatment completion).
Participant Satisfaction with the Group Treatment Program
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.
Time frame: End of Treatment (Week 11).
Home mindfulness practice time
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.
Time frame: During treatment (Weeks 1-11) and Post-Treatment Follow-Up (3 months after treatment completion).
Quality of home mindfulness practice
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.
Time frame: At Weeks 4, 8, 12, 20, and 24 from the start of the intervention.
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.
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up.
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.
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up.
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.
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up.
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.
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up.
Change from baseline in Obsessional Beliefs Questionnaire (OBQ-20) score.
The Obsessional Beliefs Questionnaire-20 (OBQ-20) is a 20-item self-report instrument designed to assess dysfunctional cognitive beliefs and attitudes critical to the development and maintenance of OCD. The scale evaluates four main domains: 1) Responsibility, 2) Threat Estimation, 3) Perfectionism, and 4) Importance/Control of Thoughts. Each item is rated on a 7-point Likert scale ranging from 1 (disagree very much) to 7 (agree very much). The total score is obtained by summing all 20 items and ranges from 20 to 140, with higher scores indicating a greater presence or severity of dysfunctional obsessional beliefs.
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up.
Change from baseline in the Self-Compassion Scale-Short Form (SCS-SF) total score.
The Self-Compassion Scale-Short Form (SCS-SF) is a 12-item self-report questionnaire designed to assess an individual's level of self-compassion. Each item is rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). Higher scores indicate a greater level of self-compassion.
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up
Change from baseline in the Mind-Wandering Questionnaire (MWQ) total score.
The Mind-Wandering Questionnaire (MWQ) is a 5-item self-report instrument designed to measure trait levels of task-unrelated thought (mind-wandering). Each item is rated on a 6-point Likert scale ranging from 1 (almost never) to 6 (almost always). Higher total scores indicate a greater propensity or frequency of mind-wandering.
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up.
Change from baseline in the Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index (GSI)
The Global Severity Index (GSI) is the primary summary score of the Symptom Checklist-90-Revised (SCL-90-R), a 90-item self-report questionnaire designed to evaluate a broad range of psychological symptoms and psychopathology. Each of the 90 items is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The GSI raw score ranges from 0 to 4, with higher scores indicating a greater overall level of psychological distress and symptom severity.
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up.
Plan to share: No
Started Aug 2026 (actual). Primary completion is estimated for May 2028, 21 months after the start.
Of 234 non-industry interventional studies with no phase under Obsessive-Compulsive Disorder, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 65. This study's planned 21 months is below that.
Counting every sponsor, half of 237 studies reached it within 43 months; a quarter within 22 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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