Obsessive - Compulsive DisorderMIND-DOCNCT07834567
Clinical and Biological Correlates of Obsessive-Compulsive Disorder and Online Mindfulness-Based Cognitive Therapy
A study testing Mindfulness-based Cognitive Therapy for OCD in people with Obsessive - Compulsive Disorder, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Obsessive - Compulsive Disorder
- What is being tested?
- Mindfulness-based Cognitive Therapy for OCD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 26 Aug 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- 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
Who cannot join
- 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
Show all 16Show fewer
- Previous mindfulness meditation practice within the 12 months prior to study enrollment
- Inability or unwillingness to provide informed consent
- Healthy subjects.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia
Mariangela Lanfredi, psychologist, 00390303501504, mlanfredi@fatebenefratelli.eu
Laura Pedrini, psychologist, 00390303501504, lpedrini@fatebenefratelli.eu
About this study
Official title: Clinical and Biological Correlates of Obsessive-Compulsive Disorder and Implementation of an Integrated, Manualized Group Mindfulness-Based Cognitive Therapy Intervention
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.
Read the detailed description
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.
- Conditions
- Obsessive - Compulsive Disorder
- Being tested
- Mindfulness-based Cognitive Therapy for OCD
- Keywords
- obsessive compulsive disorder, MBCT, OCD, on-line, mindfulness
- Medical subject headings
- Compulsive Personality Disorder, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Cognitive Therapy for OCDBehavioural
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 group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Cognitive Therapy (MBCT) for OCD | Experimental | 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. Receives: Behavioral: Mindfulness-based Cognitive Therapy for OCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Weeks 4, 8, 12, 20, and 24 from the start of the intervention.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, post-treatment (11 weeks), and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start26 Aug 2026
- Primary completionMay 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obsessive - Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariangela Lanfredi, IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Investigators
- Mariangela Lanfredi, psychologist, Principal investigator, IRCCS Centro San Giovanni di Dio Fatebenefratelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834567
- Sponsor's protocol ID
- MIND-DOC
- Acronym
- MIND-DOC
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Didonna F. (2022). Terapia Cognitiva Basata sulla Mindfulness per il Disturbo Ossessivo-Compulsivo. Edizioni Centro Studi Erickson: Trento.
Zhang T, Lu L, Didonna F, Wang Z, Zhang H, Fan Q. Mindfulness-Based Cognitive Therapy for Unmedicated Obsessive-Compulsive Disorder: A Randomized Controlled Trial With 6-Month Follow-Up. Front Psychiatry. 2021 Aug 3;12:661807. doi: 10.3389/fpsyt.2021.661807. eCollection 2021.
PubMed 34413795Lu L, Zhang T, Gao R, Zhang Z, Cao X, Chen Y, Liu Y, Zhang F, Zheng Y, Sun Y, Bai Y, Wang J, Didonna F, Zhang H, Fan Q. Mindfulness-based cognitive therapy for obsessive-compulsive disorder: Study protocol for a randomized controlled trial with functional magnetic resonance imaging and a 6-month follow-up. J Health Psychol. 2020 Nov-Dec;25(13-14):2072-2084. doi: 10.1177/1359105318780540. Epub 2018 Jul 5.
PubMed 29974808Didonna F, Rossi R, Ferrari C, Iani L, Pedrini L, Rossi N, Xodo E, Lanfredi M. Relations of mindfulness facets with psychological symptoms among individuals with a diagnosis of obsessive-compulsive disorder, major depressive disorder, or borderline personality disorder. Psychol Psychother. 2019 Mar;92(1):112-130. doi: 10.1111/papt.12180. Epub 2018 Mar 25.
PubMed 29575447Didonna F, Lanfredi M, Xodo E, Ferrari C, Rossi R, Pedrini L. Mindfulness-based Cognitive Therapy for Obsessive-Compulsive Disorder: A Pilot Study. J Psychiatr Pract. 2019 Mar;25(2):156-170. doi: 10.1097/PRA.0000000000000377.
PubMed 30849066
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biological Correlates of Obsessive-Compulsive Disorder and Implementation of an Integrated, Manualized Group Mindfulness-Based Cognitive Therapy Intervention
- ClinicalTrials.gov ID
- NCT07834567
- Acronym / sponsor ID
- MIND-DOC / MIND-DOC
- Conditions
- Obsessive - Compulsive Disorder
- Keywords
- obsessive compulsive disorder, MBCT, OCD, on-line, mindfulness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Cognitive Therapy (MBCT) for OCD | Experimental | Behavioral: Mindfulness-based Cognitive Therapy for OCDParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Cognitive Therapy for OCDThe 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. | Behavioural | Mindfulness-Based Cognitive Therapy (MBCT) for OCD |
Primary outcome
Change from baseline in the Yale-Brown Obsessive Compulsive Scale 2nd version (Y-BOCS-II) total score.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
8 secondary outcomes
Change from baseline in the Beck Depression Inventory-II (BDI-II) total score.
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up.
Change from baseline in the Beck Anxiety Inventory (BAI) total score.
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.
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.
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up.
Change from baseline in Obsessional Beliefs Questionnaire (OBQ-20) score.
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.
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up
Change from baseline in the Mind-Wandering Questionnaire (MWQ) total score.
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)
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- BackgroundDidonna F. (2022). Terapia Cognitiva Basata sulla Mindfulness per il Disturbo Ossessivo-Compulsivo. Edizioni Centro Studi Erickson: Trento.
- Background: PubMed 34413795Zhang T, Lu L, Didonna F, Wang Z, Zhang H, Fan Q. Mindfulness-Based Cognitive Therapy for Unmedicated Obsessive-Compulsive Disorder: A Randomized Controlled Trial With 6-Month Follow-Up. Front Psychiatry. 2021 Aug 3;12:661807. doi: 10.3389/fpsyt.2021.661807. eCollection 2021.
- Background: PubMed 29974808Lu L, Zhang T, Gao R, Zhang Z, Cao X, Chen Y, Liu Y, Zhang F, Zheng Y, Sun Y, Bai Y, Wang J, Didonna F, Zhang H, Fan Q. Mindfulness-based cognitive therapy for obsessive-compulsive disorder: Study protocol for a randomized controlled trial with functional magnetic resonance imaging and a 6-month follow-up. J Health Psychol. 2020 Nov-Dec;25(13-14):2072-2084. doi: 10.1177/1359105318780540. Epub 2018 Jul 5.
- Background: PubMed 29575447Didonna F, Rossi R, Ferrari C, Iani L, Pedrini L, Rossi N, Xodo E, Lanfredi M. Relations of mindfulness facets with psychological symptoms among individuals with a diagnosis of obsessive-compulsive disorder, major depressive disorder, or borderline personality disorder. Psychol Psychother. 2019 Mar;92(1):112-130. doi: 10.1111/papt.12180. Epub 2018 Mar 25.
- Background: PubMed 30849066Didonna F, Lanfredi M, Xodo E, Ferrari C, Rossi R, Pedrini L. Mindfulness-based Cognitive Therapy for Obsessive-Compulsive Disorder: A Pilot Study. J Psychiatr Pract. 2019 Mar;25(2):156-170. doi: 10.1097/PRA.0000000000000377.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariangela Lanfredi, psychologist principal investigator
IRCCS Centro San Giovanni di Dio Fatebenefratelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Cognitive Therapy for OCD in people with Obsessive - Compulsive Disorder, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariangela Lanfredi (00390303501504, mlanfredi@fatebenefratelli.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Yale-Brown Obsessive Compulsive Scale 2nd version (Y-BOCS-II) total score. (time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07834567, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.