[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656969":3},{"organization":4,"outcomesModule":7,"designInfo":66,"detailedDescription":72,"studyPopulation":65,"armGroups":73,"interventions":80,"overallOfficials":86,"centralContacts":90,"locations":99,"responsibleParty":119,"collaborators":65,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":123,"sex":129,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":65,"studyType":135,"phases":136,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":101,"whyStopped":65,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"IRCCS Centro San Giovanni di Dio Fatebenefratelli","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":39,"otherOutcomes":65},[9,13,17,21,24,28,31,35],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline, post-treatment (11 weeks), and 3-month follow-up",{"measure":14,"description":15,"timeFrame":16},"Recruitment rate","Recruitment rate will be calculated as the percentage of eligible participants who enroll in the study among all participants assessed for eligibility.","From study initiation to completion of recruitment.",{"measure":18,"description":19,"timeFrame":20},"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).","End of Treatment (Week 11).",{"measure":22,"description":23,"timeFrame":20},"Treatment attendance rate","Treatment attendance rate will be calculated as the percentage of scheduled treatment sessions attended by each participant.",{"measure":25,"description":26,"timeFrame":27},"Assessment questionnaire completion rate","Assessment questionnaire completion rate will be calculated as the percentage of scheduled assessment questionnaires completed by participants.","Baseline (Week 0), End of Treatment (Week 11), and Post-Treatment Follow-Up (3 months after treatment completion).",{"measure":29,"description":30,"timeFrame":20},"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.",{"measure":32,"description":33,"timeFrame":34},"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.","During treatment (Weeks 1-11) and Post-Treatment Follow-Up (3 months after treatment completion).",{"measure":36,"description":37,"timeFrame":38},"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.","At Weeks 4, 8, 12, 20, and 24 from the start of the intervention.",[40,44,47,50,53,56,59,62],{"measure":41,"description":42,"timeFrame":43},"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.","Baseline, post-treatment (11 weeks), and 3-month follow-up.",{"measure":45,"description":46,"timeFrame":43},"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.",{"measure":48,"description":49,"timeFrame":43},"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.",{"measure":51,"description":52,"timeFrame":43},"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.",{"measure":54,"description":55,"timeFrame":43},"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\u002FControl 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.",{"measure":57,"description":58,"timeFrame":12},"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.",{"measure":60,"description":61,"timeFrame":43},"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.",{"measure":63,"description":64,"timeFrame":43},"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.",null,{"allocation":67,"interventionModel":68,"interventionModelDescription":65,"primaryPurpose":69,"observationalModel":65,"timePerspective":65,"maskingInfo":70},"NA","SINGLE_GROUP","TREATMENT",{"masking":71,"maskingDescription":65,"whoMasked":65},"NONE","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.\n\nMindfulness-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.\n\nThis 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.\n\nThe 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.\n\nAt 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.\n\nClinical 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.\n\nClinical 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.\n\nTreatment 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.\n\nBiological 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.",[74],{"label":75,"type":76,"description":77,"interventionNames":78},"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.",[79],"Behavioral: Mindfulness-based Cognitive Therapy for OCD",[81],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":65},"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\u002For partners and a 6-hour intensive practice day.",[75],[87],{"name":88,"affiliation":5,"role":89},"Mariangela Lanfredi, psychologist","PRINCIPAL_INVESTIGATOR",[91,96],{"name":92,"role":93,"phone":94,"phoneExt":65,"email":95},"Mariangela Lanfredi","CONTACT","00390303501504","mlanfredi@fatebenefratelli.eu",{"name":97,"role":93,"phone":94,"phoneExt":65,"email":98},"Laura Pedrini, psychologist","lpedrini@fatebenefratelli.eu",[100],{"facility":5,"status":101,"city":102,"state":65,"zip":65,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"RECRUITING","Brescia","Italy","IT",{"type":106,"coordinates":107},"Point",[108,109],10.21472,45.53558,{"lat":109,"lon":108},[112,113,114,117],{"name":88,"role":93,"phone":94,"phoneExt":65,"email":95},{"name":97,"role":93,"phone":94,"phoneExt":65,"email":98},{"name":115,"role":116,"phone":65,"phoneExt":65,"email":65},"Evita Tomasoni, psychologist","SUB_INVESTIGATOR",{"name":118,"role":116,"phone":65,"phoneExt":65,"email":65},"Roberta Rossi, psychologist",{"type":89,"investigatorFullName":92,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":65,"oldOrganization":65},"psychologist","100656969","clinical-and-biological-correlates-of-obsessive-compulsive-disorder-and-online-mindfulness-based-cognitive-therapy-100656969",false,"NCT07834567","Clinical and Biological Correlates of Obsessive-Compulsive Disorder and Online Mindfulness-Based Cognitive Therapy","Clinical and Biological Correlates of Obsessive-Compulsive Disorder and Implementation of an Integrated, Manualized Group Mindfulness-Based Cognitive Therapy Intervention","MIND-DOC","Patients with OCD.\n\nInclusion Criteria:\n\n* Diagnosis of obsessive-compulsive disorder (OCD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)\n* Age between 18 and 45 years\n* Stable pharmacological treatment for at least 3 months prior to the start of the experimental intervention\n* No previous experience with mindfulness meditation, or previous mindfulness meditation experience with no practice during the 12 months prior to study enrollment\n* Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of schizophrenia spectrum or other psychotic disorders, including schizoaffective disorder\n* Diagnosis of bipolar and related disorders\n* Major depressive disorder in an acute phase\n* Active substance use disorder or alcohol use disorder as the primary diagnosis\n* Personality disorders of clinically significant severity\n* Documented major neurocognitive disorder. Neurological conditions or medical conditions with a clinically significant impact on cognitive or mental functioning\n* Previous mindfulness meditation practice within the 12 months prior to study enrollment\n* Inability or unwillingness to provide informed consent\n\nHealthy subjects.\n\nInclusion Criteria:\n\n* 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\n* Voluntary participation in the study.\n* Ability and willingness to provide written informed consent\n\nExclusion criteria:\n\n* Age younger than 18 years\n* History of psychiatric disorders, as assessed using the Structured Clinical Interview for DSM-5 Disorders - Clinician Version (SCID-CV)\n* Intellectual developmental disorder.\n* Current substance use disorder or alcohol use disorder\n* 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\n* Systemic medical conditions (e.g., diabetes mellitus, atherosclerosis, chronic arterial hypertension, or malignancies) requiring pharmacological treatment\n* Current or previous mindfulness meditation practice within the 12 months prior to study enrollment","ALL","18 Years","45 Years",{"count":133,"type":134},42,"ESTIMATED","INTERVENTIONAL",[67],"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.\n\nThis 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.\n\nParticipants 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.",[139],"Obsessive - Compulsive Disorder",[141,142,143,144,145],"obsessive compulsive disorder","MBCT","OCD","on-line","mindfulness","2026-09-22",{"date":148,"type":149},"2026-09-25","ACTUAL",{"date":151,"type":149},"2026-08-26",{"date":153,"type":134},"2028-11",{"name":5,"class":6},1]