Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:49 AM
Study NCT ID:
NCT07484750
Status:
RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Influencing Factors of Mindfulness-Based Exposure Group Therapy for OCD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Obsessive-compulsive symptoms improvement', 'timeFrame': 'Pre-treatment (Baseline), Mid-treatment (Week 5), and Post-treatment (Week 10).', 'description': 'The severity of OCD symptoms is assessed using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Obsessive-compulsive symptoms improvement is reflected by Y-BOCS reduction rate.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mindfulness', 'Exposure and Response Prevention'], 'conditions': ['Obessive-Compulsive Disorder']}, 'descriptionModule': {'briefSummary': "Obessive-Compulsive Disorder (OCD) is frequently treatment-refractory and imposes a substantial burden on affected individuals. Although Exposure and Response Prevention (ERP) is widely regarded as the first-line intervention, its inherently distressing nature contributes to treatment refusal and premature dropout in a subset of patients. The present study aims to develop and validate a novel intervention, Mindfulness-Based Exposure Therapy (MBET).\n\nIn contrast to existing protocols that incorporate mindfulness as an adjunct to ERP and have yielded mixed or limited benefits, this study seeks a theoretically grounded integration of mindfulness and exposure-based principles. We hypothesize that mindfulness training improves emotion regulation, thereby producing a synergistic effect that enhances patients' capacity to engage in and complete exposure tasks.\n\nFrom a clinical perspective, MBET is intended to offer a more tolerable and acceptable alternative to standard ERP, with the potential to improve treatment adherence and clinical outcomes among patients who experience traditional exposure procedures as excessively distressing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a primary diagnosis of Obsessive-Compulsive Disorder (OCD) according to DSM-5 criteria\n* Are between 16 and 55 years of age (inclusive)\n* Have a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score ≥ 16\n* Have an education level of junior high school or above\n* Are medication-free or have been stabilized on psychotropic medication for at least 8 weeks\n* Have sufficient visual and auditory capabilities to complete study assessments\n* Are willing to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Meet DSM-5 criteria for any other psychiatric disorder besides OCD\n* Have severe OCD symptoms that prevent completion of assessments\n* Exhibit active suicidal ideation or high suicide risk\n* Have a serious somatic disease, central nervous system disease, or substance abuse history\n* Are pregnant, breastfeeding, or planning pregnancy\n* Have metal implants contraindicated for MRI (e.g., pacemakers, intracranial clips, metal dentures, arterial stents, joint fixations)'}, 'identificationModule': {'nctId': 'NCT07484750', 'briefTitle': 'Efficacy and Influencing Factors of Mindfulness-Based Exposure Group Therapy for OCD', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Mental Health Center'}, 'officialTitle': 'Mindfulness-Based Exposure Group Therapy for Obsessive-compulsive Disorder: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SMHC-OCD-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental : active treatment group', 'interventionNames': ['Behavioral: mindfulness based exposure therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual group', 'interventionNames': ['Other: Treatment as Usual (TAU)']}], 'interventions': [{'name': 'mindfulness based exposure therapy', 'type': 'BEHAVIORAL', 'description': 'Mindfulness-Based Exposure Therapy (MBET) is a structured, 10-week group psychological intervention specifically designed for individuals with Obsessive-Compulsive Disorder (OCD). The program is delivered in weekly sessions, with each session lasting 3 hours. To ensure optimal group dynamics and personalized attention, each group consists of 6 to 8 patients and is facilitated by 1 to 2 trained therapists.To reinforce the skills acquired during the group meetings, participants are assigned daily homework at the end of each session, which requires 30 to 60 minutes of independent practice per day. At its core, the treatment process features a deep integration of mindfulness and Exposure and Response Prevention (ERP). Rather than treating these as separate components, MBET seamlessly embeds the core philosophies and practices of mindfulness directly into the ERP exercises, allowing patients to apply mindful awareness and acceptance while actively confronting their obsessional triggers.', 'armGroupLabels': ['Experimental : active treatment group']}, {'name': 'Treatment as Usual (TAU)', 'type': 'OTHER', 'description': 'treatment as usual with stable medication', 'armGroupLabels': ['Treatment as usual group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhen Wang', 'role': 'CONTACT', 'email': 'wangzhen@smhc.org.cn', 'phone': '18017311286'}], 'facility': 'Shanghai mental health center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhen Wang, MD', 'role': 'CONTACT', 'email': 'wangzhen@smhc.org.cn', 'phone': '+8618017311286'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Shanghai mental health center', 'investigatorFullName': 'Zhen Wang', 'investigatorAffiliation': 'Shanghai Mental Health Center'}}}}