Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-04 @ 7:40 AM
Study NCT ID:
NCT06466057
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metacognitive Therapy for Obsessive-Compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcomes assessor is a psychiatrist who was not involved in the randomization and treatment process.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Severity of participants' obsessive-compulsive symptoms", 'timeFrame': 'Pre-intervention to 12 weeks post-intervention', 'description': 'Assessed using the Yale Brown Obsessive-Compulsive Scale (Y-BOCS) , with higher scores indicating more severe symptoms.'}], 'secondaryOutcomes': [{'measure': "Levels of Participants' Dysfunctional Metacognitive Beliefs", 'timeFrame': 'Pre-intervention to 12 weeks post-intervention', 'description': 'Assessed using the Metacognition Questionnaire (MCQ-30), with higher scores being associated with more dysfunctional metacognition.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obsessive-Compulsive Disorder', 'Metacognitive Therapy'], 'conditions': ['Obsessive-Compulsive Disorder']}, 'referencesModule': {'references': [{'pmid': '33041948', 'type': 'BACKGROUND', 'citation': 'Wells A, Capobianco L, Matthews G, Nordahl HM. Editorial: Metacognitive Therapy: Science and Practice of a Paradigm. Front Psychol. 2020 Sep 18;11:576210. doi: 10.3389/fpsyg.2020.576210. eCollection 2020. No abstract available.'}, {'pmid': '17418090', 'type': 'BACKGROUND', 'citation': 'Fisher PL, Wells A. Metacognitive therapy for obsessive-compulsive disorder: a case series. J Behav Ther Exp Psychiatry. 2008 Jun;39(2):117-32. doi: 10.1016/j.jbtep.2006.12.001. Epub 2007 Mar 7.'}], 'seeAlsoLinks': [{'url': 'http://evpn.library.nenu.edu.cn/piswww.frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2020.576210/full', 'label': 'It contains the basic concepts of metacognitive therapy'}, {'url': 'http://evpn.library.nenu.edu.cn/pislinkinghub.elsevier.com/retrieve/pii/S000579160700002X', 'label': 'It contains a specific intervention process for metacognitive therapy'}]}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn if metacognitive therapy can be effective in a Chinese sample of obsessive compulsive disorder (OCD) . The main questions it aims to answer are:\n\nCan metacognitive therapy significantly reduce participants' levels of obsessive-compulsive symptoms? Can metacognitive therapy significantly improve participants' metacognitive adaptations?\n\nThe researchers will compare metacognitive therapy to a control condition without psychotherapy to see if metacognitive therapy is effective in treating OCD.\n\nParticipants will:\n\nReceive the metacognitive therapy intervention or under control conditions for 8 to 15 weeks.\n\nBe assessed for symptoms and metacognitive beliefs at pre-intervention, post-intervention and 12 weeks post-intervention", 'detailedDescription': "This study will be a randomised controlled clinical trial. Participants who meet the enrolment criteria will be randomised into an experimental group and a control group. Participants in the experimental group will receive 8-15 weeks of metacognitive therapy, while participants in the control group will receive the same amount of time of regular treatment without psychotherapy components.\n\nThe researchers will assess participants' obsessive-compulsive symptoms and metacognitive levels before, after, and 12 weeks after the intervention. Assessment measures will be the Yale Brown Obsessive-Compulsive Scale (Y-BOCS) and the Metacognition Questionnaire (MCQ-30).\n\nBy comparing the assessment results of the two groups of participants, conclusions will be drawn as to whether metacognitive therapy can have a positive effect on a Chinese OCD sample."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* two psychiatrists with the title of Deputy Chief Physician or above jointly determine that the above diagnostic criteria were met\n* education level of junior high school or above, without mental retardation or audio-visual disorders\n* participation in the study is voluntary, and the informed consent is signed by the patient or his/her guardian\n\nExclusion Criteria:\n\n* loss of or insufficient self-awareness, the presence of hallucinations, delusions, and other psychotic symptoms\n* the presence of severe depression, or self-inflicted suicidal attempts and behaviors\n* the presence of a history of alcohol or drug abuse\n* refusal of psychotherapy, or the ineffectiveness of those who had been involved in a full course of psychotherapy.'}, 'identificationModule': {'nctId': 'NCT06466057', 'acronym': 'MCTOCD', 'briefTitle': 'Metacognitive Therapy for Obsessive-Compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Northeast Normal University'}, 'officialTitle': 'The Efficacy of Metacognitive Therapy for Obsessive-compulsive Disorder', 'orgStudyIdInfo': {'id': 'NENU2023032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metacognitive Therapy', 'description': 'Intervention using metacognitive therapy, with sessions set for 8-15 weeks of 1-2 weekly psychotherapeutic dialogue.', 'interventionNames': ['Behavioral: Metacognitive Therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Condition', 'description': 'Do not receive any additional psychotherapy in addition to conventional treatment.', 'interventionNames': ['Other: General mental health promotion']}], 'interventions': [{'name': 'Metacognitive Therapy', 'type': 'BEHAVIORAL', 'description': 'A one-on-one face-to-face dialogue format will be used to conduct psychotherapy with each participant, and the treatment protocol will be based on the treatment manual for metacognitive therapy.', 'armGroupLabels': ['Metacognitive Therapy']}, {'name': 'General mental health promotion', 'type': 'OTHER', 'description': 'A general mental health mission will be conducted, not covering any metacognitive therapy related content, set for 8-15 weeks, 1 time per week', 'armGroupLabels': ['Control Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0431', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fan Jiang, Ph.D', 'role': 'CONTACT', 'email': 'Jiangf581@nenu.edu.cn', 'phone': '13943004788', 'phoneExt': '+86'}], 'facility': 'Northeast Normal University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Fan Jiang, Ph.D', 'role': 'CONTACT', 'email': 'Jiangf581@nenu.edu.cn', 'phone': '13943004788', 'phoneExt': '+86'}], 'overallOfficials': [{'name': 'Xiaoming Liu, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Northeast Normal University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Access to data is expected to be open by 31 January 2025 and will always be continuous.', 'ipdSharing': 'YES', 'description': 'Data might be made available to experts in the field upon request and upon the detailed description of the reason of request.', 'accessCriteria': 'Data will be made available to experts in the field upon request and upon the detailed description of the reason of request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northeast Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Fan Jiang', 'investigatorAffiliation': 'Northeast Normal University'}}}}