Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 11:39 PM
Study NCT ID:
NCT03449394
Status:
COMPLETED
Last Update Posted:
2020-01-23
First Post:
2018-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of 4-session Metacognitive Training in Chinese Adult Outpatients With Schizophrenia Spectrum Disorders and Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003702', 'term': 'Delusions'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-22', 'studyFirstSubmitDate': '2018-01-23', 'studyFirstSubmitQcDate': '2018-02-22', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attributional style as measured by the Internal, Personal and Situational Attributions Questionnaire (IPSAQ)', 'timeFrame': '6 months', 'description': 'IPSAQ consists of hypothetical scenarios. Participants are required to think of a single, most likely causal explanation to each of the hypothesized situations, and then to categorize this cause as being internal, external-personal or external-situational.'}, {'measure': 'Psychotic symptomatology as measured by Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': '6 months', 'description': 'Positive and Negative Syndrome Scale (PANSS) is an interview-based assessment of the severity of symptoms associated with schizophrenia, including positive, negative, and general psychopathology.'}, {'measure': 'Depressive symptomatology as measured by Beck Depression Inventory - II (BDI-II) and Calgary Depression Scale (CDS)', 'timeFrame': '6 months', 'description': 'Beck Depression Inventory - II (BDI-II) is a 21-item self-report inventory that assesses symptoms of depression. Scores can range from 0 to 63, with higher scores reflecting greater symptom severity. Calgary Depression Scale (CDS) is a nine-item structured interview scale that assesses depressive symptoms in patients with schizophrenia.'}, {'measure': 'Conviction of beliefs as measured by the Psychotic Symptom Rating Scale (PSYRATS)', 'timeFrame': '6 months', 'description': 'The Psychotic Symptom Rating Scale (PSYRATS) is a 17-item semi-structured interview measuring the severity of multiple dimensions of auditory hallucinations and delusions, including conviction and duration.'}, {'measure': 'Belief flexibility as measured by Maudsley Assessment of Delusions Schedule (MADS) and the BADE task', 'timeFrame': '6 months', 'description': "Maudsley Assessment of Delusions Schedule (MADS) is a standardised interview assessment that records whether participants could consider possibility of being mistaken (PM) about their delusional experience, any possible alternative explanations for the experience (EoE), and their reaction to hypothetical contradiction (RTHC). BADE task is an experimental design for measuring participants' bias against disconfirmatory evidence."}, {'measure': 'State-trait personality as measured by the State-Trait Personality Inventory (STPI)', 'timeFrame': '6 months', 'description': 'State-Trait Personality Inventory (STPI) consists of 8 self-report scales, each containing 10 items covering state and trait anger, anxiety, curiosity and depression.'}], 'secondaryOutcomes': [{'measure': 'Cognitive capacity as measured by the Chinese version of the Wechsler Adult Intelligence Scale - III (WAIS-III)', 'timeFrame': 'Baseline', 'description': "Three subtest short form - vocabulary, matrix reasoning and information - will be administered at baseline to assess the participants' cognitive capacity."}, {'measure': 'Severity of generalized anxiety disorder as measured by Generalised Anxiety Disorder 7 (GAD-7)', 'timeFrame': '6 months', 'description': 'Generalised Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and assessing severity of generalised anxiety disorder (GAD). This scale consists of seven items that measure severity of various signs of GAD according to reported response categories.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychosis', 'Depression', 'Metacognition', 'Attribution', 'Emotions'], 'conditions': ['Delusions', 'Depression']}, 'descriptionModule': {'briefSummary': 'Psychological studies have shown that individuals tend to attribute causes of positive and negative events differently. Specifically, individuals hold an internalising or externalising bias of attribution which, in the case of particular patient groups, was found to polarize to the extreme. Such extreme attributional styles have found to have a direct impact on emotions, leading to a waning course of psychiatric disorders. This project aims to further examine the theoretical links between attributions and emotions using a transdiagnostic approach, and the effect of a 4-session process-based intervention on attributional biases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-65 years\n* Clinical diagnosis of non-organic psychosis or major depressive disorder\n* Presentation of delusions/a moderate level of depression\n\nExclusion Criteria:\n\n* Clinical diagnosis of psychotic depression or depression with psychotic features\n* Primary diagnosis of substance misuse or learning disability\n* Participation of any cognitive/reasoning training program'}, 'identificationModule': {'nctId': 'NCT03449394', 'briefTitle': 'Effect of 4-session Metacognitive Training in Chinese Adult Outpatients With Schizophrenia Spectrum Disorders and Major Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Effect of 4-session Metacognitive Training in Chinese Adult Outpatients With Schizophrenia Spectrum Disorders and Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'MCT2.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Delusions (Tx)', 'interventionNames': ['Other: Metacognitive Training']}, {'type': 'NO_INTERVENTION', 'label': 'Delusions (TAU)'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Depression (Tx)', 'interventionNames': ['Other: Metacognitive Training']}, {'type': 'NO_INTERVENTION', 'label': 'Depression (TAU)'}], 'interventions': [{'name': 'Metacognitive Training', 'type': 'OTHER', 'description': '4 sessions of Metacognitive Training using 4 treatment modules each targeting different cognitive biases', 'armGroupLabels': ['Delusions (Tx)', 'Depression (Tx)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Suzanne Ho-wai So', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}