Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT00646256
Status:
UNKNOWN
Last Update Posted:
2008-03-28
First Post:
2008-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Determinants of Psychoeducation and Information in Psychoses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D012563', 'term': 'Schizophrenia, Paranoid'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'lastUpdateSubmitDate': '2008-03-25', 'studyFirstSubmitDate': '2008-03-25', 'studyFirstSubmitQcDate': '2008-03-25', 'lastUpdatePostDateStruct': {'date': '2008-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'illness knowledge, adherence to treatment, insight to the illness, satisfaction with treatment. 9-month follow-up: number of rehospitalizations, days in hospital', 'timeFrame': 'Baseline, after cognitive training, after psychoeducation, 9-month after end of psychoeducation'}], 'secondaryOutcomes': [{'measure': 'Psychopathological status'}, {'measure': 'Psychosocial rehabilitation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizoaffective', 'schizotypal'], 'conditions': ['Schizophrenia', 'Delusional Disorders (ICD-10)']}, 'referencesModule': {'references': [{'pmid': '20048350', 'type': 'DERIVED', 'citation': 'Pitschel-Walz G, Bauml J, Frobose T, Gsottschneider A, Jahn T. Do individuals with schizophrenia and a borderline intellectual disability benefit from psychoeducational groups? J Intellect Disabil. 2009 Dec;13(4):305-20. doi: 10.1177/1744629509353237.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to examine whether the efficacy of psychoeducation in patients with schizophrenia or schizoaffective disorders is dependent on their cognitive performance level and if a preceding cognitive training can enhance the therapeutic effects of psychoeducation', 'detailedDescription': 'Schizophrenic inpatients are examined shortly after admission with a broad battery of clinical and neurological rating scales and neuropsychological tests. They are then randomized to either standard treatment (including antipsychotic medications, art and occupational therapy, psychotherapy) or to standard treatment plus daily computerbased cognitive training (COGPACK; ten 1-hour sessions over two weeks). After repetition of the broad assessment battery all patients (and some of their family members) take part in a bifocal psychoeducation group program (eight 1-hour sessions over four weeks). Specific pre-post measures are illness knowledge, self and expert ratings of adherence to treatment, insight to the illness, treatment satisfaction. The study also includes a 9-month follow-up, with number of rehospitalizations, days in hospital and psychopathology as the primary outcome measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients\n* Informed consent\n* German as first language or very good knowledge of German\n\nExclusion Criteria:\n\n* Mental retardation\n* Any serious somatic illness'}, 'identificationModule': {'nctId': 'NCT00646256', 'acronym': 'COGPIP', 'briefTitle': 'Cognitive Determinants of Psychoeducation and Information in Psychoses', 'organization': {'class': 'OTHER', 'fullName': 'German Research Foundation'}, 'officialTitle': 'Psychoeducation in Patients With Schizophrenia: Neuropsychological Performance and Cognitive Training as Determinants of Outcome', 'orgStudyIdInfo': {'id': 'DFG Ja 680 / 4-2, 4-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'no training'}, {'type': 'EXPERIMENTAL', 'label': 'COGPACK training', 'interventionNames': ['Behavioral: COGPACK training, psychoeducation']}], 'interventions': [{'name': 'COGPACK training, psychoeducation', 'type': 'BEHAVIORAL', 'description': 'Bifocal psychoeducation group program (Munich Psychoses Information Program - PIP) with preceding computerbased cognitive training program (COGPACK)', 'armGroupLabels': ['COGPACK training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technical University of Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Thomas Jahn, Prof. Dr. phil. Dipl.-Psych.', 'role': 'CONTACT', 'email': 'th.jahn@lrz.tum.de', 'phone': '+49 (0)89-4140 4278'}], 'overallOfficials': [{'name': 'Thomas Jahn, Prof. Dr. phil. Dipl.-Psych.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klnikum rechts der Isar, Technbical Univesity Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Dr. phil. Dipl.-Psych. Thomas Jahn', 'oldOrganization': 'Technical University of Munich'}}}}