Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT00465920
Status:
UNKNOWN
Last Update Posted:
2009-02-20
First Post:
2007-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-19', 'studyFirstSubmitDate': '2007-04-25', 'studyFirstSubmitQcDate': '2007-04-25', 'lastUpdatePostDateStruct': {'date': '2009-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PANSS positive syndrome (sum of items P1-P7), assessed during the treatment phase (9 month) monthly and during the follow-up phase (2 years) every 6 months'}], 'secondaryOutcomes': [{'measure': 'additional symptom ratings (PSYRATS)'}, {'measure': 'social functioning (GAF)'}, {'measure': 'illness related events (suicide, suicide attempts, rehospitalisation, severe depressive symptom exacerbation)'}, {'measure': 'quality of life (MSLQ)assessed monthly during the treatment phase (9 months) and every 6 months during the follow-up phase (2 years)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['schizophrenia', 'cognitive behavioural therapy', 'early onset psychosis', 'Psychotic disorders (schizophrenia, schizoaffective disorder, delusional disorder, schizophreniform disorder according to DSM IV) in adolescents'], 'conditions': ['Psychotic Disorders', 'Schizophrenia', 'Schizoaffective Disorder', 'Delusional Disorder', 'Schizophreniform Disorder']}, 'descriptionModule': {'briefSummary': 'In the last decade cognitive behavioural therapy (CBT) approaches for patients with schizophrenia have been developed, which where especially designed to reduce severity of positive symptoms, readmission rates, treatment non-compliance and disability. Although CBT addresses the key problems of early onset psychoses (EOP)treatment and first evaluations of CBT in adults with schizophrenia are promising, no experience with CBT in adolescents with EOP are available. Therefore the present study is conducted to develop a modified CBT (mCBT) for adolescents with EOP, to explore its acceptance and feasibility and to provide data for a realistic estimation of achievable effect size. Patients are randomized to receive either mCBT+TAU or TAU over a 9 month period. mCBT is an individual outpatient treatment of 20 session and 5 psychoeducational sessions with parents. Follow-ups for two years every 6 months are planned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schizophrenia, schizophreniform or schizoaffective disorder (DSM IV 295.1- .9), delusional disorder (DSM IV 297.1)\n* Score of 4 or more on one of the PANSS-items P1, P3, G9\n* Positive psychotic symptoms for 3 months or more\n* Age between 14 and 18\n* Fluently German speaking\n\nExclusion Criteria:\n\n* Diagnosis of delirium, dementia, amnestic or other cognitive disorder, psychiatric disorders due to a somatic factor or related to psychotropic substances according to DSM IV; diseases of the central nervous system\n* Alcohol- or drug dependence according to DSM IV\n* Verbal IQ \\< 80\n* Travel time to the study centre of more than 1 hour'}, 'identificationModule': {'nctId': 'NCT00465920', 'acronym': 'mCBT', 'briefTitle': 'Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis', 'orgStudyIdInfo': {'id': '01GV0619'}}, 'armsInterventionsModule': {'interventions': [{'name': 'modified cognitive behavioural therapy (mCBT)', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andreas Bechdolf, PD Dr.', 'role': 'CONTACT', 'email': 'andreas.bechdolf@uk-koeln.de', 'phone': '+49 221 478 4825'}, {'name': 'Bettina Pohlmann, Dr.', 'role': 'CONTACT', 'email': 'bettina.pohlmann@uk-koeln.de', 'phone': '+49 221 478 3870'}, {'name': 'Andreas Bechdolf, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Psychiatry University Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'centralContacts': [{'name': 'Andreas Bechdolf, PD Dr.', 'role': 'CONTACT', 'email': 'andreas.bechdolf@uk-koeln.de', 'phone': '+49 221 478 4825'}, {'name': 'Bettina Pohlmann, Dr.', 'role': 'CONTACT', 'email': 'bettina.pohlmann@uk-koeln.de', 'phone': '+ 49 221 478 3870'}], 'overallOfficials': [{'name': 'Andreas Bechdolf, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cologne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Goethe University', 'class': 'OTHER'}, {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}]}}}