Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-02-25 @ 6:57 PM
Study NCT ID:
NCT01622166
Status:
COMPLETED
Last Update Posted:
2014-10-24
First Post:
2012-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Art Therapy in Acute Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-22', 'studyFirstSubmitDate': '2012-06-12', 'studyFirstSubmitQcDate': '2012-06-14', 'lastUpdatePostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Positive and Negative Syndrome Scale (PANSS-) scores', 'timeFrame': 'weeks 0, 6, 12', 'description': 'assessment of change of schizophrenic positive, negative and general symptom scores'}, {'measure': 'safety measures', 'timeFrame': 'weeks 0, 6, 12', 'description': 'number of participants with adverse events'}, {'measure': 'Change in Calgary depression Scale (CDS-) scores', 'timeFrame': 'weeks 0, 6, 12', 'description': 'assessment of change of depressive symptoms in schizophrenic patients as reflected by CDS-scores'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '25393414', 'type': 'DERIVED', 'citation': 'Montag C, Haase L, Seidel D, Bayerl M, Gallinat J, Herrmann U, Dannecker K. A pilot RCT of psychodynamic group art therapy for patients in acute psychotic episodes: feasibility, impact on symptoms and mentalising capacity. PLoS One. 2014 Nov 13;9(11):e112348. doi: 10.1371/journal.pone.0112348. eCollection 2014.'}], 'seeAlsoLinks': [{'url': 'http://www.kunsttherapie-berlin.de/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Randomised, controlled, single-blinded pilot study to assess the efficacy of psychodynamic art therapy in a sample of hospitalized, (sub)acutely psychotic patients with a diagnosis of schizophrenia compared to a group of patients receiving treatment as usual.\n\n\\*Main hypothesis: Art therapy has no impact on clinical symptoms and the course of remission compared to TAU.\n\n\\*Exploratory hypotheses: Art therapy has no influence on quality of life, mentalizing function, self-efficacy and neuroleptic dosage compared to TAU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of schizophrenia according to DSM-IV-TR\n* age 18-64 yrs\n* sufficient German language competency\n* written informed consent\n\nExclusion Criteria:\n\n* axis-I mental disorders other than schizophrenia\n* comorbid antisocial personality disorder, relevant substance abuse,\n* relevant severe somatic disease\n* acute suicidal tendencies or aggression\n* incapability to tolerate group settings'}, 'identificationModule': {'nctId': 'NCT01622166', 'acronym': 'KUSS', 'briefTitle': 'Art Therapy in Acute Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Art Therapy for Symptom Reduction in Acute Schizophrenia - a Randomised Controlled Trial (Kunsttherapie Zur Symptomreduktion Bei Akuter Schizophrenie - Eine Randomisierte Kontrollierte Pilotstudie)', 'orgStudyIdInfo': {'id': 'EA1/104/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'art therapy', 'description': '12 sessions of art therapy / 6 weeks', 'interventionNames': ['Behavioral: psychodynamic art therapy']}, {'type': 'NO_INTERVENTION', 'label': 'TAU', 'description': 'treatment as usual / 6 weeks'}], 'interventions': [{'name': 'psychodynamic art therapy', 'type': 'BEHAVIORAL', 'description': '2 sessions à 1.5 hrs /week, intervention duration 6 weeks', 'armGroupLabels': ['art therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10115', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Christiane Montag, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prof. K. Dannecker, Kunsttherapie Berlin Kunsthochschule Berlin-Weißensee', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christiane Montag MD', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}