Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Art Therapy in Acute Schizophrenia (KUSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01622166
Recruitment Status : Completed
First Posted : June 19, 2012
Last Update Posted : October 24, 2014
Sponsor:
Collaborator:
Prof. K. Dannecker, Kunsttherapie Berlin Kunsthochschule Berlin-Weißensee
Information provided by (Responsible Party):
Christiane Montag MD, Charite University, Berlin, Germany

Brief Summary:

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.

*Main hypothesis: Art therapy has no impact on clinical symptoms and the course of remission compared to TAU.

*Exploratory hypotheses: Art therapy has no influence on quality of life, mentalizing function, self-efficacy and neuroleptic dosage compared to TAU.


Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: psychodynamic art therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Art Therapy for Symptom Reduction in Acute Schizophrenia - a Randomised Controlled Trial (Kunsttherapie Zur Symptomreduktion Bei Akuter Schizophrenie - Eine Randomisierte Kontrollierte Pilotstudie)
Study Start Date : August 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: art therapy
12 sessions of art therapy / 6 weeks
Behavioral: psychodynamic art therapy
2 sessions à 1.5 hrs /week, intervention duration 6 weeks

No Intervention: TAU
treatment as usual / 6 weeks



Primary Outcome Measures :
  1. Change in Positive and Negative Syndrome Scale (PANSS-) scores [ Time Frame: weeks 0, 6, 12 ]
    assessment of change of schizophrenic positive, negative and general symptom scores

  2. safety measures [ Time Frame: weeks 0, 6, 12 ]
    number of participants with adverse events

  3. Change in Calgary depression Scale (CDS-) scores [ Time Frame: weeks 0, 6, 12 ]
    assessment of change of depressive symptoms in schizophrenic patients as reflected by CDS-scores



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of schizophrenia according to DSM-IV-TR
  • age 18-64 yrs
  • sufficient German language competency
  • written informed consent

Exclusion Criteria:

  • axis-I mental disorders other than schizophrenia
  • comorbid antisocial personality disorder, relevant substance abuse,
  • relevant severe somatic disease
  • acute suicidal tendencies or aggression
  • incapability to tolerate group settings

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622166


Locations
Layout table for location information
Germany
Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus
Berlin, Germany, 10115
Sponsors and Collaborators
Charite University, Berlin, Germany
Prof. K. Dannecker, Kunsttherapie Berlin Kunsthochschule Berlin-Weißensee
Investigators
Layout table for investigator information
Principal Investigator: Christiane Montag, M.D. Charite University, Berlin, Germany

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Christiane Montag MD, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01622166     History of Changes
Other Study ID Numbers: EA1/104/11
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders