Art Therapy in Acute Schizophrenia (KUSS)

October 22, 2014 updated by: Christiane Montag MD, Charite University, Berlin, Germany

Art Therapy for Symptom Reduction in Acute Schizophrenia - a Randomised Controlled Trial (Kunsttherapie Zur Symptomreduktion Bei Akuter Schizophrenie - Eine Randomisierte Kontrollierte Pilotstudie)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10115
        • Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
weeks 0, 6, 12
safety measures
Time Frame: weeks 0, 6, 12
number of participants with adverse events
weeks 0, 6, 12
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
weeks 0, 6, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Prof. K. Dannecker, Kunsttherapie Berlin Kunsthochschule Berlin-Weißensee

Investigators

  • Principal Investigator: Christiane Montag, M.D., Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 14, 2012

First Posted (ESTIMATE)

June 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 24, 2014

Last Update Submitted That Met QC Criteria

October 22, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA1/104/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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