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Art Therapy in Acute Schizophrenia (KUSS)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
psychodynamic art therapy
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

art therapy

TAU

Arm Description

12 sessions of art therapy / 6 weeks

treatment as usual / 6 weeks

Outcomes

Primary Outcome Measures

Change in Positive and Negative Syndrome Scale (PANSS-) scores
assessment of change of schizophrenic positive, negative and general symptom scores
safety measures
number of participants with adverse events
Change in Calgary depression Scale (CDS-) scores
assessment of change of depressive symptoms in schizophrenic patients as reflected by CDS-scores

Secondary Outcome Measures

Full Information

First Posted
June 12, 2012
Last Updated
October 22, 2014
Sponsor
Charite University, Berlin, Germany
Collaborators
Prof. K. Dannecker, Kunsttherapie Berlin Kunsthochschule Berlin-Weißensee
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1. Study Identification

Unique Protocol Identification Number
NCT01622166
Brief Title
Art Therapy in Acute Schizophrenia
Acronym
KUSS
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 Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Prof. K. Dannecker, Kunsttherapie Berlin Kunsthochschule Berlin-Weißensee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
art therapy
Arm Type
Experimental
Arm Description
12 sessions of art therapy / 6 weeks
Arm Title
TAU
Arm Type
No Intervention
Arm Description
treatment as usual / 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
psychodynamic art therapy
Intervention Description
2 sessions à 1.5 hrs /week, intervention duration 6 weeks
Primary Outcome Measure Information:
Title
Change in Positive and Negative Syndrome Scale (PANSS-) scores
Description
assessment of change of schizophrenic positive, negative and general symptom scores
Time Frame
weeks 0, 6, 12
Title
safety measures
Description
number of participants with adverse events
Time Frame
weeks 0, 6, 12
Title
Change in Calgary depression Scale (CDS-) scores
Description
assessment of change of depressive symptoms in schizophrenic patients as reflected by CDS-scores
Time Frame
weeks 0, 6, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christiane Montag, M.D.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus
City
Berlin
ZIP/Postal Code
10115
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25393414
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.
Results Reference
derived
Links:
URL
http://www.kunsttherapie-berlin.de/
Description
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Art Therapy in Acute Schizophrenia

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