Art Therapy in Acute Schizophrenia

Schizophrenia Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622166
• Other study ID #: EA1/104/11
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: October 22, 2014
• Start date: August 2011
• Est. completion date: January 2013

Study information

• Verified date: October 2014
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• psychodynamic art therapy
2 sessions à 1.5 hrs /week, intervention duration 6 weeks

Locations

Country	Name	City	State
Germany	Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Prof. K. Dannecker, Kunsttherapie Berlin Kunsthochschule Berlin-Weißensee

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Positive and Negative Syndrome Scale (PANSS-) scores	assessment of change of schizophrenic positive, negative and general symptom scores	weeks 0, 6, 12	No
Primary	safety measures	number of participants with adverse events	weeks 0, 6, 12	Yes
Primary	Change in Calgary depression Scale (CDS-) scores	assessment of change of depressive symptoms in schizophrenic patients as reflected by CDS-scores	weeks 0, 6, 12	No

External Links

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