Art Therapy for Symptom Reduction in Acute Schizophrenia - a Randomised Controlled Trial (Kunsttherapie Zur Symptomreduktion Bei Akuter Schizophrenie - Eine Randomisierte Kontrollierte Pilotstudie)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in Positive and Negative Syndrome Scale (PANSS-) scores
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
art therapy
12 sessions of art therapy / 6 weeks
Intervention: psychodynamic art therapy (Behavioral)
TAU
treatment as usual / 6 weeks
Outcomes
Primary Outcomes
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
safety measures
Time Frame: weeks 0, 6, 12
number of participants with adverse events
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Christiane Montag MD
Principal Investigator
Charite University, Berlin, Germany