NCT01622166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

1.4 years

First QC Date

June 12, 2012

Last Update Submit

October 22, 2014

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Positive and Negative Syndrome Scale (PANSS-) scores

    assessment of change of schizophrenic positive, negative and general symptom scores

    weeks 0, 6, 12

  • safety measures

    number of participants with adverse events

    weeks 0, 6, 12

  • 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

Study Arms (2)

art therapy

EXPERIMENTAL

12 sessions of art therapy / 6 weeks

Behavioral: psychodynamic art therapy

TAU

NO INTERVENTION

treatment as usual / 6 weeks

Interventions

2 sessions à 1.5 hrs /week, intervention duration 6 weeks

art therapy

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus

Berlin, 10115, Germany

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Christiane Montag, M.D.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 19, 2012

Study Start

August 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

October 24, 2014

Record last verified: 2014-10

Locations