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Efficiency of Art-therapy in Psychotic Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02383095
Recruitment Status : Terminated (Difficulties of recruitment)
First Posted : March 9, 2015
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date  ICMJE January 26, 2015
First Posted Date  ICMJE March 9, 2015
Last Update Posted Date October 21, 2019
Actual Study Start Date  ICMJE May 27, 2015
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
Change in Response times between baseline and after 16 therapy sessions [ Time Frame: Baseline and after 16 therapy sessions (up to 6 months) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
  • Change in Clinical scales (SAPS and SANS) between baseline and after 16 therapy sessions [ Time Frame: Baseline and after 16 therapy sessions (up to 6 months) ]
  • Change in esthetic perception between baseline and after 16 therapy sessions [ Time Frame: Baseline and after 16 therapy sessions (up to 6 months) ]
    Esthetic Perception Test
  • Change in errors in visual organization tasks between baseline and after 16 therapy sessions [ Time Frame: aseline and after 16 therapy sessions (up to 6 months) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficiency of Art-therapy in Psychotic Disorders
Official Title  ICMJE Efficiency of Art-therapy in Psychotic Disorders
Brief Summary The main purpose of the protocol is to test the efficiency of art-therapy versus metacognitive rehabilitation on the visual perception disorders observed in patients with schizophrenia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Behavioral: Art therapy
  • Behavioral: metacognitive therapy
Study Arms  ICMJE
  • Experimental: Art-therapy
    16 Art-therapy sessions
    Intervention: Behavioral: Art therapy
  • Active Comparator: Metacognitive therapy
    16 Metacognitive therapy sessions
    Intervention: Behavioral: metacognitive therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 18, 2019)
9
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2015)
40
Actual Study Completion Date  ICMJE October 2019
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • schizophrenia according to DSM IV

Exclusion Criteria:

  • addiction problem
  • invalidating visual sensory problems
  • neurological history
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02383095
Other Study ID Numbers  ICMJE 5937
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Strasbourg, France
Study Sponsor  ICMJE University Hospital, Strasbourg, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne GIERSCH, PhD Hôpitaux Universitaires de Strasbourg
PRS Account University Hospital, Strasbourg, France
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP