Back to resultsEfficiency of Art-therapy in Psychotic Disorders
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Art therapy
metacognitive therapy
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Art-therapy, Visual organization
Eligibility Criteria
Inclusion Criteria:
- schizophrenia according to DSM IV
Exclusion Criteria:
- addiction problem
- invalidating visual sensory problems
- neurological history
Sites / Locations
- Service de psychiatrie, Hôpitaux Universitaires de Strasbourg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Art-therapy
Metacognitive therapy
Arm Description
16 Art-therapy sessions
16 Metacognitive therapy sessions
Outcomes
Primary Outcome Measures
Change in Response times between baseline and after 16 therapy sessions
Secondary Outcome Measures
Change in Clinical scales (SAPS and SANS) between baseline and after 16 therapy sessions
Change in esthetic perception between baseline and after 16 therapy sessions
Esthetic Perception Test
Change in errors in visual organization tasks between baseline and after 16 therapy sessions
Full Information
NCT ID
NCT02383095
First Posted
January 26, 2015
Last Updated
October 18, 2019
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02383095
Brief Title
Efficiency of Art-therapy in Psychotic Disorders
Official Title
Efficiency of Art-therapy in Psychotic Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficulties of recruitment
Study Start Date
May 27, 2015 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Art-therapy, Visual organization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Art-therapy
Arm Type
Experimental
Arm Description
16 Art-therapy sessions
Arm Title
Metacognitive therapy
Arm Type
Active Comparator
Arm Description
16 Metacognitive therapy sessions
Intervention Type
Behavioral
Intervention Name(s)
Art therapy
Intervention Type
Behavioral
Intervention Name(s)
metacognitive therapy
Primary Outcome Measure Information:
Title
Change in Response times between baseline and after 16 therapy sessions
Time Frame
Baseline and after 16 therapy sessions (up to 6 months)
Secondary Outcome Measure Information:
Title
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)
Title
Change in esthetic perception between baseline and after 16 therapy sessions
Description
Esthetic Perception Test
Time Frame
Baseline and after 16 therapy sessions (up to 6 months)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
schizophrenia according to DSM IV
Exclusion Criteria:
addiction problem
invalidating visual sensory problems
neurological history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne GIERSCH, PhD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de psychiatrie, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficiency of Art-therapy in Psychotic Disorders
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