- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02383095
Efficiency of Art-therapy in Psychotic Disorders
October 18, 2019 updated by: University Hospital, Strasbourg, France
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Strasbourg, France, 67091
- Service de psychiatrie, Hôpitaux Universitaires de Strasbourg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- schizophrenia according to DSM IV
Exclusion Criteria:
- addiction problem
- invalidating visual sensory problems
- neurological history
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Art-therapy
16 Art-therapy sessions
|
|
Active Comparator: Metacognitive therapy
16 Metacognitive therapy sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Response times between baseline and after 16 therapy sessions
Time Frame: Baseline and after 16 therapy sessions (up to 6 months)
|
Baseline and after 16 therapy sessions (up to 6 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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
|
Baseline and after 16 therapy sessions (up to 6 months)
|
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)
|
aseline and after 16 therapy sessions (up to 6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Anne GIERSCH, PhD, Hôpitaux Universitaires de Strasbourg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 27, 2015
Primary Completion (Actual)
October 1, 2019
Study Completion (Actual)
October 1, 2019
Study Registration Dates
First Submitted
January 26, 2015
First Submitted That Met QC Criteria
March 3, 2015
First Posted (Estimate)
March 9, 2015
Study Record Updates
Last Update Posted (Actual)
October 21, 2019
Last Update Submitted That Met QC Criteria
October 18, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5937
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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