Neuroplasticity-oriented Cognitive Intervention in Early Onset and First Admission Schizophrenia
Primary Purpose
Psychosis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Brain Fitness Training, Posit Science SF
Sponsored by
About this trial
This is an interventional prevention trial for Psychosis focused on measuring Brain Oscillations, Cognitive Performance
Eligibility Criteria
Inclusion Criteria:
- Early Onset Psychosis
Exclusion Criteria:
- Chronicity
- Insufficient German skills
Sites / Locations
- University Konstanz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive Training
Arm Description
Brain Fitness Training, Posit Science SF
Outcomes
Primary Outcome Measures
change from baseline at post-training and at 3-months and at 7-months follow-up in each of the following outcome measures: neuropsychological test performance (MCCCB), GAF, PANSS, MEG event-related potentials (M50), alpha activity
Secondary Outcome Measures
change from baseline in GAF score at 3-months and 7-moths follow-up
Full Information
NCT ID
NCT01781364
First Posted
January 22, 2013
Last Updated
December 15, 2014
Sponsor
University of Konstanz
1. Study Identification
Unique Protocol Identification Number
NCT01781364
Brief Title
Neuroplasticity-oriented Cognitive Intervention in Early Onset and First Admission Schizophrenia
Official Title
Neuroplasticity-oriented Cognitive Intervention in Early Onset and First Admission Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to reveal the specific effects of computer-aided cognitive training on course and rehabilitation in early onset schizophrenia
Detailed Description
Impairment in cognitive functions is one of the main symptoms in schizophrenia and is currently one of the challenges in the treatment of the disease. We examine the beneficial effect of computer-aided training program on course and rehabilitation of young psychotic patients with early onset psychosis. In addition we develop predictors for the course of disorder from neuroimaging data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
Brain Oscillations, Cognitive Performance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Training
Arm Type
Experimental
Arm Description
Brain Fitness Training, Posit Science SF
Intervention Type
Behavioral
Intervention Name(s)
Brain Fitness Training, Posit Science SF
Intervention Description
Computer aided cognitive training based on principles of neuroplasticity
Primary Outcome Measure Information:
Title
change from baseline at post-training and at 3-months and at 7-months follow-up in each of the following outcome measures: neuropsychological test performance (MCCCB), GAF, PANSS, MEG event-related potentials (M50), alpha activity
Time Frame
baseline, post-training (training duration 4 weeks), 3-month follow-up, 7-month follow-up
Secondary Outcome Measure Information:
Title
change from baseline in GAF score at 3-months and 7-moths follow-up
Time Frame
baseline, 3-months follow-up, 7-months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Early Onset Psychosis
Exclusion Criteria:
Chronicity
Insufficient German skills
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte S Rockstroh, Prof. Dr.
Organizational Affiliation
University of Konstanz
Official's Role
Study Director
Facility Information:
Facility Name
University Konstanz
City
Konstanz
State/Province
Baden Wuerttemberg
ZIP/Postal Code
78464
Country
Germany
12. IPD Sharing Statement
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Neuroplasticity-oriented Cognitive Intervention in Early Onset and First Admission Schizophrenia
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