Brain Effects of Memory Training in Early Psychosis
Primary Purpose
Psychotic Disorders
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Peak app for memory training
Non-memory training group
Sponsored by
About this trial
This is an interventional treatment trial for Psychotic Disorders
Eligibility Criteria
Inclusion Criteria:
- Male or female and between the ages of 18 and 40
- Able to understand and sign an informed consent document in English.
- Meet diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or psychosis not otherwise specified.
Exclusion Criteria:
- Impaired intellectual functioning (full-scale IQ<70).
- Past or current history of a clinically significant central nervous system disorder that may contribute to psychotic symptoms or confound their assessment.
- Current severe substance use disorder.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Memory training group
Non-memory training group
Arm Description
The intervention is self-administration of 4 hours of memory training over 4 days per week, for 3 weeks (12 hours total). Memory training will be done with the Peak app for memory training http://www.peak.net.
The intervention is self-administration of 4 hours of training of games that do not involve memory such as language and card games over 4 days per week, for 3 weeks (12 hours total).
Outcomes
Primary Outcome Measures
Change in functional Magnetic Resonance Imaging blood oxygen-dependent signal during working memory task performance before and after a 12 hour memory training intervention in people with early psychosis
Change in diffusion tensor imaging measured change in fractional anisotropy during working memory task performance before and after a 12 hour memory training intervention in people with early psychosis
Secondary Outcome Measures
Full Information
NCT ID
NCT02584114
First Posted
October 15, 2015
Last Updated
August 6, 2021
Sponsor
University of Calgary
Collaborators
Brain & Behavior Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02584114
Brief Title
Brain Effects of Memory Training in Early Psychosis
Official Title
Brain Effects of Memory Training in Early Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Study Start Date
September 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Brain & Behavior Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: People with psychosis show profound deficits in memory. A new cognitive remediation therapy using an app on a computer or mobile phone to improve memory has been effective in this population, but the neurobiological effects are unknown.
Objectives: 1) To use functional magnetic resonance imaging (fMRI) to examine brain changes during a working memory task before and after a 12 hour memory training intervention on a computer or mobile phone, 2) To use diffusion tensor imaging (DTI) to examine white matter connecting prefrontal and parietal lobe before and after training.
Methods: 46 people with psychosis will be randomized to a computerized training of either memory training or a control condition of non-memory games (language/card games) and will self-administer 4 hours of training over 4 days per week, for 3 weeks (12 hours total). Memory training will be done with the Peak app http://www.peak.net. Imaging data will be gathered with a 3 Tesla scanner pre and post training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Memory training group
Arm Type
Experimental
Arm Description
The intervention is self-administration of 4 hours of memory training over 4 days per week, for 3 weeks (12 hours total). Memory training will be done with the Peak app for memory training http://www.peak.net.
Arm Title
Non-memory training group
Arm Type
Active Comparator
Arm Description
The intervention is self-administration of 4 hours of training of games that do not involve memory such as language and card games over 4 days per week, for 3 weeks (12 hours total).
Intervention Type
Behavioral
Intervention Name(s)
Peak app for memory training
Intervention Type
Behavioral
Intervention Name(s)
Non-memory training group
Primary Outcome Measure Information:
Title
Change in functional Magnetic Resonance Imaging blood oxygen-dependent signal during working memory task performance before and after a 12 hour memory training intervention in people with early psychosis
Time Frame
5 weeks
Title
Change in diffusion tensor imaging measured change in fractional anisotropy during working memory task performance before and after a 12 hour memory training intervention in people with early psychosis
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female and between the ages of 18 and 40
Able to understand and sign an informed consent document in English.
Meet diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or psychosis not otherwise specified.
Exclusion Criteria:
Impaired intellectual functioning (full-scale IQ<70).
Past or current history of a clinically significant central nervous system disorder that may contribute to psychotic symptoms or confound their assessment.
Current severe substance use disorder.
12. IPD Sharing Statement
Learn more about this trial
Brain Effects of Memory Training in Early Psychosis
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