Brain Effects of Memory Training in Early Psychosis

Not Applicable

Terminated

• Conditions: Psychotic Disorders
• Interventions: Behavioral: Peak app for memory training; Behavioral: Non-memory training group

• Registration Number: NCT02584114
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-22
• Study Start: 2016-09
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Male or female and between the ages of 18 and 40
2. Able to understand and sign an informed consent document in English.
3. Meet diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or psychosis not otherwise specified.

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Exclusion Criteria

1. Impaired intellectual functioning (full-scale IQ<70).
2. Past or current history of a clinically significant central nervous system disorder that may contribute to psychotic symptoms or confound their assessment.
3. Current severe substance use disorder.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Memory training group	Peak app for memory training	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.
Non-memory training group	Non-memory training group	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).

Primary Outcome Measures

Name	Time	Method
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	5 weeks
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	5 weeks