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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
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

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.

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

    First Posted
    October 15, 2015
    Last Updated
    August 6, 2021
    Sponsor
    University of Calgary
    Collaborators
    Brain & Behavior Research Foundation
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    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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