Brain Effects of Memory Training in Early Psychosis

Psychotic Disorders Clinical Trial

Official title:

Brain Effects of Memory Training in Early Psychosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02584114
• Other study ID #: REB15_2463
• Status: Terminated
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 2017

Study information

• Verified date: August 2021
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• Peak app for memory training

• Non-memory training group

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Brain & Behavior Research Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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