Brain Effects of Memory Training in Early Psychosis

NCT ID: NCT02584114

Last Updated: 2021-08-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-06-30

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.

Conditions

Psychotic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Memory training group

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.

Group Type: EXPERIMENTAL

Peak app for memory training

Intervention Type: BEHAVIORAL

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).

Group Type: ACTIVE_COMPARATOR

Non-memory training group

Intervention Type: BEHAVIORAL

Interventions

Peak app for memory training

Intervention Type: BEHAVIORAL

Non-memory training group

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brain & Behavior Research Foundation

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Lisa Buchy

Postdoctoral Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

REB15_2463

Identifier Type: -

Identifier Source: org_study_id