Brain Effects of Memory Training in Early Psychosis

NCT02584114 | Terminated

• 1 other identifier: REB15_2463
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Memory training group

EXPERIMENTAL

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.

Behavioral: Peak app for memory training

Non-memory training group

ACTIVE COMPARATOR

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).

Behavioral: Non-memory training group

Interventions

Peak app for memory training BEHAVIORAL

Memory training group

Non-memory training group BEHAVIORAL

Non-memory training group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Brain & Behavior Research Foundation: collaborator

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 22, 2015
• Study Start: September 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 13, 2021

Record last verified: 2021-08