Minnesota Community-Based Cognitive Training in Early Psychosis

Summary

The purpose of this study is to determine whether cognitive training exercises can improve cognitive functioning in young patients with recent-onset psychosis who are being treated in community mental health settings using the NAVIGATE model. The investigators will examine the effects of web-based cognitive training exercises delivered on iPads. Participants will be randomized to one of three conditions, and will be assessed at Baseline, Post-Intervention, and 6 Month Follow Up on measures of clinical, neurocognitive, and functional status.

Conditions

• Schizophrenia
• Psychosis
• Schizoaffective Disorder
• Schizophreniform Disorders
• Psychosis NOS
• Depression Psychotic Feature
• Bipolar Disorder With Psychotic Features
• Unspecified Psychosis

Interventions

DEVICE

Targeted Cognitive Training

1. Auditory Training Module (20 hours): exercises designed to improve speed and accuracy of auditory processing while engaging working memory and cognitive control. Exercises adjust difficulty level to maintain an \~80% correct performance. Exercises contain stimuli spanning the acoustic organization of speech. In the initial stages, stimuli exaggerate the rapid temporal transitions by increasing amplitude and stretching in time. The exaggeration is gradually removed so that by the end, all stimuli have characteristics representative of real-world speech. 2. Social Cognition Module (10 hours): exercises designed to improve core deficits of social cognition in psychosis. Exercises apply principles of implicit learning to restore capacity to process and utilize socially-relevant information, and includes training to improve perception of affect (visual/vocal) and social cues (faces, gazes, social situations), theory of mind, self-referential style, emotion labeling and working memory.

DEVICE

General Cognitive Exercises

The GCE will focus on executive dysfunction, as this domain is a significant, functionally important area of deficit in schizophrenia and has been the target of many previous studies. We will train this domain using a suite of engaging, adaptive web-based exercises that target executive function, intelligence, and spatial navigation developed by Posit Science. The exercises will be provide engaging, adaptive training as described in the Targeted Cognitive Training.

OTHER

Coordinated Specialty Care for First Episode Psychosis

Individuals in this study are receiving care from a coordinated specialty care clinic (CSC) for first episode psychosis. These clinics are following the NAVIGATE treatment model for early psychosis.

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• University of Minnesota

  lead OTHER

Principal Investigators

• Sophia Vinogradov, MD · University of Minnesota Department of Psychiatry

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-19

Primary Completion

2022-03-26

Completion

2022-03-26

FDA Device

Yes

Countries

• United States

Study Locations