Minnesota Community-Based Cognitive Training in Early Psychosis

NCT ID: NCT03079024

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-19
• Study Completion Date: 2022-03-26

Brief 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.

Detailed Description

The purpose of this study is to perform a double-blind randomized controlled trial (RCT) in young patients with First Episode Psychosis (FEP) to target improvement in cognitive functioning within real-world treatment settings. This study will be performed in the University of Minnesota Department of Psychiatry; patients will be recruited from local community based mental health care settings that implement a NAVIGATE model for FEP.

All participants will undergo baseline assessment in measures of clinical, neurocognitive, and functional status prior to randomization. Participants will be equally randomized to one of three groups: Targeted Cognitive Training (TCT); General Cognitive Exercises (GCE); or Treatment as Usual (TAU). Participants assigned to a cognitive training group will be loaned an iPad to complete study training at home. They will complete 60 minutes of training 5 times a week over the course of 6 weeks for a total of 30 hours of training. Participants will be allowed up to 12 weeks to complete the full 30 hours. Participants will return after 30 hours of training or 12 weeks, whichever comes first, for Post-Intervention Assessments. Then participants will enter a no-contact follow up period, until it is time for their 6 Month Follow Up assessment.

Specific Aims:

1. Perform a double-blind RCT of web-based, portable computerized cognitive training in young individuals with recent onset psychosis receiving treatment within the University of Minnesota, Department of Psychiatry's First Episode Psychosis Program or other state clinics utilizing the NAVIGATE treatment model.

2. Compare the clinical and cognitive effects of neural system-informed TCT that focuses explicitly and specifically on distributed neural system efficiency in auditory/verbal and social cognitive domains, vs. more non-specific GCE designed to enhance executive functioning and problem-solving, vs. TAU. Determine the durability of these effects and their relationship to functional outcome over a 6 month period.

3. As a secondary aim, investigate the feasibility, tolerability, and acceptability of the intervention by service providers, clients, and caregivers in these real-world treatment centers.

Hypotheses to be tested:

1. TCT subjects will show significantly greater gains in general cognition, verbal learning/memory, and social cognition compared to GCE and TAU subjects. These gains in the TCT group will be sustained at 6-month follow-up.

2. GCE subjects will show improvement in problem-solving and global cognition compared to TAU subjects. At 6 month follow-up, GCE subjects will show lower gains in global cognition and verbal learning/memory than TCT subjects.

3. Gains in general cognition and processing speed, and in social cognition in TCT subjects will correlate with improvements on 6-month measures of occupational and social functioning, respectively, as well as internalized stigma. These associations will be significantly greater in TCT subjects vs. GCE or TAU subjects.

4. Symptom ratings will show improvement in all subject groups at 6 months, with no significant between-group differences.

5. At least 70% of randomized clients will complete >20 hours of training in the TCT and GCE arms.

6. Participants and clinicians will rate the TCT and GCE interventions as equally feasible, tolerable, and acceptable.

Participants from this study will also be recruited to participate in an adjunct protocol conducted by Dr. Sophia Vinogradov, titled "Is cognitive training neuroprotective in early psychosis?" NCT03049800.

Data from this project will be analysed with a sister protocol conducted by Dr. Rachel Loewy at the University of California San Francisco, titled "Community-Based Cognitive Training in Early Schizophrenia (COTES)," NCT01973270.

Conditions

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

Study Design

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

Study Groups

Targeted Cognitive Training (TCT)

Neuroadaptive Cognitive Training

Group Type: EXPERIMENTAL

Targeted Cognitive Training

Intervention Type: DEVICE

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.

Coordinated Specialty Care for First Episode Psychosis

Intervention Type: OTHER

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.

General Cognitive Exercises (GCE)

Neuroadaptive cognitive training

Group Type: EXPERIMENTAL

General Cognitive Exercises

Intervention Type: DEVICE

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.

Coordinated Specialty Care for First Episode Psychosis

Intervention Type: OTHER

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.

Treatment as Usual (TAU)

Treatment as Usual

Group Type: ACTIVE_COMPARATOR

Coordinated Specialty Care for First Episode Psychosis

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder with psychotic features, bipolar disorder with psychotic features, psychosis disorder not otherwise specified, or unspecified schizophrenia spectrum disorder, and started receiving treatment services at a First Episode Psychosis Program within the last two years
• Good general physical health
• Aged between 16 and 35 years (inclusive)
• Fluent in spoken and written English
• No neurological disorder (diagnosis of Autism Spectrum Disorder is allowed)
• Achieved clinical stability, defined as outpatient status for at least one month prior to study participation, stable doses of psychiatric medications for at least one month prior to study participation
• Women who are pregnant or breastfeeding may participate in this study.

Exclusion Criteria

• Unable to provide informed consent
• Participated in significant cognitive training programs within the last three years
• Clinically significant substance abuse that is impeding the subject's ability to participate fully during recruitment, assessment, or training (is unable to remain sober for assessments and training).
• Prescribed >0.5mg daily benztropine (Congentin), >25mg daily diphenhydramine, or high doses of clozapine (>500 mg po qd) or olanzapine (to be determined on a case by case basis).
• Active suicidal ideation at screening or baseline, or previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 6 months, as indicated by the C-SSRS

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophia Vinogradov, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota Department of Psychiatry

Locations

University of Minnesota, Dept of Psychiatry

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PSYCH-2017-25503

Identifier Type: -

Identifier Source: org_study_id