Trials / Completed

CompletedNCT03079024

Minnesota Community-Based Cognitive Training in Early Psychosis

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 45 (actual)

Sponsor: University of Minnesota · Academic / Other
Sex: All
Age: 16 Years – 35 Years
Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

Start date: 2017-05-19
Primary completion: 2022-03-26
Completion: 2022-03-26
First posted: 2017-03-14
Last updated: 2025-01-23
Results posted: 2025-01-23

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT03079024. Inclusion in this directory is not an endorsement.