Minnesota Community-Based Cognitive Training in Early Psychosis
Condition: Schizophrenia; Psychosis; Schizoaffective Disorder; Schizophreniform Disorders; Psychosis NOS; Depression Psychotic Feature; Bipolar Disorder With Psychotic Features; Unspecified Psychosis
MeSH terms: Schizophrenia; Bipolar Disorder; Psychotic Disorders; Mental Disorders
Study type: Interventional

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.
    

Intervention name(s): Targeted Cognitive Training; General Cognitive Exercises; Coordinated Specialty Care for First Episode Psychosis
Intervention type(s): Device; Device; Other
Intervention description(s): 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.
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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Training; First Episode Psychosis; Recent Onset Psychosis