Community-Based Cognitive Training in Early Schizophrenia

Study Overview
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Brief Summary
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The purpose of this study is to determine whether cognitive training exercises can improve cognitive functioning in young patients with recent-onset schizophrenia, schizoaffective, schizophreniform, and psychosis NOS who are being treated in community mental health settings. We will investigate the effects of web-based cognitive training exercises delivered on a portable laptop computer. The findings will provide us with valuable information on whether cognitive training can improve the cognition and functioning of young individuals early in the course of schizophrenia.

Detailed Description
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The purpose of this study is to perform a double-blind randomized controlled trial (RCT) in young patients with recent-onset (RO) schizophrenia to target improvement in cognitive functioning within real-world treatment settings. This multi-site study will be performed in 4 community mental health centers with specialized Early Intervention Services (EIS). We will compare the effects of web-based targeted cognitive training (TCT) vs. web-based general cognitive exercises (GCE), both delivered via portable laptop computers. We will investigate the behavioral and functional changes seen immediately after the intervention as well as at 6-month follow-up, compared to a no-training control group (NTC). This will be the first study to investigate cognitive enhancement for young RO schizophrenia patients in community mental health settings, using scalable interactive neurotechnology, and the first to compare two distinct cognitive training approaches. This study will generate high impact data on the potential for targeted pre-emotion of the downward spiral of in cognitive and functional disability that often characterizes psychotic illness. It will also generate valuable data on the relative effects of two distinct cognitive training approaches in schizophrenia, each derived from a very different theoretical rationale, providing much-needed information on the efficacy of a targeted distributed neural system training model derived from systems neuroscience vs. a general cognitive stimulation training model derived from neuropsychological rehabilitation approaches. The aims of this project are based on the current state of early psychosis research, as well as our own experience successfully applying neuroscience-informed cognitive training in schizophrenia. It is now abundantly clear that cognitive/neural system dysfunction represents a significant risk factor for schizophrenia as well as a poor prognostic indicator. Functional outcome in RO schizophrenia is predicted by level of cognitive impairment and baseline cognitive reserve, and recent findings suggest that specialized EIS programs focusing only on symptom reduction and psychosocial support may not robustly improve long-term outcomes- indicating that critical treatment targets are not being addressed at present in early psychosis interventions. Cognitive dysfunction and underlying neural system inefficiency should therefore be one of the primary targets for pre-emptive intervention in early psychosis. In this study, we will determine whether we can achieve this goal using cognitive training delivered via a portable computer, in order to improve functional outcome in young individuals with RO schizophrenia.

Official Title
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Community-Based Cognitive Training in Early Schizophrenia

Conditions
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Schizophrenia, Psychosis

Intervention / Treatment
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* Behavioral: Neuroadaptive cognitive training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of schizophrenia, schizoaffective disorder, psychosis Not Otherwise Specified (NOS), Unspecified Schizophrenia Spectrum Disorder, Schizophrenia Spectrum Disorder, Specified, or schizophreniform disorder with onset of first psychotic episode within the last 2 years. Good general physical health Between 18 and 35 years of age Is fluent and proficient in the English language Currently enrolled in PREP/BEAM services Achieved clinical stability (e.g., outpatient status for at least 1 month before study entry) Exclusion Criteria: Any neurological disorder If clinically significant substance abuse occurs that is impeding the subject's ability to participate fully during recruitment, assessment, or training, the subject will be dropped from the study. Being treated with benztropine, diphenhydramine, or high doses of clozapine (>500 mg po qd) or olanzapine(to be determined on a case by case basis)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeted Cognitive Training - TCT<br>Neuroadaptive cognitive training | Behavioral: Neuroadaptive cognitive training<br>* TCT exercises consist of three modules: an Auditory Processing Module (40-50 hours of training); a Visual Processing Module (30 hours); a Cognitive Control Module prototype (20 hours). [Based on the results of our current RCT, Posit Science has revised aspects of the training modules in order to further optimize its effectiveness for treatment of schizophrenia. In this study, we will use updated versions of the training software: an Auditory Module (20 hours), and a Social Module (10 hours). Features from the Cognitive Control module prototype have been expanded and incorporated into these new modules.<br>|
| Experimental: General Cognitive Exercises (GCE)<br>Neuroadaptive cognitive training | Behavioral: Neuroadaptive cognitive training<br>* TCT exercises consist of three modules: an Auditory Processing Module (40-50 hours of training); a Visual Processing Module (30 hours); a Cognitive Control Module prototype (20 hours). [Based on the results of our current RCT, Posit Science has revised aspects of the training modules in order to further optimize its effectiveness for treatment of schizophrenia. In this study, we will use updated versions of the training software: an Auditory Module (20 hours), and a Social Module (10 hours). Features from the Cognitive Control module prototype have been expanded and incorporated into these new modules.<br>|
| No Intervention: Treatment as Usual<br>Treatment as Usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognition | Neurocognition will be assessed using the MATRICS Consensus Cognitive Battery [MCCB]. The MCCB assesses the following domains of neurocognitive functioning: 1) Speed of Processing, 2) Attention/Vigilance, 3) Working Memory, 4) Verbal Learning, 5) Visual Learning, 6) Reasoning and Problem Solving; and 7) Social Cognition. We will also assess Verbal Memory (HVLT delayed recall), Visual Memory (BVMT delayed recall), and administer an additional measure of Reasoning and Problem Solving [BACS Tower of London]. In addition to the MCCB measure of social cognition, we will assess the following constructs: affect recognition, emotional prosody [Penn Prosody Identification, and theory of mind [Faux Pas test.7 hours spread over 3 appointments in a 1-2 week period, 5 hours post-training and an additional 5 hours at a 6-month follow-up. | Baseline, Post-Training, 6 month Follow-up | 
| Functioning | The Quality of Life Scale-Abbreviated will be our primary outcome measure of functional status. This measure assesses quality of life using subjective questions regarding life satisfaction and objective indicators of social and occupational functioning. | Baseline, Post-Training, 6 Month Follow-up | 
| Auditory Processing Speed | Early target engagement is the degree to which an individual demonstrates initial performance improvement (learning) upon exposure to training. Early target engagement will be measured by auditory processing speed during cognitive training exercises. | Baseline, 10 hours of training | 
| Reward Sensitivity | The Temporal Experience of Pleasure Scale (TEPS) will be used to assess reward sensitivity. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Capacity | Secondary measures of functional capacity/status will include the following MATRICS-recommended measure: The UCSD Performance Based Skills Assessment [UPSA-Brief]. | Baseline, Post-Training, 6 Month Follow-up | 
| Social Functioning | Secondary measures of social functioning will include: The Social Functioning Scale. | Baseline, Post-Training, 6 Month Follow-up | 
| Internalized Stigma | In order to measure internalized stigma, a component of recovery, we will use the Internalized Stigma of Mental Illness (ISMI) Scale. | Baseline, Post-Training, 6 Month Follow-up |