Clinical trial NCT01973270: Community-Based Cognitive Training in Early Schizophrenia
Official title: Community-Based Cognitive Training in Early Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Psychosis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Neurocognition
timeFrame: Baseline, Post-Training, 6 month Follow-up
measure: Functioning
timeFrame: Baseline, Post-Training, 6 Month Follow-up
measure: Auditory Processing Speed
timeFrame: Baseline, 10 hours of training
measure: Reward Sensitivity
timeFrame: Baseline
Secondary outcomes:
measure: Functional Capacity
timeFrame: Baseline, Post-Training, 6 Month Follow-up
measure: Social Functioning
timeFrame: Baseline, Post-Training, 6 Month Follow-up
measure: Internalized Stigma
timeFrame: Baseline, Post-Training, 6 Month Follow-up
Other outcomes:
measure: Feasibility and Acceptability
timeFrame: Post-Training (6 weeks)
Locations:
city: San Francisco
country: United States
facility: Prevention and Recovery in Early Psychosis (PREP) Program
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sophia Vinogradov, MD
role: PRINCIPAL_INVESTIGATOR
References: