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Clinical Trials/NCT02267070
NCT02267070
Completed
N/A

Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode

University of California, Los Angeles1 site in 1 country48 target enrollmentNovember 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
University of California, Los Angeles
Enrollment
48
Locations
1
Primary Endpoint
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This is a randomized controlled 6-month trial of the efficacy of a novel intervention combining neuroplasticity-based cognitive training with aerobic exercise, compared to the same systematic cognitive training alone. The primary treatment targets are overall cognitive deficit level and independent living skills. The investigators hypothesize that combining neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical exercise will produce large cognitive and functional improvements, even relative to cognitive training alone. Adding aerobic exercise to a cognitive training program will have the additional benefit of helping to ameliorate medication side effects, reduce the risk for developing metabolic syndrome, and help to prevent the deterioration in physical health that usually follows the onset of schizophrenia and its pharmacologic treatment. The investigators target the period shortly after a first episode of schizophrenia to maximize the generalization of cognitive improvement to functional outcome, before chronic disability is established.

Detailed Description

The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The second 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. Aerobic exercise occurs as two 30-minute sessions at the clinic and two at home weekly. Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder. A weekly one-hour Bridging Skills Group with other members of the treatment condition is designed to aid generalization of training to everyday life situations.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
July 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Keith Nuechterlein, Ph.D.

Professor in Residence

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

  • a first episode of a psychotic illness that began within the past two years;
  • a diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia, schizoaffective disorder, mainly depressed type, or schizophreniform disorder;
  • between 18 and 45 years of age;
  • sufficient acculturation and fluency in the English language to avoid invalidating research measures of thought, language, and speech disorder or of verbal cognitive abilities; and
  • residence within commuting distance of the Aftercare Research Program at the University of California, Los Angeles.

Exclusion Criteria

  • evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
  • evidence of alcohol or substance use disorder within the six months prior to the first episode and evidence that substance abuse triggered the psychotic episode or makes the schizophrenia diagnosis ambiguous;
  • mental retardation, i.e. premorbid intelligence quotient less than 70.

Outcomes

Primary Outcomes

Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score

Time Frame: 6 months

The overall composite score from the MCCB is a summary of cognitive performance across seven domains.

Secondary Outcomes

  • Brain-derived neurotrophic factor (BDNF)(6 months)
  • Independent Living Skills Survey(6 months)
  • Prosody Task(6 months)
  • Global Functioning Scale(6 months)
  • Quality of Life Scale(6 months)
  • Independent Living rating from Role Functioning Scale(6 months)
  • Cardiorespiratory fitness(6 months)
  • University of California, San Diego (UCSD) Performance-Based Skills Assessment (UPSA)(6 months)
  • Facial Emotion Identification Test(6 months)
  • Modified Social Adjustment Scale - Work Outcome(6 months)
  • Role Functioning Scale: Work Productivity, Social Relationships, Family Relationships(6 months)

Study Sites (1)

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