Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode

University of California, Los Angeles1 site in 1 country100 target enrollmentOctober 13, 2016

ConditionsSchizophrenia Schizophreniform Disorder Schizoaffective Disorder

Overview

Phase: N/A
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: University of California, Los Angeles
Enrollment: 100
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: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a confirmatory randomized controlled trial of the efficacy of a novel intervention combining neuroplasticity-based cognitive training with aerobic exercise, compared to the same systematic cognitive training alone. Treatment occurs for 6 months after randomization, with a followup assessment at 12 months. The investigators hypothesize that combining neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical exercise will produce neurotrophin increases and cognitive and functional improvements, even relative to cognitive training alone. 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 consists of 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, 150 minutes per week. The Cognitive Training Intervention includes the same systematic cognitive training. The first 12 weeks involve neurocognitive training, using 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 45-minute sessions at the clinic and two 30-minute sessions 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. The immediate target is brain-derived neurotrophic factor. The primary treatment outcomes are overall cognitive deficit level and global functioning level.

Registry

clinicaltrials.gov

Start Date

October 13, 2016

End Date

June 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of California, Los Angeles

Responsible Party

Principal Investigator

Keith Nuechterlein, Ph.D.

Principal Investigator

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 DSM-5 of schizophrenia, schizoaffective disorder, mainly depressed type, or schizophreniform disorder;
•sufficient acculturation and fluency in the English language to avoid invalidating research measures; and
•residence likely to be within commuting distance of the UCLA Aftercare Research Program.

Exclusion Criteria

•inability to participate in aerobic exercise;
•evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
•evidence of moderate or severe alcohol or substance use disorder within the six months prior to the first episode or evidence that substance abuse triggered the psychotic episode or makes the schizophrenia diagnosis ambiguous; or
•mental retardation, i.e. estimated premorbid IQ less than 70.