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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.
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.
Age
18 - 45 years
Sex
ALL
Healthy Volunteers
No
University of California, Los Angeles
Los Angeles, California, United States
Start Date
October 13, 2016
Primary Completion Date
June 30, 2023
Completion Date
June 30, 2023
Last Updated
November 27, 2023
100
ESTIMATED participants
Cognitive Training
BEHAVIORAL
Aerobic Exercise
BEHAVIORAL
Case management and supportive psychotherapy
BEHAVIORAL
Individual Placement and Support
BEHAVIORAL
Lead Sponsor
University of California, Los Angeles
NCT07455929
NCT06740383
Data Source & Attribution
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