University of California, Los Angeles
Los Angeles, California, 90095-6968, United States
NCT Number: NCT02823041
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.
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Notify Me18 year–45 year
All sexes
Interventional
Not applicable
Los Angeles, California, 90095-6968, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
24 weeks of systematic computerized cognitive training, 4 hours per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The 2nd 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. A weekly one-hour Bridging Skills Group is designed to aid generalization of training to everyday life situations.
Other names: cognitive remediation
Aerobic exercise occurs as two 45-minute sessions at the clinic and two 30-minute sessions at home weekly. Exercise involves an adaptation of interval training, including a variety of calisthenics that can be done without specialized equipment. Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder.
Other names: physical exercise
An individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient
An job/school specialist will use the Individual Placement and Support model to help participants return to school or work and provide ongoing outreach support.
Other names: supported education/employment
Time frame: 6 months
The Overall Composite score from the MCCB is a summary of cognitive performance across seven domains.
Time frame: 6 months
A 10-point rating scale to evaluate role and social functioning
Time frame: 6 months
BDNF is a key neurochemical factor known to mediate the effects of exercise in the brain
Time frame: 6 months
Cardiorespiratory fitness and muscular endurance measured by the YMCA fitness test
Time frame: 6 months
A cardiovascular fitness measure derived from a treadmill test protocol
Time frame: 6 months
7-point ratings of Work Productivity, Independent Living, Social Relationships, Family Relationships
University of California, Los Angeles
Other
Acronym: CT&E-RCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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