University of California, Los Angeles
Los Angeles, California, 90095-6968, United States
NCT Number: NCT02267070
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.
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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 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient
All immediate family members will be invited to family psychoeducation sessions.
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. 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.
Other names: cognitive remediation
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.
Other names: physical exercise
Time frame: 6 months
The overall composite score from the MCCB is a summary of cognitive performance across seven domains.
Time frame: 6 months
BDNF is a principal growth factor known to mediate the effects of exercise in the brain.
Time frame: 6 months
Cardiorespiratory fitness, a secondary physical health outcome variable, will be measured using a ramped version of the traditional Bruce treadmill protocol.
Time frame: 6 months
The UCSD Performance-Based Skills Assessment (UPSA)assesses five all-purpose skills that are important for functioning in the community: general organization, finance, social/communications, transportation, and household chores.
Time frame: 6 months
The Facial Emotion Identification Test involves choice of emotions in facial expressions of 6 different emotions (happy, sad, angry, afraid, surprised, disgusted) plus neutral expressions.
Time frame: 6 months
The Prosody Task involves identifying emotions in audio recordings of male and female actors portraying 5 emotions.
Time frame: 6 months
A 10-point rating scale to evaluate role and social functioning
Time frame: 6 months
A measure of the quantity and type of work at a job, school, or in the home
Time frame: 6 months
The Independent Living Skills Survey is a 76-item measure based on patient interview, which provides a more detailed assessment of 11 daily living skill domains
Time frame: 6 months
The Quality of Life scale135, a 53-item interview-based inventory, assesses a patient's subjective satisfaction in several key domains
Time frame: 6 months
The Role Functioning Scale is a global clinician-rated measure of everyday functioning in several domains.
Time frame: 6 months
The Independent Living rating assesses daily living skills and extent of living independently based on a clinician interview.
University of California, Los Angeles
Other
Acronym: CT&E
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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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