NCT02823041

Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Schizophreniform Disorder
• Schizoaffective Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Training	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.
BEHAVIORAL	Aerobic Exercise	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.
BEHAVIORAL	Case management and supportive psychotherapy	An individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient
BEHAVIORAL	Individual Placement and Support	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.

Timeline

• Start date: 2016-10-13
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2016-07-06
• Last updated: 2023-11-27

Locations

1 site across 1 country: United States