Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode
NCT02823041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2023-11-27
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.
Conditions
- Schizophrenia
- Schizophreniform Disorder
- Schizoaffective Disorder
Interventions
- 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.
Sponsors & Collaborators
-
University of California, Los Angeles
lead OTHER
Principal Investigators
-
Keith Nuechterlein, Ph.D. · UCLA Department of Psychiatry & Biobehavioral Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-13
- Primary Completion
- 2023-06-30
- Completion
- 2023-06-30
Countries
- United States
Study Locations
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