Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode

NCT02823041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-11-27

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02823041 on ClinicalTrials.gov