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Completed

NCT Number: NCT02823041

Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode

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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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90095-6968, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a first episode of a psychotic illness that began within the past two years;
  • a diagnosis by DSM-5 of schizophrenia, schizoaffective disorder, mainly depressed type, or schizophreniform disorder;
  • sufficient acculturation and fluency in the English language to avoid invalidating research measures; and
  • residence likely to be within commuting distance of the UCLA Aftercare Research Program.

Exclusion criteria

  • inability to participate in aerobic exercise;
  • evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
  • evidence of moderate or severe alcohol or substance use disorder within the six months prior to the first episode or evidence that substance abuse triggered the psychotic episode or makes the schizophrenia diagnosis ambiguous; or
  • mental retardation, i.e. estimated premorbid IQ less than 70.

Treatment and study plan

Cognitive training

Behavioral

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

Behavioral

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

Case management and supportive psychotherapy

Behavioral

An individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient

Individual Placement and Support

Behavioral

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

Primary outcomes

  1. Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score

    Time frame: 6 months

    The Overall Composite score from the MCCB is a summary of cognitive performance across seven domains.

  2. Global Functioning Scale: mean of Role and Social ratings

    Time frame: 6 months

    A 10-point rating scale to evaluate role and social functioning

  3. Brain-derived neurotrophic factor (BDNF)

    Time frame: 6 months

    BDNF is a key neurochemical factor known to mediate the effects of exercise in the brain

Secondary outcomes

  1. YMCA fitness test

    Time frame: 6 months

    Cardiorespiratory fitness and muscular endurance measured by the YMCA fitness test

  2. VO2 Max

    Time frame: 6 months

    A cardiovascular fitness measure derived from a treadmill test protocol

  3. Role Functioning Scale

    Time frame: 6 months

    7-point ratings of Work Productivity, Independent Living, Social Relationships, Family Relationships

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Acronym: CT&E-RCT

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2016
Registry last updated
Nov 27, 2023

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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