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Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode (CT&E-RCT)

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ClinicalTrials.gov Identifier: NCT02823041
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : September 2, 2022
Sponsor:
Information provided by (Responsible Party):
Keith Nuechterlein, Ph.D., University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE June 29, 2016
First Posted Date  ICMJE July 6, 2016
Last Update Posted Date September 2, 2022
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2016)
  • 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.
  • Global Functioning Scale: mean of Role and Social ratings [ Time Frame: 6 months ]
    A 10-point rating scale to evaluate role and social functioning
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2018)
  • YMCA fitness test [ Time Frame: 6 months ]
    Cardiorespiratory fitness and muscular endurance measured by the YMCA fitness test
  • VO2 Max [ Time Frame: 6 months ]
    A cardiovascular fitness measure derived from a treadmill test protocol
  • Role Functioning Scale [ Time Frame: 6 months ]
    7-point ratings of Work Productivity, Independent Living, Social Relationships, Family Relationships
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2016)
  • YMCA fitness test [ Time Frame: 6 months ]
    Cardiorespiratory fitness and muscular endurance measured by the YMCA fitness test
  • VO2 Max [ Time Frame: 6 months ]
    A cardiovascular fitness measure derived from a treadmill test protocol
  • Role Functioning Scale [ Time Frame: 6 months ]
    7-point ratings of Work Productivity, Independent Living, Social Relationships, Family Relationships
  • Brief Psychiatric Rating Scale [ Time Frame: 6 months ]
    Severity of positive and negative symptom symptomatology
  • Modified Social Adjustment Scale - Work Outcome [ Time Frame: 6 months ]
    A measure of the quantity and type of work at a job, school, or in the home
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode
Official Title  ICMJE Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizophreniform Disorder
  • Schizoaffective Disorder
Intervention  ICMJE
  • 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.
    Other Name: cognitive remediation
  • 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.
    Other Name: physical exercise
  • 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.
    Other Name: supported education/employment
Study Arms  ICMJE
  • Experimental: Cognitive Training & Exercise
    This arm involves a combination of systematic computerized cognitive training plus 150 minutes per week of aerobic exercise. All participants will also receive individual case management and supportive psychotherapy as well as Individual Placement and Support.
    Interventions:
    • Behavioral: Cognitive Training
    • Behavioral: Aerobic Exercise
    • Behavioral: Case management and supportive psychotherapy
    • Behavioral: Individual Placement and Support
  • Active Comparator: Cognitive Training
    This arm includes the same systematic computerized cognitive training as the experimental condition, but without the additional aerobic exercise. All participants will also receive individual case management and supportive psychotherapy as well as and Individual Placement and Support.
    Interventions:
    • Behavioral: Cognitive Training
    • Behavioral: Case management and supportive psychotherapy
    • Behavioral: Individual Placement and Support
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 30, 2016)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. inability to participate in aerobic exercise;
  2. evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
  3. 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
  4. mental retardation, i.e. estimated premorbid IQ less than 70.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joseph Ventura, Ph.D. 310-206-3142 JVentura@mednet.ucla.edu
Contact: Luana Turner, Psy.D. 310-206-3142 LTurner@mednet.ucla.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02823041
Other Study ID Numbers  ICMJE R01MH110544( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: After primary results have been published, de-identified data for primary outcome variables will be available for sharing.
Current Responsible Party Keith Nuechterlein, Ph.D., University of California, Los Angeles
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, Los Angeles
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Keith Nuechterlein, Ph.D. UCLA Department of Psychiatry & Biobehavioral Sciences
PRS Account University of California, Los Angeles
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP