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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

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizophreniform Disorder Schizoaffective Disorder Behavioral: Cognitive Training Behavioral: Aerobic Exercise Behavioral: Case management and supportive psychotherapy Behavioral: Individual Placement and Support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode
Study Start Date : September 2016
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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.
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

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.
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: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823041


Contacts
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Contact: Joseph Ventura, Ph.D. 310-206-3142 JVentura@mednet.ucla.edu
Contact: Luana Turner, Psy.D. 310-206-3142 LTurner@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095-6968
Contact: Luana R Turner, Psy.D.    310-206-3142    luana@ucla.edu   
Contact: Joseph Ventura, Ph.D.    310-206-3142    jventura@mednet.ucla.edu   
Principal Investigator: Keith H Nuechterlein, Ph.D.         
Sub-Investigator: Joseph Ventura, Ph.D.         
Sub-Investigator: Sarah McEwen, Ph.D.         
Sub-Investigator: Kenneth L Subotnik, Ph.D.         
Sub-Investigator: Laurie Casaus, M.D.         
Sub-Investigator: Michael Boucher, M.D.         
Sub-Investigator: Gerhard Hellemann, Ph.D.         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Keith Nuechterlein, Ph.D. UCLA Department of Psychiatry & Biobehavioral Sciences
Additional Information:
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Responsible Party: Keith Nuechterlein, Ph.D., Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02823041    
Other Study ID Numbers: R01MH110544 ( U.S. NIH Grant/Contract )
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: September 2, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
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.
Keywords provided by Keith Nuechterlein, Ph.D., University of California, Los Angeles:
cognitive training
aerobic exercise
neurotrophic factors
randomized controlled trial
functional outcome
Additional relevant MeSH terms:
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Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders