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Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode (CT&E)

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ClinicalTrials.gov Identifier: NCT02267070
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Keith Nuechterlein, Ph.D., University of California, Los Angeles

Brief Summary:
This is a randomized controlled 6-month trial of the efficacy of a novel intervention combining neuroplasticity-based cognitive training with aerobic exercise, compared to the same systematic cognitive training alone. The primary treatment targets are overall cognitive deficit level and independent living skills. The investigators hypothesize that combining neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical exercise will produce large cognitive and functional improvements, even relative to cognitive training alone. Adding aerobic exercise to a cognitive training program will have the additional benefit of helping to ameliorate medication side effects, reduce the risk for developing metabolic syndrome, and help to prevent the deterioration in physical health that usually follows the onset of schizophrenia and its pharmacologic treatment. 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: Case management and supportive psychotherapy Behavioral: Family psychoeducation Behavioral: Cognitive training Behavioral: Aerobic exercise Not Applicable

Detailed Description:
The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory 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 30-minute sessions at the clinic and two 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode
Actual Study Start Date : November 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive Training and Exercise
24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions 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. Aerobic exercise occurs as two 30-minute sessions at the clinic and two 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 is designed to aid generalization of training to everyday life situations. All members receive individual case management and supportive psychotherapy, and family psychoeducation.
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: Family psychoeducation
All immediate family members will be invited to family psychoeducation sessions.

Behavioral: Cognitive training
The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The second 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. 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.
Other Name: cognitive remediation

Behavioral: Aerobic exercise
Aerobic exercise occurs as two 30-minute sessions at the clinic and two 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.
Other Name: physical exercise

Active Comparator: Cognitive Training
24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions 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. All members receive individual case management and supportive psychotherapy, and family psychoeducation.
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: Family psychoeducation
All immediate family members will be invited to family psychoeducation sessions.

Behavioral: Cognitive training
The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The second 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. 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.
Other Name: cognitive remediation




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.


Secondary Outcome Measures :
  1. Brain-derived neurotrophic factor (BDNF) [ Time Frame: 6 months ]
    BDNF is a principal growth factor known to mediate the effects of exercise in the brain.

  2. Cardiorespiratory fitness [ Time Frame: 6 months ]
    Cardiorespiratory fitness, a secondary physical health outcome variable, will be measured using a ramped version of the traditional Bruce treadmill protocol.

  3. University of California, San Diego (UCSD) Performance-Based Skills Assessment (UPSA) [ Time Frame: 6 months ]
    The UCSD Performance-Based Skills Assessment (UPSA)assesses five all-purpose skills that are important for functioning in the community: general organization, finance, social/communications, transportation, and household chores.

  4. Facial Emotion Identification Test [ Time Frame: 6 months ]
    The Facial Emotion Identification Test involves choice of emotions in facial expressions of 6 different emotions (happy, sad, angry, afraid, surprised, disgusted) plus neutral expressions.

  5. Prosody Task [ Time Frame: 6 months ]
    The Prosody Task involves identifying emotions in audio recordings of male and female actors portraying 5 emotions.

  6. Global Functioning Scale [ Time Frame: 6 months ]
    A 10-point rating scale to evaluate role and social functioning

  7. 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

  8. Independent Living Skills Survey [ Time Frame: 6 months ]
    The Independent Living Skills Survey is a 76-item measure based on patient interview, which provides a more detailed assessment of 11 daily living skill domains

  9. Quality of Life Scale [ Time Frame: 6 months ]
    The Quality of Life scale135, a 53-item interview-based inventory, assesses a patient's subjective satisfaction in several key domains

  10. Role Functioning Scale: Work Productivity, Social Relationships, Family Relationships [ Time Frame: 6 months ]
    The Role Functioning Scale is a global clinician-rated measure of everyday functioning in several domains.

  11. Independent Living rating from Role Functioning Scale [ Time Frame: 6 months ]
    The Independent Living rating assesses daily living skills and extent of living independently based on a clinician interview.



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:   Yes
Criteria

Inclusion Criteria:

  1. a first episode of a psychotic illness that began within the past two years;
  2. a diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia, schizoaffective disorder, mainly depressed type, or schizophreniform disorder;
  3. between 18 and 45 years of age;
  4. sufficient acculturation and fluency in the English language to avoid invalidating research measures of thought, language, and speech disorder or of verbal cognitive abilities; and
  5. residence within commuting distance of the Aftercare Research Program at the University of California, Los Angeles.

Exclusion Criteria:

  1. evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
  2. evidence of alcohol or substance use disorder within the six months prior to the first episode and evidence that substance abuse triggered the psychotic episode or makes the schizophrenia diagnosis ambiguous;
  3. mental retardation, i.e. premorbid intelligence quotient 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): NCT02267070


Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095-6968
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Keith H Nuechterlein, Ph.D. University of California, Los Angeles

Responsible Party: Keith Nuechterlein, Ph.D., Professor in Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02267070     History of Changes
Other Study ID Numbers: 1R34MH102529-01 ( U.S. NIH Grant/Contract )
R34MH102529 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

Keywords provided by Keith Nuechterlein, Ph.D., University of California, Los Angeles:
cognitive training
aerobic exercise
neurotrophic factors
randomized controlled trial

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders