Back to resultsEnhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode (CT&E-RCT)
Primary Purpose
Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training
Aerobic Exercise
Case management and supportive psychotherapy
Individual Placement and Support
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring cognitive training, aerobic exercise, neurotrophic factors, randomized controlled trial, functional outcome
Eligibility Criteria
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.
Sites / Locations
- University of California, Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Training & Exercise
Cognitive Training
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
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
A 10-point rating scale to evaluate role and social functioning
Brain-derived neurotrophic factor (BDNF)
BDNF is a key neurochemical factor known to mediate the effects of exercise in the brain
Secondary Outcome Measures
YMCA fitness test
Cardiorespiratory fitness and muscular endurance measured by the YMCA fitness test
VO2 Max
A cardiovascular fitness measure derived from a treadmill test protocol
Role Functioning Scale
7-point ratings of Work Productivity, Independent Living, Social Relationships, Family Relationships
Full Information
NCT ID
NCT02823041
First Posted
June 29, 2016
Last Updated
September 20, 2023
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02823041
Brief Title
Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode
Acronym
CT&E-RCT
Official Title
Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
Keywords
cognitive training, aerobic exercise, neurotrophic factors, randomized controlled trial, functional outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Training & Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Other Intervention Name(s)
cognitive remediation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Other Intervention Name(s)
physical exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Case management and supportive psychotherapy
Intervention Description
An individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient
Intervention Type
Behavioral
Intervention Name(s)
Individual Placement and Support
Other Intervention Name(s)
supported education/employment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
Description
The Overall Composite score from the MCCB is a summary of cognitive performance across seven domains.
Time Frame
6 months
Title
Global Functioning Scale: mean of Role and Social ratings
Description
A 10-point rating scale to evaluate role and social functioning
Time Frame
6 months
Title
Brain-derived neurotrophic factor (BDNF)
Description
BDNF is a key neurochemical factor known to mediate the effects of exercise in the brain
Time Frame
6 months
Secondary Outcome Measure Information:
Title
YMCA fitness test
Description
Cardiorespiratory fitness and muscular endurance measured by the YMCA fitness test
Time Frame
6 months
Title
VO2 Max
Description
A cardiovascular fitness measure derived from a treadmill test protocol
Time Frame
6 months
Title
Role Functioning Scale
Description
7-point ratings of Work Productivity, Independent Living, Social Relationships, Family Relationships
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Nuechterlein, Ph.D.
Organizational Affiliation
UCLA Department of Psychiatry & Biobehavioral Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6968
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After primary results have been published, de-identified data for primary outcome variables will be available for sharing.
Links:
URL
https://www.semel.ucla.edu/aftercare
Description
Summary of this study and others at the UCLA Aftercare Research Program
Learn more about this trial
Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode
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