- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02823041
Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode (CT&E-RCT)
November 24, 2023 updated by: Keith Nuechterlein, Ph.D., University of California, Los Angeles
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.
Study Overview
Status
Completed
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
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joseph Ventura, Ph.D.
- Phone Number: 310-206-3142
- Email: jventura@mednet.ucla.edu
Study Contact Backup
- Name: Luana Turner, Psy.D.
- Phone Number: 310-206-3142
- Email: LTurner@mednet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095-6968
- University of California, Los Angeles
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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:
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:
An individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient
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:
|
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.
|
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:
An individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Global Functioning Scale: mean of Role and Social ratings
Time Frame: 6 months
|
A 10-point rating scale to evaluate role and social functioning
|
6 months
|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
YMCA fitness test
Time Frame: 6 months
|
Cardiorespiratory fitness and muscular endurance measured by the YMCA fitness test
|
6 months
|
VO2 Max
Time Frame: 6 months
|
A cardiovascular fitness measure derived from a treadmill test protocol
|
6 months
|
Role Functioning Scale
Time Frame: 6 months
|
7-point ratings of Work Productivity, Independent Living, Social Relationships, Family Relationships
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Keith Nuechterlein, Ph.D., UCLA Department of Psychiatry & Biobehavioral Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 13, 2016
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
June 29, 2016
First Submitted That Met QC Criteria
June 30, 2016
First Posted (Estimated)
July 6, 2016
Study Record Updates
Last Update Posted (Actual)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 24, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH110544 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
After primary results have been published, de-identified data for primary outcome variables will be available for sharing.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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