SchizophreniaCT&E-RCTNCT02823041
Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode
A study testing Cognitive Training, Aerobic Exercise and Case management and supportive psychotherapy in people with Schizophrenia and Schizophreniform Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
- What is being tested?
- Cognitive Training, Aerobic Exercise and Case management and supportive psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2016to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095-6968
About this study
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.
Read the 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.
- Being tested
- Cognitive Training, Aerobic Exercise, Case management and supportive psychotherapy, Individual Placement and Support
- Keywords
- cognitive training, aerobic exercise, neurotrophic factors, randomized controlled trial, functional outcome
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
Also called cognitive remediation
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.
Aerobic ExerciseBehavioural
Also called physical 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.
Case management and supportive psychotherapyBehavioural
An individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient
Individual Placement and SupportBehavioural
Also called supported education/employment
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training & Exercise | Experimental | 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. Receives: Behavioral: Cognitive Training; Behavioral: Aerobic Exercise; Behavioral: Case management and supportive psychotherapy; Behavioral: Individual Placement and Support |
| Cognitive Training | Active comparator | 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. Receives: Behavioral: Cognitive Training; Behavioral: Case management and supportive psychotherapy; Behavioral: Individual Placement and Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Global Functioning Scale: mean of Role and Social ratings
A 10-point rating scale to evaluate role and social functioning
Measured: 6 months
Brain-derived neurotrophic factor (BDNF)
BDNF is a key neurochemical factor known to mediate the effects of exercise in the brain
Measured: 6 months
Secondary outcomes (3)
YMCA fitness test
Cardiorespiratory fitness and muscular endurance measured by the YMCA fitness test
Measured: 6 months
VO2 Max
A cardiovascular fitness measure derived from a treadmill test protocol
Measured: 6 months
Role Functioning Scale
7-point ratings of Work Productivity, Independent Living, Social Relationships, Family Relationships
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start13 Oct 2016
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Nuechterlein, Ph.D., University of California, Los Angeles
- Investigators
- Keith Nuechterlein, Ph.D., Principal investigator, UCLA Department of Psychiatry & Biobehavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823041
- Sponsor's protocol ID
- R01MH110544
- Acronym
- CT&E-RCT
- Status last verified
- Nov 2023
- First submitted
- 29 Jun 2016
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: After primary results have been published, de-identified data for primary outcome variables will be available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode
- ClinicalTrials.gov ID
- NCT02823041
- Acronym / sponsor ID
- CT&E-RCT / R01MH110544
- Keywords
- cognitive training, aerobic exercise, neurotrophic factors, randomized controlled trial, functional outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training & Exercise | Experimental | Behavioral: Cognitive Training, Behavioral: Aerobic Exercise, Behavioral: Case management and supportive psychotherapy, Behavioral: Individual Placement and SupportThis 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. |
| Cognitive Training | Active comparator | Behavioral: Cognitive Training, Behavioral: Case management and supportive psychotherapy, Behavioral: Individual Placement and SupportThis 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive TrainingAlso: cognitive remediation24 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. | Behavioural | Cognitive Training, Cognitive Training & Exercise |
| Aerobic ExerciseAlso: physical exerciseAerobic 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. | Behavioural | Cognitive Training & Exercise |
| Case management and supportive psychotherapyAn individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient | Behavioural | Cognitive Training, Cognitive Training & Exercise |
| Individual Placement and SupportAlso: supported education/employmentAn job/school specialist will use the Individual Placement and Support model to help participants return to school or work and provide ongoing outreach support. | Behavioural | Cognitive Training, Cognitive Training & Exercise |
Primary outcome
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
3 secondary outcomes
YMCA fitness test
Time frame: 6 months
VO2 Max
Time frame: 6 months
Role Functioning Scale
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Summary of this study and others at the UCLA Aftercare Research ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After primary results have been published, de-identified data for primary outcome variables will be available for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Nuechterlein, Ph.D. principal investigator
UCLA Department of Psychiatry & Biobehavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training, Aerobic Exercise and Case management and supportive psychotherapy in people with Schizophrenia and Schizophreniform Disorder, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.