SchizophreniaCT&ENCT02267070
Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode
A study testing Case management and supportive psychotherapy, Family psychoeducation and Cognitive training 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 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
- What is being tested?
- Case management and supportive psychotherapy, Family psychoeducation and Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jul 2017
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- a first episode of a psychotic illness that began within the past two years;
- a diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia, schizoaffective disorder, mainly depressed type, or schizophreniform disorder;
- between 18 and 45 years of age;
- 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
- residence within commuting distance of the Aftercare Research Program at the University of California, Los Angeles.
Who cannot join
- evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
- 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;
- mental retardation, i.e. premorbid intelligence quotient 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 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.
Read the 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.
- Being tested
- Case management and supportive psychotherapy, Family psychoeducation, Cognitive training, Aerobic exercise
- Keywords
- cognitive training, aerobic exercise, neurotrophic factors, randomized controlled trial
- 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.
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
Family psychoeducationBehavioural
All immediate family members will be invited to family psychoeducation sessions.
Cognitive trainingBehavioural
Also called cognitive remediation
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.
Aerobic exerciseBehavioural
Also called physical 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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training and Exercise | Experimental | 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. Receives: Behavioral: Case management and supportive psychotherapy; Behavioral: Family psychoeducation; Behavioral: Cognitive training; Behavioral: Aerobic exercise |
| Cognitive Training | Active comparator | 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. Receives: Behavioral: Case management and supportive psychotherapy; Behavioral: Family psychoeducation; Behavioral: Cognitive training |
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
Secondary outcomes (11)
Brain-derived neurotrophic factor (BDNF)
BDNF is a principal growth factor known to mediate the effects of exercise in the brain.
Measured: 6 months
Cardiorespiratory fitness
Cardiorespiratory fitness, a secondary physical health outcome variable, will be measured using a ramped version of the traditional Bruce treadmill protocol.
Measured: 6 months
University of California, San Diego (UCSD) Performance-Based Skills Assessment (UPSA)
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.
Measured: 6 months
Facial Emotion Identification Test
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.
Measured: 6 months
Prosody Task
The Prosody Task involves identifying emotions in audio recordings of male and female actors portraying 5 emotions.
Measured: 6 months
Global Functioning Scale
A 10-point rating scale to evaluate role and social functioning
Measured: 6 months
Modified Social Adjustment Scale - Work Outcome
A measure of the quantity and type of work at a job, school, or in the home
Measured: 6 months
Independent Living Skills Survey
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
Measured: 6 months
Quality of Life Scale
The Quality of Life scale135, a 53-item interview-based inventory, assesses a patient's subjective satisfaction in several key domains
Measured: 6 months
Role Functioning Scale: Work Productivity, Social Relationships, Family Relationships
The Role Functioning Scale is a global clinician-rated measure of everyday functioning in several domains.
Measured: 6 months
Independent Living rating from Role Functioning Scale
The Independent Living rating assesses daily living skills and extent of living independently based on a clinician interview.
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 posted17 Oct 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Keith Nuechterlein, Ph.D., University of California, Los Angeles
- Investigators
- Keith H Nuechterlein, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267070
- Sponsor's protocol ID
- 1R34MH102529-01
- Other IDs
- R34MH102529
- Acronym
- CT&E
- Status last verified
- Dec 2017
- First submitted
- 19 Nov 2013
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Subotnik KL, Ventura J, McEwen SC, Turner LR, Sturdevant YR, Distler MG, Casaus LR, Zito MF, Hellemann GS, Sugar CA, Whelan FG, Niess TL, McGraw EA, Nuechterlein KH. Aerobic Exercise Enhances the Impact of Cognitive Training on Positive Symptoms After a First Episode of Schizophrenia. Behav Modif. 2025 Nov;49(5-6):430-449. doi: 10.1177/01454455251371021. Epub 2025 Sep 10.
PubMed 40928164Le TP, Ventura J, Ruiz-Yu B, McEwen SC, Subotnik KL, Nuechterlein KH. Treatment engagement in first-episode schizophrenia: Associations between intrinsic motivation and attendance during cognitive training and an aerobic exercise program. Schizophr Res. 2023 Jan;251:59-65. doi: 10.1016/j.schres.2022.12.018. Epub 2022 Dec 26.
PubMed 36577235McEwen SC, Jarrahi B, Ventura J, Subotnik KL, Nguyen J, Woo SM, Nuechterlein KH. A combined exercise and cognitive training intervention induces fronto-cingulate cortical plasticity in first-episode psychosis patients. Schizophr Res. 2023 Jan;251:12-21. doi: 10.1016/j.schres.2022.12.001. Epub 2022 Dec 15.
PubMed 36527955Nuechterlein KH, McEwen SC, Ventura J, Subotnik KL, Turner LR, Boucher M, Casaus LR, Distler MG, Hayata JN. Aerobic exercise enhances cognitive training effects in first-episode schizophrenia: randomized clinical trial demonstrates cognitive and functional gains. Psychol Med. 2023 Jul;53(10):4751-4761. doi: 10.1017/S0033291722001696. Epub 2022 Aug 8.
PubMed 36047035
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode
- ClinicalTrials.gov ID
- NCT02267070
- Acronym / sponsor ID
- CT&E / 1R34MH102529-01
- Keywords
- cognitive training, aerobic exercise, neurotrophic factors, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2013 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 17 Oct 2014 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training and Exercise | Experimental | Behavioral: Case management and supportive psychotherapy, Behavioral: Family psychoeducation, Behavioral: Cognitive training, Behavioral: Aerobic exercise24 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. |
| Cognitive Training | Active comparator | Behavioral: Case management and supportive psychotherapy, Behavioral: Family psychoeducation, Behavioral: Cognitive training24 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- a first episode of a psychotic illness that began within the past two years;
- a diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia, schizoaffective disorder, mainly depressed type, or schizophreniform disorder;
- between 18 and 45 years of age;
- 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
- residence within commuting distance of the Aftercare Research Program at the University of California, Los Angeles.
Key exclusion criteria (3 listed)
- evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
- 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;
- mental retardation, i.e. premorbid intelligence quotient 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 |
|---|---|---|
| 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 and Exercise |
| Family psychoeducationAll immediate family members will be invited to family psychoeducation sessions. | Behavioural | Cognitive Training, Cognitive Training and Exercise |
| Cognitive trainingAlso: cognitive remediationThe 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. | Behavioural | Cognitive Training, Cognitive Training and Exercise |
| Aerobic exerciseAlso: physical exerciseAerobic 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. | Behavioural | Cognitive Training and 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.
11 secondary outcomes
Brain-derived neurotrophic factor (BDNF)
Time frame: 6 months
Cardiorespiratory fitness
Time frame: 6 months
University of California, San Diego (UCSD) Performance-Based Skills Assessment (UPSA)
Time frame: 6 months
Facial Emotion Identification Test
Time frame: 6 months
Prosody Task
Time frame: 6 months
Global Functioning Scale
Time frame: 6 months
Modified Social Adjustment Scale - Work Outcome
Time frame: 6 months
Independent Living Skills Survey
Time frame: 6 months
Quality of Life Scale
Time frame: 6 months
Role Functioning Scale: Work Productivity, Social Relationships, Family Relationships
Time frame: 6 months
Independent Living rating from 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 7 Dec 2017.
- Derived from this study: PubMed 40928164Subotnik KL, Ventura J, McEwen SC, Turner LR, Sturdevant YR, Distler MG, Casaus LR, Zito MF, Hellemann GS, Sugar CA, Whelan FG, Niess TL, McGraw EA, Nuechterlein KH. Aerobic Exercise Enhances the Impact of Cognitive Training on Positive Symptoms After a First Episode of Schizophrenia. Behav Modif. 2025 Nov;49(5-6):430-449. doi: 10.1177/01454455251371021. Epub 2025 Sep 10.
- Derived from this study: PubMed 36577235Le TP, Ventura J, Ruiz-Yu B, McEwen SC, Subotnik KL, Nuechterlein KH. Treatment engagement in first-episode schizophrenia: Associations between intrinsic motivation and attendance during cognitive training and an aerobic exercise program. Schizophr Res. 2023 Jan;251:59-65. doi: 10.1016/j.schres.2022.12.018. Epub 2022 Dec 26.
- Derived from this study: PubMed 36527955McEwen SC, Jarrahi B, Ventura J, Subotnik KL, Nguyen J, Woo SM, Nuechterlein KH. A combined exercise and cognitive training intervention induces fronto-cingulate cortical plasticity in first-episode psychosis patients. Schizophr Res. 2023 Jan;251:12-21. doi: 10.1016/j.schres.2022.12.001. Epub 2022 Dec 15.
- Derived from this study: PubMed 36047035Nuechterlein KH, McEwen SC, Ventura J, Subotnik KL, Turner LR, Boucher M, Casaus LR, Distler MG, Hayata JN. Aerobic exercise enhances cognitive training effects in first-episode schizophrenia: randomized clinical trial demonstrates cognitive and functional gains. Psychol Med. 2023 Jul;53(10):4751-4761. doi: 10.1017/S0033291722001696. Epub 2022 Aug 8.
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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 H Nuechterlein, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case management and supportive psychotherapy, Family psychoeducation and Cognitive training 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 5 inclusion and 3 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 7 Dec 2017. 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02267070, which also lists 4 linked publications.
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 7 Dec 2017.