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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH102529 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Case management and supportive psychotherapy | Behavioral | An individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Brain-derived neurotrophic factor (BDNF) | BDNF is a principal growth factor known to mediate the effects of exercise in the brain. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith H Nuechterlein, Ph.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095-6968 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40928164 | Derived | 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. | |
| 36577235 | Derived | Le 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. |
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| Family psychoeducation | Behavioral | All immediate family members will be invited to family psychoeducation sessions. |
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| Cognitive training | Behavioral | 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. |
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| Aerobic exercise | Behavioral | 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. |
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| 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. | 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. | 6 months |
| Prosody Task | The Prosody Task involves identifying emotions in audio recordings of male and female actors portraying 5 emotions. | 6 months |
| Global Functioning Scale | A 10-point rating scale to evaluate role and social functioning | 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 | 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 | 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 | 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. | 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. | 6 months |
| 36527955 | Derived | McEwen 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. |
| 36047035 | Derived | Nuechterlein 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. |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019090 | Case Management |
| D000091942 | Cognitive Training |
| D000072466 | Cognitive Remediation |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D010347 | Patient Care Planning |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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