NCT02267070

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
11 months until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

3 years

First QC Date

November 19, 2013

Last Update Submit

December 5, 2017

Conditions

SchizophreniaSchizophreniform DisorderSchizoaffective Disorder

Keywords

cognitive trainingaerobic exerciseneurotrophic factorsrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (11)

  • Brain-derived neurotrophic factor (BDNF)

    6 months

  • Cardiorespiratory fitness

    6 months

  • University of California, San Diego (UCSD) Performance-Based Skills Assessment (UPSA)

    6 months

  • Facial Emotion Identification Test

    6 months

  • Prosody Task

    6 months

  • +6 more secondary outcomes

Study Arms (2)

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.

Behavioral: Case management and supportive psychotherapyBehavioral: Family psychoeducationBehavioral: Cognitive trainingBehavioral: 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.

Behavioral: Case management and supportive psychotherapyBehavioral: Family psychoeducationBehavioral: Cognitive training

Interventions

Case management and supportive psychotherapyBEHAVIORAL

An individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient

Cognitive TrainingCognitive Training and Exercise
Family psychoeducationBEHAVIORAL

All immediate family members will be invited to family psychoeducation sessions.

Cognitive TrainingCognitive Training and Exercise
Cognitive trainingBEHAVIORAL

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.

Also known as: cognitive remediation
Cognitive TrainingCognitive Training and Exercise
Aerobic exerciseBEHAVIORAL

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.

Also known as: physical exercise
Cognitive Training and Exercise

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095-6968, United States

Location

Related Publications (3)

  • 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.

    PMID: 36577235DERIVED

  • 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.

    PMID: 36527955DERIVED

  • 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.

    PMID: 36047035DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Case ManagementCognitive TrainingCognitive RemediationExercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services AdministrationNeurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Keith H Nuechterlein, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Residence

Study Record Dates

First Submitted

November 19, 2013

First Posted

October 17, 2014

Study Start

November 1, 2013

Primary Completion

November 1, 2016

Study Completion

July 1, 2017

Last Updated

December 7, 2017

Record last verified: 2017-12

Locations

US(1)