CT&E-RCT: Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode

Sponsor

University of California, Los Angeles (Other)

Overall Status

Recruiting

CT.gov ID

NCT02823041

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizophreniform Disorder Schizoaffective Disorder	Behavioral: Cognitive Training Behavioral: Aerobic Exercise Behavioral: Case management and supportive psychotherapy Behavioral: Individual Placement and Support	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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.	Behavioral: Cognitive Training 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: cognitive remediation Behavioral: Aerobic 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. Other Names: physical exercise Behavioral: Case management and supportive psychotherapy An individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient Behavioral: Individual Placement and Support 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: supported education/employment
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.	Behavioral: Cognitive Training 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: cognitive remediation Behavioral: Case management and supportive psychotherapy An individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient Behavioral: Individual Placement and Support 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: supported education/employment

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.

Behavioral: Cognitive Training

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:

cognitive remediation

Behavioral: Aerobic 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.

Other Names:

physical exercise

Behavioral: Case management and supportive psychotherapy

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

Behavioral: Individual Placement and Support

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:

supported education/employment

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.

Behavioral: Cognitive Training

Other Names:

cognitive remediation

Behavioral: Case management and supportive psychotherapy

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

Behavioral: Individual Placement and Support

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:

supported education/employment

Outcome Measures

Primary Outcome Measures

Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score [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 [6 months]
A 10-point rating scale to evaluate role and social functioning
Brain-derived neurotrophic factor (BDNF) [6 months]
BDNF is a key neurochemical factor known to mediate the effects of exercise in the brain

Secondary Outcome Measures

YMCA fitness test [6 months]
Cardiorespiratory fitness and muscular endurance measured by the YMCA fitness test
VO2 Max [6 months]
A cardiovascular fitness measure derived from a treadmill test protocol
Role Functioning Scale [6 months]
7-point ratings of Work Productivity, Independent Living, Social Relationships, Family Relationships

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.