Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia Schizophreniform Disorder Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive Training and Exercise

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.

Group Type EXPERIMENTAL

Case management and supportive psychotherapy

Intervention Type BEHAVIORAL

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

Family psychoeducation

Intervention Type BEHAVIORAL

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

Cognitive training

Intervention Type 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.

Aerobic exercise

Intervention Type 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.

Cognitive Training

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.

Group Type ACTIVE_COMPARATOR

Case management and supportive psychotherapy

Intervention Type BEHAVIORAL

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

Family psychoeducation

Intervention Type BEHAVIORAL

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

Cognitive training

Intervention Type 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.

Interventions

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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

Intervention Type BEHAVIORAL

Family psychoeducation

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

Intervention Type BEHAVIORAL

Cognitive training

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.

Intervention Type BEHAVIORAL

Aerobic 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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cognitive remediation physical exercise

Eligibility Criteria

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Inclusion Criteria

1. a first episode of a psychotic illness that began within the past two years;
2. a diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia, schizoaffective disorder, mainly depressed type, or schizophreniform disorder;
3. between 18 and 45 years of age;
4. 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
5. residence within commuting distance of the Aftercare Research Program at the University of California, Los Angeles.

Exclusion Criteria

1. evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
2. 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;
3. mental retardation, i.e. premorbid intelligence quotient less than 70.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes