CT&E: Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode

Sponsor

University of California, Los Angeles (Other)

Overall Status

Completed

CT.gov ID

NCT02267070

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizophreniform Disorder Schizoaffective Disorder	Behavioral: Case management and supportive psychotherapy Behavioral: Family psychoeducation Behavioral: Cognitive training Behavioral: Aerobic exercise	N/A

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

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode

Actual Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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: Family psychoeducation All immediate family members will be invited to family psychoeducation sessions. 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. Other Names: cognitive remediation 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. Other Names: physical exercise
Active Comparator: 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.	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: Family psychoeducation All immediate family members will be invited to family psychoeducation sessions. 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. Other Names: cognitive remediation

Arm

Intervention/Treatment

Experimental: 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.

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: Family psychoeducation

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

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.

Other Names:

cognitive remediation

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.

Other Names:

physical exercise

Active Comparator: 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.

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: Family psychoeducation

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

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.

Other Names:

cognitive remediation

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.

Secondary Outcome Measures

Brain-derived neurotrophic factor (BDNF) [6 months]
BDNF is a principal growth factor known to mediate the effects of exercise in the brain.
Cardiorespiratory fitness [6 months]
Cardiorespiratory fitness, a secondary physical health outcome variable, will be measured using a ramped version of the traditional Bruce treadmill protocol.
University of California, San Diego (UCSD) Performance-Based Skills Assessment (UPSA) [6 months]
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.
Facial Emotion Identification Test [6 months]
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.
Prosody Task [6 months]
The Prosody Task involves identifying emotions in audio recordings of male and female actors portraying 5 emotions.
Global Functioning Scale [6 months]
A 10-point rating scale to evaluate role and social functioning
Modified Social Adjustment Scale - Work Outcome [6 months]
A measure of the quantity and type of work at a job, school, or in the home
Independent Living Skills Survey [6 months]
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
Quality of Life Scale [6 months]
The Quality of Life scale135, a 53-item interview-based inventory, assesses a patient's subjective satisfaction in several key domains
Role Functioning Scale: Work Productivity, Social Relationships, Family Relationships [6 months]
The Role Functioning Scale is a global clinician-rated measure of everyday functioning in several domains.
Independent Living rating from Role Functioning Scale [6 months]
The Independent Living rating assesses daily living skills and extent of living independently based on a clinician interview.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.