Back to resultsEnhancing Cognitive Training Through Exercise After a First Schizophrenia Episode (CT&E)
Primary Purpose
Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Case management and supportive psychotherapy
Family psychoeducation
Cognitive training
Aerobic exercise
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring cognitive training, aerobic exercise, neurotrophic factors, randomized controlled trial
Eligibility Criteria
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.
Sites / Locations
- University of California, Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Training and Exercise
Cognitive Training
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Brain-derived neurotrophic factor (BDNF)
BDNF is a principal growth factor known to mediate the effects of exercise in the brain.
Cardiorespiratory fitness
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)
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
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
The Prosody Task involves identifying emotions in audio recordings of male and female actors portraying 5 emotions.
Global Functioning Scale
A 10-point rating scale to evaluate role and social functioning
Modified Social Adjustment Scale - Work Outcome
A measure of the quantity and type of work at a job, school, or in the home
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
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
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.
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.
Full Information
NCT ID
NCT02267070
First Posted
November 19, 2013
Last Updated
December 5, 2017
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT02267070
Brief Title
Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode
Acronym
CT&E
Official Title
Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
Keywords
cognitive training, aerobic exercise, neurotrophic factors, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Training and Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Case management and supportive psychotherapy
Intervention Description
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
Intervention Name(s)
Family psychoeducation
Intervention Description
All immediate family members will be invited to family psychoeducation sessions.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Other Intervention Name(s)
cognitive remediation
Intervention 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. 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
Intervention Name(s)
Aerobic exercise
Other Intervention Name(s)
physical exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
Description
The overall composite score from the MCCB is a summary of cognitive performance across seven domains.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Brain-derived neurotrophic factor (BDNF)
Description
BDNF is a principal growth factor known to mediate the effects of exercise in the brain.
Time Frame
6 months
Title
Cardiorespiratory fitness
Description
Cardiorespiratory fitness, a secondary physical health outcome variable, will be measured using a ramped version of the traditional Bruce treadmill protocol.
Time Frame
6 months
Title
University of California, San Diego (UCSD) Performance-Based Skills Assessment (UPSA)
Description
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.
Time Frame
6 months
Title
Facial Emotion Identification Test
Description
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.
Time Frame
6 months
Title
Prosody Task
Description
The Prosody Task involves identifying emotions in audio recordings of male and female actors portraying 5 emotions.
Time Frame
6 months
Title
Global Functioning Scale
Description
A 10-point rating scale to evaluate role and social functioning
Time Frame
6 months
Title
Modified Social Adjustment Scale - Work Outcome
Description
A measure of the quantity and type of work at a job, school, or in the home
Time Frame
6 months
Title
Independent Living Skills Survey
Description
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
Time Frame
6 months
Title
Quality of Life Scale
Description
The Quality of Life scale135, a 53-item interview-based inventory, assesses a patient's subjective satisfaction in several key domains
Time Frame
6 months
Title
Role Functioning Scale: Work Productivity, Social Relationships, Family Relationships
Description
The Role Functioning Scale is a global clinician-rated measure of everyday functioning in several domains.
Time Frame
6 months
Title
Independent Living rating from Role Functioning Scale
Description
The Independent Living rating assesses daily living skills and extent of living independently based on a clinician interview.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith H Nuechterlein, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6968
Country
United States
12. IPD Sharing Statement
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Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode
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