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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
• Intervention / Treatment: Behavioral: Case management and supportive psychotherapy; Behavioral: Family psychoeducation; Behavioral: Cognitive training; Behavioral: Aerobic exercise

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095-6968
      • University of California, Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain-derived neurotrophic factor (BDNF)	BDNF is a principal growth factor known to mediate the effects of exercise in the brain.	6 months
Cardiorespiratory fitness	Cardiorespiratory fitness, a secondary physical health outcome variable, will be measured using a ramped version of the traditional Bruce treadmill protocol.	6 months
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.	6 months
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.	6 months
Prosody Task	The Prosody Task involves identifying emotions in audio recordings of male and female actors portraying 5 emotions.	6 months
Global Functioning Scale	A 10-point rating scale to evaluate role and social functioning	6 months
Modified Social Adjustment Scale - Work Outcome	A measure of the quantity and type of work at a job, school, or in the home	6 months
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	6 months
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	6 months
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.	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Keith H Nuechterlein, Ph.D., University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: November 19, 2013
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (Estimate): October 17, 2014

Study Record Updates

• Last Update Posted (Actual): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 5, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: randomized controlled trial; aerobic exercise; cognitive training; neurotrophic factors
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders
• Other Study ID Numbers: 1R34MH102529-01 (U.S. NIH Grant/Contract); R34MH102529 (U.S. NIH Grant/Contract)