Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode

Not Applicable

Completed

• Conditions: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder
• Interventions: Behavioral: Cognitive Training; Behavioral: Aerobic Exercise; Behavioral: Case management and supportive psychotherapy; Behavioral: Individual Placement and Support

• Registration Number: NCT02823041
• Lead Sponsor: University of California, Los Angeles

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.

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 Timeline

• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-06
• Study Start: 2016-10-13
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-24
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. a first episode of a psychotic illness that began within the past two years;
2. a diagnosis by DSM-5 of schizophrenia, schizoaffective disorder, mainly depressed type, or schizophreniform disorder;
3. sufficient acculturation and fluency in the English language to avoid invalidating research measures; and
4. residence likely to be within commuting distance of the UCLA Aftercare Research Program.

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Exclusion Criteria

1. inability to participate in aerobic exercise;
2. evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
3. 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
4. mental retardation, i.e. estimated premorbid IQ less than 70.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Training & Exercise	Case management and supportive psychotherapy	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.
Cognitive Training	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.
Cognitive Training & Exercise	Cognitive Training	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.
Cognitive Training & Exercise	Individual Placement and Support	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.
Cognitive Training & Exercise	Aerobic 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.
Cognitive Training	Case management and supportive psychotherapy	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.
Cognitive Training	Individual Placement and Support	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.

Primary Outcome Measures

Name	Time	Method
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.
Brain-derived neurotrophic factor (BDNF)	6 months	BDNF is a key neurochemical factor known to mediate the effects of exercise in the brain
Global Functioning Scale: mean of Role and Social ratings	6 months	A 10-point rating scale to evaluate role and social functioning

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States