Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode

Schizophrenia Clinical Trial

— CT&E-RCT  

Official title:

Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823041
• Other study ID #: R01MH110544
• Status: Completed
• Phase: N/A
• Start date: October 13, 2016
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder

Intervention

Behavioral:
• Cognitive Training
24 weeks of systematic computerized cognitive training, 4 hours 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.
• Aerobic Exercise
Aerobic exercise occurs as two 45-minute sessions at the clinic and two 30-minute sessions at home weekly. Exercise involves an adaptation of interval training, including a variety of calisthenics that can be done without specialized equipment. Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder.
• 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
• Individual Placement and Support
An job/school specialist will use the Individual Placement and Support model to help participants return to school or work and provide ongoing outreach support.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Global Functioning Scale: mean of Role and Social ratings	A 10-point rating scale to evaluate role and social functioning	6 months
Primary	Brain-derived neurotrophic factor (BDNF)	BDNF is a key neurochemical factor known to mediate the effects of exercise in the brain	6 months
Secondary	YMCA fitness test	Cardiorespiratory fitness and muscular endurance measured by the YMCA fitness test	6 months
Secondary	VO2 Max	A cardiovascular fitness measure derived from a treadmill test protocol	6 months
Secondary	Role Functioning Scale	7-point ratings of Work Productivity, Independent Living, Social Relationships, Family Relationships	6 months

External Links

•   Summary of this study and others at the UCLA Aftercare Research Program