Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode

NCT02823041 | Completed DMC

• 1 other identifier: R01MH110544
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder

Keywords

cognitive training; aerobic exercise; neurotrophic factors; randomized controlled trial; functional outcome

Outcome Measures

Primary Outcomes (3)

• 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

• Global Functioning Scale: mean of Role and Social ratings

  A 10-point rating scale to evaluate role and social functioning

  6 months

• Brain-derived neurotrophic factor (BDNF)

  BDNF is a key neurochemical factor known to mediate the effects of exercise in the brain

  6 months

Secondary Outcomes (3)

• YMCA fitness test

  6 months

• VO2 Max

  6 months

• Role Functioning Scale

  6 months

Study Arms (2)

Cognitive Training & Exercise

EXPERIMENTAL

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.

Behavioral: Cognitive Training; Behavioral: Aerobic Exercise; Behavioral: Case management and supportive psychotherapy; Behavioral: Individual Placement and Support

Cognitive Training

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Training; Behavioral: Case management and supportive psychotherapy; Behavioral: Individual Placement and Support

Interventions

Cognitive Training BEHAVIORAL

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.

Also known as: cognitive remediation

Cognitive Training; Cognitive Training & Exercise

Aerobic Exercise BEHAVIORAL

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.

Also known as: physical exercise

Cognitive Training & Exercise

Case management and supportive psychotherapy BEHAVIORAL

An individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient

Cognitive Training; Cognitive Training & Exercise

Individual Placement and Support BEHAVIORAL

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.

Also known as: supported education/employment

Cognitive Training; Cognitive Training & Exercise

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095-6968, United States

Location

Related Links

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

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Cognitive Training; Cognitive Remediation; Exercise; Case Management; Palliative Care; Employment

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration; Socioeconomic Factors; Population Characteristics

Study Officials

• Keith Nuechterlein, Ph.D.

  UCLA Department of Psychiatry & Biobehavioral Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 6, 2016
• Study Start: October 13, 2016
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)