Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode (CT&E-RCT)

• ClinicalTrials.gov Identifier: NCT02823041
• Recruitment Status: Recruiting
• First Posted: July 6, 2016
• Last Update Posted: September 2, 2022
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): Keith Nuechterlein, Ph.D., University of California, Los Angeles

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder	Behavioral: Cognitive Training; Behavioral: Aerobic Exercise; Behavioral: Case management and supportive psychotherapy; Behavioral: Individual Placement and Support	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode
• Study Start Date: September 2016
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cognitive Training & 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.	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.; Other Name: cognitive remediation; Behavioral: 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.; Other Name: physical exercise; 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: 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.; Other Name: supported education/employment
Active Comparator: 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.	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.; Other Name: cognitive remediation; 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: 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.; Other Name: supported education/employment

Outcome Measures

Primary Outcome Measures :

1. Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score [ Time Frame: 6 months ]
   The Overall Composite score from the MCCB is a summary of cognitive performance across seven domains.
2. Global Functioning Scale: mean of Role and Social ratings [ Time Frame: 6 months ]
   A 10-point rating scale to evaluate role and social functioning
3. Brain-derived neurotrophic factor (BDNF) [ Time Frame: 6 months ]
   BDNF is a key neurochemical factor known to mediate the effects of exercise in the brain

Secondary Outcome Measures :

1. YMCA fitness test [ Time Frame: 6 months ]
   Cardiorespiratory fitness and muscular endurance measured by the YMCA fitness test
2. VO2 Max [ Time Frame: 6 months ]
   A cardiovascular fitness measure derived from a treadmill test protocol
3. Role Functioning Scale [ Time Frame: 6 months ]
   7-point ratings of Work Productivity, Independent Living, Social Relationships, Family Relationships

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Joseph Ventura, Ph.D.; 310-206-3142; JVentura@mednet.ucla.edu

Contact: Luana Turner, Psy.D.; 310-206-3142; LTurner@mednet.ucla.edu

Locations

United States, California

University of California, Los Angeles; Recruiting

Los Angeles, California, United States, 90095-6968

Contact: Luana R Turner, Psy.D. 310-206-3142 luana@ucla.edu

Contact: Joseph Ventura, Ph.D. 310-206-3142 jventura@mednet.ucla.edu

Principal Investigator: Keith H Nuechterlein, Ph.D.

Sub-Investigator: Joseph Ventura, Ph.D.

Sub-Investigator: Sarah McEwen, Ph.D.

Sub-Investigator: Kenneth L Subotnik, Ph.D.

Sub-Investigator: Laurie Casaus, M.D.

Sub-Investigator: Michael Boucher, M.D.

Sub-Investigator: Gerhard Hellemann, Ph.D.

Sponsors and Collaborators

University of California, Los Angeles

Investigators

• Principal Investigator: Keith Nuechterlein, Ph.D.; UCLA Department of Psychiatry & Biobehavioral Sciences

More Information

Additional Information:

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

• Responsible Party: Keith Nuechterlein, Ph.D., Principal Investigator, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT02823041
• Other Study ID Numbers: R01MH110544 ( U.S. NIH Grant/Contract )
• First Posted: July 6, 2016
• Last Update Posted: September 2, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: After primary results have been published, de-identified data for primary outcome variables will be available for sharing.

Keywords provided by Keith Nuechterlein, Ph.D., University of California, Los Angeles:

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

Additional relevant MeSH terms:

Disease; Schizophrenia; Psychotic Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders