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

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Schizophreniform Disorder; Schizophrenia; Schizoaffective Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02823041

R01MH110544

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Cognitive Training & Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Case management and supportive psychotherapy

Behavioral: Aerobic Exercise

Behavioral: Cognitive Training

Behavioral: Individual Placement and Support

Cognitive Training

Active Comparator group

Description:

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.

Treatment:

Behavioral: Case management and supportive psychotherapy

Behavioral: Cognitive Training

Behavioral: Individual Placement and Support