Clinical trial NCT02823041: Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode
Official title: Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizophreniform Disorder
Schizoaffective Disorder
Keywords: cognitive training
aerobic exercise
neurotrophic factors
randomized controlled trial
functional outcome
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
timeFrame: 6 months
measure: Global Functioning Scale: mean of Role and Social ratings
timeFrame: 6 months
measure: Brain-derived neurotrophic factor (BDNF)
timeFrame: 6 months
Secondary outcomes:
measure: YMCA fitness test
timeFrame: 6 months
measure: VO2 Max
timeFrame: 6 months
measure: Role Functioning Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: UCLA Department of Psychiatry & Biobehavioral Sciences
name: Keith Nuechterlein, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: