Clinical trial NCT02267070: Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode
Official title: Enhancing Cognitive Training Through Exercise After 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
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-10-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled 6-month trial of the efficacy of a novel intervention combining neuroplasticity-based cognitive training with aerobic exercise, compared to the same systematic cognitive training alone. The primary treatment targets are overall cognitive deficit level and independent living skills. The investigators hypothesize that combining neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical exercise will produce large cognitive and functional improvements, even relative to cognitive training alone. Adding aerobic exercise to a cognitive training program will have the additional benefit of helping to ameliorate medication side effects, reduce the risk for developing metabolic syndrome, and help to prevent the deterioration in physical health that usually follows the onset of schizophrenia and its pharmacologic treatment. 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 involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory 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 30-minute sessions at the clinic and two 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.

Eligibility criteria: Inclusion Criteria:

1. a first episode of a psychotic illness that began within the past two years;
2. a diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia, schizoaffective disorder, mainly depressed type, or schizophreniform disorder;
3. between 18 and 45 years of age;
4. sufficient acculturation and fluency in the English language to avoid invalidating research measures of thought, language, and speech disorder or of verbal cognitive abilities; and
5. residence within commuting distance of the Aftercare Research Program at the University of California, Los Angeles.

Exclusion Criteria:

1. evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
2. evidence of alcohol or substance use disorder within the six months prior to the first episode and evidence that substance abuse triggered the psychotic episode or makes the schizophrenia diagnosis ambiguous;
3. mental retardation, i.e. premorbid intelligence quotient 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
Secondary outcomes:
measure: Brain-derived neurotrophic factor (BDNF)
timeFrame: 6 months
measure: Cardiorespiratory fitness
timeFrame: 6 months
measure: University of California, San Diego (UCSD) Performance-Based Skills Assessment (UPSA)
timeFrame: 6 months
measure: Facial Emotion Identification Test
timeFrame: 6 months
measure: Prosody Task
timeFrame: 6 months
measure: Global Functioning Scale
timeFrame: 6 months
measure: Modified Social Adjustment Scale - Work Outcome
timeFrame: 6 months
measure: Independent Living Skills Survey
timeFrame: 6 months
measure: Quality of Life Scale
timeFrame: 6 months
measure: Role Functioning Scale: Work Productivity, Social Relationships, Family Relationships
timeFrame: 6 months
measure: Independent Living rating from 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: University of California, Los Angeles
name: Keith H Nuechterlein, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: