Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode

Schizophrenia Clinical Trial

— CT&E  

Official title:

Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267070
• Other study ID #: 1R34MH102529-01
• Secondary ID: R34MH102529
• Status: Completed
• Phase: N/A
• First received: November 19, 2013
• Last updated: December 5, 2017
• Start date: November 2013
• Est. completion date: July 2017

Study information

• Verified date: December 2017
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder

Intervention

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
• Family psychoeducation
All immediate family members will be invited to family psychoeducation sessions.
• Cognitive training
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. 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.
• Aerobic exercise
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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Brain-derived neurotrophic factor (BDNF)	BDNF is a principal growth factor known to mediate the effects of exercise in the brain.	6 months
Secondary	Cardiorespiratory fitness	Cardiorespiratory fitness, a secondary physical health outcome variable, will be measured using a ramped version of the traditional Bruce treadmill protocol.	6 months
Secondary	University of California, San Diego (UCSD) Performance-Based Skills Assessment (UPSA)	The UCSD Performance-Based Skills Assessment (UPSA)assesses five all-purpose skills that are important for functioning in the community: general organization, finance, social/communications, transportation, and household chores.	6 months
Secondary	Facial Emotion Identification Test	The Facial Emotion Identification Test involves choice of emotions in facial expressions of 6 different emotions (happy, sad, angry, afraid, surprised, disgusted) plus neutral expressions.	6 months
Secondary	Prosody Task	The Prosody Task involves identifying emotions in audio recordings of male and female actors portraying 5 emotions.	6 months
Secondary	Global Functioning Scale	A 10-point rating scale to evaluate role and social functioning	6 months
Secondary	Modified Social Adjustment Scale - Work Outcome	A measure of the quantity and type of work at a job, school, or in the home	6 months
Secondary	Independent Living Skills Survey	The Independent Living Skills Survey is a 76-item measure based on patient interview, which provides a more detailed assessment of 11 daily living skill domains	6 months
Secondary	Quality of Life Scale	The Quality of Life scale135, a 53-item interview-based inventory, assesses a patient's subjective satisfaction in several key domains	6 months
Secondary	Role Functioning Scale: Work Productivity, Social Relationships, Family Relationships	The Role Functioning Scale is a global clinician-rated measure of everyday functioning in several domains.	6 months
Secondary	Independent Living rating from Role Functioning Scale	The Independent Living rating assesses daily living skills and extent of living independently based on a clinician interview.	6 months