A Trial of Cognitive Training in Schizophrenia

Schizophrenia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02478827
• Other study ID #: REB15-0526
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: August 31, 2017

Study information

• Verified date: October 2018
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Schizophrenia is associated with a wide range of symptoms impacting a number of different domains, including cognitive impairment. Given the array of cognitive deficits associated with schizophrenia and their relationship to daily functioning, numerous research groups have examined the impact of cognitive remediation on many aspects of cognition. However, it is currently unclear as to which domains of cognition should be targeted to produce the most widespread and durable benefits for schizophrenia patients. It may be the case that targeting lower-level cognitive processes that are important for higher-level and more complex aspects of cognition may produce the most widespread benefits in cognition and everyday functioning. Relatively few studies have examined the effects of working memory or processing speed training on individuals with schizophrenia, as most studies examine broad-based remediation programs. Thus, there is a need for targeted working memory and processing speed training studies to better understand the mechanisms of cognitive enhancement through training in patients. This study will aim to: 1) investigate near-transfer gains associated with working memory and processing speed training in schizophrenia patients, 2) investigate far-transfer gains associated with working memory and processing speed training (i.e., gains in other neurocognitive domains and social cognition), and 3) investigate real-world gains associated with training (i.e., gains in daily functioning). Towards this aim, 81 schizophrenia patients will be recruited and randomly assigned to a working memory training group, a processing speed training group, or a no training control group. Training will be completed at home for 30 minutes per day, 5 days per week, for a total of 10 weeks. Neurocognitive, social cognitive, and daily functioning measures will be administered both pre- and post-training to detect training-related gains.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female

• Age between 18 and 65 years

• A diagnosis of schizophrenia or schizoaffective disorder

• Minimum IQ of 70

• No uncorrected visual impairment, including colour blindness

• No uncorrected hearing impairment

• Able to provide informed consent

Exclusion Criteria:

• Meeting Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) diagnostic criteria for a current major depressive episode, manic episode, or hypomanic episode

• Past 1 month history of electroconvulsive therapy (ECT)

• Past 1 month history of Transcranial Magnetic Stimulation therapy (TMS)

• Past 3 month history of substance abuse

• Diagnosed with a medical condition known to affect cognition (e.g., endocrine disease)

• Score less than 70 on the Wechsler Abbreviated Scale of Intelligence (WASI)

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Cognitive training
The neurocognitive training program will be provided by an online platform called BrainGymmer (https://www.braingymmer.com/en/brain-games/). Users will receive an account where they will only have access to the training games they have been assigned to and where their activity will be logged. Participants randomized one of the cognitive training arms will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Schizophrenia Society of Alberta	Calgary
Canada	Schizophrenia Society of Alberta	Edmonton

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Lawlor-Savage L, Goghari VM. Working memory training in schizophrenia and healthy populations. Behav Sci (Basel). 2014 Sep 3;4(3):301-19. doi: 10.3390/bs4030301. eCollection 2014 Sep. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social Cognition: Emotion Recognition and Theory of Mind	Measured with Geneva Emotion Recognition Test and Hinting Task	Change from baseline to post-assessment (after 10 weeks of training)
Other	Daily functioning: cognitive failures in daily life, performance, social, and occupational functioning	Measured with Cognitive Failures Questionnaire, UCSD Performance-Based Skills Assessment (UPSA-Brief), and Social and Occupational Functional Assessment Scale (SOFAS)	Change from baseline to post-assessment (after 10 weeks of training)
Other	Symptoms	Measured with Positive and Negative Syndrome Scale (PANSS)	Change from baseline to post-assessment (after 10 weeks of training)
Other	Beliefs Regarding Cognition	Need for Cognition Scale and Theories of Intelligence Scale	Change from baseline to post-assessment (after 10 weeks of training)
Primary	Fluid intelligence	Measured with Raven's Standard Progressive Matrices and Cattell's Culture Fair Test	Change from baseline to post-assessment (after 10 weeks of training)
Primary	Working Memory	Measured with Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Digit Span, Spatial Maintenance and Manipulation Task, and Visual N-Back Task	Change from baseline to post-assessment (after 10 weeks of training)
Primary	Processing Speed	Measured with Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Symbol Search and Delis-Kaplan Executive Function System (D-KEFS) Color Naming Task	Change from baseline to post-assessment (after 10 weeks of training)
Secondary	Executive functions: categorization, set-shifting, and cognitive flexibility	Measured with Delis-Kaplan Executive Function System (D-KEFS) Color-Word Interference Test and Trail Making Test	Change from baseline to post-assessment (after 10 weeks of training)
Secondary	Behavioural Impulsivity	Measured with Delay Discounting Task	Change from baseline to post-assessment (after 10 weeks of training)

External Links

•   Study website