Clinical trial NCT02478827: A Trial of Cognitive Training in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Cognitive Training
Working Memory
Processing Speed
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Fluid intelligence
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
measure: Working Memory
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
measure: Processing Speed
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
Secondary outcomes:
measure: Executive functions: categorization, set-shifting, and cognitive flexibility
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
measure: Behavioural Impulsivity
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
Other outcomes:
measure: Social Cognition: Emotion Recognition and Theory of Mind
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
measure: Daily functioning: cognitive failures in daily life, performance, social, and occupational functioning
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
measure: Symptoms
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
measure: Beliefs Regarding Cognition
timeFrame: Change from baseline to post-assessment (after 10 weeks of training)
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: Schizophrenia Society of Alberta
city: Edmonton
country: Canada
facility: Schizophrenia Society of Alberta
Study officials:
References:
citation: Lawlor-Savage L, Goghari VM. Working memory training in schizophrenia and healthy populations. Behav Sci (Basel). 2014 Sep 3;4(3):301-319. doi: 10.3390/bs4030301. eCollection 2014 Sep.
citation: Cassetta BD, Goghari VM. Working memory and processing speed training in schizophrenia: study protocol for a randomized controlled trial. Trials. 2016 Jan 26;17:49. doi: 10.1186/s13063-016-1188-5.