Skip to main content
OpenTrials
Completed

NCT Number: NCT02478827

A Trial of Cognitive Training in Schizophrenia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive training

Behavioral

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.

Primary outcomes

  1. Fluid intelligence

    Time frame: Change from baseline to post-assessment (after 10 weeks of training)

    Measured with Raven's Standard Progressive Matrices and Cattell's Culture Fair Test

  2. Working Memory

    Time frame: Change from baseline to post-assessment (after 10 weeks of training)

    Measured with Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Digit Span, Spatial Maintenance and Manipulation Task, and Visual N-Back Task

  3. Processing Speed

    Time frame: Change from baseline to post-assessment (after 10 weeks of training)

    Measured with Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Symbol Search and Delis-Kaplan Executive Function System (D-KEFS) Color Naming Task

Secondary outcomes

  1. Executive functions: categorization, set-shifting, and cognitive flexibility

    Time frame: Change from baseline to post-assessment (after 10 weeks of training)

    Measured with Delis-Kaplan Executive Function System (D-KEFS) Color-Word Interference Test and Trail Making Test

  2. Behavioural Impulsivity

    Time frame: Change from baseline to post-assessment (after 10 weeks of training)

    Measured with Delay Discounting Task

Other outcomes

  1. Social Cognition: Emotion Recognition and Theory of Mind

    Time frame: Change from baseline to post-assessment (after 10 weeks of training)

    Measured with Geneva Emotion Recognition Test and Hinting Task

  2. Daily functioning: cognitive failures in daily life, performance, social, and occupational functioning

    Time frame: Change from baseline to post-assessment (after 10 weeks of training)

    Measured with Cognitive Failures Questionnaire, UCSD Performance-Based Skills Assessment (UPSA-Brief), and Social and Occupational Functional Assessment Scale (SOFAS)

  3. Symptoms

    Time frame: Change from baseline to post-assessment (after 10 weeks of training)

    Measured with Positive and Negative Syndrome Scale (PANSS)

  4. Beliefs Regarding Cognition

    Time frame: Change from baseline to post-assessment (after 10 weeks of training)

    Need for Cognition Scale and Theories of Intelligence Scale

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 23, 2015
Registry last updated
Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.