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A Trial of Cognitive Training in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02478827
Recruitment Status : Completed
First Posted : June 23, 2015
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Vina M. Goghari, University of Calgary

Tracking Information
First Submitted Date  ICMJE June 15, 2015
First Posted Date  ICMJE June 23, 2015
Last Update Posted Date October 10, 2018
Actual Study Start Date  ICMJE March 1, 2016
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2015)
  • Fluid intelligence [ Time Frame: Change from baseline to post-assessment (after 10 weeks of training) ]
    Measured with Raven's Standard Progressive Matrices
  • 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
  • Working Memory [ Time Frame: Change from baseline to post-assessment (after 10 weeks of training) ]
    Measured with Maintenance and Manipulation Task
  • 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
  • Processing Speed [ Time Frame: Change from baseline to post-assessment (after 10 weeks of training) ]
    Measured with Delis-Kaplan Executive Function System (D-KEFS) Color Naming task
Change History Complete list of historical versions of study NCT02478827 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
  • 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
  • Behavioural Impulsivity [ Time Frame: Change from baseline to post-assessment (after 10 weeks of training) ]
    Measured with Delay Discounting Task
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2015)
  • Semantic memory and verbal learning [ Time Frame: Change from baseline to post-assessment (after 10 weeks of training) ]
    Measured with California Verbal Learning Test - 2nd edition
  • Executive functions: inhibition and set-shifting [ 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
  • Executive functions: categorization and set-shifting [ Time Frame: Change from baseline to post-assessment (after 10 weeks of training) ]
    Measured with Delis-Kaplan Executive Function System (D-KEFS) Sorting Test
Current Other Pre-specified Outcome Measures
 (submitted: November 25, 2015)
  • 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
  • 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)
  • Symptoms [ Time Frame: Change from baseline to post-assessment (after 10 weeks of training) ]
    Measured with Positive and Negative Syndrome Scale (PANSS)
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: June 18, 2015)
  • Social Cognition: Emotion Recognition [ Time Frame: Change from baseline to post-assessment (after 10 weeks of training) ]
    Measured with Geneva Emotion Recognition Test
  • Social Cognition: Theory of Mind [ Time Frame: Change from baseline to post-assessment (after 10 weeks of training) ]
    Measured with Hinting Task
  • Daily functioning: Cognitive Failures Questionnaire [ Time Frame: Change from baseline to post-assessment (after 10 weeks of training) ]
    Measured with Cognitive Failures Questionnaire
  • Daily Social Functioning [ Time Frame: Change from baseline to post-assessment (after 10 weeks of training) ]
    Measured with Social Functioning Scale
  • Global Functioning [ Time Frame: Change from baseline to post-assessment (after 10 weeks of training) ]
    Measured with Global Assessment of Functioning
  • Motivation [ Time Frame: Change from baseline to post-assessment (after 10 weeks of training) ]
    Measured with Intrinsic Motivation Inventory
  • Symptoms [ Time Frame: Change from baseline to post-assessment (after 10 weeks of training) ]
    Measured with Positive and Negative Syndrome Scale (PANSS), Hamilton Depression Rating Scale (HDRS), and Young Mania Rating Scale (YMRS)
 
Descriptive Information
Brief Title  ICMJE A Trial of Cognitive Training in Schizophrenia
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Schizophrenia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Working Memory group
    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. One experimental group will complete the working memory training, which involves three games: N-back, Multi-Memory, and Moving Memory. These games are designed to engage processes involving updating and manipulation of information. All of the training games are adaptive. Participants randomized to this cognitive training arm will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks.
    Intervention: Behavioral: Cognitive training
  • Experimental: Processing Speed group
    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. One experimental group will complete the processing speed training, which involves three games: Line It Up, Sliding Search, and Bubble Math. These games are designed to engage processes involving thinking speed. Participants randomized to this cognitive training arm will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks
    Intervention: Behavioral: Cognitive training
  • No Intervention: Control group
    The control group will wait 10-weeks, during which they will receive treatment-as-usual (TAU), which might involve pharmacotherapy, psychotherapy, or both. After the 10-week waiting period, a post-assessment will be completed.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2018)
83
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2015)
70
Actual Study Completion Date  ICMJE August 31, 2017
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02478827
Other Study ID Numbers  ICMJE REB15-0526
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vina M. Goghari, University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Calgary
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP