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A Trial of Cognitive Training in Schizophrenia

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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

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Cognitive training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory Schizophrenia

Arm Intervention/treatment
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.
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.

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
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.

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02478827


Locations
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Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Canada
Schizophrenia Society of Alberta
Calgary, Canada
Schizophrenia Society of Alberta
Edmonton, Canada
Sponsors and Collaborators
University of Calgary

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vina M. Goghari, Dr. Vina Goghari, University of Calgary
ClinicalTrials.gov Identifier: NCT02478827     History of Changes
Other Study ID Numbers: REB15-0526
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Keywords provided by Vina M. Goghari, University of Calgary:
Cognitive Training
Working Memory
Processing Speed
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders