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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Cognitive training

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Calgary, Canada
    • Schizophrenia Society of Alberta
  • Edmonton, Canada
    • Schizophrenia Society of Alberta
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Behavioural Impulsivity	Measured with Delay Discounting Task	Change from baseline to post-assessment (after 10 weeks of training)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Symptoms	Measured with Positive and Negative Syndrome Scale (PANSS)	Change from baseline to post-assessment (after 10 weeks of training)
Beliefs Regarding Cognition	Need for Cognition Scale and Theories of Intelligence Scale	Change from baseline to post-assessment (after 10 weeks of training)

Collaborators and Investigators

• Sponsor: University of Calgary

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: June 15, 2015
• First Submitted That Met QC Criteria: June 18, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Processing Speed; Cognitive Training; Working Memory
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: REB15-0526