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A Trial of Cognitive Training in Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive training
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring Cognitive Training, Working Memory, Processing Speed

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Foothills Medical Centre
  • Schizophrenia Society of Alberta
  • Schizophrenia Society of Alberta

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Working Memory group

Processing Speed group

Control group

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

Fluid intelligence
Measured with Raven's Standard Progressive Matrices and Cattell's Culture Fair Test
Working Memory
Measured with Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Digit Span, Spatial Maintenance and Manipulation Task, and Visual N-Back Task
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

Secondary Outcome Measures

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
Behavioural Impulsivity
Measured with Delay Discounting Task

Full Information

First Posted
June 15, 2015
Last Updated
October 9, 2018
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT02478827
Brief Title
A Trial of Cognitive Training in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Cognitive Training, Working Memory, Processing Speed

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Working Memory group
Arm Type
Experimental
Arm Description
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.
Arm Title
Processing Speed group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Intervention Description
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 Outcome Measure Information:
Title
Fluid intelligence
Description
Measured with Raven's Standard Progressive Matrices and Cattell's Culture Fair Test
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Title
Working Memory
Description
Measured with Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Digit Span, Spatial Maintenance and Manipulation Task, and Visual N-Back Task
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Title
Processing Speed
Description
Measured with Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Symbol Search and Delis-Kaplan Executive Function System (D-KEFS) Color Naming Task
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Secondary Outcome Measure Information:
Title
Executive functions: categorization, set-shifting, and cognitive flexibility
Description
Measured with Delis-Kaplan Executive Function System (D-KEFS) Color-Word Interference Test and Trail Making Test
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Title
Behavioural Impulsivity
Description
Measured with Delay Discounting Task
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Other Pre-specified Outcome Measures:
Title
Social Cognition: Emotion Recognition and Theory of Mind
Description
Measured with Geneva Emotion Recognition Test and Hinting Task
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Title
Daily functioning: cognitive failures in daily life, performance, social, and occupational functioning
Description
Measured with Cognitive Failures Questionnaire, UCSD Performance-Based Skills Assessment (UPSA-Brief), and Social and Occupational Functional Assessment Scale (SOFAS)
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Title
Symptoms
Description
Measured with Positive and Negative Syndrome Scale (PANSS)
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Title
Beliefs Regarding Cognition
Description
Need for Cognition Scale and Theories of Intelligence Scale
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Schizophrenia Society of Alberta
City
Calgary
Country
Canada
Facility Name
Schizophrenia Society of Alberta
City
Edmonton
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25379283
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.
Results Reference
background
PubMed Identifier
26812902
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.
Results Reference
derived
Links:
URL
http://braintrainingstudy.ca
Description
Study website

Learn more about this trial

A Trial of Cognitive Training in Schizophrenia

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