NCT02478827

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

1.5 years

First QC Date

June 15, 2015

Last Update Submit

October 9, 2018

Conditions

Schizophrenia

Keywords

Cognitive TrainingWorking MemoryProcessing Speed

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Executive functions: categorization, set-shifting, and cognitive flexibility

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

  • Behavioural Impulsivity

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

Other Outcomes (4)

  • Social Cognition: Emotion Recognition and Theory of Mind

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

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

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

  • Symptoms

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

  • +1 more other outcomes

Study Arms (3)

Working Memory group

EXPERIMENTAL

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

Processing Speed group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Cognitive trainingBEHAVIORAL

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.

Processing Speed groupWorking Memory group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Schizophrenia Society of Alberta

Calgary, Canada

Location

Schizophrenia Society of Alberta

Edmonton, Canada

Location

Related Publications (2)

  • 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.

    PMID: 25379283BACKGROUND

  • 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.

    PMID: 26812902DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Vina Goghari

Study Record Dates

First Submitted

June 15, 2015

First Posted

June 23, 2015

Study Start

March 1, 2016

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

October 10, 2018

Record last verified: 2018-10

Locations

CA(3)