Healthy Controls Group - Age and Sex-matched, Major Depressive Disorder, Remitted, Mild Cognitive Impairment (MCI)
Conditions
Keywords
Neuropsychological testing, Mild Cognitive Impairment, Online neuropsychological testing, Cognition
Brief summary
The goal of this observational study is to validate the Creyos online cognitive assessment platform in individuals with mild cognitive impairment, or remitted major depressive disorder. The main objectives of this research are: 1. To confirm the feasibility of administering the Creyos cognitive battery to older adults with Mild Cognitive Impairment MCI) or Major Depressive Disorder in remission (rMDD). 2. To determine whether the Creyos battery can detect changes in cognition that are predictive of changes on paper-and-pencil neuropsychological testing ("gold standard") over up to five years. Participants will complete both in-person neuropsychological testing yearly as well as the Creyos online battery quarterly for up to 5 years, to allow us to compare performance on these two batteries over time.
Interventions
None listed
Sponsors
Centre for Addiction and Mental Health
Krembil Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
General Inclusion Criteria: * Ability to read and communicate in English * Availability of a study partner who has regular contact with the participant General
Exclusion criteria
* Lifetime DSM 5 diagnosis of schizophrenia, bipolar disorder, or OCD * DSM 5 diagnosis of alcohol or other substance use disorder within the past 12 months * High risk for suicide * Significant neurological conditions (e.g. stroke, seizure disorder, MS) * Unstable medical illnesses (e.g. uncontrolled diabetes mellitus or hypertension) * Taking anticonvulsants or other psychotropic medication that may interfere with cognitive testing that cannot be safely tapered and discontinued * Current depressive symptoms defined as a MADRS score of 10 or above Specific Eligibility Criteria for the MCI Group: Inclusion: * Aged 60 or older * Meets DSM 5 criteria for Minor Neurocognitive Disorder ("MCI") Exclusion: * Having taken a cognitive enhancer within the past 6 weeks Specific Eligibility Criteria for the rMDD Group: Inclusion: * Aged 65 or older * Meets DSM 5 criteria for one or more major depressive episode(s) (MDE) during their adult life (i.e. 18 years of age or older) with: (a) an offset of 2 months to 5 years from the screening visit date, or (b) an offset of 5 years or more, with at least one MDE receiving medical attention (e.g. previously been on an antidepressant, saw a psychiatrist, primary care physician, or had a previous hospitalization Exclusion: * Having taken a cognitive enhancer within the past 6 weeks * Having received electroconvulsive therapy (ECT) within 6 months of baseline neuropsychological testing Specific Eligibility Criteria for the Control Group: Inclusion: * Aged 60 or older Exclusion: * Meets DSM 5 criteria for MDD at anytime during their lifetime * Meets DSM 5 criteria for Minor Neurocognitive Disorder ("MCI")
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Creyos Battery Administration | Upon completion of the Creyos online cognitive platform, approximately every three months, for up to 5 years | To determine the feasibility of administering the Creyos online cognitive platform in individuals with MCI and major depressive disorder in remission, participants will complete two questionnaires after every completion of the Creyos battery. Participants will be asked to complete the System Usability Scale (10 items). Scores on the System Usability Scale range from 0 to 100, with higher scores indicating greater usability. We will look at the total score to determine how easy the participants find the Creyos online cognitive platform to use, and if usability increases with exposure to the platform. |
| Feasibility of the Creyos Battery | Upon completion of the Creyos online cognitive platform, approximately every three months, for up to 5 years | To determine the feasibility of administering the Creyos online cognitive platform in individuals with MCI and major depressive disorder in remission, participants will complete two questionnaires after every completion of the Creyos battery. Participants will be asked to complete the User Burden Scale (20 items). Scores on the User Burden Scale range from 0 to 80, with higher scores indicating greater user burden. We will look at the total score to determine how easy the participants find the Creyos online cognitive platform to use, and if usability increases with exposure to the platform. |
| Validity of the Creyos Platform | In-person testing is completed yearly, and the Creyos online battery is complete quarterly, for up to 5 years | To determine the validity of the Creyos online platform, we will compare the single test scores, domain composite scores and global composite scores between the in-person paper-and-pencil neuropsychological tests ("gold standard") and the Creyos online battery. |
Countries
Canada
Contacts
CONTACTBenoit H. Mulsant, MD
CONTACTHeather Brooks, PhD
Outcome results
None listed