Clinical trial NCT03602768: Evaluation of the Online Memory & Aging Program and Online Goal Management Training
Official title: Evaluation of Online Cognitive Fitness Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Cognitive Decline
Keywords: Healthy aging
executive functions
memory
cognitive training
cognitive intervention
subjective cognitive impairment
Lead sponsor: Baycrest
Sponsor class: OTHER
Collaborators: name: Centre for Aging and Brain Health Innovation
First posted: 2018-07-27
Enrollment: 800
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are screened, undergo a battery of cognitive testing for the pre-test, and then are randomly assigned to one of four intervention groups: MAP, GMT, Cambridge Brain Sciences brain training (active control), or waitlist. After intervention, the participants take the same test battery and complete it once more at 6 week followup.
Primary purpose: PREVENTION

Brief summary: The current study is designed to test the effectiveness of online programs for memory and executive functions in healthy aging. The investigators are testing online adaptations of two cognitive interventions that have been extensively studied, validated, and implemented in clinical settings: The Memory \& Aging Program (MAP) targets normal memory change in healthy aging, and Goal Management Training (GMT) targets executive functioning deficits in a variety of cognitive and neurological conditions including healthy aging. Both programs combine psycho-education, targeted skills training and clinical support to empower participants with knowledge and strategies to harness their cognitive faculties. These programs are being tested against a waitlist control as well as against a commercial/research brain training platform (Cambridge Brain Sciences) in a design comparing performance on memory and executive functioning measures before and after the interventions/controls. The main hypothesis is that MAP will lead to memory-specific improvements above control conditions, whereas GMT will lead to greater improvements in measures of executive functions relative to controls.


Eligibility criteria: Inclusion Criteria:

* Available to participate in all testing and intervention sessions and access to a computer
* Computer familiarity
* Cognitive complaint/concern/frustration

Exclusion Criteria:

* Health conditions with major effects on cognition, including a current or previous history of stroke, brain surgery, or diagnosed neurological disorder;
* Dependence in instrumental activities of daily living
* Cognitive impairment, defined as performance below cutoff for cognitive impairment on a standardized cognitive screening measure, the modified Telephone Interview for Cognitive Status (Welsh et al., 1993)
* Affective impairment, defined as performance below cutoff for depression on standardized depression screen, the PHQ 2/9 (Yesavage et al., 1983)

Primary outcomes:
measure: Change in dysexecutive functioning
timeFrame: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
measure: Change in cognitive failures
timeFrame: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
measure: Change in memory knowledge score
timeFrame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
measure: Change in memory strategy toolbox use
timeFrame: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
measure: Change in Multifactorial Metamemory Questionnaire (MMQ)
timeFrame: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
Secondary outcomes:
measure: Change in Patient-Specific Functional Scale
timeFrame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
measure: Change in Impact of Memory Change on Daily Activities
timeFrame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
measure: Change in intentions to seek medical attention
timeFrame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
measure: Change in Cambridge Brain Sciences online cognitive assessment
timeFrame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
measure: Change in associative memory
timeFrame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Baycrest Health Sciences
state: Ontario
Study officials:
affiliation: Rotman Research Institute
name: Brian Levine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Burgess, P. W., Alderman, N., Wilson, B. A., Evans, J. J., & Emslie, H. (1996). The dysexecutive questionnaire. Behavioural assessment of the dysexecutive syndrome. Bury St. Edmunds, UK: Thames Valley Test Company.
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