Evaluation of the Online Memory & Aging Program and Online Goal Management Training

July 23, 2021 updated by: Brian Levine, Baycrest

Evaluation of Online Cognitive Fitness Programs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6A2E1
        • Baycrest Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Goal Management Training
The online version of GMT with a therapist on the back-end monitoring progress and giving feedback throughout the program. Online GMT takes 5-9 weeks (self-paced) to complete 9 modules involving instructional video with interactive content, practice of cognitive strategies through games, and between-module exercises.
Behavioral: Goal Management Training
Pre-recorded videos and games combine psycho-education, targeted skills training, and mindfulness practice to teach a system where participants can take control of their attention and cognitive faculties.
Other Names:
  • GMT
Experimental: Memory & Aging Program
The online version of MAP with a therapist moderator on the course discussion pages. MAP takes 5-9 weeks (self-paced) to complete 8 modules involving instructional video with interactive content and practice of memory strategies through various exercises.
Behavioral: Memory & Aging Program
Pre-recorded videos and activities combine psycho-education, memory strategy training, and social support to educate about normal memory change in aging, normalize the experience of participants going through it, and equip them to handle age-related memory change.
Other Names:
  • MAP
Placebo Comparator: Cambridge Brain Sciences Training
This is a commercial and research brain training platform, composed of 7 games that are online adaptations of the standard measures of cognition including working memory and spacial planning.
Behavioral: Cambridge Brain Sciences
Commercial brain training software available for subscription to the general public and for research studies.
No Intervention: Waitlist
Participants randomized to this arm will receive no additional information or access to intervention programs until after the follow up testing measures are collected, at which point they will be given access to the intervention of their choosing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in dysexecutive functioning
Time Frame: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
Dysexecutive Functioning Index (DEX) questionnaire measures self-reported deficits in executive functions, and is composed of one scale with scores ranging from 0-80, where higher scores indicate greater executive deficit.
Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
Change in cognitive failures
Time Frame: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
Cognitive Failures Questionnaire (CFQ) measures self-reported failures in perception, memory, and motor function. It contains a single scale with scores ranging from 0-100, where higher scores indicate greater degree of impairment.
Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
Change in memory knowledge score
Time Frame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Memory Knowledge Quiz quantifies memory, lifestyle, and strategy knowledge. It is scored from 0-25, with higher scores indicating more knowledge about knowledge of lifestyle factors affecting memory and strategies to remember.
Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Change in memory strategy toolbox use
Time Frame: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
Memory Strategy Toolbox quantifies application of strategies in memory-demanding everyday situations. It is scored from 0 - 6, with higher scores indicating increased ability to apply memory strategy toolbox.
Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
Change in Multifactorial Metamemory Questionnaire (MMQ)
Time Frame: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
Quantifies subjective memory abilities, satisfaction, and strategy use. The MMQ contains 3 sub scales, but we are using total score as our outcome variable. MMQ total scores range from 0 - 228, with higher scores indicting high self-reported memory performance, satisfaction with it, and use of memory strategies.
Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient-Specific Functional Scale
Time Frame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Quantifies the impact of memory changes on daily activities and self-image. Is scored from 0 -10, with higher scores indicating greater ability to perform function, and taken as an average across number of activities scored.
Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Change in Impact of Memory Change on Daily Activities
Time Frame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Memory Impact Questionnaire (MIQ) quantifies the impact of memory changes on daily activities and self-image. The MIQ has three sub scales: Lifestyle Restriction, Positive Coping and Negative Emotion, and total score will be used as the outcome variable. Scores range from 0 - 204, with higher scores indicating greater impact of memory change on daily activities and self image.
Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Change in intentions to seek medical attention
Time Frame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Quantifies change in intentions to seek medical attention pertaining to memory concerns.
Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Change in Cambridge Brain Sciences online cognitive assessment
Time Frame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Battery of tasks that assess aspects of memory and reasoning.
Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Change in associative memory
Time Frame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Face-name task tests associative memory and sensitivity (d') will be measured as the outcome score.
Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baycrest

Collaborators

Centre for Aging and Brain Health Innovation

Investigators

  • Principal Investigator: Brian Levine, PhD, Rotman Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2018

Primary Completion (Actual)

August 30, 2020

Study Completion (Actual)

August 30, 2020

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

July 25, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 23, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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