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Completed

NCT Number: NCT03602768

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

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.

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Key information

Conditions

Aging Cognition Disorders Cognitive Decline Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baycrest Health Sciences

Toronto, Ontario, M6A2E1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Goal Management Training

Behavioral

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

Memory & Aging Program

Behavioral

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

Cambridge Brain Sciences

Behavioral

Commercial brain training software available for subscription to the general public and for research studies.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Baycrest

Other

Collaborators

  • Centre for Aging and Brain Health Innovation

Registry information

Official study title

Evaluation of Online Cognitive Fitness Programs

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2018
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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