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AgingNCT03602768

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

A study testing Goal Management Training, Memory & Aging Program and Cambridge Brain Sciences in people with Aging and Cognitive Decline, run by Baycrest at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Aging, Cognitive Decline
What is being tested?
Goal Management Training, Memory & Aging Program and Cambridge Brain Sciences
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
800 participants
Where
1 siteCanada
Study dates
18 Jun 2018to 30 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Baycrest Health Sciences

    Toronto, Ontario, M6A2E1

Other trials in Canada

About this study

Official title: 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.

Being tested
Goal Management Training, Memory & Aging Program, Cambridge Brain Sciences
Keywords
Healthy aging, executive functions, memory, cognitive training, cognitive intervention, subjective cognitive impairment
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Goal Management TrainingBehavioural

    Also called GMT

    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.

  • Memory & Aging ProgramBehavioural

    Also called MAP

    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.

  • Cambridge Brain SciencesBehavioural

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

Study groups in NCT03602768
Study groupRoleWhat they receive
Goal Management TrainingExperimentalThe 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.
Receives: Behavioral: Goal Management Training
Memory & Aging ProgramExperimentalThe 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.
Receives: Behavioral: Memory & Aging Program
Cambridge Brain Sciences TrainingPlacebo comparatorThis 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.
Receives: Behavioral: Cambridge Brain Sciences
WaitlistNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in dysexecutive functioning

    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.

    Measured: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.

  2. Change in cognitive failures

    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.

    Measured: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.

  3. Change in memory knowledge score

    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.

    Measured: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.

  4. Change in memory strategy toolbox use

    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.

    Measured: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.

  5. Change in Multifactorial Metamemory Questionnaire (MMQ)

    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.

    Measured: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.

Secondary outcomes (5)

  1. Change in Patient-Specific Functional Scale

    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.

    Measured: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.

  2. Change in Impact of Memory Change on Daily Activities

    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.

    Measured: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.

  3. Change in intentions to seek medical attention

    Quantifies change in intentions to seek medical attention pertaining to memory concerns.

    Measured: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.

  4. Change in Cambridge Brain Sciences online cognitive assessment

    Battery of tasks that assess aspects of memory and reasoning.

    Measured: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.

  5. Change in associative memory

    Face-name task tests associative memory and sensitivity (d') will be measured as the outcome score.

    Measured: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2018
  2. Study start18 Jun 2018
  3. Primary completion30 Aug 2020
  4. Study completion30 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03602768
Sponsor's protocol ID
17-24
Status last verified
Jul 2021
First submitted
12 Jul 2018
Last updated
27 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brandt, J., Spencer, M., & Folstein, M. (1988). The Telephone Interview for Cognitive Status. Neuropsychiatry, Neuropsychology, & Behavioral Neurology, 1(2), 111-117.

  • Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x.

    PubMed 7126941

  • 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.

  • Hampshire A, Highfield RR, Parkin BL, Owen AM. Fractionating human intelligence. Neuron. 2012 Dec 20;76(6):1225-37. doi: 10.1016/j.neuron.2012.06.022.

    PubMed 23259956

  • Levine B, Stuss DT, Winocur G, Binns MA, Fahy L, Mandic M, Bridges K, Robertson IH. Cognitive rehabilitation in the elderly: effects on strategic behavior in relation to goal management. J Int Neuropsychol Soc. 2007 Jan;13(1):143-52. doi: 10.1017/S1355617707070178.

    PubMed 17166313

  • Levine B, Robertson IH, Clare L, Carter G, Hong J, Wilson BA, Duncan J, Stuss DT. Rehabilitation of executive functioning: an experimental-clinical validation of goal management training. J Int Neuropsychol Soc. 2000 Mar;6(3):299-312. doi: 10.1017/s1355617700633052.

    PubMed 10824502

  • Levine B, Schweizer TA, O'Connor C, Turner G, Gillingham S, Stuss DT, Manly T, Robertson IH. Rehabilitation of executive functioning in patients with frontal lobe brain damage with goal management training. Front Hum Neurosci. 2011 Feb 17;5:9. doi: 10.3389/fnhum.2011.00009. eCollection 2011.

    PubMed 21369362

  • Troyer, A. K. (2001). Improving memory knowledge, satisfaction, and functioning via an education and intervention program for older adults. Aging, Neuropsychology, and Cognition, 8(4), 256-268

  • Troyer AK, Murphy KJ, Anderson ND, Moscovitch M, Craik FI. Changing everyday memory behaviour in amnestic mild cognitive impairment: a randomised controlled trial. Neuropsychol Rehabil. 2008 Jan;18(1):65-88. doi: 10.1080/09602010701409684.

    PubMed 17943615

  • Troyer AK, Rich JB. Psychometric properties of a new metamemory questionnaire for older adults. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P19-27. doi: 10.1093/geronb/57.1.p19.

    PubMed 11773220

  • Walker SN, Sechrist KR, Pender NJ. The Health-Promoting Lifestyle Profile: development and psychometric characteristics. Nurs Res. 1987 Mar-Apr;36(2):76-81.

    PubMed 3644262

  • Welsh, K. A., Breitner, J.C.S., & Magruder-Habib, K.M. (1993) Detection of dementia in the elderly using telephone screening of cognitive status. Neuropsychiatry, Neuropsychology, and Behavioral Neurology, 6, 103-110.

  • Wiegand MA, Troyer AK, Gojmerac C, Murphy KJ. Facilitating change in health-related behaviors and intentions: a randomized controlled trial of a multidimensional memory program for older adults. Aging Ment Health. 2013;17(7):806-15. doi: 10.1080/13607863.2013.789000. Epub 2013 Apr 23.

    PubMed 23611105

  • Yusupov Rose I, Lass JW, D'Amico D, Zhu L, Rich JB, Levine B, Vandermorris S, Troyer AK. A self-guided e-learning program improves metamemory outcomes in healthy older adults: a randomized controlled trial. Aging Ment Health. 2025 Jun;29(6):1090-1099. doi: 10.1080/13607863.2024.2438839. Epub 2024 Dec 13.

    PubMed 39672101

Questions about this trial

What is this clinical trial studying?

A study testing Goal Management Training, Memory & Aging Program and Cambridge Brain Sciences in people with Aging and Cognitive Decline, run by Baycrest at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in dysexecutive functioning (time frame: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03602768, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021; AzTrials last refreshed its copy on 30 Oct 2026.

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