NCT03602768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

2.2 years

First QC Date

July 12, 2018

Last Update Submit

July 23, 2021

Conditions

Keywords

Healthy agingexecutive functionsmemorycognitive trainingcognitive interventionsubjective cognitive impairment

Outcome Measures

Primary Outcomes (5)

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

Secondary Outcomes (5)

  • Change in Patient-Specific Functional Scale

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

  • Change in Impact of Memory Change on Daily Activities

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

  • Change in intentions to seek medical attention

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

  • Change in Cambridge Brain Sciences online cognitive assessment

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

  • Change in associative memory

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

Study Arms (4)

Goal Management Training

EXPERIMENTAL

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

Memory & Aging Program

EXPERIMENTAL

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

Cambridge Brain Sciences Training

PLACEBO COMPARATOR

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

Waitlist

NO INTERVENTION

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.

Interventions

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.

Also known as: GMT
Goal Management Training

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.

Also known as: MAP
Memory & Aging Program

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

Cambridge Brain Sciences Training

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baycrest Health Sciences

Toronto, Ontario, M6A2E1, Canada

Location

Related Publications (14)

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

    BACKGROUND
  • 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.

    PMID: 7126941BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 23259956BACKGROUND
  • 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.

    PMID: 17166313BACKGROUND
  • 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.

    PMID: 10824502BACKGROUND
  • 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.

    PMID: 21369362BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 17943615BACKGROUND
  • 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.

    PMID: 11773220BACKGROUND
  • Walker SN, Sechrist KR, Pender NJ. The Health-Promoting Lifestyle Profile: development and psychometric characteristics. Nurs Res. 1987 Mar-Apr;36(2):76-81.

    PMID: 3644262BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 23611105BACKGROUND
  • 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.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Brian Levine, PhD

    Rotman Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The study personnel who conduct screening and send pre/post-test surveys to participants are all blinded. Randomizer is blinded to all participant pre-test outcomes. Care providers know what their participants are doing, but not aware of the full study design, including details of the other conditions or outcome test characteristics.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

July 12, 2018

First Posted

July 27, 2018

Study Start

June 18, 2018

Primary Completion

August 30, 2020

Study Completion

August 30, 2020

Last Updated

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations