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

NCT ID: NCT03602768

Last Updated: 2021-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-18

Study Completion Date

2020-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Aging Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Goal Management Training

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Memory & Aging Program

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Cambridge Brain Sciences

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Cambridge Brain Sciences

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

Intervention Type BEHAVIORAL

Other Intervention Names

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GMT MAP

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre for Aging and Brain Health Innovation

OTHER

Sponsor Role collaborator

Baycrest

OTHER

Sponsor Role lead

Responsible Party

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Brian Levine

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian Levine, PhD

Role: PRINCIPAL_INVESTIGATOR

Rotman Research Institute

Locations

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Baycrest Health Sciences

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 7126941 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 23259956 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17166313 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10824502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21369362 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 17943615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11773220 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 3644262 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 23611105 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39672101 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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17-24

Identifier Type: -

Identifier Source: org_study_id

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