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

Study Overview
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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.

Official Title
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Evaluation of Online Cognitive Fitness Programs

Conditions
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Aging, Cognitive Decline

Intervention / Treatment
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* Behavioral: Goal Management Training
* Behavioral: Memory & Aging Program
* Behavioral: Cambridge Brain Sciences


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal Management Training<br>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<br>* 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.<br>* Other names: GMT;|
| Experimental: Memory & Aging Program<br>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<br>* 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.<br>* Other names: MAP;|
| Placebo Comparator: Cambridge Brain Sciences Training<br>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<br>* Commercial brain training software available for subscription to the general public and for research studies.<br>|
| No Intervention: Waitlist<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion. | 
| 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. | Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion. | 
| Change in intentions to seek medical attention | 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy aging, memory, executive functions, cognitive training, cognitive intervention, subjective cognitive impairment