A Multidimensional Behavioral Intervention for Those at Risk for Alzheimer's Dementia

Study Overview
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Brief Summary
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This intervention is designed to promote enhanced use of compensation strategies including calendar and task list use, and organization systems, as well as increased engagement with brain health activities including physical exercise, cognitive activities, and stress reduction.

Detailed Description
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The purpose of this study is to test the feasibility and efficacy of a 10-week multi-dimensional intervention for older adults with subjective cognitive concerns (SCC). The goal of this intervention is to enhance compensation skills related to everyday executive and everyday memory functions through training in the systematic use of a calendar system, goal setting and task list system, and organizational strategies within the context of the individual's daily life. This multidimensional intervention program also targets engagement in healthy lifestyle activities (physical exercise, intellectual stimulation, positive emotional functioning) to further promote brain health and functional resilience. Importantly, both treatment components work synergistically as the use of compensation strategies assists in building healthy activities into daily routines (e.g., scheduling exercise into one's calendar and putting it on a task list).

Official Title
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A Randomized Evaluation of a Multidimensional Behavioral Intervention for Those at Risk for Alzheimer's Dementia

Conditions
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Compensation Strategies, Functional Aging, Subjective Cognitive Concerns, Brain Health Activities

Intervention / Treatment
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* Behavioral: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A positive complaint in response to two questions ('Do you feel like your memory or other aspects of thinking are becoming worse?'; 'Does this worry you?') normal cognitive performance corrected for age and education on a global measure of cognitive functioning independent in all activities of daily living. English speaking; Available informant to complete surveys; Ambulatory Exclusion Criteria: Known neurological condition; Severe psychiatric illness (e.g., current depression).

Ages Eligible for Study
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Minimum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will complete an initial assessment within 2 weeks prior to starting the course or during the first class. The course will include 10 sessions conducted on a weekly basis. Following completion of the course, participants will again complete another assessment during the last class or within 2 weeks of course completion. Participants may be invited to complete assessments at 3- and 6-months following course completion. | Behavioral: Intervention<br>* Subjects will attend a series of 2 hour classes, once a week for 10 weeks. Topics discussed in group sessions will cover compensation strategies (e.g., calendar, goal setting and task lists, functional zones) and brain health behaviors (e.g., exercise, cognitive activity, stress reduction and mindfulness). Subjects may be asked to wear an actigraphy monitor (that looks like a wrist watch) and/or heart rate sensor that is designed to collect information regarding physical activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Everyday Compensation Questionnaire | a 54-item self-report questionnaire that asks participants how often they engage in a variety of activities that help them stay cognitively and physically active. | Change from baseline to immediately post-intervention and through 6 month follow up | 
| Everyday Cognition | self-rated questionnaire of cognitively-based everyday abilities. The ECog comprises of 39 items on which the participant's current level of everyday functioning is compared to 10 years earlier. Items are rated on a four-point scale: 1= better or no change compared to 10 years earlier; 4= consistently much worse. Higher scores indicate greater functional limitations | Change from baseline to immediately post-intervention and through 6 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory | Measures depressive symptomatology | Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits | 
| Beck Anxiety Inventory | Measures anxiety symptomatology | Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits | 
| List learning task | measures learning and memory | Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits | 
| Executive function task | measures executive function | Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits | 
| psychomotor speed task | measures psychomotor speed function | Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits | 
| GRIT | an 8-item questionnaire assessing consistency of interest and perseverance of effort on a five-point scale: 1 = not at all like me, 5 = very much like me. | Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits |