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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03549078
Enrollment
69
Registered
2018-06-07
Start date
2017-01-01
Completion date
2019-08-14
Last updated
2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

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).

Interventions

BEHAVIORALIntervention

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.

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Everyday Compensation QuestionnaireChange from baseline to immediately post-intervention and through 6 month follow upa 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.
Everyday CognitionChange from baseline to immediately post-intervention and through 6 month follow upself-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

Secondary

MeasureTime frameDescription
List learning taskMeasured at baseline, immediately after intervention, and 3 and 6 month follow up visitsmeasures learning and memory
Executive function taskMeasured at baseline, immediately after intervention, and 3 and 6 month follow up visitsmeasures executive function
Beck Depression InventoryMeasured at baseline, immediately after intervention, and 3 and 6 month follow up visitsMeasures depressive symptomatology
GRITMeasured at baseline, immediately after intervention, and 3 and 6 month follow up visitsan 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.
psychomotor speed taskMeasured at baseline, immediately after intervention, and 3 and 6 month follow up visitsmeasures psychomotor speed function
Beck Anxiety InventoryMeasured at baseline, immediately after intervention, and 3 and 6 month follow up visitsMeasures anxiety symptomatology

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026