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Nonrandomized Evaluation of a Multidimensional Behavioral Intervention

A Nonrandomized 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
NCT03717597
Acronym
BBLite
Enrollment
15
Registered
2018-10-24
Start date
2018-04-26
Completion date
2021-12-10
Last updated
2022-02-03

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

Conditions

Subjective Cognitive Concerns (SCC)

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

Intervention model description

While subjects will be enrolled in multiple groups, all subjects will receive the same intervention and will complete the same study activities.

Eligibility

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

Inclusion criteria

* a diagnosis of subjective cognitive complaints (SCC) * Age 65+ * 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
Change in compensation usebaseline and 6 months follow upMeasured using the 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 in cognitionbaseline and 6 months follow upMeasured using the Everyday Cognition (ECog) scale, a 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.

Secondary

MeasureTime frameDescription
List learning taskbaseline, immediately after intervention, and 3 and 6 month follow-up visitsmeasures learning and memory
Executive function taskbaseline, immediately after intervention, and 3 and 6 month follow-up visitsmeasures executive function
Beck Depression Inventorybaseline, immediately after intervention, and 3 and 6 month follow-up visitsMeasures depressive symptomatology
GRITbaseline, immediately after intervention, and 3 and 6 month follow-up visits8-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 Taskbaseline, immediately after intervention, and 3 and 6 month follow-up visitsmeasures psychomotor function
Beck Anxiety Inventorybaseline, 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 4, 2026