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Completed

NCT Number: NCT03549078

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

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.

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Key information

Conditions

Functional Aging Brain Health Activities Compensation Strategies Subjective Cognitive Concerns

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis

Sacramento, California, 95816, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intervention

Behavioral

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.

Primary outcomes

  1. Everyday Compensation Questionnaire

    Time frame: Change from baseline to immediately post-intervention and through 6 month follow up

    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.

  2. Everyday Cognition

    Time frame: Change from baseline to immediately post-intervention and through 6 month follow up

    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 outcomes

  1. Beck Depression Inventory

    Time frame: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits

    Measures depressive symptomatology

  2. Beck Anxiety Inventory

    Time frame: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits

    Measures anxiety symptomatology

  3. List learning task

    Time frame: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits

    measures learning and memory

  4. Executive function task

    Time frame: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits

    measures executive function

  5. psychomotor speed task

    Time frame: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits

    measures psychomotor speed function

  6. GRIT

    Time frame: Measured at baseline, immediately after intervention, and 3 and 6 month follow up visits

    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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2018
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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