BBLite: Nonrandomized Evaluation of a Multidimensional Behavioral Intervention

Sponsor
University of California, Davis (Other)
Overall Status
Completed
CT.gov ID
NCT03717597
Collaborator
(none)
15
1
1
43.5
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intervention
N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.While subjects will be enrolled in multiple groups, all subjects will receive the same intervention and will complete the same study activities.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Nonrandomized Evaluation of a Multidimensional Behavioral Intervention for Those at Risk for Alzheimer's Dementia
Actual Study Start Date :
Apr 26, 2018
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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
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.

Outcome Measures

Primary Outcome Measures

  1. Change in compensation use [baseline and 6 months follow up]

    Measured 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.

  2. Change in cognition [baseline and 6 months follow up]

    Measured 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 Outcome Measures

  1. Beck Depression Inventory [baseline, immediately after intervention, and 3 and 6 month follow-up visits]

    Measures depressive symptomatology

  2. Beck Anxiety Inventory [baseline, immediately after intervention, and 3 and 6 month follow-up visits]

    measures anxiety symptomatology

  3. List learning task [baseline, immediately after intervention, and 3 and 6 month follow-up visits]

    measures learning and memory

  4. Executive function task [baseline, immediately after intervention, and 3 and 6 month follow-up visits]

    measures executive function

  5. Psychomotor Speed Task [baseline, immediately after intervention, and 3 and 6 month follow-up visits]

    measures psychomotor function

  6. GRIT [baseline, immediately after intervention, and 3 and 6 month follow-up visits]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California Davis Sacramento California United States 95816

Sponsors and Collaborators

  • University of California, Davis

Investigators

  • Principal Investigator: Michelle Chan, PhD, University of California, Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT03717597
Other Study ID Numbers:
  • 1210286
First Posted:
Oct 24, 2018
Last Update Posted:
Feb 3, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 3, 2022