Nonrandomized Evaluation of a Multidimensional Behavioral Intervention

Subjective Cognitive Concerns (SCC) Clinical Trial

— BBLite  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03717597
• Other study ID #: 1210286
• Status: Completed
• Phase: N/A
• Start date: April 26, 2018
• Est. completion date: December 10, 2021

Study information

• Verified date: February 2022
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 10, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Subjective Cognitive Concerns (SCC)

Intervention

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.

Locations

Country	Name	City	State
United States	University of California Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (5)

Farias ST, Lau K, Harvey D, Denny KG, Barba C, Mefford AN. Early Functional Limitations in Cognitively Normal Older Adults Predict Diagnostic Conversion to Mild Cognitive Impairment. J Am Geriatr Soc. 2017 Jun;65(6):1152-1158. doi: 10.1111/jgs.14835. Epub 2017 Mar 17. — View Citation

Greenaway MC, Duncan NL, Smith GE. The memory support system for mild cognitive impairment: randomized trial of a cognitive rehabilitation intervention. Int J Geriatr Psychiatry. 2013 Apr;28(4):402-9. doi: 10.1002/gps.3838. Epub 2012 Jun 7. — View Citation

Greenaway MC, Hanna SM, Lepore SW, Smith GE. A behavioral rehabilitation intervention for amnestic mild cognitive impairment. Am J Alzheimers Dis Other Demen. 2008 Oct-Nov;23(5):451-61. doi: 10.1177/1533317508320352. — View Citation

Lau KM, Parikh M, Harvey DJ, Huang CJ, Farias ST. Early Cognitively Based Functional Limitations Predict Loss of Independence in Instrumental Activities of Daily Living in Older Adults. J Int Neuropsychol Soc. 2015 Oct;21(9):688-98. doi: 10.1017/S1355617715000818. Epub 2015 Sep 22. — View Citation

Tomaszewski Farias S, Schmitter-Edgecombe M, Weakley A, Harvey D, Denny KG, Barba C, Gravano JT, Giovannetti T, Willis S. Compensation Strategies in Older Adults: Association With Cognition and Everyday Function. Am J Alzheimers Dis Other Demen. 2018 May;33(3):184-191. doi: 10.1177/1533317517753361. Epub 2018 Jan 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in compensation use	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.	baseline and 6 months follow up
Primary	Change in cognition	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.	baseline and 6 months follow up
Secondary	Beck Depression Inventory	Measures depressive symptomatology	baseline, immediately after intervention, and 3 and 6 month follow-up visits
Secondary	Beck Anxiety Inventory	measures anxiety symptomatology	baseline, immediately after intervention, and 3 and 6 month follow-up visits
Secondary	List learning task	measures learning and memory	baseline, immediately after intervention, and 3 and 6 month follow-up visits
Secondary	Executive function task	measures executive function	baseline, immediately after intervention, and 3 and 6 month follow-up visits
Secondary	Psychomotor Speed Task	measures psychomotor function	baseline, immediately after intervention, and 3 and 6 month follow-up visits
Secondary	GRIT	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.	baseline, immediately after intervention, and 3 and 6 month follow-up visits