An interventional study of Intervention in Subjective Cognitive Concerns (SCC), sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-03.
Sponsored by University of California, Davis · Not applicable, Interventional, and Prevention
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.
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).
University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Time frame: baseline and 6 months follow up
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.
Time frame: baseline and 6 months follow up
Beck Depression Inventory
Measures depressive symptomatology
Time frame: baseline, immediately after intervention, and 3 and 6 month follow-up visits
Beck Anxiety Inventory
measures anxiety symptomatology
Time frame: baseline, immediately after intervention, and 3 and 6 month follow-up visits
List learning task
measures learning and memory
Time frame: baseline, immediately after intervention, and 3 and 6 month follow-up visits
Executive function task
measures executive function
Time frame: baseline, immediately after intervention, and 3 and 6 month follow-up visits
Psychomotor Speed Task
measures psychomotor function
Time frame: baseline, immediately after intervention, and 3 and 6 month follow-up visits
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.
Time frame: baseline, immediately after intervention, and 3 and 6 month follow-up visits
Plan to share: No
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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University of California, Davis