Nonrandomized Evaluation of a Multidimensional Behavioral Intervention (BBLite)
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|ClinicalTrials.gov Identifier: NCT03717597|
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Subjective Cognitive Concerns (SCC)||Behavioral: Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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.|
|Masking:||None (Open Label)|
|Official Title:||A Nonrandomized Evaluation of a Multidimensional Behavioral Intervention for Those at Risk for Alzheimer's Dementia|
|Actual Study Start Date :||April 26, 2018|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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.
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 [ Time Frame: 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.
- Change in cognition [ Time Frame: 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.
- Beck Depression Inventory [ Time Frame: baseline, immediately after intervention, and 3 and 6 month follow-up visits ]Measures depressive symptomatology
- Beck Anxiety Inventory [ Time Frame: baseline, immediately after intervention, and 3 and 6 month follow-up visits ]measures anxiety symptomatology
- List learning task [ Time Frame: baseline, immediately after intervention, and 3 and 6 month follow-up visits ]measures learning and memory
- Executive function task [ Time Frame: baseline, immediately after intervention, and 3 and 6 month follow-up visits ]measures executive function
- Psychomotor Speed Task [ Time Frame: baseline, immediately after intervention, and 3 and 6 month follow-up visits ]measures psychomotor function
- GRIT [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717597
|Contact: Katherine G Denny, PhDfirstname.lastname@example.org|
|Contact: Sarah Farias, PhDemail@example.com|
|United States, California|
|University of California Davis||Recruiting|
|Sacramento, California, United States, 95816|
|Contact: Katherine G Denny, Ph.D. 916-734-4301 firstname.lastname@example.org|
|Principal Investigator:||Katherine G Denny, PhD||University of California, Davis|