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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
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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
Subjective Cognitive Concerns (SCC) Behavioral: Intervention Not Applicable

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).

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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)
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 : April 26, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Beck Depression Inventory [ Time Frame: baseline, immediately after intervention, and 3 and 6 month follow-up visits ]
    Measures depressive symptomatology

  2. Beck Anxiety Inventory [ Time Frame: baseline, immediately after intervention, and 3 and 6 month follow-up visits ]
    measures anxiety symptomatology

  3. List learning task [ Time Frame: baseline, immediately after intervention, and 3 and 6 month follow-up visits ]
    measures learning and memory

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

  5. Psychomotor Speed Task [ Time Frame: baseline, immediately after intervention, and 3 and 6 month follow-up visits ]
    measures psychomotor function

  6. 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: Katherine G Denny, PhD 916-734-4301 kgdenny@ucdavis.edu
Contact: Sarah Farias, PhD 916-734-6442 farias@ucdavis.edu

Locations
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United States, California
University of California Davis Recruiting
Sacramento, California, United States, 95816
Contact: Katherine G Denny, Ph.D.    916-734-4301    kgdenny@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Katherine G Denny, PhD University of California, Davis

Publications:
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03717597     History of Changes
Other Study ID Numbers: 1210286
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No