Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment
NCT01299766 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 221
Last updated 2018-12-12
Summary
The goal of this study is to determine whether increasing participation in cognitive, physical, and/or social activities prevents cognitive decline in older African Americans (AAs) with Mild Cognitive Impairment (MCI). Patients with MCI are at increased risk for Alzheimer's Disease (AD); we propose that increasing participation in activities will prevent cognitive decline and may delay the onset of Alzheimer's Disease (AD). We will test this hypothesis by conducting a clinical trial in which older AAs with MCI (aged 65 years and older) will be randomized to Behavior Activation (BA) (a behavioral intervention that increases participation in daily activities) or Supportive Therapy (ST) (a person-centered psychotherapy that involves active listening and offering support focusing on participants' problems and concerns). We hypothesize that BA-treated subjects will have fewer declines in cognitive and functional abilities, fewer depressive and neuropsychiatric symptoms, and better quality of life than ST-treated subjects at 24 months.
Conditions
- Mild Cognitive Impairment (MCI)
Interventions
- BEHAVIORAL
-
Behavioral Activation (BA)
BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.
- BEHAVIORAL
-
Supportive Therapy (ST)
ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.
Sponsors & Collaborators
-
Dartmouth College
collaborator OTHER - collaborator OTHER
- collaborator OTHER
-
National Institute on Aging (NIA)
collaborator NIH -
Thomas Jefferson University
lead OTHER
Principal Investigators
-
Robin J Casten, PhD · Thomas Jefferson University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-06-21
- Primary Completion
- 2016-12-13
- Completion
- 2016-12-13
Countries
- United States
Study Locations
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