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Sponsored by: |
Oregon Health and Science University |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00558402 |
The goal is to determine how 8-week programs may decrease stress in primary caregivers of people with Alzheimer's disease. The 3 intervention programs are meditation, education, and respite care. There will be approximately 108 subjects over 3 years. Subjects will have a screening session over the phone to see if they are eligible (50-85 years old, spending at least 20 hours per week taking care of a person with Alzheimer's disease who is a family member or close relationship, willing to be in any of the 3 groups, and without any very serious medical problem). The subjects will have 3 testing sessions, 1 before classes/respite and 2 after classes are over, each lasting about 2 hours. The classes/respite are 90 minutes per week for 8 weeks. Respite care is provided for the person with Alzheimer's disease in all the groups. Measurements include people's ratings of stress, psychological testing, and biological measurements of stress (from collections of saliva, blood and recordings of brain waves and electrocardiogram).
Condition | Intervention | Phase |
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Caregivers Alzheimer's Disease |
Behavioral: Meditation Behavioral: Education Behavioral: Respite only |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Meditation for Alzheimer Caregivers: Stress & Physiology |
Estimated Enrollment: | 108 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Meditation class, 90min/week for 8 weeks, with home assignments, adapted from MBCT program
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Behavioral: Meditation
meditation class 1/week for 8 weeks
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2: Active Comparator
Education
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Behavioral: Education
Education class, 90 min per week for 8 weeks along with home assignments based on Powerful Tools for Caregivers
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3: Active Comparator
Respite care only, 90 mins per week for 8 weeks
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Behavioral: Respite only
Respite care 90 mins per week for 8 weeks
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Stress has a negative effect on many aspects of health. Older adults may be particularly sensitive to adverse effects of stress because of lower physiologic reserves and coexistence of other health problems. Since mind-body interventions may be most effective in conditions associated with psychological stress, this research will evaluate the effectiveness of a mind-body intervention in seniors who have a significant stress: being the primary caregiver for a person with dementia (PWD) secondary to Alzheimer's disease. The well-being of this large and growing group of Americans is a significant public health issue. We plan to study a Mindfulness Based Cognitive Therapy (MBCT) program for caregivers of a PWD in a randomized 3-arm intervention trial. There are two comparison groups: an education group and a pragmatic, respite only group. The two more active interventions, MBCT and education, also include identical respite care for the PWD to allow the caregiver to attend the classes. There will be 108 subjects aged 50-85 years including subjects from an African-American subgroup that have been followed by the Oregon Health & Science University (OHSU) Alzheimer's Disease Center. Each intervention will last 8 weeks, and consist of one 90-minute session per week along with at-home implementation of knowledge learned from the two more active interventions. Homework for the two groups will consist of home meditation practice for the MBCT group and development of an action plan and reading for the education group. Outcome measures will be assessed at 8 weeks and at 20 weeks (immediately and 12 weeks after the intervention class has been completed). Our primary outcome measure will be a self-rated measure of caregiver stress. There are a number of secondary outcome measures representing biomarkers of stress including: salivary cortisols measured over the day to include the awakening response and trough levels; inflammatory markers; and electrophysiologic markers measured with an innovative 24-hour physiologic data acquisition device (heart rate and heart rate variability, movement, respiration, and EEG). Other secondary outcome measures include self-efficacy, health-related quality of life, mood, and cognitive function. We will use several measures to predict response to MBCT and education in an aptitude by treatment interaction analysis. These measures include the personality trait absorption, emotion-based versus problem-based coping, and expectancy of improvement from each intervention. We will also use the 24-hour acquisition device to evaluate the ability of subjects randomized to MBCT to induce physiologic changes during self-reported mindfulness meditation and relate the magnitude of these changes to improvements in outcome measures.
Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alexandra Amen, BA | 503-494-5650 | amena@ohsu.edu |
Contact: Daniel Zajdel | 503-494-5650 | zajdeld@Ohsu.edu |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Principal Investigator: Barry S Oken, MD |
Principal Investigator: | Barry S Oken, MD | Oregon Health and Science University |
Responsible Party: | Oregon Health & Science University ( Barry S. Oken, M.D. ) |
Study ID Numbers: | IRB00002226 |
Study First Received: | November 14, 2007 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00558402 History of Changes |
Health Authority: | United States: Institutional Review Board |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Stress |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |