Full Text View
Tabular View
No Study Results Posted
Related Studies
Meditation or Education for Alzheimer Caregivers
This study is currently recruiting participants.
Verified by Oregon Health and Science University, April 2009
First Received: November 14, 2007   Last Updated: April 28, 2009   History of Changes
Sponsored by: Oregon Health and Science University
Information provided by: Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00558402
  Purpose

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
Caregivers
Alzheimer's Disease
Behavioral: Meditation
Behavioral: Education
Behavioral: Respite only
Phase II

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Caregivers Alzheimer's Disease Caregivers
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: Meditation for Alzheimer Caregivers: Stress & Physiology

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Caregiver stress (Revised Memory and Behavior Problems Checklist) [ Time Frame: 8 and 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CESD, Perceived Stress Scale, Caregiver self-efficacy, Neuropsychiatric INventory, AD-related quality of life, salivary cortisol, cytokines, telomere length, telomerase, heart rate, heart rate variability [ Time Frame: 8 and 20 weeks ] [ Designated as safety issue: Yes ]

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
1: Experimental
Meditation class, 90min/week for 8 weeks, with home assignments, adapted from MBCT program
Behavioral: Meditation
meditation class 1/week for 8 weeks
2: Active Comparator
Education
Behavioral: Education
Education class, 90 min per week for 8 weeks along with home assignments based on Powerful Tools for Caregivers
3: Active Comparator
Respite care only, 90 mins per week for 8 weeks
Behavioral: Respite only
Respite care 90 mins per week for 8 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 50-85 year olds who are the primary caregiver of someone with Alzheimer disease (family member or other close relationship)

Exclusion Criteria:

  • cognitively impaired
  • unstable medical problems
  • untreated significant depression
  • taking CNS-active medications that have not been stable for 2 months
  • significant visual impairment (acuity worse than 20/50 OU)
  • experience with meditation classes of with Powerful Tools for Caregivers classes
  • not have significant baseline stress
  • evidence on history of certain significant neurological diseases
  • unwilling to accept randomization or to commit to attending classes and practicing the interventions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558402

Contacts
Contact: Alexandra Amen, BA 503-494-5650 amena@ohsu.edu
Contact: Daniel Zajdel 503-494-5650 zajdeld@Ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Barry S Oken, MD            
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Barry S Oken, MD Oregon Health and Science University
  More Information

No publications provided

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

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Stress
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009