Meditation or Education for Alzheimer Caregivers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Barry S. Oken, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00558402
First received: November 14, 2007
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

The goal is to determine how 6-week stress reduction techniques 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 12 hours per week caring for a close relative with Alzheimer's disease, 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 3 hours. The classes are taught in a one-on-one setting, and they are 50 minutes per week for 6 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, including the following: saliva, blood, and urine collection; waist-to-hip ratio; weight; blood pressure; heart rate; respiration; reaction time task; voice recordings; electrocardiogram; electroencephalogram; and electro dermal activity.


Condition Intervention Phase
Caregivers
Alzheimer's Disease
Behavioral: Meditation
Behavioral: Education
Behavioral: Respite only
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Meditation for Alzheimer Caregivers: Stress & Physiology

Resource links provided by NLM:


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:
  • 5-Facet Mindfulness Questionnaire [ Time Frame: 0, 8 and 20 weeks ] [ Designated as safety issue: No ]
    This self-report questionnaire measures different aspects of mindfulness

  • Perceived Self-Efficacy [ Time Frame: Measured 0, 8, and 16 Weeks ] [ Designated as safety issue: No ]
    The General Perceived Self-Efficacy Scale developed by Schwarzer and Jerusalem in 1995 contains 10 items asking about sense of control.

  • EEG measuring reaction time [ Time Frame: Measured at 0, 8, and 16 weeks ] [ Designated as safety issue: No ]
    EEG is recorded during reaction time tests to measure attention


Estimated Enrollment: 108
Study Start Date: November 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Meditation class, 90min/week for 8 weeks, with home assignments, adapted from MBCT program
Behavioral: Meditation
meditation class 1/week for 8 weeks
Other Name: Mindfulness Based Stress Reduction
Active Comparator: 2
Education
Behavioral: Education
Education class, 90 min per week for 8 weeks along with home assignments based on Powerful Tools for Caregivers
Other Name: Powerful Tools for Caregivers
Active Comparator: 3
Respite care only, 90 mins per week for 8 weeks
Behavioral: Respite only
Respite care 90 mins per week for 8 weeks
Other Name: Respite care

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 active interventions, MBCT and education, also include identical respite care for the PWD to allow the caregiver to attend the classes. Each intervention will last 6 weeks, and consist of one 50 minute class and/or or 2-3 hours of respite per week along. Homework for the two groups in the classes 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. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558402

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
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: Barry S. Oken, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00558402     History of Changes
Other Study ID Numbers: IRB00002226
Study First Received: November 14, 2007
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 18, 2014