Meditation or Education for Alzheimer Caregivers
Condition: Caregivers; Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

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.
    

Intervention name(s): Meditation; Education; Respite only
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): meditation class 1/week for 8 weeks; Education class, 90 min per week for 8 weeks along with home assignments based on Powerful Tools for Caregivers; Respite care 90 mins per week for 8 weeks
Other intervention name(s): Mindfulness Based Stress Reduction; Powerful Tools for Caregivers; Respite care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment