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Meditation or Education for Alzheimer Caregivers

Primary Purpose

Caregivers, Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Meditation
Education
Respite only
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caregivers

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Meditation class, 90min/week for 8 weeks, with home assignments, adapted from MBCT program

Education

Respite care only, 90 mins per week for 8 weeks

Outcomes

Primary Outcome Measures

Caregiver stress (Revised Memory and Behavior Problems Checklist)

Secondary Outcome Measures

5-Facet Mindfulness Questionnaire
This self-report questionnaire measures different aspects of mindfulness
Perceived Self-Efficacy
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
EEG is recorded during reaction time tests to measure attention

Full Information

First Posted
November 14, 2007
Last Updated
October 27, 2014
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT00558402
Brief Title
Meditation or Education for Alzheimer Caregivers
Official Title
Meditation for Alzheimer Caregivers: Stress & Physiology
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregivers, Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Meditation class, 90min/week for 8 weeks, with home assignments, adapted from MBCT program
Arm Title
2
Arm Type
Active Comparator
Arm Description
Education
Arm Title
3
Arm Type
Active Comparator
Arm Description
Respite care only, 90 mins per week for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Meditation
Other Intervention Name(s)
Mindfulness Based Stress Reduction
Intervention Description
meditation class 1/week for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Education
Other Intervention Name(s)
Powerful Tools for Caregivers
Intervention Description
Education class, 90 min per week for 8 weeks along with home assignments based on Powerful Tools for Caregivers
Intervention Type
Behavioral
Intervention Name(s)
Respite only
Other Intervention Name(s)
Respite care
Intervention Description
Respite care 90 mins per week for 8 weeks
Primary Outcome Measure Information:
Title
Caregiver stress (Revised Memory and Behavior Problems Checklist)
Time Frame
8 and 20 weeks
Secondary Outcome Measure Information:
Title
5-Facet Mindfulness Questionnaire
Description
This self-report questionnaire measures different aspects of mindfulness
Time Frame
0, 8 and 20 weeks
Title
Perceived Self-Efficacy
Description
The General Perceived Self-Efficacy Scale developed by Schwarzer and Jerusalem in 1995 contains 10 items asking about sense of control.
Time Frame
Measured 0, 8, and 16 Weeks
Title
EEG measuring reaction time
Description
EEG is recorded during reaction time tests to measure attention
Time Frame
Measured at 0, 8, and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry S Oken, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Meditation or Education for Alzheimer Caregivers

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