CaregiversPhase 2NCT00558402
Meditation or Education for Alzheimer Caregivers
A Phase 2 study testing Meditation, Education and Respite only in people with Caregivers and Alzheimer's Disease, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Caregivers, Alzheimer's Disease
- What is being tested?
- Meditation, Education and Respite only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50-85 year olds who are the primary caregiver of someone with Alzheimer disease (family member or other close relationship)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Meditation for Alzheimer Caregivers: Stress & Physiology
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.
Read the 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.
- Conditions
- Caregivers, Alzheimer's Disease
- Being tested
- Meditation, Education, Respite only
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
Also called Mindfulness Based Stress Reduction
meditation class 1/week for 8 weeks
EducationBehavioural
Also called Powerful Tools for Caregivers
Education class, 90 min per week for 8 weeks along with home assignments based on Powerful Tools for Caregivers
Respite onlyBehavioural
Also called Respite care
Respite care 90 mins per week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Meditation class, 90min/week for 8 weeks, with home assignments, adapted from MBCT program Receives: Behavioral: Meditation |
| 2 | Active comparator | Education Receives: Behavioral: Education |
| 3 | Active comparator | Respite care only, 90 mins per week for 8 weeks Receives: Behavioral: Respite only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver stress (Revised Memory and Behavior Problems Checklist)
Measured: 8 and 20 weeks
Secondary outcomes (3)
5-Facet Mindfulness Questionnaire
This self-report questionnaire measures different aspects of mindfulness
Measured: 0, 8 and 20 weeks
Perceived Self-Efficacy
The General Perceived Self-Efficacy Scale developed by Schwarzer and Jerusalem in 1995 contains 10 items asking about sense of control.
Measured: Measured 0, 8, and 16 Weeks
EEG measuring reaction time
EEG is recorded during reaction time tests to measure attention
Measured: Measured at 0, 8, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiversStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barry S. Oken, Oregon Health and Science University
- Investigators
- Barry S Oken, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558402
- Sponsor's protocol ID
- IRB00002226
- Status last verified
- Oct 2014
- First submitted
- 14 Nov 2007
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation for Alzheimer Caregivers: Stress & Physiology
- ClinicalTrials.gov ID
- NCT00558402
- Acronym / sponsor ID
- IRB00002226
- Conditions
- Caregivers, Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: MeditationMeditation class, 90min/week for 8 weeks, with home assignments, adapted from MBCT program |
| 2 | Active comparator | Behavioral: EducationEducation |
| 3 | Active comparator | Behavioral: Respite onlyRespite care only, 90 mins per week for 8 weeks |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 50-85 year olds who are the primary caregiver of someone with Alzheimer disease (family member or other close relationship)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeditationAlso: Mindfulness Based Stress Reductionmeditation class 1/week for 8 weeks | Behavioural | 1 |
| EducationAlso: Powerful Tools for CaregiversEducation class, 90 min per week for 8 weeks along with home assignments based on Powerful Tools for Caregivers | Behavioural | 2 |
| Respite onlyAlso: Respite careRespite care 90 mins per week for 8 weeks | Behavioural | 3 |
Primary outcome
Caregiver stress (Revised Memory and Behavior Problems Checklist)
Time frame: 8 and 20 weeks
3 secondary outcomes
5-Facet Mindfulness Questionnaire
Time frame: 0, 8 and 20 weeks
Perceived Self-Efficacy
Time frame: Measured 0, 8, and 16 Weeks
EEG measuring reaction time
Time frame: Measured at 0, 8, and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry S Oken, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Meditation, Education and Respite only in people with Caregivers and Alzheimer's Disease, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver stress (Revised Memory and Behavior Problems Checklist) (time frame: 8 and 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2014.