Plain English Summary
Background and study aims
A caregiver or carer is an unpaid or paid person who helps another individual with an impairment with his or her activities of daily living. Caregiving for a dementia patient is associated with increased risk of psychological and physical health problems. Mindfulness Based Stress Reduction (MBSR) may help to reduce stress among non-professional caregivers of patients with dementia. This study was designed to investigate the effectiveness of and the mechanisms by which a MBSR-based training course may reduce stress in non-professional caregivers of patients with dementia.
Who can participate?
Adult children or grandchildren, spouses, and non-professional caregivers (age over 21) of persons with dementia.
What does the study involve?
Participants attend an eight-week Mindfulness Based Stress Reduction-based training course designed to better accommodate the needs of non-professional caregivers. Participants complete psychological questionnaires and provide blood samples before and after completion of the MBSR training course to evaluate the effects of the course.
What are the possible benefits and risks of participating?
Participants do not benefit directly from being in this research study. The researchers hope to learn more about how the Mindfulness for Caregivers class benefits caregivers in both their psychological and physical health. This might help caregivers in the future. There is a slight risk associated with blood sampling, which includes a brief sense of pain with the needle stick, possible bruising of the skin, and a very small risk of infection. There is a small risk that answering the psychological assessments may cause emotional distress. To guide against the risk of loss of privacy, all results from psychological assessments and blood tests will be identified using non-identifiable codes not linked to any personal information such as name or social security number.
Where is the study run from?
Martha Stewart Center for Living, the geriatrics outpatient practice of the Brookdale Department of Geriatric and Palliative Medicine at the Icahn School of Medicine at Mount Sinai in New York, NY (USA).
When is the study starting and how long is it expected to run for?
May 2009 to May 2010
Who is funding the study?
Icahn School of Medicine at Mount Sinai Pilot Grant
Who is the main contact?
Dr Patricia A Bloom
patricia.bloom@exchange.mssm.edu
Trial website
Contact information
Type
Scientific
Primary contact
Dr Giulio Pasinetti
ORCID ID
Contact details
Icahn School of Medicine at Mount Sinai
1468 Madison Avenue
Annenberg 20-02b
New York
10029
United States of America
+1 (0)212 241 7938
giulio.pasinetti@mssm.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The development of clinically accessible biomarkers for predicting the health benefits of mindfulness-based stress reduction for caregivers of patients with dementia
Acronym
Study hypothesis
We hypothesise that a Mindfulness-Based Stress Reduction training course that was designed to better accommodate the needs of non-professional caregivers may help reduce stress among non-professional caregivers of patients with dementia
Ethics approval
Institutional Review Board, Icahn School of Medicine at Mount Sinai, approval number 090354
Study design
Single-center prospective single-arm behavioral intervention study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Self-perceived stress, depression, burden and grief in non-professional caregivers of dementia patients
Intervention
Mindfulness Based Stress Reduction (MBSR) has been shown to reduce stress and improve chronic disease outcomes for many different medical problems. This study was designed to investigate the effectiveness of, and the mechanisms by which a MBSR-based training course that is designed to better accommodate the needs of caregivers may reduce stress in non-professional caregivers of patients with dementia. Our MBSR training course for caregivers is closely modeled after the MBSR curriculum originally established by the Center of Mindfulness at the University of Massachusetts. Caregivers generally have a difficult time getting away to attend Mindfulness training. Based on evidence demonstrating that the length of classes is not correlated with mean effect, our MBSR course is especially modified to reduce class duration from 2.5 hours to 1.5 hours to accommodate the needs of caregivers. The course consists of a series of eight weekly classes meeting for 1.5 hours each, plus a four-hour retreat during week six. During the sessions, participants learn and practice several mindfulness exercises, such as the body scan, sitting meditation, mindful yoga postures, and walking meditation, which aim to develop mindfulness and the ability to attend to the present moment “without judgment”.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Overall score from the Caregiver Self-Assessment Questionnaire, a validated self-administered tool for assessing caregivers’ own perceived depression, burden, stress and grief
2. Overall score from the Five Facet Mindfulness Questionnaire, a validated self-administered tool for assessing the acquisition of mindfulness skills
3. Gene expression profiles in peripheral blood mononuclear cells
Secondary outcome measures
1. Self-perceived depression assessed using the Center for Epidemiological Studies Depression Scale
2. Self-perceived stress assessed using the 10-Item Perceived Stress Scale
3. Self-perceived burden assessed using the Rapid Screen for Caregiver Burden
4. Self-perceived grief assessed using the Inventory of Traumatic Grief Pre-Loss
Overall trial start date
12/05/2009
Overall trial end date
12/05/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Non-professional, adult caregiver of a person with dementia
Participant type
Carer
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
Acute psychiatric illness or active substance abuse which precludes active participation in the course and commitment to practice
Recruitment start date
12/05/2009
Recruitment end date
12/05/2010
Locations
Countries of recruitment
United States of America
Trial participating centre
Icahn School of medicine at Mount Sinai
1428 Madison Ave
New York
10029
United States of America
Sponsor information
Organisation
Icahn School of Medicine at Mount Sinai (USA)
Sponsor details
1468 Madison Avenue
Annenberg 20-02b
New York
10029
United States of America
+1 (0)212 241 7938
giulio.pasinetti@mssm.edu
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Icahn School of Medicine at Mount Sinai Pilot Grant (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
A manuscript has been submitted for publication
Intention to publish date
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary