MBDC-The Mindfulness Based Dementia-Care Study
Conditions: Caregiver Burnout
Sponsor: HealthPartners Institute

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MBDC-The Mindfulness Based DemenƟa-Care Study -Protocol 
 
NCT Number: NCT04062227 
PI: Bhavani Kashyap, MBBS, PhD 
Version 5 
Original Date: Aug 16, 2019 
 
 
 
 
 

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Summary 
 
Mindfulness refers to a particular type of attention that is focused on the present moment, with 
non-judgmental awareness and acceptance of that experience, with a general attitude of 
openness and curiosity.  Mindfulness-Based training was designed to enhance the range and use 
of coping skills, decrease levels of stress, improve mood, and reduce tendencies to react in 
maladaptive ways 1-3.  We are evaluating a program being conducted at multiple sites, called the 
Mindfulness Based Dementia-Care (MBDC) in caregivers (CG) for dementia, which combines the 
traditional mindfulness training approaches with dementia specific education. MBDC is housed 
by The Presence Care Project non-profit, which offers training to certify MDBC Facilitators.   
The overall objective of this study is to evaluate the efficacy of the Mindfulness-Based Dementia 
Care Program by conducting a prospective, pre-post, observational study with members 
participating in the MBDC program across multiple sites. Results will be included in a future 
grant submission for a larger scale research project that will include a control group, as well as 
objective measures, such as cortisol levels, and blood pressure. 
 
Study aims 
Aim 1: Evaluate change in self-reported measures in caregivers parƟcipaƟng in Mindfulness 
Based DemenƟa-Care (MBDC) program. 
Primary Outcome: Change in pre-post stress scores. 
Secondary Outcome: Change in pre-post self-reported depressions scores  
Exploratory Outcomes: 
• 
Change in pre-post self-reported measures of confidence, self-compassion, sleep, 
resilience and well-being 
• 
Change in Pre-Follow-up of self-reported measures of stress, depression, confidence, 
self-compassion, sleep, resilience, well-being 
Aim 2: Describe the MBDC program based on parƟcipaƟon, instructor and program saƟsfacƟon 
using a post-program survey 
 
Approach 
a. Study design 
We are conducting a prospective pre-post observational study with members of the 
Mindfulness-Based Dementia Care (MBDC) program. 
 
The MBDC program is an 8-week program designed for family caregivers for those living 
with dementia. The program is offered typically twice in a year at the HealthPartners 
Neuroscience center (program brochure attached) and other presence care project 
sites. Additional sites currently include the University of Michigan, the Ray Dolby Brain 
Health Center in San Francisco, and through a community offering in Grand Marais, MN.  
Participants attend a 1-hour orientation session, 2-hour classes each week for 7 weeks, 

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at-home practice between classes, and a 6-hour retreat. Some of the focuses of the 
weekly lessons include stress reduction, awareness of breath, grief contemplation, self-
compassion, communication, responding to challenges, and mindfulness in everyday 
life. At the beginning and end of each weekly class, participants are evaluated based on 
their stress levels during the week prior and immediately after the class. At the end of 
the 8-week session, participants fill out a survey that includes a program evaluation, an 
instructor rating, and a self-evaluation of how well they will incorporate what they have 
learned from the course into their every-day life. Through surveys, the participant’s 
mindfulness and well-being is also evaluated before, immediately after, and 3 months 
following the 8-week session. The following chart illustrates the timeline for this 
program, and the table indicates the study measures and at what point on the timeline 
they are evaluated. 
The Program 
Mindfulness-Based DemenƟa Care (MBDC) is an eight-week, group-based program designed for 
people who care for cogniƟvely impaired individuals.  
While not all stress is inherently bad, there are unique stressors experienced in the demenƟa 
care exchange that can become mentally, physically, and emoƟonally overwhelming. A 
mindfulness pracƟce speciﬁcally geared to the care exchange oﬀers invaluable resources and 
coping pracƟces for responding to these stressors. The Mindfulness-Based DemenƟa Care 
program oﬀers a way to establish a pracƟce of mindfulness that is integrated with the day-to-day 
realiƟes of caring for a loved one with demenƟa. Such a pracƟce, especially if sustained over 
Ɵme, can help improve the quality of life for both the care partner and the person living with 
demenƟa.   
MBDC groups typically consist of ﬁve to twelve parƟcipants. The program consists of seven two-
hour sessions and one six-hour Day of Mindfulness. The sessions include formal meditaƟons and 
informal mindfulness pracƟces, role play, and lectures on demenƟa-related topics. ParƟcipants 
receive a workbook with literature related to the session topics and journaling prompts. The 
program also involves pracƟce between classes.  
Teaching and pracƟces include formal meditaƟon pracƟces, as well as intervenƟons borrowed 
from therapeuƟc modaliƟes, such as CogniƟve Behavioral Therapy, and Acceptance and 
Commitment Therapy. The goal is to reward parƟcipants with a transformaƟve experience that 
may help sustain their wellbeing over the care journey. Though MBDC is not a therapy program, 
per se, it is quite therapeuƟc. It is also not a support group, but parƟcipants share that they feel 
very supported by the process, the inƟmacy of the program, and the new network of fellow 
demenƟa caregivers.   

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b. Population 
i. Inclusion/Exclusion Criteria 
Inclusion criteria: 
• 
Must be ages ≥ 18 years  
• 
Must be able to read and understand English   
• 
Participant of the MBDC Program at any site 
 
ii. Sample size 
The MBDC program at a time has only 12-15 participants. We hope to enroll at 
multiple offerings of the MBDC program. For the study, we plan to contact ~ 60 
participants, and enroll ~ 50 in the study. Plan is to enroll through 5 sessions. 
Depending on the recruitment we may extend beyond the 5 sessions up to a 
maximum of 7 consecutive sessions.  With multiple sites, we will be able to 
reach this number more quickly and prepare for a grant application to study the 
MBDC class as an intervention and include a control group. 
c. Intervention, treatment 
N/A. This is a prospective observational study of the MBDC program. 
  
d. Outcomes/endpoint and other variable definitions, and instruments used 
Please see all the surveys and the variables spreadsheet attached. The 
measures/instruments are defined below. 
Primary Outcome: The Perceived Stress Scale (PSS): The Perceived Stress Scale is a 
widely used measure for stress perception. It measures how often and to what degree 
situations are characterized as stressful. This measures as been used to evaluate stress 
associated with chronic disease 9.  
 
Secondary Outcome: Center for Epidemiologic Studies Depression Scale (CES-D): The 
Center for Epidemiologic Studies Depression Scale measures self-reported symptoms 
associated with depression. It has been validated for dementia and multiple other 
diagnoses, and it is sensitive to differences between caregivers and non-caregivers 10. 
 
Exploratory Outcomes: 
Self-Compassion: To evaluate self-compassion, participants indicated how often they 
acted in the manner stated in each of the items on a scare of 1 (almost never) to 5 
(almost always). The survey evaluates self-kindness verses self-judgement, common 
humanity verses isolation, and mindfulness versus over-identification 11.  
 
Zarit Burden Inventory: The Zarit Burden Inventory is an interview that evaluates 
caregiver burden through a self-report measure. The survey scores are positively 
correlated with behavior problems in older adults and depression scores of caregivers 12. 
 
The Resilience Scale: The Resilience Scale has been used with people of different ages, 
education, and socioeconomic backgrounds. It evaluates the individual’s stress, anxiety, 
forgiveness, and health promoting activities 13.  

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Pittsburgh Sleep Quality Index (PSQI): This is a validated self-report questionnaire that 
evaluates sleep quality over a 1-month time interval 15. The measure takes about 5 min 
to complete. 
 
Five Facet Mindfulness Questionnaire (FFMQ) Mindfulness: This scale evaluates five 
components, which includes observing, describing, acting with awareness, non-judging 
of inner experience, and non-reactivity to inner experience. This measure was 
developed by Ruth Baer at the University of Kentucky 16.  
 
Likert Scale Stress Rating: Attitudes are measured by asking people to respond to a 
series of statements, indicating the extent to which they agree with them.  
 
Confidence Survey: A set of questionnaires developed by University of Michigan to 
understand the confidence of caregiver in their ability to respond to caregiver needs and 
access to resources (questionnaire # 1, survey). 
 
MBDC Program Evaluation Survey: 
Program Evaluation: This survey demonstrates how the participant evaluates the quality 
and usefulness of the program.  
 
Instructor Rating: The participant evaluates the instructor’s ability to give clear 
expectations, knowledge of the subject matter, and attitude.  
 
Participation in Practice: The participant reports the level of effort that they invested in 
formal meditation between classes.  
 
e. Statistical analysis plan 
Aim 1: 
We will describe the patient characteristics using means and standard deviations (for 
continuous variables) and frequencies (for binary and categorical variables).Mean and 
standard deviations of scores for each of these validated scales will be calculated.  
1. Pre-Post 
2. Pre-Follow up 
The mean and standard deviation of pre-post and pre-follow-up change in scores within 
participants will also be calculated. The 3 scores (pre, post and follow up) for each of the 
scales will be plotted on a histogram and we will describe any trends that we might see 
over time. 
 
As the primary analysis, we will do paired t-test for change in scores of the PSS. As an 
exploratory analysis we will do a linear regression model with age and number of classes 
as covariates.  
 
Aim 2:  

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We will describe the post-survey measures (evaluation of the program) using means and 
standard deviations (for continuous variables) and frequencies (for binary and 
categorical variables) and report qualitatively the themes of the open ended questions. 
 
 
f. Power analysis or statement of precision 
With a sample size of 50, the primary analysis is powered at 80% to detect a mean 
paired different of -1.8 with an estimated standard deviation of differences of 4.5, based 
on previous data from mindfulness program. This change is clinically meaningful and 
seems reasonable given previous research in this area.  
 
g. Strengths and limitations 
Strength: Pragmatic way of assessing the mindfulness program 
Limitations: 
1. Lack of control group in the study. 
2. Limited sample size. 
3. Observational study. 
4. Multiple confounders 
Risks and Beneﬁts 
There are almost no risks associated with being in this study. The standardized testing may make 
you uncomfortable because some parts may be too easy and you may feel self-conscious, while 
some parts of it may be difficult or tiring. The health history survey probes for personal health 
history information that may be sensitive information. 
 
By being in this study you may or may not receive any direct benefit. You may feel better and 
more connected with the community. 
Data ConﬁdenƟality and Privacy 
Only research staﬀ on the study will have access to the data. In addiƟon, we also assign study ID 
for the parƟcipants. All the paper based assessment will be kept in a secure locaƟon in a locked 
oﬃce. For the web based survey, we will use a secure portal to collect data and the data will be 
stored on a secure server with password access to the research staﬀ only. 
 
 
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Oken BS, Fonareva I, Haas M, et al. Pilot controlled trial of mindfulness meditation and 
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