Mindful Self-Compassion Training to Improve Retention, Job Satisfaction, and Attitudes Toward Dementia Among Long-Term Care Nursing Assistants
Phase: NA
Conditions: Stress and Burnout
Sponsor: University of North Carolina, Chapel Hill

NCT03720652 
v. 3.18.2021 
 
 
 
Mindful Self-Compassion Training 
 to Improve Retention, Job Satisfaction, 
 and Attitudes toward Dementia among 
Long-Term Care Nursing Assistants:  
 
Certified Nursing Assistants’ Wellbeing 
 
 
 

v. 3.18.2021 
MINDFUL SELF-COMPASSION TRAINING TO IMPROVE RETENTION, 
JOB SATISFACTION, AND ATTITUDES TOWARD DEMENTIA AMONG 
LONG-TERM CARE NURSING ASSISTANTS 
Principal Investigator: 
Philip D. Sloane, MD, MPH (University of North Carolina at Chapel Hill) 
Co-Principal Investigator: 
Christine Lathren, MD, MPH (University of North Carolina at Chapel Hill) 
Supported by: 
The National Institute on Aging 
 (Grant #: 1R21AG058133-01A1) 
 
 
 
 
 

v. 3.18.2021 
Version 7 
March 18th, 2021
TABLE OF CONTENTS 
Page 
TABLE OF CONTENTS ............................................................................................................. ii 
PRÉCIS ......................................................................................................................................... iii 
Study Title .................................................................................................................................. iii 
Objectives .................................................................................................................................. iii 
Interventions and Duration ........................................................................................................ iii 
Sample Size and Population....................................................................................................... iii 
STUDY TEAM ROSTER............................................................................................................. 1 
1 
STUDY OBJECTIVES ......................................................................................................... 2 
1.1 
Aim 1 Objective .............................................................................................................. 2 
1.2 
Aim 2 Objective .............................................................................................................. 2 
2 
BACKGROUND AND RATIONALE ................................................................................ 2 
3 
STUDY DESIGN ................................................................................................................... 4 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS ............................................ 5 
4.1 
Inclusion Criteria ............................................................................................................ 5 
4.2 
Study Enrollment Procedures ......................................................................................... 5 
5 
STUDY INTERVENTIONS ................................................................................................ 6 
5.1 
Interventions, Administration, and Duration .................................................................. 6 
5.2 
Handling of Study Interventions ..................................................................................... 8 
5.3 
Adherence ....................................................................................................................... 8 
6 
STUDY MEASURES ............................................................................................................ 8 
6.1 
Schedule of Evaluations .................................................................................................. 9 
6.2 
Description of Evaluations ............................................................................................ 10 
6.2.1 Screening Evaluation ................................................................................................ 10 
6.2.2 Enrollment, Baseline, and/or Randomization ........................................................... 11 
6.2.3 Follow-up Visits........................................................................................................ 11 

v. 3.18.2021 
ii 
6.2.4 Completion/Final Evaluation .................................................................................... 11 
7 
SAFETY ASSESSMENTS ................................................................................................. 12 
7.1 
Specification of Safety Parameters ............................................................................... 12 
7.2 
Adverse Events and Serious Adverse Events ............................................................... 12 
7.3 
Reporting Procedures .................................................................................................... 12 
7.4 
Follow-up for Adverse Events ...................................................................................... 13 
8 
INTERVENTION DISCONTINUATION........................................................................ 14 
9 
DATA COLLECTION AND QUALITY ASSURANCE ................................................ 14 
9.1 
Data Collection Forms .................................................................................................. 14 
9.2 
Data Management ......................................................................................................... 17 
10 PARTICIPANT RIGHTS, Reimbursment AND CONFIDENTIALITY ...................... 17 
10.1 
Institutional Review Board (IRB) Review .................................................................... 17 
10.2 
Informed Consent Forms .............................................................................................. 17 
10.3 
Reimbursement Schedule for Participants .................................................................... 18 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

v. 3.18.2021 
iii 
PRÉCIS 
Study Title  
Mindful Self-Compassion Training to Improve Retention, Job Satisfaction, and Attitudes 
toward Dementia among Long-Term Care Nursing Assistants: Certified Nursing 
Assistants’ Wellbeing Program 
Objectives  
 This preliminary study will modify, refine, and test a MSC training intervention, 
otherwise to be known as the CNA Wellbeing Program, for CNAs who care for nursing 
home residents. The proposed research will be conducted in 3 similarly rated and 
structured community NHs. 
 
Aim 1: Determine the feasibility, acceptability, and adaptations of the CNA Wellbeing 
Program by conducting 8-week course in one NH with a goal of 15 CNAs, and up to 20 
CNAs per NH. Evaluation will focus on a) participation (including home practice 
adherence); b) attendee evaluation of training; c) barriers/facilitators of participation; d) 
use and retention of session materials by participants; and e) recommendations for 
improvement.    
 
Aim 2: Conduct a pilot test of adapted protocols and intervention in sample of 30 CNAs 
from 2 NHs to reexamine feasibility and acceptability. Evaluate fidelity and impact of 
training by measuring a) attendance, b) satisfaction with training, c) pre-post measures 
of self-compassion, intent to leave job, perceived stress, job satisfaction, burnout, and 
attitudes towards persons with dementia.  
Interventions and Duration  
Mindful Self-Compassion has been developed and validated in other populations as a 
course of eight 2.5- hour weekly sessions. A modified version of this program will be 
tested in Aim 2, which is also a validated version of the MSC program. This version is 
six, 1-hour weekly sessions. Each session begins with meditation, follows with discussion 
of previous week’s home practice, introduction of main theme of session and new formal 
and informal practices. Each session will be offered in a location convenient to the NH, 
outside of work hours, at times convenient for participants, and offered at two different 
times to accommodate schedules.   
Sample Size and Population  
Eligibility to this study will include: Certified Nursing Assistant employed by 
participating nursing homes; over the age of 18; able to speak and write in English; 
works at NH 20 or more hours per week; expects to be employed with NH for the 
duration of the course; and expects to be able to attend 75% of the sessions. Up to 20 
CNAs per NH will be able to participate, with a goal of 15 participants. If over 20 CNAs 
are interested, the study will enroll the 20 CNAs who score highest on the Screening 
Questionnaires’ Perceived Stress Scale who are interested in participating.  

v. 3.18.2021 
1 
STUDY TEAM ROSTER  
RESEARCH TEAM 
Name 
Role 
Telephone 
Email 
Philip Sloane, MD, MPH 
Principal Investigator 
(919) 966-7173 
psloane@med.unc.edu 
Christine Lathren, MD, 
MPH 
Post Doctoral Fellow and Co-Principal 
Investigator 
(984) 974-0293 
lathren@email.unc.edu 
Sheryl Zimmerman, PhD 
Co-Investigator, Evaluation and 
Research Design 
(919) 966-7173 
sheryl_zimmerman@unc.edu 
Karen Bluth 
Co-Investigator/Intervention Director 
 
karen_bluth@med.unc.edu 
Dr. Karen Sheffield-
Abdullah 
Consulting Co-Investigator 
 
ksheffie@email.unc.edu  
Christopher Wretman 
Analyst 
 
wretman@live.unc.edu  
Johanna Silbersack 
Research Assistant  
(919) 843-3085 
jvtsilbersack@unc.edu  
Laura Prochnow Philips 
Intervention Instructor 
 
laura@lauraprochnowphillips.com 
Julia Thorp, BA 
Office Manager 
(919) 966-7173 
julia_thorp@unc.edu 
 
 
 

v. 3.18.2021 
2 
1 
STUDY OBJECTIVES 
This preliminary study will modify, refine, and test a MSC training intervention, to be known as CNA 
Wellbeing Program, for CNAs who care for nursing home residents. Our goal is to increase CNA coping 
skills and well-being, thereby reducing intent to leave the job, reducing burnout, and improving job 
satisfaction and attitudes toward people with dementia. The proposed research will be conducted in 3 
similarly rated and structured community NHs. 
1.1 Aim 1 Objective 
Determine the feasibility, acceptability, and necessary adaptations of the CNA Wellbeing Program 
needed to meet the diverse cultural background, limited literacy, and job and family challenges of the 
nursing home CNA workforce, including the unique challenges of caring for persons with dementia, and of 
the data collection methods. 
A. Conduct a field trial of the standardized 8-week CNA Wellbeing Program with 15 CNAs within a single 
community NH. Evaluation will focus on: (a) participation (including home practice adherence and 
attendance); (b) attendee evaluation of the training; (c) barriers to and facilitators of participation; (d) 
use and retention of session material by participants; and (e) recommendations for improvement of 
training. 
 
B. Field test the feasibility and acceptability of our study recruitment and evaluation strategy. 
 
C. Use data collected from the field test to modify recruitment strategies, protocols, and course structure, 
content and materials so as to be maximally feasible, acceptable and effective in a CNA population.  
1.2 Aim 2 Objective 
Conduct a pilot test of the adapted protocols and intervention in a sample of 30 CNAs from 2 similarly 
rated and structured community NHs to reexamine feasibility and acceptability, identify trends in key 
intermediate and long-term outcomes, and estimate effect size in preparation for a future randomized 
trial. 
 
A. Evaluate the fidelity and immediate impact of the modified training by measuring (a) training 
attendance; (b) satisfaction with the training; and (c) pre-and post-training measures of self-
compassion, perceived stress, job satisfaction, job burnout symptoms, and attitudes towards persons 
with dementia. 
 
B. Evaluate the sustained impact of the training by comparing baseline, 3-and 6-month post-training 
measurements of: intent to leave job, self-compassion, perceived stress, job satisfaction, job burnout 
symptoms, and attitudes towards persons with dementia. 
2 
BACKGROUND AND RATIONALE  
Critical role of certified nursing assistants (CNAs) in nursing homes (NHs). U.S. NHs serve 
approximately 1.6 million complex and vulnerable persons daily, the majority of whom have Alzheimer’s 
disease or a related cognitive disorder, require extensive help with activities of daily living, and have 
multiple chronic illnesses.1 In these settings, most hands-on care is provided by an estimated 634,000 
certified nursing assistants (CNAs) – a workforce that is racially diverse, predominantly female, with a 
high school or lower education, and an annual income equivalent to the poverty threshold for a family of 
four.2 
 
CNA workforce experiences high stress and turnover, compromising resident care. Demand for 
CNAs is high and projected to grow;2 however, retaining CNA staff is a major challenge. National turnover 
rates average 65% annually.3 Equally concerning is CNA absenteeism, as nearly 10% do not report to 
work as scheduled.4 Turnover, absenteeism, and staff shortages have been linked to poor care, including 
negative resident outcomes such as pressure ulcers, infections, pain, and reduced overall quality of life.3-8  

v. 3.18.2021 
3 
CNAs are predominately female; nearly half are racial/ethnic minorities; and 75% have a high 
school degree or less.9 Two thirds live on a family income near or below poverty level and nearly a third 
receive public assistance and/or head a single-parent household. Given limited resources, hardships 
such as inconsistent childcare, personal illness or injury, or transportation issues can be large sources of 
stress.10  
CNAs also face emotionally and physically demanding job tasks, particularly when working with 
persons with Alzheimer’s disease and related dementias. Challenging behaviors such as verbal 
aggression and physical assault are common, especially during personal care11-13 with 56% of CNAs 
reporting at least one work-related injury in the prior year, including scratches, open wounds or cuts, back 
injuries, bruises, black eyes and human bites.9 Additionally, CNAs report distress due to unappreciative 
residents and unhappy family members.14 
Job burnout, defined as a response to prolonged work-related stress that reduces job satisfaction, 
productivity, performance, turnover and well-being, is high among CNAs.15 In dementia care, CNA 
burnout has been correlated with reduced empathy and fewer positive attitudes towards persons with 
dementia.16 In contrast, our previous work and that of others found that positive attitudes towards persons 
with dementia are associated with increased job satisfaction.17,18 
 
Current strategies to decrease job stress and improve job satisfaction have significant 
drawbacks. Driven by a desire to improve CNA recruitment and retention, many interventions have been 
identified, including increased compensation and benefits, organizational culture change, improved 
staffing ratios, and career advancement opportunities.3 Although these address important issues, most 
require significant financial resources and organizational change. Moreover, none address the adaptive 
skills necessary for an individual worker to effectively respond to inevitable job, life, and interpersonal 
stressors. Furthermore, healthcare provider well-being and resilience are a priority focus,19 given that 
optimal resident care is impossible without provider self-care.20 The current project proposes to arm CNAs 
with larger life skills useful in difficult situations, many of which are beyond the person’s immediate 
control. These skills are an important adjunct to organizational change interventions and can yield 
positive effects beyond the workplace. 
 
Mindfulness-based stress reduction (MBSR) is a proven strategy for stress reduction and 
promotion of well-being in heterogeneous populations. Mindfulness has been described as paying 
attention to the present with nonjudgmental awareness.21 MBSR training is a standardized approach that 
promotes well-being in a wide variety of populations, including healthy individuals,22 persons with chronic 
conditions,23 and family caregivers.24 Taught in a series of classes, MBSR is inexpensive and highly 
accessible. In health care professionals, MBSR training decreases burnout, perceived stress, anxiety, 
and depression, while increasing well-being, empathy and compassion for others.25,26 
MBSR has been extensively studied in nurses.27,28 In the limited research that has been 
conducted on CNAs, sample sizes were small and results mixed.29 No published research has been 
conducted in NHs – where CNA roles are most extensive (although a pilot study in dementia care homes 
is underway in Wales).30 Given the magnitude of job-related stress among NH CNAs and the success of 
MBSR with professionals, further exploration is needed. Indeed, the relative simplicity and low cost of 
mindfulness training coupled with high potential impact has led to calls for formal and informal 
mindfulness practices to be incorporated into CAN educational programs,31 and for research on the 
downstream effects of mindfulness on patient care.32 
 
Self-Compassion (SC) and Mindful Self-Compassion (MSC): an enhanced, focused training that is 
promising yet largely unexplored. SC – a closely related construct to mindfulness – is a particularly 
powerful new tool to reduce stress and burnout.32,33 Compassion is “sensitivity to the experience of 
suffering, coupled with a deep desire to alleviate that suffering,” and SC is this same concept focused 
inward, often described as “like treating oneself as one would a good friend when they are struggling.”34 
SC has three main, interrelated components: self-kindness (responding to challenges with self-support 
and understanding); common humanity (recognizing hardships are part of the shared human experience), 
and mindfulness (responding to negative thoughts and emotions with a balanced rather than 
“catastrophic” response). Since its initial description in 2003, SC has been positively linked to multiple 
measures of well-being;35 inversely correlated to stress, depression and anxiety;36 and associated with 
resilience in the face of stressful life events.37 There is also evidence that persons with greater levels of 

v. 3.18.2021 
4 
self-compassion experience better interpersonal relationships and express more empathy and 
compassion for others.32,38–40 Furthermore, in nurses and nurse midwives, self-compassion protects 
against job burnout and compassion fatigue.41–43 A current training format for SC integrates it with 
mindfulness in an 8-session program entitled MSC which, in the limited intervention studies conducted to 
date, has demonstrated large, positive effects on compassion for others, stress, anxiety, depression and 
life satisfaction in community-based, mainly white, female, educated populations.44 MSC interventions 
have also been successfully adapted for adolescents by our research team,45,46 and for those with 
diabetes.47 MSC interventions in NH CNAs have not, however, been studied. 
Because CNAs have particularly high work and life stress burdens and fewer opportunities than 
more educated populations to learn stress management techniques, MSC skills hold particular promise 
for improving outcomes. Indeed, one study of residential dementia care found that CNAs employ a range 
of strategies, many of which are unhelpful, such as defensiveness/shutting down, unhealthy distraction 
(e.g., overeating), and psychological distress (e.g., anxiety or depression); and the authors suggested 
that mindfulness training might have a “preventive focus” by promoting self-care.48 Additionally, there is 
evidence that people with high levels of self-compassion more often use “positive cognitive restructuring” 
or changing one’s view of a negative situation to more a positive one,49 a reaction that has been found to 
buffer against burnout in CNAs.15 
 
Conceptual Model and Potential Impact. Figure 1 (below) illustrates our conceptual model. Among NH 
CNAs, work and life stress combine with low coping skills to result in high levels of perceived stress, 
which in turn lead to negative attitudes toward the people they care for, life and work dissatisfaction, and 
burnout, culminating in high rates of absenteeism and turnover, leading to impairment on the quality of 
care they provide. The 
intervention we propose has 
been proven in other settings to 
improve performance by 
enhancing coping skills. If 
successful, MSC could be 
incorporated into the curricula of 
CNA training programs, thereby 
helping create a more resilient, 
stable, competent workforce, 
and one better able to provide 
dementia-sensitive care. 
3 
STUDY DESIGN 
This is a single-arm feasibility trial that will refine an existing MSC intervention in preparation for a future, 
randomized controlled trial with the primary goal of improving CNA job retention. We will recruit 15 CNAs 
from a single nursing home (NH), pilot the 8-week intervention, and collect feedback via questionnaires, 
interviews and a semi-structured focus group at the end of the course. Data from this cohort will be used 
to refine study protocols and course structure/materials for maximum feasibility and acceptability. A 
refined intervention will subsequently be tested in 30 CNAs from two NH settings (15 CNAs per home), 
with pre, post, and follow-up measurements of stress, burnout, self-compassion, job satisfaction, attitudes 
towards dementia, and intent to leave their job. 
 
 
 

v. 3.18.2021 
5 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
In nursing home settings, most hands-on care is provided by an estimated 634,000 certified nursing 
assistants (CNAs) – a workforce that is racially diverse, predominantly female, with a high school or lower 
education, and an annual income equivalent to the poverty threshold for a family of four. The participants 
of this study will include only CNAs employed with the partnering three Nursing Homes. 
 
The three nursing homes that have been chosen for participation fit the following criteria: overall quality 
(as defined by receiving a 4 or 5 star rating on CMS compare), bed size (80-120 beds), non-profit status, 
and within 30 miles of the research team.  
4.1 Inclusion Criteria  
Participants must meet all of the following inclusion criteria to participate in this study: 
• 
Certified Nursing Assistant working at 3 participating NHs 
• 
Works at least 20 hours a week (on average) with participating NHs 
• 
Speaks and reads English 
• 
Over 18 years old 
• 
Intends to work with NH for the duration of the MSC course  
• 
Expects to be able to attend a majority (75%) of the sessions 
If over 20 CNAs are interested in the course, and we are not able to accommodate all whom would like to 
participate, an additional inclusion criteria will be scores on the Perceived Stress Scale portion of the 
Screening Questionnaire (see Appendix D1). The 20 CNAs with the highest scores on the PSS will be 
eligible for the intervention course. As of the completion of this trial, this measure was unnecessary. 
4.2 Study Enrollment Procedures  
All candidates will be identified and recruited from the three participating Nursing Homes. The recruitment 
process will be a multi-step process, and will gather input from the participating NHs, as well as meeting 
with CNA representatives from the nursing homes to gather their thoughts on recruitment materials and 
strategy. See Table 1 (below) for details. 
 
Table 1. Recruitment/Enrollment Schedule 
Week -10 
Meet with CNA representatives/leaders 
Week -9, -8, -7, -6 
Finalize logistics RE CNA Wellbeing Program times, locations, etc. 
 
Finalize/Submit materials 
Week -5 
• 
Begin posting flyers, Version 1 in Week -5 and Version 2 in Week -4 
around NH to advertise.  
• 
Have available phone version of the Screening Questionnaire for 
interested CNAs to complete 
• 
Begin adding interested CNA’s information the interest list  
Week -4 
Week -3 
• 
Hold information sessions during shift changes 
• 
Hold presentation during staff meeting  
o 
Shift changes/days to hold will be determined by discussions 
with CNA representatives. 
• 
Collect the in-person Screening Questionnaire. 
• 
Collect the interest sheet from interested participants 

v. 3.18.2021 
6 
• 
Post additional round of flyers  
Week -2 
• 
Hold an additional 2 information sessions 
• 
Continue to collect interest sheet of interested CNAs 
• 
Continue to collect Screening Questionnaire 
• 
Begin consenting CNAs one-on-one, in person.  
• 
Begin administering baseline interview after consent process 
Week -1 
• 
Hold additional information sessions as needed, based on enrollment. 
• 
Continue to collect interest sheet of interested CNAs as needed.  
• 
Continue to collect Screening Questionnaire as needed. 
• 
Continue consenting CNAs one-on-one, in person. During consenting 
session, also administer baseline interview.  
• 
Begin to finalize final program participant roster. 
Week 0 
• 
CNA Wellbeing Program begins 
• 
Finish any last consenting and administering of baseline interview as 
needed. 
5 
STUDY INTERVENTIONS  
5.1 Interventions, Administration, and Duration  
CNA Wellbeing Program and Measures Intervention 
The study will take place over the course of 8 months for each participant – this includes the duration of 
the intervention as well as follow up measures (see details below).  
Before the onset of the intervention, interested participants will complete the Screening Questionnaire, in 
order to gather their scores on the Perceived Stress Scale. If over 20 CNAs are interested in joining the 
course, this screening data will be used to choose the 20 CNAs with the highest scores on the Perceived 
Stress Scale, and invite these participants to join the full study. Otherwise, all eligible CNAs will be 
included. This Screening Questionnaire will be administered in person, at the recruitment sessions. 
Alternatively, for CNAs unable to attend the recruitment sessions and who choose to reach out to the 
study staff directly instead, an option to have a verbal consent and phone version of the Screening 
Questionnaire will be provided. 
Once the final program list has been determined, the study will begin with informed, written consent, and 
an initial Baseline Interview, no more than 2 weeks before the onset of the course.  
The intervention will be administered over the course of 8-weeks for Nursing Home 1, and over the 
course of 6-weeks for Nursing Home 2 & 3, and follows the pre-created agenda for the Mindful Self-
Compassion course (see below, Table 2). Participants will be texted weekly by study staff, with reminders 
of the next session, as well as a recap of the previous session. At the beginning of the course, study staff 
will collect Weekly Questionnaires on each participant. This will be given by the intervention instructors 
during the sessions. If a participant has missed a session, study staff will follow up to collect a modified 
Weekly Questionnaire by phone. Towards the end of the course, a half-day (4 hour) retreat was offered to 
participating CNAs (of Nursing Homes 1). They were encouraged to attend this retreat, however, it was 
not required and attendance (or non-attendance) did not impact their participation in the study. Ultimately, 
the retreat was not held due to difficulties with scheduling.  
No more than two weeks after the termination of the course, study staff will administer an End-of-Program 
Interview either in person or via telephone, according to the convenience of the participant.  
Additionally, there will be one shortened weekly focus group session (1 hour in length) after the last week 

v. 3.18.2021 
7 
of the CNA Wellbeing Program in order to solicit further feedback on the course. This session will be 
audio recorded and transcribed, in order to collect and analyze feedback. The sessions for Nursing Home 
#2 & #3 were formalized into focus groups, whereas the session for Nursing Home #1 was an open 
discussion session.  
Study staff will reach back out to all participants after the culmination of the program, in order to 
administer the 3/6 Month Interviews either in person or via telephone. After the 6-month interview has 
been completed, participation in the study will have concluded. 
Additionally, in order to compare the stress levels and demographic information of CNAs who participate 
in the program versus those who work at the participating nursing home, we will ask CNAs present at a 
staff meeting to fill out a short survey with the Perceived Stress Scale and demographic information.  
 
Table 2A:  Training Course Outline – 8 Week Version 
Session 
Title 
Content 
1 
Discovering Mindful 
Self-Compassion 
Introduction and orientation to the program. The main concepts 
are defining self-compassion and becoming familiar with the link 
between self-compassion and well-being. 
2 
Practicing Mindfulness 
Focuses on mindfulness, defined as awareness of present-
moment experience. Resistance is described and presented as a 
source of much of our suffering. Awareness meditations are 
“warmed up” with affection and appreciation. 
3 
Practicing 
Lovingkindness 
Participants learn the difference between lovingkindness, 
compassion and mindfulness, and learn how to use phrases in 
lovingkindness meditation. 
4 
Discovering Your 
Compassionate Voice 
Lovingkindness meditation is practiced, and participants learn to 
self-motivate with encouragement rather than criticism. Stages of 
progress are identified and discussed. 
5 
Living Deeply 
Participants discover core values (what gives their lives meaning) 
and learn how to re-orient themselves to them in daily life. 
Compassion and self-compassion are practiced through listening 
to others. 
6 
Meeting Difficult 
Emotions 
Participants learn to transform difficult emotions using 
mindfulness and self-compassion practices. Self-compassion is 
presented as a way to alleviate shame. 
7 
Exploring Challenging 
Relationships 
Self-compassion practices are used to meet unmet needs in 
relationships as well as to manage caregiving fatigue. 
8 
Embracing Your Life 
Focuses on how to maintain meditation practice after the course 
ends, as well as how to practice savoring, gratitude, and self- 
appreciation as corrective measures for negativity bias. 
 
 
Table 2B:  Training Course Outline – 6 Week Version 
Session 
Title 
Content 
1 
What is Self-
Compassion? 
Introduction and orientation to the program. The main concepts 
are defining self-compassion and becoming familiar with the link 
between self-compassion and well-being. 
2 
Practicing Self-
Compassion 
Focuses on the physiology of self-compassion, as well as how to 
practice various MSC techniques including supportive touch and 
self-compassion break. Also reviews mindfulness, defined as 
awareness of present-moment experience. 
3 
Discovering your 
Compassionate Voice 
Lovingkindness meditation is practiced, and participants learn to 
self-motivate with encouragement rather than criticism. Stages of 
progress are identified and discussed. 
4 
Self-Compassion and 
Participants learn to transform difficult emotions using 

v. 3.18.2021 
8 
Resilience 
mindfulness and self-compassion practices. Self-compassion is 
presented as a way to alleviate shame. 
5 
Self-Compassion and 
Burnout 
Self-compassion practices are used to meet unmet needs in 
relationships as well as to manage caregiving fatigue. 
6 
Going Forward 
Focuses on how to maintain meditation practice after the course 
ends, as well as how to practice savoring, gratitude, and self- 
appreciation as corrective measures for negativity bias. 
 
5.2 Handling of Study Interventions  
This intervention will be given by Karen Bluth, PhD and Laura Prochnow Philips, both of whom are 
Certified Mindful Self-Compassion Trainers.  
5.3 Adherence  
Full participation will be encouraged and asked for all participants. Because this is a feasibility study, 
study staff will record adherence and non-adherence to the CNA Wellbeing Program through following 
attendance (including times in and times out of participants) and practice between sessions. However, 
participants will have the option of continuing on, even if they do not adhere completely to the program.  
 
Study staff will continue to follow participants with the opportunity to complete questionnaires and 
interviews, regardless of their adherence to the program.   
6 
STUDY MEASURES 
The following table lays out the various measures and data that will be collected from participants 
throughout the course of the study – including before, during, and at 3 and 6 months after the conclusion 
of the intervention. 

v. 3.18.2021 
9 
6.1 
Schedule of Evaluations 
Measure 
Pre-Course* 
Course 
3 Months 
6 Months 
1 
2 
3 
4 
5 
6 
7 
8 
9 
Feasibility Measures 
 
Attendance  
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Attrition (Withdrawal) 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Audio Recording 
 
 
 
 
 
 
 
 
 
X 
 
 
Screening Questionnaire  
X 
 
 
 
 
 
 
 
 
 
 
 
(Demographics & PSS) 
Baseline Interview  
X 
 
 
 
 
 
 
 
 
 
 
 
(JSS, Intent to Leave, ADQ, MBI, PSS, SCS, PROMIS) 
Weekly Questionnaire  
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
(PROMIS, Home Practice, Adverse Events) 
End-of-Program Interview  
 
 
 
 
 
 
 
 
X 
X 
 
 
(Acceptability Measure, JSS, Intent to Leave, ADQ, 
MBI, PSS, SCS, PROMIS, Adverse Events) 
3 Month & 6 Month Interview  
 
 
 
 
 
 
 
 
 
 
X 
X 
(JSS, Intent to Leave, ADQ, MBI, PSS, SCS, PROMIS, 
Adverse Events) 
Measures of Adverse Events and Safety 
Monitoring 
Pre-Course* 
Course 
3 Months 
6 Months 
1 
2 
3 
4 
5 
6 
7 
8 
9 
PROMIS Depression Screen  
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
Adverse Event Monitoring Form  
 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
Adverse Event Reporting Form  
 
 
 
 
X 
 
 
 
X 
 
X 
X 
Nursing Home Level Data 
2018 
2019 
2020 
Administrator Interview  
 
X 
 
CMS NH Compare Website  
X 
X 
X 
*Begins 2 weeks before onset of program 

v. 3.18.2021 
10 
6.2 Description of Evaluations  
6.2.1 Screening Evaluation 
Consenting Procedure 
 
Two consenting processes are included in this study, an embedded consent for participation in the 
Screening Questionnaire and a written consent for participation in the study.  
 
A. The initial consent process is for the Screening Questionnaire of eligible participants. In the event that 
there are over 20 CNAs interested in a course at a single nursing home, eligible participants will be 
chosen from the highest scores on the Screening Questionnaire (which includes the Perceived Stress 
Scale). This questionnaire will be collected during information sessions by the research assistant.  
 
While presenting on the course during the information session, the research staff will have with them 
a sign-in/interest sheet in the course. The interest sheet will have ID numbers preprinted (i.e. for the 
Nursing Home in Aim 1, 101, 102, 103, 104, etc.). The Screening Questionnaire will have the ID 
number pre-printed onto the questionnaire, so that when any individual chooses to sign up to the 
interest list, and wants to do the Screening Questionnaire, they will be immediately given an ID# and 
then handed the corresponding questionnaire. 
 
Once they’ve received the Screening Questionnaire, they will be able to independently read the 
embedded consent form and determine their interest in participating in the Screening Questionnaire. 
Any CNAs interested in participating in the full study and adding their name to the interest sheet will 
be told that the Screening Questionnaire must be eventually be completed in order to be eligible for 
the full study, but that by completing the Screening Questionnaire, they are not automatically enrolled.  
 
Alternatively, for CNAs who reach out to the study staff directly from the posted recruitment flyers, a 
verbal consent will be read to them to participate in the Screening Questionnaire, if they are 
interested.  
 
While study staff is recruiting CNAs, [s]he will have a folder with them in order to collect all 
Questionnaires. Identifiable information from the interest sheets and linking ID#s will be transferred to 
an electronic folder, stored on the Cecil G. Sheps Center for Health Services Research’s secure 
servers, separately from any data.  
 
B. The second consent process will be with all participants’ who are committed to joining the intervention 
program. Throughout the recruitment process, participants will be able to sign up on an interest sheet 
to indicate their interest. These participants will be able to sign up physically, during the recruitment 
sessions, or reach out directly to study staff to have their name included on the interest sheet. Once 
CNAs have expressed interest, the study staff will reach out to them one-on-one through their 
preferred method of communication (telephone, text, or email), and verify their commitment to the 
program.  
 
Once commitment and eligibility have been confirmed, study staff will set up one-on-one meetings 
with participants in order to review the written consent form. This will take place up to 2 weeks before 
the start date of the program. During these in-person meetings, study staff will review the consent 
form with participants and answer any questions they may have. Additionally, study staff will ensure 
participants have their own copy of the consent form for their files. Once collected, all physical 
consent forms will be kept in a locked office in the Cecil G. Sheps Center for Health Services 
Research, where only study staff will have access.  
 
 
 
 

v. 3.18.2021 
11 
Screening   
 
This study will take up to 20 CNAs per Nursing Home. If 20 or fewer CNAs are interested in the CNA 
Wellbeing Program, all those interested will be able to participate. However, if over 20 CNAs are 
interested in the program (within one Nursing Home), the Screening Questionnaire administered during 
the recruitment process will be used to determine the 20 CNAs with the highest scores on the Perceived 
Stress Scale. The study’s goal is to recruit 15 CNAs per Nursing Home. 
 
In the event that there are over 20 CNAs interested and the study is not able to accommodate all CNAs, 
some Mindful Self-Compassion materials will be provided to those who are not able to join the program.  
 
6.2.2 Enrollment, Baseline, and/or Randomization 
CNAs will be enrolled in the screening process after they have read the embedded consent form on the 
Screening Questionnaire, and have chosen to fill out the questionnaire. The Screening Questionnaire 
involves demographic questions as well as the Perceived Stress Scale. 
 
For the intervention portion of the study, CNAs will be enrolled after reviewing and signing the written  
consent form with study staff in a one-on-one process. This process will occur up to 2 weeks before 
enrollment in the course begins.  
 
Once enrolled, participants complete an in-person interview (the Baseline Interview) with study staff. This 
baseline interview will capture their preliminary scores on: 
 
• 
Stress levels 
• 
Attitudes towards dementia 
• 
Job satisfaction and intent to leave job 
• 
Burnout score 
• 
Self-compassion score 
• 
Depression score 
 
6.2.3 Follow-up Visits 
After initial enrollment, and collection of the Baseline Interview, CNAs will begin participating in the 
intervention, the CNA Wellbeing Program. There will be 8 intervention sessions, as well as a 9th session 
for feedback (or, 6 intervention sessions, and a 7th for feedback, if taking the 6-week version of the 
program). Additionally, CNAs will be approached at the End-of-Program mark, and the 3/6 month mark 
post course, to gather additional survey responses. These interviews will continue to capture the 
participants’ scores on:  
 
• 
Stress levels 
• 
Attitudes towards dementia 
• 
Job satisfaction and intent to leave job 
• 
Burnout score 
• 
Self-compassion scores 
• 
Depression score 
 
See above (in section 6.1 Schedule of Evaluations) for an exact list of what will be collected from CNAs at 
each point, baseline, weekly, post course, 3-months, and 6-months.  
6.2.4 Completion/Final Evaluation 
Study staff will continue to follow up with participants until the point of the final evaluation, the 6-month 
Follow Up Interview.  

v. 3.18.2021 
12 
7 
SAFETY ASSESSMENTS  
 
Potential Risks and Benefits for Participants  
 
Potential Risks:  
 
The potential risks to study participants include:  
• 
Emotional discomfort caused by study questions.  
• 
Emotional or psychological discomfort or distress (e.g., agitation, anxiety) caused by exercises, 
group discussion, or home practices.  
• 
Physical discomfort during sitting exercises.  
• 
Emotional or economic (employment-related) harm due to breech of confidentiality. This includes 
breech of confidentially regarding any personal information shared during the group intervention 
sessions, questionnaire data, or outcome data collected from administrative records. 
 
Potential Benefits:  
 
The potential benefits to study participants include:  
• 
Stress-management skills that may improve well-being and positively impact relationships and job 
performance.  
• 
Lifetime access to resources (e.g., audio guided meditations, course materials) that may help 
sustain well-being and stress-management skills.  
7.1 Specification of Safety Parameters 
This study employs a Safety Monitoring Committee (SMC), composed of 3 members in order to monitor 
the safety of this study. See below for details on the process by which Adverse Events/Serious Adverse 
Events are defined, and will be handled.    
7.2 Adverse Events and Serious Adverse Events  
Adverse event (AE): Any unfavorable and unintended change in physical or mental health status (i.e. 
new or worsening physical or mental health signs, symptoms, or disease) or loss of employment 
associated with participation in the study, regardless of whether it is considered related to the study. 
 
A serious adverse event (SAE): Any AE that: results in death; is life threatening, or places the 
participant at immediate risk of death from the event as it occurred; requires or prolongs hospitalization; 
causes persistent or significant disability or incapacity; results in congenital anomalies or birth defects 
 
Unanticipated problems (UPs): Involves risks to subjects or others to include, in general, any incident, 
experience, or outcome that meets all of the following criteria: 
o 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the IRB-approved research protocol and 
informed consent document; and (b) the characteristics of the subject population being studied; 
o 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
o 
Suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
7.3 Reporting Procedures 
Given course content can bring up difficult emotions, study staff will monitor depressive symptoms 
weekly. Study staff will also ask participants to report any changes in their physical health that may be 

v. 3.18.2021 
13 
related to their participation in the study, with the exception of transient discomfort during sitting practices. 
Examples of potentially relevant, although unlikely, physical health changes include: headaches, body or 
joint aches, or an injury occurring during mindfulness practice. These examples will be given to 
participants, with the caveat that they should err on the side of caution and over-reporting. Additionally, in 
order to monitor for participants’ at risk of giving birth to a child with a birth defect, the intervention 
instructors will report to Principal Investigator and study staff if they learn of any pregnancy within their 
program participants.  
 
In order to facilitate the reporting of potential AEs to study staff, the following procedures will be in place:  
 
[1] During the 8-week intervention period, participants will be engaged in weekly group discussions about 
home practice, challenges to practice, and well-being. Any participant endorsing difficulties that the 
course facilitators feel are potentially beyond transient or typical will be approached privately to gather 
details.  
 
[2] Participants will be given study staff contact information, including study phone and e-mail addresses. 
Participants will be encouraged to contact study staff in the event of psychological or potentially relevant 
physical health concerns. 
 
[3] At the beginning of each weekly session, and at 3 and 6-months post-intervention, we will administer a 
brief adverse event form, through the Weekly Questionnaire. On this form, we will collect data on any 
serious adverse events in the previous week, depressive symptoms via the validated 8-question PROMIS 
Depression Short Form and physical health changes possibly related to study participation. Regarding 
depressive symptoms monitoring, we will collect the PROMIS depression screen at baseline. For the 
purposes of this study, any participant whose PROMIS depression score moves from a lower category 
into the severe category (i.e. greater than or equal to a T-score of 70) will be flagged as a potential 
adverse event and will prompt follow up by the study team via a phone call by the study staff to gather 
details. Study staff will also notify the course instructors of the increased emotional distress so that extra 
support can be provided as needed. 
 
The study team member receiving information from participants about a potential AE related to the study 
will complete an Adverse Event Form.  
7.4 Follow-up for Adverse Events 
 
Data on AEs and UPs will be collected on an ongoing basis from study start to study completion.  
 
General AE Procedures. The project manager or study staff will report all AEs to the PI immediately using 
the Adverse Event Reporting Form, after having gathered all necessary details (from the Weekly 
Questionnaire, as well as further communication with the participant if needed). The PI will determine the 
severity and the relatedness of the AE, and will confer with the SMC as needed. If the AE is serious 
and/or unexpected, possibly related to study participation, and suggests increased risk for participants, 
the procedures outlined below will also be followed.  
 
AE reports will collected by the project manager or study staff, summarized and de- identified. A summary 
report of all AEs to date will be sent to the PI and the SMC in both Phases at: 1) mid-intervention (4-week 
mark); 2) post-intervention (8-week mark); 3) post 3-month follow-up; 4) post 6-month follow-up.  
 
Furthermore, all AEs will be summarized as part of the Data and Safety Monitoring Report submitted 
post-Phase 1 and post-Phase 2 to the SMC and NIA program officer. As per UNC IRB guidelines, all AEs 
will reported to the UNC IRB during the yearly study review process.  
 

v. 3.18.2021 
14 
Serious AE Procedures. The project manager or study staff will report all SAEs to the PI immediately 
using the Adverse Event Reporting Form, after having gathered all necessary details. For all deaths and 
for any SAE related or possibly related to study participation, the PI will send this report and any 
additional information, including corrective actions already taken, within 24 hours to the SMC chair, UNC 
IRB and NIA program officer. The PI will follow any additional course of action recommended by the UNC 
IRB, NIA, and/or SMC.  
 
Unexpected and Related AEs/UPs with increased risk. All AEs that are deemed 1) unexpected; 2) 
possibly or probably related to study participation; and 3) suggests increased risk for study participants 
will be reported to the UNC IRB, NIA project officer, and the SMC chair within 48 hours of study team 
awareness of the event, using each organizations’ respective reporting formats. In these reports, the PI 
will identify any corrective action planned or already undertaken. The PI will follow any additional course 
of action recommended by the UNC IRB, NIA, and/or SMC.  
 
The SMC will meet in person (or virtually for long-distance members as needed) at least 3 times 
throughout the study to review the Data and Safety Monitoring Report: 1) prior to first enrollment; 2) after 
completion of the field test (Phase 1) using the standardized intervention; 3) after completion of the 
refined intervention (Phase 2).  
 
Additional meetings (ad-hoc) will occur as requested by the PI for review of unexpected adverse events 
or any SAEs that occur. Any recommended changes by the SMC will be submitted to the UNC IRB for 
approval. 
8 
INTERVENTION DISCONTINUATION  
 
We will prepare interim analyses to evaluate the safety of the intervention after Phase 1 and again after 
Phase 2. One of the tasks of the Safety Monitoring Committee (SMC) will be to review preliminary data 
from the study and make a recommendation RE whether or not the study should continue. The following 
are the reasons we propose for discontinuing the study early:  
 
• 
The occurrence of a serious adverse event, possibly or definitely related to the study protocol, 
occurring in any participant. In this study, it would include serious psychological distress causing 
death, suicide attempt, or hospitalization.  
• 
Severe adverse events, possibly or definitely related to the study protocol, occurring in 3 or more 
participants. In this study, this would include participants who withdrew from the study due to new 
psychological symptoms or who were hospitalized for mental health treatment. Given the high-
stress nature of the participants jobs and lives, and given MSC involves prompting participants to 
become aware of and attend to their own needs, it is possible that study participation prompts 
mental health care that had been needed previously, but was perhaps ignored or not prioritized. 
Thus, severe cases will be examined carefully by the PI and SMC to determine if the cases 
warrant study discontinuation.  
• 
Interim analyses will provide summary data related to the above bullets and study staff will make 
these data available to the SMC at least 2 weeks before meeting, or within 24 hours  
 
 
9 
DATA COLLECTION AND QUALITY ASSURANCE 
9.1 Data Collection Forms 
ID# Convention:  
 
All data will be de-identified with by using an ID# rather than names or other identifying information. 
This ID# will be composed of three numbers. The first number will be the Nursing Home with which 

v. 3.18.2021 
15 
the participant is associated. The following ID#s numbers will be filled out by study staff after 
collecting completed Screening Questionnaires, starting with 01 and ending with 99.  
 
ID# 
Nursing Home 
1 
Aim 1 NH 
2 
Aim 2 NH 
3 
Aim 2 NH 
 
A sample ID# will be as follows: 
 
First Digit: NH 
Second and Third Digit: Participant 
1-3 
01-99 
 
 
Screening Questionnaire:  
 
Initial data collection will begin with the Screening Questionnaire.  
 
The Screening Questionnaire will be collected during information sessions by the research assistant. 
While presenting on the course during the information session, study staff will have an interest sheet, 
pre-printed with ID#s, as well as Screening Questionnaires, pre-printed with ID#s. For CNAs 
interested in signing into the interest sheet and participating in the Screening Questionnaire, they will 
sign up to a specific ID# slot, and given the corresponding Screening Questionnaire. The first page of 
each questionnaire will have an embedded consent form. Those present at the information sessions 
will be able to independently read the consent form and determine their interest in participating in the 
Screening Questionnaire. Any CNAs interested in participating in the full study and adding their name 
to the interest sheet will be told that the Screening Questionnaire must be completed in order to be 
eligible for the full study, but that by completing the Screening Questionnaire, they are not 
automatically enrolled.  
 
While study staff is recruiting CNAs, [s]he will have a folder with them in order to collect all 
Questionnaires, and will instruct CNAs to bring all completed Questionnaires directly to the study 
staff. 
 
Alternatively, this process will be available to CNAs over the phone if necessary (they reach out 
directly from flyers, are only able to stay for a few minutes at a recruitment session, but wish to 
complete the Screening Questionnaire at another time, etc.). In these cases, a verbal consent will be 
read aloud to CNAs, and the Screening Questionnaire will be read for completion.  
 
Identifiable information from the interest sheet and linking ID#s will be transferred to an electronic 
folder, stored on the Cecil G. Sheps Center for Health Services Research’s secure servers, 
separately from any data.  
 
Baseline Interview:  
 
This data will be collected in-person or by phone by the study staff. Study staff will bring a copy of the 
Baseline Interview to each in-person interview, or have a hard copy of the interview present during 
the telephone call. Before beginning, the study staff will write the appropriate ID# onto each interview. 
This ID# will have previously been assigned from the Screening Questionnaires. This interview will be 
done immediately after collecting consent from the participant, and will be done one-on-one, in 
person with the study staff. If a participant cannot complete it at the time of consenting, research staff 
and the participant will complete the interview at another convenient time over the phone (or in 
person). To aid in the data collection, study staff will provide the participant with Likert Scale cards 
(laminated cards with response options to various questions within the interview). This data will be 
collected no more than 2 weeks before the first session. 

v. 3.18.2021 
16 
Weekly Questionnaire: 
 
During the weekly sessions, the Weekly Questionnaire as well as the Weekly Attendance will be 
collected by the two study instructors.  
 
In order to collect this questionnaire confidentially, the study instructors will have a set of manila 
folders – one for each participant in the program. On the manila folders, will be a Post-It note with the 
participants’ name. Within each folder, will be a Weekly Questionnaire (with their ID# already put into 
their questionnaire). The instructor will hand out each folder to the study participants at the beginning 
of the session. Study participants will be instructed to complete the questionnaire, and put their 
answers back into the manila folder. At this point, the study instructor will collect all manila folders, 
and remove the Post-It notes with names, in order to immediately de-identify the collected data. This 
process will happen weekly, at each session. 
 
For participants who need to miss a session, for whatever reason, they will be followed up with on the 
phone by study staff. Study staff will administer the Weekly Questionnaire – Absent Version.  
 
For weekly sessions, study staff will meet with the intervention instructors once a week, in order to 
collect weekly hard copies of data from study instructors.   
 
Semi-Structured Focus Group Guide: 
 
The final session, a semi-structured feedback session on the Program and concepts explored in the 
program, includes a semi-structured focus group guide. This session will be audio-recorded. 
 
End-of-Program Interview:  
 
This data will be collected in phone or in person by the study staff. Research assistant will attend the 
final session, and bring an Sign Up for End-of-Program Interview for participants to choose when and 
in what form they would like to do the End-of-Program interview. Slots will be offered immediately 
following the session, and for immediately before and after the final semi-structured focus group. For 
interviews that cannot be completed at those times, study staff and participant will arrange an 
alternative time to either conduct a phone interview, or an in-person interview, according to the 
participants’ convenience. Study staff will bring a copy of the End-of Program Interview to each in-
person interview, or have a hard copy of the interview present during the telephone call. Once 
interview is confirmed (in person or phone call), study staff will arrange to either bring with them, or 
email or mail beforehand Likert cards (with response options for various questions in the interview) to 
aid in participants’ responses. Before beginning, the study staff will write the appropriate ID# onto 
each interview. This ID# will have previously been assigned. This interview will be collected no more 
than two weeks after the end of the final session.  
 
3/6 Month Follow Up Interview:  
 
This data will be collected in phone or in person by the study staff. Study staff will bring a copy of 3/6 
Month Follow Up Interview to each in-person interview, or have a hard copy of the interview present 
during the telephone call. Once interview is confirmed (in person or phone call), study staff will 
arrange to either bring with them, or email or mail beforehand Likert cards (with response options for 
various questions in the interview) to aid in participants’ responses. Before beginning, the study staff 
will write the appropriate ID# onto each interview. This ID# will have previously been assigned. This 
data will be collected as close to the 3 month and 6 month mark post Wellbeing Program as is 
possible within the participants’ schedules. This means data will be collected either within the two 
weeks before the 3/6 month mark, or within the two weeks after the 3/6 month mark. 
 

v. 3.18.2021 
17 
9.2 Data Management  
All data will be stored on computers and secure servers in locked offices within the Cecil G. Sheps Center 
for Health Services Research. All hardcopies of data will be stored in locked offices within the Sheps 
Center, accessible only to study staff. All hardcopies of data will be de-identified, with a linking ID# (as is 
the case for the Screening Questionnaire, Baseline Interview, Weekly Questionnaire, End-of-Program 
Interview, and 3/6 Month Follow Up Interview). 
Study staff will be double entering data into Access Databases housed on the Cecil G. Sheps servers to 
ensure mistakes are not made during data entry. Analysis will be completed by the study staff analyst 
with the Program on Aging, Christopher Wretman. 
10 
PARTICIPANT RIGHTS, REIMBURSMENT AND CONFIDENTIALITY  
10.1 Institutional Review Board (IRB) Review 
This protocol and the informed consent document and any subsequent modifications will be reviewed and 
approved by the IRB or ethics committee responsible for oversight of the study.  
10.2 Informed Consent Forms 
Two consenting processes are included in this study, an embedded consent for participation in the 
Screening Questionnaire and a written consent for participation in the study. 
 
A. The initial consent process is for the Screening Questionnaire of eligible participants. In the event 
that there are over 20 CNAs interested in a course at a single nursing home, eligible participants 
will be chosen from the highest scores on the Screening Questionnaire (which includes the 
Perceived Stress Scale). This questionnaire will be collected during information sessions by the 
research assistant.  
 
While presenting on the course during the information session, study staff will have with them 
Screening Questionnaires with pre-printed ID#s, as well as an embedded consent on the first 
page of the questionnaire. For CNAs who choose to take the Screening Questionnaire over the 
phone, a verbal consent will be read out to them for their response.  
 
B. The second consent process will be with all participants’ who are committed to joining the CNA 
Wellbeing Program. Throughout the recruitment process, participants will be able to sign up on 
the interest sheet to indicate their interest. These participants will be able to sign up physically, 
during the recruitment sessions, or reach out directly to study staff to have their name included on 
the interest sheet. Once CNAs have expressed interest, the study staff will reach out to them one-
on-one through their preferred method of communication (telephone, text, or email), and verify 
their commitment to the Wellbeing Program.  
 
Once commitment and eligibility have been confirmed, study staff will set up one-on-one 
meetings with participants in order to review the written consent form. This will take place up to 2 
weeks before the start date of the CNA Wellbeing Program. During this in-person meeting, study 
staff will review the consent form with participants and answer any questions they may have. The 
study staff will ensure that they have one copy of the consent form, and that the participant has 
another copy. Once collected, all physical consent forms will be kept in a locked office in the Cecil 
G. Sheps Center for Health Services Research, where only study staff will have access.  
 

v. 3.18.2021 
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10.3 Reimbursement Schedule for Participants 
Each component of the study is associated with a separate compensation (refer to Table 3), and is a 
nominal, non-coercive amount, to reflect the time that they will be dedicating to the study.  
The CNA Wellbeing Program is being administered in two different forms of the intervention:  
1. Nursing Home 1 will have the standard, MSC program (8 weeks, 2.5 hours per week) 
administered 
2. Nursing Home 2 & 3 will have the modified, MSC program (6 weeks, 1.25 hours per week) 
The original compensation of $180 was awarded to persons in the NH #1, 8-week program, in which they 
were reimbursed $25 per interview, and $10 per class ($25 x 4, $10 x 8 = $180). This equates to $5.00 
per 1.25 hours of class, and $25.00 per interview. This reimbursement amount & schedule was changed 
after Nursing Home #1, after receipt of feedback from participants that the reimbursement was not 
commensurate to their time dedicated to the project. We also readjusted our reimbursement schedule in 
response to feedback – rather than waiting until the end of the intervention to reimburse participants for 
the first time, we added in a mid-intervention reimbursement point.  
In response to feedback, the compensation per time spent in class doubled. For those in the 6-week, 1.25 
hour-Program, participants will be reimbursed a total of $140. This includes $80 in participation in all 4 
interview ($20 each), and $60 for their participation in 7.5 hours of intervention ($10 per 6, 1.25 hours 
classes). 
 
Table 3A – Reimbursement Payments/Schedule (for 2.5 Hour, 8-Week Program) 
Study Component 
Reimbursement Amount 
Schedule 
Baseline Interview 
$20.00 
Reimbursed once: 
1. After End of Program (up to $100) 
Weekly Questionnaire 
$20/per class/questionnaire 
End-of-Program Interview 
$20.00 
3-Month Interview 
$20.00 
To be reimbursed after completion of 3-
Month Interview (up to $20) 
6-Month Interview 
$20.00 
To be reimbursed after completion of 6-
Month Interview (up to $20) 
 
 
Table 3B – Reimbursement Payments/Schedule (for 1.25 Hour, 6-Week Program) 
Study Component 
Reimbursement Amount 
Schedule 
Baseline Interview 
$20.00 
To be reimbursed twice: 
1. After mid-way point (week 3) of 
program (up to $50) 
2. After End of Program (up to $50) 
Weekly Questionnaire 
$10/per class/questionnaire 
End-of-Program Interview 
$20.00 
3-Month Interview 
$20.00 
To be reimbursed after completion of 3-
Month Interview (up to $20) 
6-Month Interview 
$20.00 
To be reimbursed after completion of 6-
Month Interview (up to $20)