Easing the Burden of Dementia Caregiving: A Telephone-delivered Mindfulness Intervention for Rural, African American Families
Phase: NA
Conditions: Alzheimer Dementia, Caregiver, Dementia Alzheimers
Sponsor: University of North Carolina, Chapel Hill

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Easing the Burden of Dementia Caregiving: A Telephone-
delivered Mindfulness Intervention for Rural, African 
American Families 
 
 
NCT number:  
NCT04058886 
 
 
Version:   
April 12, 2023 
 
 
Study Chairman or Principal Investigator: 
Susan A. Gaylord, PhD 
Sharon W. Williams, PhD 
Supported by: 
The National Institute on Aging 
1R21 AG061728-0 
Study Intervention Provided by:  
Not applicable  
Sponsor of IND (IDE):  
Not applicable  
 

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TABLE OF CONTENTS 
 
PRÉCIS ....................................................................................................................................... viii 
Study Title ................................................................................................................................ viii 
Objectives ................................................................................................................................ viii 
Design and Outcomes .............................................................................................................. viii 
Interventions and Duration ........................................................................................................ ix 
Sample Size and Population....................................................................................................... ix 
STUDY TEAM ROSTER........................................................................................................... 10 
Principal Investigator: Name .................................................................................................. 10 
Co-Investigators: Name.......................................................................................................... 10 
PARTICIPATING STUDY SITES ........................................................................................... 12 
1 
Study objectives ................................................................................................................... 12 
1.1 
Primary Objective ......................................................................................................... 12 
1.2 
Secondary Objectives.................................................................................................... 12 
2 
BACKGROUND AND RATIONALE .............................................................................. 13 
2.1 
Background on Condition, Disease, or Other Primary Study Focus ............................ 13 
2.2 
Study Rationale ............................................................................................................. 14 
3 
STUDY DESIGN ................................................................................................................. 16 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS .......................................... 19 
4.1 
Inclusion and Exclusion Criteria ................................................................................... 19 
4.2 
Study Enrollment Procedures ....................................................................................... 20 
5 
STUDY INTERVENTIONS .............................................................................................. 21 
5.1 
Interventions, Administration, and Duration ................................................................ 21 

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5.2 
Handling of Study Interventions ................................................................................... 21 
5.3 
Concomitant Interventions ............................................................................................ 23 
5.3.1 Allowed Interventions ............................................................................................... 22 
5.3.2 Required Interventions .............................................................................................. 22 
5.3.3 Prohibited Interventions ............................................................................................ 22 
5.4 
Adherence Assessment ................................................................................................. 22 
6 
STUDY PROCEDURES .................................................................................................... 23 
6.1 
Schedule of Evaluations ................................................................................................ 23 
6.2 
Description of Evaluations ............................................................................................ 24 
6.2.1 Screening Evaluation ................................................................................................ 24 
6.2.2 Enrollment, Baseline, and/or Randomization ........................................................... 25 
6.2.3 Follow-up Visits........................................................................................................ 27 
6.2.4 Completion/Final Evaluation .................................................................................... 27 
7 
SAFETY ASSESSMENTS ................................................................................................. 28 
7.1 
Specification of Safety Parameters ............................................................................... 29 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters .... 30 
7.3 
Adverse Events and Serious Adverse Events ............................................................... 29 
7.4 
Reporting Procedures .................................................................................................... 31 
7.5 
Follow-up for Adverse Events ...................................................................................... 31 
7.6 
Safety Monitoring ......................................................................................................... 31 
8 
INTERVENTION DISCONTINUATION........................................................................ 33 
9 
STATISTICAL CONSIDERATIONS .............................................................................. 33 
9.1 
General Design Issues ................................................................................................... 33 
9.2 
Sample Size and Randomization .................................................................................. 35 
9.2.1 Treatment Assignment Procedures ........................................................................... 35 
9.3 
Interim analyses and Stopping Rules ............................................................................ 35 
9.4 
Outcomes ...................................................................................................................... 36 
9.4.1 Primary outcome ....................................................................................................... 36 
9.4.2 Secondary outcomes ................................................................................................. 36 
9.5 
Data Analyses ............................................................................................................... 36 

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10 DATA COLLECTION AND QUALITY ASSURANCE ................................................ 38 
10.1 
Data Collection Forms .................................................................................................. 38 
10.2 
Data Management ......................................................................................................... 38 
10.3 
Quality Assurance ......................................................................................................... 38 
10.3.1 
Training ................................................................................................................. 38 
10.3.2 
Quality Control Committee................................................................................... 39 
10.3.3 
Metrics .................................................................................................................. 39 
10.3.4 
Protocol Deviations ............................................................................................... 41 
10.3.5 
Monitoring ............................................................................................................ 41 
11 PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................. 40 
11.1 
Institutional Review Board (IRB) Review .................................................................... 40 
11.2 
Informed Consent Forms .............................................................................................. 41 
11.3 
Participant Confidentiality ............................................................................................ 40 
11.4 
Study Discontinuation ................................................................................................... 40 
12 ETHICAL CONSIDERATIONS ....................................................................................... 41 
13 COMMITTEES................................................................................................................... 41 
14 PUBLICATION OF RESEARCH FINDINGS ................................................................ 42 
15 REFERENCES .................................................................................................................... 42 
16 SUPPLEMENTS/APPENDICES .....................................................................................  48 
16.1 ......... Appendix A: Adverse Event Monitoring Form……………………………….…..48 
16.2       Appendix B: Adverse Event Reporting Form……………………….…………….49 
16.2 
Appendix C: Consent Forms………………………………………………………51 
 
 
 
 
 
 

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TABLE OF FIGURES 
Figure 1: Stress process and uncertainty theories informing caregiver mindfulness training
....................................................................................................................................................... 14 
 
Figure 2:  Intervention design 
 
Protocol/IRB Change Log* (not all IRB changes necessitated protocol changes): 
 
2/2019 
1. Modified consent form to include Certificate of Confidentiality language 
 
9/2019 
1. Added new personnel (Elondra Harr, research assistant) 
2. Updated flyer and consent forms to include more details, including increasing 
reimbursement offered (increased total reimbursement from $50 to $100) 
 
12/2019 
• Updated screening script to match consent form and flyer language 
• We inserted the short form, used in place of the long form (where appropriate), for 
quantitative measures to decrease participant burden. Measures that will use the short 
form include: 
o Zarit Burden Interview-SF 12 (ZBI-12) 
o Intolerance of Uncertainty (IUS-12) 
o Cognitive Emotion Regulation-Short Form (CERQ-18) 
o PROMIS General Self-efficacy-Short Form 4a 
o PROMIS Self-efficacy Manage Emotions-Short Form 4a 
o PROMIS Anxiety-Short Form 4a 
o PROMIS Anger-Short Form 5a 
o PROMIS Emotional Support-Short Form 4a 
o PROMIS Instrumental Support-Short Form 4a 
o PROMIS Informational Support-Short Form 4a 
• Pre-participation Interview: guided questions added for participants to share their 
thoughts about mindfulness, telephone sessions, and comfortability with technology 
• Mindfulness scale: substituted Cognitive and Affective Mindfulness Scale-Revised 
(CAMS-R) for Self-Compassion Scale (SCS). Questions for CAMS-R are shorter. The 
research team thought this would decrease the questionnaire burden for participants. 
• Added new personnel (Karen, Sheffield-Abdullah, co-investigator) 
 
3/2020: 
1. In response to COVID, we changed the protocol as follows: 
a. All assessments and consent processes could be completed over the telephone (in 
home left as an option) 

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b. The 3.5 hour in-person retreat was changed to a 1.5 hour video-conference retreat  
4/2020: 
1. Added new recruitment methods in response to COVID, including email announcements, 
radio/newspaper ads, and Facebook ads 
2. Added new personnel (Nandie Elhadidy, Rachel Mason, research assistants) 
3. Modified eligibility criteria for care recipients. Recipients would be considered eligible if 
care recipient has received a diagnosis of dementia, OR receives a score of 2 or higher 
rating by the primary caregiver on the AD-8 scale OR at least an 8 on the FAST scale. 
 
6/2020: 
1. Minor flyer update to emphasize over the phone options 
2. Expanded geographic eligibility area to include all of rural Eastern NC (and defined 
these) 
3. Received IRB approval to allow community partners to share potential subjects contact 
information with the team, if permission by the potential subject is given 
 
7/2020: 
1. Added website site (Study Pages) and NC registry for Brain Health/Duke Family 
Caregiver e-news as recruitment sources 
 
8/2020:  
1. Updated study personnel, added Dr. Jessica Barnhill as study physician 
 
9/2020: 
1. Consent modified to state online retreat length could vary (up to 4 hours) 
 
10/2020: 
1.Added questions to enrollment process to assess home internet status, for purposes of 
distribution of tablets 
 
12/2020 
1. Added emergency contact information and a UNC consent addendum to allow 
unencrypted texting/emailing for primarily to allow scheduling and reminders of study-
related activities 
2. Added protocol for emergency situations over the phone 
 
7/2021 
1. Added Jenni Shafer to the research team 
 
10/2021 

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1. Added script/instructions to assessments to emphasize voluntary nature/ability to skip 
questions 
 
 
 

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PRÉCIS 
Study Title: Easing the Burden of Dementia Caregiving: A Telephone-delivered 
Mindfulness Intervention for Rural, African American Families 
Objectives  
SPECIFIC AIM 1: To determine the feasibility and acceptability of a telephone-delivered 
mindfulness training intervention (TMT) in decreasing caregiver burden among rural, 
African American, informal caregiving teams of people with dementia.  
 
SPECIFIC AIM 2: To explore, on a preliminary basis, the effects of the training on 
caregiver burden and relevant secondary outcomes for both caregiving team members, 
including (1) emotion regulation; (2) tolerance of uncertainty; (3) emotional and physical 
health; (4) family conflict within the informal caregiving team; and (5) self-efficacy. 
 
SPECIFIC AIM 3: To explore comfort with and willingness to adopt technologies (e.g. 
telephone-based, web-based) to access mindfulness practices and existing caregiving 
educational resources. 
Design and Outcomes   
The proposed study utilizes a single-group, uncontrolled design to assess the feasibility and 
acceptability of telephone-delivered mindfulness training designed to alleviate caregiver 
burden for rural caregivers of African American individuals with moderate to severe 
dementia, A care partner—the person who provides the most support in addition to the 
primary caregiver—is included in the intervention. The primary outcome is feasibility as 
assessed by an 85% retention rate with completion of at least 6 of the intervention sessions. 
Pre- and post-participation interviews will assess acceptability.   
 
At baseline, after obtaining informed consent, study staff will interview primary caregivers 
in their homes (or via a phone call post-COVID) and will administer a set of questionnaires, 
including the 12-item Zarit Burden Interview as well as measures of:  
1) family satisfaction; 
2) tolerance of uncertainty;  
3) cognitive emotion regulation;  
4) general self-efficacy;  
5) anxiety and anger; 
6) self-efficacy in managing emotions;  
7) global physical health;  
8) family conflict; 
9) social support (emotional, instrumental, informational); 

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10) meaning and purpose; 
11) cognitive and affective mindfulness 
Study staff will interview the care partner in person or over the telephone.  After the 8-week 
intervention, study staff will interview the caregiver (in the home, or via telephone), care 
partners (on the telephone) once more, and administer the questionnaires. 
Interventions and Duration  
The intervention consists of mindfulness training delivered by telephone once weekly for 8 
weeks.  The intervention also includes one weekend part-day retreat.. The intervention, 
based on Kabat-Zinn’s mindfulness-based stress reduction (MBSR) and adapted for this 
study population, emphasizes the following:  1) mindful experiencing, including 
mindfulness of body sensations, feelings, thoughts and emotions ; 2) mindful 
communication, including non-verbal mindfulness, mindful listening, and mindful speaking; 
and 3) mindful compassion for self and others. 
Sample Size and Population  
Planned study participants include 32 adult caregivers, aged 18 and older, who live with or 
near an African American dementia care recipient and provide at least four hours of care per 
day.  Additional participants include an additional adult, the care partner, who the caregiver 
identifies as another person who helps with the care.  This person may be a blood relative or 
a non-blood relative.   Hence, 32 caregiver-care partner dyads comprise the study 
population.  

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STUDY TEAM ROSTER  
Principal Investigators:  
Susan A. Gaylord, PhD    Director, Program on Integrative Medicine 
Associate Professor, Dept. of Physical Medicine & Rehabilitation
 
184 Medical School Wing D, CB#7200 
University of North Carolina at Chapel Hill 
Chapel Hill, NC 27599-720 
Tel: 919-966-8586\Fax:  919-843-5452 
gaylords@med.unc.edu 
Main responsibilities/Key roles: Fiscal and administrative management, intervention refinement, 
regulatory communication, qualitative analysis, and data interpretation. 
 
Sharon W. Williams, PhD, Director, Division of Speech and Hearing Sciences 
Associate Professor, Department of Allied Health 
         3130 Bondurant Hall, CB#7190 
University of North Carolina at Chapel Hill 
Chapel Hill NC 27599-7190 
Telephone:  (919) 966-9462; Fax: (919) 966-0100 
sharon_w_williams@med.unc.edu 
Main responsibilities/Key roles: Project implementation, analysis and implementation of 
recommendations from key informants and advisory council members as well as intervention 
participants, development of caregiver resources, data analysis and interpretation.   
 
Co-Investigators: 
 
Keturah Faurot, PhD, PA, Assistant Director, Program on Integrative Medicine 
Asst. Professor, Dept. of Physical Medicine & Rehabilitation 
 
171 Medical School Wing D, CB#7200 
University of North Carolina at Chapel Hill 
Chapel Hill, NC 27599-720 
Tel: 919-966-3578\Fax:  919-843-5452 
faurot@med.unc.edu 
Main responsibilities/Key roles: Protocol development, data management, and data analyses. 
 
Christine Lathren, MD, MPH; Faculty Affiliate, Program on Integrative Medicine 
 
 
 
 
 
 
Asst. Professor, Dept. of Physical Medicine & Rehabilitation 
186 Medical School Wing D, CB#7200 
University of North Carolina at Chapel Hill 
Chapel Hill, NC 27599-720 
Tel: 919-966-9656\Fax: 919-843-5452 
lathren@email.unc.edu 
Main responsibilities/Key roles: Caregiver handbook development (caregiver education and 
mindfulness training) development, qualitative data analyses. 
 
Isabel Roth, DrPH; Faculty Affiliate, Program on Integrative Medicine 
 
 
 
 
 
 
Asst. Professor, Dept. of Physical Medicine & Rehabilitation 
186 Medical School Wing D, CB#7200 
University of North Carolina at Chapel Hill 

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Chapel Hill, NC 27599-720 
Tel: 919-966-9656\Fax: 919-843-5452 
iroth@email.unc.edu 
Main responsibilities/Key roles: Assist with recruitment, community engagement, including key 
informant interviews. 
 
Jessica Barnhill, MD; Study Physician, Program on Integrative Medicine;  
 
 
 
 
 
 
Faculty Affiliate, Program on Integrative Medicine 
 
 
 
 
 
 
Asst. Professor, Dept. of Physical Medicine & Rehabilitation 
186 Medical School Wing D, CB#7200 
University of North Carolina at Chapel Hill 
Chapel Hill, NC 27599-720 
Tel: 919-966-9656\Fax: 919-843-5452 
jbarnhill@med.unc.edu 
Main responsibilities: Safety protocols, adverse events consultations 
Karen Sheffield-Abdullah, Asst. Professor, School of Nursing 
University of North Carolina at Chapel Hill 
Chapel Hill, NC 27599 
Main responsibilities: Safety protocols, adverse events consultations 
Main responsibilities: Qualitative data analysis, mindfulness instructor 
OTHER STUDY TEAM MEMBERS: 
Jenni Shafer, PhD; T32 Post-doctoral Fellow, Program on Integrative Medicine 
 
 
 
 
 
187 Medical School Wing D, #7200 
University of North Carolina at Chapel Hill 
Chapel Hill, NC 27599-720 
Tel: 919-966-8586 
Jenni_Shafer@med.unc.edu 
Main responsibilities/Key roles: qualitative data analyses 
Kelly Eason, BA; Coordinator, Program on Integrative Medicine; Research Assistant;  
 
 
 
 
 
185 Medical School Wing D, #7200 
University of North Carolina at Chapel Hill 
Chapel Hill, NC 27599-7200 
Tel: 919-966-8586 
Kelly_Eason@med.unc.edu 
Main responsibilities/Key roles: intervention assistant 
Elondra Harr; Research Assistant;  
 
 
 
 
 
185 Medical School Wing D, #7200 
University of North Carolina at Chapel Hill 
Chapel Hill, NC 27599-7200 
Tel: 919-966-8586 
Kelly_Eason@med.unc.edu 
Main responsibilities/Key roles: intervention assistant 

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PARTICIPATING STUDY SITES  
Not applicable. 
 
1 
STUDY OBJECTIVES 
1.1 Primary Objective 
SPECIFIC AIM 1: To determine the feasibility and acceptability of a telephone-delivered 
mindfulness training intervention (TMT) in decreasing caregiver burden among rural, informal 
caregiving teams caring for African Americans with dementia. 
 
Hypothesis 1:  TMT will be feasible within the informal caregiving teams. Feasibility is 
established when 85% (95% CI:  72.5, 97.5) of participants in the telephone-delivered 
mindfulness training intervention complete at least six sessions of the intervention.  
 
Hypothesis 2:  The adapted TMT will be acceptable to informal caregiving teams as evidenced 
by an 85% (95% CI:  72.5, 97.5) endorsement of the program in post-participation interviews. 
1.2 Secondary Objectives 
SPECIFIC AIM 2: To explore, on a preliminary basis, the effects of the training on caregiver 
burden and relevant secondary outcomes for both caregiving team members, including: 
 
Hypothesis 1:  Compared with baseline levels, we hypothesize that mindfulness training will 
reduce caregiver burden (Zarit Burden Interview). 
 
Hypothesis 2:  Compared with baseline levels, we hypothesize that mindfulness training will 
improve emotion regulation by increasing positive coping styles (acceptance, positive 
refocusing, positive reappraisal) and decreasing negative coping styles (rumination, 
catastrophizing, self-blame) as measured by the Cognitive Emotion Regulation Questionnaire. 
 
Hypothesis 3:  Compared with baseline levels, we hypothesize that mindfulness training will 
increase tolerance of uncertainty as measured by (an adapted form of) the Intolerance of 
Uncertainty Scale. 
 
Hypothesis 4:  Compared with baseline levels, we hypothesize that training in mindful 
communication will increase perceived social support among the caregivers (PROMIS Social 
Support short forms).  
 
 Hypothesis 5:  Compared with baseline levels, we hypothesize that training in mindful 
communication reduce family conflict around caregiving (Family Conflict Scale). 
 
Hypothesis 6:  Compared with baseline levels, we hypothesize that mindfulness training will 
reduce anger and anxiety (PROMIS scales). 
 

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Hypothesis 7:  Compared with baseline levels, we hypothesize that mindfulness training increase 
global self-perceived physical health (PROMIS short forms). 
 
Hypothesis 8:  Compared with baseline levels, we hypothesize that mindfulness training increase 
meaning and purpose (PROMIS short form). 
 
Hypothesis 9:  Compared with baseline levels, we hypothesize that mindfulness training along 
with a caregiver resources handbook will increase caregiver general and emotional self-efficacy 
(PROMIS scales). 
 
Hypothesis 10: Compared with baseline levels, we hypothesize that mindfulness training will 
increase family satisfaction (Family Satisfaction Scale). 
 
Hypothesis 11: Compared with baseline levels, we hypothesize that mindfulness training will 
increase mindfulness (Cognitive and Affective Mindfulness Scale). 
 
SPECIFIC AIM 3: To explore comfort with and willingness to adopt technologies (e.g. 
telephone-based, web-based) to access mindfulness practices and existing caregiving educational 
resources.  
As part of intervention planning, using interviews, we will investigate comfort with a 
smartphone/tablet. We will implement the tablets among half of the intervention groups so that 
we can compare acceptance between groups with and without the technology. 
2 
BACKGROUND AND RATIONALE  
2.1 Background on Condition, Disease, or Other Primary Study Focus 
The number of individuals and families impacted by Alzheimer’s disease and related 
dementia (ADRD) is projected to triple by 2050 and many of those impacted will be African 
Americans (AAs).1 Further, many older AAs live in rural areas and experience disadvantages by 
living in areas with fewer resources and poorer infrastructure.2 Given that AAs and rural older 
adults are often disproportionately affected by ADRD, this research seeks to meet the need for 
culturally and geographically tailored research for rural AA caregivers of older adults with 
ADRD.1,3–6  Most families, including AA families, provide dementia care in the home and when 
compared with other caregivers (CGs), dementia CGs experience higher levels of physical, 
financial, and emotional burden, including anxiety and stress as well as higher rates of family 
discord.16–19,9 One study reported over 50% of spousal CGs and over 80% of adult children CGs 
endorsed some level of family conflict.10 Some researchers have called dementia ‘the great 
divider’, as caregiving stress tends to accentuate long-standing interpersonal issues between 
family members.11 Aspects of family functioning most strongly associated with caregiving 
burden include ineffective communication and difficulties around roles (i.e. distribution of 
caregiving tasks).12 In AA families, often a cultural expectation of high family involvement 
exists,13 so family conflict around roles and provision of social support may be particularly 
distressing.14  Despite these findings, few CG interventions address family relationship 
difficulties. 

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We know that race and cultural experiences, ways of coping, and ways of seeking help often 
differ for AA compare with caregivers of other ethnicities.15–18 Evidence also suggests that, 
contrary to previous findings, AA caregivers, who are likely to be adult children, also experience 
high levels of anxiety and distress.19,20 Therefore, within-group studies of African Americans, 
and other racial minorities, are needed to provide characteristics and processes critical for 
tailored interventions.21   Hence, innovative theory-based programs, culturally and 
geographically tailored to rural AA populations, are needed to ease the burden of dementia-
related caregiving in rural AA populations. 
2.2 Study Rationale 
Pearlin et al.’s Stress Process Model posits complex relationships between background 
characteristics (demographics), primary stressors (care recipient neuropsychiatric symptoms and 
level of functional and cognitive impairment), secondary stressors/outcomes (interpersonal and 
intrapersonal strain) and caregiver health outcomes (physical and mental health) all mediated by 
coping and social support.22  The theory conceptualizes family conflict as a secondary, but potent 
source of stress outside of the caregiving situation, with both direct and indirect effects on 
negative caregiver (CG) outcomes.22 Family conflict is associated with high CG burden and 
negative CG mental and physical health outcomes,10,23–25 even after controlling for CG and care 
recipient characteristics typically associated with stress outcomes. Moreover, there is evidence 
that the structured, often repetitious ways that family members interact with one another, can 
either promote positive CG outcomes or contribute to CG distress in families caring for someone 
with dementia.26  In addition to these interpersonal strains, intrapersonal stressors such as role 
captivity and poor self-efficacy both result from and contribute to negative health outcomes.22
 
 
Figure 1: Stress process and uncertainty theories informing caregiver mindfulness training 
  
 
Mishel’s Reconceptualized Uncertainty in Illness Theory (RUIT),27,28 like her original theory, 
conceptualizes uncertainty as either a danger or an opportunity. Unlike the original theory, the 
reconceptualized model recognizes that when the outcome is negative, such as decline of a 
relative, appraisal of uncertainty as negative versus positive can change over time.27  In  a study 
applying the RUIT to dementia caregiving, uncertainty  was seen to impact the appraisal of 
primary stressors,29 making it conceptually consistent with other mediators. Mindfulness has 
been associated with cognitive flexibility, a related construct.30 Accordingly, in our proposed 
intervention, we hypothesize that mindfulness training could enhance the CG’s shift from a 
resistance to uncertainty to an acceptance of it as a natural part of life. Similarly, mindfulness 
CR = Care recipient; 
NPI=Neuropsychiatric Inventory; 
ZBI = Zarit Burden Interview; 
CERQ = Cognitive Emotion 
regulation Questionnaire; IUS = 
Intolerance of Uncertainty scale 

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training can shift emotion regulation strategies from negative (e.g., self-blame) to positive (e.g., 
planning). Additionally, the proposed focus on improving family conflict should affect perceived 
social support, another mediator of health outcomes, thereby leading to greater self-efficacy and 
positive emotions. 
 
Mindfulness-based Stress Reduction for reducing burden in dementia caregivers.  
Mindfulness meditation has been described as “a behavioral technique involving the intentional 
self-regulation of attention to present-moment experience, combined with release of cognitive 
fixation on thoughts (whether simple images or complex storylines) regarding the past or 
future.”31,32 Through training in mindfulness, individuals learn to evoke and sustain a non-
judgmental state of present-moment awareness.31,33 Research has shown that mindfulness 
training programs such as Mindfulness-based Stress Reduction (MBSR), which also incorporate 
exercises to generate compassion for oneself and others, result in reduced stress, improved 
coping, and a host of improved physical and psychological health outcomes.34,35 Mindfulness 
training programs have been adapted and successfully utilized for a wide range of conditions, 
populations, and cultures including in AAs and in CGs.36–38 Studies with AAs have shown 
mindfulness training to be culturally acceptable and feasible.39 Studies with CGs, including 
informal CGs of persons with dementia, have shown that mindfulness interventions can decrease 
CG burden and improve coping skills, including decreased emotion-based coping and increased 
tolerance for uncertainty, as well as improve psychological well-being and quality of life.38,40 
Two studies have also shown mindfulness to improve relationship quality and 
communication.41,42  
 
In order to increase geographic accessibility, mindfulness training programs have been 
successfully adapted to distance-based formats, particularly involving use of the internet43,44 and 
occasionally have incorporated smart-phone or telephone-delivered mindfulness training 
formats.45–48 An additional advantage of distance-based formats for CGs is their flexibility in 
terms of the CG’s often restricted and demanding lifestyle. For rural caregivers, a telephone-
delivered mindfulness program would seem to be particularly accessible, useable, and feasible, 
overcoming both distance and infrastructure barriers. Moreover, such a program would easily 
lend itself to facilitating communication between CG family members, including those who are 
geographically distant, thereby increasing our intervention’s reach.   
 
 
Developing a Telephone-Delivered Mindfulness Training Intervention (TMT) for Care 
Teams.  In light of the above findings, and relying on Dr. Gaylord’s extensive experience in 
adapting mindfulness-training programs and Dr. Williams’ extensive experience working with 
African American caregivers, we plan to implement a telephone-delivered mindfulness training 
intervention that will incorporate:  
1) Training for primary caregivers (CG) and their caregiving partner (CP) in an 8-week, 
telephone-based, mindfulness-based stress reduction (MBSR) program, which places 
additional emphasis on training in the following:  
a. mindful experiencing, including mindfulness of feelings and body sensations as 

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well as thoughts and emotions; 
b. mindful communication, including non-verbal mindfulness, mindful listening, and 
mindful speaking; and  
c. mindful compassion for self and others.   
 
2) Groups of up to eight participants (four CG-CP pairs) plus an instructor, on a shared 
telephone line; and  
 
Additionally, homework assignments for CG will involve listening to exercise recordings 
via a dial-in telephone line or computer tablet and assignments for CG-CP dyads (e.g. mindful 
listening and communication practices) as well as CG mindfulness practices in the presence of 
CRs (e.g. mindful eating, and mindful listening). Based on theory and evidence from previous 
mindfulness studies, we believe that this intervention holds promise of making a significant 
impact on reducing burden in AA rural CGs. 
 
The study pilots a telephone-delivered mindfulness-training intervention (TMT) for 
caregiving teams (rather than in-person or web-based) aimed at reducing caregiver burden.  Our 
rationale is that members of rural communities are less likely to have access to the internet, but 
have high likelihood of some form of telephone service, and are limited by caregiving 
responsibilities in their ability to attend training programs. Currently, the intervention is planned 
for eight weekly, one-hour telephone sessions along with one 1.5-hour retreat. Adjustments to 
the format are possible, based on input from key informants and the Advisory Council.   
 
In pre-post studies, mindfulness training in pre-post studies has shown a moderate positive 
effect on clinical outcomes such as depression, anxiety, and physical conditions with a Hedge’s g 
of 0.57 (95% CI 0.5, 0.64).35 A meta-analysis of studies of mindfulness training for caregivers 
showed consistently positive effects on psychological outcomes.38    
 
Adverse events are rarely reported in mindfulness training studies.  However, the training 
prompts participants to attend to emotions, thoughts, and physical sensations, some of which 
may be unpleasant.  Hence, emotional discomfort or distress (EDD) may arise for some 
participants.  Usually, EDD resolves quickly with guidance from an experienced instructor and, 
as participants become more skilled in mindfulness, they recover from EDD more quickly. 
Mindfulness training has the potential to exacerbate dissociation in susceptible individuals—
therefore, it is important to exclude such individuals unless the program is monitored by an 
experienced mental health clinician.   
3 
STUDY DESIGN 
The proposed study utilizes a single-group, uncontrolled design to assess the feasibility and 
acceptability of telephone-delivered mindfulness training designed to alleviate caregiver burden 
for rural caregivers of African American individuals with moderate to severe dementia. A care 
partner—the person who provides additional help —is included in the intervention. The primary 
outcome is feasibility of the telephone-delivered mindfulness intervention as assessed by an 85% 
retention rate with completion of at least 6 of the intervention sessions. Pre- and post-
participation interviews will assess acceptability. A diagram of the intervention and assessment 
plan is provided in Figure 2. 

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Figure 2. Intervention design* 
*In-person assessments and retreat were changed in March 2020 due to COVID pandemic 
 
SPECIFIC AIM 1: To determine the feasibility and acceptability of a telephone-delivered 
mindfulness training intervention (TMT) in decreasing caregiver burden among informal 
caregiving teams caring for African Americans with dementia. 
 The primary outcomes are feasibility and acceptability among primary caregivers and also 
among care partners.   
 
SPECIFIC AIM 2: To explore, on a preliminary basis, the effects of the training on caregiver 
burden and relevant secondary outcomes for both caregiving team members.  Secondary 
outcomes include the following: 
1. Pre-post intervention differences in caregiver burden (Zarit Burden Interview); 
2. Pre-post intervention differences in coping emotion regulation and coping styles 
(Cognitive Emotion Regulation Questionnaire); 
3. Pre-post intervention differences in tolerance of uncertainty (Intolerance of Uncertainty 
Scale); 
4. Pre-post intervention differences in anger, anxiety, and global self-perceived health 
(PROMIS short forms); 
5. Pre-post intervention differences in family satisfaction (Family Satisfaction Scale), 
perceived social support among the caregivers (PROMIS Social Support short forms) and 
family conflict around caregiving (Family Conflict Scale); 
6. Pre-post intervention differences in caregiver self-efficacy; 
7. Pre-post intervention differences in mindfulness (CAMS-R scale), hopefulness, and 
optimism (Meaning and Purpose Scale). 
 

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SPECIFIC AIM 3: To explore comfort with and willingness to adopt technologies (e.g. 
telephone-based, web-based) to access mindfulness practices and existing caregiving educational 
resources.  
1. In interviews with both the primary caregivers and the care partners, we will investigate 
comfort and experience with internet devices, including smartphones, tablets, and 
computers. For half of the intervention groups, we will ask these questions in post-
participation interviews, including exploring how individuals are currently using or 
would like to use these technologies (e.g., voice activation, use of bookmarks). 
2. For half of the intervention groups, we will ask questions about technology before the 
intervention and will offer each family a tablet loaded with intervention materials, 
including the contents of the participant binder.  Post-participation interviews will include 
questions about the ease of use and perceived value of the tablets. 
 
The study population will consist of 32 caregivers (CG) of African Americans care recipients 
(CR) with a cognitive or memory problem severe enough to prevent them from caring for 
themselves without assistance.  Because African Americans with Alzheimer’s disease and related 
dementias (ADRD) are less likely to have a formal diagnosis and because a formal diagnosis 
would not impact the potential value of the intervention for the caregiver, the study does not 
require a formal diagnosis.  Instead, the study will require a level of disability as perceived by 
the caregiver to be at least moderate (see Inclusion Criteria).  The study population also includes 
the 32 additional caregivers, care partners (CP) identified by the primary caregiver as informal 
team members who provide assistance.  No control group is planned. 
 
Additional participants in the study will include approximately 10 key informants from the 
community who will provide context, advice on cultural relevance, and advice on intervention 
language.  These individuals may consist of informal caregivers, former caregivers, members of 
the Council on Aging, members of African American sororities affiliated with the Alzheimer’s 
Association of Eastern North Carolina, or African American formal caregivers affiliated with 
hospitals in Eastern North Carolina. 
 
Primary caregivers will come from Lenoir County, Wayne County, and surrounding 
counties in rural Eastern North Carolina.  Caregiver assessments will take place in the home, or 
another location of the caregiver’s choice. (During and following the COVID pandemic, this 
assessment will take place via telephone for all participants.) Care partners are not restricted 
geographically.  Assessments of Care Partners will take place by telephone (or in a separate 
room in the home if they are present).    
 
The research team will work with the individuals and organizations including the 
Alzheimer’s Association of Eastern North Carolina (AAENC), the Study Physician, Research 
Fellows, and local pastors to develop a handbook of relevant caregiving resources for families 
(available both as a hard copy and, in half of the groups, electronically) as well as mindfulness 
exercises.  Included in the handbook will be information about additional training for addressing 
CR behavioral problems (e.g., WeCare Advisor), training not covered explicitly by the proposed 
intervention.  

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The total duration of participation includes: 1) a pre-participation assessment up to 6 weeks 
prior to the intervention; 2) eight weeks of intervention calls plus retreat; and 3) a post-
participation interview and assessment within four weeks of the last intervention call.  
Interventions will take place over the telephone for the 8 mindfulness training sessions.  The 
retreat, occurring between sessions 5 and 6, will take place either at a community location 
convenient to the majority of the group participants, or online via Zoom, during and after the 
COVID..  Please see Table 1 and the intervention handbook for details of the intervention. 
 
Table 1: Proposed curriculum for telephone-delivered mindfulness training 
Session Topics 
Caregiver/Care Partner Home 
Assignments 
1 
Introductions; what is mindfulness?  
Relevance to caregiving; Mindful 
relaxation breath and Mindfulness of 
sound 
Practice mindful relaxation breath 3-5 
minutes each day.  Discuss your experiences 
with one another (CG-CP dyad).     
2 
Stress:  How mindfulness can help 
us cope; Sitting meditation and 
mindful walking 
Practice sitting meditation for 5 minutes once 
daily.  Discuss your experiences with one 
another (CG-CP dyad).   
3 
Being and Doing Mind; Body scan 
and Mindful eating 
Practice Body scan +/- mindful eating.  
Discuss your experiences with one another 
(CG-CP dyad).   
4 
Approaching Daily Life with 
Mindful Awareness; Breathing 
space/Mindful listening 
Practice breathing space daily.  Practice 
Mindful listening techniques in CG-CP dyad.  
5 
Mindfulness and Self-Care; 
instruction in self-compassion 
Practice techniques learned. Continue to 
practice mindful listening in CG-CP dyad.  
Begin a self-compassion journal. 
Retreat Mindful communication: Listening, 
speaking, difficult conversations 
(no homework but participants are 
encouraged to reflect upon the day and 
discuss with one another) 
6 
Mindfulness and Resilience; 
Compassion for the difficult person 
Practice techniques learned. Practice mindful 
listening and speaking and explore 
compassion practice in CG-CP dyad. 
7 
Gratitude:  Appreciating the 
Journey; learning to express our 
appreciation and gratitude to self 
and others 
 
Practice techniques learned for 10 minutes 
twice daily.  Practice mindful speaking and 
listening dyad, focusing on gratitude for 
others.  Reflect on and discuss what 
techniques you found useful and may wish to 
continue. 
8 
Mindfulness and Meaning in 
Everyday Life—the Journey 
continues 
 
 
 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 Inclusion and Exclusion Criteria  
Informal caregiving teams will be composed of a primary and secondary informal caregiver, as 
defined as:  

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any relative, partner, friend or neighbor who has a significant personal relationship with, and 
provides a broad range of assistance for, an older person or an adult with a chronic or disabling 
condition [in this case, Alzheimer’s Disease or a related dementia].  These individuals may be 
primary or secondary caregivers and live with, or separately from, the person receiving care. 
(Family Caregiver Alliance, www.caregiver.org) 
The primary caregiver (CG) are adults who must: 
• Care for a family member with dementia who identifies as Black or African American 
o Defined: Care recipient must have a diagnosis of dementia (reported by caregiver) 
or have a score of at 2 or higher on the AD-8 or a score of 8 or higher on the 
Functional Activities Questionnaire (FAQ).  
• Provide regular, daily care (at least 4 hours per day) for a family member who has 
dementia 
• Have another adult care partner (CP) who is willing to participate; someone who shares 
caregiving or helps make decisions regarding the person with dementia or Alzheimer's 
disease (may be remote and family member or friend) 
• Have a telephone and be willing to participate in weekly calls 
• Live in rural areas in Eastern North Carolina. 
o Defined: Eastern is defined as east of Wake County NC; rural is defined as listed 
as rural within the website https://www.ruralhealthinfo.org/am-i-rural 
The primary caregiver is excluded if they: 
• Are receiving active treatment for cancer 
• Have been hospitalized 3 or more times in the last year 
 
The care partner is eligible if they are 18 or older, have a telephone and are willing to attend 
weekly sessions. Care partners do not need to be living in the same geographic region as the 
primary caregiver. 
4.2 Study Enrollment Procedures  
Community involvement.  Because little research has investigated dementia caregiver 
needs in eastern NC, our team proposes adjunctive qualitative methods.  To assist in adapting the 
mindfulness-training intervention components and the handbook, we plan to conduct key 
informant interviews. Key informants will include local pastors, members of African American 
sororities affiliated with the AAENC, and members of the local Council on Aging.  Additionally, 
we will plan interviews with African American caregivers of people with dementia 
 
Advisory Council.  We will also recruit an Advisory Council of 5-8 individuals. We will 
share the results of feasibility data and qualitative analyses with the Advisory Council and utilize 
their input in refining improving the intervention.  The Advisory Council may also review the 
intervention manual and study logistics and provide recommendations. 

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    Recruitment, screening and consent. We plan to recruit participants in conjunction with 
local service providers and community organizations in Eastern NC Counties, including AAENC 
and local pastors.   These counties are chosen for their high AA populations (>30%) and existing 
relationships with UNC researchers.   Should recruitment from these counties be insufficient, we 
will extend the intervention to neighboring rural Eastern NC counties (e.g., Duplin, Sampson).  
 
 
Recruitment partners (AAAENC, affiliated sororities, pastors, Council on Aging) will 
advertise the study to their membership.  We will have a study website where potentially 
interested people can indicate interest. We will also provide study flyers to the UNC Hospitals 
clinics in Eastern NC counties and participate in local fairs and church-sponsored events in the 
counties. Once COVID pandemic occurred, we also relied on Facebook ads, radio/newspaper 
ads, NC Brain Registry and Duke family Caregiver Support e-news, and ‘snowballing’ (referrals 
from past participants).   Interested individuals may contact the study directly or may provide 
permission to recruitment partners for the study staff to contact them.  Recruitment partners may 
forward contact information to study staff. 
 
After we identify individuals, we will provide details of the intervention and screen CGs 
over the telephone and pre-screen individuals with a telephone consent.  We will visit CGs who 
meet the eligibility criteria in their homes to obtain a formal written consent for participation and 
to administer the baseline measures.  (During COVID, these procedures will be conducted 
completely over the phone, with verbal consent process and phone assessments. In addition, staff 
will obtain a verbal consent addendum to allow unencrypted texting and emailing for the main 
purpose of study activities reminders.) At that time, we will provide a binder with local and 
downloaded caregiver resources as well as mindfulness activity instructions. Participants may 
also access audio files with recorded mindfulness activities.  In the second half of the program, 
participants will receive a tablet loaded with all of the contents of the binder as well as 
bookmarked links to ADRD information sites. 
 
The primary caregiver will be asked to invite a care partner to participate in the study and 
will obtain that person’s permission for us to contact them.  Once permission is confirmed with 
the caregiver, study staff will contact the potential care partner, describe the study, and obtain 
verbal consent to proceed with assessments (and unencrypted messaging) as well as an invitation 
to participate in the intervention.  
5 
STUDY INTERVENTIONS  
5.1 Interventions, Administration, and Duration  
The study intervention is the mindfulness training for caregivers and care partners.  The 
mindfulness training is offered in 8 weekly telephone sessions plus one weekend retreat.  Respite 
care for the care recipient is provided for the retreat if needed.   
5.2 Handling of Study Interventions  
Each participant will receive a resources handbook (binder) containing the following:   

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• Descriptions of each class section and suggested homework exercises; 
• Detailed descriptions of mindfulness practices taught in the class; 
• Instructions for how to access recorded mindfulness practices; 
• A list of community resources for individuals with ADRD and their caregivers, including 
contact information; 
• A list of national resources for individuals with ADRD and their caregivers;  
• Instructions for caregivers based on material published by the researchers (Lathren, 
Kaufer); 
• Select downloaded materials from the Alzheimer’s Association of Eastern NC and other 
relevant websites. 
 
Half of the groups will receive an electronic tablet loaded with the handbook, recordings, and 
links to resources bookmarked. We will program voice-enabled personal assistants on the tablet 
to enable access to bookmarked resources. We will investigate the best way to provide internet 
service for each participating family for at least 4 months (e.g., cell, DSL, cable).  During the 
baseline (in-home) visit, we will teach CGs how to use the handbook.  CGs who receive the 
tablet will also learn how to use it in the baseline visit. In follow-up interviews, we will ask to 
what extent CGs used the handbook, tablet (if relevant), and call-in lines. Given it is unclear if 
and how technologies will be used in this population, this aspect of the study will provide insight 
on which components of the intervention will be most useful to include in future iterations.  
Because half of the groups will receive the tablets, we will be able to examine the difference in 
adherence and engagement between groups with the tablets and without the tablets. 
 
For the intervention, each trained, experienced mindfulness instructor will work from an 
instructor’s manual prepared by Dr. Gaylord. The instructor’s manual, designed for experienced 
mindfulness instructors, will detail the intervention components, providing tips on teaching the 
material and responding to participant questions.  Consultant Mary Brantley, an expert in 
telephone-delivered mindfulness, will review and edit the instructor’s manual.  
5.3.1 Allowed Interventions 
Caregivers and care partners are not restricted from participating in any care 
recommended by their physicians. We ask that they delay additional mindfulness-based 
therapies until after the end of the intervention. 
5.3.2 Required Interventions  
No interventions are required outside of the mindfulness training intervention with the 
accompanying handbook (on paper alone or on paper plus a tablet). 
5.3.3 Prohibited Interventions 
No interventions are prohibited, but we will ask participants to delay engaging in mindful 
yoga or mindfulness-based therapy until after the intervention, if possible. 
5.3 Adherence Assessment  
Adherence is assessed via a class participation log kept by the instructor as well as a data-

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tracking website kept up by the project manager and her staff.  The tracking website documents 
attendance at class sessions, instructions for participants outside of class sessions (if sessions are 
missed), and completion of study assessments.  
Acceptance of the treatment and control programs as measured by attendance at ≥ 6 intervention 
sessions.  
6 
STUDY PROCEDURES 
Table 2 outlines the schedule of evaluations for participants during their study participation. 
 
 
Table 2: Schedule of Evaluations 
Assessment 
Telephone 
Screening:  
(≤5 Wks prior 
to enrollment) 
Baseline, 
Enrollment: 
Visit 1 
 (W-4 to W0) 
Telephone 
sessions 
Visits 2-6  
(W1 to W5) 
Retreat 
Visit 7 
 (W5.5) 
Telephone 
sessions  
Visits 8-10 
(W6 to 
W8) 
Follow-up:  
Final Visit 
(by W15) 
Screening consent 
X 
 
 
 
 
 
Preliminary review of 
eligibility 
X 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
Informed Consent 
 
X  
  
  
  
  
Inclusion/Exclusion 
Criteria  
 
X  
  
  
  
X 
Enrollment 
 
X 
 
 
 
 
Baseline interview 
 
X 
  
  
  
X 
Baseline questionnaires 
(by interview or paper 
for CG; by interview or 
online for CP) 
 
X 
  
  
  
  
Attendance 
 
 
X 
X   
X  
 
Homework assessments 
 
 
 X 
  
X  
  
Post-participation 
interview 
 
 
 
  
  
X 
Follow-up 
questionnaires 
(by interview or paper 
for CG) 
(by interview or online 
for CP) 
 
 
 
 
 
X 
Adverse Event 
assessment  
  
 
X 
 
X 
X 

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6.1 Description of Evaluations  
6.1.1. Screening Evaluation 
These evaluations occur to determine if the candidate is eligible for the study.   
 
Consenting Procedure 
Prior to enrollment, interested caregivers will have an opportunity to hear more 
details about the study. If they continue to be interested, they will provide a telephone 
consent for review of eligibility and collection of demographic information. If they 
are eligible and wish to participate in the intervention, study staff (research assistant 
and/or project manager) will make an appointment for a home visit for enrollment 
and baseline assessments of the caregiver and/or care partner (during/post-COVID, 
this changed to a phone appointment). At that time, study procedures will be 
reviewed again and the caregiver will provide written informed consent (verbal 
consent and consent addendum for unencrypted messaging post-COVID).    
 
The caregiver will identify a care partner and, with their permission, provide contact 
information to the study staff. Because care partners may live in a distant geographic 
location, their consent may be obtained by verbal consent over the telephone. 
Screening and consenting can take place at the same time or in two different calls, at 
the discretion of the care partner.   
 
If changes are made in the study that affect the risk of the intervention before 
completion of their part of the study, study staff will contact participants again to 
review a revised consent. Participants who have completed the study will receive a 
letter explaining the increased risks. 
 
Physical, signed consent documents are stored in a consent binder, to be locked in a 
portable file cabinet. Study staff will upload the consent documents into the study 
REDCap site. At intervals, study staff will transport the consent forms and all paper 
assessments to the project manager to be locked in a file cabinet controlled by the PIs. 
Once verbal consent processes are in place, verbal consent will be documented on 
consent forms by the research staff obtaining consent, and stored using TEAMS. 
 
Screening   
Caregivers must be screened within 5 weeks of the baseline assessment.  It is 
anticipated that class sessions will begin within four weeks of baseline assessments 
for each caregiver and care partner.  
• At the time of the screening call, the caregiver will verify that they provide at 
least 4 hours of care per day to the care recipient.  
• The caregiver will also verify that they have a family member or friend who 
assists with care and who is likely to be agreeable to participation in the 
telephone mindfulness sessions.   

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• At the time of the baseline visit, the eligibility criteria will be reviewed and 
completed via an inclusion/exclusion checklist.   
• The caregiver will obtain permission for contact from the care partner and 
give this information to the study staff. 
6.1.2. Enrollment, Baseline, and/or Randomization 
Enrollment 
The first enrollment date is defined as the date that the primary caregiver reviews and 
signs the written informed consent document. A primary caregiver may still choose to 
withdraw from the intervention prior to the first intervention session. The primary 
caregiver will become ineligible for the first intervention session if a care partner 
does not agree to participate. Hence, a second definition of enrollment, akin to the 
point of randomization, is the date of the first intervention session. Each individual 
who participates in the first class session will be considered to be a participant in the 
intervention. The date of enrollment (baseline assessment) and attendance at the first 
class session are recorded in the secure study database, REDCap.  
 
Baseline Assessments 
At baseline, the caregiver will participate in a pre-participation interview, lasting 10-
15 minutes. The purpose of the interview is to assess, qualitatively, the caregiver’s 
knowledge about mindfulness or centering prayer, perceived value of telephone-based 
group classes, and comfort with technology.   
 
Table 3: Questionnaire assessments 
Measure (construct) 
Reliability, validity 
Outcome:  Zarit Burden Interview 
(ZBI) (distress associated with 
caregiving)49  
 
This 12-item (SF) version of the popular original 29-item 
questionnaire measures role strain (α=0.88) and personal 
strain (α=0.77) The short form was highly correlated 
with the original (0.96) both at baseline and follow-up. 
 
Outcome and secondary stressor:  
Family Conflict Scale (Negative 
family interactions around 
caregiving)22  
 
The 4-item Family Conflict scale measures the degree of 
conflict the family experiences about the seriousness of 
the CR’s condition, concerns about the CR’s safety, what 
the CR can do for him/herself, and whether a nursing 
home is indicated. 
 
Mediating outcome:  Cognitive 
emotion regulation questionnaire 
(coping styles)50 
 
The 18-item short form of the CERQ measures 5 positive 
coping strategies (acceptance, positive refocusing, 
planning, positive reappraisal, putting into perspective) 
and 4 negative strategies (rumination, catastrophizing, 
self-blame, other-blame).  Subscale reliability (α=0.68-
0.81) and convergent validity was good. 
 
Mediating outcome:  Intolerance of 
Uncertainty Scale (discomfort with 
uncertainty)51 
 
The12-item IUS correlates highly (0.96) with the original 
27-item scale and results in a 2-factor (prospective, 
inhibitory) scale. Item responses range from 1(not at all 
characteristic of me) to 5 (entirely characteristic of me). 
Its reliability was high for both the overall score (ρ=0.92) 
and subscales and it demonstrated convergent validity. 52 
We will contact the scale developers to obtain permission 

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The caregiver will also complete questionnaires. The primary way these questionnaires 
to adjust to language of the responses to accommodate 
individuals without a high school education. 
 
Mediating outcome:  PROMIS 
social support measures (emotional, 
informational, instrumental 
support)  
 
All three 4-item social support scales assess the 
frequency of perceived support with responses ranging 
from 1 (Never) to 5 (Always).  Scoring is implemented in 
REDCap to preserve response pattern metrics. 
 
Outcome:  PROMIS self-efficacy:  
general [4], and emotion 
management self-efficacy [4]53 
 
PROMIS investigators created population-standardized 
scales with improved reliability, validity, and precision.54  
In 1,087 patients, self-efficacy measures were correlated 
with other self-report measures as expected.53  We will 
be using the 4-item general self-efficacy short form as 
well as the 4-item short form for self-efficacy of emotion 
management. 
 
Outcome: PROMIS Emotional 
Distress (anxiety and anger) 55 
 
The 4-item anxiety short form and 5-item anger short 
form are measured across the past 7 days with responses 
ranging from 1 (Never) to 5 (Always). In MDD, CHF, 
and back pain patients, the measures were responsive to 
change with treatment.  
 
Outcome:  PROMIS global physical 
health (Self-rated health)56  
 
The global health measure is based on the well-validated 
RAND measure, assessing general self-rated physical 
health, physical function, pain, and fatigue.  The 4-item 
scale has a marginal reliability of 0.81. 
 
Process measure:  Cognitive and 
Affective Mindfulness Scale-Revised 
 
This is a 12-item scale measuring mindfulness that uses a 
4-pont Likert scale with responses ranging from 1 
(Rarely/Not at all) to 4 (Almost always). Scores range 
from 12-48. Higher scores indicate higher levels of 
mindfulness. 
Process measure:  Family 
Satisfaction Scale (perceived 
cohesion, flexibility, 
communication)59 
 
The 10-item Family Satisfaction Scale has been tested in 
a variety of populations.  In a sample of 2,465, the mean 
was 37.5 with SD of 8.5.  The 10-item scales has test 
retest reliability of 0.85 and alpha of 0.92. Convergent 
validity was demonstrated in survivors of TBI60 
 
 
Potential Moderator:  
Neuropsychiatric Inventory 
(caregiver distress associated with 
neuropsychiatric symptoms)61,62  
 
The NPI measures the severity of 12 symptoms in a 
patient with dementia (e.g., delusions, anxiety, appetite 
change) along with the caregiver’s distress regarding 
symptoms (0-Not distressing at all; 5-Extreme).   
Potential Moderator: Functional 
Assessment Staging of Alzheimer’s 
disease63–65 
 
The caregiver assesses the stage of AD based on clearly 
defined descriptions corresponding to deficits in IADLs 
and ADLs. The scale has high inter-rater reliability and 
convergent validity. This is a single question. 
 
Outcome:  PROMIS Meaning and 
Purpose (hopefulness and optimism) 
 
The 7-item meaning and purpose scale is a reliable, 
validated population-normed well-being measure 
developed to assess positive emotions.  
 
Potential Moderator:  
Demographics 
 
Age, sex, marital status, education, employment status, 
income, relationship to CR, duration of dementia 
caregiving 
 

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will be completed is via interview with study staff over the phone. If they prefer, they may 
complete the questionnaires on paper, or via a secure REDCap link, with assistance from 
study staff as needed. Questionnaire assessments are provided in Table 3.  It is anticipated 
that the questionnaires will take up to an hour to complete. 
 
The care partner will have the choice of completing the baseline questionnaires with the 
study staff over the phone or to complete the measures online using the REDCap survey 
interface (which can also be configured to read the questions to participants).   
 
Randomization 
Not applicable 
6.1.3. Follow-up Visits 
▪ Visits 2-6 (Week 2 – Week 5): 
(Telephone class sessions may be delayed by one week for unavoidable 
circumstances, e.g., instructor illness, inclement weather) 
 
o The instructor will submit information on intervention attendance weekly 
o Study staff will call participants to inquire about practice and adverse 
events at least once during this period  
▪ Visit 7 (Week 5.5)  
Retreat may be delayed by one week for unavoidable circumstances, e.g., 
instructor illness, inclement weather 
o The instructor will submit information on intervention attendance  
 
▪ Visits 8-10 (Week 6 – Week 8) 
Telephone class sessions may be delayed by one week for unavoidable 
circumstances, e.g., instructor illness, inclement weather 
 
o The instructor will submit information on intervention attendance weekly 
o Study staff will call participants to inquire about practice and adverse 
events at least once during this period 
 
6.1.4. Completion/Final Evaluation 
Study staff will make an appointment with the primary caregiver to complete 
assessments within 4 weeks of the last telephone class session, regardless of how 
many sessions the caregiver attended.  With the research assistant, the caregiver will 
complete the following assessments: 
• Post-participation interviews will address the caregiver’s attitudes and 
experiences with the program, including:  
o most memorable aspects of program;  
o perceived value and cultural congruence of the mindfulness training; 

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o usefulness, challenges, and recommended changes;  
o perceived value for management of stress related to caregiving or family 
conflict;  
o tools that might help maintain practices;  
o unfulfilled expectations of the program;  
o usefulness of the technology components (e.g., call-in lines, tablets), if 
relevant.  
Study staff will complete a similar interview with the care partner over the telephone. 
With permission of the participants, each interview will be audio-recorded and 
transcribed. 
 
• Questionnaires to be completed with the caregiver and care partner at the final 
visit include all previously administered outcome measures. 
 
If participants withdraw before the end of the intervention, study staff will ask them to 
complete the interview and questionnaires associated with the final visit, if possible, 
either in person or over the telephone.  Study staff will also inquire about adverse 
events that may have led to discontinuation.  
 
7 
SAFETY ASSESSMENTS  
The risks leading to adverse experiences for participants enrolled in the study are minimal, but 
do exist. Potential adverse experiences for participants as a result of the telephone-delivered 
mindfulness intervention include: 
 
• Emotional or psychological discomfort or distress, including: 
o Avoidance 
o Agitation 
o Anxiety 
o Difficulty focusing 
o Irritability 
o Nervousness 
o Obsessive thoughts 
o Panic 
o Restlessness 
• Physical symptoms associated with emotional/psychological discomfort or distress: 
o Body or joint aches (resulting from intervention practices) 
o Headaches (resulting from intervention practices) 
o Heavy sweating (without performing strenuous activity) 
o Hyperventilation or rapid breathing (without performing strenuous activity) 
o Nausea or gastrointestinal problems (outside of sickness) 
o Rapid heart rate (without performing strenuous activity) 
 
Study staff will encourage participants that they do not have to answer any questions that make 

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them feel uncomfortable on study questionnaires. During intervention sessions, participants will 
be encouraged to participate, but can choose not to do an activity that makes them feel 
uncomfortable. Study staff and the intervention instructor will make participants aware of the 
experiences that can occur prior and during their time in the study. Study staff will encourage 
participants to report emotional distress/discomfort and physical symptoms during intervention 
sessions and through follow-up calls with study staff, which will occur up to 3 times during the 
intervention. Adverse events will be captured using the Periodic Telephone Administered 
Adverse Event Monitoring Form. 
7.1 Specification of Safety Parameters 
Measures used to assess safety for participants include periodic telephone check-in with 
participants.  In the check-in, study staff query participants regarding both psychological and 
physical health.  Any event that does not clearly meet the criteria for a mild AE will be 
investigated by the designated principal investigator and Study Physician (medical officer).  The 
PIs with the Study Physician will determine the severity of the AE, relatedness to the study, and 
recommended follow-up. Follow-up will include providing the participants with a list of 
resources and, in more acute cases, recommendations to see their primary care provider. 
7.2 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
Timing for assessing, recording, and analyzing safety and adverse events will be completed 
in the following ways: 
 
• Assessing: instructors will prompt the study staff to follow-up with any participants 
that is endorsing emotional or physical difficulties during the telephone sessions to 
further assess for adverse experiences. 
 
Study staff will contact participants up to 3 times during the intervention to complete 
the Periodic Telephone Administered Adverse Event Monitoring Form to assess for 
safety and adverse events (see Supplementary Materials). 
 
• Recording: study staff will document safety and adverse events in the Adverse Event 
Reporting Form (See Supplementary Materials). 
 
• Analyzing: all safety and adverse events will be reviewed by the PI, or a designee to 
assess the severity and level of follow-up needed for each participant. Moderate and 
severe level AEs will also be reviewed by the Study Physician, as needed. All 
reported events will be reported to the Safety Monitoring Committee and IRB for 
review twice a year and annually, respectively. SAEs will be reported to the Safety 
Monitoring Committee and IRB within 24 hours of the study staff receiving the 
report from a participant. 
7.3 Adverse Events and Serious Adverse Events  
The study team, led by the PIs, will monitor all participants for 3 categories of events: 
adverse events (AEs), serious adverse events (SAEs) and unanticipated problems 
(UPs). These three categories are defined as follows: 

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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) associated with participation in the study, regardless of whether it is 
considered related to the study. 
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) involving risks to subjects or others to include, in 
general, any incident, experience, or outcome that meets all of the following criteria: 
 
• 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; 
• 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 
• 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. 
This study uses the following AE grading scale: 
 
• Mild: An experience that is transient and requires no special treatment or 
intervention. The experience does not generally interfere with usual 
daily activities. In this study, an example includes mild emotional 
distress that persists after a class session has ended. 
 
• Moderate: An experience that is alleviated with simple therapeutic treatments. 
The experience impacts usual daily activities. In this study, an example 
includes moderate emotional distress requiring counseling. 
 
• Severe: An experience that requires therapeutic intervention. The experience 
interrupts usual daily activities. In this study, an example includes depressive 
symptoms requiring pharmacological intervention or withdraw from the study. 
If any hospitalization (or prolongation of hospitalization) is required for 
treatment, it becomes an SAE. 
 
This study uses the following AE attribution scale: 

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• Not related: The AE is clearly not related to the study procedures (i.e., another cause of 
the event is most plausible and/or a clinically plausible temporal sequence is inconsistent 
with the onset of the event). 
• Possibly related: An event that follows a reasonable temporal sequence from the initiation 
of study procedures, but that could readily have been produced by a number of other 
factors. 
• Related: The AE is clearly related to the study procedures. This study uses the following 
AE expectedness scale: 
o Unexpected: nature or severity of the event is not consistent with information 
about the intervention in the protocol or consent form 
o Expected: event is known to be associated with the intervention under study 
7.4 Reporting Procedures 
All reported events will be reported to the Safety Monitoring Committee and IRB for review 
twice a year (after the second, fourth, sixth, and eighth groups) and annually, respectively. SAEs 
will be reported to the Safety Monitoring Committee and IRB within 24 hours of the study staff 
receiving the report from a participant. 
 
7.5 Follow-up for Adverse Events 
Any event that does not clearly meet the criteria for a mild AE will be investigated by the 
designated principal investigator and Study Physician (medical officer).  The PI and/or Study 
Physician will determine the severity of the AE, relatedness to the study, and recommended 
follow-up. Follow-up will include providing the participants with a list of resources (also 
available in the study handbook provided at enrollment).  Participants may be advised to see their 
primary care provider.  Study staff will check in with the participant weekly to ascertain 
resolution of the AE. 
7.6 Safety Monitoring 
Study staff will collect data on AEs and UPs 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 
PIs monthly using the Adverse Event Reporting Form, after having gathered all 
necessary details. Study staff will report AEs that are more than mild and possibly 
related to study participation to the PIs right away.  Together the PIs will determine 
the severity and the relatedness of the AE, and will confer with the SMC and the 
Study Physician, Dr. Jessica Barnhill, 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 be 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 PIs at each 
monthly full-team meeting. 

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All AEs will be summarized as part of the Data and Safety Monitoring Report 
submitted subsequent to the second, fourth, sixth, and eighth 8-week sessions to 
the SMC and NIA program officer. As per UNC IRB guidelines, all AEs will be 
reported to the UNC IRB during the yearly study review process. 
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. 
All other SAEs (not unanticipated or related) will be summarized and reported to the SMC and 
the NIA Program Officer quarterly.  
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 4 times throughout the study to review the Data and Safety Monitoring 
Report: 1) prior to first enrollment; 2) after the first 2 cohorts (2 8-week sessions); 
3) after 6 cohorts have completed (6 8-week sessions); 4) at study completion (8 8-
week sessions). 
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. 
7.7  Emergency situations 
Given participation is completely virtual, for any potential emergency situation that occurs 
while on the phone with participants, the study staff will ask the participant to call 911 or 
their physician as needed. Permission will be obtained at study outset (consent) to contact an 
emergency contact as needed. The study physician and key staff will also be informed 
ASAP, and an AE form will be recorded. (Emergency numbers are listed in TEAMS.) 
 
 

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8 
INTERVENTION DISCONTINUATION  
8.1 Discontinuation of Intervention for a Participant 
Participants will be discontinued if adverse events cause: 
• Cognitive impairment that prevents participant’s understanding or ability to comply with 
study requirements; or 
• Emotional distress that results in psychosis or hospitalization for psychological trauma.  
In these situations, study staff will continue to follow-up until participants are under the care of 
their provider. 
Participants may voluntarily withdraw their participation in the study at any time and for any 
reason. We anticipate that the family care team may wish to withdraw at the time of the death of 
the care recipient.  Participants will continue to be followed, with their permission, even if 
withdrawal occurs prior to all study activities being completed. All participants that withdraw 
early, but continue to be followed, will receive follow-up calls to complete the Telephone 
Administered Adverse Event Monitoring Form.  Participants will be asked to complete the Final 
Evaluation for the study (see Section 6.1.4) at the same time point of those in their cohort. If 
participants withdraws prior to completing all study activities and refuses to be followed, they 
will be instructed to connect with their primary care provider for any unresolved adverse events 
and asked to complete the Final Evaluation for the study (see Section 6.1.4) at the time of 
withdrawing from the study.  
If the withdrawal rate is higher than anticipated (see Section 9.3), additional cohorts may be 
recruited to reach an adequate sample size. 
9 
STATISTICAL CONSIDERATIONS  
9.1 General Design Issues  
Hypotheses related to the study are provided in this protocol.  A single-arm, pre-post design will 
assess the primary outcomes of feasibility and acceptability.  Eight weekly intervention sessions 
with a retreat is considered the minimum amount of time needed to deliver all components of the 
intervention.  Please see Table 3 for reliability and validity information for each of the scales. 
 
SPECIFIC AIM 1: To determine the feasibility and acceptability of a telephone-delivered 
mindfulness training intervention (TMT) in decreasing caregiver burden among rural, African 
American, informal caregiving teams of people with dementia. 
 
Hypothesis 1:  TMT will be feasible within the rural, African American, informal caregiving 
teams. Feasibility is established when 85% (95% CI:  72.5, 97.5) of participants in the telephone-
delivered mindfulness training intervention complete at least six sessions of the intervention.  
 

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Hypothesis 2:  The adapted TMT will be acceptable to rural, African American, informal 
caregiving teams as evidenced by an 85% (95% CI:  72.5, 97.5) endorsement of the program in 
post-participation interviews. 
SPECIFIC AIM 2: To explore, on a preliminary basis, the effects of the training on caregiver 
burden and relevant secondary outcomes for both caregiving team members, including:  
 
SPECIFIC AIM 2: To explore, on a preliminary basis, the effects of the training on caregiver 
burden and relevant secondary outcomes for both caregiving team members, including: 
 
Hypothesis 1:  Compared with baseline levels, we hypothesize that mindfulness training will 
reduce caregiver burden (Zarit Burden Interview). 
 
Hypothesis 2:  Compared with baseline levels, we hypothesize that mindfulness training will 
improve emotion regulation by increasing positive coping styles (acceptance, positive 
refocusing, positive reappraisal) and decreasing negative coping styles (rumination, 
catastrophizing, self-blame) as measured by the Cognitive Emotion Regulation Questionnaire. 
 
Hypothesis 3:  Compared with baseline levels, we hypothesize that mindfulness training will 
increase tolerance of uncertainty as measured by (an adapted form of) the Intolerance of 
Uncertainty Scale. 
 
Hypothesis 4:  Compared with baseline levels, we hypothesize that training in mindful 
communication will increase perceived social support among the caregivers (PROMIS Social 
Support short forms).  
 
 Hypothesis 5:  Compared with baseline levels, we hypothesize that training in mindful 
communication reduce family conflict around caregiving (Family Conflict Scale). 
 
Hypothesis 6:  Compared with baseline levels, we hypothesize that mindfulness training will 
reduce anger and anxiety (PROMIS scales). 
 
Hypothesis 7:  Compared with baseline levels, we hypothesize that mindfulness training increase 
global self-perceived physical health (PROMIS short forms). 
 
Hypothesis 8:  Compared with baseline levels, we hypothesize that mindfulness training increase 
meaning and purpose (PROMIS short form). 
 
Hypothesis 9:  Compared with baseline levels, we hypothesize that mindfulness training along 
with a caregiver resources handbook will increase caregiver general and emotional self-efficacy 
(PROMIS scales). 
 
Hypothesis 10: Compared with baseline levels, we hypothesize that mindfulness training will 
increase family satisfaction (Family Satisfaction Scale). 
 

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Hypothesis 11: Compared with baseline levels, we hypothesize that mindfulness training will 
increase mindfulness (Cognitive and Affective Mindfulness Scale). 
 
 
SPECIFIC AIM 3: To explore comfort with and willingness to adopt technologies (e.g. 
telephone-based, web-based) to access mindfulness practices and existing caregiving educational 
resources. As part of intervention planning, using interviews, we will investigate comfort with a 
smartphone/tablet. For half of the groups of participants, we will provide a tablet loaded with the 
handbook and all of the intervention materials.  In this way we can compare engagement and 
program acceptability rates between groups who received the tablets and those who did not. 
 
9.2 Sample Size and Randomization 
We calculated the effect size for the feasibility outcome, the acceptability outcome, and the Zarit 
Burden Interview.  The sample size depends on the number of individuals who can reasonably 
participate in a telephone mindfulness intervention and takes into consideration the challenges of 
recruiting study participants in rural areas among underprivileged groups.  We expect that no 
more than 8 caregivers could participate in a call at one time.  Limiting the group size to 8 will 
ensure that all participants have an opportunity to contribute and that the instructor can keep 
track of all participants.   
We anticipate being able to recruit no more than 36 CG-CP dyads in two years and expect a 
withdrawal rate of 10-15%. We anticipate having 32 dyads join the intervention and complete all 
baseline assessments and that 28 of those will complete all post-participation assessments.  We 
will make every effort to follow-up with every participant, either in person or on the telephone, 
resulting in little missing qualitative data.  We will use multiple imputation procedures to 
account for missing quantitative data.   
Based on a sample size of 32 and a pre-post correlation of 0.5-0.7, we will have 75-80% power 
to detect a pre-post difference in the ZBI means of 3.3 – 4.2 consistent with an effect size of 
about 0.5 utilizing and alpha of 0.05.  This effect size is consistent with those reported in other 
mindfulness interventions.  The sample size of 32 with a feasibility of 85% would result in a 
95% CI of 72.5 to 97.5.  Similarly, a sample size of 32 with an acceptability of 85% (based on 
interviews with participants) will result in a 95% CI of 72.5 to 97.5.  If we have higher than 
anticipated withdrawal rates, we will have lower precision. 
9.2.1 Treatment Assignment Procedures 
           This is a single-arm study.  Randomization and masking do not apply. 
9.3 Interim analyses and Stopping Rules 
We do not plan an interim analysis. The study will be stopped if 3 or more individuals have a 
serious adverse event probably or definitely related to the study. 

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9.4 Outcomes  
9.4.2 Primary outcome   
1) The primary outcome is feasibility.  We define feasibility as 85% of participants who 
start the intervention will complete at least 6 of the intervention sessions.  Feasibility 
is measured by class session attendance records collected at the time of the calls by 
the instructor.  The instructor will notify the project manager who attended the call 
and the project manager will document attendance in the REDCap database. 
 
2) (Qualitative) A second primary outcome is acceptability.  We define acceptability as 
85% of participants expressing comfort with the majority of the intervention 
components and homework.  
9.4.3 Secondary outcomes   
3) Change in caregiver burden as measured with the Zarit Burden Interview; 
4) Change in emotion regulation/coping styles as measured with the Cognitive Emotion 
Regulation Questionnaire (CERQ); 
5) Change in uncertainty tolerance as measured with the Intolerance of Uncertainty 
Scale (IUS); 
6) Change in mindfulness as measured by the CAMS-R. 
7) Change in perceived social support among caregivers as measured with the PROMIS 
social support short forms for emotional, informational, and instrumental support; 
8) Change in family conflict around caregiving as measured by the Family Conflict 
Scale; 
9) Change in emotional distress as measured by the anger and anxiety PROMIS short 
forms; 
10) Change in perceived health as measured by the PROMIS global health short form; 
11)  Change in hopefulness and optimism as measured by the PROMIS meaning and 
purpose short form;  
12)  Change in caregiver self-efficacy as measured by the PROMIS self-efficacy short 
forms. 
13)  (Qualitative) Evaluation of the comfort with and willingness to adopt technologies to 
access mindfulness practices and existing caregiving educational resources. 
9.5 Data Analyses 
This is a single-arm pilot feasibility study with one baseline and one post-intervention measure.  
Quantitative variables 
For all quantitative questionnaire measures (outcomes 3-11), the change in the measure 
from baseline to post-participation is the outcome.  First, we will examine variable distributions 
and missing data patterns. Next, we will conduct exploratory, descriptive analyses to assess 
patterns of change associated with participation in the programs for each of the variables 
including proximal mediating outcomes, intermediate outcomes (secondary stressors), and distal 
health outcomes.  Because all analyses are exploratory, we will next perform bivariate 
assessments utilizing a paired t-test, analyzing caregivers and care partners separately.  We do 

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not plan to adjust for multiple comparisons, but will interpret results conservatively and with 
great caution. 
We will also explore the use of multivariable methods to enable us to control for 
variables that could influence the outcomes.   Adjusted models will utilize repeated measures 
mixed models with individuals nested in families as random effects. We will control for the 
baseline FAST score (severity of dementia) and the relationship to the care recipient (spouse, 
adult child, other relative). In this small study (32 dyads), it will not be possible to formerly 
assess subgroups defined by gender.  However, we will produce descriptive statistics by gender 
and age group. 
We plan to invoke an intention-to-treat analysis in dealing with missing data using multiple 
imputation or full information maximum likelihood methods.   
 
Qualitative variables 
We will collect three types of formal qualitative data: 1) telephone interviews with key 
informants; 2) interviews with CG and CP prior to and following each 8-week class; and 3) 
transcriptions of audio-recorded classes. See key informant topics above. We will use the 
insights from key informants to adjust the intervention including the content and the logistics as 
needed. 
Pre-participation interviews will address participant expectations and concerns about the research 
process in general and the intervention in particular.  
Post-participation interviews will address CG/CP’s attitudes and experiences with the 
intervention, including:  
• The most memorable aspects of the class sessions;  
• The perceived value and cultural congruence of the mindfulness training;  
• The usefulness, challenges, and recommended changes in intervention 
components or language;  
• The perceived value of various intervention components for management of stress 
related to caregiving or family conflict;  
• Their recommendations for tools that might help maintain practices, if desired;  
• Their unfulfilled expectations of the intervention;  
• The usefulness of the technology components (e.g., call-in lines and/or tablets).   
Each interview will be audio-recorded and transcribed. Using transcripts of key informant 
interviews and post-participation interviews, two or more research team members will apply a 
thematic analysis strategy, coding each transcript and identifying themes within and across 
interviews, with subsequent discussion of themes among members of the qualitative analysis 
team and resolution of discrepancies. The qualitative analysis team, who will include the PIs and 
Dr. Roth, among others on the study team, will categorize the themes and present them to the 
Advisory Council for further input.  Results will inform improvements in subsequent iterations 
of the intervention as well as the development of larger-scaled interventions. 

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10 
DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms 
 We will include data from multiple sources. For pre-post assessments with the caregiver, 
research assistants will collect demographic and questionnaire data on paper and input data into a 
secure, password-protected, web-based database for analysis.  The research assistant will lock 
the paper case report forms in a portable filing cabinet until they can be transported to UNC for 
storage.  The research assistant (RA) will follow a detailed Manual of Procedures for each aspect 
of data collection for each study visit and complete a visit checklist.  On each checklist, the 
research assistant will document aspects of the visit that were completed, omitted (e.g., refused), 
and provide comments.  Each checklist will be signed and dated by the RA and will become a 
CRF.   
10.2 Data Management  
The UNC Program on Integrative Medicine will be responsible for all study staff and data 
collection.  The study research assistant will collect data in the home of the caregiver and over 
the telephone for the care partner.  UNC utilizes the REDCap database from which the study can 
download validated paper case report forms that correspond to the online database.  All of the 
PROMIS measures are already available.  Measures currently unavailable will be created with 
the assistance of the Clinical Data Manager at the North Carolina Translational and Clinical 
Sciences Institute.   
 
Program Fidelity. With the permission of all participants, all program sessions will be audio-
recorded. The purpose of the recording is two-fold: 1) to identify any systematic variations in 
instructors’ attitude, communication, or behavior between groups and to screen for any group-
dependent differences in communication in content or style between the instructors and 
participants; and 2) to capture participants’ input and comments during the classes (for 
qualitative analysis). We will develop an evaluation matrix based on written protocols.  Dr. 
Gaylord will listen to each program session to rate adherence to the protocol and will discuss 
deviations with the instructor, who may suggest changes to the intervention based on participant 
feedback. 
10.3 Quality Assurance  
10.3.1 
Training 
All study staff will maintain up-to-date Good Clinical Practice, HIPAA, and Research 
Ethics training.  Before participant data is collected, a PI or Project Manager will ensure 
that staff has completed training for applicable tasks. A log including dates and type of 
training will be kept in the Study Regulatory Binder. 
 
The study’s Manual of Operating Procedures (MOP) will include detailed procedures for 
each of the following: 
• Consent forms: 
o Telephone/screening with detailed script and instructions included 
o Full Consent (detailed description in section 6.2 of protocol) 

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o HIPAA Consent 
• REDcap data entry (used to track recruitment data, initial and post-intervention 
evaluations, study visits, and questionnaires) 
• Interview techniques along with procedures for recording interview data 
• Verbal and written administration of questionnaires. 
 
 
10.3.2 Quality Control Committee  
The Quality Control Committee will consist of the project manager, the data manager, 
and the PIs.  They will meet monthly to review data or process problems. 
10.3.3 Metrics 
The data manager will audit 10% of the data entries each month in preparation for full 
team meetings of the study.  She will identify and correct systematic errors in data entry 
by reviewing procedures with the research assistant.  She will correct data entry errors 
using the original case report forms.  If data entry error rates >10% persist, all data will 
be double entered. 
10.3.4 Protocol Deviations 
Staff will be trained to record any protocol deviation that may occur while performing 
their specific research related activities. Many of the data collection forms will include 
comment sections to capture protocol deviation information. The project manager will 
document all protocol deviations in the secure online database, REDCap, as they occur.  
The entire study team will discuss deviations at monthly team meetings and report them 
to the IRB annually.  Corrective action plans will be developed and submitted to the IRB 
as part of the reporting process 
10.3.5 Monitoring 
The data manager (co-investigator) will review REDCap data for protocol compliance 
(including eligibility criteria) and audit data entry monthly within one month of the 
beginning of the first intervention group.  This will include a biannual review of study 
instruments for range and consistency checks, and descriptive analyses to assess 
distributions of study variables. The project manager will review consent forms for 
completeness and institute remedial training for the research assistant as needed.  The 
project manager is responsible for creating and reviewing the MOPs. 
Quality assurance of qualitative measures (project manager) include 1) maintaining a 
database of scheduled, completed, transcribed, and analyzed classes and group 
evaluations; 2) establishing a transcription template to ensure data are uniform in 
appearance; 3) arranging for secure storage of recordings and transcripts; and 4) review 
of recordings to assess accuracy of transcriptions. 

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11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review 
This protocol and the informed consent documents and any subsequent modifications will be 
reviewed and approved by the IRB and the Scientific Review Committee responsible for 
oversight of research at the University of North Carolina at Chapel Hill. The IRB application, 
modification and renewal procedures will be adhered to throughout the study.    
11.2 Informed Consent Forms 
Interested caregivers meeting the screening criteria for eligibility in the study will be given a 
copy of the informed consent form (ICF) in the presence of the research assistant. The research 
assistant will read the ICF to the potential participant pointing out important aspects in each 
section and answering any questions.  The caregiver may choose to sign the ICF at that time or to 
make another appointment for the research assistant to return. The ICF will describe the purpose 
of the study, the procedures to be followed, reasons not to be in the study, the risks and benefits 
of participation, responsibilities of the participant, incentives and remunerations, privacy and 
confidentiality measures, and the names and contact information for the PI and the study staff. 
After the caregiver agrees to participate and signs the ICF, the research assistant will sign.  If 
verbal consent, the staff member will indicate verbal consent was given on the consent form. A 
copy will be given to each caregiver and this fact will be documented in the participant’s record. 
 
Because care partners may live at some distance from the caregiver, a telephone consenting 
procedure will be implemented.  The procedure will include all of the aspects of the written 
consent, but will enable interested care partners to give their verbal consent over the telephone.  
Each care partner will receive a copy of the ICF in the mail.  Their verbal consent will be 
documented in their record. 
 
11.3 Participant Confidentiality  
Participant confidentiality will be maintained according to the Health Insurance Portability and 
Accountability Act (HIPAA). Research records arising from this study will be retained at a 
secure UNC-maintained locked site for 15 years with access limited to the PI and named 
designees. 
 
Any data, forms, reports, and other records that leave the site will be identified only by a 
participant identification number (Study ID) to maintain confidentiality. All paper records will 
be kept in a locked file cabinet. All computer entry and networking programs will be done using 
Study IDs only. Information will not be released without written permission of the participant, 
except as necessary for monitoring by IRB, the FDA, the NIA, and the OHRP. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NIA, the OHRP, the FDA, or other 
government agencies as part of their duties to ensure that research participants are protected.  

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12 
ETHICAL CONSIDERATIONS 
The guiding ethical principles being followed by this study are in accordance with international 
policy, e.g. the Declaration of Helsinki, regarding ethical principles for medical research 
involving human subjects, and include the following considerations:  
- 
that the study is designed to act in the best interests of our participants’ health and well-
being, and in fact participation in the study, which involves training in a mind-body 
intervention, is likely to improve their well-being;  
- 
that it is designed to safeguard their health, including not over-burdening them with 
questionnaires and making sure that the intervention – which is a telephone based 
mindfulness training intervention, is reasonable in terms of amount of time being spent, 
and is evaluated in terms of safety, effectiveness, accessibility and quality;  
- 
that it promotes equity and protection of the subjects’ health and rights; that it recognizes 
that individual research subjects’ rights and interest take precedence over the generation 
of new knowledge; that it protects the dignity, health, privacy and confidentiality of 
personal information of the research subjects by carefully following IRB procedures;  
- 
that it causes minimum harm to the environment by minimizing amount of paper used 
where possible; 
- 
 that the research team members are all qualified and well trained health professionals 
competent to perform this research, and that they have taken the Good Clinical Practice 
training;  
- 
that participants are appropriately compensated monetarily, but without being coerced 
into being in the study, and that they are expected to benefit from their participation in 
this research, with little or no harm expected to be caused by their participation in this 
research; 
- 
that the confidentiality of data is carefully protected, and the consent forms appropriately 
describe any risks that could be caused, due to any breach of confidentiality, as well as 
possible benefits; 
- 
that the research is being carried out on a non-vulnerable population, who are capable of 
giving informed consist; 
- 
that the research was assessed via peer review and found to follow generally accepted 
scientific principles, and be based on a thorough knowledge of the scientific literature; 
- 
that the design and proposed performance of the study is clearly described and justified in 
a research protocol, which has been submitted for review; 
- 
that the protocol contains a statement (as described here) of the ethical considerations 
involved and addressed in this study; 
- 
that the study is being submitted for consideration, guidance  and approval to the UNC 
Committee on the Protection of Human Subjects, and that the principal investigators and 
the research team will provide monitoring information to the committee, especially any 
information about serious adverse events; 
- 
and that the researchers plan to submit a final report of their study’s findings and 
conclusions. 
     
13 
COMMITTEES 
The study includes a Safety Monitoring Committee and an Advisory Council.  The Safety 
Monitoring Committee will review adverse event data over the course of the study.  The 

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Advisory Council will review study procedures and the intervention manual and make 
recommendations for study improvements. 
14 
PUBLICATION OF RESEARCH FINDINGS 
Publication of the results of this trial will be governed by the policies and procedures of the 
University of North Carolina.  Any presentation, abstract, or manuscript will be made 
available for review by NIA prior to submission. 
15 
REFERENCES 
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PJ D, Holt AM C. Factors Associated with Unmet Needs among African-American 
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Dilworth-Anderson P, Pierre G, Hilliard T. Social justice, health disparities, and culture in 
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Merritt MM, McCallum TJ, Fritsch T. How much striving is too much? John Henryism 
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Strawbridge WJ, Wallhagen MI. Impact of family conflict on adult child caregivers. 
Gerontologist. 1991;31(6):770-777. doi:10.1093/geront/31.6.770 
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Mitrani VB, Lewis JE, Feaster DJ, Czaja SJ. The Role of Family Functioning in the Stress 
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Mishel MH. Reconceptualization of the Uncertainty in Illness Theory. Image J Nurs Sch. 
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Mishel MH. Theories of Uncertainty in Illness. In: Smith MJ, Liehr PR, eds. Middle 
Range Theory for Nursing. Third. New York: Springer Publishing Company, LLC; 
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Unson C, Flynn D, Glendon MA, Haymes E, Sancho D. Dementia and Caregiver Stress: 
An Application of the Reconceptualized Uncertainty in Illness Theory. Issues Ment Health 
Nurs. 2015;36(6):439-446. doi:10.3109/01612840.2014.993052 
30.  
Moore A, Malinowski P. Meditation, mindfulness and cognitive flexibility. Conscious 
Cogn. 2009. doi:10.1016/j.concog.2008.12.008 
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Garland EL. The meaning of mindfulness: A second-order cybernetics of stress, 
metacognition, and coping. Complement Health Pract Rev. 2007;12(1):15-30. 
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Garland E, Gaylord S. Envisioning a Future Contemplative Science of Mindfulness: 
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Pract Rev. 2009;14(1):3-9. doi:10.1177/1533210109333718.Envisioning 
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meditation. Trends Cogn Sci. 2008;12(4):163-169. doi:10.1016/j.tics.2008.01.005 
34.  
Greeson JM. Mindfulness Research Update: 2008. Complement Health Pract Rev. 
2009;14(1):10-18. 
35.  
Khoury B, Lecomte T, Fortin G, et al. Mindfulness-based therapy: A comprehensive 
meta-analysis. Clin Psychol Rev. 2013;33(6):763-771. doi:10.1016/j.cpr.2013.05.005 
36.  
Woods-Giscombé CL, Gaylord SA. The Cultural Relevance of Mindfulness Meditation as 
a Health Intervention for African Americans: Implications for Reducing Stress-Related 
Health Disparities. J Holist Nurs. 2014;32(3):147-160. doi:10.1177/0898010113519010 
37.  
Liu Z, Chen QL, Sun Y. Mindfulness training for psychological stress in family caregivers 
of persons with dementia: a systematic review and meta-analysis of randomized controlled 
trials. Clin Interv Aging. 2017;Volume 12:1521-1529. doi:10.2147/CIA.S146213 
38.  
Li G, Yuan H, Zhang W. The Effects of Mindfulness-Based Stress Reduction for Family 
Caregivers: Systematic Review. Arch Psychiatr Nurs. 2016;30(2):292-299. 
doi:10.1016/j.apnu.2015.08.014 
39.  
Cheryl L. Woods-Giscombe, Gaylord SA, Li Y, et al. Mindfulness-Based Diabetes 
Education for African Americans with Prediabetes: A Pilot, Sequential Mixed-Methods, 
Two-Arm, Randomized Clinical Trial. Diabetes Educ. 
40.  
Whitebird RR, Kreitzer M, Crain AL, Lewis BA, Hanson LR, Enstad CJ. Mindfulness-
Based Stress Reduction for Family Caregivers: A Randomized Controlled Trial. 
Gerontologist. 2013;53(4):676-686. doi:10.1093/geront/gns126 
41.  
Schellekens MPJ, Karremans JC, van der Drift MA, et al. Are Mindfulness and Self-
Compassion Related to Psychological Distress and Communication in Couples Facing 
Lung Cancer? A Dyadic Approach. Mindfulness (N Y). 2017;8(2):325-336. 
doi:10.1007/s12671-016-0602-0 
42.  
Amutio-Kareaga A, García-Campayo J, Delgado L, Hermosilla D, Martínez-Taboada C. 
Improving Communication between Physicians and Their Patients through Mindfulness 
and Compassion-Based Strategies: A Narrative Review. J Clin Med. 2017;6(3):33. 
doi:10.3390/jcm6030033 
43.  
Spijkerman MPJ, Pots WTM, Bohlmeijer ET. Effectiveness of online mindfulness-based 
interventions in improving mental health: A review and meta-analysis of randomised 
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44.  
Jayewardene WP, Lohrmann DK, Erbe RG, Torabi MR. Effects of preventive online 
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45.  
Rosen RK, McGarrity LA, Salmoirago-Blotcher E, Rich C, Rana A, Carey MP. 
Telephone-Delivered Mindfulness Training for People Living with HIV: A Qualitative 
360° Inquiry. AIDS Behav. 2017;21(11):3194-3201. doi:10.1007/s10461-017-1857-8 
46.  
Gross CR, Reilly-Spong M, Park T, Zhao R, Gurvich O V., Ibrahim HN. Telephone-
adapted Mindfulness-based Stress Reduction (tMBSR) for patients awaiting kidney 
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doi:10.1016/j.cct.2017.03.014 
47.  
Aivaliotis VI, Lee Y, Zia J, Wassef W, Abramson M, Park W. Telephone-Based 
Mindfulness Therapy Intervention for Patients with Chronic Pancreatitis. Dig Dis Sci. 
2017;62(2):502-509. doi:10.1007/s10620-016-4389-6 
48.  
Cox CE, Porter LS, Buck PJ, et al. Development and preliminary evaluation of a 
telephone-based mindfulness training intervention for survivors of critical illness. Ann Am 
Thorac Soc. 2014;11(2):173-181. doi:10.1513/AnnalsATS.201308-283OC 
49.  
Bédard M, Molloy DW, Squire L, Dubois S, Lever JA, O’donnell M. The Zarit Burden 
Interview: A new short version and screening version. Gerontologist. 2001;41(5):652-657. 

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doi:10.1093/geront/41.5.652 
50.  
Garnefski N, Kraaij V. Cognitive emotion regulation questionnaire - development of a 
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doi:10.1016/j.paid.2006.04.010 
51.  
Carleton RN, Norton MAPJ, Asmundson GJG. Fearing the unknown: A short version of 
the Intolerance of Uncertainty Scale. J Anxiety Disord. 2007;21(1):105-117. 
doi:10.1016/j.janxdis.2006.03.014 
52.  
Hale W, Richmond M, Bennett J, et al. Resolving uncertainty about the intolerance of 
uncertainty scale-12: Application of modern psychometric strategies. J Pers Assess. 
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53.  
Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the PROMIS® 
measures of self-efficacy for managing chronic conditions. Qual Life Res. 
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54.  
Broderick J, DeWit EM, Rothrock N, Crane P, Forrest CB. Advances in Patient Reported 
Outcomes: The NIH PROMIS Measures. eGEMs (Generating Evid Methods to Improv 
patient outcomes). 2013;1(1):12. doi:10.13063/2327-9214.1015 
55.  
Schalet BD, Pilkonis PA, Yu L, et al. Clinical validity of PROMIS Depression, Anxiety, 
and Anger across diverse clinical samples. J Clin Epidemiol. 2016;73:119-127. 
doi:10.1016/j.jclinepi.2015.08.036 
56.  
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doi:10.1007/s11606-015-3290-x 
57.  
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doi:10.1002/cpp.702 
58.  
Neff KD, Whittaker TA, Karl A. Examining the Factor Structure of the Self-Compassion 
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60.  
Underhill AT, LoBello SG, Fine PR. Reliability and validity of the Family Satisfaction 
Scale with survivors of traumatic brain injury. J Rehabil Res Dev. 2004;41(4):603. 
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61.  
Kaufer DI, Cummings JL, Ketchel P, et al. Validation of the NPI-Q, a Brief Clinical Form 
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neuropsychiatric inventory. Neurology. 1994;44(December):2308-2314. 
63.  
Reisberg B. Functional assessment staging (FAST). Psychopharmacol Bull. 
1988;24(4):653-659. http://www.ncbi.nlm.nih.gov/pubmed/3249767. Accessed February 
11, 2018. 
64.  
Sclan SG, Ph D, Reisberg B. Functional Assessment Staging ( FAST ) in Alzheimer ’ s 
Disease : Reliability , Validity , and Ordinality. 1992;4. 
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1997;9(S1):167-171. doi:10.1017/S1041610297004869 
Provide the citations for all publications and presentations referenced in the text of the 
protocol. 
 
 

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Supplementary Materials 
15.1.1 Appendix A.1: Periodic Telephone Administered Adverse Event Monitoring Form 
STUDY ID:  
 
Date:  
 
 
1. In the past week, have you: 
 
a. been hospitalized for any reason? 
☐No 
☐Yes (Please explain): 
b. experienced any life-threatening 
events?  
☐No 
☐Yes (Please explain): 
c. given birth to a child with birth 
defects? 
☐No 
☐Yes (Please explain): 
d. become physically disabled in some 
way? 
☐No 
☐Yes (Please explain): 
e. experienced any new or worsening 
emotional health problems (for example, 
worry, nervousness, sadness, or stress)?  
☐No 
☐Yes (Please explain, including if 
participant feels change is related to 
study participation): 
Also, if yes, administer the PROMIS 
Anxiety SF.  If the participant’s T 
scores increase by >9 points and the T 
score is >65, consult with the PIs. 
e. experienced any new or worsening 
physical health problems that you think 
might be related to being part of this 
study?   
☐No 
☐Yes (Please explain): 
 
 
______________     _______________________________     _______________ 
Signature of study personnel completing form              Print Name 
                         Date 

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15.1.2 Appendix A.2: Adverse Event (AE) Reporting Form (version 1.0) 
 
 
 

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15.2 Consent Forms 
IRB TEMPLATE 
Version 2.0-12/5/2018 
 
**DO NOT CHANGE THIS FIELD-IRB USE ONLY** 
University of North Carolina at Chapel Hill 
Consent to Participate in a Research Study 
Adult Participants 
Consent Form Version Date: January 3, 2021 
IRB Study # 19-0053 
Title of Study: Easing the Burden of Dementia Caregiving: A Telephone-delivered Mindfulness 
Intervention for Rural, African American Families  
Short Name of Study: Mindful Coping and Communication in Caregiving (MC3) 
Principal Investigator: Susan Gaylord 
Principal Investigator Department: Physical Medicine and Rehabilitation 
Principal Investigator Phone number: (919) 966-8586 
Principal Investigator Email Address: gaylords@med.unc.edu 
Funding Source and/or Sponsor: National Institutes of Health (NIH) 
 
Study Contact Telephone Number: (919) 370-6744 
Study Contact Email: mc3@med.unc.edu  
 
What are some general things you should know about research studies? 
You are being asked to take part in a research study.  To join the study is voluntary. 
You may choose not to participate, or you may withdraw your consent to be in the study, for 
any reason, without penalty. 
 
Research studies are designed to obtain new knowledge. This new information may help people 
in the future.   You may not receive any direct benefit from being in the research study. There 
also may be risks to being in research studies.  
 
Details about this study are discussed below.  It is important that you understand this 
information so that you can make an informed choice about being in this research study.  
 
You will be given a copy of this consent form.  You should ask the researchers named above, or 
staff members who may assist them, any questions you have about this study at any time. 
 
What is the purpose of this study? 
The purpose of this research study is to understand if mindfulness-based stress reduction 
(MBSR) training is helpful training for lowering the burden for caregivers of persons with 
Alzheimer’s disease and related dementia (ADRD). The MBSR training will happen over the 
phone, which is known as telephone-based mindfulness training intervention (TMT). Our 
training will be for rural African American or Black caregivers. We are testing to see if it is 
appropriate to do MBSR training over the phone with African American caregivers. 
 This project will test the following: 

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• 
determine how and why a TMT may be helpful in lowering caregiver burden among 
rural, African American caregiving teams of persons with ADRD; 
• 
look at how TMT may impact emotional and physical health, uncertainty, family conflict 
and support between caregivers, and confidence of the caregiver;  
• 
learn if technology over the phone, internet, and tablet will help rural African American 
caregivers get access to educational resources.   
We will ask questions to caregivers through interviews to answer what the project is testing. 
 
You are being asked to be in the study because you are an African American or Black caregiver 
of a person with ADRD who lives in a rural area. 
 
Are there any reasons you should not be in this study? 
You should not be in this study if you: 
• 
do not identify as African American or Black 
• 
do not live in a rural area 
• 
do not have a telephone to use for the telephone training 
• 
are being treated for cancer 
• 
have been hospitalized 3 times in the past year 
• 
do not care for a person with a dementia or Alzheimer’s diagnosis  
• 
do not provide care for a person with ADRD for 4 or more hours in a day 
• 
do not have someone who shares caregiving or helps make decisions regarding the 
person with ADRD 
How many people will take part in this study? 
There will be approximately 64 people in this research study. 
 
What will happen if you take part in the study? 
If you join the project, we will go through the following steps with you: 
• 
Enrollment Visit: This visit will be in-person at your home or over the phone. At this 
visit we will give you more about the project, get your consent to join, and do surveys 
with you.  We can speak with your care partner either in-person or over the phone. 
During this visit we will complete: 
o Consent: We will review the consent form with you. You will have the chance to 
ask us any questions about the study before signing the consent. 
o Pre-participation Interview:  We will ask you questions to get your thoughts 
about mindfulness, how helpful you think telephone mindfulness training will be, 
and how comfortable you are using technology. 
 
o Baseline Assessments: You will be asked to answer questionnaires about different 
stresses related to caregiving, how you deal with difficult emotions, your social 
support, how you communicate with your family, how you use mindfulness, and 
symptoms experienced by the person you care for. The study staff will ask you 
each question, but you can complete it on paper or online, if you prefer.  
 
• 
Telephone-based Mindfulness Training (TMT):  

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o Weekly Sessions: You and your care partner will be asked to call in to the 
telephone training for one hour per week for 8 weeks with three other families. A 
mindfulness instructor will introduce you to mindfulness and lead you through 
different practices. 
 
We will check in with you at 3 different time points while you’re participating in 
the weekly sessions to see if your caregiving distress is changing. 
 
o Home Assignments: Home assignments are a key element of TMT weekly 
sessions. You will be assigned daily home practice based on the previous weeks’ 
content.  Most weeks will also include one assignment to be carried out with your 
care-partner, either over the phone or in-person. Home assignments range from 
10-minute practices, to reflections, to interactive discussions among care-partners. 
For example, you might be asked to eat mindfully or listen mindfully while you’re 
around the person you’re caring for. Mindful practices will be given to you either 
on a CD, paper handouts, or through downloadable recordings onto your 
computer or Smartphone. 
 
o Saturday Retreat: One Saturday during the 8 weeks you will be invited to attend 
a retreat where you can meet the other families. The study will help cover the cost 
of hiring someone to stay with your relative during that time, if you need it. The 
retreat will occur in-person. In the event of adverse weather or situations, the 
retreat will take place over the phone or using video conference. The retreat will 
be up to 4 hours, depending on whether in person, over the telephone, or via video 
conference. 
In addition to the telephone classes and retreat, we will give you and your care partner a 
notebook with information on local and national resources for people with memory 
disorders and the families who care for them. We will also put the information on a tablet 
for some of the participants.   
 
• 
Follow-up Visit: Within 4 weeks of the last telephone session being completed, we will 
complete a follow-up visit with you. This visit will occur in-person at your home or over 
the phone. We will go through the questionnaires and get your opinion about the 
telephone training. Your feedback will help us make the program better so that it can be 
more helpful to caregiving families.  
 
o Post-participation Interview: We will ask you questions to get your thoughts 
about the telephone sessions in which you participated. 
 
o Follow-up Assessments: You will be asked questionnaires like those completed 
for the baseline assessment. We will not ask you about symptoms experienced by 
the person you care for. The study staff will ask you each question, but you can 
complete it on paper or online, if you prefer. 

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How long will your part in this study last? 
You will be in the study for up to 12 weeks. It will take the following amount of time to 
complete activities for the study: 
• 
Enrollment Visit (Total = 1 hour 45 minutes). The total time includes: 
o Consent = 30 minutes 
o Pre-participation Interview = 10-15 minutes 
o Baseline Assessments = 1 hour 
• 
TMT training (Total= up to 12 hours 15 minutes). The total time includes: 
o 8 weekly sessions = 1 hour each session (8 hours) 
o Saturday group retreat = up to 4 hours 
o 3 check-in calls = 5 minutes each (15 minutes) 
• 
Follow-up Visit (Total = 1 hour 45 minutes). The total time includes: 
o Post-participation Interview = 30-45 minutes 
o Follow-up Assessments = 1 hour 
What are the possible benefits from being in this study? 
Research is designed to benefit society by gaining new knowledge. Our study hopes you will 
benefit from the telephone training and resources we provide, but we cannot guarantee that 
you will. 
 
What are the possible risks or discomforts involved from being in this study? 
During the study, you may feel uncomfortable about some of the questions we ask you. You 
may also feel embarrassed, agitated or anxious during the telephone training (TMT), especially 
if you become more aware of negative thoughts, emotions, or how your body feels. 
There may be uncommon or previously unknown risks. You should report any problems to the 
researcher. 
 
Will I receive any other clinical results?  
You will not receive any clinical results during this study. 
 
How will information about you be protected? 
We will use a secure web system to protect your privacy and confidentiality. Only research 
team members with login rights can see your information. We will use ID numbers to identify 
you. The file that links your name and ID number will be maintained in our secure web system 
that can only be accessed by a few members of the research team. 
 
Participants will not be identified in any report or publication about this study.  We may use de-
identified data and/or specimens from this study in future research without additional consent. 
We also may contact you about future research opportunities. 
 
Although every effort will be made to keep research records private, there may be times when 
federal or state law requires the disclosure of such records, including personal 
information.  This is very unlikely, but if disclosure is ever required, UNC-Chapel Hill will take 
steps allowable by law to protect the privacy of personal information.  In some cases, your 
information in this research study could be reviewed by representatives of the University, 
research sponsors, or government agencies (for example, the FDA) for purposes such as quality 
control or safety. 

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A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S. 
Law. This website will not include information that can identify you. At most, the website will 
include a summary of the results. You can search this website at any time. 
Also, the telephone sessions (TMT) will be audio recorded. 
• Audio recordings will be collected during telephone sessions by the instructor. 
• The instructor will give audio recordings to the team member who will type out a 
document of everything on the audio recording from each session. The team member 
typing the document will identify each person talking on the audio recording as an ID 
number, instead of your name. After the document is reviewed by the research team, the 
audio recording will be destroyed.  
• You can request that audio recordings be turned off during times when you would like to 
share something that you do not want to be reviewed by the research team. 
Check the line that best matches your choice: 
 
____ OK to record me during the study 
_____ Not OK to record me during the study 
 
Participants must agree not to reveal anything they learn from about others during the telephone 
group sessions. 
What if you want to stop before your part in the study is complete? 
You can withdraw from this study at any time, without penalty.  The investigators also have the 
right to stop your participation at any time. This could be because you have had an unexpected 
reaction to the training, or have failed to follow instructions, or because the entire study has been 
stopped. 
 
Will you receive anything for being in this study? 
You can receive up to $100 for completing study visits. Payment will be provided for: 
• 
Enrollment Visit: 
o Pre-participation Interview: $25 
o Baseline Assessments: $25 
• 
Follow-up Visit: 
o Post-participation Interview: $25 
o Follow-up Assessments: $25 
 
We will also give you up to $99 to cover costs of care for your relative during the Saturday 
Retreat. This will be given to you only if you need it. 
All payments will be given to you on a Visa reloadable gift card. You will keep the same gift 
card for the entire study.  
 
Any payment provided for participation in this study may be subject to applicable tax 
withholding obligations. 
 
Will it cost you anything to be in this study? 
It will not cost you anything to be in this study.  
 

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Who is sponsoring this study? 
This research is funded by National Institute on Aging. This means that the research team is 
being paid by the sponsor for doing the study. The researchers do not, however, have a direct 
financial interest with the sponsor or in the final results of the study. 
 
What is a Certificate of Confidentiality? 
Most people outside the research team will not see your name on your research 
information. This includes people who try to get your information using a court order in 
the United States. One exception is if you agree that we can give out research information 
with your name on it or for research projects that have been approved under applicable 
rules. Other exceptions are for information that is required to be reported under law, such 
as information about child or disabled abuse or neglect or certain harmful diseases that can 
be spread from one person to another. Personnel of a government agency sponsoring the 
study may also be provided information about your involvement in the research study. 
 
What if you have questions about this study? 
You have the right to ask, and have answered, any questions you may have about this research. If 
you have questions about the study (including payments), complaints, concerns, or if a research-
related injury occurs, you should contact the researchers listed on the first page of this form. 
 
What if you have questions about your rights as a research participant? 
All research on human volunteers is reviewed by a committee that works to protect your rights 
and welfare.  If you have questions or concerns about your rights as a research subject, or if you 
would like to obtain information or offer input, you may contact the Institutional Review Board 
at 919-966-3113 or by email to IRB_subjects@unc.edu. 
Participant’s Agreement: 
I have read the information provided above.  I have asked all the questions I have at this time.  I 
voluntarily agree to participate in this research study. 
  
______________________________________________________ 
Signature of Research Participant 
 
____________________ 
Date 
 
_____________________________________ 
Printed Name of Research Participant 
 
 
______________________________________________________ 
Signature of Research Team Member Obtaining Consent 
 
_______________ 
Date 
 
______________________________________________________ 
Printed Name of Research Team Member Obtaining Consent 
  
 
 
 
 
 

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University of North Carolina-Chapel Hill 
Consent Addendum for Unencrypted Communication 
________________________________________________________________________ 
Consent Form Version Date: December 11, 2020  
IRB Study # 19-0053  
Title of Study: Easing the Burden of Dementia Caregiving: A Telephone-delivered Mindfulness 
Intervention for Rural, African American Families   
Short Name of Study: Mindful Coping and Communication in Caregiving (MC3)  
Principal Investigator: Dr. Susan Gaylord  
Principal Investigator Department: Physical Medicine and Rehabilitation  
Principal Investigator Phone number: (919) 966-8586  
Principal Investigator Email Address: gaylords@med.unc.edu  
Funding Source and/or Sponsor: National Institutes of Health (NIH)  
Study Contact Telephone Number: (919) 370-6744  
Study Contact Email: mc3@med.unc.edu 
The following information is regarding un-encrypted communication (e.g., texting or email) by 
study staff and should be read as an addition to the consent information you have already been 
provided.  All information previously provided is still true and remains in effect. Your 
participation continues to be voluntary. You may refuse to participate or may withdraw your 
consent to participate at any time, and for any reason, without jeopardizing your future care at 
this institution or your relationship with your study team. 
The study team would like to message you by texting and/or e-mail.  However, you may say 
“no” to receiving these messages and still participate in this study.  If you say “yes”, messages 
may contain personal information about you and may be sent or received by the study 
team’s personal electronic devices or in a method that is not able to be encrypted (protected) and 
there is the risk your information could be shared beyond you and the study team.  This 
information may include information such as reminders and notifications to contact the study 
team.    
If you wish to stop receiving unprotected communication from the study team or have lost access 
to your device, please notify the study team using the study contact information on the first page 
of this addendum to the consent.  After the study is complete and all research activities finished, 
or you withdraw from the study or request to stop receiving unprotected communication, you 
will no longer receive un-encrypted (un-protected) messages specific to this study.  
_____ Yes, I consent to the study team utilizing the following cell phone/email address to send 
communication: _______________________________________________ 
_____ No, I do not consent to receive un-protected communication from the study team.    
Subject’s Agreement: I have read the information provided above.  I have asked all the 
questions I have at this time.  I voluntarily agree to continue to participate in this research study.