Mindfulness-based Cognitive Therapy for the Chronic Pain-early Cognitive Decline Co-morbidity Among Older Black Individuals in the Community; The Feeling of Being Open Pilot
Phase: NA
Conditions: Chronic Pain, Early Cognitive Decline
Sponsor: Massachusetts General Hospital

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Version 3.0, 7/25/26
Institutional Review Board
Intervention/Interaction Detailed Protocol
Principal Investigator:
Tony V Pham, MD, MScGH
Project Title:
Mindfulness-based cognitive therapy for the chronic pain-
early cognitive decline co-morbidity among older Black individuals in the community; 
The Feeling of Being Open Pilot
Version Date:
4/03/26
Version Name/Number:
2.0
1.
 Background and Significance
Chronic Pain (CP) and Early Cognitive Decline (ECD) commonly co-occur, worsen each 
other over time, and synergistically decrease physical, emotional, and cognitive function 
increasing risk for ADRD. Older adults with CP are two times more likely to also report 
ECD. The presence of both CP and ECD has an even greater negative impact on physical 
and emotional functioning than either of these conditions separately. In addition, pain 
has an independent, negative effect on cognitive functioning and is a documented 
modifiable risk factor for Alzheimer’s Disease and Related Dementias (ADRDs). Recent 
research shows that the CP-ECD relationship is bidirectional among older adults. CP 
accelerates ECD and increases risk for dementia, while ECD alters pain perceptions 
increasing CP and impairing emotional and physical function. Consequently, older adults 
with CP and ECD can become caught in a “disability spiral” whereby physical, cognitive, 
and emotional function progressively worsen over time. By addressing the common CP-
ECD comorbidity we can stop the disability spiral, promote healthy aging; improve 
emotional, physical, and cognitive function; and prevent transition to ADRDs.1
Older Black individuals have the highest rates of CP and ECD and are at the highest risk 
for negative health outcomes due to this comorbidity. Up to 78% of Black older 
individuals experience CP, a rate substantially higher than that experienced by non-
Hispanic White older adults. Although Black older adults are less likely to discuss pain 
concerns, when they do, they describe higher impairment in physical and emotional 
function symptoms than their White counterparts. Prevalence of cognitive impairment, 
including the spectrum from ECD to ADRD, is also higher among Black compared to non-
Hispanic White adults. Black adults represent a high-risk group for ECD and have an 
overall 2-fold higher risk of dementia. This high disease burden, combined with lack of 
appropriate treatments, also explain the higher rates of mortality among Black 

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individuals. Developing innovative solutions to bypass barriers to engagement in care 
and to meaningfully address the CP-ECD comorbidity among older Black individuals are 
urgently needed.2 
Older Black individuals with chronic pain and early cognitive decline more frequently 
fear medications and medication related side-effects (patient factor), providers who may 
misunderstand and discriminate against them (provider factor), and psychotherapies 
that do not relate to their lived experience (system factor). Conventional 
psychotherapies, per reports from older Black individuals, evoke stigma, lack credibility, 
and misunderstand Black culture.5 Thus, older Black individuals do not typically seek 
out, engage, or follow-up with conventional psychotherapies such as Cognitive 
Behavioral Therapy (CBT), the often recommended, non-pharmacological standard for 
treating chronic pain and delaying or slowing cognitive decline. On the other hand, 
mindfulness-based cognitive therapy (MBCT), although not generally considered the gold 
standard for chronic pain and mild cognitive impairment, has demonstrated benefit in 
treating chronic pain6 and delaying or slowing early cognitive decline among older 
adults7 while overlapping with health practices well-recognized by older Black 
individuals (e.g., mindfulness meditation in comparison to contemplative prayer, group-
based effects in comparison to community support, strengthening self-awareness in 
comparison to empowering ethnoracial identity).8
Despite MBCT’s potential, Black individuals have been grossly underrepresented in the 
clinical trials backing MBCT,9 with several negative downstream consequences. 
Promoters tend to advertise mind-body interventions to White populations,10 and mind-
body interventions have been taught almost exclusively in White, middle-and upper-
class settings with minimal utilization among underrepresented groups because of 
access barriers, high costs, the lack of Black representation among attendees and 
instructors, and conflicting Buddhist undertones.11,12 Researchers and providers must 
then repackage MBCT to broaden its appeal among older Black individuals.13 Based on 
focus groups I conducted with older Black individuals with CP-ECD from the Greater 
Boston Area, a culturally adapted MBCT (“Feeling of Being”) could be acceptable and 
feasible if abbreviated (e.g., 8, 1-hour sessions) and delivered by a lay instructor from the 
Black community. 
2.
Specific Aims and Objectives 
To continue the development of Feeling of Being, a culturally tailored mindfulness-based 
cognitive  therapy  (MBCT)-based  intervention  for  older  Black  adults  to  be  delivered 
within the community, by training a lay group instructor from the Black community and 
conducting  an  open  pilot  with  exit  interviews  among  older  Black  individuals  with 
chronic  pain  and  early  cognitive  decline to  determine  the  initial  feasibility  and 
acceptability of Feeling of Being and the feasibility and fidelity of instructor training. 

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Hypothesis: Our guiding hypothesis is that MBCT, culturally adapted for the CP-ECD co-
morbidity  among  older  Black  individuals,  will  improve  physical  function  (primary 
outcome), emotional function, pain, and intervention targets (i.e., delaying or slowing 
cognitive decline). I will formally test this hypothesis in a subsequent R01. 
3.
General Description of Study Design
Older Black individuals have expressed concern and skepticism when asked to enroll in 
scientific trials because of prior exploitative studies (e.g., the Tuskegee trials). To address 
these concerns, I worked with the MGH Community Access, Recruitment and 
Engagement (CARE) Research Center, the Center for Racial Equity and Justice), 
community navigator Michael Kincade (MGH) and Union Capital Boston (UCB), a hub 
where thousands of Black individuals living within under-resourced Boston 
neighborhoods have engaged in network nights, resource fairs, and other forms of 
community engagement. We formed a community advisory board (CAB) composed of 20 
older Black individuals with CP-ECD. I facilitated four focus groups with our CAB to 
explore the potential acceptability and feasibility of MBCT (P30AG083196). Thematic 
analysis of these focus groups suggested that MBCT may be feasible for older Black 
individuals with the ECD-CP co-morbidity but needs to be (1) centered around values, 
attitudes, and practices accepted by the older Black adults with CP-ECD, (2) delivered 
within the community setting, and (3) delivered by lay instructors to mitigate historical 
issues of lack of trust. Thus, using an abbreviated, evidence-based MBCT protocol (8 60-
minute sessions) as a starting point, we then worked with our CAB to develop a 
preliminary manual for a culturally tailored MBCT (“Feeling of Being”). In collaboration 
with Jin Joo who has deep NIH funded research experience training lay instructors to 
support people in community settings and Ana-Maria Vranceanu who has experience 
developing training fidelity protocols (GetActive NCCIH R01AT010462) as a starting 
point,15 we also developed protocols for lay instructor training and fidelity testing, and 
study procedures for a feasibility pilot study in Black communities. In this proposal, I will 
train a Black lay individual to deliver Feeling of Being via an open pilot and assess 
preliminary feasibility and fidelity. All participant activities within this proposal will 
take place at the Central Boston Elder Services (CBES) conference space, a community-
suggested location. CBES is a non-profit access point for aging services that 
predominantly caters to older people of color. Virtual accommodations will be made 
available for those who cannot attend in-person. 
Open Pilot. I will train a lay group instructor from the Black community and conduct an 
open pilot with exit interviews (n=8; 1 group) to determine the initial feasibility and 
acceptability of Feeling of Being and the feasibility and fidelity of instructor training. 
Based on the 2007-2011 American Community Survey of Roxbury, I estimate that the 
total number of Black individuals over the age of 50 with chronic pain and co-morbid 
depression to be 1,325. This estimate indicates that the eligible sample size is in excess of 
the recruitment requirement of N=8 participants.
The first two months will involve developing material and conducting trainings with 
study staff. Recruitment, intervention delivery, and refinement of materials will occur 
over the subsequent 10 months. 
Below, I present proposed milestones for this open pilot.

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Table 1. Study Timeline
Major Task 1: Start-up, prepare, and conduct the open pilot for Aim 
1.
Months
SUBTASK 1: Clinical protocol for NCCIH; prepare IRB. No Data Safety Monitoring Board 
(DSMB) is required.
Develop manual, consent forms, protocol, assessments, and tracking 
forms.
0-2
Coordinate recruitment with CBES and ensure recruitment of racial 
and ethnic minorities
0-2
Finalize data/time for study weekly meetings as well as check-
ins with CBES for recruitment.
0-2
Milestones Achieved: IRB submitted and approved; protocol approved by NCATS; materials developed; 
meetings set.
SUBTASK 2: Train study staff in study procedures consistent with protocol.
Train RA on study procedures, including how to teach participants Zoom for 
remote delivery.
3
Train lay instructor on Feeling of Being manualized protocol
3
Present to CBES staff and train in study procedures.
3
Milestones Achieved: Study team assembled and trained; PI ready to deliver pilot 
intervention.
SUBTASK 3: Start recruitment, intervention, and data collection at all assessment 
periods.
Recruit 8 participants (8-week intervention)
4-6
Conduct post-intervention assessments and exit interviews with 
participants.
5-7
Prepare for data analysis.
7-8
Database locked.
8
Milestones Achieved: Recruitment, treatment, and follow-up are completed; database 
is locked.
SUBTASK 4: Refine Feeling of Being intervention and study procedures (to prepare for 
Aim 3).
Analyze data using mixed methods approaches.
8-9
Refine intervention and study procedures based on findings.
9-11
Disseminate initial findings in peer-reviewed journals and/or conferences.
11-12
Milestones Achieved: Intervention and study procedures refined; ready to test for feasibility in Study 3 
(Aim 3).
4.
Subject Selection
We  will recruit older  Black participants  with chronic musculoskeletal pain and co-
occurring early cognitive decline (Table 1). 

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Table 2. Inclusion and Exclusion Criteria
Participant Inclusion Criteria
1. Older adult (age ≥ 50)
2. All individuals who identify with one or more nationalities or ethnic groups originating in any 
of the Black racial groups of Africa
3. Pain in muscles, joints, bones, or associated soft tissues (NRS>4) lasting longer than 3 months
4. Subjective ECD or MCI
5. Telephone Interview for Cognitive Status-30 score ≥ 17
6. Functional Activities Questionnaire score < 9
7. English fluency/literacy
8. Ability and willingness to participate via in-person and video
9. Willing to provide informed consent and comply with all aspects of the protocol
Participant Exclusion Criteria
1. Current substance abuse/dependence
2. Significant cognitive impairment
3. History of more than 8 sessions of cognitive-behavioral therapy
4. History of previous training in mindfulness or undergoing counseling more than once a month
5. History of or current diagnosis of psychosis
6. Active suicidal ideation or self-harm within the past 90 days
Enrolled participants must be older than 50 years of age, based on community feedback 
and  because  chronic  diseases  are  noted  in  Black  Americans  at  an  earlier  age. 35–38
Participants must have either preclinical (subjective) or early objective (Mild Cognitive 
Impairment (MCI)) because they are both comorbid with chronic pain, they are both 
early precursors of Alzheimer's Disease and Related Dementias (ADRD), and they both 
require  similar  adaptations  to  skill  acquisition.  Including  both  also  increases 
generalizability and scalability. Participants must score 
 17 on the Telephone Interview
≥
 
for Cognitive Status to ensure that participants do not have prevalent dementia or severe 
cognitive impairment that would preclude them from meaningfully engaging with the 
study. Participants must also score < 9 on the Functional Activities Questionnaire to 
ensure that participants are able to meaningfully engage with the program. Participants 
must report chronic (
 3 months) 
≥
musculoskeletal pain with a severity of 
 4 on the Pain
≥
 
Numeric Rating Scale (NRS).40 These cut off values are similar to those of other NIH-
funded mind-body trials for chronic musculoskeletal pain in community settings.41 
5.
Subject Enrollment
We will recruit from Central Boston Elder Services (CBES) affiliated Catherine Hardaway 
Residence, a collection of 57 housing units originally developed in 2011 to address the 
elder housing crisis in the Roxbury community of Boston. The Roxbury community is 
predominantly Black and has been described by the city as the "heart of Black culture in 
Boston."42 I have been working with CBES for the past two years to establish 
infrastructure to support this project. I will present the study aims to CBES to explain this 
study and facilitate referrals.

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Our CE Studio community navigators (Kincade, Linton) will also assist with referrals but 
will only be assisting in referring potential participants to the program (i.e., not 
conducting study procedures). To assist with recruitment, community navigators will 
present to CBES in-person to distribute IRB approved study fliers. Our community 
navigators will also e-mail the CBES listserv using an email script. At no point will we 
cold call any prospective participants. Instead, participants will call our team to indicate 
interest based on the flyer. 
Prospective participants will complete screening and full consent procedures either in-
person at CBES via written consent or remotely via eConsent. The primary RA will 
perform the screening of prospective open pilot participants. She will inform 
participants that their participation is voluntary, they can refuse to answer any 
questions, and they can withdraw from the study at any time. The screening form 
includes a statement about the preference for correspondence over secure vs. 
unencrypted email, details about the risks using unencrypted email, and a place for the 
participant to state their preference. Capacity to provide consent will be assessed via the 
Telephone Interview for Cognitive Status scale. To ensure any cognitive impairment is 
mild in severity, participants may only provide consent if they score greater than or 
equal to 17 on the Telephone Interview for Cognitive Status scale. 
For in-person screening and full written consent (whenever allowed according to MGH 
and CDC guidelines), the screening will be conducted face-to-face, and participants will 
be handed a hard copy of the consent form. If preferred by the participant, the RA will 
verbally review the study consent form and provide further instructions for signing if 
the participant expresses confusion. Following completion of consent, the RA who 
obtained consent will countersign and the participant will receive a hard copy of the 
completed consent form as well as their first set of surveys.
Remote screening will be through REDCap eConsent. First, each eConsent form will be set 
up and sent to prospective participants. The participant will then independently review 
the eConsent form on their own time and have the opportunity to address any study-
related questions or concerns with an RA prior to signing. If preferred by the participant, 
the RA will verbally review the study eConsent form over the phone and provide further 
instructions for digitally signing eConsent if the participant expresses confusion. 
Following completion of eConsent, the RA who obtained eConsent will countersign and 
the participant will receive the completed eConsent in their inbox. 
After participants provide either written consent or eConsent, the RA will collect 
demographic information using REDCap determine which open pilot dates work best for 
the participant, , email participants a packet with study program materials, and send 
participants their first set of surveys. The RA will keep track of the number of 
participants who agree to participate and who participated from those available. I will 

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review these numbers weekly. The MGH IRB will review and approve all study 
procedures. 
6.
STUDY PROCEDURES
Following enrollment, we will train a Black lay individual on how to deliver Feeling of 
Being using our preliminary Feeling of Being manualized protocol. Training will follow 
Dr. Ana-Maria Vranceanu’s protocol currently used in an NIH funded multi-site 
feasibility study (R01AT010462). Training will be completed in-person over the course of 
1 week. Trainings will include presentations on (1) the rationale of the program 
including the fear avoidance model and the CP-ECD co-morbidity (2 1-hour long 
presentations); (2) Feeling of Being goals, potential challenges and strategies to problem 
solve them, and modeling process factors (e.g., engagement; 2 1- hour sessions) and (3) 
role-play scenarios that ensure fidelity to intervention. 
To assess  training fidelity: (a)  Feeling of Being  as delivered by a lay instructor will be 
video-recorded and rated by me on training fidelity forms; (b) the lay instructor will 
complete  post-training  surveys  assessing  their  quantitative  knowledge  about  the 
program;  (c)  the  lay  instructor’s  adherence  and  competence  in  conducting  mock 
intervention sessions will be evaluated on standardized rating scales to establish training 
fidelity prior to delivery to participants. Additional trainings will be delivered, as needed, 
until  our  a  priori  benchmarks  are  met.  The  lay  instructor  will  provide  qualitative 
feedback on any recommended modifications to training procedures that they perceive 
would improve the training process in preparation for a future pilot RCT and efficacy 
RCT. Lay instructors will have to meet the following benchmarks for training fidelity: (1) 
an instructor score 
8 on training adherence and competency of video-recorded training
≥
 
sessions and mock group sessions (1=poor, 10=outstanding); (2) instructor score 
80% on
≥
 
post-training knowledge/competency testing. 
After the instructor passes all the competencies, the instructor, as part of an open pilot, 
will lead Feeling of Being among 8 older Black individuals with CP and ECD at the CBES 
conference room. Open pilot sessions will be audio-recorded and reviewed weekly by me 
for adherence and competence using structured rating scales. Feedback will be provided 
in weekly supervision. Attendance and home practice will also be tracked. Participants 
who miss a session will be offered make-up sessions. Instructor fidelity to Feeling of Being 
delivery  during  the  open  pilot  will  again  be  determined  using  the  aforementioned 
benchmarks. If drift or deficiencies are noted in the instructor, we will re-train them via 
“booster sessions” as needed. 
At baseline, post-test (i.e., after completing the 8-week program), and 3-month follow-up, 
participants will complete a reliable and valid battery of questionnaires online via the 
secure REDCap system. At baseline, we will survey participants for their demographic 
background (i.e., age, gender, biological sex, religion, race, ethnicity, education, income, 
marital status) and past/current medical history (i.e., medical diagnoses, treatments, 
substance use). This demographic data will better characterize the sample and provide 
valuable information towards a pilot RCT and efficacy trial using the R01 mechanism. At 
baseline, post-test, and 3-month follow-up, participants will also be surveyed about their 

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pain (Numerical Rating Scale), physical function (PROMIS Physical Function), cognitive 
function (Everyday Cognition Scale, Montreal Cognitive Assessment), emotional function 
(PROMIS Anxiety, PROMIS Depression, PROMIS Emotional Support), adaptive coping, and 
mindfulness (Measure of Current Status Part A, Cognitive and affective mindfulness 
scale-revised, Chronic Pain Acceptance Questionnaire, Pain Self-Efficacy Questionnaire, 
Pain Catastrophizing Scale, Tampa Kinesiophobia Scale). Intervention acceptability will 
be assessed using individual exit interviews and questionnaires (The Credibility and 
Expectancy Questionnaire, The Client Satisfaction Questionnaire, Modified Patient Global 
Impression of Change).
Participants will be compensated $315 for participation in the study. Participants will be 
made aware of this in the study flyer and during the screening and consent process. 
7.
Risks and Discomforts
It is unlikely that participants will incur any risk for physical harm from study 
participation. It is possible that participants will find some topics and questions to be 
emotionally upsetting, or that they may experience some psychological discomfort while 
discussing their experiences during the open pilot. I am excluding patients who endorse 
acute, cancerous, or non-musculoskeletal pain, suicidality, or who have untreated 
psychosis or substance dependence disorder given that would require a higher level of 
specialized care. 
In the case that any patient or participant endorses active suicidality while screening (or 
throughout the course of the study), the trained research assistant will immediately 
contact the Principle Investigator, who will conduct a formal risk assessment. If the 
participant is assessed to be at acute risk for self-harm or harm to others, the participant 
will be referred to a higher level of care, including going to the nearest emergency room. 
A similar procedure will be followed if the participant scores 
 30 on the PROMIS 
≥
Depression scale, if the participant scores <17 on the Telephone Interview for Cognitive 
Status scale, or if active suicidal ideation is raised during screening, the intervention, or 
at any other point of contact with the participant. Safety will always be prioritized over 
study participation. Participants who score 
 30 on the PROMIS Depression scale, score 
≥
<17 on the Telephone Interview for Cognitive Status scale, or endorse active suicidality 
will not be permitted to remain in the study even while seeking evidence-based 
treatment for worsening depression/suicidal ideation.
Patients are not obligated to answer any screening or exit interview questions that are 
uncomfortable
with. Participation in this study will not affect the medical care within the Partners 
network or any other

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healthcare network. Patients can withdraw from the study at any time without 
consequences. In the
extremely unlikely event that a patient has a severe adverse emotional disturbance 
while completing
screening or any other study procedure, the trained RA will immediately contact the 
Principal
Investigator to conduct a thorough risk assessment as soon as possible
Collecting identifiable information carries the risk of loss of confidentiality. However, we 
will take numerous steps to minimize this risk. Study data will be maintained in a locked 
filing cabinet and on password protected computers on Partners encrypted Storage 
Fusion Architectures (SFA).  Interviews and questionnaire data will not become part of 
the patient’s medical record and will not contain medical record numbers or names. 
Hardcopies of study related data and forms will be stored in a lockable file cabinet.  
Patient information will remain confidential by keeping identifying information (name, 
medical record number, and subject number) in a separate locked file cabinet.  Only the 
investigators and study staff specified on the consent form will have access to this 
information. Prior to the audio-recorded interview, participants will be instated not to 
share identifiable information, and if they do, it will be omitted by study staff in the 
transcription process. 
8.
Benefits
There are no direct benefits for participation. However, open pilot participants may 
benefit from knowing that their participation may help improve care for other older 
Black community members with chronic pain and co-occurring depression.
9.
Statistical Analysis
We will analyze qualitative data derived from exit interviews using a hybrid deductive–
inductive 
 
 approach
 
 91   with the socio-ecological and fear avoidance frameworks informing
 
  
the structure of the coding framework and the data itself informing the codes. A trained 
research  assistant  (RA)  and  I  will  meet  weekly  with  Dr.  Vranceanu  to  discuss  the 
thematic framework, categories, and coding plan. We will share the data with  our 
community advisory board and the rest of the mentoring and advisory team to get their 
input  with  data  interpretation.  We  will  carry  out  all  qualitative  analysis  using  the 
QualCoder software (Version 2.9). We will analyze quantitative data using “R” (version 
4.2.0). We will calculate descriptive statistics comparing pre-, post-, and 3 months post-
intervention  scores  on  the  standardized  outcome  instruments.  For  mixed  methods 
analysis, I will use an Integrative Exploratory Design.111 This approach is flexible and 
allows for the integration of qualitative and quantitative data across multiple timepoints, 
although of note, this open pilot is primarily focused on feasibility and acceptability and 
not statistical significance or efficacy.111 Frequency and proportions will be used to assess 

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feasibility of recruitment and retention procedures. We will not be counting participants 
who drop out as meeting applicable feasibility criteria. If the proposed benchmarks are 
not met, revisions will be necessary. 
The proposed benchmarks were previously used in NCCIH funded studies by the primary 
mentor  (e.g.,  #3R34AT009356)  and  are  consistent  with  guidelines  for  intervention 
development.112 The  proposed  protocol  for  fidelity  to  treatment  follows  NIH 
recommendations,113 co-mentor  Joo’s  training  protocol  for  the  PEERS  Program,  and 
primary mentor Vranceanu’s clinical adherence protocol for GetActive.35,37,37,38 
10.   Monitoring and Quality Assurance
Sources of material for this study will include participant qualitative interviews and 
survey questionnaires before and after the open pilot. The PI will monitor the validity of 
the data and adherence to the IRB approved protocol on a daily basis. A member of study 
staff will verify that all items on all questionnaires have been addressed. All study staff 
will complete required Partners human subjects trainings prior to the start of study 
procedures. 
Participant Confidentiality. The PI will obtain all materials strictly for research purposes. 
Data from individuals deemed ineligible will be immediately shredded, and only study 
staff will have access to the data. Participants’ data will be identified by an ID number 
only, and a link between names and ID numbers will be kept separately under lock and 
key. Interviews will not become part of the patient’s medical record and will not contain 
medical record numbers or names. 
Data Validity and Security. Recordings will be immediately deleted from the recording 
device and stored under password protection. All study forms will be stored in locked 
storage spaces, to which only study staff will have access and electronic forms stored on 
an encrypted Partners SFA. All interventionists and assessors will have advanced 
training in clinical interviewing and assessment. Participants will be informed that they 
may refuse to answer questions that make them feel uncomfortable or they do not wish 
to answer.
Study data will be maintained in a locked filing cabinet and on password protected 
computers.  Hardcopies of study related data and forms will be stored in a lockable file 
cabinet.  Patient information will remain confidential by keeping identifying information 
(name, medical record number, and subject number) in a separate locked file cabinet.  
Only the investigators and study staff specified on the consent form will have access to 
this information. Data from this study will be stored for three years after the publication 
of all study results, at which time all paper screening and consent forms will be 
shredded, and computer files will be deleted. 

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To maximize accuracy and security, all survey data will be collected and stored on 
REDCap. Research staff will ensure that proper consent has been obtained before 
sending the REDCap survey to each participant. REDCap (Research Electronic Data 
Capture) is a free, secure, HIPAA compliant web-based application hosted by the Partners 
HealthCare Research Computing Enterprise Research Infrastructure & Services (ERIS) 
group. Vanderbilt University, with collaboration from a consortium of academic and 
non-profit institutional partners, has developed this software toolset and workflow 
methodology for electronic collection and management of research and clinical study 
data. Data collection projects rely on a study-specific data dictionary defined by members 
of the research team with planning assistance from Harvard Catalyst, The Harvard 
Clinical and Translational Science Center EDC Support Staff. This iterative development 
and testing process results in a well-planned data collection strategy for individual 
studies. Using REDCap, the research team can also design web-based surveys and engage 
potential respondents using a variety of notification methods. REDCap provides flexible 
features that can be used for a variety of research projects and provides an intuitive 
interface to enter data with real time validation (automated data type and range checks). 
The system offers easy data manipulation with audit trails, reports for monitoring and 
querying participant records, and an automated export mechanism to common 
statistical packages (SPSS, SAS, Stata, R/S-Plus). 
Safety Monitoring. Risks to participants are minimal. the PI will discuss with Drs. 
Vranceanu and Jackson strategies to ensure the safety the participants. Additionally, all 
participants will provide contact information (phone number and email) for at least 1 
friend or family member that we can contact in case of emergency. In the unlikely event 
that a participant will be at risk for self-harm or actively suicidal, the PI, under the 
supervision of the Dr. Vranceanu, will contact the participant and/or the friend or family 
member depicted as a safety contact to conduct a safety assessment (assessment, 
referral, emergency room visit, as needed). Safety will always be prioritized over study 
participation.
All study staff have been trained in responsible research conduct through a Collaborative 
Institutional Training Initiative (CITI) course. In addition, the study RA will be trained 
during onboarding procedures on the importance of maintaining confidentiality through 
the assignment of ID numbers. All data will be kept confidential, under lock-and-key, 
accessible only to trained study staff. Participants’ data will be identified by ID number 
only, and a link between names and ID numbers will be kept separately. Interview 
recordings will be immediately downloaded from the recording device to the secure 
computer and subsequently deleted from the recording device. Recordings will be 
labeled with the participants’ ID and will be password protected. 

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Throughout the study subjects will be monitored for the occurrence of events defined as 
any undesirable experience or unanticipated risk. Lack of effect of treatment is not 
considered an event. If the PI or a member of his research team identifies an adverse 
event (e.g., via study participants, research team members), they will follow the steps 
below:
Serious Adverse Events. Any event that meets the Food and Drug Administration (FDA) 
definition of a serious adverse event or that is deemed by the PI or team to impose 
significant hazard, contraindication, side effect, precaution, will be reported to IRB 
within 24 hours; and to NCCIH (including responses of the IRB) within 7 days. Under this 
categorization, (1) spontaneous expression of suicidal ideation and (2) 
answers of 1, 2, or 3 on Question 9 of the PHQ-9 will result in will result in emergent 
evaluation by a licensed clinician member of study staff (Dr. Pham, licensed psychiatrist) 
for appropriate assessment and triage.
Non-Serious Adverse Events. At the end of the year, the IRB and NCCIH will receive a 
summary of adverse events, including number and types of events, severity, time point, 
and determination of whether the events were study related.
Other Safety-Related Reports. At the end of the year, the IRB and NICCH will receive an 
un-blinded report of study retention and reasons for nonparticipation.
Study Stopping Rules. No stopping rules exist for phase 1 activities, which involve a 
single interview per dyad and the completion of survey assessments.
All adverse events will be reported on an adverse event form. The Principle Investigator 
has the responsibility of reporting serious adverse events (death, life threatening illness 
or injury, serious injury, or permanent disability) to PHRC within 24-72 hours of 
notification.
11. Data and Research Material Sharing
Screening results, consent forms, survey responses, exit interview data, and analyses will 
be sent among investigators and study staff only. To maintain confidentiality, patients 
will be identified using a specific ID. Only the RA and study clinicians will have access to 
the file connecting patients’ names and study Ids. All data and materials will not be 
linked back to individual participants such that the investigators could re-identify 
participants. The recipient of the data and materials will not be able to use a link to re-
identify participants. Data and materials will only be sent using encrypted email and 
stored on password protected computers on Partners encrypted Storage Fusion 
Architectures (SFA). Data and materials will not be stored at collaborating sites outside 
Mass General Brigham for future use. All participants have the right to withdraw their 

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data/materials by contacting the study team. This will be explained during the consent 
process. 
A)Receiving Data/Materials from Research Collaborators 
outside Mass General Brigham
Data and materials will not be received by research collaborators outside Mass General 
Brigham.
B) Sending Data/Materials to Research Collaborators outside 
Mass General Brigham
Data and materials will not be sent to research collaborators outside Mass General 
Brigham.
12. Privacy and Confidentiality
☒Study procedures will be conducted in a private setting.
☒Only data and/or specimens necessary for the conduct of the study will be 
collected.
☒Data collected (paper and/or electronic) will be maintained in a secure location 
with appropriate protections such as password protection, encryption, physical 
security measures (locked files/areas)
☐Specimens collected will be maintained in a secure location with appropriate 
protections (e.g. locked storage spaces, laboratory areas)
☒Data and specimens will only be shared with individuals who are members of the 
IRB-approved research team or approved for sharing as described in this IRB 
protocol.
☒ Data and/or specimens requiring transportation from one location or electronic 
space to another will be transported only in a secure manner (e.g. encrypted files, 
password protection, using chain-of-custody procedures, etc.)
☒   All electronic communication with participants will comply with Mass General 
Brigham secure communication policies.
☒Identifiers will be coded or removed as soon as feasible and access to files linking 
identifiers with coded data or specimens will be limited to the minimal necessary 
members of the research team required to conduct the research.
☒All staff are trained on and will follow the Mass General Brigham policies and 
procedures for maintaining appropriate confidentiality of research data and 
specimens.
☒The PI will ensure that all staff implement and follow any Research Information 
Service Office (RISO) requirements for this research.
☒Additional privacy and/or confidentiality protections

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13.   References
1
Eshkoor SA, Hamid TA, Mun CY, Ng CK. Mild cognitive impairment and its 
management in older people. Clin Interv Aging 2015;10:687–93. 
https://doi.org/10.2147/CIA.S73922.
2
Weuve J, Barnes LL, Mendes de Leon CF, Rajan KB, Beck T, Aggarwal NT, et al. 
Cognitive Aging in Black and White Americans: Cognition, Cognitive Decline, and 
Incidence of Alzheimer Disease Dementia. Epidemiol Camb Mass 2018;29:151–9. 
https://doi.org/10.1097/EDE.0000000000000747.
3
Reyes-Gibby CC, Aday LA, Todd KH, Cleeland CS, Anderson KO. Pain in Aging 
Community-Dwelling Adults in the United States: Non-Hispanic Whites, Non-Hispanic 
Blacks, and Hispanics. J Pain 2007;8:75–84. https://doi.org/10.1016/j.jpain.2006.06.002.
4
Nguyen M, Ugarte C, Fuller I, Haas G, Portenoy RK. Access to care for chronic pain: 
racial and ethnic differences. J Pain 2005;6:301–14. 
https://doi.org/10.1016/j.jpain.2004.12.008.
5
Awosan CI, Sandberg JG, Hall CA. Understanding the experience of Black clients in 
marriage and family therapy. J Marital Fam Ther 2011;37:153–68. 
https://doi.org/10.1111/j.1752-0606.2009.00166.x.
6
Day MA, Ward LC, Ehde DM, Thorn BE, Burns J, Barnier A, et al. A Pilot Randomized 
Controlled Trial Comparing Mindfulness Meditation, Cognitive Therapy, and 
Mindfulness-Based Cognitive Therapy for Chronic Low Back Pain. Pain Med 
2019;20:2134–48. https://doi.org/10.1093/pm/pny273.
7
Foulk MA, Ingersoll-Dayton B, Kavanagh J, Robinson E, Kales HC. Mindfulness-Based 
Cognitive Therapy With Older Adults: An Exploratory Study. J Gerontol Soc Work 
2014;57:498–520. https://doi.org/10.1080/01634372.2013.869787.
8
Veehof MM, Trompetter HR, Bohlmeijer ET, Schreurs KMG. Acceptance- and 
mindfulness-based interventions for the treatment of chronic pain: a meta-analytic 
review. Cogn Behav Ther 2016;45:5–31. https://doi.org/10.1080/16506073.2015.1098724.
9
Waldron EM, Hong S, Moskowitz JT, Burnett-Zeigler I. A Systematic Review of the 
Demographic Characteristics of Participants in US-Based Randomized Controlled 
Trials of Mindfulness-Based Interventions. Mindfulness 2018;9:1671–92. 
https://doi.org/10.1007/s12671-018-0920-5.
10 Gregoire C. Actually TIME, This Is What The ‘Mindful Revolution’ Really Looks Like. 
HuffPost. 2014. URL: https://www.huffpost.com/entry/this-is-proof-that-
mindfu_n_4697734 (Accessed 12 May 2022).
11 Salmon P, Sephton S, Weissbecker I, Hoover K, Ulmer C, Studts JL. Mindfulness 
meditation in clinical practice. Cogn Behav Pract 2004;11:434–46. 
https://doi.org/10.1016/S1077-7229(04)80060-9.
12 Woods-Giscombé CL, Gaylord SA. The Cultural Relevance of Mindfulness Meditation 
as a Health Intervention for African Americans: Implications for Reducing Stress-

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Related Health Disparities. J Holist Nurs 2014;32:147–60. 
https://doi.org/10.1177/0898010113519010.
13 Watson-Singleton NN, Black AR, Spivey BN. Recommendations for a culturally-
responsive mindfulness-based intervention for African Americans. Complement Ther 
Clin Pract 2019;34:132–8. https://doi.org/10.1016/j.ctcp.2018.11.013.
14 Keisler-Starkey K, Bunch LN. Health Insurance Coverage in the United States: 2019 
2019:26.
15 Mace RA, Gates MV, Bullard B, Lester EG, Silverman IH, Quiroz YT, et al. Development 
of a Novel Mind–Body Activity and Pain Management Program for Older Adults With 
Cognitive Decline. The Gerontologist 2021;61:449–59. 
https://doi.org/10.1093/geront/gnaa084.
16 Ford ME, Tilley BC, McDonald PE. Social support among African-American adults 
with diabetes, Part 2: A review. J Natl Med Assoc 1998;90:425–32.
17 Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of 
changes in chronic pain intensity measured on an 11-point numerical pain rating 
scale. PAIN 2001;94:149–58. https://doi.org/10.1016/S0304-3959(01)00349-9.
18 Janevic M, Robinson-Lane SG, Murphy SL, Courser R, Piette JD. A Pilot Study of a 
Chronic Pain Self-Management Program Delivered by Community Health Workers to 
Underserved African American Older Adults. Pain Med 2021:pnaa468. 
https://doi.org/10.1093/pm/pnaa468.
19 Kroll T, Neri M. Designs for Mixed Methods Research. Mix. Methods Res. Nurs. Health 
Sci. John Wiley & Sons, Ltd; 2009. p. 31–49.
20 Czajkowski SM, Powell LH, Adler N, Naar-King S, Reynolds KD, Hunter CM, et al. From 
ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic 
diseases. Health Psychol 2015;34:971–82. https://doi.org/10.1037/hea0000161.
21 Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, et al. Enhancing 
Treatment Fidelity in Health Behavior Change Studies: Best Practices and 
Recommendations From the NIH Behavior Change Consortium. Health Psychol 
2004;23:443–51. https://doi.org/10.1037/0278-6133.23.5.443.
APPENDIX
 
  A
  
Data Monitoring Committee / Data and Safety Monitoring Board
Appendix
•
To be completed for studies monitored by Data Monitoring Committee (DMC) or Data 
and Safety Monitoring Board (DSMB) if a full DMC/DSMB charter is not available at the 
time of initial IRB review.

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•
DMC/DSMB Charter and/or Roster can be submitted to the IRB later via Amendment, 
though these are not required if this Appendix has been completed and approved by 
the IRB. 
A Data Monitoring Committee (DMC) or Data and Safety Monitoring Board (DSMB) 
will be convened for safety monitoring of this research study.  The following 
characteristics describe the DMC/DSMB convened for this study (Check all that apply):
☐The DMC/DSMB is independent from the study team and study sponsor.
☐A process has been implemented to ensure absence of conflicts of interest by 
DMC/DSMB members.
☐The DMC/DSMB has the authority to intervene on study progress in the event of 
safety concerns, e.g., to suspend or terminate a study if new safety concerns have 
been identified or need to be investigated. 
☐Describe number and types of (i.e., qualifications of) members:
Click or tap here to enter text.
☐ Describe planned frequency of meetings:
Click or tap here to enter text.
☐DMC/DSMB reports with no findings (i.e., “continue without modifications”) will 
be submitted to the IRB at the time of Continuing Review.
☐DMC/DSMB reports with findings/modifications required will be submitted 
promptly (within 5 business days/7 calendar days of becoming aware) to the IRB 
as an Other Event.