Addressing the Epidemic of Chronic Pain Among Older Adults in Underserved Communities; The GetActive+ Study
Phase: NA
Conditions: Chronic Pain, Musculoskeletal Pain
Sponsor: Massachusetts General Hospital

 
Version 2021.06.10 
Page 1 of 24 
 
 
 
 
 
Official Title: Addressing the Epidemic of Chronic Pain Among Older Adults in 
Underserved Communities; The GetActive+ Study   
 
Protocol ID: 2023P000362 
 
Protocol Version Date: 4-8-24 
 
Document Date: 4-16-2024 (date approved by IRB) 
 
 
 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 2 of 24 
 
 
Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
 
Principal Investigator: 
Ana-Maria Vranceanu, PhD; Christine Ritchie, MD 
 
Project Title: 
iHOPE Study (Aim 2) 
 
Version Date: 
4/8/24 
 
 
Version Name/Number: 
10 
 
 
 
1. 
 Background and Significance 
 
Chronic musculoskeletal pain among older adults is prevalent and costly.  
Chronic musculoskeletal pain (pain >3 months)1 is common among older adults, with an estimated 
60%–75% of older adults reporting at least some persistent pain2. The incidence of chronic pain 
among older adults is expected to increase given the exponential growth in the older adult 
population over the next three decades and accompanying comorbidities3. Estimated US health 
care costs of chronic pain range from $261-300 billion, far exceeding the cost of diabetes, 
hypertension, heart disease, cancer, and other common chronic conditions4. Among older adults, 
chronic pain leads to a significant decline in physical and emotional function with substantial 
disability from reduced mobility, avoidance of activity, falls, depression, anxiety, sleep 
impairment, and social isolation5–8. Sedentarism, lack of engagement in activities of daily living, 
and impairments in balance and gait9 are common in older adults with chronic pain and further 
increase risk for morbidity and mortality.  
 
Older adults from underserved communities are at the highest risks for negative outcomes 
due to chronic pain.  
 
Older adults from underserved communities have disadvantaged backgrounds, low income, poor 
education, and tend to be racial and ethnic minorities and immigrants.  Chronic pain is often poorly 
recognized, underestimated, and inadequately managed among these older adults. Disparities in 
chronic pain management are multidimensional, including gaps in patient/health care provider 
communication, variability in decision making, and gaps in access to effective treatment10,11.  
Discrimination, systemic racism, stigma, social marginalization, lower education, and Medicaid 
insurance status are all associated with higher reports of pain intensity, higher psychological 
distress and disability among older adults with chronic pain.  
 
Management of chronic pain among older adults is inadequate, particularly for older adults 
from underserved communities. 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 3 of 24 
For older adults, pain medications including opioid analgesics have limited efficacy12,13, increase 
risk for adverse events such as falls14, and can lead to confusion and cognitive decline15.  
Nonpharmacological treatments for chronic pain such as Cognitive Behavioral Therapy (CBT) or 
Mindfulness Based Interventions (MBIs) are safe for older adults and can improve pain outcomes 
including physical, and emotional function16,17..    However, treatment effects are small, decrease 
over time, and access to timely treatment is scarce18. A recent systematic review published in 
JAMA highlighted the need for novel nonpharmacological treatments for chronic pain in older 
adults that can produce stronger and sustained effects18.   
Access to nonpharmacologic therapies is limited for many older adults from disadvantaged 
populations because therapies are not affordable, not recommended by providers, or not available 
in their community19-22. For example, a recent study of specialty pain clinics found that close to 
half did not accept Medicaid and did not offer psychosocial treatment options23. Our qualitative 
work also suggests that older adults with chronic pain are experiencing significant unrelieved pain 
and cannot easily access psychosocial interventions in their communities to better manage it24.  
 
Group Visits (aka Shared Medical Appointments) may be a viable model to overcome many 
barriers experienced by older, underserved adults to high-quality chronic pain 
management25,26.  
Group medical visits seek to improve patient health through a blend of medical care, education, 
and peer support27. Previous research on group visits, which has included underserved community 
health centers28 and older adults29, has demonstrated the feasibility, acceptability, and health 
benefits of group visits for patients with diabetes30, cancer31, and headaches32. Group visits for 
older adults with chronic pain have substantial potential to overcome the challenges of patient 
stigma and insufficient clinician skills by: 1) creating a supportive community of patients who 
navigate pain together in a supportive clinical setting familiar to them with easy access to their 
clinical team; 2) providing evidence-based nonpharmacological pain treatment delivered by 
trained clinic staff; 3) efficiently integrating pain management into the routine flow of primary 
care; and 4) being financially feasible, scalable, and sustainable within primary care settings, as 
group medical visits can be reimbursed by Medicare, Medicaid and third party payers 33.  
 
The GetActive program is an evidence-based intervention developed by our team that is 
feasible and produces sustained moderate to large improvements in pain outcomes. 
GetActive34,35 was developed by our interdisciplinary team using the fear avoidance theoretical 
model (development and maintenance of pain occurs due to perception of pain as  a threat and 
subsequent avoidance of activity)36, and guidelines from the International Classification of 
Functioning, Disability and Health (ICF)37 and the Initiative on Methods, Measurement and Pain 
Assessment in Clinical Trials (IMMPACT)38. GetActive combines “top down” CBT and MBI 
skills with walking, a “bottom up”, safe and preferred activity for older adults39.  GetActive directly 
targets improvement in all aspects of physical function delineated by IMMPACT38: 1) self-report; 
2) performance based/exercise capacity; and 3) objective (step-count). GetActive teaches: (1) 
walking skills based on behavioral/operant principles (e.g., how to gradually increase step-count 
by setting SMART (specific, measurable, attainable, realistic, time bound) goals; how to pair 
increases in walking with engagement in activities of daily living that are meaningful and valued; 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 4 of 24 
how to apply pacing to safely break the connection between pain and activity; (2) mind–body skills 
to change one’s relationship with pain (e.g., reduce reactivity, fear, ruminative self-talk  through 
relaxation response and mindfulness exercises) and to facilitate walking; (3) pain, behavior 
awareness skills to understand the disability spiral (e.g., how lack of activity perpetuates chronic 
pain and emotional and physical disfunction); and (4) positive psychology skills to engage social 
support for walking; manage negative reactions from others and cope with stress or walking 
setbacks (positivity, self-compassion, and gratitude).   
 
The GetActive program can be tailored for the unique needs of disadvantaged, older adults 
and for routine integration in primary care clinics in underserved communities, as part of 
Group Medical Visits, with high potential for sustainability and scalability.  
While group visits for chronic pain have been initiated40,41, they have not been developed 
specifically for older adults, and have not been rigorously tested in older adults or incorporated 
into routine care for older, disadvantaged adults. Community health centers (CHC) provide 
primary care for over 24 million patients in the United States, often in medically underserved and 
lower-income urban and rural communities42. Because of the diversity of older patients seen by 
CHCs, they offer a unique and compelling opportunity to provide high quality psychosocial 
interventions for chronic pain and improve overall access to chronic pain management.  
We partnered with the MGH-Revere HealthCare Center (RHC), which serves a diverse, 
underserved community, to integrate GetActive+ into the group visit workflow of their practice to 
fit the need of their older patients, clinic staff and administration.   RHC has a longstanding history 
of group visits for diabetes and obesity delivered by trained NPs, 
and will provide an optimal setting, infrastructure, and context for 
integrating GetActive+ into a group visit framework. By 
developing, implementing, and evaluating this integrated model 
of GetActive+ at RHC, we will set the stage for our long-term 
goal to implement and disseminate GetActive+ in other 
community health centers in MA and nationally. 
 
2. 
Specific Aims and Objectives  
 
Conduct an open pilot trial (i.e., Aim 2 of P# 2022P001691) of 
the GetActive+ program (i.e., a novel mind-body and activity 
program) followed by optional qualitative exit interviews with 
RHC patients (up to N=50). We will determine if the feasibility, 
acceptability, and fidelity of the program meet a priori 
benchmarks. We also hope to establish preliminary efficacy that 
the program improves physical function and other study 
outcomes we describe in sections below. We will use qualitative 
data to optimize the intervention and study procedures for future 
trials. See Figure 2 for aim 2 study schema.  
 
 
Enrollment 
1.
Referrals: clinic staff from 
MGH-RHC 
2.
In-clinic approaches: study 
staff from MGH-CHOIR 
3.
Flyers: RHC patients self-
select and screen
Baseline 
1.
Performance based physical 
function (6-minute walk test) 
2.
Objective physical function 
(Accelerometer step count) 
3.
Self-report physical function 
and other outcomes
GetActive+ Program
Post-Program Assessments 
1.
Performance based physical 
function (6-minute walk test) 
2.
Objective physical function 
(Accelerometer step count) 
3.
Self-report physical function 
and other outcomes
Participant Exit Interviews 
*Total number of patient participants (up to N=50)
Figure 2. Aim 2 Study Schema

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 5 of 24 
3. 
General Description of Study Design 
 
We will conduct an open pilot trial of the GetActive+ program followed by individual qualitative 
exit interviews. We plan to conduct 3-6 groups of approximately 5-10 participants each (up to 
N=50). At least one of the 3-6 groups will be offered in Spanish and led by a fully trained 
Spanish speaking social worker and member of study staff. The goal of this phase will be to 
establish feasibility (primary), acceptability, and fidelity of the GetActive+ program and study 
procedures. We will also explore improvements in study outcomes. We will recruit English and 
Spanish speaking older adults (55+) with chronic pain currently receiving medical care from 
RHC. Recruitment will be facilitated through posted IRB approved flyers, in-clinic approaches 
made by study staff, and referrals from RHC physicians, nurses, psychologists and other relevant 
staff (see section 4). These recruitment strategies are informed by recommendations from RHC 
staff and are supported by xxxxxxxxxxxxxxxxxxx. If patients indicate interest in participating, 
they will be guided through eligibility screening by study staff (see section 4). After screening, 
interested patients will discuss their availability for a baseline visit and the 10-week GetActive+ 
program. A Research Assistant (RA) will keep track of potential participant preferences with 
regard to the days and times for intervention delivery and in person versus remote participation. 
The number of participants per group will vary based on availability, while typically ranging 
between 3 and 10. At the subsequent in person baseline assessment, patients will provide their 
informed consent in the presence of study staff and complete all assessments. They will also pick 
up their ActiGraph watch to wear for 7-10 days (see section 6). They will later return their 
ActiGraph either in person or in the mail via pre-paid envelop. These same procedures will be 
followed for Spanish speaking patients. All Spanish speaking patient interactions will be 
conducted by a native Spanish speaking RA. Additionally, all study materials have either already 
been translated and validated or will be translated into Spanish by a translation service or a 
native Spanish-speaking researcher. 
 
The 10-week GetActive+ program will be conducted either in-person or via Zoom and led by a 
fully trained member of study staff. Spanish speaking groups will follow the same structure and 
will be led by a fully trained native Spanish speaking member of study staff. In the event that 
group sessions are conducted virtually, we will use an MGB Zoom account. Zoom specifically 
states that their software is equipped to keep information secure, and the software does not have 
access to identifiable information. Zoom is HIPPA compliant, MGB approved, and the current 
video software standard for patient care within our Department of Psychiatry. Participants will be 
encouraged to attend as many group sessions as possible and complete their home practice 
assignments between sessions. Participants who can’t attend the group sessions will be offered 
make-up sessions. Throughout these ten weeks, the RA will send participants daily reminders via 
text message to practice program skills, log home practice, and attend the sessions (contingent on 
their consent to receive such text messages). These text messages will be sent using Twilio, 
which will be integrated with our REDCap database. Participants will have the option to attend a 
5-10 minute 1-on-1 medical check-in with the nurse practitioner before or after each group 
session. Within 3 days after the last group session, participants will complete the in person post-
program assessments and pick up their ActiGraph to wear for the next 7-10 days (see section 6). 
They will return the ActiGraph in person or via a pre-paid envelope. 
 
 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 6 of 24 
 
4. 
Subject Selection 
 
Recruitment for potential open pilot participants (i.e., RHC patients) will be facilitated through 
1) IRB approved flyers, 2) RHC provider referrals, and 3) in-clinic approaches made by study 
staff (see bullet points below).  
1. IRB Approved Flyers: Patients who find the flyer will be able to indicate their interest 
and provide their contact information by accessing the REDCap link provided on the 
flyer. Study staff will then follow up over the phone with the patients to discuss the study 
in more detail and schedule an in-person screening visit. Alternatively, patients may have 
the option to complete screening over the phone with the RA. 
2. IRB Approved Rally Post: Patients who find our study via Rally will be able to indicate 
their interest on the platform. An RA will follow up with all inquiries over the phone. 
Once contact has been made, the RA will discuss the study with interested participants 
and either schedule an in-person screening visit or conduct screening virtually over the 
phone. 
3. RHC Provider Referrals: Patients who receive referrals for the study from their provider 
or medical interpreter will either self-screen via the link provided on the flyer, be guided 
through screening at RHC by study staff or be contacted directly via phone call by study 
staff. Only patients who give their medical provider verbal consent to be called by study 
staff will be contacted. It will be clearly communicated to medical providers at RHC that 
they should confirm with their patients that they would like to be contacted by study staff 
prior to giving referrals. In all cases a baseline in person visit will be conducted with 
those participants who screen in.  
4. In-Clinic Approaches by Study Staff: An RA will facilitate patient recruitment via in-
clinic approaches. These approaches will ideally be informed through precursory 
eligibility assessments made by the RA based on the patient’s medical record. If time 
restrictions do not allow for precursory eligibility assessments, the RA will consult RHC 
staff regarding their patient recommendations. The trained RA will then approach the 
patient and ask if they can introduce the study and answer any related questions. If 
patients indicate they are interested in participating, they will be guided through 
eligibility screening with the RA in person at RHC, or later on over the phone if the 
participant expresses interest but cannot be screened at that time. A baseline visit will be 
conducted in person. 
At the conclusion of all screenings, the RA will gather patient availability for the in-person 
baseline assessment and the 10-week GetActive+ program and email, mail or hand a copy of the 
informed consent form to participants. This will allow potential participants ample time to 
review the consent form prior to the baseline visit. All patients will be instructed not to sign it 
until they undergo formal consent at the in person visit. The recruitment strategies described 
above are informed by recommendations from RHC staff and are supported by xxxxxxxxxxxxx. 
Patients who choose to provide their consent will do so electronically (i.e., eConsent) in the 
presence of the research assistant to ensure that all questions or concerns associated with 
participation are answered. Consent will be collected via REDCap, a validated password-
protected signature platform approved by MGB. They will receive a signed paper or digital copy 
of the informed consent form. All participants will be notified that their participation in the 
following open pilot is voluntary and that they are able to withdraw at any time. All study 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 7 of 24 
participants who are deemed not eligible after screening will be offered a chronic pain resource 
sheet to provide them with additional pain management resources (email or paper copy). 
Recruitment procedures for Spanish speaking patients will be identical. All screening for 
Spanish-speaking patients will be completed with a native Spanish speaking RA. The described 
methodology has been used successfully by Dr. Vranceanu in other behavioral health studies 
(P#: 2021P002811; P#: 2020P000095). Per MGB policies on email communication, we will be 
using secure email to communicate with participants. This will be done using the “SEND 
SECURE” encryption function. To further protect participants’ confidentiality, we will 
discourage participants from communicating with study staff by non-secure email.  
 
After all group sessions and study assessments have finished, we will create a recruitment 
video that contains clips of participants speaking briefly to their experience in our groups. 
Submitting video clips for this recruitment project will be entirely optional, and participants will 
be informed that the final video will be included in promotional materials for the study. The 
names or any identifying information for the participants in the video will not be released. All 
participants will be given the opportunity to contribute a clip to the recruitment video. 
Participants will be shown their contribution to the video and required to provide written 
permission by email or paper for the video to be used for recruitment purposes, as described 
above. We have used this methodology successfully in prior studies (Protocol #2017P000143 
and #2022P001766) for creation of a recruitment video, and we found it to work very well with 
no issue. Participants will also be given the option to submit a group photo for recruitment 
purposes. All individuals in the photo will also sign the photo release consent form. 
 
 
Inclusion Criteria: 
1. Older Adults (i.e., age >=55, since aging is accelerated by impoverished lifestyles43) 
2. Has diagnosed musculoskeletal chronic pain of any type (e.g., pain duration > 3 months)  
3. Pain score >=4 (moderate) on the Numerical Rating Scale 
4. Cognitively able to participate as measured by the Short Portable Mental Health 
questionnaires (e.g., <4 errors) 
5. No self-reported current active, untreated psychotic or substance use disorder that would 
interfere with participation in the research study  
6. Self-reported ability to complete the 6-minute walk test  
7. Patient at RHC who is cleared for participation by medical staff 
8. English or Spanish fluency.   
 
Exclusion Criteria: 
1. Current serious medical illness that is expected to worsen in the next 6 months (e.g., 
cancer) 
2. Individuals who are unwilling or unable to wear the ActiGraph device 
 
5. 
Subject Enrollment 
 
Potential participants will be informed about the study through one of the methods described 
above (e.g., flyer, provider-including medical interpreters-referral, or via research assistant in the 
clinic). Participants will complete eligibility screening following any one of the procedures 
described in section 4. Only after having ample time to review the consent form will the RA 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 8 of 24 
officially guide patients through written informed consent to take part in the research study. 
Patients who choose to provide their consent will do so electronically (i.e., REDCap eConsent) 
in the presence of the RA to ensure that all questions or concerns associated with participation 
are answered. The RA will track participants’ preferences with regard to the days and times for 
intervention delivery and in-person versus Zoom participation. The number of people per group 
will vary based on participant availability with an expected range between 3 and 10 participants. 
Once a group is formed and no more than 2 weeks before the first group visit, the RA will 
schedule an in person visit to conduct informed consent and baseline assessments (see section 6). 
At this visit patients will receive an ActiGraph watch to wear for 7-10 days, and instructions on 
how to wear it.   
All participants must be capable of understanding the nature of this study as well as the risks and 
potential benefits. All potential participants will have ample time and opportunity to ask questions 
or clarify concerns in person (if screened with research assistant) or over email or phone (if 
screened remotely over REDCap).   
All stages of the study will be detailed, including the risks and benefits of the study. No 
information will be withheld from prospective or active participants regarding the study design. 
The participant will be reminded that they may decline to participate in this study, and they may 
discontinue study participation at any time. In this case, a participant will be asked their 
reason(s) for discontinuation, which may provide valuable feedback for improving future 
recruitment, retention, or study procedures. 
 
 
6. 
STUDY PROCEDURES 
 
Once group times have been set, the RA will meet with participants individually over the phone 
to schedule a visit to review and sign informed consent, answer any remaining questions, 
complete the baseline assessments, and distribute program manuals. The RA will supervise the 
participants as they complete all baseline assessments, providing assistance when needed. 
Additionally, these participants will receive the program manual and an ActiGraph device to 
wear for the next 7-10 days with instructions on how to use it. Only participants who have 
consented and enrolled in the study will complete the baseline assessment. Assessments include 
sociodemographic surveys (e.g., age, race, ethnicity, etc.), clinical information surveys (pain 
diagnoses, duration, concurrent medical and psychological treatment, narcotic intake), self-report 
psychosocial measures (physical function, cognitive function, pain intensity, depression, anxiety, 
coping, pain catastrophizing, mindfulness, fear of pain, gratitude, compassion), and performance 
based physical function measurements (e.g., 6-minute walk test) and objective physical function, 
(activity level over 7-day period via ActiGraph).  See Table 2 for a full list of study measures. 
Following the completion of the baseline questionnaires, participants will be provided with and 
directed to wear an ActiGraph watch which will measure their activity over the next 7-days. 
After 7-days of valid wear time, participants will return their ActiGraph in their first group 
session (for in person visits) or mail it in a pre-paid envelope (for zoom visits). Additionally, 
prior to their first session, all participants will receive a program manual and access to a web 
platform to support skill practice. 
 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 9 of 24 
Table 2. Aim 2 Open Pilot Measures 
Domain 
Measurement Tool and Schedule  
Demographic 
Age/birth date; gender; biological sex; race/ethnicity; education level; 
employment status; marital status; household income; disability status; 
language fluency; people and/or children in the household; RUCA code 
(i.e., zip code); country of birth; country lived in prior to age 12; years 
lived in the US, parents’ countries of origin; ethnic identity; languages 
spoken at home; assessment of English fluency. Pre 
Clinical 
Type of pain; pain location and number; pain treatments; pain 
medications; cannabis use for pain; medical comorbidities; mental 
health conditions and medications. Pre and post, when applicable (chart 
review and self-report: pain, medication, and medical history 
questionnaire) 
 
Tobacco, Alcohol, Prescription medications, and other Substance 
(TAPS)44; assess substance use behaviors. Pre, post 
 
Other 
The Everyday Discrimination Scale – Short (EDS-S)45; assesses 
experiences of daily discrimination against minority populations. Pre, post 
 
PROMIS Sleep Disturbance – Short Form 6a v1.0; assesses duration and 
quality of sleep. Pre, post 
 
The Pittsburgh Sleep Quality Index (PSQI)5446; assesses sleep quality. 
Using single item from this scale to assess sleep duration. Pre, post 
Quota-based pacing questionnaire – assesses ability to engage in 
meaningful activities and increase activity level gradually. Weekly 
 
 
Multimodal physical function 
PROMIS Physical Function – Short Form 6b v2.0; assesses one’s ability 
to carry out activities that require physical actions, ranging from self-care to 
social and work. Pre, post 
 
ActiGraph GT3X-BT; watch with blank screen that assesses average step 
count. Pre, post 
 
Six-minute walk test (6MWT) – assesses distance walked in 6 minutes. Pre, 
post 
 
Emotional function 
Generalized Anxiety Disorder – 7 (GAD)47; 7-item measure of anxiety 
symptoms. Pre, post 
 
Patient Health Questionnaire – 8 (PHQ)48; 8-item measure of depressive 
symptoms. Pre, post 
 
Perceived Stress Scale (PSS-4)49; assesses stress perception levels. Pre, 
post 
 
The Post-Traumatic Checklist – 6 (PCL-C)50; assess current Post 
Traumatic Stress Disorder symptoms. Pre, post 
 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 10 of 24 
Contrast Avoidance Questionnaire – Shortened (CAQ-S)51; a measure of 
sustaining negative emotionality to protect against sudden shifts in emotion. 
Pre, post 
 
Pain intensity 
Brief Pain Inventory (intensity and interference) – Short Form (BPI); 
measures pain at its “worst,” “least,” “average,” and “now”. Pre, post  
 
Patient Global Impression of Change (PGIC)52, 53; measures fluctuations 
in pain. Post 
 
Nonadaptive pain reactions 
 
 
Pain Catastrophizing Scale (PCS)54; assesses magnification, helplessness, 
and rumination about pain. Pre, Post 
The Pain, Enjoyment of Life, and General Activity Scale (PEG)55; brief 
measure of a participant’s self-reported pain intensity and pain interference. 
Pre, post 
 
Tampa Kinesiophobia Scale (TSK)56; assesses fear of pain and activities 
that cause pain. Pre, Post 
 
Loneliness 
UCLA-3 Loneliness Scale; assesses loneliness in relational connectedness, 
social connectedness and self-perceived isolation dimensions. Pre, post  
Social support  
Interpersonal Support Evaluation List (ISEL-12)57; assesses perceived 
availability to potential social resources. Pre, post 
Adaptive coping 
Self-Compassion Scale – Short Form (SCS-SF)58; assesses participants’ 
capacity for self-compassion. Pre, post 
 
Gratitude Questionnaire (GQ-6)59 assesses individual differences in the 
proneness to experience gratitude in daily life. Pre, post 
 
Applied Mindfulness Process Scale (AMPS)60; assesses how participants’ 
use mindfulness when facing challenges in daily life. Pre, post 
 
Cognitive and Affective Mindfulness Scale – Revised (CAMS-R)61; 
measures mindfulness and the degree to which respondents’ experience 
thoughts and feelings. Pre, post 
 
Measure of Current Status (MOCS)62; assesses current self-perceived 
status on the ability to relax at will, recognize stress-inducing situations, 
restructure maladaptive thoughts, be assertive about needs, and choose 
appropriate coping responses as needed. Pre, post   
 
 
The GetActive+ program will be conducted either virtually or in person (depending on patients’ 
preferences) by trained staff (psychologist or nurse practitioner, or both depending on 
availability) over the course of 10 weekly sessions. It is important that all eligible patients be 
able to participate should they choose to enroll. Thus, participants that wish to attend virtually 
but do not have the appropriate technology will be provided with a smart device, the type of 
which will be dependent on study funds and device availability. Prior to or directly after each 
session, participants will have the option to attend a 5-10 minute 1-on-1 medical check-in with 
the nurse practitioner. The purpose of these check-ins is to ensure that participants feel 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 11 of 24 
physically safe and comfortable with the activity-based component of the program throughout 
the duration of their participation. Each of the 10 sessions will last approximately 60-minutes. 
Group sizes will be approximately 3-10 participants, however, this may be subject to change 
depending on the rate of attrition. Currently, we estimate approximately 20% attrition with the 
understanding that participant retention for this population might be less than what was observed 
in prior trials with GetActive. The interventionist will be trained by Dr. Vranceanu and 
Greenberg and supervised weekly. 
 
The GetActive + program used in the open pilot, will incorporate mind-body skills, cognitive 
behavioral and physical restoration skills (e.g., quota-based pacing) to help individuals increase 
self-reported, performance based and objective (step count) physical function. This program will 
teach participants four core skills: 1) weekly goal setting for gradual increase in time spent 
walking paired with activities of daily living that are meaningful and important to participants 
(i.e. walk instead of drive to the store; walk to the park with kids) 2) quota-based pacing 
(increasing walking goal gradually non-contingent of pain); 3) mind-body skills (e.g., 
diaphragmatic breathing to manage intense pain flares and pain anxiety; body scan to increase 
body awareness and reduce reactivity to pain sensations; mindfulness exercises to understand the 
transience of pain and change one’s relationship with it; self-compassion when falling short of 
set goals); and 4) understanding the disability spiral (e.g. how reducing activity perpetuates pain 
and disability), correcting myths about pain or automatic pain-related thoughts that interfere with 
meeting program goals. Throughout the 10-week program, participants will be encouraged to 
increase their time spent walking each week. As in prior mind-body and activity studies, the RA 
will determine a new walking goal weekly based on whether the open pilot participant met their 
walking goal in the prior week. Each week participants will increase their activity goal by 10%-
20% if they met their prior goal, maintain the same goal if they did not meet it, or decrease the 
goal by 10%-20% if they did not meet their goal for 2 consecutive weeks. Any risks due to 
walking will be controlled and monitored by the clinician during the first 20 minutes of each 
session. The clinician will do so by discussing with each participant how walking went in the 
week prior, troubleshooting any barriers to walking safely, and coming up with an individualized 
walking plan for the coming week. Participants will have the opportunity to provide informal 
feedback on the manual and content throughout the study. 
 
Participants will be encouraged to complete their homework (logs for mind-body practice, 
physical activities) each day. Participants will be given the option to receive homework and 
session reminders via text messages from study staff. This between-session contact will focus on 
increasing treatment adherence, maintaining engagement, and session reminders. Specifically, 
Twilio will be used to send session reminders, reminders to practice program skills, and for links 
to home practice surveys using a standardized protocol. Twilio is an MGH-approved smartphone 
app that participants will have the option to consent to using. Text messages will be sent once or 
twice a week for the duration of the study, for participants who expressed interest in receiving 
text messages. Participants may opt-out of text message reminders at any point. See Table 3 for 
details of each program session. 
Table 3. Session Content for GetActive+ 
Session 
Topic 
Skills 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 12 of 24 
Session 1 
Live Well with Pain 
Deep breathing 
Session 2 
Outsmarting the Pain 
Catching unhelpful thoughts, quota-
based pacing
Session 3 
Becoming Away 
Mindfulness, body scan 
Session 4 
Staying Engaged with your Life 
Mindful walking, meaningful activities 
Session 5 
Working with Unhelpful Thoughts  
Identifying and challenging Negative 
Automatic Thoughts (NATs)
Session 6 
Staying in the Upward Spiral 
Skill review 
Session 7 
Caring for Yourself When in Pain 
Self-compassion, mindfulness of pain 
Session 8 
Feeling Connected with Others 
Social connectedness, reducing 
loneliness
Session 9 
Promoting Acceptance 
Acceptance 
Session 10 
Staying on Track and Maintaining 
Your Progress
Maintenance skills 
 
All participants will wear ActiGraph devices to monitor activity levels for 7-10 days after their 
baseline assessment and post-intervention assessment. Following the baseline assessment period, 
participants will return the ActiGraph device either in person at their first group session or mail 
the device back to study staff if they will be attending group sessions virtually. The post-
intervention assessments will be scheduled to take place approximately 3 days after the last 
group session (e.g., Session 10). Participants will receive their ActiGraph device and wear it for 
the following 7-10 days. Participants will return their ActiGraphs via pre-paid envelopes 
provided by study staff. Participants will also be given the option to share contact information 
with the other group members following the post-program assessments. This is an optional 
procedure for those interested in staying in touch following group sessions. 
Only trained study staff will have access to the data collected at baseline and post-program. 
Participants’ data will be identified by an ID number only, and a link between names and ID 
numbers will be password-protected and kept separately. The information on the ActiGraph 
accounts will be password protected and only the study staff and patient will have access to that 
information. Training sessions will be audio-recorded and reviewed to ensure fidelity. All group 
sessions will be audio-recorded. Recordings will be used for weekly clinical supervision (e.g., 
problem solve challenging cases), and to assess study therapist’s competency and fidelity to the 
content of each session. All study staff will have up to date Collaborative Institutional Training 
Initiative (CITI) certifications. All study procedures will be conducted using our published 
methodology. 
 
Following the conclusion of the program, patients will have the option to participate in an exit 
interview. These interviews will be conducted utilizing procedures outlined by Krueger63, 64 and 
guided by a semi-structured IRB approved interview guide. The goal of these interviews will be 
to understand the experiences of participants and garner feedback on the program. This feedback 
will eventually be used to further optimize the GetActive+ program for use in future studies. 
Participants will be able to choose whether they would like to attend the exit interview in person 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 13 of 24 
or remotely (i.e., over Zoom). In the event that exit interviews are conducted virtually, we will 
use an MGB Zoom account. Zoom specifically states that their software is equipped to keep 
information secure, and the software does not have access to identifiable information. Zoom is 
HIPPA compliant, MGB approved, and the current video software standard for patient care 
within our Department of Psychiatry. We will audio record the focus groups with consent from 
participants using MGB encrypted devices. We will transcribe recordings after each group and 
use these transcriptions to conduct qualitative analyses. No PHI will be included in the 
transcriptions. Outcomes will be used to guide subsequent manual adaptations and protocol, 
training, and fidelity procedures for the GetActive+ program. 
 
At the end of study enrollment (e.g., no longer recruiting/enrolling participants or conducting 
follow-ups with participants), we will conduct open-ended focus group or individual interviews 
with up to 20 participants who have completed the study. These group or individual interviews 
will be used to inform the future development of the program and to understand ways to better 
teach session content to increase understanding and engagement. Participants will be selected 
based on clinician perception on improvement and benefit and ability to engage in the material in 
a meaningful way. Interested participants will verbally consent after receiving a study fact sheet. 
Since we will be pulling from individuals who previously enrolled, we will only be re-consenting 
individual who choose to participate. We will contact participants via phone to gauge interest in 
participating, and the focus groups or individual interviews will be conducted in-person for up 60 
minutes. We will be compensating participants an additional $40 for their participation. 
 
Our primary outcomes for the open pilot will be the feasibility, acceptability, and fidelity of the 
GetActive+ program. Preliminary effectiveness outcomes will also be examined (e.g., 
multimodal physical function (self-report, 6-minute walk test and activity level measured via 
ActiGraph) and emotional function (depression and anxiety).  
 
Participants will be compensated $60 for completing the baseline visit and up to $100 for the 7–
10-day baseline ActiGraph assessment (e.g., $10 per day up to 7-days; additional $30 for 7 days 
of complete and valid data). Participants will also receive up to $150 worth of travel 
compensation (e.g., if sessions are in person, $15 per session for 10 sessions). If participants 
attend group sessions virtually, they will not be subject to the compensation associated with 
transportation. To incentivize long-term engagement with the program, participants will receive 
a $50 bonus for attending at least 8 of the 10 sessions. Participants will also receive $100 for the 
completion of the post-program assessments and up to $155 for the post-program ActiGraph data 
collection period (e.g., $15 per day up to 7-days; additional $50 provided for 7 days of complete 
and valid data). In addition to all the above, participants will be given the opportunity to earn $40 
for attending an in-person post-program exit interview ($25 for remote exit interviews). Select 
participants (based on randomization and interest) can also receive $40 for an additional focus 
group. Payments will be submitted and sent to participants following each major time point (i.e., 
baseline, final group session, and post-program exit interview). Overall, participants of the open 
pilot will earn up to $695.  
 
All study procedures for Spanish speaking groups will be identical to English groups. Participant 
interactions will be in Spanish through a native Spanish speaking RA and group facilitator (i.e., a 
native Spanish-speaking social worker). Spanish speaking study staff will be fully trained in the 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 14 of 24 
GetActive+ intervention and study procedures. All study materials are translated and spot check 
by a Spanish speaking RA.  
 
7. 
Risks and Discomforts 
 
Potential Risks & Protections Against Risks 
We anticipate minimal risk to subjects due to their participation in this study; however, some 
risks are associated with conducting the study. Potential risks are: (a) loss of confidentiality and 
(b) potential feelings of distress while completing assessments or participating in the open pilot. 
Participants may find it inconvenient to participate in the open pilot. Additionally, participants 
may experience muscle soreness as they increase walking, and this will be discussed, as part of 
the program, as normal. Following a quota-based pacing regimen will also help minimize this 
risk because activity will be increased gradually. All participants will be cleared for participation 
by their medical doctor. There is no risk associated with wearing the ActiGraph other than 
possible inconvenience. Special attention will be paid to the fact that we are asking older adults 
to walk. We will ensure that we help identify appropriate spaces to walk, use the Buddy system 
when applicable (older adults walk with friends or family), and monitor any side effects (e.g., 
injuries, falls) (See section 6). 
Loss of confidentiality 
A potential risk is the loss of confidentiality. In order to protect confidentiality, data will be 
identified only by subject codes, with all identifying information removed. The identity of 
patients will not be revealed in the presentation or publication of any results from the project. All 
study personnel will be educated about the importance of strictly respecting patients’ rights to 
confidentiality and will fulfill the required HIPAA training. This study will be conducted in 
compliance with HIPAA and IRB guidelines on privacy and confidentiality in order to strictly 
respect and safeguard participants’ confidentiality. All identifying data will be stored in locked 
or password protected files only accessible by study staff. All research data will be identified 
only by subject codes and identifying information will be removed. The code key connecting IDs 
to identifying information will be kept in a separate, secure and password protected location. 
Data in databases will be similarly identified only by coded ID number and will be stored in  
password protected drives and devices. We have extensive experience in strictly respecting 
patients’ rights and maintaining confidentiality and do not anticipate any breach of 
confidentiality occurring during the present proposal. Participants will be informed about these 
risks and told that they may withdraw from the study and have their data removed from the study 
database at any time. 
Experiences of distress while completing assessments  
Throughout the course of the open pilot, it is possible that participants experience distress during 
group visits and/or home practice. In the unlikely event that a participant is determined to be in 
distress or actively suicidal and at risk for self-harm during any study procedure study staff will 
intervene. We will use a standardized protocol for assessing and monitoring risk developed by 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 15 of 24 
Dr. Vranceanu that has been successfully used in other trials. Alternatively, in event that 
suicidality is determined during one of the open pilot group sessions, the study clinicians will 
contact the PI immediately. We are hoping to avoid this scenario by excluding patients after 
screening who endorse suicidality or who have untreated severe mental health conditions that 
would require a higher level of care. We do not expect this unlikely event to occur, as there have 
been so such occurrences in our previous studies.  
It is also important to note that participation this study does not involve treatment or diagnosis. 
However, it is possible that we may detect previously unknown problems during the open pilot 
group sessions or from the assessments. If any potential abnormality or medical problem is 
detected during the course of the study, the participant will be provided with an appropriate 
referral for medical follow-up. There is some risk of distress associated with the detection of a 
potential abnormality or medical problem. 
Some participants may feel uncomfortable about the exit interviews being taped and transcribed. 
However, participation in exit interview will be optional.  The purpose of the taping will be 
explained, confidentiality will be maintained, and verbal consent for taping will be obtained. 
 
8. 
Benefits 
Potential Benefits to Participants 
During the open pilot (e.g., aim 2), we expect that participants may experience benefits including 
improvement in physical (self-report, performance, and objective) and emotional (depression and 
anxiety) function, increases in coping ability, and decrease in catastrophizing and fear of pain. 
These participants are also expected to benefit from the support of the therapist and group 
members. The knowledge gained from the research will benefit others by answering questions 
regarding effective nonpharmacological strategies to provide treatment for chronic pain in this 
population. Interested participants may also be sent a copy of publications from the open pilot 
once available.  The risks to subjects are reasonable in relation to the anticipated benefits to 
research participants and others. The risks for participation in both the intervention and 
assessments are minimal, while the potential benefits are substantial. 
 
Potential Benefits to Society 
Our goal is to learn more about the feasibility, acceptability, and fidelity of implementing a 
group medical visit program in the primary care setting for older adults with chronic pain in 
underserved communities. We believe that the open pilot will provide insight into what 
individual, provider, community and environmental/systemic changes are possible and which of 
these changes may best support treatment for chronic pain in older, ethnically diverse adults. 
Chronic pain is prevalent and costly, particularly among underserved minority groups. Current 
standards for psychosocial interventions have several limitations including underwhelming 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 16 of 24 
improvements in pain outcomes, in particular performance based and ambulatory activity (step 
count). As previously mentioned, the open pilot will enable us to establish the feasibility, 
acceptability, and fidelity of GetActive+ program and study procedures. We will use this 
knowledge to further optimize the program in preparation for the R33 phase of this project as 
well as future studies and may ultimately help researchers and clinicians better care for patients 
with chronic pain. 
 
9. 
Statistical Analysis 
Aim 2 open pilot data analysis will be conducted with the primary goal of establishing feasibility 
as opposed to powering for specific effects for the quantitative outcomes. We propose a priori 
benchmarks for feasibility, acceptability and fidelity based upon our prior research and 
recommendations in the field (see Table 4). Since this pilot study was powered for establishing 
feasibility, we will assess preliminary efficacy by testing for signals of improvement in our 
secondary outcomes. We will first examine the distribution and normality of the data through a 
combination of histograms and the Shapiro-Willks test, and then conduct pre-post comparisons 
using paired t-tests or the 
Wilcoxon signed rank test as 
the non-parametric 
equivalent. Cohen’s d effect 
sizes will be interpreted 
using the following pilot-
recommended guidelines: 
small (Cohen’s d = 0.2), 
medium (Cohen’s d = 0.5), 
and large (Cohen’s d = 0.8). 
For outcomes analyzed with 
the Wilcoxon signed rank 
test, we will calculate effect 
size via the equation r=Z/√N. 
Effect sizes will be interpreted using values commonly published in the literature for non-
parametric measures: small (r=0.10 - <0.3), moderate (r=0.30 - <0.5) and large (r ≥ 0.5). SPSS 
Version 28 will be used for all quantitative analyses.  
We will utilize rapid data analysis (RDA) to analyze the exit interview data. We will review each 
transcript in the 24 hours after the interview and then create an RDA matrix to better synthesize 
responses and inform manual revisions. The matrix format will be synthesized using a deductive 
approach based on the domains outlined in the guide: Domain 1: The GetActive+ Program, 
Domain 2: GetActive+ Skills, Domain 3: Clinician and Nurse Practitioner, Domain 4: 
Assessments, Domain 5: Group Session Modality, Domain 6: Home Practice, Domain 7: 
Individualized Barriers and Facilitators. Our team has used these methods is prior work in 
community clinics which gives confidence that these procedures are feasible and effective in 
detecting nuanced aspects of program and protocol adaptation to inform subsequent 
implementation of the proposed changes. 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 17 of 24 
 
10.   Monitoring and Quality Assurance 
Data Monitoring 
The MPIs (Drs. Vranceanu and Ritchie) will have overall responsibility for monitoring the 
integrity of study data and participant safety 
A number of procedures are in place to assure data integrity and protocol adherence. The MPIs 
will oversee management of the study database. In order to ensure confidentiality, data will be 
identified only by subject number and date of visit. By recording the study data in this manner, 
the information can be considered ‘de-identified’ and therefore compliant with the Standards for 
Privacy of Individually Identifiable Health Information (“Privacy Rule”) of the Health Insurance 
Portability Act of 1996 (HIPAA). Any data that is transmitted electronically will be fully 
encrypted and password protected. Subjects’ names will not be entered into any database; each 
will be uniquely identified only by an ID number. Hardcopy data will be kept and filed in locked 
office cabinets. We will not store identifiable participant data for those who do not enroll. 
Safety Monitoring 
The MPIs and study staff will be responsible for monitoring patient safety throughout the 
duration of the study. All participants will be instructed on how to contact study clinicians with 
any questions regarding their safety in the study.  
11.  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 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 18 of 24 
☒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 
 
12.   References 
 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 19 of 24 
1. Bennett MI, Kaasa S, Barke A, et al. The IASP classification of chronic pain for ICD-11: 
chronic cancer-related pain. Pain. 2019;160(1):38-44. 
doi:10.1097/j.pain.0000000000001363 
 
2. Molton IR, Terrill AL. Overview of persistent pain in older adults. Am Psychol. 
2014;69(2):197-207. doi:10.1037/a0035794 
 
3. Sun M, Yu B, Zhang X, et al. Trends in Multimorbidity of Multiple Noncommunicable 
Diseases Among Adults in the United States, 1999-2016. SSRN Electronic Journal. 
Published online 2019. doi:10.2139/ssrn.3433889 
 
4. Gaskin DJ, Richard P. The Economic Costs of Pain in the United States. National 
Academies Press (US); 2011. Accessed December 1, 2021. 
https://www.ncbi.nlm.nih.gov/books/NBK92521/ 
 
5. Eggermont LHP, Leveille SG, Shi L, et al. Pain characteristics associated with the onset 
of disability in older adults: the maintenance of balance, independent living, intellect, and 
zest in the Elderly Boston Study. J Am Geriatr Soc. 2014;62(6):1007-1016. 
doi:10.1111/jgs.12848 
 
6. Zis P, Daskalaki A, Bountouni I, Sykioti P, Varrassi G, Paladini A. Depression and 
chronic pain in the elderly: links and management challenges. Clin Interv Aging. 
2017;12:709-720. doi:10.2147/CIA.S113576 
 
7. Karttunen N, Lihavainen K, Sipilä S, Rantanen T, Sulkava R, Hartikainen S. 
Musculoskeletal pain and use of analgesics in relation to mobility limitation among 
community-dwelling persons aged 75 years and older. Eur J Pain. 2012;16(1):140-149. 
doi:10.1016/j.ejpain.2011.05.013 
 
8. Chronic Musculoskeletal Pain and the Occurrence of Falls in an Older Population | 
Geriatrics | JAMA | JAMA Network. Accessed November 29, 2021. 
https://jamanetwork.com/journals/jama/fullarticle/184945 
 
9. Ling SM, Fried LP, Garrett ES, Fan MY, Rantanen T, Bathon JM. Knee osteoarthritis 
compromises early mobility function: The Women’s Health and Aging Study II. J 
Rheumatol. 2003;30(1):114-120. 
 
10. Green CR, Anderson KO, Baker TA, et al. The unequal burden of pain: confronting racial 
and ethnic disparities in pain. Pain Med. 2003;4(3):277-294. doi:10.1046/j.1526-
4637.2003.03034.x 
 
11. Craig KD, Holmes C, Hudspith M, et al. Pain in persons who are marginalized by social 
conditions. Pain. 2020;161(2):261-265. doi:10.1097/j.pain.0000000000001719 
 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 20 of 24 
12. Cravello L, Di Santo S, Varrassi G, et al. Chronic Pain in the Elderly with Cognitive 
Decline: A Narrative Review. Pain Ther. 2019;8(1):53-65. doi:10.1007/s40122-019-
0111-7 
 
13. Knight R, Khondoker M, Magill N, Stewart R, Landau S. A Systematic Review and 
Meta-Analysis of the Effectiveness of Acetylcholinesterase Inhibitors and Memantine in 
Treating the Cognitive Symptoms of Dementia. Dement Geriatr Cogn Disord. 
2018;45(3-4):131-151. doi:10.1159/000486546 
14. Yoshikawa A, Ramirez G, Smith ML, et al. Opioid Use and the Risk of Falls, Fall 
Injuries and Fractures among Older Adults: A Systematic Review and Meta-Analysis. J 
Gerontol A Biol Sci Med Sci. 2020;75(10):1989-1995. doi:10.1093/gerona/glaa038 
 
15. Wright RM, Roumani YF, Boudreau R, et al. Effect of central nervous system medication 
use on decline in cognition in community-dwelling older adults: findings from the 
Health, Aging And Body Composition Study. J Am Geriatr Soc. 2009;57(2):243-250. 
doi:10.1111/j.1532-5415.2008.02127.x 
 
16. Veehof MM, Oskam MJ, Schreurs KMG, Bohlmeijer ET. Acceptance-based 
interventions for the treatment of chronic pain: a systematic review and meta-analysis. 
Pain. 2011;152(3):533-542. doi:10.1016/j.pain.2010.11.002 
 
17. Jackson W, Zale EL, Berman SJ, et al. Physical functioning and mindfulness skills 
training in chronic pain: a systematic review. J Pain Res. 2019;12:179-189. 
doi:10.2147/JPR.S172733 
 
18. Niknejad B, Bolier R, Henderson CR, et al. Association Between Psychological 
Interventions and Chronic Pain Outcomes in Older Adults. JAMA Intern Med. 
2018;178(6):830-839. doi:10.1001/jamainternmed.2018.0756 
 
19. Zivin K, Miller BF, Finke B, et al. Behavioral Health and the Comprehensive Primary 
Care (CPC) Initiative: findings from the 2014 CPC behavioral health survey. BMC 
Health Serv Res. 2017;17(1):612. doi:10.1186/s12913-017-2562-z 
 
20. Gleicher Y, Croxford R, Hochman J, Hawker G. A prospective study of mental health 
care for comorbid depressed mood in older adults with painful osteoarthritis. BMC 
Psychiatry. 2011;11:147. doi:10.1186/1471-244X-11-147 
 
21. Paez KA, Zhao L, Hwang W. Rising out-of-pocket spending for chronic conditions: a 
ten-year trend. Health Aff (Millwood). 2009;28(1):15-25. doi:10.1377/hlthaff.28.1.15 
 
22. Soh ED, Portanova J. Chronic Noncancer Pain Management: Systemic Inequities of 
Access. J Gerontol Nurs. 2017;43(10):4-6. doi:10.3928/00989134-20170914-01 
 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 21 of 24 
23. Lagisetty P, Slat S, Thomas J, Macleod C, Golmirzaie G, Bohnert AS. Access to 
Multimodal Pain Management for Patients with Chronic Pain: an Audit Study. J Gen 
Intern Med. 2021;36(3):818-820. doi:10.1007/s11606-020-05866-3 
 
24. Ritchie CS, Garrett SB, Thompson N, Miaskowski C. Unintended Consequences of 
Opioid Regulations in Older Adults with Multiple Chronic Conditions. Gerontologist. 
2020;60(7):1343-1352. doi:10.1093/geront/gnaa016 
 
25. Beck A, Scott J, Williams P, et al. A randomized trial of group outpatient visits for 
chronically ill older HMO members: the Cooperative Health Care Clinic. J Am Geriatr 
Soc. 1997;45(5):543-549. doi:10.1111/j.1532-5415.1997.tb03085.x 
 
26. Noffsinger E. The Physicals Shared Medical Appointment Model: A Revolutionary 
Access Solution for Private Physical Examinations. Published online March 31, 2009. 
doi:10.1007/b106441_5 
 
27. Scott J, Gade G, McKenzie M, Venohr I. Cooperative health care clinics: a group 
approach to individual care. Geriatrics. 1998;53(5):68-70, 76-78, 81; quiz 82. 
28. Thompson-Lastad A. Group Medical Visits as Participatory Care in Community Health 
Centers. Qual Health Res. 2018;28(7):1065-1076. doi:10.1177/1049732318759528 
29. Scott JC, Conner DA, Venohr I, et al. Effectiveness of a group outpatient visit model for 
chronically ill older health maintenance organization members: a 2-year randomized trial 
of the cooperative health care clinic. J Am Geriatr Soc. 2004;52(9):1463-1470. 
doi:10.1111/j.1532-5415.2004.52408.x 
30. Sanchez I. Implementation of a diabetes self-management education program in primary 
care for adults using shared medical appointments. Diabetes Educ. 2011;37(3):381-391. 
doi:10.1177/0145721711401667 
31. Charlot M, D’Amico S, Luo M, Gemei A, Kathuria H, Gardiner P. Feasibility and 
Acceptability of Mindfulness-Based Group Visits for Smoking Cessation in Low-
Socioeconomic Status and Minority Smokers with Cancer. J Altern Complement Med. 
2019;25(7):762-769. doi:10.1089/acm.2019.0016 
32. Maizels M, Saenz V, Wirjo J. Impact of a group-based model of disease management for 
headache. Headache. 2003;43(6):621-627. doi:10.1046/j.1526-4610.2003.03104.x 
33. Coding for Group Visits. Accessed November 29, 2021. https://www.aafp.org/family-
physician/practice-and-career/getting-paid/coding/group-visits.html 
 
34. Greenberg J, Lin A, Zale EL, et al. Development And Early Feasibility Testing Of A 
Mind-Body Physical Activity Program For Patients With Heterogeneous Chronic Pain; 
The GetActive Study. J Pain Res. 2019;12:3279-3297. doi:10.2147/JPR.S222448 
 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 22 of 24 
35. Greenberg J, Popok PJ, Lin A, et al. A Mind-Body Physical Activity Program for 
Chronic Pain With or Without a Digital Monitoring Device: Proof-of-Concept Feasibility 
Randomized Controlled Trial. JMIR Form Res. 2020;4(6):e18703. doi:10.2196/18703 
 
36. Vlaeyen JWS, Crombez G, Linton SJ. The fear-avoidance model of pain. Pain. 
2016;157(8):1588-1589. doi:10.1097/j.pain.0000000000000574 
 
37. Organization WH. International classification of functioning, disability and health: ICF. 
Published online 2001. 
 
38. Taylor AM, Phillips K, Patel K, et al. Assessment of physical function and participation 
in chronic pain clinical trials: IMMPACT/OMERACT recommendations. Published 
online 2016. 
 
39. Valenti G, Bonomi AG, Westerterp KR. Walking as a Contributor to Physical Activity in 
Healthy Older Adults: 2 Week Longitudinal Study Using Accelerometry and the Doubly 
Labeled Water Method. JMIR Mhealth Uhealth. 2016;4(2):e56. 
doi:10.2196/mhealth.5445 
 
40. Thompson-Lastad A, Rubin S. A crack in the wall: Chronic pain management in 
integrative group medical visits. Soc Sci Med. 2020;258:113061. 
doi:10.1016/j.socscimed.2020.113061 
 
41. Gardiner P, Luo M, D’Amico S, et al. Effectiveness of integrative medicine group visits 
in chronic pain and depressive symptoms: A randomized controlled trial. PLoS One. 
2019;14(12):e0225540. doi:10.1371/journal.pone.0225540 
 
42. Rieselbach RE, Epperly T, Friedman A, et al. A New Community Health 
Center/Academic Medicine Partnership for Medicaid Cost Control, Powered by the Mega 
Teaching Health Center. Acad Med. 2018;93(3):406-413. 
doi:10.1097/ACM.0000000000001901 
 
43. Aging & Socioeconomic Status. https://www.apa.org. Accessed December 1, 2021. 
https://www.apa.org/pi/ses/resources/publications/age 
 
44. McNeely J, Wu LT, Subramaniam G, et al. Performance of the Tobacco, Alcohol, 
Prescription Medication, and Other Substance Use (TAPS) Tool for Substance Use 
Screening in Primary Care Patients. Ann Intern Med. 2016;165(10):690-699.  
45. Williams, D.R., Yu, Y., Jackson, J.S., and Anderson, N.B. Racial Differences in Physical 
and Mental Health: Socioeconomic Status, Stress, and Discrimination. Journal of Health 
Psychology. 1997; 2(3):335-351.  

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 23 of 24 
46. Buysse, DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep 
Quality Index (PSQI): A new instrument for psychiatric research and practice. Psychiatry 
Research. 28:193-213, 1989  
47. Spitzer RL, Kroenke K, Williams JBW, Löwe B. A Brief Measure for Assessing 
Generalized Anxiety Disorder: The GAD-7. Arch Intern Med. 2006;166(10):1092–1097.  
48. Ory MG, Ahn S, Jiang L, Lorig K, Ritter P, Laurent DD, Whitelaw N, Smith ML. 
National study of chronic disease self-management: six- month outcome findings. 
Journal of Aging Health. 2013;25(7):1258-1274.  
49. Raes, F., Pommier, E., Neff, K. D., & Van Gucht, D.. Construction and factorial 
validation of a short form of the Self-Compassion Scale. Clinical Psychology & 
Psychotherapy. 2011;18, 250-255 
50. Lang, A.J., Stein, M.B. (2005) An abbreviated PTSD checklist for use as a screening 
instrument in primary care. Behaviour Research and Therapy, 2005:43, 585-594.  
51. Llera, S. J., & Newman, M. G.. Development and validation of two measures of 
emotional contrast avoidance: The contrast avoidance questionnaires. Journal of Anxiety 
Disorders, 2017;49, 114–127. https://doi.org/10.1016/j.janxdis.2017.04.008  
52. Farrar JT, Young JP Jr, 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(2):149-15 8. 
53. Perrot S, Lantéri-Minet M. Patients' Global Impression of Change in the management of 
peripheral neuropathic pain: Clinical relevance and correlations in daily practice. Eur J 
Pain. 2019; 23(6):1117-1128.  
54. Sullivan MJL, Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and 
validation. Psychological Assessment. 1995;7(4):524-532. doi:10.1037/1040-
3590.7.4.524  
55. Krebs EE, Lorenz KA, Bair MJ, Damush TM, Wu J, Sutherland JM, Asch SM, Kroenke 
K. Development and initial validation of the PEG, a three-item scale assessing pain 
intensity and interference. J Gen Intern Med. 2009;24(6):733-738.  
56. Monticone M, Ambrosini E, Rocca B, Foti C, Ferrante S. Responsiveness and minimal 
clinically important changes for the Tampa Scale of Kinesiophobia after lumbar fusion 
during cognitive behavioral rehabilitation. Eur J Phys Rehabil Med. 2017;53(3):351-358. 
doi:10.23736/S1973-9087.16.04362-8 
57. Cohen, S., Mermelstein, R., Kamarck, T., & Hoberman, H. M.. Measuring the functional 
components of social support. Social Support: Theory, Research and Applications, 
1985;73–94. https://doi.org/10.1007/978-94-009-5115-0_5  

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 24 of 24 
58. Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a 
short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011;18(3):250-255. 
doi:10.1002/cpp.702  
59. Mccullough ME, Emmons RA, Tsang J-A. The grateful disposition: a conceptual and 
empirical topography. J Pers Soc Psychol. 2002;82(1):112-127. doi:10.1037//0022-
3514.82.1.112 
60. Li, M. J., Black, D. S., Garland, E. L. The Applied Mindfulness Process Scale (AMPS): 
A process measure for evaluating mindfulness-based interventions. Personality and 
Individual Differences, 2016; 93,6-15. https://www.ncbi.nlm.nih.gov/pubmed/26858469  
61. Feldman, G., Hayes, A., Kumar, S. et al. Mindfulness and Emotion Regulation: The 
Development and Initial Validation of the Cognitive and Affective Mindfulness Scale-
Revised (CAMS-R). J Psychopathol Behav Assess. 2007;29: 177. doi:10.1007/s10862-
006-9035-8  
62. Carver CS. Measure of Current Status (MOCS). Published online 2006. 
doi:10.13072/midss.541  
63. Krueger RA, Casey MA. Focus Groups: A Practical Guide for Applied Research. SAGE; 
2009. 
64. Krueger RA, Casey MA. Focus Groups: A Practical Guide for Applied Research. SAGE; 
2000. 
65. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for 
the analysis of qualitative data in multi-disciplinary health research. BMC Medical 
Research Methodology. 2013;13(1):117. doi:10.1186/1471-2288-13-117