The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain: Multi-site Feasibility RCT
Phase: NA
Conditions: Chronic Pain
Sponsor: Massachusetts General Hospital

 
 
Official Title: Improving multimodal physical function in 
adults with heterogeneous chronic pain; Multi-site 
feasibility RCT 
NCT: NCT05700383 
Document Date: 03-21-2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1. Background and Significance 
 
Chronic pain is prevalent, costly, and associated with decreased physical function. Chronic pain, 
defined as persistent pain that lasts more than 3-6 months1, has an estimated incidence of 100 million adults 
in the US2. The total annual incremental cost of health care due to pain ranges between $560 and $635 
billions in the US, which combines the medical costs of pain care and the economic costs related to 
disability days and lost wages and productivity2. As a consequence, NCCIH has designated chronic pain as 
a national priority area4. A large body of research documents that patients with chronic pain have decreased 
physical function21,22, regardless of the location and severity of pain5,23. Patients with chronic pain also 
report nonadaptive coping strategies with pain catastrophizing and fear of pain being the most salient, and 
both associated with decreases in physical function24–27.  
  
Mind-body programs show promise with chronic pain but fail to meaningfully improve physical function.  
Over the last decade, psychosocial treatments have evolved toward acceptance of pain and increased 
function regardless of pain sensations28–30. Mind-body programs such as Acceptance and Commitment 
Therapy and Mindfulness Skills Training focus on engaging in value driven behaviors, even if those are 
painful6,30–32. However, these interventions produce only small to moderate effect sizes for psychosocial 
outcomes like depression, anxiety, stress, and overall quality of life and effects diminish over time6,30,33,34. 
Further, although IMMPACT 9,35 clearly specifies that physical function should be a required outcome in 
pain clinical trials, few studies include it10. When physical function is included as outcome, effect sizes are 
small and fade over time30,36. There is a critical need for novel interventions to improve physical function, 
an outcome consistently depicted as top concern by patients with chronic pain8. 
  
Physical function is a multidimensional construct. Physical function, defined following the ICF11, 
implies “a person’s capacity in a set of situations and includes engagement in meaningful aspects of one’s 
life including performing activities of daily living such as household chores, walking, work and self-care”, 
is a marker of an individual’s health and well-being22. IMMPACT recommendations9 stress the pivotal role 
of addressing physical function, and urge researchers to: 1) directly target it during pain clinical trials as a 
primary outcome, and 2) conceptualize it comprehensively not only through self-report measures of activity 
of daily living but also through performance based measures (functional capacity during a time limited 
standard test), and objective measures of activity (ambulatory step-count measured by accelerometers that 
capture daily activity across a specified time period, usually a week37.) This comprehensive approach to the 
conceptualization and assessment of physical function aligns with the 2021-2025 NCCIH strategic plan that 
focuses on whole person health38. Our recent systematic review10 showed that no mind-body clinical trials 
in chronic pain have comprehensively assessed and addressed improvement in all facets physical 
function consistent with ICF11 and IMMPACT9 criteria.  
  
Quota based walking is associated with improved outcomes in patients with chronic pain, but it is not 
incorporated within mind-body programs. This is a missed opportunity. The US Department of Public 
Health’s research has shown a clear relationship between daily walking and several health outcomes such 
as mortality, cardiovascular disease and cancer39, with more steps incrementally increasing positive 
outcomes40–42. Patients with chronic pain are sedentary (< 5,000 steps a day, which is less than an average 

healthy adult43–46). Deconditioning is common and a significant risk factor for further pain conditions and 
increased disability and overall wellbeing46 . This contention is consistent with the fear avoidance 
model25,47,48 that explains how chronic pain is perpetuated through a disability spiral of decreased 
activity/deconditioning, negative emotions, and avoidance (Fig. 2) Focus groups with patients with chronic 
pain have consistently showed that walking is their preferred method of activity49. A 2020 Cochrane 
systematic review46,50 has showed that walking “is acceptable, beneficial and unlikely to cause harm in 
people with chronic pain. However, many fear that it would increase their pain in the future” and, as a result, 
uptake and adherence are problematic45,46,51 . Quota-based pacing – engagement in an a priori specified 
activity goal (e.g., quota) that is not contingent on pain – shows promising results52–54 but decreased mood, 
pain, coping difficulties (e.g., fear avoidance, catastrophic thinking about pain), programs that are too 
challenging (e.g., going to the gym), not meaningful, interfering with one’s life, or too difficult to 
implement50,55–57 have been depicted as important barriers in prior research. Mind-body skills can bypass 
these barriers to activity and, if combined with quota-based pacing (walking linked to activities of 
daily living), may be an effective way to break the disability spiral (fig. 2) and improve all aspects of 
physical function. 
  
Fitbits can track and reinforce activity over time while maintaining motivation, and safely allowing 
individuals to increase step-count. Fitbits are user friendly and low-cost devices that allow individuals to 
track their step-count and receive real time feedback to increase motivation and reinforce activity.  They 
are also a novel way for clinicians to get objective data on patients’ activity, thereby further buttressing 
motivation, treatment alliance and adherence 13,14,58. Fitbits can bypass some of the challenges (e.g., 
problematic adherence, lack of real time feedback) of prior more cumbersome activity tracking devices 
(e.g., pedometers and accelerometers) 59,60, increasing their ability to act as an intervention61,62. Fitbits allow 
setting step goals that are individualized to each chronic pain patient’s ability and gradually increased16 
over time. While the accuracy of measurement of step count with the Fitbit is controversial, and 
accelerometers are considered the gold standard for assessment of activity in research, Fitbits show higher 
adherence than accelerometers or pedometers when worn for a long period of timel14,15,63.  Very few studies 
have examined the Fitbit in patients with chronic pain. Two recent studies used the Fitbit alone (e.g., with 
no additional skills) to increase activity among people with chronic pain and did not observe significant 
increases in step-count64 or self-reported physical function65.  Among people with chronic pain, the Fitbit 
appears promising (good adherence), but does not lead to sustained increase in step count on its own.  
  
Combining mind-body skills with the Fitbit is a novel solution to the problem of low physical function 
among people with chronic pain.  Mind-body skills can bypass barriers to engaging and adhering to 
activity (e.g., low mood, over-focus on control of pain rather than acceptance, fear avoidance and 
nonadaptive thoughts about pain), which are also hypothesized mechanisms for improvement in 
function66,67. Fitbits can be used to reinforce an individualized quota-based pacing plan with gradual 
increased activity while enhancing adherence and maintaining motivation. Further, step-count activity goals 
can be linked to a patient’s valued activities50,55,56, with important implications for sustainability and whole 
person health.  
 
Conceptual model: We propose that intervention targets such as 1) nonadaptive reactions to nociception 
(kinesiophobia, and catastrophizing), 2) adaptive coping strategies (e.g., mindfulness, resiliency); 3) 

social-emotional factors (depression, anxiety, social support, social isolation) will be interrelated and 
synergistically lead to improvement in physical function. Activity goal setting skills (pairing of step-count 
with activities of daily living depicted by patients as important, gradually increasing step goals via quota-
based pacing, using the Fitbit live reinforcement of activity) are conceptualized as key factors in 
improving outcomes in GetActive-Fitbit. The program skills act by directly addressing habitual negative 
affective reactions to pain and negative pain thoughts by focusing on accepting and learning to tolerate 
pain sensations (including during increased activity68), while Fitbit based on operant approaches 
previously depicted as promising in this population, acts by directly targeting increased activity through 
“quota-based” pacing and immediate feedback on number of steps achieved69,70 . In our conceptualization, 
the mind-body skills are necessary in order to bypass barriers to activity, and the Fitbit is necessary in 
order to maintain motivation and reinforce activity in real time.  
  
With funding from NCCIH we iteratively developed and refined the first mind-body activity 
programs (GetActive and GetActive-Fitbit) and conducted a single-site, pilot randomized controlled 
trial in individuals with heterogeneous chronic pain (R34 AT009356; see Figure 4). Both programs 
showed excellent feasibility, expectancy, and satisfaction in the target population. We also observed, in both 
programs,  within-group improvements in self-report and performance-based physical function across all 
participants, and in step-count across sedentary participants. Although programs were relatively similar in 
feasibility markers and signal of improvement in physical function, patients in GetActive-Fitbit reported on 
the Modified Impression of Change that the Fitbit “greatly increased” their ability to improve physical 
function. Qualitative exit interviews also confirmed preference for using a Fitbit17. Program attendance and 
credibility were superior for GetActive-Fitbit. Clinicians noted that it was challenging to assist patients in 
GetActive to gradually increase activity without an objective step goal. Furthermore, although any 
quantitative analyses must be considered preliminary at this stage, 71,72 we found significant improvement 
in emotional function in the GetActive-Fitbit but not the GetActive group.  Taken together, these findings 
support the goal of this 3-year R01 to test multisite feasibility of GetActive-Fitbit vs an educational control 
across geographically diverse sites, which is necessary before conducting a multi-site efficacy trial. A 
multisite feasibility trial of GetActive-Fitbit vs GetActive vs control followed by a 3-arm multisite efficacy 
trial is too expensive and not justified by our preliminary data. 
  
Summary of significance of the proposed NCCIH R01: Chronic pain is a serious public health concern. 
Improving physical function is a top concern of people with chronic pain8. Prior treatments are associated 
with only small improvement in physical function which tend to fade over time. No prior clinical trials in 
chronic pain have followed IMMPACT and ICF recommendations of assessing and addressing physical 
function comprehensively (e.g., self-report, performance based and objective)10. Improving all aspects of 
physical function is imperative if we are to decrease the medical and economic burden of chronic pain 
and improve the lives of individuals with chronic pain (e.g., whole person). We demonstrated that 
GetActive-Fitbit met or exceeded a-priori set feasibility benchmarks and was associated with improvements 
in comprehensive physical function among sedentary (5,000 steps/day)18 patients with chronic pain17. 
Before conducting a multisite efficacy trial to demonstrate the efficacy of GetActive-Fitbit, we must 
demonstrate fidelity, feasibility/acceptability benchmarks, and refine our protocols in order to move from a 
local/single-site to a multi-site randomized controlled trial. Multiple sites allow for strong generalizability, 
and are necessary to generate a rate of recruitment for a targeted sample that will permit timely enrollment, 
long-term follow up, and evaluation of treatment mediators and moderators73. Further, the multi-site 
feasibility testing allows us to correct limitations of our prior single-site study including recruitment of 

racially and ethnically diverse populations, accurate recruitment of the population of interest (chronic pain 
individuals who take less than 5,000 steps/day) and determining ability to follow-up participants after 
program completion in order to understand sustainability of improvements. We will also be able to further 
optimize the protocol and explore systemic barriers (through focus groups with staff) to enhance the rigor 
and success of the future efficacy testing. This project directly fits the NCCIH priority areas74 and 2021-
2025 strategic plan of: 1) advancing research on the whole person (e.g., we are focused on improving 
comprehensive physical function - self-reported, performance based and step-count  linked to valued 
activities, and emotional function); 2) integrating complementary and conventional care (e.g., we are 
recruiting patients who seek conventional medical care in pain clinics and integrating a mind-body activity 
within their care); 3) improving health in minorities and eliminating health disparities (e.g., we are 
specifically focused on recruiting a diverse sample of >38% racial and ethnic minorities); and 4 ) utilizing 
complementary and integrative management of pain. This project directly aligns with the NCCIH R01 PAR-
21-241 to establish multi-site fidelity and feasibility benchmarks through a non-efficacy RCT. There is an 
opportunity for a patient centered paradigm shift in how chronic pain is currently treated in pain clinics, 
with important implications for improving physical function among this high-need population.    
 
 
2. Specific Aims and Objectives  
 
Aim 1: To test multisite fidelity of training and implementation of GetActive-Fitbit vs HEP, among 
adults with heterogeneous, non-malignant, musculoskeletal chronic pain. 
 
Hypothesis: We hypothesize that study clinicians can be trained consistently and competently 
across sites to achieve implementation of the 2 programs with high adherence and competence 
based on a-priori set benchmarks.  
 
 
Aim 2: To evaluate multisite feasibility benchmarks including ability to recruit sedentary chronic pain 
patients and racial and ethnic minorities for a protocol involving randomization to GetActive-Fitbit 
versus HEP with post-program and 6 months follow up. 
 
Hypothesis: We hypothesize that we will meet a-priori set feasibility benchmarks including 
ability to recruit and retain racial and ethnic minorities through a 6-months follow-up (38% 
minorities). 
 
Aim 3: To optimize our fidelity and study implementation protocol procedures in preparation for a 
future fully powered multisite efficacy RCT through the UH3/UG3 mechanism (PAR-21-243). 
 
Hypothesis: We expect that we will successfully refine training, implementation and procedures 
using an iterative approach with separate focus groups with patients and staff, and within and 
cross-site meetings.  
 
 
3. General Description of Study Design 

In Aim 1, we aim to test the multisite fidelity of training and implementation of GetActive-Fitbit vs HEP, 
internally among study staff. In Aim 2, we aim to evaluate multisite feasibility benchmarks for a protocol 
involving randomization to GetActive-Fitbit versus HEP with post-program and 6 months follow up. Both 
programs will be delivered in-person to adults with chronic musculoskeletal pain. In Aim 3, we aim to 
optimize our fidelity and study implementation protocol procedures in preparation for a future fully 
powered multisite efficacy RCT through the UH3/UG3 mechanism. 
During Aim 1, we aimed to test the fidelity of training and implementation of GetActive-Fitbit and Health 
Enhancement Program (HEP). This multisite training included study clinicians at the Massachusetts 
General Hospital, Duke University, and Rush University sites. The training consisted of presentations 
reviewing the theoretical and empirical study background, treatment goals, population challenges, process 
factors, and study manuals. Following the presentations, training study clinicians role-played key skills 
and conducted mock groups with staff members. During these mock groups, the training study clinicians 
followed the study manuals and protocols intended for the single-blind RCT (Aim 2). Fidelity checks are 
being conducted iteratively to ensure proper training for the implementation of GetActive-Fitbit and 
Health Enhancement Program (HEP). Quantitative assessment of clinicians’ knowledge will occur 
throughout this training process and will mark the final step of their training. This aim of the study will 
slightly overlap with recruitment for Aim 2 and will be completed by April 15th, 2023, before the first 
group of participants enroll in the single-blind RCT. 
In this current phase of the study (Aim 2), we propose to evaluate the multisite feasibility benchmarks of 
GetActive-Fitbit and Health Enhancement Program (HEP). This multisite feasibility randomized 
controlled trial will include Massachusetts General Hospital (MGH), Duke University, and Rush 
University as study sites. First, adults with chronic pain will be recruited from physician referrals and 
medical records at Duke and IRB-approved flyers throughout all MGH, Duke, and Rush outpatient clinics 
and community health centers, and from the community. In the event that a provider refers a patient 
without sharing contact information and the patient agrees to be contacted by the study team, the research 
assistant will use the patient’s medical record to access this information. 
 
The research assistant will conduct individual phone screens with interested adults to learn more about the 
study and be screened for eligibility. At Duke, the study team will send a letter via postal mail and/or 
email and follow up with the potential participant by phone. Participants will also have the option of 
completing a portion of this screening on their own via REDCap. There will be a QR code and link 
directing potential participants to the screening REDCap on our study flyers. Eligibility will be 
determined by the research assistant who conducted the phone screening, and the larger study team, if 
needed. If eligible, the research assistant will briefly review the consent form with participants who 
express interest and intent to participate in the study. The research assistant will ask eligible participants 
to provide dates and times that they are available to attend the group program and maintain a detailed log 
of this information. Study staff will continue to follow-up with interested participants via phone until a 
date for the groups has been selected (group times are based off a majority of participants’ availability). 
Once a mutual date and time for the groups has been selected for about 8-20 participants, a research 
assistant will call eligible participants to schedule an in-person group baseline assessment at each of the 3 
sites, which includes the informed consent procedure with a trained research assistant. The research 
assistant will ask eligible participants who are not available at the set time if they want to be contacted for 
the next round of groups. Individuals who do not meet study criteria will be offered a resource sheet with 
relevant health and mental health information. 
 

Eligible participants who are able to attend the scheduled group sessions will meet in person at each of the 
3 sites for the baseline assessment which includes: i) informed consent process through RedCap; ii) 6 
minute walk test (6MWT) using a standardized protocol; iii) self-report questionnaires; iv) instructions on 
ActiGraph wear with special attention to explaining the importance of adherence and reducing reactivity 
(e.g., ensuring that participants know not to make changes in activity levels during the week long baseline 
assessment, and developing individualized plans for ActiGraph wear including option for Twilio text 
reminders). Participants will next be randomized to one of the 2 conditions. Allocation will be performed 
by each site study coordinator using REDCap. Each program involves audio-recorded group sessions for 
10 consecutive weeks, 60 minutes per week at a time that is convenient to participants. Participants will 
receive a check-in message via email or mail from the study team in between post-tests and follow-up 
assessments to maintain study relationships. All participants will be offered the other group’s content (i.e., 
group manual and website) at the end of the 6-month follow up assessments. 
 
All participants will wear the ActiGraph devices at the baseline, post-intervention, and 6-month follow up 
assessments. All participants will be instructed on ActiGraph maintenance using standard operating 
procedures used in a prior feasibility trial at MGH. Participants will return the ActiGraph watches after 
the assessments, provided they have logged seven consecutive days of valid data. Participants with 
missing data will be instructed to continue wearing the device until seven days have been reached. The 
RA will provide participants with ActiGraphs either in-person or via mail, and participants will be asked 
to return their devices during in-person assessments, during sessions, or via mail with a prepaid postage 
envelope. The RA will remotely monitor ActiGraph adherence using CentrePoint Sync. For participants in 
the GetActive-Fitbit condition, participants will be asked to wear a Fitbit for the duration of the program 
and sync the Fitbit to a Fitbit application on their smartphone. Using the Fitbit steps, the RA will 
determine a new step count goal weekly based on whether the GetActive-Fitbit participant met their step 
goal in the prior week. If a participant met their step-count goal, they will increase their steps by 10%. If 
they did not meet the goal, they will continue with the same goal. If they do not meet the goal for 2 
consecutive weeks, their goal will be decreased by 10%.   
 
Aim 3 will commence following Aim 2, and this aim of the study is intended to optimize fidelity and 
study implementation protocol procedures in preparation for a future fully powered multisite efficacy 
RCT. This aim will entail conducting focus groups with staff and patients to refine study materials and 
procedures. A future IRB submission will detail this aim in greater detail. 
 
 
4. Subject Selection 
 
An important goal of this proposal is to improve upon our R34 trial at MGH and recruit a diverse sample 
that is representative of the USA demographics with regard to race and ethnicity. Our goal is to follow the 
race and ethnicity distribution of the USA (below) and recruit at least 38% racial and ethnic minorities. 
The MGH Pain Clinic population includes ~80% Whites/Caucasians, and this was reflected in the sample 
we obtained with our R34 pilot study. Specifically, within our feasibility RCT at MGH our sample was 
primarily White (80%) and Not Hispanic (85%). The enrolled sample included 3% American 

Indian/Alaskan, 4% Asian, 9% Black/African American and 4% Multi-race. During this R01 we will 
directly focus on recruitment of racial and ethnic minorities at all sites including MGH. Yearly at MGH, 
we will have available 95 American Indians/Alaskan, 127 Asians, 286 Blacks/African Americans, and 127 
individuals who identify as Multiracial. The Rush Pain Clinic treats chronic pain patients who are diverse 
with regard to race/ethnicity and sex. In our recent R01 NR013910 our sample corresponded with regard 
to race and ethnicity to the general sample seen at our pain clinic. Across the entire sample 51% were 
Black/African American, 35% white, 7% multiracial and 6% other race. With regard to ethnicity 10% 
were Hispanic/Latino and 90% Non-Hispanic/Latino. The Duke Pain Clinics in Durham, NC serve 
patients primarily that live in Durham, NC as well as the larger full count of Durham and outlying rural 
areas. Durham county 2020 reports the population to be 48% White, 40 African-American, 5% Asian, and 
7% other races. In an ongoing R01 recruiting patients with persistent pain at Duke University Medical 
Center, of 291 recruited participants race is 60% White, 34% African-American, 3% Asian, and 5% other. 
In this work, we will be able to increase our recruitment numbers to match with the county wide statistics 
and recruit participants that are no more than 48% White and no less than 40% African-American, 5% 
Asian, and 7% another race.  
 
We developed strategies to ensure recruitment of racial and ethnic minority samples, including: 1) 
encouraging referring physicians and all study staff to engage in trainings around cultural competence and 
internalized racism to ensure interactions with patients are able to be rooted in trust and respect; 2) clearly 
explaining the research study and ensure that patients have all information needed to make a decision 
regarding participation, to helps to address mistrust of research and underline respect for patient 
autonomy; 3) at MGH, we will approach all racial and ethnic minorities. This will not be done at Rush 
and Duke given that their racial and ethnic representation is much more diverse. The goal will be to 
ensure that patients of all racial and ethnic backgrounds feel that they are part of a community that aims to 
improve quality of care for chronic pain patients. 
 
 
Inclusion/Exclusion Criteria 
 
Inclusion Criteria 
1. Male and female outpatients, age 18 years or older 
 
2. Fluent in English 
 
 
 
 
 
3. Have nonmalignant chronic musculoskeletal pain for more than 3 months 
4. Able to perform a 6-minute walk test (6MWT)  
 
 
 
 
 
5. Owns a smartphone with Bluetooth 4.0 or computer   
 
 
 
6. Willingness and ability to participate in one of the 2 programs and to comply with the 
requirements of the study protocol.  
 
 
 
 
7. Free of concurrent psychotropic medication for at least 2 weeks prior to initiation of 
treatment, OR stable on current medication for a minimum of 6 weeks and willing to 
maintain a stable dose  
 
 
 
 
 
 
 
 

8. Low-level of activity (must meet 2/3 criteria; if difficult to assess, recruiter may ask 
participant to report their recent step data from their smartphone to better understand their 
activity level) 
a. Sitting for more than 8 hours/day per self-report 
b. Exercising for fewer than 3 days/week (30+min of exercise constitutes an “exercise 
day”) per self-report 
c. Walking for fewer than 7 days/week (30+min of walking constitutes a “walking day”) 
per self-report 
 
Exclusion Criteria 
1. Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy) 
2. Serious mental illness or instability for which hospitalization may be likely in the next 6 
months  
3. Current active suicidal ideation with plan or intent reported on self-report 
4. Untreated and/or unstable schizophrenia, bipolar disorder, or other psychotic disorder  
5. Current, active substance abuse or dependence, and current alcohol dependence within the 
past 6 months 
6. Practice of yoga, meditation, guided imagery or other mind body techniques that elicit the 
RR, once per week for >45 min 3 times/week within the last 3 months or less.  
7. Regular use of Fitbit DMD in the last 3 months  
8. Unable to walk/in a wheelchair 
9. Mild cognitive decline for participants 65+ only (Short Portable Mental Status Questionnaire; 
PMSQ 4 or more errors). 
 
 
 
 
 
 
 
 
 
Participants will be adult patients with chronic, heterogeneous, non-malignant pain diagnosed by their 
medical provider. Participants will only include English speakers, due to study resources and access to 
translators. Participants who do not have access to a personal smartphone equipped with Bluetooth 4.0 or 
later may be provided with one. As in our feasibility R34 we anticipate that the majority of recruitment 
will occur from the Pain Clinics affiliated with each site, due to an overabundance of available study 
participants and due to the larger goal of implementation of programs within the Pain Clinic. Adults with 
chronic pain will be recruited from physician referrals and IRB approved flyers throughout all MGH, 
Duke, and Rush outpatient clinics and community health centers, social media, and from the community. 
In the event that a provider refers a patient without sharing contact information and the patient agrees to 
be contacted by the study team, the research assistant will use the patient’s medical record to access this 
information. Participants may also be recruited via referrals from related research studies, if they agree to 
be contact by our study team. In addition to the shared recruitment strategies, each site will have site-
specific methods of recruitment. MGH will utilize the Mass General Brigham Rally platform to recruit 
patients from the greater Boston area. Duke University will also recruit via medical record review. Rush 
will also promote the study during the hospital "hold message" when people call Rush Medical Center. 
Screening will take place remotely and consent will occur in person. 
 
 
5. Subject Enrollment 
 

The screening process will take place remotely and consent will occur in person. Remote screening will 
be conducted by the research assistant over the phone. During the screening call, a research assistant will 
provide study details to participants and assess eligibility via self-report questions. Participants will also 
have the option of completing a portion of this screening on their own via REDCap. There will be a QR 
code and link directing potential participants to the screening REDCap on our study flyers. If eligible 
after individual screening, the participant will receive a call from the research assistant. A research 
assistant will briefly review the consent form with eligible participants who express interest and intent to 
participate in the study. The research assistant will ask eligible participants to provide (1) their height and 
weight information, to initialize their ActiGraph, (2) dates and times that they are available to attend the 
group program and maintain a detailed log of this information. Study staff will continue to follow-up with 
interested participants via phone until a date for the groups has been selected (group times are based off a 
majority of participants’ availability). Once a mutual date and time for the groups has been selected, a 
research assistant will call eligible participants to schedule an in-person group baseline assessment at each 
of the 3 sites, which includes the informed consent procedure. The research assistant will ask eligible 
participants who are not available at the set time if they want to be contacted for the next round of groups 
or for future trials. Though the timeline to hear back from the study team may vary, participants on the 
waiting list can expect to hear from us within a month and are guaranteed to be recontacted. Individuals 
who do not meet study criteria will be offered a resource sheet with relevant health and mental health 
information. During the in-person baseline assessment, participants will sign consent forms electronically 
on REDCap through the eConsent framework. 
 
 
6. Study Procedures 
 
Eligible participants who are able to attend the scheduled group sessions will meet in person at each of the 
3 sites for the baseline assessment. If other eligible participants are available at the same time, there is an 
option to conduct the baseline concurrently as a group. The baseline assessment includes: i) informed 
consent process through REDCap; ii) 6 minute walk test (6MWT) using a standardized protocol; iii) self-
report questionnaires; iv) instructions on ActiGraph wear with special attention to explaining the 
importance of adherence and reducing reactivity (e.g., ensuring that participants know not to make 
changes in activity levels during the week long baseline assessment, and developing individualized plans 
for ActiGraph wear including option for Twilio text reminders). Participants will next be randomized to 
one of the 2 conditions. Allocation will be performed by each site study coordinator using REDCap. Each 
program involves audio-recorded group sessions (e.g., ~4-10 participants per group) for 10 consecutive 
weeks, 60 minutes per week at a time that is convenient to participants. Program sessions will be led by 
clinical psychologists who have undergone extensive training in these interventions and have expertise in 
chronic pain. Participants will also be invited to participate in a group exit interview following a semi-
structured script. The group interview will occur during the post-intervention assessment. Those who are 
interested in participating but cannot attend the group interview session can participate individually at 
another time. All participants will also be given the opportunity to share contact information after the 
post-test assessments to maintain the community and relationships developed during the in-person group 
sessions. 
 

The GetActive-Fitbit program is a group mind-body program developed iteratively from the Relaxation 
Response Resiliency Program (3RP) that incorporates additional cognitive behavioral and physical 
restoration skills (e.g., quota-based pacing) to help individuals increase self-reported, performance-based, 
and objectively measured (step count) physical function. Participants randomly assigned to this 
intervention condition will receive daily text/email reminders to practice program skills, record their 
walking, and record their skills practice via methods such as Twilio, if they consent to receive text 
reminders. A health education program (“Healthy Living for Pain”) will serve as the comparison 
condition for this aim of the study and will teach participants about health topics such as sleep, nutrition, 
and exercise. Participants randomly assigned to this comparison condition will receive journaling 
homework with daily text/email reminders. Participants will be given the option to share a copy of their 
journal with the study clinician throughout the program. 
 
All participants will wear the ActiGraph wGT3X-BT devices to measure step-count at baseline, post-
intervention, and 6-month follow-up assessments. All participants will be instructed on ActiGraph 
maintenance using standard operating procedures used in a prior feasibility trial at MGH. Participants will 
return the ActiGraph watches after the assessments, provided they have logged seven consecutive days of 
valid data. Participants with missing data will be instructed to continue wearing the device until seven 
days have been reached. The RA will provide participants with ActiGraphs either in-person or via mail, 
and participants will be asked to return their devices during in-person assessments, during sessions, or via 
mail with a prepaid postage envelope. The RA will remotely monitor ActiGraph adherence using 
CentrePoint Sync. For participants in the GetActive-Fitbit condition, participants will be asked to wear a 
Fitbit Inspire 3 for the duration of the program and sync the Fitbit to a Fitbit application on their 
smartphone. Using the Fitbit steps, the RA will determine a new step count goal weekly based on whether 
the GetActive-Fitbit participant met their step goal in the prior week. If a participant met their step-count 
goal, they will increase their steps by 10%. If they did not meet the goal, they will continue with the same 
goal. If they do not meet the goal for 2 consecutive weeks, their goal will be increased by 10% of the 
average step count they had accomplished the week prior. Study clinicians may also conduct independent 
check-ins with participants who do not meet their goal to ensure barriers are known. The standard 
baseline goal for all participants randomized to the GetActive-Fitbit condition is that they experience a 
1,000 step increase by the end of the program, though this will be variable depending on participant 
ability. 
 
 
The following measures will be administered at all timepoints, to participants in both study arms, unless 
otherwise stated. The measures assess physical and emotional function, behavior, medical symptoms, and 
coping strategies with pain. These measures will be administered on hospital-owned encrypted devices or 
paper and pencil, depending on participant comfort, and should take about 30 minutes to complete. 
 
 
Demographics (baseline only)  
Treatments (post-tests and follow-up only) 

Pain, Enjoyment of Life and General Activity scale (PEG-3) 
WHO Disability Assessment Scale (WHODAS) 
6 Minute Walk Test (6MWT) 
ActiGraph wGT3X-BT Accelerometer  
PROMIS depression v1.08b  
 
 
 
 
 
PROMIS anxiety v1.08a  
Pain Catastrophizing Scale (PCS) 
Tampa Kinesiophobia Scale (TSK) 
Measure of Current Status (MOCS) 
Cognitive and Affective Mindfulness Scale (CAMS) 
 
 
 
 
Modified Global Impression of Change (MGIC) – only at post-test 
Credibility/Expectancy Questionnaire (CEQ) (post-tests or as soon as possible after post-tests) 
Client Satisfaction Questionnaire (CSQ-3) (post-tests or as soon as possible after post-tests) 
Fitbit Use (GetActive Only)- only at 6-month follow-up 
 
Table 1. Study Procedures 
Time 
Task 
Details 
6-7 Weeks 
Before 
Intervention 
Recruitment and 
Screening 
RA receives referrals, screens via telephone, records availability for eligible participants 
3 Weeks 
Before 
Intervention 
Scheduling 
RA selects baseline time based on participant availability. RA calls participants to confirm time. 
~1 Week 
Before 
Intervention 
Consent and 
Baseline Assessment 
Review and sign consent. Participants complete: self-report measures, 6-minute walk test, 
Participants also receive ActiGraph devices and instructions. 
10-Week 
Intervention 
Group Sessions 1-10 
Participants complete 10 weeks of group sessions of either GetActive-Fitbit or Healthy Living for 
Pain. 
Sessions will be audio recorded, to ensure accuracy of delivery and assess fidelity. 
1 Week Post 
Intervention 
Post-Intervention 
Assessments 
Participants repeat procedures from the baseline assessment. Participants return ActiGraph devices 
after the post-test assessment in person. 
2 Weeks 
Before 6-
Month 
Assessments 
ActiGraphs Mailed 
Out 
RA mails ActiGraphs to participants to be worn in week prior to 6-Month Follow up 
6 Months 
Post 
Intervention 
6-Month Follow-Up 
Assessments 
Participants repeat procedures from the baseline and post-test assessments. Participants return 
ActiGraph devices after the 6-month follow-up assessment in person.  
 
 
Participants will be paid $945 for completing the study in its totality. If participants do not complete the 
study, we will pay based on the following study visits and tasks completed: 

 
• 
For the baseline assessment, participants will receive $60 for the completion of study tasks and up 
to $100 additional dollars for ActiGraph wear ($10 dollar per day, plus an additional $30 for 7 
days with complete valid wear).  
• 
For the post-test assessment, participants will receive $100 for the completion of study tasks and 
up to $155 additional dollars for ActiGraph wear ($15 dollar per day, plus an additional $50 for 7 
days with complete valid wear).  
• 
For the 6-month follow-up assessment, participants will receive $100 for the completion of study 
tasks and up to $190 additional dollars for ActiGraph wear ($20 dollar per day, plus an additional 
$50 for 7 days). 
• 
For transportation costs for session attendance, participants will be paid $150 for travel 
compensation ($15 per session) and can receive an additional $50 if 8/10 sessions are attended. 
• 
For the optional exit interview, participants will receive $40. 
 
Participants should expect to receive payment following each major assessment timepoint (i.e., baseline, 
post-test, and 6-month follow-up) as well as following the program sessions. MGH and Rush will pay 
participants via checks, as per their respective hospitals payment systems, and Duke will pay participants 
via ClinCards, per their hospital system. 
 
 
7. Risks and Discomforts 
 
Patients will be informed that the foreseeable physical risks from this research study are minimal. They 
will be informed that there is some risk of breach of privacy/confidentiality associated with the use of 
written communication (e.g., emailing, text messages) and audio recording software. They will also be 
informed of the unlikely situation that they might feel uncomfortable with the topics discussed within the 
group, and they can alert the group leader who will provide help, as needed. The group leaders are 
experienced clinical psychologists who have specific expertise with chronic pain in adults. They will also 
be informed that they may feel uncomfortable completing various psychological questionnaires and that 
they may find it time-consuming to participate in weekly 60-minute groups. 
 
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, we will use a standardized protocol for assessing and monitoring 
risk developed by Dr. Vranceanu that has been successfully used in other remote trials. In this protocol, 
the research assistant would contact the MPI (Vranceanu) and the appropriate clinical intervention would 
be executed. In case we are unable to contact the participant we will contact their safety contacts (see 
Potential Risks to participant section). In case suicidality is determined during the intervention or control 
sessions, the study clinicians will perform safety procedures in real time and immediately contact the 
MPIs. Further, we set serious mental illness and current suicidal ideation as exclusion criteria to further 
reduce the chance that enrolled participants would express harm towards themselves or others at any point 
during the study.  
 

Direct adverse events from increasing walking are not expected. The increase in activity will be safe, 
quota-based and gradual, contingent upon meeting step count criteria in the previous week. All study staff 
have been trained in responsible conduct of research. Adverse events during the study will be tracked as 
part of the daily adherence/home practice log. Specifically, participants will be asked if they experienced 
any negative outcomes because of becoming more physically active during that day. Any participants 
reporting adverse events will be immediately contacted and, if necessary, assessed by the study clinician 
before being referred for appropriate care as needed.  
 
As mentioned above, we will be using secure email to communicate with participants. All email 
communication with participants will be encrypted using the send secure function. To further protect 
participants’ confidentiality, we will discourage participants from communicating about medical issues by 
non-secure email.   
 
 
8.  Benefits 
 
We expect many benefits from study participations among individuals in GetActive-Fitbit including 
improvement in physical (self-report, performance and objective) and emotional (depression and anxiety) 
function, increased coping ability, and decreases catastrophizing, fear of pain, and pain intensity. All 
participants are expected to benefit from the support of the therapist and group members. The potential 
benefits from this study far outweigh the potential risks. The data collected as part of this study may 
ultimately help researchers and clinicians better care for patients with chronic pain. 
 
 
 
9. Statistical Analysis 
 
We plan to enroll N=120 participants across sites, with 40 participants recruited per site. We believe that 
this sample size is appropriate for a feasibility trial, including similar proposals previously funded NCCIH 
(e.g., 1U01AT010462). The proposed sample provides good power to achieve our multisite fidelity and 
feasibility benchmarks. Specifically, if 90 participants are enrolled, the study will have an 80% probability 
of meeting all seven Aim 2 feasibility benchmarks if the expected proportion of participants enrolling, 
completing at least 7 of 10 sessions, rating the program as credible and satisfactory, and completing post-
treatment follow-up is at least 89% and if the expected proportion of protocol checklists deemed accurate 
is at least 95%. Moreover, the planned sample size will provide adequate precision for estimating fidelity 
and feasibility benchmarks.  
 
Statistical analyses:  
First, we will report: 
• 
percent eligible sedentary chronic pain patients who enroll after being determined eligible during 
screening (benchmark ≥ 80% AND 34/90 racial and ethnic minorities).  

• 
Total duration of recruitment in months overall and at each site. 
• 
Percent of patients who attend ≥7/10 sessions for each program (benchmark is 80%). 
• 
Percent patients with credibility scores higher than the scale’s mid point (Credibility and 
Expectancy scale; benchmark is 80%) 
• 
Percent patients with satisfaction scores higher than the scale’s mid point (Client Satisfaction scale; 
benchmark is 80%) 
• 
Percent patients who complete post-treatment (benchmark is 80%) and 6 months follow up 
(benchmark is 70%) including self-report, performance based and Actigraph valid data. 
• 
Percent accuracy of standardized protocol checklists for all assessments (benchmark is 90% 
accuracy).  
• 
We will also report additional information necessary to complete the CONSORT diagram. 
Next, we will use Fisher's exact tests to make comparisons of number of people meeting each 
benchmark across sites and between the intervention arms, while also plotting performance metrics 
across sites to account and assess for trends in differences due to the low statistical power.  
 
Estimates of variance components required for design of a future efficacy trial will be obtained from 
preliminary analysis of outcome report, performance based, and objective/ambulatory measurements 
in mixed model repeated-measures analyses. 
 
 
 
10. Monitoring and Quality Assurance 
 
The MPIs 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. Data 
will be checked for out of range values using frequency distributions prior to analyzing the data. The 
MPIs will be responsible for ensuring compliance with IRB procedures.  
• 
Ongoing monitoring: For each intervention session, an intervention checklist will be completed, 
detailing the information and exercises covered per session. Study therapists will undergo weekly 
supervision. All intervention sessions will be audio-recorded.  
Participant Confidentiality. All study materials will identify participants only by study ID, visit number, 
and visit date. The study research assistant will be trained in procedures to protect study participant 
confidentiality. Recordings of each session will be immediately de-identified (e.g., only ID, visit number 
and date) and stored on a password protected computer; the recording will be subsequently and 
immediately deleted from the recording device.  
Data Validity and Security. The research team will develop standard operating procedures for data 
collection, data management, and quality control. Drs. Vranceanu and Greenberg will oversee all 
procedures related to secure data collection and management, along with Dr. Parker and the project 
manager. Electronic information will be stored in REDCap (Research Electronic Data Capture), a free, 
secure, and HIPAA-compliant web-based application hosted by the Partners HealthCare Research 
Computing Enterprise Research Infrastructure & Services (ERIS) group (based at the PHS Needham 

corporate datacenter). All data will be stored on password protected computers that will be stored in 
secure locations at all times. Only research staff will have access to these data locations.  
 
Participants’ data will be identified by an ID number only, and a link between names and ID numbers will 
be kept on a separate folder on a Partners DropBox. Recordings will be immediately deleted from the 
digital recording device and stored under password protection. Among the 3 recruitment sites (MGH, 
Duke, Rush), PHI will be shared related to enrolled study participants. MGH will send and receive PHI 
to/from Duke and Rush using encrypted email as well as shared storage in the Partners-approved platform 
Dropbox. This PHI will be shared as sparingly as possible, but may include sharing names, ages, and 
contact information, among other identifiers. PHI will not be shared with any study collaborators outside 
of MGH, Duke, and Rush. 
 
Data from this study will be stored for seven 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.  
 
10.1 Review and Report Adverse Events and Unanticipated Problems  
If the research team identifies an adverse event (e.g., via study participants, research team members, 
clinicians, or review of electronic health records), we will follow the steps below:  
Serious Adverse Events. Any event that meets the FDA definition of a serious adverse event or that is 
deemed by the research team or safety and monitoring committee to impose significant hazard, 
contraindication, side effect, or precaution, will involve expedited review. All relevant information will be 
reported to the committee via secure e-mail within 2 days. The committee will review the information and 
determine the extent to which the event was relevant to the study procedures. Reporting to the IRB will be 
done within 24 hours; reporting to NIA (including responses of the committee and the IRB) will be done 
within 7 days.  
Non-Serious Adverse Events. Per study year and at study completion, the data safety and monitoring 
committee will receive a summary of adverse events per randomized group, including number and types 
of events, severity, time point, and determination of whether the events were study related.  
Study Stopping Rules. Give low risk associated with this behavioral study, we have not identified a 
stopping rule. However, during the study period, if the data safety and monitoring committee deems that 
participant risk outweighs participant benefit, the committee may choose to recommend study 
termination.  
10.2 External Factors That May Impact Participant Safety or Study Ethics  
Dr. Vranceanu and Greenberg will review relevant literature at least twice per study year to ensure that no 
new developments may affect the study or participants. The study will not place limits on usual care and 
all activities will be conducted over and above what patients and caregivers normally receive as part of 
usual care.