Integrating Mind Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Heterogeneous Chronic Pain
Phase: NA
Conditions: Pain, Chronic Pain, Physical Activity
Sponsor: Massachusetts General Hospital

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Integrating Mind-Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Chronic 
Pain 
NCT: 2017P000628  
January 3, 2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PARTNERS HUMAN RESEARCH COMMITTEE DETAILED PROTOCOL 
 
Version Date: 1.3.20 
 
 
I. BACKGROUND AND SIGNIFICANCE 
1.1. Chronic pain is prevalent, costly, and associated with decreased emotional and 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 emotional26-28, and physical function 29,30, regardless of the location and 
severity of pain31,32 . 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 and emotional function 33-36.  
1.2. Mind body programs show promise with chronic pain, but fail to improve physical function. Over the last decade, 
psychosocial treatments have evolved toward acceptance of pain and increased function regardless of pain sensations37-39. 
Mind body programs such as Acceptance and Commitment Therapy (ACT) and Mindfulness Skills Training (MST) programs 
focus on engaging in value driven behaviors, even if those are painful 39-42. 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 time43. Further, although IMMPACT44,8 recommendations clearly specify that physical function should 
be a required outcome in pain clinical trials, few studies include it45 ; when physical function is included as an outcome, 
effect sizes are small and fade over time46,47.. Thus, there is a need for novel interventions to improve emotional and 
physical functioning in this population.  
Physical function, defined following the ICF9, 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” and is consistently associated with mental and physical health benefits30. New recommendations from IMMPACT 
released during the summer of 20168 focus primarily on physical function, and urge researchers to directly target it during 
pain clinical trials as well as to conceptualize it comprehensively through self report measures of activity of daily living and 
physical activity (biased due to perceptions but important to patients), performance based measures (e.g., walk test; still 
subject to bias due to motivation and perceptions), and more objective measures of physical activity such as accelerometers 
or other digital monitoring devices like the Fitbit (which are valid and comparable to live observations of activity). No mind 
body studies in chronic pain to date have comprehensively addressed and assessed physical function/activity consistent with 
ICF9 and IMMPACT8 2016 criteria. This represents an unexplored opportunity to improve outcomes and sustain 
improvements in this population.  
1.3. Quota based walking is associated with improved outcomes in chronic pain patients, but not incorporated within mind 

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body programs. The US Department of Public Health’s research has shown a clear relationship between daily physical activity 
such as a 30-minute walk and several health related outcomes such as mortality, cardiovascular diseases and cancer48. 
Patients with chronic pain are sedentary and take significantly fewer steps per day than an average healthy adult49-52. 
Deconditioning, common in chronic pain, can be a significant risk factor for further pain conditions and disability52. Aerobic 
exercise has been shown to be the mainstay of chronic pain treatments for multiple, heterogeneous pain conditions including 
low back pain, fibromyalgia, and chronic myofascial conditions, with walking being the most commonly prescribed, but 
adherence being problematic51-53. When walking is quota-based (i.e., not contingent on pain level), results are even more 
promising54-56. Prior research has identified barriers to engaging and adhering to physical exercise in chronic pain, which 
included decreased mood, pain, coping difficulties (e.g., fear avoidance, catastrophic thinking about pain), programs that were 
too challenging (e.g., going to the gym), not meaningful, interfering with one’s life, or too difficult to implement57-60. Focus 
groups and qualitative interviews with patients with chronic pain have consistently showed that walking is the preferred 
method of physical activity in this population59. Despite the aforementioned evidence physical activity including walking are 
not addressed or assessed in mind body programs.  
1.4. Digital monitoring devices (DMDs) simultaneously reinforce and assess objective physical function/activity while 
maintaining motivation and safely increasing physical activity. Digital monitoring devices can make tracking activity in 
healthcare more convenient, accurate and cost effective for patients. Pedometers are associated with a significant increase in 
physical activity and decrease in body mass and blood pressure61,62. Piezoelectric accelerometers measure proper 
acceleration (“g-force”) and already have several clinical applications including validating self-report measures, assessing 
physical function via expended energy (EE) in different populations, as a novel way for clinicians to track physical activity and 
as a potential motivator for behavior, treatment alliance and adherence17,18,63. Although pedometers and accelerometers 
have been around for a long time61,62, long term adherence to their use has been problematic, and the lack of real time 
feedback has limited their ability to act as an intervention 64, 65. With the miniaturization of these devices and the advent of 
low energy Bluetooth 4.0 peripheral devices such as FitBit DMD, patients can now track their activity and receive real time 
feedback to increase motivation and reinforce activity. Fitbit DMDs represent an opportunity to directly measure objective 
physical functioning/activity, while actively reinforcing the patient in incremental, quota-based gains in activity that are 
individualized to each patient’s ability and gradually increased20. They are just beginning to see promising use with disabling 
illness66, while documentation of their adoption to chronic pain in adults has been through only anecdotal case reports. 
DMDs represent an unexplored opportunity to objectively measure, target and reinforce improvements in physical 
activity/function in chronic pain patients.  
1.5. Combining mind body programs with the Fitbit DMD represents an opportunity to directly target increased physical 
activity and improve physical and emotional outcomes in chronic pain patients. Mind body program teach patients skills that 
can address some of the barriers to engaging and adhering to activity delineated above such as low mood, over focus on 
control of pain rather than acceptance, fear avoidance and nonadaptive thoughts about pain. Fitbit DMDs can provide real 
time reinforcements that can increase motivation and enhance adherence. Further, physical activity can be individualized 
based on patient’s interest and paired with activities of daily living that are meaningful to participants and fit individual 
schedules, further decreasing barriers to engagement in exercise programs identified in prior research57-59.  
1.6. The Relaxation Response Resiliency Program (3RP10) is a comprehensive, multimodal mind body group based program 
that lends itself to the incorporation of the DMD. The 3RP is a novel multimodal mind body intervention that combines 

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relaxation response (RR) elicitation strategies (e.g. mindfulness, meditation) with increased awareness of emotional, cognitive, 
physical, behavioral and relational correlates of stress and symptoms and adaptive strategies such as positive perspectives, 
reappraisals and coping, social support and healthy lifestyle behaviors. All components of the 3RP have been individually 
found efficacious in improving outcomes in prior research42,43,67-69. Multimodal programs that incorporate a variety of 
skills (as the 3RP does) are more efficacious than unimodal programs70 . The 3RP, a skills based multimodal treatment 
program, is a perfect fit for adaptation for chronic pain management including addressing increased activity aided by the DMD 
to address comprehensively physical function, consistent with IMMPACT recommendations. (Figure 1; Table 1).  
Justification for using the 3RP: 1) it is a multimodal program consistent with recommendations for research in chronic pain70; 
2) has built in SMART (Specific, Measurable, Attainable, Realistic and Time based) goal setting in each session thus providing a 
built in framework for setting goals for increased activity paired with activities of daily living that are meaningful to patients 
and monitoring through DMDs. 3) teaches evidenced based skills that were previously found promising in medical populations 
including chronic pain42, 43, 67-69 when tested individually; 4) it has embedded educational information on the positive role 
of physical activity for healthy lifestyle; 5) it is designed to help patients adjust to chronic symptoms, rather than eliminate 
them, which is consistent with IMMPACT8; 6) the program accommodates a 6th grade reading level allowing for patients with 
low health literacy or learning disabilities; 7) it has evidence of high feasibility and acceptability in effectiveness studies11-14, 
16and a recent preliminary RCT16.; 8) it has an already developed time and dose matched attention placebo educational 
control, The Health Enhancement Program (HEP)21, that has already been adapted for pain and is currently used with 80% 
feasibility in the Pain Clinic at MGH.  
1.7. Preliminary research with the 3RP is encouraging. The 3RP has evolved over the years from its inception as Medical 
Symptom Reduction Program to its current standardized form. Effectiveness and pilot studies have found that attendance of 
the 3RP is associated with improvement in mental and physical symptoms in a variety of populations11-16. The 3RP was also 
found to have high adherence and improve pain intensity, frequency, tolerability and objective functioning in an open pilot 
with patients with refractory chronic mandibular join disorder14, and improve psychoemotional variables and pain 
catastrophizing in patients with neurofibromatosis 15,16. In a RCT of the 3RP versus an attention placebo control HEP, 
Vranceanu et al.16 found 100% adherence in both groups and significant improvement in both physical health and 
psychological quality of life in the 3RP group, which was over the minimal clinically important difference (MCID). Further, in 
patients with moderate and severe pain there was a decrease in both pain intensity and pain interference in the 3RP group, 
which were over the MCID. The 3RP is currently being tested in large RCT in medical populations such as multiple myeloma 
(PI: Denninger) and patients with comorbid PTSD and respiratory problems (PI: Gonzalez). Further, large RCTs of the 3RP are 
currently under review with NIH (e.g., U01NS102183 NINDS, Vranceanu PI; NINR Donelly PI) and DOD (PI: Vranceanu).  
1.8. The Fitbit is a popular, user friendly and accurate DMD, but not yet incorporate in the care of patients with chronic pain. 
Fitbit is the most popular and easy to use digital monitoring device71. Similar to Accelerometers, it uses tri-axis piezoelectric 
accelerometers and sophisticated algorithms to accurately measure the number of steps one takes while wearing these 
devices with only a 10.1% error rate, as well as number of active minutes72. Even though these consumer-based activity 
trackers are popular, inexpensive, convenient and accurate, “the widespread integration of this technology into medical 
practice remains limited”20. Despite this, several studies have utilized Fitbit with positive results. Washington et, al (2014)73 
found that the use of Fitbit within an operant quota based exercise program was associated with a 23% increase in step count 
in healthy adults, which was significant. In sedentary adults who used the Fitbit and set step goals, number of steps increased 

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by 108% average, with adherence rates between 92 and 95%19. Fitbit DMDs are superior to Acccelerometers and pedometers 
when worn for a long period of time, with activity and/or number of steps doubled, and higher number of days wearing the 
tracker for the Fitbit group18,19,74. Adherence is also higher with the Fitbit, with 96% of participants wearing the tracker 4 or 
more days/week; 88% using the Fitbit website; 52% logging on 2-3 days per week; 72% viewing the tracker data 1 or more 
times per day; 80% having no computer issues or ; technical issues with tracker; 100% liked wearing the tracker; and 96% 
stating that the tracker was helpful in increasing activity vs. 32% thought a pedometer was helpful. Very few studies have 
examined the Fitbit DMD in patients with chronic pain. A recent study in patients with rheumatoid arthritis74 who wore both 
the wrist Fitbit and an accelerometer as part of a 4-week protocol study found high adherence to the use of both devices, and 
higher preference for the Fitbit. Kulich et al (2015) conducted a case study and found an increase by 1,175 steps over 4 weeks 
in a sedentary adult with chronic hip pain75. In sum, the Fitbit DMD appears to have high adherence and acceptability, shows 
promise in increasing activity when paired with a behavioral program, but has not yet been properly tested in patients with 
chronic pain.  
2.1. Conceptual model: Our conceptual model of adaptation of the general 3RP10 follows recommendations from IMMPACT 
and combines key concepts of ICF with key features of relevance to patients with heterogeneous chronic pain that specifically 
target improved physical activity/function, and recommendations of multimodal programs to improve outcomes in chronic 
pain clinical trials70. We used a comprehensive conceptualization of physical function that includes patient reported 
outcomes (e.g., patient’s perception of engagement in physical activity and activities of daily living), performance based 
function (e.g., a more objective test of walking ability) and objective function (in vivo assessment of number of steps). This 
comprehensive conceptualization is important because it provides data on the impact of pain and treatment effects beyond 
symptom reduction alone, a primary concern depicted by patient focus groups and surveys32. Our model is based on the 
guiding hypotheses that the synergistic association between the evidence based skills of the 3RP adapted for the needs of 
patients with chronic pain, and DMD is the most efficient and effective way to improve emotional function as well as ALL 
aspects of physical function depicted above, which have been shown as independent in prior research8 . Adaptations of the 
multimodal general 3RP will be done consistent with theoretical models of the fear- avoidance model of pain34, cognitive 
model of pain6, acceptance and commitment therapy76, mindfulness77, and positive psychology78, to help patients engage 
in activities that are meaningful and mapped to each individual’s level of functioning and life circumstance through the use of 
quota based pacing with in vivo reinforcement facilitated by the DMD (Figure 1). As depicted, we propose that the 
interrelation among pain specific RR elicitation techniques, pain and activity awareness and adaptive strategy including 
increased activity will lead to decreased reactivity to pain, increased activity and promote awareness and calm during 
activities, even when these are painful. The built in, live reinforcement of activity through the DMD and pairing of physical 
activity with activities of daily living depicted by patients as important are conceptualized as key factors in improving 
outcomes will maintain motivation and help participants stay accountable for meeting specific physical activity goals. The 
p3RP and Fitbit DMD are conceptualized as acting synergistically. p3RP acts 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 activity) by using various RR strategies, positive psychology concepts and adaptive thinking10, while Fitbit 
DMDs, based on operant approaches previously depicted as promising in this population, directly increased activity through 
“quota-based” non “pain contingent” activity and direct feedback on number of steps achieved 79,80. In our 
conceptualization the DMD is necessary in order to bypass barriers to physical activity, maintain motivation and reinforce 
activity in real time.  

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In sum, both the adapted 3RP and the operant based Fitbit DMD approach improve physical and emotional function by 
focusing on increasing activity regardless of pain81,19,10, and their interaction is hypothesized to further improve outcomes. 
Proposed changes to the general 3RP are depicted in CAPS IN RED. The DMD will give direct reinforcement and monitoring of 
activity, while the 3RP will aid with pain specific coping skills that act as deterrents from activity in chronic pain, such as 
nonadaptive cognitions, fear of pain, hypervigilence to pain sensations, among others. Adaptations for the pain specific 3RP 
(p3RP) will be identical but will not target adherence to the DMD including meeting daily step goals. The model depicted in 
the figure below  specifies that the p3RP and DMD (e.g., p3RP-DMD) will interact and improve physical function both directly 
and indirectly through improved coping, decreased pain catastrophizing and decreased fear of pain.  
3.1 Procedures Overview  
The present proposal aims to adapt, pilot and examine the credibility, acceptability, adherence and feasibility of the 3RP 
adapted for chronic pain (p3RP), and the p3RP-DMD, which is the pain specific 3RP integrated with a commercial digital 
monitoring device (DMD), the Fitbit. This R34 feasibility project will lay the groundwork for a large RCT of the p3RP-DMD vs 
p3RP vs pHEP attention placebo control, and will help understand whether the DMD Fitbit is  
   
   
necessary to comprehensively improve function. Consistent with prior theory within a subsequent R01 we will test the 
hypothesis that the p3RP-DMD will be superior to the p3RP and pHEP in improving and sustaining improvements in 

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objective, performance based and self-reported physical and emotional function in patients with heterogeneous chronic 
pain. Using the specific NCCIH R34 mechanism we now follow an iterative design 82,83 to adapt the general 3RP and refine 
both the p3RP and the integrated p3RP-DMD interventions to maximize feasibility, acceptability, credibility, recruitment 
protocol, adherence and measurements for patients with heterogeneous chronic pain. To allow objective measurement of 
activity in both p3RP and p3RP-DMD groups, we will use Accelerometer DMDs for 1 week at baseline and post-test. The 
Fitbit DMD will be used to address/reinforce activity consistent with an individualized pacing plan, and to assess daily 
activity during the program only for those randomized to the p3RP-DMD.  
During the RCT phase, participants will be randomized 1:1 to p3RP-DMD or p3RP using block randomization. The study 
team will be blinded and the program manager, not involved in the study, will be responsible for assigning numbers to 
each participant. Participants will not know whether they are assigned to the p3RP-DMD intervention or the p3RP control. 
Rather, they will be informed that they will be randomized to one of 2 physical activity groups, in an effort to identify 
which one works best in patients with chronic pain. In order to prevent unblinding, participants will be asked to not share 
information discussed in the group on social media sites (e.g., Facebook groups or internet chat groups) or with other 
acquaintances for the duration of the study. We will also explain to study participants how sharing of information would 
potentially negatively impact the validity of study results. 
3.2. The 3RP. The novel 8-week group-based general 3RP10 has been developed by a team led by Dr. Park aided by Dr. 
Vranceanu, and will be further adapted for patients with heterogeneous chronic pain including increased physical activity. Drs. 
Vranceanu and Park have extensive experience adapting and delivering the 3RP to a variety of populations (see preliminary 
data). Dr. Vranceanu published the first and only RCT16 of the 3RP adapted for patients with neurofibromatosis (NF; 3RP-NF) 
and found excellent feasibility and acceptability, as well as level 2 evidence of improvement in quality of life in those 
randomized to 3RP-NF versus those who attended the attention placebo control HEP-NF; improvements maintained at 6 
months follow-up. The 3RP model and proposed adaptations for the needs of patients with chronic pain, including integration 
of DMD are depicted in Figure . A description of each of the 8 general 3RP group sessions as well as adaptations for proposed 
for the p3RP-DMD are depicted in Table 1. Adaptations for the pain specific p3RP will be identical but will not include DMD 
integration adaptations. The 3RP introduces and reinforces new skills through didactics, in-session activities, discussions, and 
daily home practice assignments. Homework involved setting SMART goals, recording type and amount of daily RR practice, 
and recording daily 1-3 appreciations. Each session begins with the practice of a new exercise to elicit the RR. The relaxation 
method is then coordinated with the remaining session content. For instance, the clinician may introduce imagery of a 
peaceful place as a relaxation method, and then transition to didactics and exercises that focus on skills for building a positive 
perspective. The main proposed adaptation is the focus on pain as a stressor, rather than on general stress, and uses skills to 
directly target increased physical activity. General adaptations will include: 1) setting weekly SMART goals specific to quota 
based pacing to increase activity, individualized to each patient based on baseline or subsequent activity level in the previous 
block, and instruction on how to pair these with feedback from Fitbit (in the p3RP-DMD only; 2) modification of all RR 
exercises to address habituation to pain, mindfulness when experiencing pain; 3) employment of RR during exercise to cope 
with pain and increase enjoyment; 4) pairing exercise with activities of daily living that are important to participants, and link 
these within the SMART goals; 5) education information of the benefits of exercise, decrease sedentary time, and healthy 
patterns of activity in chronic pain through non pain contingent pacing; 6) pain specific adaptations of all skills (pain 
acceptance, restructuring of nonadaptive pain thoughts, etc); 7) specific Fitbit instructions (charging, downloading, using 
feedback, etc).  
 
 

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Inclusion Criteria  
Rationale  
Male and female outpatients, age 18 years or older  
Population under study  
   
Have nonmalignant chronic pain for more than 3 months  
International Association for Study of 
Pain (IASP)1 criteria  
Able to perform a 6-minute walk test  
Program will involve increase 
number of steps/outcome measure  
Owns a smartphone with Bluetooth 4.0  
Necessary for pairing with DMD and 
storing/downloading data.    
Willingness and ability to participate in the 3RP-DMD intervention and to comply with the 
requirements of the study protocol (including weekly sessions and daily DMD use).  
Human Subjects concern, feasibility  
Free of concurrent psychotropic or pain medication for at least 2 weeks prior to initiation 
of treatment, OR stable on current psychotropic or pain medication for a minimum of 6 
weeks and willing to maintain a stable dose  
Treatment confound  
Leads a sedentary lifestyle 
Treatment confound 
Exclusion Criteria  
Rationale  
Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., 
malignancy)  
Treatment confound  
Serious mental illness or instability for which hospitalization may be likely in the next 6 
months  
Feasibility, participant safety  
Current suicidal ideation reported on self-report  
Subject safety  
Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, current 
substance abuse or dependence and  
Treatment confound  
Current substance use disorder, within the past 6 months  
Treatment confound  
Practice of yoga/meditation, or other mind body techniques that elicit the RR, once per 
week for 45min or more within the last 3 months or less.  
Treatment confound  
Regular use of DMD in the last 3 months. 
Treatment confound 

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Adaptations for the p3RP will follow the same framework without any of the DMD specific adaptations. All adaptations will 
occur after input from patients through the focus groups.  
II. 
SPECIFIC AIMS 
Specific aims for phase I are: 
Aim 1: In the first step our multidisciplinary team will propose modifications to the general 3RP to address the needs of 
patients with chronic pain reported in the literature, with a focus on improving physical activity and function (see Figure , 
Table 1). Based on this information, we will develop a semi-structured qualitative interview script.  
 Hypotheses: NA 
Aim 2: In the second step we will use the semi-structured qualitative interview to guide focus groups (30 total) to gather 
feedback on the intervention components, gauge treatment needs and expectations, as well as barriers and ways to facilitate 
participation in the intervention and adherence to the use of DMD and 3RP specific practice, among chronic pain patients. 
Participants will also be given an exit interview to answer questions that they might not feel comfortable discussing during the 
group setting (e.g., triangulation).  
Hypotheses: NA 
Specific aims for phase II are: 
Aim 3: In the first step, we will pilot the adapted p3RP-DMD and p3RP programs in two initial groups (N=10/group, 20 total) of 
chronic pain patients and assess preliminary credibility, acceptability, satisfaction of treatment, feasibility (of recruitment and 
instruments) and adherence to the use of the DMD and to p3RP-specific homework.  
Hypotheses: N/A 
Aim 4: In the second step, we will conduct a semi-structured comprehensive qualitative exit interview at the end of the groups 
focused on discussing patients’ perception of the rationale for and helpfulness of each individual p3RP specific module, 
patients’ perception of the rationale and helpfulness of using the DMD in increasing physical activity/function, patients’ 
perception of the importance and ease of adherence to DMD and adherence to p3RP specific homework, and patients’ 
burden of questionnaire completion. 
Hypotheses: N/A 
 
Specific aims for phase III are: 
 
Aim 5: We will conduct an RCT (N = 80 chronic pain patients, 40/arm, 8 groups total, accounting for 25% attrition) of the newly 
refined p3RP-DMD versus the newly refined p3RP. We will compare the credibility, acceptability, adherence, satisfaction with 
treatment, feasibility (of recruitment, refined intervention, study procedures, and instruments) between the two 
interventions.  
Hypotheses: N/A 
 
Aim 6: By the end of this trial we aim to have two interventions (p3RP-DMD and p3RP) with high credibility, acceptability and 
feasibility, a recruitment, retention plan and study procedures protocol to ensure minimal random error, and outcome 
measures sensitive to change.  
Hypotheses: N/A 
Engagement in regular intensive physical exercise for >30 min daily. 
Treatment confound 
Unable to walk without use of assistance (e.g., walker, cane, wheelchair) 
Treatment confound  
Limitations/restrictions on physical activity due to health conditions 
Feasibility, participant safety  

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Aim 7: At the end of study enrollment (e.g., no longer recruiting or enrolling participants and only conducting follow-ups with 
participants and conducting data analysis), we will conduct semi-structured qualitative interviews (12 total) once participants 
have completed all study procedures (e.g., completing both baseline and post-test questionnaires and wearing the 
accelerometer at both time points). This interview will be used to inform the future development of the program and to 
understand ways to better improve physical activity and discuss participants perceptions of the accelerometer.  
Hypotheses: N/A 
 
 
III. 
SUBJECT SELECTION 
Subjects will be adult new patients presenting to Partners-affiliated medical practices (e.g., the Pain Clinic at Massachusetts 
General Hospital, the Spine Center at Massachusetts General Hospital, Brigham and Women’s Hospital Anesthesia and Pain 
Management Center, and Spaulding Rehabilitation Hospital’s outpatient center), and Boston area pain centers and medical 
practices that treat chronic pain patients. The MGH Center for Pain Medicine sees approximately 15,000 patient visits yearly. 
The main diagnoses are: chronic low back pain and fibromyalgia. Inclusion and exclusion criteria were selected following 
guidelines for psychosocial treatment development 82-83 (see Table 1. Above).  
Participants will be recruited among patients with heterogeneous chronic pain who present to Partners-affiliated medical 
practices (e.g., the Pain Clinic at Massachusetts General Hospital, the Spine Center at Massachusetts General Hospital, 
Brigham and Women’s Hospital Anesthesia and Pain Management Center, and Spaulding Rehabilitation Hospital’s outpatient 
center), Boston area pain centers and medical practices that treat chronic pain patients, and meet study criteria. Participants 
may also hear about the study from Partners Rally, from chronic pain groups online, or recruitment flyers with tear-off 
research coordinator contact information that will be posted in the hospital and around referral sites. We will also post to our 
Twitter page, with the following content: “Can increased physical activity with or without the help of a Fitbit help with chronic 
pain? IBHCRP’s GetActive! study is looking to find out! To learn more or get involved, click here:” with a link to our study on 
Rally or an attachment of the flyer. All patients within the clinic meet with a medical provider for a medical evaluation as part 
of usual care, which also includes a urine toxicology pain profile for patients on controlled substances and review of the MA 
Prescription Monitoring Program.  
Recruitment will also occur through the Research Patient Database Registry (RPDR). The RPDR is a centralized clinical data 
registry that gathers data from various hospital legacy systems and stores it in one place. Researchers access this data using 
the RPDR online Query Tool. They may query the RPDR data for aggregate totals and, with proper IRB approval, obtain medical 
record data. The RPDR ensures the security of patient information by controlling and auditing the distribution of patient data 
within the guidelines of the IRB and with the use of several built-in, automated security measures. To identify potentially 
eligible patients: 
1.) An RPDR query will be performed to identify those patients with chronic pain diagnoses. Study staff will review 
the medical record to confirm potential participant eligibility and to identify their linkage to an MGH primary care 
physician. Access to patients’ medical records will be restricted to this pre-enrollment recruitment phase. 
2.) Study staff then will obtain permission for initial contact from each potentially eligible patient’s PCP by having 
providers review letters and discard ones that they do not approve. 
3.) For physician-approved patients, study staff will send a study introduction letter from the patient’s physician (with 
the clinician’s name at the bottom) and a study opt-out letter signed by Ana-Maria Vranceanu (PI). The letter from 
the PCP informs the patient that he or she is allowing the study to contact patients with chronic pain in case they 
are interested in learning about the study. Dr. Vranceanu’s letter is an opt-out letter describing the study, the 
procedure to opt out of further contact, and whom to call for further information.  
4.) Should study staff receive no reply within 10 days, staff members will call the patient on the phone to assess 
interest in the study and to describe the study over the phone. If the patient remains interested, staff will confirm 
eligibility and assess for inclusion and exclusion criteria.  

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5.) For potentially eligible patients who are enrolled in the MGH Research Options Direct to You (RODY) Program, we 
will send them an opt-out letter and call 10 days later to inform them about the study. RODY identifies patients 
who are willing to be contacted directly about research studies. Patients who have agreed to be contacted 
directly are identifiable through the RPDR search; each patient’s RODY status is available in the demographics 
table included in the RPDR output. 
 
A research assistant will provide study details to interested participants and screen for eligibility; those who wish to participate 
will complete the informed consent process. These procedures will be done in a private setting, and will not impact in any way 
the delivery of care within the practice. This strategy has been used successfully in prior studies conducted by the PI. Data will 
be collected in MGH Integrated Brain Health Clinical and Research Program and will be managed and analyzed collaboratively 
by investigators at MGH. 
4. Feasibility The Pain Clinic at MGH is a busy clinical and research practice. The Center has approximately 15,000 patient 
visits yearly. Of these, approximately 47% are new chronic pain patients and the rest are follow-ups. Approximately 10% of 
participants come in a wheelchair and would be excluded from this study. As such, we can be confident that we will be able to 
identify and recruit the necessary number of participants.  
IV. 
SUBJECT ENROLLMENT 
Interested participants who meet study criteria will be consented and then scheduled to participate in one of the focus groups 
(in Phase I) or intervention groups (in Phases II and III).  
V. 
STUDY PROCEDURES 
Phase I:  
After enrollment, participants will be asked to attend one of the focus groups. The focus groups will be conducted in person at 
MGH by Dr. Vranceanu and Zale. At the end of the focus group participants will be asked to complete a paper and pencil exit 
interview including demographic questionnaire.  Participants will be compensated $10 for transportation and $10 for 
completion of the focus group including the exit interview (maximum $20 per participant). 
Focus group participants will be given an exit interview to provide additional private information that they might not be 
comfortable sharing in a group. Utilizing different data collection modalities (group and individual, in-person and written) is a 
qualitative strategy, known as triangulation, to enrich data collection and enhance data credibility. Focus group interview 
domains will include: 1) case based scenarios of perceived effects of chronic pain on quality of life and function; 2) areas of 
need for skills training; 3) impact of pain on activity, work, relationships, and 4) best strategies for recruitment and retention 
for chronic pain patients; 5) difficult situations/challenges experienced by chronic pain patients, 6) specific topics they would 
like to learn about; 7) knowledge about mild exercise such as walking and chronic pain; 8) barriers to exercise/walking; 9) 
barriers or concerns about the use of the DMD.  
Focus group script (will be finalized in aim 1). 
Exit interview (will be finalized in aim 2).  
End of phase 1 deliverables: 1) adapt the original 3RP intervention/manual to address the needs of patients with chronic pain 
including incorporation of DMD and improvements in physical and emotional function (see Figure 1; Table 1); 2) 
identify/problem solve potential barriers to adherence to 3RP homework and DMD use during the duration of the program, and 
Accelerometer use for baseline and posttest assessments, including acceptability, credibility, feasibility, recruitment and 
adherence; 3) solidify inclusionary and exclusionary criteria and 4) finalized instruments to use in phase 2. At the end of this 
phase we will have 2 interventions: p3RP (3RP adapted for chronic pain and increased activity) and p3RP-DMD adapted for 
chronic pain and increased activity with live reinforcement through Fitbit DMD reinforcement.  
Phase II:  

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After enrollment, participants will be asked to attend one of the two intervention groups, p3RP or p3RP-DMD (N= 30) in an 
open pilot. Participants will have a choice of either the p3RP or p3RP-DMD until one group is full; the remaining participants 
will then be assigned to the available group. The intervention groups will be conducted in person at MGH trained study 
therapists over 8 weeks. Participants will complete demographics questions, baseline psychological and behavioral 
questionnaires, as well as an exit interview. Interview domains will include: 1) satisfaction with the intervention, 5) areas that 
were most helpful, 6) areas that were least helpful, 7) ways to improve the intervention and its acceptability (e.g., satisfaction, 
fit of the intervention within daily life, confidence in treatment and therapist), 8) perceived increased in self report, objective 
and performance function. Participants will also give feedback about the assessments and whether they capture aspects 
important to them, and we will refine the length, timing, and content of these as needed. We will ask specific questions about 
any problems with adherence to DMD and 3RP homework. Questions will also be asked about the therapeutic alliance with 
the group leader, and the extent to which participants felt connected and understood by the group leader. Finally, we will ask 
questions about the best approaches for participant recruitment and retention. Drs. Vranceanu and Park have used these 
types of procedures in other mind-body intervention studies. Information from qualitative interviews will be corroborated 
with information from the satisfaction and the credibility questionnaires and will serve to refine the intervention for Phase 3. 
 
Participants in the p3RP-DMD group will pair their Fitbit DMD to a smartphone with Bluetooth, and the Fitbit will inform an 
individualized quota-based behavioral plan to improve both adherence and efficacy. All participants will also wear an 
accelerometer for 7 days at baseline and at the end of the intervention. After 7 days, participants will return the 
accelerometers in addition to an accelerometer wear time log. Participants will be compensated $20 for each assessment 
completed, $10 for transportation (for each visit), and $10 for completion of the exit interview.   
Phase III: 
During enrollment, participants have the option to consent to receiving reminders in the form of phone calls, text messages, 
or email over the course of the intervention, depending on personal preference. Between-session contact will be used with 
the goal of increasing treatment adherence and engagement. Participants may opt-out of the text message contact option at 
any point. 
After enrollment, participants will be assigned to one of the two intervention groups using a randomized block design to 
ensure that equal numbers of patients are split into the p3RP-DMD and p3RP groups. To prevent participant unblinding, 
participants will be asked not to share specific information discussed in the group (e.g., skills learned, topics discussed) on 
social media sites (e.g., Facebook groups or internet chat groups) or with other acquaintances for the duration of the study. 
The groups will be conducted in person at MGH by trained study therapists over 12 weeks and include 10 active intervention 
sessions. Each session will last approximately 90 minutes. Participants will also be asked to answer follow-up assessment 
questionnaires 3 months following program completion. These questionnaires will be administered over the phone for 30-45 
minutes.  
Participants will complete demographics assessments at baseline, in addition to psychological/behavioral assessments and a 
6-minute walk test at both baseline and post-test timepoints. Participants in the p3RP-DMD group will pair their Fitbit DMD to 
a smartphone with Bluetooth, and the Fitbit will inform an individualized quota-based behavioral plan to improve both 
adherence and efficacy. All participants will also wear an accelerometer for 7 days before the first treatment session (baseline) 
and for 7 days after the final treatment session (post-test). After each assessment week, participants will return the 
accelerometers in addition to a wear time log.  
 
The following measures will be administered at all timepoints unless otherwise stated. Questionnaires at 3-month follow-up 
will be administered over the phone. 
Demographics – baseline only 
Credibility and Expectancy Questionnaire (CEQ) – baseline only 
Pittsburgh Sleep Quality Index (PSQI) 
PROMIS Physical Function SF 
Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) 
WHO Disability Assessment Scale (WHODAS) 2.0 

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Numerical Rating Scale for Pain (NRS) 
Pain Resilience Scale (PRS) 
PROMIS Anxiety SF 
PROMIS Depression SF 
PROMIS Social Isolation SF 
PROMIS Emotional Support SF 
Measure of Current Status (MOCS) 
Pain Catastrophizing Scale (PCS) 
Tampa Kinesiophobia Scale 
Cognitive and Affective Mindfulness Scale (CAMS-R) 
Patient Global Impression of Change (PGIC) – post-test and 3-month follow-up only 
Client Satisfaction Questionnaire (CSQ-3) – post-test and 3-month follow-up only 
Participants will be given the option to complete a maximum of two make-up sessions via the Vidyo teleconferencing 
software. Vidyo is a HIPAA approved, secure web platform used in clinical care for patients at MGH. Participants will have a 
Vidyo meeting with study staff to ensure that they are comfortable using Vidyo for make-up sessions only. Ratings of patient 
satisfaction are high, and there have been no complaints of technological difficulties. Participants will be compensated $20 for 
each of three assessments completed and $10 for transportation (for each group session attended). They can also receive up 
to two additional $25 payments for completing 6 group sessions and 8 group sessions. The maximum compensation per 
participant is $230.  
 
At study enrollment completion (e.g., no longer recruiting or enrolling, and only completing follow-up measures and data 
analysis), we will conduct 12 qualitative exit interviews with participants who have completed all study measures (e.g., 
completing questionnaires at both baseline and post-test and wearing the accelerometer at both baseline and post-test). 
Participants will be randomly selected to complete the interview, which will last 15 minutes and will be completed over the 
phone with the study clinician. We will conduct qualitative exit interviews within the following four categories: 1) 3 
participants who were sedentary at baseline (i.e, less than 5,000 steps) and increased their step-count at post-test; 2) 3 
participants who were sedentary and did not increase their step-count at post-test; 3) 3 participants who were not sedentary 
at baseline and did increase their step-count; 4) 3 participants who were not sedentary at baseline and did not increase their 
step-count at post-test. Participants will be called and will be contacted until clinician is able to speak to participant. If a 
participant declines, a new random participant number will be selected.  
 
VI. 
BIOSTATISTIC ANALYSIS 
Phase I 
The qualitative focus group data and individual exit interview data will be transcribed and analyzed, using NVivo 10 qualitative 
software, and we will conduct thematic content analysis using guidelines provided by Miles and Huberman (1984). The 2 
coders (AMV and study clinician) will meet on an ongoing basis with Dr. Park to discuss the structural thematic framework, 
categories, and coding plan. To ensure coding reliability, coding discrepancies will be resolved through discussion and 
comparison of raw data. Coding will continue until a high reliability (Kappa= >0.80) is established. Once these data analyses 
are completed, the multidisciplinary team will provide the expert review of data, to discuss the interpretation of our findings 
in the context of current research on chronic heterogeneous pain. 
Phases II and III 
The p3RP-DMD intervention group will use a Fitbit DMD through which participants will use Fitbit accounts with deidentified 
physical measurements (i.e., height and weight) and profile information with approximate birthdays (e.g., month and year 
only). Participant account names will be set up with a study ID number as the first name and “Participant” as the last name. 
De-identified DMD data will be processed securely though the Fitbit data collection company, Fitabase. Fitabase does not 
store identifiable data and all participant data is uploaded through encrypted server communication and stored in a highly 
secure infrastructure.  

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The qualitative exit interview data will be transcribed and analyzed, using NVivo 10 qualitative software, and we will conduct 
thematic content analysis using guidelines provided by Miles and Huberman (1984). The 2 coders (AMV and study clinician) 
will meet on an ongoing basis to discuss the structural thematic framework, categories, and coding plan. To ensure coding 
reliability, coding discrepancies will be resolved through discussion and comparison of raw data. Coding will continue until a 
high reliability (Kappa= >0.80) is established. Once these data analyses are completed, the multidisciplinary team will provide 
the expert review of data, to discuss the interpretation of our findings in the context of current research on chronic 
heterogeneous pain. 
 
VII. RISKS AND DISCOMFORTS 
Patients will be informed that there are no foreseeable physical risks from this research study. They will be informed that in 
the unlikely situation that they might feel uncomfortable with the topic of discussing within the group, they can alert the 
group leader who will provide help, as needed.   
As Vidyo is HIPAA approved and secure, there are no risks associated with its use. However, participants will be asked to 
ensure that they are in a private room during the group sessions, to protect their privacy and that of group members. As with 
any group studies, there may be confidentiality issues, but we will discuss the importance of maintaining confidentiality at the 
beginning of each group. 
VIII. POTENTIAL BENEFITS 
Patients will be informed that there may be no direct benefit from participating in this research study. Some patients may 
become more physically active, more resilient, better able to cope with pain and stress, and experience a better quality of life.  
In the future, knowledge from this research may benefit others by providing information on how to better mind body 
interventions for patients with chronic pain. 
IX. MONITORING AND QUALITY ASSURANCE 
Phase I: The focus groups will be conducted uniformly using a semi structured interview script that will be finalized during the 
first few months of the study.  The Principal Investigator will be responsible for ensuring compliance with IRB procedures. 
 
Phase II: Study therapists will have weekly team meetings and clinical supervision. Study staff will follow the patient manuals 
for each group and assure that all items on all questionnaires have been addressed. Once completed, data will be checked for 
out of range values using frequency distributions prior to analyzing the data. The Principal Investigator will be responsible for 
ensuring compliance with IRB procedures. 
 
Phase III: Feasibility will be assessed as depicted in the prior section. We will calculate the proportion of patients who 
complete at least 6 of the 8-planned treatment sessions (75%), along with the 95% confidence interval (CI) around this 
discontinuation rate. Treatments are considered feasible if over 70% of participants complete at least 6 treatment sessions. 
 
Adherence to treatment manual: Drs. Vranceanu and Park will assess adherence to treatment by listening to the 
audio recorded sessions, completing and analyzing the therapist adherence checklists. Dr. Park will rate adherence for the 
groups led by Dr. Vranceanu in phase 3. Dr. Vranceanu will rate adherence of study clinician in phase 3. The therapists will also 
complete session adherence checklists. 
 
Adherence to Accelerometer and Fitbit DMD: We will report number of days participants in both groups wore the 
Accelerometers at baseline and at post-test, and average number of days the Fitbit was used in the p3RP-DMD group. 
 
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