Healthy Mind Healthy You: A Study of Mindfulness
Phase: NA
Conditions: Stress
Sponsor: Massachusetts General Hospital

 
 
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Institutional Review Board 
Application to Conduct Research with Human Participants 
Patient-Centered Outcomes Research Institute 
Healthy Mind Healthy You: A Study of Mindfulness 
Protocol #HMHY002 
 
I. 
Personnel  
Table 1: Coordinating Site 
 
 
Principal Investigator 
(PI) 
Other  
Investigators 
Correspondent (primary 
point of contact for 
correspondence, if 
applicable) 
Name 
(First and 
Last, 
Degree) 
Andrew Nierenberg, 
MD 
(1) Louisa Sylvia, PhD 
(2) Thilo Deckersbach, PhD 
(1) Sophie Greenebaum, 
BA 
(2) Alec Shannon, BS 
(3) Nevita George, BS 
Organiza
tion and 
Departm
ent  
Massachusetts General 
Hospital, Psychiatry 
Massachusetts General 
Hospital, Psychiatry 
Massachusetts General 
Hospital, Psychiatry 
Mailing 
Address 
50 Staniford Street, 
Suite 580 
Boston, MA 02114 
50 Staniford Street, Suite 
580 
Boston, MA 02114 
50 Staniford Street, 
Suite 580 
Boston, MA 02114 
Preferred 
Phone  
617-724-0837 
(1) 617-643-4804 
(2) 617-643-2076 
(1) 617-724-9033 
(2) 617-724-1858 
(3) 617-726-0360 
Preferred 
E-Mail 
Address 
anierenberg@mgh.har
vard.edu 
(1) 
lsylvia2@mgh.harvard.edu 
(2) 
deckersbach.thilo@mgh.ha
rvard.edu 
(1) 
sgreenebaum@mgh.har
vard.edu 
(2) 
apshannon@mgh.harva
rd.edu  
(3) 
ngeorge5@mgh.harvard
.edu 
 
 
Internal office use only: 
Full Board ____ Expedited____ 

 
 
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    Table 2: Recruitment Sites 
PPRN Site 
Investigators 
Correspondent (primary 
point of contact) 
Alzheimer PPRN (Mayo Clinic) 
 
Ronald Petersen, PI 
Email: 
peter8@mayo.edu 
 
Alex Alexander 
Email: 
Alexander.Alex@mayo.edu 
 
ABOUT Network (University 
of S. Florida) 
 
Rebecca Sutphen, PI 
Email: 
rebecca.sutphen@gmail.co
m 
 
 
Beth Ann Clark 
Email: 
Beth.Clark@epi.usf.edu 
 
AR-PoWER (Global Healthy 
Living Fdn) 
 
Ben Nowell, PI 
Email: 
bnowell@ghlf.org 
 
Ben Nowell 
Email: 
bnowell@ghlf.org 
 
CCFA (University of North 
Carolina) 
 
Millie Long, PI 
Email: 
millie_long@med.unc.edu 
 
Anne Green 
Email: 
annegree@email.unc.edu 
 
CENA (Genetic Alliance) 
 
Sharon Terry, PI 
Email: 
sterry@geneticalliance.org 
 
1) Andrea Goodman 
    Email: 
agoodman@geneticalliance.
org 
 
2) Kathleen Murphy 
     Email: 
kmurphy@geneticalliance.or
g 
 
COPD (Kaiser) 
 
Richard Mularski, PI 
Email: 
Richard.A.Mularski@kpchr.o
rg 
 
Cara Pasquale 
Email: 
cpasquale@COPDFoundatio
n.org 
Duchenne Registry 
Ann Martin, PI 
Email: 
ann@parentprojectmd.org 
Holly Peay 
Email: 
hpeay@rti.org 
 

 
 
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Health eHeart Alliance 
Mark Pletcher, PI 
Email: 
Mark.Pletcher@ucsf.edu 
 
Madelaine Faulkner 
Email: 
Madelaine.Faulkner@ucsf.e
du 
 
ImproveCareNow 
Michael Seid, PI 
Email: 
Michael.Seid@cchmc.org 
Melissa Mock 
Email: 
Melissa.Mock@cchmc.org 
 
Interactive Autism Network 
Kiely Law, PI 
Email: 
LawK@kennedykrieger.org 
Paul Lipkin 
Email: 
lipkin@kennedykrieger.org 
 
MS PPRN 
Robert McBurney, PI 
Email:  
rmcburney@acceleratedcur
e.org 
 
Sara Loud 
Email: 
sloud@acceleratedcure.org 
 
PARTNERS PPRN 
Esi Morgan, PI 
Email: 
Esi.Morgan_DeWitt@cchmc.
org 
 
Anne Paul 
Email: 
Anne.Paul@cchmc.org 
 
Phelan-McDermid Syndrome 
Data Network 
 
1) Megan O'Boyle, Co-PI 
    Email: 
meganoboyle@gmail.com 
 
2) Liz Horn, Co-PI 
    Email: 
elizabeth.horn@gmail.com 
 
Brittany McLarney 
Email: 
brittany@pmsf.org 
 
PI Connect (Immune 
Deficiency Foundation) 
Christopher Scalchunes PI 
Email: 
cscalchunes@primaryimmun
e.org 
Sarah Rose 
Email: 
srose@primaryimmune.org 
PRIDEnet 
Mitchell Lunn 
Email: 
lunn@stanford.edu 
Zubin Dastur 
Email: 
zdastur@stanford.edu 
 
SAPCON 
1) Susan Redline, PI SAPCON 
PPRN 
   Email:  
Rebecca Rottapel 
Email: 
rrottapel@partners.org 

 
 
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sredline1@partners.org 
2) Jessie Bakker, PI Cross-
PPRN study 
    Email: 
jpbakker@partners.org 
 
 
 
Vasculitis PPRN 
Peter Merkel, PI 
Email: 
Peter.Merkel@pennmedicin
e.upenn.edu 
Kalen Young 
Email: 
kyoung@vasculitisfoundatio
n.org 
 
 
 
a. PI has completed human research participant protections training (such as NIH or CITI) 
[Required] 
 
 Yes    
 No     
b. Other key study personnel (co-PIs, project manager and/or study coordinator) has 
completed human research participant protections training [Required] 
 
 Yes    
 No     
 
c. PI will benefit significantly (financially or personally) through this research. 
 
 Yes    
 No     
 
If yes, please explain: 
 
II. 
Research Description Regulation 45CFR46.111(1)(a) 
 
Nature and Purpose of Proposed Study  
a. Technical (Scientific) Abstract:  
 
Background: Individuals with chronic diseases and their caretakers experience stress and 
decreased well-being.  In 2011, the American Psychological Association (APA) conducted the 
“Stress in America” survey of over 1,000 individuals with chronic illnesses (e.g., depression, 
type two diabetes, obesity or heart disease, etc.), all of which are represented in the 
PCORnet patient-powered research networks (PPRNs). The survey found that 44% of 
participants reported being fair or poor at “preventing themselves from becoming stressed” 

 
 
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and 39% reported being fair or poor at “managing or reducing stress”. The APA survey found 
that 44% of adults perceived that their stress continued to increase over the previous 5 
years; 53% reported having physical health problems as a result of feeling stressed. 
Significance: Most Americans experience stress at some point in their lives, with nearly 50% 
of the US population reporting negative consequences from stress, such as, poor sleep, 
hypertension, heart disease, periodontal disease, and increased rates of breast cancer. 
Thus, it is imperative to have better methods to reduce stress and improve overall well-
being.  
 
Objectives/Hypothesis: The aim of this study is to examine what the briefest, least 
burdensome intervention (as perceived by the individual) is to effectively decrease stress 
and enhance one’s overall sense of well-being. 
 
Specific Aims: We will recruit and randomize at least 2117 adult participants from the 
several PPRNs involving individuals with over 100 conditions and special populations and 
caregivers. Specific aims: 1) to determine if standard (8-session) mindfulness-based 
cognitive therapy (MBCT) compared to a brief 3-session mindfulness intervention will 
improve well-being in participants, and 2) to explore the heterogeneity of treatment effects 
to both interventions. We hypothesize that the standard MBCT will be superior to 
mindfulness-light in increasing well-being, and functioning and mindfulness as well as 
decreasing stress, anxiety, and depression.  
 
Participation will take 20 weeks and will involve up to 8 weeks of online MBCT treatment 
and a 12-week follow-up period. Participants will use desktop computers, laptops, tablet 
devices, or phones to participate in this study. 
 
b. Research Design, Methodology, and Data Analysis:    
 
Research Design and Methodology 
Participants (N ≥ 2117) will be recruited across all PPRNs and randomized to internet-based 
(1) standard 8-session MBCT or (2) 3 sessions of “mindfulness-light”. Participation will take 
20 weeks and will involve up to 8 weeks of receiving online MBCT and 12 weeks of follow-
up. Participants will use desktop computers, laptops, tablet devices, or phones to participate 
in this study. These procedures are described in detail below. 
 
Participants will enroll in this study via the MGH-hosted study platform. Each PPRN has been 
a part of this study since its conception. They helped to establish the research question, how 
to design a study to answer this question, and will be recruiting for the study.  Additionally, 
they will assist in overseeing the study with the study team. 
 
DESCRIPTION OF THE MGH-HOSTED STUDY PLATFORM 
 
Individuals from all PPRNs will go through the same registration process on the MGH Study 
Platform. Participants already enrolled in the MoodNetwork registry (IRB Protocol # 

 
 
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2014P001346) will have the ability to enroll in this study as a part of the MoodNetwork 
PPRN. Prospective participants who are at least age 18 will be able to register for this study 
through the MGH-hosted study platform.  All participants will first register with the study 
platform and then consent for the study. The eConsent process can be conducted via any 
electronic device that has access to the internet (e.g., cell phone, computer, tablet, etc.). 
Once each participant has read and electronically signed the eConsent for this study, he or 
she will be asked to complete a set of brief questions to provide additional information 
about their background as well as identify whether they are eligible to participate. These 
questionnaires include: 
 
• Demographics questions 
• Medical and psychiatric history questions 
• Whether the participant has practiced mindfulness prior to the study 
• Self-report which PPRN the participant is from 
• Self-report how the participant is related to the PPRN (i.e., as a caregiver or patient) 
 
The self-report PPRN questions will be able to determine whether the participant belongs to 
a PPRN as either a caregiver or patient/member of special population.  
 
PPRNs that are recruiting for this study will also be given unique, PPRN-specific tokens that 
will each be added to specific website Uniform Resource Locators (URLs), or internet 
addresses. The MGH Study Coordination team will provide one of these unique URLs to each 
PPRN for them to distribute within their community. These PPRN-specific URLs will allow the 
study platform to link participants back to their recruiting PPRNs by “tagging” them as a 
member upon registration. Once participants consent to join the study and enter the 
randomization process, they will be assigned a unique participant ID that begins with a two-
digit code specific to their PPRN. The eConsent process addresses the second exclusionary 
criterion, specifically “not able to read, understand, and/or participate in mindfulness 
exercises.” It is made clear at the beginning of the eConsent process that the person 
completing the study must be able to do so on their own. In addition to determining 
eligibility, the data collected from these questions will allow for analysis after the study is 
complete to determine how different individuals were impacted by the interventions, and 
whether this impact was different between interactions. 
 
Eligible participants will be randomly assigned to either the MBCT or Mindfulness Light 
intervention group through the MGH-hosted study platform. Randomization is performed 
using a stratified block randomization technique with a block size of 4 to maintain even 
distribution across each PPRN participant group. If the participant is not eligible to 
participate, they will receive a message saying that they are not eligible and thanking them 
for their interest in participating.  If the participant is eligible for the study, they will click 
“next” which will bring them to the study interventions which are also hosted on the MGH 
study platform. Randomization is achieved through the MGH-hosted study platform. 
 

 
 
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Assessments administered for all study participants:  
(1) World Health Organization-5 Well-Being Index (WHO-5 Well-Being Index): a brief self-
report (5-item) of positively-worded statements related to positive mood (good spirits, 
relaxation), vitality (being active and waking up fresh and rested), and general interests 
(being interested in things) over the prior two weeks. 
 
(2) Perceived Stress Scale (PSS): the most widely used psychological instrument for 
assessing perception of stress.  This scale measures the extent to which situations in one’s 
life are labeled as stressful. 
 
(3) Patient Reported Outcomes Measurement Information System (PROMIS): Emotional 
Distress-Depression Short Form: an 8-item measurement of perceived depressive 
symptoms over the past week. 
 
(4) PROMIS: Emotional Distress-Anxiety Short Form: a 4-item measurement of self-
reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, 
nervousness, restlessness), and somatic symptoms related to arousal (racing heart, 
dizziness). 
 
(5) PROMIS: Ability to Participate in Social Roles and Activities Short Form: a 4-item 
measurement of the perceived ability to perform one’s everyday social roles and activities. 
Higher scores represent fewer limitations (better abilities). 
 
(6) Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated: a 15-item assessment that 
examines two aspects of mindfulness: non-judging of inner experience and non-reactivity to 
inner experience. Both of these facets are represented in a different subscale. 
 
PPRN-specific assessments: 
 
AR-POWER: 
1) PROMIS Fatigue Short Form 8a: This is an 8-item assessment that examines the 
effect of fatigue on a person’s daily functioning.  
2) PROMIS Pain Interference Short Form 8a: This is an 8-item assessment that 
examines the amount that pain interferes with a person’s daily functioning.  
3) PROMIS Sleep Disturbance Short Form 8a: This is an 8-item assessment that 
examines the effect of sleep quality on a person’s daily functioning.  
4) PROMIS Physical Function Short Form 8b: This is an 8-item assessment that 
examines how a person’s health limits their ability to complete chores and perform 
daily tasks.  
 
CCFA: 
1) Global assessment of current disease activity:  A single rating of the extent to which 
a person’s IBD symptoms are active. 

 
 
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2) Manitoba Index: A single measure of the frequency of symptoms over the past six 
months. 
3) PROMIS Pain Interference Short Form 8a: This is an 8-item assessment that 
examines the amount that pain interferes with a person’s daily functioning. 
 
COPD: 
1)  COPD Assessment Test (CAT): An 8-item assessment that evaluates ease of 
respiration.  
2) Modified Medical Research Council Dyspnea Scale: A single measurement of ease of 
respiration. 
 
IAN: 
1) Parental Stress Scale: An 18-item assessment that measures perceptions about the 
experience of being a parent.  
 
SAPCON: 
1) PROMIS Sleep Disturbance Calibrated Items: This is an assessment that examines a 
person’s sleep quality and restlessness.  
2) PROMIS Sleep Related Impairment Calibrated Items: This is an assessment that 
examines the effect of sleep quality and restlessness on a person’s daily functioning.  
 
VPPRN: 
1) PROMIS Fatigue Short Form 8a: This is an 8-item assessment that examines the 
effect of fatigue on a person’s daily functioning.  
2) RAPID3: An assessment of physical function in relation to pain. 
3) Patient Global Assessment: A 2-item assessment that evaluates the severity of a 
person’s vasculitis disease. 
  
The MGH-hosted study platform does not have a built-out assent option to enroll minors. 
Therefore, we cannot recruit participants under 18 years old.  
 
Both treatments will be administered on the MGH-hosted study platform in the format of 
online videos and activities that are broken down into short, digestible sections. The 8-
session MBCT intervention is an evidence-based 8-session structured curriculum of guided 
meditation exercises, with 1 session administered each week for 8 weeks (e.g., mindfulness 
of the breath, mindfulness of breath and body, mindfulness of thoughts and feelings). Over 
the course of these exercises, participants learn to adopt an observing, accepting stance 
(mindfulness) towards difficult thoughts, feelings, and bodily sensations. Participants also 
learn to bring mindfulness to everyday situations and practice how to recognize and 
disengage from negative, ruminative thoughts. 
 
The mindfulness light is an evidence-based 3-session structured treatment of 
mindfulness, 1 session administered each week over 3 weeks. The sessions focus on 

 
 
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teaching one single breath-awareness meditation exercise during which participants 
learn to focus on the flow of their breath.  
 
Participants can print the content from the website if they choose. However, all 
interactive work must be entered into the website for changes and progress to be saved. 
There are worksheets completed during the interventions that are available to be 
printed if the participant desires. 
 
Each participant will complete their weekly session and complete the outcome 
assessments every 2 weeks. Participants will be reminded via email that they should 
complete these self-report questionnaires every 2 weeks as well as log back in to access 
the intervention material.  
 
After the 8 or 3 weeks of treatment (depending on randomization group), participants 
will begin a 12-week follow up period. During this time, participants will be asked to 
complete assessments monthly. Participants will be reminded via email that they should 
complete these self-report questionnaires every 4 weeks.  
 
 
Specific Aims and Data Analysis: 
 
Specific Aim 1: To determine if standard (8-session) mindfulness-based cognitive therapy 
(MBCT) compared to a brief 3-session mindfulness intervention will improve well-being in 
PPRN participants. Specifically, we plan to conduct a randomized trial comparing the impact 
of standard 8 sessions of MBCT or a brief, 3-session mindfulness intervention (“mindfulness-
light”) over the course of 8 weeks plus a 3 months follow-up period  for participants in all 
PCORnet PPRNs including participating adults and caregivers and explore the impact on (1) 
self-reported well-being (WHO-5 well-being index, primary outcome), (2) stress, (3) anxiety, 
(4) depression, (5) quality of life, and (6) psychosocial functioning and (7) mindfulness  
(secondary outcomes).  
 
Hypothesis 1: Because MBCT is the longer and more comprehensive intervention, we 
hypothesize that standard MBCT over 8 weeks will be superior to mindfulness-light in 
increasing well-being, quality of life and functioning as well as decreasing stress, anxiety and 
depression. Primary outcome measures will be the WHO-5 well-being index for the periods: 
a) baseline to 8 weeks; and b) baseline to 20 weeks).  
 
Since the data for hypothesis 1 uses repeated measures on subjects, we will conduct 
analyses for hypothesis 1 using general linear mixed models that account for the covariance 
of observations within subjects (both for 8-week and 20 weeks). We will model a random 
intercept and slope for subjects and site and fixed effects for treatment, time, and 
potentially confounding covariates. The treatment by time interaction will be used to assert 
the statistical significance of treatment effects. Canonical links will be used to correctly 
model the distribution of dependent variables; Poisson regression models will be fit with the 

 
 
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Poisson family and the log link and for normally distributed data linear regression models 
will be fit with the Gaussian distribution and identity link.  
 
To choose the correct model, we will use the Shapiro-Wilk test to assess for 
normality as well as the deviance statistic, the Akaike information criterion and the Bayesian 
information criterion to assess the best fitting model. We will compare nested models with 
the likelihood ratio chi-square statistics. When a treatment effect is significant, we will clar-
ify its clinical significance by computing, for each time point, effect size statistics that convey 
the magnitude of treatment group differences. For effect size we will use the standardized 
mean difference for continuous variables.  Our primary analyses for hypothesis one will use 
the well-being index as measured by the WHO-5 (primary outcome), and then the PSS, 
PROMIS Emotional Distress-Depression, PROMIS Emotional Distress-Anxiety, and PROMIS 
Ability to Participate in Social Roles and Activities (Functioning), and FFMQ.  
 
Specific Aim 2: To explore the heterogeneity of treatment effects (HTE, predictors and 
moderators of treatment response) to both interventions. This aim will allow us to explore 
who will benefit from either standard MBCT or mindfulness-light (predictors) and to 
determine the factors that can help match patients to either intervention (moderators or 
who will have better outcomes with standard MBCT versus mindfulness-light). Moderators 
include (1) PPRN site, (2) age, (3) role (patient, caregiver), (4) baseline levels of well-being 
(WHO-5 score), stress (perceived stress score), anxiety, and depression scores, as well as 
quality of life and psychosocial functioning and baseline mindfulness.  Using the statistical 
methods described above we will assert the presence of an HTE when we find a significant 
three-way time by study group by heterogeneity variable interaction. A significant 
interaction would indicate that the heterogeneity variable moderates differences between 
groups in how quality of life, for example, changes over time.  When an HTE is significant, 
we will clarify its clinical significance by computing, at each time point, effect size statistics 
that convey the magnitude of treatment group differences for patients above and below the 
median of the variable that moderates the treatment effect.  For effect size we will use the 
standardized mean difference for continuous variables.    
 
 
c. Lay Summary:  
 
This study seeks to identify how a standard 8-session mindfulness-based cognitive 
therapy (MBCT) intervention will compare to a briefer, 3-session mindfulness intervention to 
reduce stress and increase well-being in participants. Participants will be adults who belong to 
one of several patient-powered research networks (PPRNs), or organizations that represent 
over 100 chronic conditions and include special populations and rare diseases. Participants 
may be patients or caregivers—both groups that have been demonstrated to experience 
higher levels of stress, which contributes to poor physical and mental health and, as a result, 
higher rates of disease and premature death. The goal of this study is to identify the best 
treatment length of mindfulness to reduce stress and increase well-being as well as allow 
clinicians and researchers to better personalize treatments across a variety of conditions. 

 
 
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III. 
Human Participant Protection Regulation 45CFR46.111(3) 
 
Research Population 
a. Define the proposed age group of your target population:   
Ages 18 years and older. 
b. Define the intended number of participants:  
At least 2117 
c. Will you recruit from any of the following vulnerable populations? 
 
 Pregnant woman 
 Human fetuses 
 Neonates 
 Prisoners 
 Decisionally impaired 
 Children 
 
Please provide justification for inclusion of the vulnerable population(s):  
 
Pregnant women will not be excluded from participating in this study because there are no 
risks to participants associated with specifically being a pregnant woman. The study has the 
potential to benefit this population. 
 
Explain how you will protect the rights and welfare of the individuals in these populations: 
There are no additional precautions to take for the participation of pregnant women. 
 
 
 
Identifying Research Participants 
 
For this study, participants will be recruited through the PPRNs and will be randomly 
assigned to participate in either the longer or shorter mindfulness intervention. They will be 
given access to new online material each week on mindfulness and meditation, and every two 
weeks they will complete self-report questionnaires that assess their overall well-being, stress, 
mental health, and mindfulness skills. After their intervention is over (either 8 weeks or 3 
weeks), they will begin a 12-week follow-up period, during which they will be asked to 
complete the same self-report assessments monthly.  
 

 
 
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d. Check how will you identify potential research subjects and attach your outreach plan with 
additional details.  
 
  Invitation from advocacy organization  
  Invitation through the usual course of clinical care  
  Self-referral in response to IRB approved ads or websites 
  Referrals by clinical partners 
  Database searches:  
  Other:  
e. Explain why you feel confident you will be able to recruit the population and number of 
subjects indicated in Section III-A: Research Population.  
 
We are confident in our ability to recruit this population and number of subjects because 
the PPRNs were polled on the number of participants that they feel they will be able to 
recruit, and the populations of the PPRNs are diverse and sizeable. Specifically, each of the 
PPRNs proposed to recruit a specific number of participants as individual recruitment sites. 
Based on our smaller recruitment target, each PPRN is estimated to recruit the following:  
 
PPRN Name 
Site Leader 
Recruitment 
Goals 
MoodNetwork 
Andrew Nierenberg 
155 
Health eHeart Alliance 
Mark Pletcher 
375 
Population Research in Identity and 
Disparities for Equality Patient-Powered 
Research Network (PRIDEnet) 
Mitchell Lunn 
250 
Community-Engaged Network for All 
(CENA) 
Sharon Terry 
36 
National Alzheimer’s and Dementia 
Patient and Caregiver-powered Research 
Network 
Ronald Petersen 
250 
Interactive Autism Network 
Kiely Law  
125 
Multiple Sclerosis Patient-Powered 
Research Network 
Robert McBurney 
75 
PI Patient Research Connection, PI-
CONNECT 
Christopher Scalchunes 
393 
COPD Patient Powered Research 
Network 
Richard Mularski 
108 
ImproveCareNow: A Learning Health 
System for Children with Crohn’s Disease 
and Ulcerative Colitis 
Michael Seid 
100 
American BRCA Outcomes and Utilization 
of Testing Patient-Powered Research 
Network (ABOUT Network) 
Rebecca Sutphen 
38 

 
 
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ARthritis patient Partnership with 
comparative Effectiveness Researchers 
(AR-PoWER PPRN) 
Ben Nowell 
50 
CCFA Partners Patient Powered Research 
Network 
Millie Long 
33 
Duchenne Registry 
Ann Lucas 
35 
Patients, Advocates, and Rheumatology 
Teams Network for Research and Service 
(PARTNERS) Consortium 
Esi Morgan 
38 
Phelan-McDermid Syndrome Data 
Network 
Megan O'Boyle 
5 
Sleep Apnea Patient Centered Outcomes 
Network 
Jessie Bakker 
38 
Vasculitis Patient-Powered Research 
Network 
Antoine Sreih 
13 
f. What are the inclusion/exclusion criteria you will use to determine eligibility for your 
registry or study? 
 
Inclusion: 
• Age 18 years and older  
• Belong to one of the several PPRNs as either a patient/member of special 
population or caregiver (family member or non-family member) 
Exclusion: 
• Under the age of 18 years  
• Not able to read, understand, and/or participate in mindfulness exercises 
g. Will subject recruitment be equitable? (Meaning: will all relevant ethnic/racial groups, 
genders/sexes, and populations have access to the study?)      
 
 Yes    
 No 
 
If no, describe why your research population is limited by race, gender, or ethnicity or 
other factors:  
 

 
 
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h. Will you use recruitment materials such as advertisements, flyers, or brochures?  
 
     
 Yes    
 No   
 
If yes, specify how the materials will be distributed.  
 
Each PPRN will recruit through their own means and with their own specific materials. 
Recruitment for study participants from the PPRNs may include: 
 
  Websites: Websites of each PPRN and their affiliated advocacy groups and 
organizations  
  Email lists: Newsletters and PPRN member listservs  
  Social media: Facebook, Twitter (any other social media platform utilized by PPRNs)  
  Hospital/clinic  
  Local communities: Communities around and within the PPRNs  
  Newspapers  
 
  Radio  
 
  Television  
  Other:  
 
NOTE: Recruitment materials must be submitted for IRB review and approval before use 
and additional or revised materials must also be submitted for re-approval through a 
protocol amendment. While it is not necessary to submit the precise, final set of 
materials that you will use, you should provide a representative sampling of the 
messaging you will use for recruitment.  The IRB will assess this material for any undue 
influence language or for any sensitive content. 
 
IV. 
Informed Consent Process  
 
a. Describe the process for obtaining informed consent:   
 
INFORMED CONSENT ON THE MOODNETWORK PLATFORM 
 
The MGH-hosted study platform is approved by the Partners Healthcare IRB (Protocol # 
2014P001346). Only participants 18 years of age and older will be enrolled into the study. 
Participants will be asked to go through the eConsent module for this study. In this 
eConsent process, participants will scroll through sections that detail: 
 
• What the study is about 
• Use of eConsent 
• What is mindfulness 
• The comparators of the study 
• What will happen if the participant decides to participate in the study 

 
 
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• Descriptions of the baseline and follow-up surveys 
• Details on the mindfulness programs 
• Impact on the participant’s time 
• Information on reminders that participants will receive from the study 
• Privacy and data safety information 
• Potential benefits of participating in the study 
• Notice that the participant will not receive payment or medical advice during 
participation 
• Potential risks of participating in the study  
• Details on how their information will be used and by whom 
• Contact information if participants have questions 
 
In the “Use of eConsent” section, the participant will click to agree to use the eConsent 
process rather than a written consent form. Participants will have to agree to use this 
eConsent form in order to participate in the study. A copy of the eConsent form will be 
saved in their profile. Participants are expected to only enroll in the study for themselves 
and not for anyone else.  
 
Participants will be able to access the eConsent form via a computer, tablet, or mobile device. 
Participants will be provided the email address: healthyminds@partners.org and phone 
number 617-643-2076 to use to contact study staff should questions arise regarding the 
project. They will be able to triage questions to the appropriate study team member. The 
phones will be answered weekdays between the hours of 9:00am and 5:00pm, and 
participants can expect a response within 2 business days. They are also given the contact 
information of the Genetic Alliance IRB if they would like to speak to someone not directly 
involved in the study. 
 
b. Will potential research subjects be provided with sufficient opportunity and time to 
consider whether or not to participate?      
 
 Yes    
 No   
 
If No, please explain: 
 
c. Parent/Guardian Permission and Assent:  
 
Only adults (participants aged >/= 18) will be able to enroll in this study. Therefore, there is 
no parent/guardian consent on this platform. 
 
d. Are there special issues in this study where there is a possibility of coercion or undue 
influence or transient impairment (e.g. recent pain medication, age, ICU inpatient) during 
the consent process?   
 

 
 
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Yes    
 No           
 
If Yes, please describe, what steps will be taken to minimize this possibility: 
 
 
e. Will this study screen and/or enroll participants or legally authorized representatives that 
speak a language other than English? 
 
Yes   
No  
   
If Yes, describe and complete the question below. 
 
If English is not the subjects’ native language, will the consent process (information sheet 
and data sharing and access settings process) be translated into their native language?    
Yes   
No 
 
If No, describe the process: 
 
Participants who do not speak English will not be recruited for this study because all 
aspects of the study, including pre-recorded mindfulness interventions, will be in English. 
Participants must be able to speak, read, and understand the English language in order to 
be a part of the study. 
 
f. Risks and Inconveniences:  
 
This study poses minimal risks to participants. Participants may experience some discomfort 
or anxiety from discussing personal material and completing self-report questionnaires. If a 
subject feels uncomfortable responding to a question, he or she will not be required to give a 
response. Participants also are free to withdraw from the study and have their data removed 
at any time. A further risk is a breach of confidentiality. This breach could occur when personal 
health information is accidentally made visible to other researchers or to the public. The 
potential harm from this risk is psychological or social harm from having personal data made 
public. 
 
g. Benefits:  
 
Stakeholders across various Patient-Powered Research Networks (PPRNs) have identified low 
rates of well-being caused by high rates of stress, anxiety, and depression as the most 
significant problem across the more than 100 conditions and populations represented by the 
network of PPRNs. Thus, the proposed research study addresses the needs of a variety of 
patient populations and has the potential benefit of reducing stress and increasing well-being 
in people with chronic diseases, as well as their caregivers. Mindfulness-based treatments 
have been demonstrated as acceptable and effective interventions for improving overall well-
being, and it is hoped that this study will determine the briefest and least burdensome 

 
 
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intervention to effectively decrease stress and enhance overall well-being. This is particularly 
of interest given the substantial amount of time and effort necessary to complete standard 
treatments. If we can shorten these interventions and achieve substantial treatment effects, 
we will be able to identify the best dose of mindfulness to manage stress and increase 
wellness, as well as determine which treatment (i.e. standard or light) works best for different 
subgroups within a large range of populations. 
 
h. Risk/Benefit Analysis:  
 
It is anticipated that the potential benefits to study participants, as well as society, will far 
outweigh the minimal risk of discomfort that may result from answering personal questions.  
Although participants may not be comfortable answering personal questions and self-report 
questionnaires, they are free to withdraw from the study at any time; if they choose to 
continue their participation, they will be delivered mindfulness interventions that have the 
potential to decrease stress and increase well-being. Furthermore, it is hoped that this study 
will yield results that allow researchers and clinicians to develop more personalized and time-
efficient treatments. 
 
i. Plan for Withdrawals:  
Participants may withdraw from the study by contacting study staff to request their record be 
removed for them.  
 
j. Plan to Compensate: Will participants be compensated or reimbursed?       
 
Yes    
No    
 
If Yes, describe: 
 
Five individuals will win $200 based on a lottery system ($1000 total). 
 
V. 
Data Confidentiality 
Describe how will you ensure the safety of participant data collected in this study:  
 
The MGH-hosted study platform’s data confidentiality and security has been reviewed by 
the Partners Healthcare IRB as well as the Research Information Science and Computing 
(Protocol # 2014P001346).  The MoodNetwork PPRN will act as the National Coordinating 
Center (NCC) for the study, coordinating and collecting the data for the intervention 
portion of the project. Data drawn from and collected on the MGH-hosted study platform 
will be housed on the Partners Research Computing Cloud Infrastructure (DIPR and RFA). 
The Discovery Information Platform for Research (DIPR) provides a set of virtual services 
within the Partners secure data center and within the Partners network which consist of 
virtual servers for web or application hosting, file storage and database management. All 
systems are secured behind the Partners firewall and follow Partners Healthcare 
Information Security policies for authenticated, minimum access. All systems are patched, 

 
 
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monitored and scanned routinely for vulnerabilities and intrusions by the systems 
administrator and PHS Information Security. The web server and database server are 
hosted within the Partners Firewall. The web server makes use of standard 128-bit Secure 
Socket Layer (SSL) encryption to protect data in transit. 
 
Randomized unique identifiers will identify all data. No data generated by this project will 
be inserted into MGH or Partners Healthcare medical records. Participant data will have 
been deidentified when drawn from the portal. Each participant will have been assigned a 
unique identifier.  
 
Any data stored as a physical copy will be stored in a locked room within MoodNetwork 
PPRN study team’s facilities located at the MGH Dauten Family Center for Bipolar 
Treatment Innovation. Names will not be included in computerized data files or in any 
published reports. Case records will be reviewed only by study personnel or, if necessary, 
by institutional, state, or federal regulatory personnel. All research personnel will have 
completed the Collaborative Institutional Training Initiative (CITI) Program on-line training 
and final exam, be well versed in Health Insurance Portability and Accountability Act 
(HIPAA) regulations and procedures and be approved as study staff by the IRB. All HIPAA 
guidelines will be followed and all research personnel will be educated about the 
importance of strictly protecting participants' rights to confidentiality. 
 
 
VI. 
Future Data Use  
Future Uses:  
 
The MoodNetwork PPRN as the NCC for the study will handle the data management 
generated by the intervention. Research data will be stored for 7 years per Partners 
Healthcare regulations. Participants are also free to withdraw from the study and have the 
application removed at any time. 
Participant data collected as part of this study will go into a research database, which will be 
reviewed for future analyses other than described here (see Data Use Agreement), if data 
sharing and access settings allow. Survey data will be collected and stored on MGH-hosted 
study platform for the duration of the study. Following the study, each PPRN will receive data 
from their participants (individuals recruited and identified as originating from their PPRN) in 
the form of a comma-separated values (CSV) file. To assist with data linkage between the 
MGH-hosted study platform and participants’ data in the PPRN recruitment sites, we will use a 
three-tiered data linkage system: 
• Tier 1:  Subjects will be assigned a unique string of numbers, called a “study participant 
ID.” This unique study participant ID will be generated by the study platform when 
participants are randomized. These unique study participant IDs will begin with a two-
digit code unique to each PPRN to ensure participants are linked back to their 
recruiting PPRN. To obtain a study participant ID that accurately reflects a person’s 

 
 
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PPRN affiliation, participants must first access the study landing page through a PPRN-
specific URL that has embedded in it a PPRN-specific “token,” or code (e.g., a111, b111, 
c111). These individualized website URLs can be shared in emails to PPRN members.  
• Tier 2:  Participants will be asked in recruitment emails and on the study’s landing page 
to register for the study with the same email they used to sign up for membership to 
their PPRN. This will facilitate merging the Healthy Mind Healthy You Study data with 
PPRNs’ existing data, as email addresses are designed to be unique identifiers. 
• Tier 3:  We will also be able to match Healthy Mind Healthy You users to existing PPRN 
members by comparing a set of the demographic values they enter into the Healthy 
Mind Healthy You demographics form with the demographic values they entered when 
registering for their PPRN. 
 
We have also created a data use agreement (DUA) (see attachments) to describe how data will 
be shared between Massachusetts General Hospital and the recruitment sites/repositories, or 
PPRNs, that refer patients to the study. Given that the PPRNs have other data on participants 
that they refer to participate in this study, it is important that PPRNs can link the data 
collected in this study with data that they have in their repositories. For example, a PPRN 
focused on improving the care of people with Alzheimer’s and dementia would be interested 
in merging these data collected as part of this study on mindfulness with the data that they 
have on these participants’ cognition and course of illness to better understand the degree to 
which someone’s cognitive function impacts their ability to practice and be impacted by 
mindfulness. We have included two key sections from the DUA below, specifying how the data 
can be used and its restrictions on use. 
 
PERMITTED USE.  The Study Coordination Team will provide the Data to RECIPIENT [PPRN 
recruitment sites] in the form identified herein, as a limited data set as indicated above.  
RECIPIENT agrees that it shall treat the Data in confidence and shall avoid disclosure of the 
Data to any other person, firm or corporation unless necessary to complete the Purpose.  
RECIPIENT shall have the right to use the Data only for its analysis related to the Project and 
not for any other purpose, including commercial use or otherwise.  The Data may be shared 
with RECIPIENT’s Project Team Members, or its employees, agents and subcontractors only on 
a need-to-know basis, and shall not be shared with any third party without the express written 
prior consent of the Coordination Team.  In the event RECIPIENT discloses the Data to its 
authorized agents or subcontractors who have a need to use and access the Data to enable 
RECIPIENT to fulfill the Purpose, RECIPIENT will ensure that such agents or subcontractors 
enter into an agreement with no less restrictive terms than those contained herein including, 
but not limited to, those addressing data privacy, security, and breach notification. 
 
RESTRICTIONS ON USE.  RECIPIENT agrees that the Data it receives will not be used in any 
manner not allowed by the informed consent and/or authorization provided by individual 
subjects, if applicable, or in any manner inconsistent with the Purpose, or with the terms of 
RECIPIENT’s IRB’s approval of RECIPIENT’s use and receipt of the Data.  RECIPIENT further 
agrees that it, any Project Team Members identified herein, and any other employees, agents 
and subcontractors to whom it discloses the Data, will not use or further disclose the Data 

 
 
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other than as permitted by this Agreement, or as otherwise required by law or regulation.  No 
license or additional rights are provided to RECIPIENT in connection with the Data under any 
patent applications, copyrights, trade secrets, or other proprietary rights of PCORnet, the 
Coordination Team, or the PPRNs. 
 
 
 
THE PRINCIPAL INVESTIGATOR (PI) MUST SIGN IN BOTH PLACES.  NO ONE CAN SIGN FOR THE 
PI.   
 
The principal investigator confirms that: 
 
 Appendix of key study personnel, including NIH-style biosketches or CVs and 
documentation of human participant protections training, is attached.  
 Survey instruments are attached. 
 Intervention materials (questionnaires, participant information sheets, etc.) are attached. 
 Outreach plan and sample outreach materials (screenshots, video links, PDFs, etc.) are 
attached. 
 
The principal investigator also confirms that: 
 
I have read the PEER application to Western IRB and will require my staff do so as well. 
 
____________________________________________             _7.8.19____ 
Signature                                                                                            Date 
 
 
By signing this document, the Principal Investigator attests: 
 
I certify that I accept responsibility for the scientific conduct and design of the project.  I assure 
that research staff assigned to this project has sufficient time and resources to conduct and 
complete the research.   I have determined that the resources necessary to protect participants 
are present before conducting the research study and I agree to provide the required 
administrative reports if this application is approved and activated. 
 
I agree to obtain permission, if necessary, from any department or institution that will provide 
services, resources, or space used in the conduct of this research. 
 
I will conduct the study identified above in the manner described on the attached application.  If 
I decide to make any changes in the study design or key personnel, I will obtain approval by the 
IRB prior to making the change.  If a participant is injured, or if any unanticipated problems 
occur which involve risk or the possibility of risk to participants, I will immediately report such 
occurrences to the Genetic Alliance Institutional Review Board. 
 

 
 
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  7.8.19_______________ 
Signature 
 
 
 
 
 
 
 
Date submitted 
 
 Andrew A. Nierenberg 
 
 
 
 
 
anierenberg@mgh.harvard.edu  
Typed or Printed Name 
 
 
 
 
 
Email 
 
 617-724-0837 
 
Telephone