Mindfulness-Based Stress Reduction Study for Couples
Phase: NA
Conditions: Metabolic Syndrome
Sponsor: Yale University

Page 1 of 24 
 
                    
                                    
HRP-503B – BIOMEDICAL RESEARCH PROTOCOL  
 
 
 
 
Protocol Title: Mindfulness Based Stress Reduction for Older Couples with Metabolic Syndrome 
 
 
Principal Investigator: Joan Monin, PhD 
 
 
Version Date: 7/19/17 
 
 
(If applicable) Clinicaltrials.gov Registration #: Click or tap here to enter text. 
 
 
 
INSTRUCTIONS 
 
This template is intended to help investigators prepare a protocol that includes all of the necessary 
information needed by the IRB to determine whether a study meets approval criteria. Read the 
following instructions before proceeding: 
 
1. Use this protocol template for a PI initiated study that includes direct interactions with 
research subjects. Additional templates for other types of research protocols are available in 
the system Library. 
 
2. If a section or question does not apply to your research study, type “Not Applicable” 
underneath. 
 
3. Once completed, upload your protocol in the “Basic Information” screen in IRES IRB system.  
 
 
 
 
 
 
 

Page 2 of 24 
 
 
1. Probable Duration of Project: 2 years 
 
2. Does this study have a Clinical Trials Agreement (CTA)?  
Yes☐   
No☒ 
a. If so, does it require compliance with ICH GCP (E6)?  
Yes☐   
No☐ 
 
3. Will this study have a billable service?  Yes ☐   No☒ 
 
A billable service is defined as any service rendered to a study subject that, if he/she was not on a study, 
would normally generate a bill from either Yale-New Haven Hospital or Yale Medical Group to the 
patient or the patient’s insurer. The service may or may not be performed by the research staff on your 
study, but may be provided by professionals within either Yale-New Haven Hospital or Yale Medical 
Group (examples include x-rays, MRIs, CT scans, specimens sent to central labs, or specimens sent to 
pathology). Notes: 1. There is no distinction made whether the service is paid for by the subject or their 
insurance (Standard of Care) or by the study’s funding mechanism (Research Sponsored). 2. This 
generally includes new services or orders placed in EPIC for research subjects.  
 
If answered, “yes”, this study will need to be set up in OnCore, Yale’s clinical research 
management system, for Epic to appropriately route research related charges. Please contact 
oncore.support@yale.edu 
 
4. Are there any procedures involved in this protocol that will be performed at YNHH or one of its 
affiliated entities?  Yes ☐  No ☒  
 
If Yes, please answer questions a through c and note instructions below.   
a. Does your YNHH privilege delineation currently include the specific procedure that you will 
perform? Yes ☐  No ☐ 
b. Will you be using any new equipment or equipment that you have not used in the past for 
this procedure? Yes ☐  No ☐ 
c. Will a novel approach using existing equipment be applied? Yes ☐  No ☐ 
  
If you answered “no” to question 4a, or "yes" to question 4b or c, please contact the YNHH Department 
of Physician Services (688-2615) for prior approval before commencing with your research protocol. 
 
IMPORTANT REMINDER ABOUT RESEARCH AT YNHH  
Please note that if this protocol includes Yale-New Haven Hospital patients, including patients at the 
HRU, the Principal Investigator and any co-investigators who are physicians or mid-level practitioners 
(includes PAs, APRNs, psychologists and speech pathologists) who may have direct patient contact with 
patients on YNHH premises must have medical staff appointment and appropriate clinical privileges at 
YNHH. If you are uncertain whether the study personnel meet the criteria, please telephone the 
Physician Services Department at 203-688-2615. By submitting this protocol as a PI, you attest that 
you and any co-investigator who may have patient contact has a medical staff appointment and 
appropriate clinical privileges at YNHH. 

Page 3 of 24 
 
 
SECTION I: RESEARCH PLAN 
 
1. Statement of Purpose:  
 
A promising intervention likely to benefit older couples with metabolic syndrome is Mindfulness 
Based Stress Reduction (MBSR)(Kabat-Zinn, 2013).  MBSR is a standardized 8-week manualized 
program in which a trained clinician teaches participants to engage in mindful meditation in their daily 
lives to reduce stress.  A growing number of MBSR studies show psychological and physical health 
benefits across multiple health contexts (Grossman, Niemann, Schmidt, & Walach, 2004).  The 
overarching goal of this study is to adapt MBSR to older couples with metabolic syndrome to maximize 
stress reduction effects on both partners’ psychological and physical health.  The specific aims of this 
project are:  
1. To determine the feasibility of Mindfulness Based Stress Reduction (MBSR) for older 
cohabiting, intimate couples in which one, or both partners, has metabolic syndrome.  We will 
(a) monitor recruitment, (b) adherence, and (c) missing data for the intervention. We will explore how 
being a couple impacts the MBSR experience, assessing (a) the prevalence of both partners having 
metabolic syndrome versus one partner, (b) shared decision making about participation and adherence, 
(c) how MBSR can be tailored to the needs of older couples, and (d) the impact on relationship quality 
and shared health behaviors.  
  
2. To determine whether MBSR improves self-reported physical health status (SF-36) 
(Ware Jr & Sherbourne, 1992) for each partner. Hypothesis 1: The intervention group will have a 
significantly greater score on the SF-12 scale than does the control group. 
3. To determine if MBSR reduces perceived stress (Perceived Stress Scale (Roberti, 
Harrington, & Storch, 2006)) and increases mindfulness (Kentucky Inventory of Mindfulness 
Skills (Baer, Smith, & Allen, 2004)).  Hypothesis 2: Perceived stress will be reduced and mindfulness 
will increase for the MBSR group compared to the control group. 
4. Exploratory aim: To determine if an MBSR intervention is associated with decreases in 
the composite measure of metabolic syndrome (blood pressure, waist circumference, glucose 
levels, cholesterol, triglycerides) for each partner. Hypothesis 3: The metabolic syndrome 
composite score for partners will be smaller at the end of the study in the MBSR group compared to the 
control group.  
 
2. Background:  
 
Metabolic syndrome is a common multifactorial disorder that increases risk for cardiovascular 
disease and diabetes and affects a substantial proportion of older adults(Eckel, Grundy, & Zimmet). 
Between 23 and 55% of older adults meet metabolic syndrome criteria, which consists of having three 
of the following: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, 
high blood pressure, and high fasting glucose (Denys et al., 2009).  Although this is a common 
syndrome, there are few preventive interventions targeting metabolic syndrome (Dunkley et al., 2012).  
This is despite the fact that the NHLBI suggests that treatment start with lifestyle changes including 
diet, exercise, maintaining healthy weight, and stress reduction, with medications as a secondary 
treatment. With the increasing number of medications that older adults take (Charlesworth, Smit, Lee, 
Alramadhan, & Odden, 2015), lifestyle interventions are becoming even more important. To date, most 
lifestyle interventions target diet and exercise without explicitly addressing stress reduction.  As stress 
is related to overall psychological and physical health as well as each metabolic syndrome biomarker 
(Matthews & Kuller, 2002), research on the efficacy of stress reduction interventions for older adults is 
critical. 

Page 4 of 24 
 
Lifestyle interventions that target older couples may be more effective than lifestyle interventions 
that target older individuals. The majority of older adults (especially men) are in close, committed 
relationships (US Census Bureau).  Within close relationships, especially older intimate cohabiting 
couples, partners’ characteristics and environments make them similar not only in terms of stress, but 
also health behaviors and mental and physical health (Hoppmann, Michalowski, & Gerstorf, 2016).  
Partners also have important positive and negative influences on each other.  By targeting both 
partners within a couple, lifestyle interventions have the capability of maximizing the positive influences 
and minimizing the negative influences.  There is some preliminary evidence that this is the case, as 
multiple weight control interventions show added benefit of involving relationship partners in their 
programs (Black, Gleser, & Kooyers, 1990).   
A promising intervention likely to benefit older couples with metabolic syndrome is Mindfulness 
Based Stress Reduction (MBSR).  MBSR is a standardized 8 week manualized program in which a 
trained clinician teaches participants to engage in mindful meditation in their daily lives to reduce stress 
(Kabat-Zinn, 2013).  MBSR shows robust psychological (Gu, Strauss, Bond, & Cavanagh, 2015) and 
physical (Grossman et al., 2004) health benefits across multiple health contexts.  MBSR reduces blood 
pressure (Nyklíček, Mommersteeg, Van Beugen, Ramakers, & Van Boxtel, 2013), helps obese 
individuals lose weight (Olson & Emery, 2015), and improves glycemic control (Rosenzweig, Reibel, 
Greeson, & Edman, 2007).  MBSR has also been shown to reduce loneliness and pro-inflammatory 
gene expression in older adults (Creswell et al., 2012).  
Aim 1 (Feasibility of addressing couples): Emerging studies are showing the benefits of 
simultaneous participation of couple members.  There a few pilot studies using MBSR with couples, 
namely cancer patients and their spouses (Birnie, Garland, & Carlson, 2010) and frail elders and their 
caregivers (McBee, 2003). MBSR is a standardized and well-known intervention beginning to be 
adopted and covered by healthcare plans and employers. If MBSR proves to be beneficial for older 
couples, this intervention can be easily disseminated to the increasingly large population of older 
American couples. It is important to note that because of the standardization that makes MBSR easy to 
disseminate, research is needed to test its efficacy in different disease contexts, with different 
populations, and on multiple health outcomes, without substantially changing the intervention itself.  
This is why our adaptation to the context of couples dealing with metabolic syndrome will include 
minimal changes that can be easily incorporated into the existing MBSR manual. This approach has 
been taken by other researchers who have applied MBSR to couples, for instance with cancer(Birnie et 
al., 2010), in which couples participated simultaneously in MBSR but the MBSR curriculum was not 
changed to focus on relational issues. Qualitative findings from this couples MBSR cancer pilot study 
showed that partners supported each other with attendance and adherence to home practice and 
experienced improvements in relationship quality.  
Aim 2 (Hypothesis 1): Self-reported physical health will improve for each partner in the MBSR 
intervention group compared to a wait-list control group. Our primary outcome will be improvement of 
self-reported physical health status.  We chose to focus on self-reported physical health as measured 
by the SF-12, which captures functional ability, specific health symptoms, and overall assessment of 
health, as it is a patient-oriented outcome that has been shown to relate to having metabolic 
syndrome(Jahangiry, Shojaeezadeh, Montazeri, Najafi, & Mohammad, 2016).  In addition, studies show 
that individual components of metabolic syndrome, for example waist circumference, are related to 
overall physical functioning and specific health symptoms (e.g. impaired sleep)(Jennings, Muldoon, & 
Hall, 2007).   
Aim 3 (Hypothesis 2): MBSR will reduce each partner’s self-reported stress score and increase 
their mindfulness score. A great deal of MBSR research supports this hypothesis in both individually 
focused and couple focused studies in multiple health contexts (Grossman et al., 2004) using the 
Perceived Stress Scale (Roberti et al., 2006) and the Kentucky Inventory of Mindfulness Skills (Baer et 
al., 2004).  Our aim is to replicate these findings in older couples with metabolic syndrome.   
Aim 4 (Hypothesis 3): The metabolic syndrome composite score for partners will be smaller at 
the end of the study in the MBSR group compared to the control group. There is some existing 

Page 5 of 24 
 
evidence that individual factors that constitute metabolic syndrome such as glycemic control 
(Rosenzweig et al., 2007), blood pressure (Carlson, Speca, Faris, & Patel, 2007), and weight 
(Katterman, Kleinman, Hood, Nackers, & Corsica, 2014) may be affected by MBSR. Although it may be 
difficult to achieve changes in biomarkers in such a short time frame, these changes are thought to 
occur after a person has incorporated mindfulness practice into their daily lives (Carlson et al., 2007).  
By examining potential changes in these biomarkers, this will provide preliminary data and effect sizes 
for longer term studies of the impact of MBSR for older couples with metabolic syndrome. 
 Importantly, we will explore the dyadic effects of couple members’ simultaneous engagement in 
the MBSR intervention.  In addition to using proper statistical techniques to understand the effects of 
MBSR on each partner’s outcomes, we will examine partner influences.  For each primary hypothesis, 
we will examine the secondary hypothesis that each partner’s improvement in each health outcome 
(self-report physical health, stress, mindfulness, and metabolic syndrome composite biomarker score) 
will be associated with improvement in the other partner’s health outcome.  In addition, we will examine 
the effects of the intervention on both partners’ relationship satisfaction.  Showing that relationship 
satisfaction can be enhanced is an important goal on its own, but we may also find that health 
outcomes improve when relationship quality improves.  
 
3. Research Plan: 
 
Procedures 
 
Forty couples (N=80) will participate in a baseline visit to have blood drawn, BMI and BP 
measured, and to complete questionnaires assessing demographics, contextual factors, and baseline 
primary outcomes. Couples will be randomized to the MBSR condition (n=20 couples/ 40 individuals) or 
the wait list control condition (n=20 couples).  The baseline blood draws and survey administration will 
take place at the CSRU, with the HRU as back up as needed. The blood analysis will be done by the 
YCCI Core lab.  All participants will receive an informational sheet about metabolic syndrome. 
Participants will be randomized to the intervention or wait-list group after informed consent is 
obtained, the initial blood is drawn and survey baseline is completed at the CSRU.  A random digit 
generator will be used that assigns a condition (in this case, intervention or wait list) to each couple ID 
number. 
MBSR condition: MBSR is a standardized protocol consisting of 8-weekly 2.5 hour sessions, 
homework consisting of 30-45 minutes of mindfulness meditation practice six days per week and a one-
time half-day (4-6 hour) retreat.  This will be offered at the Social Gerontology and Health lab, Suite 
801, 55 Church street, New Haven, CT Our MBSR intervention is based upon the standard regimen 
taught at the University of Massachusetts.(Kabat-Zinn, 2013) Participants will attend weekly group 
sessions at the Yale Stress Center at the Yale School of Medicine taught by an experienced MBSR 
instructor (Anne Dutton MA MSW) who collaborates closely with Co-I Dr. Ali. Each weekly session will 
consist of an instructor-led mindfulness meditation, followed by a discussion of the meditation and its 
application into participants’ everyday life. Formal meditations that will be led and discussed include 
eating meditation, body scan, sitting meditation, Hatha Yoga, and walking meditation. Participants will 
take their partners blood pressure reading with an automated Carescaoe cuff at each MSBR class. In 
addition, informal mindfulness practices of awareness of pleasant and unpleasant events and 
awareness of routine events will be discussed. Participants will be recording their daily mindfulness 
practice minutes on attached form. 
Wait list condition: After the MBSR condition groups have completed their sessions, the 
participants in the Wait List group may choose to participate in the 8-week MBSR class.  Participants 
will be provided with a coupon to participate starting July 2018.  In the meantime, participants in the 
Wait list group will complete the same measures at the same time points as participants enrolled in 
Cohort 1 and Cohort 2 of the MBSR conditions.   

Page 6 of 24 
 
Accounting for simultaneous participation of couple members in MBSR for manual 
development.  Prior to recruitment, the team will meet with Ms. Dutton, the MBSR instructor to adapt 
the MBSR manual so that it accounts for couples participating in the classes.  Although the MBSR 
curriculum will not be substantially altered from its validated form, Ms. Dutton will provide suggestions 
about how each practice and assignment in the program can acknowledge the partner’s presence.  We 
will maintain the standard MBSR program so that is can be easily disseminated to the public in later 
phases of this research.  We are not developing a new relationship oriented MBSR. Rather, we will 
provide instruction about how each assignment should be carried out knowing that the partner is also in 
the program at the same time. Upon completion of the study, we will obtain interventionist feedback 
about how couple participation may have altered the MBSR program. Ms. Dutton will keep notes about 
the influence of couple dynamics in her classes throughout the study and summarize them in a team 
meeting with the PI, Co-Is, and Project manager every 4 weeks and at the end of the study. 
 
Measurement Schedule 
 
# of 
items 
Variable 
type 
Recruit Baseline 
assess 
8-week 
assess 
Recruitment 
 
 
 
 
 
Referral or chart review:  
Potential participant has 3 of the following? 
(a) Abdominal obesity: waist 
circumference >102 cm in men, >88 cm in 
women;  
(b) Hypertriglyceridemia: ≥150 mg/dL 
(1.69 mmol/L);  
(c) Low high-density lipoprotein (HDL) 
cholesterol: <40 mg/dL (1.04 mmol/L) in 
men, <50 mg/dL (1.29 mmol/L) in women;  
(d) High blood pressure (BP): ≥130/85 
mm Hg and/or taking BP medication;  
(e) High fasting glucose: ≥110 mg/dL 
(≥6.1 mmol/L). 
1 
Inclusion 
criteria 
X 
 
 
Participant is 60 or over. 
1 
Inclusion 
criteria 
X 
 
 
Participant married or in romantic relationship? 
1 
Inclusion 
criteria 
X 
 
 
Are they living together? 
 
1 
Inclusion 
criteria 
X 
 
 
Participant’s partner interested in being in the 
study? 
1 
Inclusion 
criteria 
X 
 
 
Both partners age 60 or over? 
1 
Inclusion 
criteria 
X 
 
 
Either partner non-English speaking? 
1 
Exclusion 
criteria 
X 
 
 
Either partner practice mind-body therapies more 
than once/week (yoga, meditation)? 
1 
Exclusion 
criteria 
X 
 
 
Either partner taking psychiatric medications? 
1 
Exclusion 
criteria 
X 
 
 
Random assignment to intervention or waitlist 
control group 
1 
Intervention/
control status 
 
 
 

Page 7 of 24 
 
Self-report Measures (Both partners)  
 
 
 
 
 
Socio demographics: age, gender, education, 
income 
4 
Covariates 
 
X 
X 
Physical health symptoms (SF-12)  
12 
Primary 
outcome 
 
X 
X 
Perceived stress scale (Roberti et al., 2006)  
10 
Primary 
outcome 
 
X 
X 
Kentucky Inventory of Mindfulness Skills (Baer et 
al., 2004)  
39 
Primary 
outcome 
 
X 
X 
Relationship Assessment Scale (Hendrick, 1988) 
7 
Secondary 
outcome 
 
X 
X 
Health behavior questionnaire (sleep, physical 
activity, eating behavior, medication adherence 
(Schulz et al., 1997)) 
22 
Secondary 
outcome 
 
X 
X 
Couples’ decision making in participation and 
adherence:  
1) How was your partner involved in your 
decision to first participate in the intervention? 
(Responses: a. encouraged you, b. discouraged 
you, c. neither) 
2) How was your partner involved in your 
decision to continue with each class? 
(Responses: a. encouraged you, b. discouraged 
you, c. neither) 
3) Open ended question: Describe how 
participating with your partner influenced your 
experience with the intervention. 
3 
Exploring 
couple 
dynamics 
 
 
X 
Biological Measures (Both partners) 
 
 
 
 
 
Blood draw: to assess hypertriglyceridemia and 
low high-density lipoprotein (HDL) cholesterol 
and high fasting glucose 
3 
Secondary 
outcome 
 
X 
X 
Abdominal obesity- waist circumference per 
WHO protocol (2011) 
1 
Secondary 
outcome 
 
X 
X 
Blood pressure (automated Carescape cuff) 
1 
Secondary 
outcome 
 
X 
X 
Do both partners, only the husband, or only the 
wife have metabolic syndrome at baseline? 
1 
Exploring 
couple 
dynamics 
 
 
 
Feasibility Measures (Both partners) 
 
 
 
 
 
Percent of couples who screen versus enroll 
(Project manager keeps a record.) 
1 
Feasibility 
outcome 
X 
 
 
# of MBSR sessions attended 
(Interventionist takes attendance.) 
1 
Feasibility 
outcome 
 
 
X 
Total minutes of home MBSR practice 
(Participants keep a daily record.) 
1 
Feasibility 
outcome 
 
 
X 
 

Page 8 of 24 
 
Recruitment, Data management plan, and Retention.  We will use the OnCore Clinical 
Research Management System for recruitment and data management. Dr. Ali and his team have 
extensive experience using OnCore in a variety of clinical trials. The OnCore product suite includes 
integrated patient registries, biospecimen management, billing compliance, paperless committee 
management, data management, and EDC functionality. Patient identifiers and demographics tracked 
in the standard OnCore form are stored independently of analysis data. All data within OnCore is stored 
within an Oracle RDBMS database server.  EPIC’s Registry tool allows consistent identification of 
subsets of patients with conditions which will allow for advanced subject recruitment. In addition, we will 
use MyChart and the Yale Center of Clinical Investigation’s Help Us Discover database, as well as the 
Joint Data Analytics Team (JDAT), a unified Yale School of Medicine and Yale-New Haven Health 
Systems team, to identify potential participants. We will also be accepting physician referrals for 
participants. The YCCI will send email blasts to area endocrinologists and primary care physicians to 
identify patients. The Program on Aging Field core, led by Joanne McGloin, will work with the YCCI and 
JDAT to help our team identify participants.  Participants who are identified but are not in the epic 
system may receive a pre-screening consent phone call.. Specifically, a trained nurse familiar with the 
EPIC system, Kathleen Williams RN, project coordinator, will efficiently identify patients based on chart 
reviews.  We will also place an ad in the Senior Blue Book and consult with the POA Community 
Advisory Board.  Co-I Dr. Jastreboff will also recruit participants through her clinic. Kathleen Williams, 
Project manager, will contact and screen potential subjects. 
The baseline, 8-week, and 3-month visits will entail data collection using validated 
questionnaires and self-report paper forms at the CSRU. The eight week visit will take place between 
five to eleven weeks after enrollment. The three month visit will occur from 10 to 14 weeks after 
enrollment. At the 8-week visit participants will be asked to complete a qualitative interview in addition 
to the paper surveys. Responses  will be recorded on a cell phone and we will use transcription plus 
LLC https://www.transcriptionplus.net transcription services. Participants will complete the forms 
themselves, and they will be entered into the OnCore system by the project manager.  These forms will 
be kept in paper form in each study participant’s record and will be kept in a locked file cabinet at the 
Yale Center for Clinical Investigation. Only the PI and project manager will have access to the 
participant’s records. Forms will be coded with subject number; no personally identifiable information 
will be associated with these forms. Blood will be drawn by staff at the Church Street Research Unit 
and sent to the YCCI Core Lab for processing of the glucose, cholesterol, and triglyceride markers. The 
biomarker information will then be linked to our study on OnCore. The OnCore database will be 
supported by the Yale Center for Clinical Investigation/ CTSA.  Incomplete or missing data prompts 
follow-up calls or electronic queries in OnCore. Our OnCore database will be checked for completeness 
in real-time from internal checks; while the PI and project manager will perform weekly audits for 
complete data.  
 The project manager will use a study cell phone for the purposes of recruitment, and reminder 
texts for participants.The project manager will make routine follow-up calls to remind study subjects of 
their appointments. Attrition will be minimized and data collection optimized with a relatively short 
intervention duration together with a $150 individual participant remuneration..Payment will be made 
through the ONCORE bank of America gift card program with renumeration to be as follows. ($50 
dollars at baseline,$50 dollars at eight weekfollow-up and $50 dollars at three month follow- up)  In Dr. 
Ali’s ongoing studies in fibromyalgia and Irritable Bowel Syndrome patients (n=108), he has achieved 
complete (no missing data) datasets based on robust data collection, retention, and follow-up 
procedures in collaboration with the YCCI. 
 
 
Timeline. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 9 of 24 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
July-Aug 2017: finalize study materials, MBSR manual, train staff, build Oncore database, recruit 
 
September 2017- March 2018: Cohort 1 (baseline, intervention, 8-week follow-up, 3 month follow up) 
 
January 2017-June 2018: Cohort 2 (baseline, intervention, 8-week follow-up, 3 month follow up) 
 
 
 
 
4. Genetic Testing    N/A ☒ 
 
5. Subject Population: Provide a detailed description of the types of human subjects who will be 
recruited into this study. 
 
Older married couples in which both partners are 60 years or older and one or both partners have 
metabolic syndrome. 
 
6. Subject classification: N/A 
 
NOTE: Is this research proposal designed to enroll children who are wards of the state as potential 
subjects? Yes ☐  No ☒  
 
 
7. Inclusion/Exclusion Criteria: What are the criteria used to determine subject inclusion or    
exclusion? 
 
Eligibility criteria. (1) The couple is in a cohabiting, committed, intimate relationship (sexual minority 
couples not excluded). (2) Both partners are age 60 or older. (3) One or both partners have 3 of the 
following: (a) Abdominal obesity: waist circumference >102 cm in men, >88 cm in women; (b) 
Hypertriglyceridemia: ≥150 mg/dL (1.69 mmol/L); (c) Low high-density lipoprotein (HDL) cholesterol: 
<40 mg/dL (1.04 mmol/L) in men, <50 mg/dL (1.29 mmol/L) in women; (d) High blood pressure 

Page 10 of 24 
 
(BP): ≥130/85 mm Hg and/or taking BP medication; (e) High fasting glucose: ≥110 mg/dL (≥6.1 
mmol/L). 
 
Exclusion criteria. Non-English speaking, practicing mind–body therapies more than once/week 
(e.g., meditation, yoga), taking psychiatric medications, substance abusers, persons with suicidal 
ideation, or severe psychopathology. 
 
8. How will eligibility be determined, and by whom?  
 
Preliminary eligibility will be determined by the Project Manager based on responses to questions 
on telephone screening. Final eligibility will be determined by Dr. Jastreboff based on corroborating 
the diagnosis of metabolic syndrome from their medical chart. 
 
9. Risks:  
 
Mindfulness-based stress reduction has been studied in a number of clinical trials for many conditions. 
There are no known side effects of mindfulness-based stress reduction. There are potential risks of 
increased symptoms because mindfulness training can increase awareness of body sensations. As the 
mindfulness-based stress reduction program incorporates yoga, there is also a risk of physical injury, 
such as pulled or strained muscles.There are theoretical risks of meditation programs including increased 
psychological distress in persons with unstable psychological conditions or that are suicidal. However, 
persons with these conditions will not be allowed to participate in this study. 
 
Other risks from participating in the study include the breach of confidentiality about subject’s health 
status and participation in the study. This is very unlikely to occur, as all study investigators are trained 
and certified in research privacy. 
 
The risks involved in drawing blood from a vein may include, but are not limited to, momentary 
discomfort at the site of the blood draw, possible bruising, redness, and swelling around the site, 
bleeding at the site, feeling of lightheadedness when the blood is drawn, and rarely, an infection at the 
site of the blood draw. There are no major risks associated with these procedures. 
 
There is a risk of breach of confidentiality. 
 
Dobkin notes possible risks noted in other types of meditation programs including increases in anxiety, 
panic, tension, less motivation in life, boredom, pain, impaired reality testing, confusion and 
disorientation, feeling ‘spaced out’, depression, increased negativity, being more judgmental and feeling 
‘addicted to meditation.’ (Dobkin, Irving, & Amar, 2012) 
 
Dobkin also notes a case report where mania was precipitated by meditation as well as transient 
meditation-induced psychosis (Dobkin et al., 2012). Our MBSR teacher (Ms. Dutton) notes 
contraindications in active substance abusers, persons with suicidal ideation, or severe psychopathology 
 
 
10. Minimizing Risks:  
 
a. Recruitment and Informed Consent   

Page 11 of 24 
 
 
For patients who have indicated interest through the YCCI, patients identified and referred for screening 
will be contacted by the Project Manager by telephone. Yale EPIC electronic medical records will also 
be reviewed to assess eligibility. Interested patients/partners will be informed about the study using 
IRB/HIC-approved screening scripts in order to determine preliminary eligibility. All screening, 
recruitment, and data capture will take place in OnCore, the YCCI’s Clinical Trials Management System 
 
At the baseline visit, consent will be obtained by the PI or research assistant Consent forms will include 
information about the procedures and the risk and benefits involved in the study. All subjects will be 
informed of the option of not participating, or of stopping at any time during the study. In addition to the 
consent forms, participants will complete a Commitment Agreement that outlines the activities 
conducted during the study. Consent forms will be kept in a locked file cabinet. 
 
Prior to signing the consent documents, the PI or research assistant will provide subjects with additional 
information about the study and review the consent forms and other study-related documentation.  All 
subjects participating in the study will provide written consent.  All subjects will be informed of the 
option of not participating, or of stopping at any time during study. The ability and capacity to consent 
will be determined by the Principal Investigator or research assistant by thorough questioning during 
the process of consent. Potential subjects will be asked, “Could you explain to me what we are going to 
ask you to do in this study?  This will help me be to be sure that you understand the research,” as well 
as, “What more would you like to know about this study?” 
 
Protections against risk  
 
Safety and tolerability will be assessed through participant self-report of symptoms or changes in 
symptoms since baseline (obtained from adverse event logs and direct query at the sessions and at the 
8 week and 3 month follow up visits) until completion of the study.  Comparison of tabulated safety 
events by grade (mild, moderate, severe) between intervention and control groups will help identify any 
unforeseen consequences of the treatment regimen. Based on the safety profile of MBSR, there is 
minimal risk of adverse events. Should any subjects experience adverse effects related to the 
intervention, these will be reported using a standard form to the Yale Human Research Protection 
Program. All subjects will have direct (phone and email) access to the Principal Investigator. If any 
adverse events occur requiring immediate medical attention, the PI will guide and advise subjects in the 
medical management of acute and/or emergent reactions. In most cases, this will entail calling ‘911’ 
and an immediate emergency department referral.    
 
In recent systematic reviews of MBSR for a variety of conditions, no adverse effects were reported 
(Cramer, Haller, Lauche, & Dobos, 2012; Katterman, Kleinman, Hood, Nackers, & Corsica, 2014). 
There are, however, theoretical risks of MBSR, including increased symptomology resulting from 
awareness training (Fjorback, Arendt, Ornbol, Fink, & Walach, 2011), as well as using mindfulness 
interventions instead of more effective treatments (Marchand, 2013).  
 
Dobkin notes possible risks noted in other types of meditation programs including increases in anxiety, 
panic, tension, less motivation in life, boredom, pain, impaired reality testing, confusion and 
disorientation, feeling ‘spaced out’, depression, increased negativity, being more judgmental and feeling 
‘addicted to meditation.’ (Dobkin, Irving, & Amar, 2012) 
 
Dobkin also notes a case report where mania was precipitated by meditation as well as transient 
meditation-induced psychosis (Dobkin et al., 2012). Our MBSR teacher (Ms. Dutton) notes 
contraindications in active substance abusers, persons with suicidal ideation, or severe 

Page 12 of 24 
 
psychopathology.   
 
Data and Safety Monitoring Plan:  
 
11. Data and Safety Monitoring Plan: Include an appropriate Data and Safety Monitoring Plan (DSMP) based on 
the investigator’s risk assessment stated below. (Note: the HIC will make the final determination of the risk to 
subjects.) 
 
a.  
What is the investigator’s assessment of the overall risk level for subjects participating in this 
study? Minimal risk 
b. 
If children are involved, what is the investigator’s assessment of the overall risk level for the 
children participating in this study? n/s 
c. 
Include an appropriate Data and Safety Monitoring Plan. Examples of DSMPs are   
available here http://your.yale.edu/policies-procedures/forms/420-fr-01-data-and-safety-
monitoring-plans-templates for 
i. Minimal risk 
ii. Greater than minimal 
 
12.  
 
The principal investigator is responsible for monitoring the data, assuring protocol compliance, and 
conducting the safety reviews at the specified frequency [monthly].  During the review process the 
principal investigator will evaluate whether the study should continue unchanged, require 
modification/amendment, or close to enrollment. 
 
The principal investigator and the Institutional Review Board (IRB) have the authority to stop or 
suspend the study or require modifications. 
 
This protocol presents minimal risks to the subjects and Unanticipated Problems Involving Risks to 
Subjects or Others (UPIRSOs), including adverse events, are not anticipated. In the unlikely event that 
such events occur, Reportable Events (which are events that are serious or life-threatening and 
unanticipated (or anticipated but occurring with a greater frequency than expected) and possibly, 
probably, or definitely related) or Unanticipated Problems Involving Risks to Subjects or Others that 
may require a temporary or permanent interruption of study activities will be reported immediately (if 
possible), followed by a written report within 5 calendar days of the Principal Investigator becoming 
aware of the event to the IRB (using the appropriate forms from the website) and any appropriate 
funding and regulatory agencies. The investigator will apprise fellow investigators and study personnel 
of all UPIRSOs and adverse events that occur during the conduct of this research project through regular 
study meetings and via email as they are reviewed by the principal investigator.  
 
13. Statistical Considerations: Describe the statistical analyses that support the study design.  
 
Feasibility outcomes will be observed, recorded, and qualitatively evaluated.  Descriptive 
characteristics of the cohort will be summarized with means and standard deviations and counts and 
percentages according to intervention group. Although this pilot study will not be powered to test all 
outcomes for statistical significance, the primary quantitative outcomes are expected to have 
continuous Gaussian distributions making possible the comparison of intervention and control group 
results with linear mixed effects regression models that can accommodate the clustering of outcome 
results within couples. Finally, in anticipation of future studies of the metabolic syndrome outcome, 

Page 13 of 24 
 
selected analyses will be conducted to compare the utility of the composite metabolic syndrome 
outcome and with a version of this outcome yielded by a measurement model in a structural equation 
modeling context. 
Hypothesis 1: Self-reported physical health will be greater on average for participants in the 
MBSR intervention group compared to a wait-list control group. A multivariable linear mixed effects 
model will be used to assess whether self-reported physical health is greater in the intervention group 
than in the control group. A random effect will be used to account for the clustering of outcome values 
within couples.  A pre-specified set of covariates will be entered into the regression model including 
baseline self-reported physical health and demographics and contextual factors that differ significantly 
across intervention and control groups.  Model goodness of fit will be assessed with residual analysis, 
influence statistics, and goodness-of-fit statistics.  
Hypothesis 2: MBSR will reduce each partner’s self-reported stress and increase their 
mindfulness. The analyses for these two secondary outcomes will proceed according to the same 
procedures as cited for Hypothesis 1 above. 
Hypothesis 3: The metabolic syndrome composite score for participants will be smaller at the 
end of the study in the MBSR group compared to the control group. Given the exploratory nature of this 
hypothesis and the lack of consensus as to how to code a variable for metabolic syndrome, this 
Hypothesis 3 will be analyzed in three different ways: 1) with the outcome as a binary indicator variable 
indicating the occurrence of 3 or more of the 5 syndrome components; 2) with the outcome as a 
continuous variable obtained from the summation of Z-score transformations of the 5 syndrome 
components; and 3) as continuous latent factor or principal component construct obtained from a factor 
analytic measurement model.  Performing these three analyses will provide invaluable insights for 
determining how the metabolic syndrome outcome will be coded in future studies using older samples. 
We will explore the dyadic effects of couple members’ simultaneous engagement in the MBSR 
intervention. In addition to the above analyses, we will use SPSS mixed models for analyzing repeated 
measures in couples. In this analytic approach, reports of health (primary outcome) (Level 1) are 
nested within time-invariant individual and couple variables (i.e., background variables, intervention 
condition (primary predictor), and moderators) at Level 2. The program allows for the analysis of 
intercepts and slopes of the hypothesized associations between Level 1 variables (i.e., within-couple 
relations between each partner’s health) across all assessment points (baseline, 8 weeks, and 3 
months), as well as interactions between Level 2 variables and Level 1 intercepts and slopes. In other 
words, we will assess whether the intervention was successful at the couple level by looking at the 
overall intervention effect, as well examine, for heterosexual couples, differential effects for husbands 
and wives by looking at the role (husband or wife) X intervention interaction. 
How quantitative and qualitative data will be combined to understand outcomes.  Qualitative 
data will be analyzed using Atlas.ti software and themes will be identified regarding partner influence on 
study experience.  Key demographic characteristics and results from quantitative questions regarding 
decision making in participation and adherence will be entered into the software as coded attributes.  
Queries will be conducted to investigate the relationships between identified themes and coded 
attributes.  Finally, the results of this qualitative analysis will be used to formulate hypotheses about the 
meanings and mechanisms underlying the quantitative results for Hypotheses 1 and 2, and especially, 
for the results of dyadic analyses of couple members’ simultaneous engagement in the MBSR 
intervention.  
Power:  The sample size procedure in PASS shows that in anticipation of loss-to-follow-up, and 
with recognition of dependency in results from couples, the effective sample size is estimated to be 70, 
a reduction of 10 from the enrollment of 80 study participants.  Assuming power of 80%, an outcome 
standard deviation of 10, and equal assignments to the intervention and control groups, this effective 
sample size will allow for detection of a difference between intervention and control groups mean 
values for the SF-12 outcome of 6.43 or more at the two-sided level of significance of 0.05. The sample 
size procedure in PASS was performed. 
 

Page 14 of 24 
 
SECTION III: RECRUITMENT/CONSENT AND ASSENT PROCEDURES  
1. Targeted Enrollment: Give the number of subjects: 80 participants 
 
a. Targeted for enrollment at Yale for this protocol: 80 
b. If this is a multi-site study, give the total number of subjects targeted across all sites: N/A 
 
2. Indicate recruitment methods below.  Attach copies of any recruitment materials that will be used. 
 
 Flyers 
 
 
 
 
 Internet/Web Postings 
 
 
 Radio 
 Posters 
 
 
 
 
 Mass E-mail Solicitation  
 
 Telephone 
 Letter 
 
 
 
  
 Departmental/Center Website 
 
 Television 
 Medical Record Review*  
 
 Departmental/Center Research Boards 
 Newspaper 
 Departmental/Center Newsletters  
 Web-Based Clinical Trial Registries 
 
  YCCI Recruitment database 
 
 Clinicaltrials.gov Registry (do not send materials to HIC) 
 Other (describe): 
 
* Requests for medical records should be made through JDAT as described at 
http://medicine.yale.edu/ycci/oncore/availableservices/datarequests/datarequests.aspx 
 
 
3.  Recruitment Procedures:  
a. Describe how potential subjects will be identified. 
 
Endocrinologist and Co-I, Dr. Ania Jastreboff, MD at Yale is eager to refer patients for this study. Dr. 
Jastreboff will provide study information to potentially eligible patients. 
 
We can also recruit from Yale-affiliated community practices and other relevant sources through our 
local networks.  The investigators have active referral networks through primary care and general 
pediatric specialty clinics throughout Connecticut.  
 
We will also work with the Program on Aging field core, YCCI recruitment specialists, and JDAT to 
identify participants. We will be using the staff at the YCCI Recruitment call center as well. 
 
b. Describe how potential subjects are contacted.  
 
Patients identified for screening through YCCI will be referred to the Project Manager via phone. 
Interested patients/partners will be informed about the study using IRB/HIC-approved screening scripts 
in order to determine preliminary eligibility. The phone screening will entail a review of the eligibility 
criteria and verbal and written description of the intervention procedures. We will collect 
eligibility/exclusion criteria information (except for the biological indicators of metabolic syndrome) 
which includes marital/ couple status, age, whether they practice mindfulness, whether they take 
psychiatric medication, whether they have a substance abuse problem. All screening, recruitment, and 
data capture will take place in OnCore, the YCCI’s Clinical Trials Management System. 
 
c. Who is recruiting potential subjects?  
 
Dr. Monin (Principal Investigator), co-investigators (Drs. Jastreboff and Dr. Ali), and the study 
project manager (Kathleen Williams) will recruit participants. The Yale Center for Clinical 

Page 15 of 24 
 
Investigation (YCCI) will also be used for study recruitment, which includes dedicated recruitment 
staff, community outreach personnel, and the use of YCCI’s Clinical Research at Yale website, 
www.yalestudies.org.  The Program on Aging will also help with recruitment.   
 
 
 
4. Assessment of Current Health Provider Relationship for HIPAA Consideration: 
Does the Investigator or any member of the research team have a direct existing clinical relationship 
with any potential subject?  
 Yes, all subjects 
 Yes, some of the subjects 
 No 
 
If yes, describe the nature of this relationship. 
 
Some of the participants may be patients of Dr. Jastreboff. 
 
5. Request for waiver of HIPAA authorization: (When requesting a waiver of HIPAA Authorization 
for either the entire study, or for recruitment purposes only.  Note: if you are collecting PHI as part of 
a phone or email screen, you must request a HIPAA waiver for recruitment purposes.) 
 
Choose one:  
☐ For entire study  
☒ For recruitment/screening purposes only 
 
☐ For inclusion of non-English speaking subject if short form is being used and there is no translated 
HIPAA research authorization form available on the University’s HIPAA website at hipaa.yale.edu. 
 
i. Describe why it would be impracticable to obtain the subject’s authorization for 
use/disclosure of this data: 
 
With waiver of HIPAA authorization, databases can be accessed identify patients to contact 
about the study. Without the waiver, this rich source of potential subjects would not be available. 
 
 
ii. If requesting a waiver of signed authorization, describe why it would be impracticable to 
obtain the subject’s signed authorization for use/disclosure of this data: 
 
N/A 
 
The investigator assures that the protected health information for which a Waiver of 
Authorization has been requested will not be reused or disclosed to any person or entity other 
than those listed in this application, except as required by law, for authorized oversight of this 
research study, or as specifically approved for use in another study by an IRB. 
 
Researchers are reminded that unauthorized disclosures of PHI to individuals outside of the Yale 
HIPAA-Covered entity must be accounted for in the “accounting for disclosures log”, by subject name, 

Page 16 of 24 
 
purpose, date, recipients, and a description of information provided.  Logs are to be forwarded to the 
Deputy HIPAA Privacy Officer. 
 
6. Process of Consent/Assent: Describe the setting and conditions under which consent/assent will be 
obtained, including parental permission or surrogate permission and the steps taken to ensure 
subjects’ independent decision-making.  
 
At the baseline visit at Yale School of Medicine, prior to signing the consent/assent document, the 
Principal Investigator or research assistant will provide subjects with additional information about the 
study and review the consent forms and other study-related documentation.  All subjects participating in 
the study will provide written consent.  All subjects will be informed of the option of not participating, or of 
stopping at any time during the interview.   
 
7. Evaluation of Subject(s) Capacity to Provide Informed Consent/Assent: Indicate how the 
personnel obtaining consent will assess the potential subject’s ability and capacity to consent to the 
research being proposed.  
 
The ability and capacity to consent/assent will be determined by the Principal Investigator or research 
assistant by thorough questioning during the process of consent. Potential subjects will be asked, 
“Could you explain to me what we are going to ask you to do in this study?  This will help me be to be 
sure that you understand the research,” as well as, “What more would you like to know about this 
study?” 
 
8. Non-English Speaking Subjects: Explain provisions in place to ensure comprehension for research 
involving non-English speaking subjects. If enrollment of these subjects is anticipated, translated 
copies of all consent materials must be submitted for approval prior to use.  
 
Non-English speaking is part of the exclusion criteria for this study. 
 
As a limited alternative to the above requirement, will you use the short form* for consenting process if 
you unexpectedly encounter a non-English speaking individual interested in study participation and the 
translation of the long form is not possible prior to intended enrollment?  
YES ☐  NO ☒ 
 
Note* If more than 2 study participants are enrolled using a short form translated into the same 
language, then the full consent form should be translated into that language for use the next time a 
subject speaking that language is to be enrolled. 
 
Several translated short form templates are available on the HRPP website (yale.edu/hrpp) and translated 
HIPAA Research Authorization Forms are available on the HIPAA website (hipaa.yale.edu). If the 
translation of the short form is not available on our website, then the translated short form needs to be 
submitted to the IRB office for approval via modification prior to enrolling the subject.   Please review 
the guidance and presentation on use of the short form available on the HRPP website. 
 
If using a short form without a translated HIPAA Research Authorization Form, please request a 
HIPAA waiver in the section above.  
 

Page 17 of 24 
 
 
9. 
Consent Waiver: In certain circumstances, the HIC may grant a waiver of signed consent, 
or a full waiver of consent, depending on the study. If you will request either a waiver of consent, or a 
waiver of signed consent for this study, complete the appropriate section below.   
 
☐Not Requesting any consent waivers  
 
☐Requesting a waiver of signed consent: 
   
☐ Recruitment/Screening only  
☐ Entire Study (Note that an information sheet may be required.) 
 
 
  
   
☒ Requesting a waiver of consent: 
 
☒ Recruitment/Screening only   
 
☐ Entire Study  
 
 
 
 
 
  
  
 For a waiver of signed consent, address the following: 
 
• Would the signed consent form be the only record linking the subject and the research?          
YES ☐  NO ☐  
• Does a breach of confidentiality constitute the principal risk to subjects? YES ☐  NO ☐ 
  
 
OR 
• Does the research pose greater than minimal risk? YES ☐    NO☐  
 
• Does the research include any activities that would require signed consent in a non-research 
context? YES ☐   NO ☐ 
 
For a waiver of consent, please address the following: 
• Does the research pose greater than minimal risk to subjects?   
☐ Yes  If you answered yes, stop. A waiver cannot be granted.   
☒ No 
• Will the waiver adversely affect subjects’ rights and welfare? YES ☐    NO☒ 
• Why would the research be impracticable to conduct without the waiver? We will need to 
view medical records to determine eligibility before we call potential subjects 
 
• Where appropriate, how will pertinent information be returned to, or shared with subjects at a 
later date? na 
 

Page 18 of 24 
 
 
SECTION IV: PROTECTION OF RESEARCH SUBJECTS 
 
    Confidentiality & Security of Data: 
a.    What protected health information (medical information along with the HIPAA identifiers) about 
subjects will be collected and used for the research?    
 
Name, date of birth, telephone number, address, email address, sex, metabolic syndrome status, 
medications, other diagnoses. Only the PI and research assistant will have access to PHI. 
 
        
b. How will the research data be collected, recorded and stored?  
 
The baseline, 8-week, and 3 month visits will entail data collection using validated questionnaires and 
self-report forms. These forms will be kept in paper form in each study participant’s record and will be 
kept in a locked file cabinet at the Yale Center for Clinical Investigation. Only the PI and study assistant 
will have access to the participant’s records. Forms will be coded with subject number; no personally 
identifiable information will be associated with these forms. Data will be entered to a secure OnCore 
database hosted at Yale University. OnCore is a secure, web-based application designed to support data 
capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for 
tracking data manipulation and export procedures; 3) automated export procedures for seamless data 
downloads to common statistical packages; and 4) procedures for importing data from external sources. 
The OnCore database will be supported by the Yale Center for Clinical Investigation/CTSA.  
 
Incomplete or missing data prompts follow-up calls or electronic queries in OnCore. Our OnCore 
database will be checked for completeness in real-time from internal checks; while the PI and project 
manager will perform weekly audits for complete data.  
 
We work closely with the Yale Program on Aging and the biostatistics core director, Dr. Peter Van 
Ness, an expert in the design and analysis of clinical trials with older adults.  
 
c.    How will the digital data be stored? 
 CD  
 DVD  
 Flash Drive  
 Portable Hard    
       Drive  
 Secured Server  
 Laptop Computer  
 Desktop Computer  
 Other 
 
d.    What methods and procedures will be used to safeguard the confidentiality and security of     
the identifiable study data and the storage media indicated above during and after the subject’s 
participation in the study? 
 
All documents and subject information will be strictly maintained according to HIC and HIPAA regulations 
to ensure confidentiality at all times.  Access to subject information will be limited to a “need to know” 
basis and all data will be coded to maintain confidentiality.  Only those investigators with appropriate 
Human Subjects training will have access to subject data.  All electronic files are encrypted and password 
protected; paper files are kept in locked file cabinets. All data will be managed to assure strict 
confidentiality of subjects at all times. 
 
All portable devices must contain encryption software, per University Policy 5100.  If there is a 
technical reason a device cannot be encrypted please submit an exception request to the Information 

Page 19 of 24 
 
Security, Policy and Compliance Office by clicking on url http://its.yale.edu/egrc or email 
it.compliance@yale.edu 
 
e. What will be done with the data when the research is completed? Are there plans to destroy     the 
identifiable data? If yes, describe how, by whom and when identifiers will be destroyed. If no, describe 
how the data and/or identifiers will be secured. 
 
Data will be kept for five years after the study ends. Data will then be de-identified using a “Safe Harbor” 
(45CFR164.514(b)(2)) approach consistent with the HIPAA Privacy rule. De-identified data will be 
certified by a statistician that there is a very small risk that use of the protected health information could 
lead to a subject being identified. The principal investigator (Dr. Monin) is responsible for the 
implementation of data de-identification. 
 
Any data, specimens, forms, reports, video recordings, and other records that leave the site will be 
identified only by a participant identification number (Participant ID, PID) to maintain confidentiality. All 
computer entry and networking programs will be done using PIDs only. Information will not be released 
without written permission of the participant, except as necessary for monitoring by IRB and the OHRP. 
 
f.   Who will have access to the protected health information (such as the research sponsor, the  
investigator, the research staff, all research monitors, FDA, Yale Cancer Center Data and Safety 
Monitoring Committee (DSMC), SSC, etc.)? (please distinguish between PHI and de-identified data)  
 
Only the principal investigator and research team will have access to PHI.  
 
g.   If appropriate, has a Certificate of Confidentiality been obtained? 
 
A Certificate of Confidentiality is not needed and therefore has not been obtained. 
 
h.   Are any of the study procedures likely to yield information subject to mandatory reporting   
requirements? (e.g. HIV testing – reporting of communicable diseases; parent interview -incidents of child 
abuse, elderly abuse, etc.). Please verify to whom such instances will need to be reported.  
 
No. 
 
 
SECTION V: POTENTIAL BENEFITS 
 
 
Potential Benefits: Identify any benefits that may be reasonably expected to result from the research, 
either to the subject(s) or to society at large. (Payment of subjects is not considered a benefit in this 
context of the risk benefit assessment.)  
 
The potential improved patient satisfaction, functional status, and quality of life for older adults with 
metabolic syndrome can have far reaching implications, including greater receptivity to the benefits of 
interventions, superior adherence, and enhanced resiliency to the inevitable variations in chronic disease 
presentation. Adding MBSR to metabolic syndrome treatment regimens could provide tremendous 
benefit to the many older adults, in addition to relieving a sub-optimal and overburdened healthcare 
system. The relative risk to subjects participating in this pilot study is negligible. The greatest risk may be 

Page 20 of 24 
 
that subjects are involved in alternative treatment that ultimately proves to be no more effective than the 
usual care they have already received. Thus, the risk-benefit ratio strongly favors the study participant.  
 
The identification of a practical stress reduction regimen of that can produce symptomatic and 
psychological relief has the potential to help alleviate the suffering of patients with metabolic syndrome 
and improve public health. Results obtained from this initial line of inquiry will be the first step in 
developing a graduated, stepwise integrative medicine algorithm for the treatment of metabolic syndrome 
in older adults. The long-term intention is to expand this approach to a larger sample and to older couples 
with other types of medical risk factors. 
 
 
 
         SECTION VI: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS 
 
1. Alternatives: What other alternatives are available to the study subjects outside of the research?  
 
Alternatives to participating in the study would be to continue with their usual medical care, often 
involving pharmacotherapy. 
 
2. Payments for Participation (Economic Considerations): Describe any payments that will be made 
to subjects, the amount and schedule of payments, and the conditions for receiving this 
compensation. 
  All payments will be made in the form of Visa® prepaid debit cards.  As a thank you for their  
  time, each participant will receive $50 after completing the baseline assessment, $50 after 
  completing the 8-week assessment, and $50 at 3 month follow-up, for a total of $150.   
 
3. Costs for Participation (Economic Considerations): Clearly describe the subject’s costs 
associated with participation in the research, and the interventions or procedures of the study that 
will be provided at no cost to subjects.  
 
    Subjects will not incur any costs associated with participation in the research besides 
    transportation fees.  Parking stubs for the Doctor’s Building parking lot are validated at each 
    office visit and parking will be provided at the Social and Gerontology Health Laboratory at 55 
Church Street.  The MBSR intervention is provided at no cost to the subject. 
 
4. In Case of Injury: This section is required for any research involving more than minimal risk, and 
for minimal risk research that presents the potential for physical harm (e.g., research involving blood 
draws). 
 
This research does not involve more than minimal risk. There are no known risks associated 
with MBSR. Numerous clinical trials of MBSR have not reported significant adverse effects 
related to the intervention. 
 
b. Will medical treatment be available if research-related injury occurs?  
 
The YCCI CSRU will provide this service. 
 

Page 21 of 24 
 
c. Where and from whom may treatment be obtained?  
The YCCI CSRU. 
 
d. Are there any limits to the treatment being provided?  
 
 
No. 
 
e. Who will pay for this treatment?  
 
 
The YCCI has liability for these circumstances. 
 
f. How will the medical treatment be accessed by subjects?  
 
 
The YCCI CSRU treatment will be available immediately if there is an injury. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
References 
 
Baer RA, Smith GT, Allen KB. Assessment of mindfulness by self-report the Kentucky inventory of 
mindfulness skills. Assessment. 2004;11(3):191-206. 
 
Biegel GM, Brown KW, Shapiro SL, Schubert CM. Mindfulness-based stress reduction for the treatment 
of adolescent psychiatric outpatients: A randomized clinical trial. J Consult Clin Psychol. 
2009;77(5):855-866. 
 
 

Page 22 of 24 
 
Birnie K, Garland SN, Carlson LE. Psychological benefits for cancer patients and their partners 
participating in mindfulness‐based stress reduction (MBSR). Psycho‐Oncology. 
2010;19(9):1004-1009. 
 
 
Black DR, Gleser LJ, Kooyers KJ. A meta-analytic evaluation of couples weight-loss programs. Health 
Psychology. 1990;9(3):330-347. 
 
 
Bureau US. Current Population Survey (October, 2010). Available at: http://www.census.gov/cps/. 
 
 
Carlson LE, Speca M, Faris P, Patel KD. One year pre–post intervention follow-up of psychological, 
immune, endocrine and blood pressure outcomes of mindfulness-based stress reduction 
(MBSR) in breast and prostate cancer outpatients. Brain, behavior, and immunity. 
2007;21(8):1038-1049. 
 
 
Charlesworth CJ, Smit E, Lee DSH, Alramadhan F, Odden MC. Polypharmacy Among Adults Aged 65 
Years and Older in the United States: 1988–2010. The Journals of Gerontology Series A: 
Biological Sciences and Medical Sciences. 2015. 
 
 
Cramer H, Haller H, Lauche R, Dobos G. Mindfulness-based stress reduction for low back pain. A 
systematic review. BMC Complement Altern Med. 2012;12:162. 
 
 
Creswell JD, Irwin MR, Burklund LJ, et al. Mindfulness-Based Stress Reduction training reduces 
loneliness and pro-inflammatory gene expression in older adults: A small randomized controlled 
trial. Brain, Behavior, and Immunity. 2012;26(7):1095-1101. 
 
 
Creswell JD, Myers HF, Cole SW, Irwin MR. Mindfulness meditation training effects on CD4+ T 
lymphocytes in HIV-1 infected adults: a small randomized controlled trial. Brain Behav Immun. 
2009;23(2):184-188. 
 
 
Denys K, Cankurtaran M, Janssens W, Petrovic M. METABOLIC SYNDROME IN THE ELDERLY: AN 
OVERVIEW OF THE EVIDENCE. Acta Clinica Belgica. 2009;64(1):23-34. 
 
Dobkin P, Irving J, Amar S. For whom may participation in a mindfulness-based stress reduction 
program be contraindicated? Mindfulness. 2012;3(1):444-450. 
 
 
Dunkley A, Charles K, Gray L, Camosso‐Stefinovic J, Davies M, Khunti K. Effectiveness of 
interventions for reducing diabetes and cardiovascular disease risk in people with metabolic 
syndrome: Systematic review and mixed treatment comparison meta‐analysis. Diabetes, 
Obesity and Metabolism. 2012;14(7):616-625. 
 

Page 23 of 24 
 
 
Fjorback LO, Arendt M, Ornbol E, Fink P, Walach H. Mindfulness-based stress reduction and 
mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Acta 
psychiatrica Scandinavica. 2011;124(2):102-119. 
 
 
Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health 
benefits: A meta-analysis. Journal of Psychosomatic Research. 2004;57(1):35-43. 
 
Gu J, Strauss C, Bond R, Cavanagh K. How do mindfulness-based cognitive therapy and mindfulness-
based stress reduction improve mental health and wellbeing? A systematic review and meta-
analysis of mediation studies. Clinical Psychology Review. 2015;37:1-12. 
 
 
Hendrick SS. A generic measure of relationship satisfaction. Journal of Marriage and the Family. 
1988:93-98. 
 
 
Hoppmann CA, Michalowski V, Gerstorf D. Spousal interrelationships in health across adulthood: 
health behaviors and everyday stress as potential underlying mechanisms. In: Bookwala J, ed. 
Couple Relationships in the Middle and Late Years: Their Nature, Complexity, and Role in 
Health and Illness. Washington, D. C.: American Psychological Association; 2016. 
 
 
Jahangiry L, Shojaeezadeh D, Montazeri A, Najafi M, Mohammad K. Health-related Quality of Life 
Among People Participating in a Metabolic Syndrome E-screening Program: A Web-based 
Study. Int J Prev Med. 2016;7:27. 
 
Jennings J, Muldoon M, Hall M. Self-reported sleep qual-ity is associated with the metabolic syndrome. 
Sleep. 2007;30:219-223. 
 
Kabat-Zinn J. Full catastrophe living, revised edition: how to cope with stress, pain and illness using 
mindfulness meditation. Hachette UK; 2013. 
 
Katterman SN, Kleinman BM, Hood MM, Nackers LM, Corsica JA. Mindfulness meditation as an 
intervention for binge eating, emotional eating, and weight loss: A systematic review. Eating 
behaviors. 2014;15(2):197-204. 
 
 
Lengacher CA, Johnson-Mallard V, Post-White J, et al. Randomized controlled trial of mindfulness-
based stress reduction (MBSR) for survivors of breast cancer. Psychooncology. 
2009;18(12):1261-1272. 
 
 
Marchand WR. Mindfulness meditation practices as adjunctive treatments for psychiatric disorders. The 
Psychiatric clinics of North America. 2013;36(1):141-152. 
 
 

Page 24 of 24 
 
Matthews KA, Kuller LH. The relationship between psychological risk attributes and the metabolic 
syndrome in healthy women: antecedent or consequence? Metabolism. 2002;51(12):1573-
1577. 
 
McBee L. Mindfulness practice with the frail elderly and their caregivers: Changing the Practitioner‐
Patient Relationship. Topics in Geriatric Rehabilitation. 2003;19(4):257-264. 
 
 
Olson KL, Emery CF. Mindfulness and weight loss: A systematic review. Psychosomatic medicine. 
2015;77(1):59-67. 
 
Roberti JW, Harrington LN, Storch EA. Further psychometric support for the 10‐item version of the 
perceived stress scale. Journal of College Counseling. 2006;9(2):135-147. 
 
Rosenzweig S, Reibel DK, Greeson JM, Edman JS. Mindfulness-based stress reduction is associated 
with improved glycemic control in type 2 diabetes mellitus: a pilot study. Alternative Therapies in 
Health and Medicine. 2007;13(5):36. 
 
 
Schulz R, Newsom J, Mittelmark M, Burton L, Hirsch C, Jackson S. Health effects of caregiving: the 
caregiver health effects study: an ancillary study of the Cardiovascular Health Study. Annals of 
Behavioral Medicine. 1997;19(2):110-116. 
 
 
Ware Jr JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual 
framework and item selection. Medical care. 1992:473-483.