Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals and Trainees: A Randomized Clinical Trial
Phase: NA
Conditions: Stress, Professional, Stress, Psychological
Sponsor: National Institutes of Health Clinical Center (CC)

Your Answers for OHSRP Determination '17-NIMH-00118' (05/08/2017)
You may click here to return to OHSRP's Determinations website at any time.
SHOULD I STOP OR GO FORWARD WITH AN OHSRP SUBMISSION?
Question
"If this is a new request (i.e. not an amendment to a previously approved project), have you already   started or
completed your research activity? (If amending your project select "No" below) "
Your Answer
 • No
Question
"Are the specimens/data that will be used in this project coming from an active, NIH IRB-approved protocol; or is the
proposed activity a component of an active, NIH IRB-approved protocol, (e.g. the results of this activity will be used in
support of the protocol)?"
Your Answer
 • No
Question
"Does the NIH investigator or NIH collaborator know the identity of (have identifiers associated with) the living  human
sources of the specimens/data that will be used on this project?  (If the specimens/data are not individually  identifiable,
but the identity of the subjects may readily be ascertained by the investigator, e.g. because of a small  sample size,
please answer "Yes" below. Answer "No" below if interacting with subjects to  conduct survey, interview or focus group
research)."
Your Answer
 • No
Question
"Does this activity involve prisoners?"
Your Answer
 • No
Question
"For this project, is NIH conducting a research activity that is part of an FDA-regulated protocol approved by an IRB, 
e.g. the protocol is studying the safety or efficacy of unapproved drugs/devices or new uses of approved
drugs/devices?"
Your Answer
 • No
Question

"* If yes, has the collaborator confirmed that the planned research activity, which will occur at NIH, is included in the
IRB/ethics committee-approved protocol and consent form at his/her institution?"
Your Answer
** DID NOT ANSWER **

SECTION I - GENERAL INFORMATION
Question
"Project Title:"
Your Answer
Mindfulness Based Self Care (MBSC)
Question
"Project Description:"
Your Answer
At the Clinical Center Pain and Palliative Care Service (PPCS) we are currently developing a self-care program for
clinical fellows and attending physicians, the Mindfulness Based Self-Care (MBSC) program. This program incorporates
key components of the well-known mindfulness based stress reduction (MBSR).  The program will offer 5 one and a half
hour sessions for a total of 7.5 hours. The program will be offered to Hospice and Palliative Medicine fellows, first,
second, and third year Hematology-Oncology fellows. We plan to have 10-15 participants per session on a first come
first served basis.  If successful, we will offer this class multiple times throughout the year so everyone who is interested
will be able to participate.  See attached narrative.
Question
"Upload Additional Project Information or  Narrative Template (More Information):"
Your Answer
Narrative_Template_for_Survey_Research_rev._5_23_17.docx
Question
"Proposed Start Date:"
Your Answer
07/05/2017
Question
"Proposed Completion Date:"
Your Answer
07/01/2019
Question
"Search for Requestor (your name):"
Your Answer
Rezvan  Ameli
Question
"If you are not the Senior Investigator (SI), what is your role?"
Your Answer
 • Other investigator
Question

"Other - please enter additional information here"
Your Answer
** DID NOT ANSWER **
Question
"Search for Senior Investigator*:"
Your Answer
Rezvan  Ameli
Question
"Search for Supervisor**:"
Your Answer
Ann M Cohen-Berger
Question
"Are there any additional NIH Investigators on your team conducting this research  (e.g. junior investigator, contractor,
fellow, student, etc...)?"
Your Answer
 • No
Question
"Search for Additional Investigator #1:"
Your Answer
** DID NOT ANSWER **
Question
"Search for Additional Investigator #2:"
Your Answer
** DID NOT ANSWER **
Question
"Search for Additional Investigator #3:"
Your Answer
** DID NOT ANSWER **
Question
"Search for Additional Investigator #4:"
Your Answer
** DID NOT ANSWER **
Question
"Search for Additional Investigator #5:"

Your Answer
** DID NOT ANSWER **

SECTION II - SPECIAL CATEGORIES
Question
"Only select the applicable activities or materials below, if they are involved in the project.   PLEASE NOTE: The majority
of projects do not involve any of the activities listed below. Skip to the next question unless your are sure your activities
are listed below.  (Select all that apply.)"
Your Answer
** DID NOT ANSWER **
Question
"I (the Senior Investigator) certify that the proposed project:"
Your Answer
 • Involves other types of specimens/data or research activities than those listed above. Please continue completing the
request for determination form.

SECTION III -  COLLABORATORS AND OTHER ENTITIES
Question
"Collaborator #1:"
Your Answer
** DID NOT ANSWER **
Question
"Institution/IC Name:"
Your Answer
** DID NOT ANSWER **
Question
"FWA #:"
Your Answer
** DID NOT ANSWER **
Question
"City/State/Country:"
Your Answer
** DID NOT ANSWER **
Question
"Email Address:"
Your Answer
** DID NOT ANSWER **
Question
"Collaborator Actions"
Your Answer
 • N/A
Question
"Additional Collaborator Details:"
Your Answer
** DID NOT ANSWER **
Question
"Collaborator #2:"
Your Answer
** DID NOT ANSWER **

Question
"Institution/IC Name:"
Your Answer
** DID NOT ANSWER **
Question
"FWA #:"
Your Answer
** DID NOT ANSWER **
Question
"City/State/Country:"
Your Answer
** DID NOT ANSWER **
Question
"Email Address:"
Your Answer
** DID NOT ANSWER **
Question
"Collaborator Actions"
Your Answer
** DID NOT ANSWER **
Question
"Additional Collaborator Details:"
Your Answer
** DID NOT ANSWER **
Question
"Collaborator #3:"
Your Answer
** DID NOT ANSWER **
Question
"Institution/IC Name:"
Your Answer
** DID NOT ANSWER **
Question
"FWA #:"

Your Answer
** DID NOT ANSWER **
Question
"City/State/Country:"
Your Answer
** DID NOT ANSWER **
Question
"Email Address:"
Your Answer
** DID NOT ANSWER **
Question
"Collaborator Actions"
Your Answer
** DID NOT ANSWER **
Question
"Additional Collaborator Details:"
Your Answer
** DID NOT ANSWER **
Question
"Upload Additional Collaborator Information:"
Your Answer
** DID NOT ANSWER **

SECTION IV - RESEARCH WITH SPECIMENS AND DATA
Question
"Does this activity include any of the following?  (Select all that apply)"
Your Answer
 • Prospective data collection involving Survey, Interview/Focus Group procedures, Observation  of public behavior,
Educational tests, Educational research, or Research on Public benefit/service programs
 • Program Evaluation (not meeting the definition under Special Categories)
Question
"Other - please enter additional information"
Your Answer
** DID NOT ANSWER **
Question
"If you selected Program Evaluation or QA/QI above, does the activity only involve interview or survey procedures?"
Your Answer
 • Yes
Question
"What role(s) will the NIH Investigator(s) have on this research project?  (Select all that apply)"
Your Answer
 • Interacting with subjects to conduct surveys, interviews/focus groups, observations of public behavior, educational
research or tests, or research on public benefit or service programs
 • Analyzing specimens or data
 • Authoring publication(s)/manuscript(s) pertaining to this research
Question
"Other - please enter additional information here"
Your Answer
** DID NOT ANSWER **
Question
"Identify the types of data or specimen involved in this project  (Select all that apply)"
Your Answer
 • Data, specify below:
Question
"Medical Records - specify source"
Your Answer
** DID NOT ANSWER **
Question
"Data - specify type"

Your Answer
questionnaires
Question
"Specimens - specify type"
Your Answer
** DID NOT ANSWER **
Question
"Imaging - specify type"
Your Answer
** DID NOT ANSWER **
Question
"Other - please enter additional information here"
Your Answer
** DID NOT ANSWER **
Question
"Biorepository - specify name"
Your Answer
** DID NOT ANSWER **
Question
"Database or website - Enter name and URL"
Your Answer
** DID NOT ANSWER **
Question
"Select attachment to upload:"
Your Answer
Doc1.docx

SECTION IV - RESEARCH WITH SPECIMENS AND DATA - Continued
Question
"Do all the specimens/data or information already exist?"
Your Answer
 • No
Question
"If Yes, were the specimens/data for this project originally collected for:"
Your Answer
 • N/A
Question
"Is/was there IRB/Ethics Committee approval for the collection or use of the specimens/data at your collaborator's site (if
applicable)?"
Your Answer
 • No
Question
"Please select the response that best describes the specimens/data utilized for this activity: (Please confirm this with
your collaborator, if applicable, prior to submitting this form.)"
Your Answer
 • Specimens/data will not be coded nor contain any identifiable information that  can be used to identify the  human
source(s), and cannot be linked to individual subjects by you or your collaborators (if applicable).
Question
"If an existing identifiable specimens/data set will be de-identified before the research commences, please indicate who
will conduct the de-identification:"
Your Answer
 • N/A
Question
"NIH SENIOR INVESTIGATOR CERTIFICATION FOR RESEARCH INVOLVING CODED SPECIMENS/DATA  Answer
below only when the other party can identify the human source(s) directly,  through a code-key or  when using an
Honest Broker:  
I (the Senior Investigator) certify that I will not be able to re-identify the human source(s) of the specimens/data in  this
project, and I have obtained one or more of the following to confirm this. Further, I promise to retain this  documentation
and provide it upon request.  (Select all that apply)"
Your Answer
** DID NOT ANSWER **
Question
"If applicable, will the recipient of the specimens/data be returning results to the sender?  (Select all that apply)"
Your Answer

** DID NOT ANSWER **
Question
"* If coded results are being returned to a collaborator who has the code-key to re-identify the human sources of the 
specimens/data, is there IRB/ethics committee approval for this research collaboration at the collaborator's institution?"
Your Answer
** DID NOT ANSWER **
Question
"Additional Info:"
Your Answer
** DID NOT ANSWER **

SECTION V - RESEARCH INVOLVING EDUCATIONAL RESEARCH OR TESTING, SURVEY  OR
INTERVIEW PROCEDURES, OR OBSERVATION OF PUBLIC BEHAVIOR
Question
"Specify the types of research or procedures involved in this project:  (Select all that apply)"
Your Answer
 • Survey
Question
"Other - please enter additional information here"
Your Answer
** DID NOT ANSWER **
Question
"How will data collection be conducted?  (Select all that apply)"
Your Answer
 • In-person at an NIH site
 • Other, specify below:
Question
"In-person at my collaborator's institution(s) or research site(s) - please enter additional information here"
Your Answer
** DID NOT ANSWER **
Question
"In-person at another site(s) - please enter additional information here"
Your Answer
** DID NOT ANSWER **
Question
"Other - please enter additional information here"
Your Answer
Possibly completed by participants in their homes
Question
"Who will be conducting the data collection?  (Select all that apply)"
Your Answer
 • Other, specify below:
Question
"Off-site contractor - please enter additional information here"
Your Answer

** DID NOT ANSWER **
Question
"Online survey tool - please enter additional information here"
Your Answer
** DID NOT ANSWER **
Question
"Other - please enter additional information here"
Your Answer
Participants will complete the surveys on paper
Question
"What is the age range of subjects involved in the research?"
Your Answer
 • Adults aged >= 18 years
Question
"* If children aged less than 18 years and the project involves observation of public behavior, will the NIH investigator(s)
participate in the activities being observed?"
Your Answer
** DID NOT ANSWER **
Question
"Does your project fall into any of the categories of 'clinical research' as defined by the NIH? (See  NIH Glossary &
Acronym List for the full NIH definition of 'clinical research'.)"
Your Answer
 • NONE OF THE ABOVE
Question
"If the Planned Enrollment Report is required per above, confirm that it has been approved by the IC approver as
scientifically valid: (This step must be completed before uploading)"
Your Answer
** DID NOT ANSWER **
Question
"What is the z-number for this project?"
Your Answer
** DID NOT ANSWER **
Question
"Upload Planned Enrollment Report"
Your Answer

** DID NOT ANSWER **
Question
"Upload Consent Language/Script"
Your Answer
** DID NOT ANSWER **
Question
"Upload Survey Instrument /Interview Questions /Focus Group Script"
Your Answer
Measurement-full_set_of_measures_for_the_MBSC_program_5-23-17.pdf
Question
"Additional Info:"
Your Answer
The consent information is included in the narrative template.

Your Answers for OHSRP Determination '17-NIMH-00118-1' (08/25/2017)
You may click here to return to OHSRP's Determinations website at any time.
SHOULD I STOP OR GO FORWARD WITH AN OHSRP SUBMISSION?
Question
"If this is a new request (i.e. not an amendment to a previously approved project), have you already   started or
completed your research activity? (If amending your project select "No" below) "
Your Answer
 • No
Question
"Are the specimens/data that will be used in this project coming from an active, NIH IRB-approved protocol; or is the
proposed activity a component of an active, NIH IRB-approved protocol, (e.g. the results of this activity will be used in
support of the protocol)?"
Your Answer
 • No
Question
"Does the NIH investigator or NIH collaborator know the identity of (have identifiers associated with) the living  human
sources of the specimens/data that will be used on this project?  (If the specimens/data are not individually  identifiable,
but the identity of the subjects may readily be ascertained by the investigator, e.g. because of a small  sample size,
please answer "Yes" below. Answer "No" below if interacting with subjects to  conduct survey, interview or focus group
research)."
Your Answer
 • No
Question
"Does this activity involve prisoners?"
Your Answer
 • No
Question
"For this project, is NIH conducting a research activity that is part of an FDA-regulated protocol approved by an IRB, 
e.g. the protocol is studying the safety or efficacy of unapproved drugs/devices or new uses of approved
drugs/devices?"
Your Answer
 • No
Question

"* If yes, has the collaborator confirmed that the planned research activity, which will occur at NIH, is included in the
IRB/ethics committee-approved protocol and consent form at his/her institution?"
Your Answer
** DID NOT ANSWER **

SECTION I - GENERAL INFORMATION
Question
"Project Title:"
Your Answer
Mindfulness Based Self Care (MBSC)
Question
"Project Description:"
Your Answer
This is an amendment. See narrative for details. Below is a summary of revisions:  
A. The evaluation will involve NIH staff and trainees instead of just fellows.
B. We will attempt to recruit an equal number of participants and non-participants (to act as controls) to participate in the
evaluation. Controls will be chosen from the waiting list of participants who havent participated. 
C. Recruitment will all be done via flyers.
D. The timing of the instruments has changed from what it was previously.  We added 3 administrations to the two-item
burn out measure (which we are already administering pre-post) for the participant group.  The MBI (2 items) instrument
will now be completed by MBSC participants before classes 2, 3, 4, and 5, along with the Stress/Anxiety Thermometer
(1 item), the MASS at Time of Assessment (5 items), and the Mindful Self-Care (3 items) instruments.  The
Stress/Anxiety Thermometer (1 item), the MASS at Time of Assessment (5 items), and the Mindful Self-Care (3 items)
instruments will be repeated after classes 1,2,3,and 4.
E. The controls (non-participants) will now fill out surveys on 3 instead of 6 occasions.   
F. I have removed the Activity Record as one of the instruments that the non-participants complete. 
G. The class evaluation form has been modified to reflect ratings of the various techniques used during the sessions
instead of rank ordering.   
H. I have modified the attached narrative template including the consent language and the narrative template to reflect
these changes.
Question
"Upload Additional Project Information or  Narrative Template (More Information):"
Your Answer
Narrative_Template_for_Survey_Research_9_13_17.docx
Question
"Proposed Start Date:"
Your Answer
10/01/2017
Question
"Proposed Completion Date:"
Your Answer
10/01/2020
Question
"Search for Requestor (your name):"

Your Answer
Rezvan  Ameli
Question
"If you are not the Senior Investigator (SI), what is your role?"
Your Answer
 • Other investigator
Question
"Other - please enter additional information here"
Your Answer
** DID NOT ANSWER **
Question
"Search for Senior Investigator*:"
Your Answer
Rezvan  Ameli
Question
"Search for Supervisor**:"
Your Answer
Ann M Cohen-Berger
Question
"Are there any additional NIH Investigators on your team conducting this research  (e.g. junior investigator, contractor,
fellow, student, etc...)?"
Your Answer
 • No
Question
"Search for Additional Investigator #1:"
Your Answer
Ninet  Sinaii
Question
"Search for Additional Investigator #2:"
Your Answer
** DID NOT ANSWER **
Question
"Search for Additional Investigator #3:"
Your Answer
** DID NOT ANSWER **

Question
"Search for Additional Investigator #4:"
Your Answer
** DID NOT ANSWER **
Question
"Search for Additional Investigator #5:"
Your Answer
** DID NOT ANSWER **

SECTION II - SPECIAL CATEGORIES
Question
"Only select the applicable activities or materials below, if they are involved in the project.   PLEASE NOTE: The majority
of projects do not involve any of the activities listed below. Skip to the next question unless your are sure your activities
are listed below.  (Select all that apply.)"
Your Answer
** DID NOT ANSWER **
Question
"I (the Senior Investigator) certify that the proposed project:"
Your Answer
 • Involves other types of specimens/data or research activities than those listed above. Please continue completing the
request for determination form.

SECTION III -  COLLABORATORS AND OTHER ENTITIES
Question
"Collaborator #1:"
Your Answer
** DID NOT ANSWER **
Question
"Institution/IC Name:"
Your Answer
** DID NOT ANSWER **
Question
"FWA #:"
Your Answer
** DID NOT ANSWER **
Question
"City/State/Country:"
Your Answer
** DID NOT ANSWER **
Question
"Email Address:"
Your Answer
** DID NOT ANSWER **
Question
"Collaborator Actions"
Your Answer
 • N/A
Question
"Additional Collaborator Details:"
Your Answer
** DID NOT ANSWER **
Question
"Collaborator #2:"
Your Answer
** DID NOT ANSWER **

Question
"Institution/IC Name:"
Your Answer
** DID NOT ANSWER **
Question
"FWA #:"
Your Answer
** DID NOT ANSWER **
Question
"City/State/Country:"
Your Answer
** DID NOT ANSWER **
Question
"Email Address:"
Your Answer
** DID NOT ANSWER **
Question
"Collaborator Actions"
Your Answer
** DID NOT ANSWER **
Question
"Additional Collaborator Details:"
Your Answer
** DID NOT ANSWER **
Question
"Collaborator #3:"
Your Answer
** DID NOT ANSWER **
Question
"Institution/IC Name:"
Your Answer
** DID NOT ANSWER **
Question
"FWA #:"

Your Answer
** DID NOT ANSWER **
Question
"City/State/Country:"
Your Answer
** DID NOT ANSWER **
Question
"Email Address:"
Your Answer
** DID NOT ANSWER **
Question
"Collaborator Actions"
Your Answer
** DID NOT ANSWER **
Question
"Additional Collaborator Details:"
Your Answer
** DID NOT ANSWER **
Question
"Upload Additional Collaborator Information:"
Your Answer
** DID NOT ANSWER **

SECTION IV - RESEARCH WITH SPECIMENS AND DATA
Question
"Does this activity include any of the following?  (Select all that apply)"
Your Answer
 • Prospective data collection involving Survey, Interview/Focus Group procedures, Observation  of public behavior,
Educational tests, Educational research, or Research on Public benefit/service programs
 • Program Evaluation (not meeting the definition under Special Categories)
Question
"Other - please enter additional information"
Your Answer
** DID NOT ANSWER **
Question
"If you selected Program Evaluation or QA/QI above, does the activity only involve interview or survey procedures?"
Your Answer
 • Yes
Question
"What role(s) will the NIH Investigator(s) have on this research project?  (Select all that apply)"
Your Answer
 • Interacting with subjects to conduct surveys, interviews/focus groups, observations of public behavior, educational
research or tests, or research on public benefit or service programs
 • Analyzing specimens or data
 • Authoring publication(s)/manuscript(s) pertaining to this research
Question
"Other - please enter additional information here"
Your Answer
** DID NOT ANSWER **
Question
"Identify the types of data or specimen involved in this project  (Select all that apply)"
Your Answer
 • Data, specify below:
Question
"Medical Records - specify source"
Your Answer
** DID NOT ANSWER **
Question
"Data - specify type"

Your Answer
questionnaires
Question
"Specimens - specify type"
Your Answer
** DID NOT ANSWER **
Question
"Imaging - specify type"
Your Answer
** DID NOT ANSWER **
Question
"Other - please enter additional information here"
Your Answer
** DID NOT ANSWER **
Question
"Biorepository - specify name"
Your Answer
** DID NOT ANSWER **
Question
"Database or website - Enter name and URL"
Your Answer
** DID NOT ANSWER **
Question
"Select attachment to upload:"
Your Answer
Combined_measures_9_13_17.docx

SECTION IV - RESEARCH WITH SPECIMENS AND DATA - Continued
Question
"Do all the specimens/data or information already exist?"
Your Answer
 • No
Question
"If Yes, were the specimens/data for this project originally collected for:"
Your Answer
 • N/A
Question
"Is/was there IRB/Ethics Committee approval for the collection or use of the specimens/data at your collaborator's site (if
applicable)?"
Your Answer
 • No
Question
"Please select the response that best describes the specimens/data utilized for this activity: (Please confirm this with
your collaborator, if applicable, prior to submitting this form.)"
Your Answer
 • Specimens/data will not be coded nor contain any identifiable information that  can be used to identify the  human
source(s), and cannot be linked to individual subjects by you or your collaborators (if applicable).
Question
"If an existing identifiable specimens/data set will be de-identified before the research commences, please indicate who
will conduct the de-identification:"
Your Answer
 • N/A
Question
"NIH SENIOR INVESTIGATOR CERTIFICATION FOR RESEARCH INVOLVING CODED SPECIMENS/DATA  Answer
below only when the other party can identify the human source(s) directly,  through a code-key or  when using an
Honest Broker:  
I (the Senior Investigator) certify that I will not be able to re-identify the human source(s) of the specimens/data in  this
project, and I have obtained one or more of the following to confirm this. Further, I promise to retain this  documentation
and provide it upon request.  (Select all that apply)"
Your Answer
** DID NOT ANSWER **
Question
"If applicable, will the recipient of the specimens/data be returning results to the sender?  (Select all that apply)"
Your Answer

** DID NOT ANSWER **
Question
"* If coded results are being returned to a collaborator who has the code-key to re-identify the human sources of the 
specimens/data, is there IRB/ethics committee approval for this research collaboration at the collaborator's institution?"
Your Answer
** DID NOT ANSWER **
Question
"Additional Info:"
Your Answer
Below is the tracked version of the Narrative :  
Narrative Template for Educational, Survey or Interview Research
Prepare a narrative, either within the project description section of the form, or upload an attachment into the web-based
system, which addresses all the questions below. Be sure to discuss in detail the role of the NIH research team and
every other entity who will assist or collaborate in the research, including companies with whom you are subcontracting.
Collaborators or subcontractors, who are not NIH employees and who are conducting the research off-site, will
commonly need IRB approval or an exemption from their own IRB of record. 
Remember to also upload a copy of any recruitment scripts, screening questions, survey, interview, or focus group
questions or scripts as well as the consent language that will be used for your project into the system. Note that the
functionality in the system only allows one document per upload.  If you have more than three documents to upload,
combine them into a single PDF and upload that instead. 
1. What is the research question or purpose of this research activity?
At the Clinical Center Pain and Palliative Care Service (PPCS) we are currently offering a self-care program to NIH staff
and trainees, developing a self-care program for clinical fellows and attending physicians, the Mindfulness Based
Self-Care (MBSC) program. This program incorporates key components of the well-known mindfulness based stress
reduction (MBSR) which typically spans over 9 sessions for 30 hours.  In our program, 5 sessions will be devoted to this
activity and each class will be 1.5 hours in length for a total of 7.5 hours.   Exposure to mindfulness based practices are
found to be effective even when shorter than 30 hours of teachings are provided.  Initially, Wwe will conduct an
evaluation of the effectiveness of the program by comparing MBSC class participants responses over time as well as
comparing their responses to those of non-participants. These participants will all be NIH staff and trainees.  all be
clinical fellows.
2. Describe the target population, including the number of planned participants. Subject selection must be equitable or
otherwise justified here. (See NIH HRPP SOP 6, 6.12.)
The program is offered to NIH staff and trainees. will be offered to Hospice and Palliative Medicine, as well as first,
second, and third year Hematology-Oncology fellows. Maximum enrollment is 15 We plan to have 10-15 participants per
session on a first come first served basis.  If successful, wWe will offer this class multiple times throughout the year so
anyone who is interested will be able to participate.  Approximately 40-50 fellows could potentially partake in the
program this year.  Moving forward the program will also be offered to attending physicians. We will also attempt to
recruit an equal number of 20-25 non-participants to serve as a control group for the project.   
3. Which entity(ies) will conduct recruitment?  How will it be conducted (telephone, email, regular mail, on-line, in person
or some combination of these)?  If one entity will simply send out a link through a mass mailing, state that. Will that
entity receive and/or maintain any personal identifiers as part of this process? If so, what type of identifiers? (See the list
of possible identifiers is included in NIH HRPP SOP 5, Appendix 2.)
This project doesnt involve any outside collaborators. The class will be advertised by flyers and emails that will include

relevant (dates, times, location, content) class information. an initial introductory lecture during the fellows orientation
sessions and followed up by emails from NIH training directors/designee and Rezvan Ameli, Ph.D. that will include the
class information, brief description of each session, and information about the program evaluation.  
AAfter finalizing the list of participants, they will be invited to participate in the project as a volunteer.   Those on waiting
list will be invited to participate as the control subject group. fter the fellows have signed up for the class, another email
will be sent out inviting those who have not signed up to participate in the evaluation portion only.  Dr. Ameli will have
email addresses and names as part of her role in recruiting for, teaching the classes, and implementing the evaluation,
but none of the questionnaire data collected will be linked to these personal identifiers. 
4. If the project involves any pre-screening for eligibility, which entity(ies) will conduct pre-screening?  How will it be
conducted specifically (telephone, email, regular mail, on-line, in person or some combination of these)?  Will that entity
receive and/or maintain any personal identifiers as part of this process? If so, what type of identifiers?
N/A.  
5. What type of research procedures will be used? For example, will this project involve surveys, interviews, focus
groups, educational tests, etc.?  How will data collection be conducted (telephone, email, regular mail, on-line, in person
or some combination of these)?  If not through a website, which entity(ies) will be conducting the various activities?  If
different entities will conduct different parts of the data collection, be clear about which entity will conduct what part.  Will
that entity receive and/or maintain any personal identifiers as part of this process? 
EightSeven short paper and a demographic questionnaire will be completed by both participants and non-participants.
The MBSC participants will also complete a class evaluation.  
MBSC class participants will complete the all eight questionnaires prior to participation in the class 1, after class 5r they
have completed the series, and at a two-month follow up. Therefore, besides the demographic questionnaire, they will
complete a total of 24 1 questionnaires in three time points (3 sets of 87 questionnaires at each time point).  In addition,
before classes 2, 3, 4, and 5 tThey will also complete fourthree short of the questionnaires (MBI, Stress/Anxiety
Thermometer (1 item), MAAS at Time of Assessment (5 items), and Mindful Self-Care (3 items) and after classes 1, 2, 3,
and 4, they will complete three short of the questionnaires (Stress/Anxiety Thermometer (1 item), MAAS at Time of
Assessment (5 items), and Mindful Self-Care (3 items))before and after each of the 5 class sessions.  Therefore tefore,
they will complete a total of 2830 questionnaires during the program (10 sets of 3 questionnaires) in addition to the
above three time points25 questionnaires. The MBSC participants will also complete a class evaluation.   
The non-MBSC class participants will receive the same eight questionnaires in three times points, i.e. before the start of
the class, at the conclusion of the class, and at a follow up as appropriateas the MBSC class but with slightly different
frequency.  
They will complete the questionnaires before, after the classes and at a two-month follow up. Therefore, they will also
complete a total of 21 questionnaires in these three time points (3 sets of 7 questionnaires at each time point).  They will
be also asked to fill out an activity record during the same 1.5 hours that the MBSC participants were in class, and the
same 3 questionnaires as the MBSC group for a total of 15 questionnaires (5 sets of 3 questionnaires).  The non-MBSC
class participants will pick up paper copies of the questionnaires from the instructor and will receive unique numbers
following the same process above.
Each participant will be provided with a binder that includes uniquely numbered questionnaires with appropriate weekly
designation. The non-MBSC class participants will pick up paper copies of the questionnaires from the instructor and will
receive unique numbers.  The instructor will not maintain any link between these numbers and the participants names or
other identifiers.  The numbered questionnaires will allow the instructor to link the questionnaire data to the same
participant without the use of any personal identifiers.  No personal identifiers will be maintained that can be linked to the
data.  For participants, aAttendance will be obtained via an attendance sheet that will include numbers only.
Dr. Ameli will oversee the data collection.  The completed questionnaires by the MBSC group will be collected after each
class.  The packet of numbered questionnaires will be handed to non-MBSC group in numbered envelopes in person
and collected in person at the designated time pointse conclusion of the program.  Group email reminders will be sent
out by the instructor to remind both groups to fill out the designated questionnaires. Both groups will be reminded that
they do should not send in this information by email.  

Only answer question #6 if contact information for the NIH staff will be provided to subjects in case they have questions
about the research OR if NIH staff will be interacting with subjects for this project; for example:
a. to conduct screening or consent; 
b. to invite them to participate in the research;
c. to email them a web link to access a survey; 
d. to mail a paper copy of a survey; or
e. to collect data via interview/focus group, etc.
When contact information for NIH staff is being provided, or NIH staff are interacting with potential subjects, you must
provide information to subjects that includes certain elements of informed consent for research and upload it in the
system. (See Required Elements of Consent Language below.)
6. How will consent information be shared (e.g. mailed or emailed to potential subjects before data collection, read aloud
to participants over the telephone or in person, or included as part of an on-line instrument, etc.)? Whose contact
information will be provided to subjects in case they have questions about the research? (This person should be one of
the researchers involved in the project.)  If applicable, which entity, will read the consent language aloud? Will the
subject sign a hard copy informed consent form (ICF) or provide electronic consent?  (Note: Obtaining written or
electronic consent is not mandatory for exempt research.) If a signed ICF will be obtained, who will receive the signed
forms?   
Consent information will be provided to the class participants both in writing and verbally and to non-participants in
writing.  The initial email to the NIH staff and trainees fellows interested in the MBSC program will include the following
information about the evaluation:
We will be conducting an evaluation As part of the implementation of the Mindfulness Based Self-Care (MBSC)
program, we will be conducting an evaluation to look at the programs effectiveness in reducing stress and enhancing
wellbeing and self-care among the NIH staff and trainees.  clinical fellows.  In addition to assessment of the programs
effectiveness, Tthe evaluation is being conducted for research purposes.  We will ask you to complete a demographic
questionnaire and  eightseven short self-administered pre- and post-questionnaires at three time points for a total of 21
questionnaires. Before the first class, at the conclusion of the 5 classes, and at a two-month follow up.  This should take
15 minutes or less each time.  We will also ask you to complete four three  similar shortof the questionnaires in the
beginning and three at the end of each class for a total of 30 questionnaires. This should take less than 5 minutes each
time. The questions will be focused on mindfulness, positive and negative mood states, self-care, and your general level
of stress/distress.  Your participation in the evaluation is completely voluntary., i.e. you can choose to participate in the
program without participating in the evaluation .  Your responses will be collected anonymously. Please call or email
Rezvan Ameli, Ph.D.  (Rezvan.ameli@NIH.Gov;  tel: 301 402 7360) with any questions or concerns about this activity.
The initial email to the non-MBSC class participants will include the following information:
We will be conducting an evaluation of the As part of the implementation of the Mindfulness Based Self-Care (MBSC)
program, we will be conducting an evaluation to look at the methods that the NIG staff and trainees clinical fellows use
to reduce their stress and enhance their wellbeing and self-care.  The evaluation is being conducted for research
purposes. We are asking you to complete a demographic questionnaire and eightseven short self-administered
questionnaires at three time points for a total of 21 questionnaires. This should take about 15 minutes or less each time. 
The questions will be focused on mindfulness, positive and negative mood states, and your general level of
stress/distress.  We will also ask you to keep a record of your activity/ies and fill out three brief questionnaires during five
specified time points and fill out three brief questionnaires for a total of 15 questionnaires (less than 5 minutes each
time).  Your participation is completely voluntary.  Your responses will be collected anonymously. Please call or email
Rezvan Ameli, Ph.D.  (Rezvan.ameli@NIH.Gov;  tel: 301 402 7360) with any questions or concerns about this activity.
7. Which entity(ies) will have access to the individual subjects responses?  Will data or results be shared between
entities?  Who will share data and what specifically will be shared (e.g. data and/or results; if results, aggregate or
individual level)?  Will it include identifiers? If so, what type of identifiers will be included?  If NIH will have access to
identifiable data as a part of this project, describe how you will maintain the confidentiality of the data, e.g. 
Confidentiality of data is ensured by good data practices, including, as applicable, locked file cabinets, storage of
electronic data on the network that has firewall protection, strong passwords on computer files, and data access only for
those involved in the study. (NIH HRPP SOP 6, Section 6.12).  Which entity(ies) will be responsible for analysis of data?

 Will the results be published or presented in conferences, etc.?  Which entity(ies) will be involved in authoring these
documents?  
Dr. Ameli will receive the completed questionnaires and will be responsible for the data management and analysis. She
will share a summary of results with Ann Berger, M.D. Chief of Pain and Palliative Care Service.  Dr. Berger will share
this information with appropriate NIH supervisors training directors at her discretion. Publications or conference
presentations will also be decided under Dr. Bergers discretion with Dr. Amelis input.   
8. If any collaborators or sub-contractors are involved, do they have IRB approval or an exemption from IRB review for
their role in the project?  If not, is this in process?  Please note, IRB approval may be required, if we determine these
individuals to be engaged in human subjects research as part of this project.
No non-NIH staff will be involved in the project.evaluation of this program.
Required Elements of Consent Language  
If your research project must include consent language, according to question #6 above, the language should include
the following elements: 1) that the activity is being conducted for research purposes; 2) that participation is voluntary; 3)
a description of the procedures involved (e.g. approximate time commitment, number of questions, number of follow
ups, etc.), and 4) the name and contact information for one of the researchers.  Your project will not be approved unless
each of these elements is included as part of the instrument/interview script, recruitment script/email, or as a separate
consent document uploaded into the system.
In addition, you should consider addressing the following topics: 1) purpose of the research; 2) description of the
subjects being targeted (number and eligibility criteria); 3) any anticipated risks or benefits; 4) methods for withdrawal
from the study and whether subjects data will be maintained after withdrawal; 5) whether personal identifiers will be
collected or not; 6) if identifiers will be collected, how confidentiality will be ensured (see examples in question #7
above); and 7) compensation.

SECTION V - RESEARCH INVOLVING EDUCATIONAL RESEARCH OR TESTING, SURVEY  OR
INTERVIEW PROCEDURES, OR OBSERVATION OF PUBLIC BEHAVIOR
Question
"Specify the types of research or procedures involved in this project:  (Select all that apply)"
Your Answer
 • Survey
Question
"Other - please enter additional information here"
Your Answer
** DID NOT ANSWER **
Question
"How will data collection be conducted?  (Select all that apply)"
Your Answer
 • In-person at an NIH site
 • Other, specify below:
Question
"In-person at my collaborator's institution(s) or research site(s) - please enter additional information here"
Your Answer
** DID NOT ANSWER **
Question
"In-person at another site(s) - please enter additional information here"
Your Answer
** DID NOT ANSWER **
Question
"Other - please enter additional information here"
Your Answer
Possibly completed by participants in their homes
Question
"Who will be conducting the data collection?  (Select all that apply)"
Your Answer
 • Other, specify below:
Question
"Off-site contractor - please enter additional information here"
Your Answer

** DID NOT ANSWER **
Question
"Online survey tool - please enter additional information here"
Your Answer
** DID NOT ANSWER **
Question
"Other - please enter additional information here"
Your Answer
Participants will complete the surveys on paper
Question
"What is the age range of subjects involved in the research?"
Your Answer
 • Adults aged >= 18 years
Question
"* If children aged less than 18 years and the project involves observation of public behavior, will the NIH investigator(s)
participate in the activities being observed?"
Your Answer
** DID NOT ANSWER **
Question
"Does your project fall into any of the categories of 'clinical research' as defined by the NIH? (See  NIH Glossary &
Acronym List for the full NIH definition of 'clinical research'.)"
Your Answer
 • NONE OF THE ABOVE
Question
"If the Planned Enrollment Report is required per above, confirm that it has been approved by the IC approver as
scientifically valid: (This step must be completed before uploading)"
Your Answer
** DID NOT ANSWER **
Question
"What is the z-number for this project?"
Your Answer
** DID NOT ANSWER **
Question
"Upload Planned Enrollment Report"
Your Answer

** DID NOT ANSWER **
Question
"Upload Consent Language/Script"
Your Answer
** DID NOT ANSWER **
Question
"Upload Survey Instrument /Interview Questions /Focus Group Script"
Your Answer
Combined_measures_9_13_17.docx
Question
"Additional Info:"
Your Answer
The consent information is included in the narrative template. Here is the tracked version of combined measures:  
Demographic information and course evaluation
Demographic Questionnaire
1. How old are you? 
2. What is your gender?  Male  Female Other (describe)__________________________ 
3. What is your race?  
American Indian/Alaska Native  Asian  Black or African American Caucasian Native Hawaiian/Pacific
Islander Mixed/Two or more (describe) __________________________  
Other (describe) __________________________ 
4. Are you Hispanic or Latino?  Yes  No
5. What is your marital status? 
Single  Married  Divorced/Separated
Widowed  Living with partner  Other (describe)_________________
6. What is the highest level of education you have completed?   
 Completed grade school   Completed high school/GED 
 Completed vocational training  Some college/university  
 Completed college/university  Completed graduate school/advanced degree
Other (describe)__________________________
7. What is your religion?  
Christianity  Islam  Hinduism Buddhism  Judaism Agnostic
Atheist Not affiliated  Other (describe) __________________________
8. What is your employment status?    Full time Part time  Not employed 
Other (describe) __________________________
9. If working, what kind of work do you do?
10. Please rate your current level of stress:
No stress

Mild
Moderate
Severe
Extreme 
Other (describe)__________________________
11. Please list 3 main sources of stress:
1.
2.
3.
Others (please list):
12. What is your current level of social support (friends, family, community, religion/spirituality, other)?
No support
Some support
Good support
Excellent support
Other (describe) __________________________
13. Please list the 3 main sources of support:
1.
2.
3.
Other (describe)__________________________
14. Do you have a medical diagnosis? Yes  No
If yes, please list:
1. 
2.
3.
15. How do you rate your current overall health status?
Poor
Manageable 
Satisfactory/Fair 
Good
Excellent
Other (describe)__________________________
16. Do you have a psychiatric diagnosis?  Yes  No
If yes, please list: 
1.
2.
3.
17. How do you rate your current overall mental health status?
Poor
Manageable 
Satisfactory/Fair 
Good

Excellent
Other (describe)__________________________
18. How do you rate your quality of life?
Poor
Manageable 
Satisfactory/Fair 
Good
Excellent
Other (describe) __________________________
MBSC Course Evaluation
Your evaluation will be greatly appreciated and will inform our self-care program for our staff and trainees.   Thank you in
advance.   
       Not 1 2 3 4 5   Very        at all          Much             
How effective was the course for you in the 
following ways: 
Help reduce your overall stress level at work?  1 2 3 4 5 
Help reduce your overall stress in your personal life? 1 2 3 4 5
Help you practice mindfulness formally or informally? 1 2 3 4 5
 Motivated you to take better care of yourself?  1 2 3 4 5
Help improve general quality of life?    1 2 3 4 5
How many sessions did you attend (please circle one)?  
1 2 3 4 5
Rate the following practices that were introduced in class, based on your preference from 1-15. The practice you
preferred most will be assigned 1, the one you preferred next would be 2 etc. You can use the same rating for more than
one practice if two or more practices were equally preferred.  (E.g. several practices could be designated as 1 or 2 etc. 
The larger numbers will indicate your least preferred practice/s.) 
# Practice # Practice
 Mindful Breathing  Mindful seeing and contemplation
 Body Scan  Four Rivers of Life
 Mindful Eating  Smiling
 Mindful Walking  Gratitude
 Mindful Movements  List of Joys
 Sound as an anchor  Mindful Pause
 Loving Kindness meditation   Tips for Mindfulness at work
 R.A.I.N. practice  
How do you rate the overall quality of this course? 

(Poor)  1__       2__       3__       4___       5__ (excellent) 
How do you rate the material in the binder that was prepared for you?
(Poor)  1__       2__       3__       4___       5__ (excellent) 
 
Do you have any suggestions or comments that could make future Mindfulness classes more helpful?
Do you have suggestions for the teacher?  
Do you have any other suggestions?
Complete set of measures administresedadministered at 3 times points to both 
participants and non-participants
Please indicate your level of Stress/Anxiety during the past week including now: 
 
MASS: Experiences at Time of Assessment 
Instructions: Using the 0-6 scale shown, please indicate to what degree you have each experience described below.
Please answer according to what really reflects your experience rather than what you think your experience should be.
not at all       very much 
1. I was finding it difficult to stay focused on what was    0  1  2  3  4  5  6
happening.
2. I was doing something without paying attention.    0  1  2  3  4  5  6
3. I was preoccupied with the future or the past.    0  1  2  3  4  5  6
4. I was doing something automatically,      0  1  2  3  4  5  6
without being aware of what I was doing.

5. I was rushing through something without being really    0  1  2  3  4  5  6
attentive to it.
Mindful Self-Care
Check the box that reflects the frequency of your behavior (how much or how often) within past week (7 days) including
today:  
 Never zero days (0)  Rarely one day  (1) Sometimes-2 to 3 days (2) Often-3 to 5 days (3) Regularly-6 to 7 days (4) 
1. I engaged in a variety of self-care strategies (e.g., mindfulness, support, exercise, nutrition, spiritual practice). 
     
2. I planned my self-care     
3. I explored new ways to bring self-care into my life     
Perceived Stress Scale- 10 Item
Instructions: The questions in this scale ask you about your feelings and thoughts during the last month.  In each case,
please indicate with a check how often you felt or thought a certain way. 
 
1. In the last month, how often have you been upset because of something that happened unexpectedly?
 ___0=never ___1=almost never ___2=sometimes ___3=fairly often ___4=very often 
2. In the last month, how often have you felt that you were unable to control the important things in your life?
 ___0=never ___1=almost never ___2=sometimes ___3=fairly often ___4=very often
3. In the last month, how often have you felt nervous and "stressed"?
___0=never ___1=almost never ___2=sometimes ___3=fairly often ___4=very often
4. In the last month, how often have you felt confident about your ability to handle your personal problems?
___0=never ___1=almost never ___2=sometimes ___3=fairly often ___4=very often
5. In the last month, how often have you felt that things were going your way?
___0=never ___1=almost never ___2=sometimes ___3=fairly often ___4=very often
6. In the last month, how often have you found that you could not cope with all the things that you had to do?
___0=never ___1=almost never ___2=sometimes ___3=fairly often ___4=very often
7. In the last month, how often have you been able to control irritations in your life?
___0=never ___1=almost never ___2=sometimes ___3=fairly often ___4=very often
8. In the last month, how often have you felt that you were on top of things?
___0=never ___1=almost never ___2=sometimes ___3=fairly often ___4=very often
9. In the last month, how often have you been angered because of things that were outside of your control?
___0=never ___1=almost never ___2=sometimes ___3=fairly often ___4=very often
10. In the last month, how often have you felt difficulties were piling up so high that you could not overcome them?
___0=never ___1=almost never ___2=sometimes ___3=fairly often ___4=very often
Cohen, S., Kamarck, T., Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social
Behavior, 24, 385-396.
Geneva Emotion Wheel Version 3.0
Instructions

This instrument, called the Geneva Emotion Wheel, is used to measure as precisely as possible the emotions you
experienced during the past week including today and right now.  
Our emotions are often blended or mixed and contain many different components. Please rate the intensity of all the
emotions in the wheel with respect to what you felt, even if the intensities are very low. For those emotions that were not
at all part of your reaction, please check the small box under the smallest circle, respectively.
 
The PANAS
This scale consists of a number of words that describe different feelings and emotions. Read each item and then mark
the appropriate box. Indicate to what extent you have experienced these feelings during the past week including today
and right now. Use the following scale to record your answers.
 1
Very slightly or not at all 2
A little 3
Moderately  4
Quite a bit 5
Extremely
Interested     
distressed     
excited     
upset     
strong     
Guilty      
Scared      
Hostile      
Enthusiastic      
Proud     
Irritable      
Alert      
Ashamed     
Inspired      
Nervous      
Determined      
Attentive      
Jittery      
Active      
Afraid      

Below is a collection of statements about your everyday experience.  Using the 1-6 scale below, please indicate how
frequently you currently have each experience. 
Please answer according to what really reflects your experience rather than what you think your experience should be.
Treat each item separately from every other item.  
 
MBI- 2-item
(Adapted from West et al, 2012, JGIM)
 Never  A few times a year or less Once a month or less A few times a month Once a week A few times a week Every
day
How often I feel burned out from work? 
       
How often Ive become callus toward people since you started your job?       
West et al (2012) concurrent validity of single-item measures of emotional exhaustion and depersonalization in burnout
assessment, J Gen Intern Med. 2012 Nov; 27(11): 14451452.Published online 2012 Feb 24. doi: 
10.1007/s11606-012-2015-7
Measures per class session 
Please indicate your level of Stress/AnxityAnxiety during the past week including now: 
 
MBI- 2-item
(Adapted from West et al, 2012, JGIM)
 Never  A few times a year or less Once a month or less A few times a month Once a week A few times a week Every
day
How often I feel burned out from work? 
       
How often Ive become callus toward people since you started your job?       

West et al (2012) concurrent validity of single-item measures of emotional exhaustion and depersonalization in burnout
assessment, J Gen Intern Med. 2012 Nov; 27(11): 14451452.Published online 2012 Feb 24. doi: 
10.1007/s11606-012-2015-7
MASS: Experiences at Time of Assessment 
Instructions: Using the 0-6 scale shown, please indicate to what degree you have each experience described below.
Please answer according to what really reflects your experience rather than what you think your experience should be.
not at all       very much 
1. I was finding it difficult to stay focused on what was    0  1  2  3  4  5  6
happening.
2. I was doing something without paying attention.    0  1  2  3  4  5  6
3. I was preoccupied with the future or the past.    0  1  2  3  4  5  6
4. I was doing something automatically,      0  1  2  3  4  5  6
without being aware of what I was doing.
5. I was rushing through something without being really    0  1  2  3  4  5  6
attentive to it.
Mindful Self-Care
Check the box that reflects the frequency of your behavior (how much or how often) within past week (7 days) including
today:  
 Never zero days (0)  Rarely one day  (1) Sometimes-2 to 3 days (2) Often-3 to 5 days (3) Regularly-6 to 7 days (4) 
4. I engaged in a variety of self-care strategies (e.g., mindfulness, support, exercise, nutrition, spiritual practice). 
     
5. I planned my self-care     
6. I explored new ways to bring self-care into my life

5/23/17 
 
1 
 
17-NIMH-00118: “Mindfulness Based Self Care (MBSC)” STUDY STATISTICS 
Sample Size 
Using PASS software, sample size was determined based on a “Test for Two Means in a Repeated 
Measures Design.” This compared MBSC and control groups, from baseline to post-intervention. Using 
the primary outcome of PSS-10, a detection of a 1.0 difference was determined to be a meaningful 
change. 
Sample size calculation details included: two-sided test, power set at 0.90, alpha at 0.05, with equal group 
allocation. The effect size tested a range of differences from 0.25 to 1.5 in increments of 0.25. Since the 
primary comparison was between MBSC and controls from baseline to post-intervention, repeated 
measurements were specified as two intervals. 
Due to the repeated measure, the covariance structure specifications were set as compound symmetry, 
with a sigma of 1, and rho of 0.5.  
The estimates yielded the following range of sample sizes: 
Numeric Results 
──────────────────────────────────────────────────────────── 
Two-Sided Test. Null Hypothesis: D = 0. Alternative Hypothesis: D ≠ 0. 
Covariance Type = Compound Symmetry 
Target 
Actual 
 
 
 
 
 
 
 
 
Power 
Power 
N1 
N2 
N 
M 
D1 
Sigma 
Rho 
Alpha 
0.90 
0.90092 
253 
253 
506 
2 
0.250 
1.000 
0.500 
0.050 
0.90 
0.90423 
64 
64 
128 
2 
0.500 
1.000 
0.500 
0.050 
0.90 
0.90951 
29 
29 
58 
2 
0.750 
1.000 
0.500 
0.050 
0.90 
0.90423 
16 
16 
32 
2 
1.000 
1.000 
0.500 
0.050 
0.90 
0.92293 
11 
11 
22 
2 
1.250 
1.000 
0.500 
0.050 
0.90 
0.93373 
8 
8 
16 
2 
1.500 
1.000 
0.500 
0.050 
 
For the detection of a score of 1.0, a total of 32 subjects would be needed (16 per group). A drop-out rate 
of 10-15% would require an additional 1-2 subjects per group, for a total of 34-36 subjects. 
To detect a smaller difference (ie, 0.750), a total of 58 subjects (29 per group) would be needed. 
For a power of 0.80, the following estimates were calculated: 
Numeric Results 
──────────────────────────────────────────────────────────── 
Two-Sided Test. Null Hypothesis: D = 0. Alternative Hypothesis: D ≠ 0. 
Covariance Type = Compound Symmetry 
Target 
Actual 
 
 
 
 
 
 
 
 
Power 
Power 
N1 
N2 
N 
M 
D1 
Sigma 
Rho 
Alpha 
0.80 
0.80130 
189 
189 
378 
2 
0.250 
1.000 
0.500 
0.050 
0.80 
0.80743 
48 
48 
96 
2 
0.500 
1.000 
0.500 
0.050 
0.80 
0.80130 
21 
21 
42 
2 
0.750 
1.000 
0.500 
0.050 
0.80 
0.80743 
12 
12 
24 
2 
1.000 
1.000 
0.500 
0.050 
0.80 
0.82298 
8 
8 
16 
2 
1.250 
1.000 
0.500 
0.050 
0.80 
0.85084 
6 
6 
12 
2 
1.500 
1.000 
0.500 
0.050 
 
The MBSC training with a 15-person class size would need to be repeated three times in order to ensure 
adequate number of participants in each group, accounting for drop-outs and missing data. 
 
 
 

5/23/17 
 
2 
 
Statistical Analysis Plan 
The study is a randomized control trial of MBSC intervention vs controls. The sessions will be 
repeated three times, enrolling 15 participants and 15 controls each time to ensure adequate 
numbers. 
The analysis will be intent-to-treat based on randomized group allocation. 
The primary outcome is PSS-10, compared between MBSC and controls, and within groups over 
time. The secondary outcomes are VAS-A, MBI-2, MAAS-T, MAAS-S, MSCS-G, and PANAS-
pos, and PANAS-neg. These will be obtained at three time points for the MBSC group (baseline, 
post-intervention, and 13-week follow-up), and twice for the control group (baseline and post-
intervention). 
Demographic characteristics include age, sex, race, ethnicity, marital status, religion, current 
position, presence of medical conditions, and presence of psychiatric conditions.   
Data will be assessed for their distributional assumptions, and analyzed accordingly either with 
parametric or non-parametric methods, as appropriate. Continuous data between MBSC and 
controls will be compared using two-sample t-tests or Wilcoxon rank sum tests. Categorical data 
between groups will be compared using chi-square or Fisher’s exact test, as appropriate.  
For the main analyses, generalized linear mixed modeling (PROC MIXED) for repeated 
measures will be used to compare post-intervention and follow-up measures for each outcome. 
These models will involve both between and within group analyses, utilizing statistical power 
and accounting for missing data. In addition, within-subject correlations will be accounted for by 
compound symmetry covariance structure. Post-hoc comparisons will be corrected using the 
Bonferroni method. 
Effect size will also be computed for both between and within groups, using bias-corrected 
Cohen’s d (Hedges’ g). 
Data will be described by frequency (percentages), mean (SD), median (IQR), and 95% 
Confidence Intervals, accordingly. 
Data will be analyzed using SAS v9.4 (SAS Institute, Inc, Cary, NC).