Effects of Two Psychosocial Wellness Workshops on Sleep, Stress Management and Well-being: Exploration of Psychophysiological Mechanisms
Phase: NA
Conditions: Stress, Stress, Psychological, Stress Reaction, Adjustment, Adjustment, Social, Adjustment, Emotional
Sponsor: University of Arizona

F200: Application for Human Research 
 
 
 
 
Page 1 of 17 
 
HSPP Use Only: 
Form 200 v 2015-05 
PROJECT TITLE: 
Effects of two psychosocial wellness workshops on sleep, stress management and 
well-being: Exploration of psychophysiological mechanisms 
 
INVESTIGATOR INFORMATION 
Principal Investigator Name, 
Degree(s): 
John J.B. Allen, PhD 
Affiliation 
 UA            
 B–UMG            
 Other:     
Principal Investigator UA NetID 
John.JB.Allen 
Status/Rank: 
Distinguished Professor 
Center: 
  
Department: 
Psychology 
College: 
College of Science 
Contact phone:  
520-621-7448 
Official Institutional Email: 
John.JB.Allen@arizona.edu 
 
 
ADVISOR CONTACT INFORMATION (REQUIRED FOR ALL STUDENTS AND RESIDENTS) 
Name, Degree(s), UA NetID: 
 
Contact phone:  
 
Official University Email: 
 
 
 
ALTERNATE/COORDINATOR or Co-PI CONTACT INFORMATION 
Name, UA NetID: 
Michael R. Goldstein, mgoldstein 
Contact phone:  
608-208-0016 
Official University Email: 
mgoldstein@email.arizona.edu 

 
 
 
 
 
 
 
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SECTION 1: REQUIRED SIGNATURES 
1. PRINCIPAL INVESTIGATOR 
I will conduct my study according to the University of Arizona HSPP policies and procedures for research with human 
subjects. 
 
 
 
 
 
 
 
Signature 
 
Date 
 
Print Name 
 
2. ADVISOR (FOR ALL STUDENTS AND RESIDENTS ACTING AS THE PI) 
I will oversee the student researcher according to the University of Arizona HSPP policies and procedures for research with 
human subjects. 
 
 
 
 
 
 
 
Signature 
 
Date 
 
Print Name 
 
3. SCIENTIFIC/SCHOLARLY REVIEW (SEE HSPP GUIDANCE ON REQUIREMENTS FOR SCIENTIFIC/SCHOLARLY ASSESSMENT  - INCLUDE 
DOCUMENTATION FOR OPTIONS A AND B WITH SUBMISSION MATERIALS.) 
a. 
 Nationally based, federal funding organization (NIH, NSF) subject to full peer review 
b. 
 Nationally based, non-federal funding organization (March of Dimes, Amer Academy of Pediatrics) subject to peer 
review 
c. 
 Locally constituted peer review (signature required)  
 
 
 
 
 
 
 
 
Signature 
 
Date 
 
Print Name 
 
4. DEPARTMENT/CENTER/SECTION REVIEW 
I have reviewed this application and determined that all departmental requirements are met and that the investigator has 
adequate resources to conduct the Human Research. 
 
 
 
 
 
 
 
Signature 
 
Date 
 
Print Name/Email 
 
5. RESPONSIBLE PHYSICIAN (PROJECTS INVOLVING MEDICAL PROCEDURES WHICH THE PI IS NOT AUTHORIZED TO CONDUCT) 
I am a physician licensed by the State of Arizona (or US license for the SAVAHCS). I will be responsible for ensuring that all 
procedures that are part of this project and that require the attendance of a licensed physician will have a suitable physician 
present during the procedures. If at any time this is not possible, I will inform the IRB before any procedures are conducted. 
 
 
 
 
 
 
 
Signature 
 
Date 
 
Print Name 
 
6. NATIVE AMERICAN OR INTERNATIONAL INDIGENOUS POPULATIONS REVIEW 
Signature needed only if research takes place in Indian Country or among international Indigenous populations, actively 
recruits Native Americans or international Indigenous populations for enrollment, and/or requires stratification of Native 
Americans or international Indigenous populations as one of the statistical analyses or study aims.  
• 
Contact American Indian Studies, (520) 621-7108 
I have examined the proposal cited above and advise that further appropriate tribal/Indigenous approval  
 is or 
 is not 
necessary. 
 
 
 
 
 
 
 
Signature 
 
Date 
 
Print Name 

 
 
 
 
 
 
 
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SECTION 2: GENERAL INFORMATION 
1. How many Human Research studies does the PI have open? 
8 
2. How many research staff will be involved in the Human Research? 
3 
3. What is the expected length of this project?   
18 months 
4. Retention of study materials before, during, and after completion of the project:  
a. 
Where will original signed consent and PHI Authorization documents be stored (building 
name and room)?  Location:  
Psychology room 312 
How long will consents be maintained after conclusion of the project? 
             
 6 years (UA standard)     
 6 years after child reaches 18    
 Other (explain): 
5. Project funding - If the proposed study is or will be funded, complete below: 
a. UAccess  
i. Development Proposal #: 
ii. Institutional Proposal #: 4206880 
b. eDoc # (Required for For-profit sponsored research): 
c. Total funding amount OR per subject amount: $15,000 from the Mind & Life Institute 
(Varela Award to Michael Goldstein) 
Submit complete copy, cover-to-cover, of grant or award.  
6. Conflict of Interest (COI): 
The Principal Investigator hereby affirms that ALL individuals who meet the definition of investigator 
for this project in the current Policy on Investigator Conflict of Interest in Research have completed 
the mandatory Conflict of Interest training and Disclosure of Significant Financial Interests. 
 
 Yes - All individuals who meet the definition of "investigator" have completed COI training and     
      disclosure.        
 No (explain):       
 
7. Additional requirements: 
Certain types of research require additional regulatory documentation. Please identify which of the 
following apply to your project. Complete the appropriate Appendix and submit as part of the 
submission materials. 
 
 Children (subjects under 18) - Appendix A  
 Drugs/Devices (A clinical investigation of a drug or device) - Appendix B 
 Multi-Site study (The UA IRB will review research activities for an investigator or research staff 
not affiliated with the UA who is ‘engaged in the research’ (e.g. consenting, collecting data, or 
analyzing identifiable information) - Appendix C  
 Pregnant Women/Neonates - Appendix D 
 Prisoners - Appendix E 
 Waivers of consent, waiver of a signature, or waiver or alteration of PHI - Appendix F 
 None apply to the proposed study 

 
 
 
 
 
 
 
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8. Location of Research Check all that apply 
 
Banner – University Medicine Group: 
 Phoenix Campus 
 
 
 
 Biological specimens 
 Clinical Data 
 Tucson Campus      
 
 
 
 Biological specimens 
 Clinical Data 
 South Campus  
 
 
 
 Biological specimens 
 Clinical Data 
 
University of Arizona Cancer Center: 
 North Campus  
 
 
 
 Biological specimens 
 Clinical Data 
 Orange Grove Clinics   
 
 
 Biological specimens 
 Clinical Data 
 Phoenix 
 
 
 
 
 Biological specimens 
 Clinical Data 
 
Other:  University of Arizona, Department of Psychology (Biological specimens) 
 
 
 
SECTION 3.  PROJECT NARRATIVE 
 
1) Background 
The transition from adolescence to adulthood, particularly for college students, is accompanied by 
several major life changes and challenges. For many individuals, this is a period when one moves 
away from home, begins interacting with different peer groups, and has greater financial and academic 
responsibilities. The emotional stress associated with these changes is correlated with less time 
devoted to sleep,1 increased alcohol intake,2 reduced academic performance,2,3 and increased rates of 
anxiety disorders and/or depression.4 
 
Your Enlightened Side (plus more) (YES+) is a life skills workshop with a strong emphasis on 
breathing practices for reducing stress and increasing well-being. Additional stress management tools 
including meditation, yoga, and interpersonal exercises that impart social emotional learning skills 
and stress reduction strategies complement the breathing techniques.  
 
The central practice taught in YES+ is a unique rhythmical breathing technique called Sudarshan 
Kriya.5 It is taught along with two preparatory breathing practices: an advanced form of Ujjayi 
breathing (breathing against airway resistance) and bhastrika (forceful nasal breathing). Collectively, 
these three breathing practices are referred to as Sudarshan Kriya Yoga (SKY).  
 
Prior literature has demonstrated significant improvements in psychological and physiological 
outcomes of SKY in adults, including decreases in subjective stress,6 clinical and subclinical 
depression and anxiety,6–8 posttraumatic stress symptoms,9–11 impulsivity,12 and tobacco use,13 as well 
as increases in calm, mental focus,14 emotion regulation,15,16 and overall well-being.6,17   
 
However, little is known about the effects of SKY specifically taught in the YES+ workshop format 
designed for college students. One randomized controlled trial has demonstrated attenuated levels of 
subjective stress and several hematological parameters, including lymphocytes and platelet count, 
during exam periods following SKY training.18 These findings have not yet been replicated, and the 
extent to which the effects of YES+ generalize to other health-related changes such as cardiovascular 
function remain unclear.    

 
 
 
 
 
 
 
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2) Purpose 
Addressing the gap in the literature described above and to provide further preliminary data on the 
specific effects of YES+ on well-being and stress physiology, this study aims to evaluate measures of 
self-reported wellness across a variety of questionnaires, in addition to changes in heart rate variability 
and salivary cortisol levels with a stress induction task.  To control for expectancy effects, overall time 
spent with the workshop, social contact, and exposure to cognitive stress management strategies that 
may influence the observed effects of YES+ not specific to the yogic breathing and deep social 
connectedness at the core of the YES+ targets, a comparison workshop with all of these potential 
supplementary contributors will be included, titled “Wisdom On Wellness” (WOW!). 
 
3) Lay Summary (approximately 400 words) 
 
While efficacy of Sudarshan Kriya Yoga (SKY) has been demonstrated in a number of prior studies, 
little is known about the effects of SKY taught as part of the Your Enlightened Side (YES+) workshop 
designed for college students. Thus, this study aims to assess the effects of YES+ on well-being, 
including sleep patterns, and physiological stress response.  
 
4) Setting of the Human Research 
Laboratory visits will be conducted in the Respiratory Physiology laboratory of Dr. Fiona 
Bailey, located in room 44 of the Ina Gittings Building (University of Arizona main campus).  
This room is set up for human subject experiments and is the site at which the Dr. Bailey has 
conducted all previous research involving human participants.   
Workshops will be conducted on the UofA campus in a room reserved through the Psychology 
Department or other campus reservation procedures. 
 
5) Resources available to conduct the Human Research  
 
Professor Allen’s psychophysiology research laboratory (University of Arizona, Psychology Building, 
Room 409) has extensive experience with similar research protocols. Additional resources will be 
provided through collaborations with the Psychology Department’s Sleep Research Laboratory, which 
has more than 20 Actiwatches, a downloading station, and relevant software, as well as the 
Physiology Department’s Respiratory Physiology Laboratory, where the necessary resources are 
available for the laboratory visits. These resources include dedicated computers and software from 
Grass/Telefactor for electrocardiogram (ECG) data acquisition, processing, and analysis. In addition, 
the University of Arizona maintains full computer and data analytic processing components available 
to all university faculty on a fiber-optic network system, with automatic daily backup available on a 
secure server. 
 
6) Study Population 
 

 
 
 
 
 
 
 
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100 college students (50% female) will be recruited into the current study. Persons expressing interest 
in the study will be screened along several health dimensions and invited to participate in the 
proposed research according to the following criteria:  
 
a) 18-35 years of age. This age range is recommended for the YES+ workshop to capture qualitative 
consistencies in the unique challenges that face college students and optimize social connectedness 
during the workshop. 
 
b) Current identification with student status, which may include undergraduate, graduate, continuing 
studies, or post-baccalaureate/pre-doctoral. 
 
c) No history of panic disorder, psychosis, or mania (with or without psychotic features), which may 
be risk factors for adverse effects of the yogic breathing intervention.  These symptoms will be pre-
screened via online questionnaire.  The use of psychoactive medication will be monitored via sleep 
diary. 
 
d) No current substance dependence, assessed via online self-report pre-screening questionnaire. 
 
e) No current use of medications with known effects on sleep or stress physiology including 
antidepressants (SSRI, SNSI, NDRI, atypical, TCA, MAOI), anitpsychotics, benzodiazepines, non-
benzodiazepine receptor agonists, melatonin and melatonin receptor agonists, orexin/hypocretin 
receptor antagonists, barbiturates, mood stabilizers, anticonvulsants, anticholinergics, first generation 
antihistamines, and stimulants including NRI, antihypertensives, opioids, or systemic (non-topical) 
corticosteroids. 
 
  
In addition, a total of 4 workshop instructors are expected to enroll in this study to provide 
questionnaire information regarding expectancy of workshop benefit for participants.  All instructors 
must have prior training with the specific workshop to be led. 
 
7) Recruitment Methods and Consenting Process 
a. Recruitment Process: 
Potential participants will be recruited primarily through the University of Arizona campus and 
broader Tucson communities. Potential subjects will be identified through targeted placement of study 
flyers in campus and community locations (e.g. bookstores, coffee shops, and community centers), 
and through placements of ads on websites (e.g. Facebook) and University listservs (University of 
Arizona 3D Memos, Lo Que Pasa, Psychology Department Graduate Student Listserv, etc.).  Flyers 
and other advertisement may include the following language: 
 
-- 
Research participants wanted! 
Student Wellness Workshops 
 
With an aim to help students reduce stress and enhance well-being, the University of Arizona 
Psychophysiology Research Laboratory is investigating the effects of two innovative workshops on 
wellness and stress physiology. 
 

 
 
 
 
 
 
 
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Participation involves: 
- 
Online questionnaires 
- 
Three laboratory visits (approximately one hour each) 
- 
Measurement of sleep patterns with a wrist-worn device 
- 
Attendance at one workshop held across four consecutive days (Thurs & Fri evenings, Sat & Sun 
mid-day) 
 
Compensation provided! 
 
If you are a student 18-35 years of age, you may qualify!  Invite friends to participate, too! 
 
E-mail mgoldstein@email.arizona.edu for more info! 
 
An Institutional Review Board responsible for human subjects research at The University of Arizona 
reviewed this research project and found it to be acceptable, according to applicable state and federal 
regulations and University policies designed to protect the rights and welfare of participants in research. 
-- 
 
b. Informed Consent:  
All interested individuals who are eligible for the study will undergo an in-person informed consent 
procedure prior to the first laboratory visit. Subjects, including workshop instructors, will be assigned 
identifying numbers and the association between the numbers and names will be destroyed upon 
completion of the study.  No minors or individuals incompetent to provide informed consent will 
participate in the present study. They will be reminded that their participation in the study is entirely 
voluntarily, they may withdraw at any time, and they will be compensated for their time. 
  
8) Research procedures involved in the Human Research 
An overview of the study involvement is illustrated in Figure 1.  Participation will include three 
laboratory visits at pre-workshop (T1), post-workshop (T2), and 1-2 month follow-up (T3) time points 
and four workshop sessions described below. 
 
 
 
 
Screening: Interested participants will first be directed to an online pre-screening survey.  The survey 
will begin with a prompt describing the study and requiring understanding via checkbox that the 
survey is for screening purposes.  The survey will collect information such as name, e-mail address, 
date of birth, motivation for the study, student status, prior contemplative practice experience, ability 
to meet the time commitment, panic and bipolar symptoms, and potential affiliation with other 

 
 
 
 
 
 
 
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participants.  If any of the exclusion criteria indicated above are met, the participant will be notified of 
ineligibility. 
 
Enrollment and randomization: Eligible participants will be first grouped in clusters with any other 
participants with known affiliations stated in the online screener, in order to minimize possibility of 
learning about material of the other workshop, then assigned a workshop via random number 
generator.  
 
Laboratory Visits: In-person laboratory visits will be conducted at the University of Arizona 
Respiratory Physiology Laboratory on the main UA campus.  Workshops will be conducted in various 
buildings on the main UA campus depending on reservation availability. 
 
Actigraphy, sleep diary, online questionnaires and practice logs measures will be completely remotely 
after the instruments are provided to participants during an in-laboratory visit. 
 
In addition to actigraphy, sleep diary, online questionnaires, and home practice logs (for T2 and T3 
time points) the following data will be collected during each laboratory visit: electrocardiography 
(ECG) with concurrent respiratory inductance plethysmography (RIP) and pulse oximetry recordings, 
as well as salivary cortisol at baseline, post-stress induction task, 30-min post-stress-induction-onset, 
and 45-min post.  ECG, RIP belts, and pulse oximetry will be recorded continuously, in addition to the 
designated resting recording periods.  An overview of the laboratory visit (identical across T1, T2 and 
T3) is provided in Figure 2.   
 
Workshop evaluations: Both workshop participants and instructors will complete a brief questionnaire 
at two time points (end of Day 1 and end of Day 4) during the workshop to indicate expectation of 
workshop benefit. 
 
 
 
 
 

 
 
 
 
 
 
 
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Intervention conditions: 
YES+ workshop. Your Enlightened Side, plus more (YES+) is an four-day, 15-hour eclectic life skills 
workshop with a strong emphasis on breathing techniques and social connectedness to enhance stress 
management, intervene in the potential negative behavioral cycles, and improve overall well-being.  In 
addition to specific contemplative techniques such as yoga, mindfulness meditation, and compassion 
meditation that help cultivate inner peace, YES+ incorporates discussions and other activities to facilitate 
social connectedness, leadership, and community service.  
During the workshop, participants will have ample time to learn and practice the Sudarshan Kriya 
Yoga (SKY) technique, as well as to ask questions.  SKY has four sequential, form- and rhythm-specific 
breathing components interspersed with normal breathing while sitting in a relaxed position with eyes 
closed, followed by Yoga Nidra (tranquil state of rest) for 10-15 minutes in a supine position, yielding a 
total duration of approximately 30 minutes for the entire home practice.  A longer version of SKY will be 
practiced as a group twice during the workshop.  Following the workshop, participants will be instructed 
to practice SKY at home daily.  A certified instructor with a minimum of 1,000 hours of SKY instruction 
training will lead each workshop.  
 
WOW! workshop. A comparison workshop titled “Wisdom On Wellness” (WOW!) will be implemented 
to control for potential expectancy effects, time commitment, group-based interactions, and 
wisdom/knowledge of YES+ that is anticipated to have beneficial effects on stress management and well-
being, allowing for more rigorous evaluation of the contemplative practices and other activities unique to 
the YES+ workshop. The material used to guide interactions in WOW! will be similar to the material of 
YES+ and will be taught by a trained instructor with supervision by the Principal Investigator and Study 
Coordinator.  This workshop differs from YES+ due to the increased focus on cognitive approaches to 
conceptualizing and managing stress (e.g. thoughts about the past and future versus present moment), and 
absence of physical or somatic activities.  Using a focus group format, whereby the instructor primarily 
facilitates discussion, a variety of topics will be covered such as the nature of stress for humans, response 
to stressful events, time management, study skills, alcohol and drug use, personal values, career 
exploration, sleep habits, and nutrition. 
 
 
Experimental manipulations: 
Stress Induction.  The Maastricht Acute Stress Test (MAST), a previously described and increasingly 
used stress induction task,19,20 will be utilized.  A research staff member in a white laboratory coat will 
explain that the session will be video-recorded to then be coded afterwards by trained raters, provide 
background information regarding performance norms, and express an expected ability of the participant 
to perform comparably.  Next, the researcher will provide instructions for the task that will be guided by a 
Powerpoint presentation.  The MAST consists of a 10 minute acute stress phase that combines elements 
of both the commonly used Cold Pressor Test and Trier Social Stress Test, adding an element of 
uncertainty by cycling between these two tests at slightly unpredictable time intervals (Figure 3).  For the 
hand immersion trials (HIT), participants will insert their dominant hand and wrist in a bucket of ice water 
(approximately 2° C) for up to 90 seconds.  Participants are instructed they may remove their hand at any 
time.  Upon removal, participants will place their hand on a towel and immediately begin a serial 
subtraction task, for which participants will be instructed to count backwards by 13, 17, or 18 from a 
randomly selected number between 2013 and 2073, with interjections to start over from the beginning if 
any calculations are incorrect.  Neutral or negative feedback will be provided throughout the task, 
including comments such as “That’s wrong.  Start over” and “You’re going too slowly.” 
 

 
 
 
 
 
 
 
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Measures: 
Sleep diaries. Participants will be instructed to fill out a sleep diary for one week at each of the three time 
points. The sleep diary includes entries for the time that participants go to bed, turn off the lights, awake 
in the morning, and arise from bed in the morning. Participants also record sleep onset latency, the 
number and duration of awakenings, and quality of sleep (1 = very restless to 5 = very sound). From these 
items, the following weekly average sleep summary parameters will be computed: total sleep time (TST), 
time in bed (TIB), wake time after sleep onset (WASO), number of awakenings, sleep-onset latency 
(SOL), sleep quality, time of going to bed in the evening, time the lights are turned out with the intention 
to sleep (lights-out time), wake time in the morning (awakening time), time of getting out of bed in the 
morning (arising time), and sleep efficiency (SE) which is TST divided by sleep period time; the time 
from lights out to lights on at arising.  
 
Actigraphy. Concurrent with the sleep diaries, participants will be instructed to wear a wrist Actiwatch 
(Philips Respironics) from the time of getting into bed until the time of getting out of bed for one week. 
Participants will be instructed to press a button on the face of the Actiwatch that serves as an event marker 
in the downloaded data on two occasions during each sleep period: when participants intend to fall asleep 
and when they awaken for the final time at the end of their sleep period. These markers serve as measures 
of lights-off and lights on times, providing outside boundaries for subsequent calculation of sleep onset 
and offset. When this is not done, the estimated lights-off and lights-on times given by the participant in 
their sleep diaries will be used. Sleep onset will be defined as the beginning of the first 5 min of 
contiguous quiescence with less than 30 sec of any recorded activity counts that occur after lights-off time 
as used in. Once lights off, lights on, sleep onset, and sleep offset are established, these four values will be 
entered into a sleep-scoring algorithm to identify WASO, and to calculate the sleep indexes of SOL, TST, 
and SE. In addition to providing an objective measure of sleep variables, actigraphy has been particularly 
useful in documenting sleep-wake circadian patterns.  
 
Questionnaires. Participants will be asked to complete a custom survey inquiring about information such 
as GPA and self-rated stress of specific situations, as well as the Morningness-Eveningness Quesitonnaire 
(MEQ)21 with an online format at T1.  In addition, participants will be asked to complete a custom survey 
inquiring about information such as current stress-management techniques, the short-form Mood and 
Anxiety Symptom Questionnaire (MASQ),22,23 Perceived Stress Scale (PSS),24 Pittsburgh Sleep Quality 
Index (PSQI),25 Big Five personality inventory (Big-5),26 Rosenberg Self-Esteem Scale (RSES),27 
Satisfaction With Life Scale (SWLS),28 and Social Connectedness (SC)29 measures online for all three 
time points.  During each laboratory visit, participants will also be asked to complete the state-specific 
items of the State-Trait Anxiety Inventory (STAI).30 
 
Electrocardiogram (ECG) measures. Individual electrodes will be placed at collarbone and lower 
ribcage locations to collect ECG recordings.  Participants will be instructed to sit quietly for 2 minutes for 
each of the four resting recordings (baseline, post-stress, 30-min-post, 45-min-post).  ECG data will then 
be processed to determine measures including resting heart rate (HR), heart rate variability (HRV), and 

 
 
 
 
 
 
 
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respiratory sinus arrhythmia (RSA).  Supplementary HR data will be collected via pulse oximetry, a 
device consisting of a soft clip place around the participant’s pointer finger.  To control for respiration 
that may influence HR data, respiratory inductance plethysmography will be recorded concurrently via 
two adjustable belts placed around the participant’s abdomen, one passing around the sternum and the 
other passing around the navel. As an additional covariate of Body Mass Index (BMI) for ECG analysis, 
height and weight will also be measured at each laboratory visit. 
 
Salivary cortisol.  In conjunction with the ECG recordings, saliva samples will be collected using 
Salivettes (Sarstedt, Nümbrecht, Germany).  Participants will be instructed to avoid particularly stressful 
activities or events on the day of the laboratory visit prior to data collection in order to minimize potential 
effects on cortisol secretion and maximize data specific to the stress-induction task.  In addition, 
participants will be asked to refrain from drinking, eating, and any dental hygiene for the 15 minutes prior 
to the arriving for the laboratory visit, which will also be confirmed verbally prior to the first sample 
collection.  Following data collection, samples will be stored in a freezer at -70 °C on the University of 
Arizona campus.  Samples will then be de-identified and shipped to an independent site for high 
sensitivity enzyme-linked immunosorbent assay (ELISA) preparation. 
 
Visual Analog Scales (VAS).  To assess momentary stress-related ratings, Visual Analog Scale (VAS) 
measures will be collected throughout each laboratory visit.  VAS measures will include items such as 
“discomfort/pain” and “distress” with a 0-100 scale corresponding to low and high values for each item.  
One of the two researchers conducting the experimental session will present a whiteboard with the scales 
to the participant at each measurement point and will ask the participant to simply wipe a single point 
along the temporarily drawn horizontal line for each scale.  The score for analysis will be the nearest 5-pt 
value on a scale of 0 to 100 (e.g. 35) of the wiped mark, judged by the researcher.  The researcher will 
transfer the two rating scores to a recording sheet, erase both temporary lines, and redraw them using a 
straight-edged guide to be ready for the next measurement.  The whiteboard with each of the participant’s 
ratings (wiped marks) will be visible to the videorecorder in case time between measurements (e.g. during 
the MAST) does not allow for transfer of the information to the recording sheet while the experiment is in 
progress. 
 
Workshop expectancy evaluations.  To assess potential expectancy effects, both participants and 
workshop instructors will be asked to complete a short questionnaire at the end of the first and final days 
of the workshop.  Questions will inquire about information such as confidence in anticipated benefit, 
willingness, credibility, and likelihood to recommend to others.  These questionnaires follow a format of 
previously used and validated expectancy scales.31–33  
 
Home practice logs.  Participants will be asked to track daily practice of any techniques provided from 
the workshops.  In order to maintain consistency across participants and workshops, the same log will be 
provided to everyone.  An example entry for the yogic breathing-based workshop (YES+) may be the use 
of a specific breathing technique prior to an exam.  An example entry for the psychoeducation workshop 
(WOW!) may be the use of a cognitive strategy such as recognizing that an exam grade is only a portion 
of a final semester grade. 
 
 
9) Cost to subjects  
There is no monetary cost to the subject, although participation in the study involves time to complete 
the online screening, measures associated with the three laboratory visits, and workshop.  
 

 
 
 
 
 
 
 
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10) Risks to subjects 
 
Few risks or complications are posed to the study participants. Participation in either workshop 
involves interaction with other participants and possible discussion of personal background 
information that may be uncomfortable for some individuals.  Some participants with sensitive skin 
may experience mild discomfort at the electrode sites for ECG data collection and around the wrist 
from wearing the Actiwatch.  However, the equipment used for ECG recordings is widely used for 
research and clinical purposes with minimal averse reactions reported, and the Actiwatch device has 
been tested for safety and has been FDA approved for use in adults.  
 
Subjects will be instructed to report any skin irritations related to study procedures to research 
personnel and to seek medical care if the irritations persist longer than 24 hours. 
 
 
11) Potential benefits to subjects and/or society 
Benefit to participants is anticipated from both workshops in terms of stress-management tools and 
overall well-being, although some may benefit more than others in one workshop or the other.  
Participants may also benefit by contributing to scientific knowledge stress physiology and well-being 
in college students and other adults. 
 
12) Provisions to protect the privacy of subjects and the confidentiality of data 
a. Protection of subject privacy:   
Participant contact will be conducted through a password-protected e-mail account designated 
specifically for the study. Information collected via online pre-screening survey will also 
involve password-protected access. The online nature of the screening survey allows for 
increased privacy of the participant, as individuals are able to complete the survey at the 
remote location of their choice without intrusions from study personnel or others from the 
laboratory. In-person informed consent will be conducted in a private room within the 
laboratory. 
b. Protection of data confidentiality:  
Consent forms will be stored in a locked cabinet in Psychology 409 until the end of the study. 
Per Psychology Department guidelines, at the end of the study all consent forms will be moved 
to the Psychology main office, room 312. Each participant will be given a unique participant 
identifying number that will not be recorded on his or her consent form. This unique 
participant number only (and not any identifying information) will be recorded on all 
experimental data collected. Therefore, all of the data in Psychology 409 will be de-identified. 
The date of the participant’s intake will be recorded on the consent form. This date will also be 
recorded in an excel sheet of de-identified participant data. Consent forms will be stored in the 
Psychology building for up to six years should data ever need to be re-identified, as requested 
by the IRB. De-identified data, including questionnaire information, will be secured 
indefinitely in electronic form on Dr. Allen’s secure server. Paper copies, with no identifying 
information, will be shredded once entered onto the server.  
 
13) Subject compensation 

 
 
 
 
 
 
 
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The maximum total amount a participant may receive is $100.  Payment will be provided at two 
points across the study: $60 upon completion of T2 and an additional $40 upon completion of T3.  
This payment plan has been carefully devised to ensure adequate payment that is proportional to the 
challenge of maintaining commitment through the entire study, while not overly lucrative in order to 
minimize chance of possible coercion and/or substantial monetary motivation that would be 
detrimental to the workshop dynamics.  To help ensure appropriate attendance at the workshops, 
which is critical to enable group cohesiveness as part of the workshop benefit for individual 
participants, payment will not be pro-rated for drop-outs prior to completion of T2.  
 
14) Medical care and compensation for injury  
There is no expectation of risk for participants. No compensation will be available for medical care. If 
there should be an unexpected injury, the session will be terminated immediately and the researcher 
will contact emergency services.  
 
15) Withdrawal of subjects 
 
Participants may voluntarily withdraw at any time, as indicated in the consent form.  Researchers may 
ask participants to cease participation in the study if study procedures are not followed (e.g. 
incomplete workshop attendance).  In the event that a participant either undergoes adverse experiences 
associated with the workshop or voluntarily withdraws while the workshop is in progress, the 
workshop instructor will follow up with the participant to offer support, if needed, and help facilitate 
transition out of the study.  In the event of withdrawal during laboratory visits, the researchers 
conducting the visit will likewise follow up with the participant to help facilitate transition out of the 
study.  Withdrawal due to any adverse, study-related circumstances will be reported to the IRB. 
 
16) Sharing of results with subjects  
Participants may follow up with the research staff upon completion of the study to learn about study 
results. 
 
17) Future use and long-term storage of data or specimens 
As described above, de-identified data, including questionnaire information, will be secured 
indefinitely in electronic form on Dr. Allen’s secure server. Paper copies, with no identifying 
information, will be shredded once entered onto the server.   
 
 
SECTION 4: LIST OF ATTACHMENTS FOR THIS SUBMISSION (REQUIRED) (Items listed here are 
expected to be attached as separate documents. These documents will appear in the UA HSPP IRB 
approval letter as 'documents submitted concurrently' with the review.) 
Document Name 
Version Date 
1. F200 Allen – signature page.pdf 
1. 08/19/2015 
2. F107 Allen - Student Wellness Workshops 20150915.doc 
2. 09/15/2015 

 
 
 
 
 
 
 
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3. Allen_biosketch.pdf 
3. 08/19/2015 
4. SWW_Consent_20150908.doc 
4. 09/08/2015 
5. 2012 Varela Grant Docs  letter Goldstein, Michael.pdf 
5. 08/19/2015 
6. Actiwatch_510k_approval.pdf 
6. 08/19/2015 
7. SWW_ScreeningQuestions_20150915.docx 
7. 09/15/2015 
8. SWW_SleepDiary.docx 
8. 07/17/2015 
9. SWW_Debrief_20150908.docx 
9. 09/08/2015 
10. SWW_MAST_20150908.ppt 
10. 09/08/2015 
11. SWW_T1_QuestionnairePacket.pdf 
11. 07/16/2015 
12. SWW_T2_QuestionnairePacket.pdf 
12. 07/16/2015 
13. SWW_T3_QuestionnairePacket.pdf 
13. 07/16/2015 
14. SWW_Day1_InstructorExpenctancyEval.docx 
14. 07/16/2015 
15. SWW_Day4_InstructorExpenctancyEval.docx 
15. 07/16/2015 
16. SWW_Day1_ParticipantExpenctancyEval.docx 
16. 07/16/2015 
17. SWW_Day4_ParticipantExpenctancyEval.docx 
17. 07/16/2015 
18. SWW_PracticeLog.docx 
18. 07/17/2015 
19. SWW_Consent_INSTRUCTORS_20150916.doc 
19. 09/16/2015 
See HSPP website for submission requirements. 
Items needed for approval: 
• 
F107: Verification of Training Form 
• 
Current PI/Co-PI CVs or biosketch, if not included with copy of grant application 
• 
Informed Consent/Permission/Assent Form(s) – including study specific release of information documents, DHHS 
approved sample consent forms.  If consent will not be documented in writing, a script of information to be provided 
orally to subjects 
 
Other Items as applicable: 
• 
Appendix A - Children 
• 
Appendix B - Drug/Device 
• 
Appendix C- Multi Site Research 
• 
Appendix D- Pregnant Women and Neonates 
• 
Appendix E- Prisoners 
• 
Appendix F- Waiver of Consent/ PHI 
• 
Biosafety Review letter (for UA - Institutional Biosafety Committee) 
• 
Certificate of Confidentiality 
• 
Compressed Gases Review letter (for UA – Research Instrumentation) 
• 
Contract – complete or draft copy of contract including budget 
• 
Data Collection Tools – surveys, questionnaires, diaries not included in the protocol, data abstraction form for 
records review 
• 
Data Monitoring Charter and Plan  

 
 
 
 
 
 
 
Page 15 of 17 
 
HSPP Use Only: 
Form 200 v 2015-05 
• 
Drug/Device information – Investigator's Brochure, drug product sheet, device manual, user's manual, instructions 
for use, package insert, IND/IDE documentation, FDA 1572 form, 510k indication, FDA exemption, sponsor 
determination of device risk, etc. 
• 
Export Control Review 
• 
Grant Application(s) – cover-to-cover copy of grant, regardless of home institution or funding agency, and a copy of 
the Notice of Grant Award.   
• 
Other Approval letters (e.g., school districts, Tribal, other IRB approvals) 
• 
Participant Materials – written materials to be provided to or meant to be seen or heard by subjects (e.g. study 
newsletter, physician to participant letter, wallet cards, incentive items, holiday/birthday cards, certificates, 
instructional videos/written guides, calendars, certification of achievement, etc.) 
• 
Payer coverage analysis 
• 
PHI Authorization Form(s) 
• 
Protocol – including all amendments/revisions, sub- or extension-studies 
• 
Radiation Safety Review letter- needed regardless if the radiation device is approved and used standard of care 
• 
Recruitment Materials – telephone scripts, flyers, brochures, websites, email texts, radio/television spots, 
newspaper advertisements, press releases, etc. 
• 
Scientific Review Committee letter (for cancer related projects – AZCC SRC; other units as applicable if the unit has a 
scientific review committee) 
• 
Site Authorizations for research purposes and/or access to administrative records/samples 
o 
External sites (such as schools, other hospitals or campuses, etc.) 
o 
B–UMG approval 
• 
Supplemental site information (for sites engaged in research where the UA is the IRB of record)  
o 
Copy of any approvals granted from that site (including determinations if this site has an IRB of its own) 
o 
Site-specific F107 
o 
Copy of the site's human subjects training policy 
o 
CV and medical license (if applicable) of site PI 
• 
Travel Authorization documentation (for UA – Office of Global Initiatives) 
• 
Use of retrospective research samples and/or data – IRB approval letter, original consent under which 
samples/data were collected, letter allowing access to samples 
 
 
 
 
 
 
 
 
 
 
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