Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct Current Stimulation
Phase: NA
Conditions: Social Anxiety
Sponsor: University of Nevada, Reno

 
 
 
 
Study Protocol with Statistical Analysis Plan 
 
Study Title: Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct 
Current Stimulation 
NCT03743571 
Document Date: Submitted to the IRB on March 26, 2020 

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Study Protocol and Statistical Analysis Plan (SAP).docx 
Part II Application – Social Behavioral/Education Research 
Note the following: 
1. A Part I Cover sheet is required for each project submitted in IRBNet; see Locating the Cover Sheet 
2. See IRB policy for submission requirements for new projects for Full Committee Review or Expedited 
Review. 
PI Responsibilities 
1. How will the PI ensure that all study personnel are 
informed about the research plan and their research-
related duties? 
_X_ Routine meetings 
__ Regular communication (e.g., email, phone) 
__ Other research staff training, describe: 
Study Sites and Collaborating IRBS 
2. List/describe the study sites: 
UNR campus only  
3. Will this research be reviewed by other IRBs? 
_X_ No 
__ Yesi (Consider contacting our office for 
assessment and coordination of single IRB 
review.) 
Selection of Research Participants 
4. How many participants (or records) will be enrolled? 200   
Number of participants 
(NOTE: This is for participants enrolled in the in-
person portion of the study. However, we expect that 
many of those who complete the online prescreen 
may not meet criteria for participating in the full/in-
person study or may not wish to schedule in-person 
lab visits. We therefore expect the number of 
individuals who complete the online prescreen will be 
much higher than 200.)   
5. What are the participant eligibility inclusion criteria? 
 
Inclusion criteria:  
1) Age 18 or older (i.e., adult able to provide consent).  
2) Identifies as Latino, or non-Latino and Caucasian 
3) NOT currently receiving in exposure therapy for social anxiety.  
4) Levels of social anxiety that are sufficiently high, defined as:  
• 
Reporting a 6 or higher in response to the question “How anxious would you feel giving a formal speech 
before a live audience?” on a 0 (no anxiety) to 8 (extreme anxiety) scale  
• 
Reporting a 5 or higher in response to the question “How likely would you be to avoid taking a class that 
required an oral presentation?” on a 0 (never avoid) to 8 (always avoid) scale  
 
_x_ Age, specify: 18 or older  
 
 
6. What are the participant exclusion criteria? 
 
Exclusion criteria: To ensure the safety of all participants 
using transcranial direct current stimulation (tDCS) 
participants will be excluded if they:  
__ N/A, no exclusion criteria 
Description: 
Research Integrity 
218 Ross Hall / 331, Reno, Nevada 89557 
775.327.2368 / 775.327.2369 fax 
www.unr.edu/research-integrity 

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Study Protocol and Statistical Analysis Plan (SAP).docx 
• 
A) Have ever had a seizure or any other 
neurological diagnosis 
• 
B) Have had a traumatic brain injury (including 
concussion) within the last year  
C) Have any metal in skull (plates, steel sutures, 
etc.) 
• 
D) Are currently taking anti-convulsant, 
sedative/hypnotic, or antipsychotic medications 
• 
E) Are pregnant  
• 
F) Have already participated in a tDCS/tACS study 
on a study day in which they must receive tDCS 
stimulation  
 
7. Justify exclusions based on age, gender, or race: 
Justification:  
Age: The aim of the study is improving exposure 
therapy for adults, so participants must be adults, 
defined as 18 years or older.  
Race/Ethnicity: The secondary aim of the study is to 
compare the responses of Latino and non-
Latino/Caucasians to ethnicity matched and un-
matched public speaking audiences. Therefore we 
will only include individuals from one of these two 
racial/ethnic categories.   
8. Will the research involve researchers’ clients, 
students, or employees; or persons who are 
educationally or economically disadvantaged (see IRB 
policy for inherently influential situations)? 
__ No 
_X_ Yes, specify and describe additional precautions 
to ensure participants are fully informed and 
agree voluntarily: 
 
Because the PI and CO-PI are actively teaching in the 
psychology department, it is possible that one or 
more of their students could enroll to participate in 
the study. We determined that it would be unfair to 
these students to exclude them from the study for 
this reason alone. Although students would be able 
to sign up for the study via SONA, and we will also 
recruit by announcements in classes, we will not 
announce the study in our own classes in order to 
reduce any potential for perceived coercion.  
 
Recruitment Methods and Materials 
__ Check here if there are no processes/mechanisms to recruit participants; skip to next section. 
9. Who will recruit prospective participants? 
_X_ Recruitment through SONA 
_X_ PI 
__ Co-investigators 
_X_ Study coordinator 
_X_ Research assistants 

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Study Protocol and Statistical Analysis Plan (SAP).docx 
__ Third party, specify and describe the party’s 
relationship to the study population: 
__ Other, specify: 
10. Describe where, when, and how recruitment will take 
place: 
__ N/A, recruitment exclusively through SONA 
Description of recruitment process: 
Participants will be recruited through SONA; we will 
use our own SONA posting and the posting of an IRB-
approved combined prescreen (1490019 Lancaster 
Psychology Studies Prescreening Questionnaire). 
Additionally they will be recruited by brief 
announcements to small groups such as 
organizations and classes. Recruitment will also take 
place with the use of flyers and social media 
announcements (both are included in the Appendix).  
 
11. What recruitment 
materials will be used?ii 
_X_ Flyers/advertisements 
__ Emails/letters 
_X_ Scripts 
__ Slide or computer presentation 
_X_ SONA post – Our own post as 
well as the Lancaster 
Psychology Studies 
Prescreening Questionnaire 
(1490019) 
_X_ Social media, specify: posts on 
facebook, craigslist, twitter, 
etc. 
__ List serves 
__ Other, specify:  
Assessing Participants for Eligibility 
__ Check here if participants will NOT be assessed for eligibility; skip to next section. 
12. How will researchers confirm participants’ eligibility 
for the research? 
Participants will complete a brief pre-screening form 
via Qualtrics during which they will answer 
questions related to the study inclusion and 
exclusion criteria  
 
13. How will researchers inform participants about the 
process to assess eligibility? 
Pre-screening survey: Participants will see a brief 
screen at the end of the pre-screening survey that 
will inform them whether or not they are eligible to 
participate in the study.  
 
Baseline evaluation: After the completion of their 
baseline evaluation during visit 1 of the study, 
participants will be informed whether or not they are 
eligible by the experimenter.  
 
14. What will happen to screening/eligibility data for 
individuals who are not eligible to participate?iii 
These data will be retained alongside with the full 
dataset for the study. These data need to be retained 
for scientific purposes (information relates to 
external validity of the study), so that the PI can 

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Study Protocol and Statistical Analysis Plan (SAP).docx 
describe the population that was excluded from the 
study.   
Recruitment Incentives/Payments 
__ Check here if there are no recruitment incentives/payments; skip to next section. 
15. What types of recruitment incentives/payments will 
researchers give participants?iv 
_X_ Credit through SONA 
__ Course credit; equivalent, alternative 
opportunities must be available 
_X_ Money; specify amount: up to $50 (in amazon 
gift cards) 
__ Raffle or drawing; specify value, and odds of 
winning: 
__ Other; specify and value: 
16. When and how will researchers distribute 
incentives/payments? 
_X_ SONA credit awarded via standard procedures 
 
Description:  
Participants can elect to receive payment for their 
participation or SONA credits. 1 SONA credit is 
provided for completing the pre-screening 
assessment. 1 SONA credit is provided for every half 
hour of study participation for in-person visits.  
 
Money:  
No payment in amazon gift cards will be provided for 
completing the pre-screening assessment. No 
payment will be provided if the participant is deemed 
ineligible for study participation at the beginning of 
study visit 1.  
 
SONA credits and Amazon gift card payments across 
lab visits will be distributed as follows: 
 
Prescreening:  
1 SONA Credit  
No amazon gift card offered 
 
Completing Visit 1:  
$25 Amazon Gift Card 
or 4 SONA credits 
 
Completing Visit 2:  
$25 Amazon Gift Card 
or 2 SONA credits  
 
Completing Online Follow-up Survey during 
Campus Closure: 
$10 Amazon Gift Card 

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Study Protocol and Statistical Analysis Plan (SAP).docx 
or 2 SONA credits 
 
 
17. For all incentives/payments, explain why the amount 
or value is reasonable for the research: 
_X_ SONA credit, standard amounts 
Explanation: 
 
Amazon Gift Card Reimbursement: The full duration 
of the study is estimated at 3 hours. Therefore, 
compensation is approximately $16.67 per hour, 
which is commensurate with many standard wages.   
 
18. Will participants be required to provide Protected 
Personally Identifiable Information (PPII) including 
social security numbers, to receive 
incentives/payments?v 
__ No 
_X_ Yes, specify the PPII required for payment, to 
whom it will be provided, and how it will be 
protected during this process: 
 
Participants will provide their name and phone 
number, and email address on their pre-
screening intake. Their payment will be linked to 
their name on the payment log for the purpose of 
tracking payments in this multi-session study. 
Furthermore their study ID number will be linked 
to their name on a master code list, for the 
purpose of scheduling study visits.  
 
Modifications to procedures due to COVID-19 
restrictions: 
One-month follow up surveys will be 
administered online instead of in person.  The 
participant’s email address, provided previously 
during the prescreening procedure, will be used 
to send the survey link to the participant. In order 
to link information back to the ID number, the 
survey response will be linked to the participant’s 
email address (sent through qualtircs) and they 
will also report their full name in the survey. This 
will ensure that we link the appropriate study ID 
number to the survey response.  
 
 
Informed Consent Methods/Procedures 
__ Check here if you do not plan to obtain informed consent from participants); skip to the next section. vi 
19. Describe the process for obtaining legally effective 
informed consent from each participant (i.e., describe 
when, where, and how each recruit will be told about 
the research and agree to her/his participation). 
__ N/A, research only involves childrenvii 
__ N/A, research only involves adults with impaired 
consent capacity and surrogate consentviii 

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Study Protocol and Statistical Analysis Plan (SAP).docx 
 
Description of informed consent process: 
Participants will complete an online consent form 
prior for the prescreening survey.  
  
Participants will complete the full informed consent 
process (for the in-person study visits) at the 
beginning of their first visit to the laboratory. A 
research assistant will provide a brief overview of the 
purpose, risks/benefits, and procedures involved in 
the study, including stating that participation is 
completely voluntary. Participants will then be 
provided with the informed consent document and 
offered the opportunity to ask any follow up 
questions prior to signing the informed consent 
document if they wish to participate in the study.   
 
At the second study visit, participants will be verbally 
reminded of what will be happening on that specific 
visit, and the experimenter will reiterate that 
participation in the study is voluntary and that 
participants may withdraw from the study at any time. 
 
Modifications to procedures due to COVID-19 
restrictions: For the online follow-up survey used during 
campus closure, a brief explanation of the modified 
procedures and the reduced gift card compensation amount 
will be included in the email with the survey link. Participants 
will be offered the opportunity to ask questions via email. 
Additionally, the first page of the survey will be a consent 
form describing the modified procedures and new gift card 
compensation amount. Participants can click to consent.  
 
20. Specify which researchers will obtain informed 
consent from participants: 
_X_ For online pre-screening only - Via online or 
electronic information sheet  
_X_ PI 
__ Co-investigators 
_X_ Study coordinator 
_X_ Research assistants 
__ Other, specify: 
21. How will researchers ensure consent is obtained in a 
language understandable to participants? 
Check all that apply: 
_X_ Consent materials reflect the expected literacy of 
the sample population 
_X_ Participants speak English 
__ Researcher fluent in participants’ language will 
interpret 
__ Person in community will interpret 
__ Professional interpreter will be present 

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Study Protocol and Statistical Analysis Plan (SAP).docx 
__ Consent materials translated in participants’ 
language or short-form consent process used 
__ Other, specify: 
22. How will researchers ensure individuals have 
sufficient opportunity to consider participation? 
For the online prescreening survey and the follow-up 
survey (when the campus is closed), participants will 
have as much time as they need to read the 
document. For the in person consent process, 
participants will be informed to take their time in 
reading over the consent document for the study, 
and will be invited to ask the experimenters any 
follow up questions prior to providing consent.  
23. How will researchers protect participants from undue 
influence/coercion during the consent process? 
During the consent process for the in person study 
visits, experimenters will state that participation in 
the study is completely voluntary, and that they will 
not be penalized if they decide not to participate in 
the study or to withdraw from the study.   
 
Modifications to procedures due to COVID-19 
restrictions: For the online follow-up survey used during 
campus closure, participants will be reminded via email and 
the informed consent page that participation is voluntary, so 
they may choose to not complete the survey. 
 
24. How will researchers assess each person’s 
comprehension of the research? 
_X_ As recommended by the IRB 
For the in-person consent: We will ensure 
comprehension through one-on-one discussion 
with the researcher/experimenter who is 
completing the consent process.  
For the online consent (prescreening and follow-up 
survey used during campus closure): Participants 
will have as much time as they need to review 
the consent form. The consent form will also 
include contact information for the PI and study 
coordinators.  
 
__ Other, specify: 
Documentation of Consent 
25. Will participants sign an IRB-approved consent form, 
as required at 45CFR46.117? 
__ N/A, minimal risk research that is NOT 
conducted/supported by a federal agency 
(including the VA); and does NOT involve 
incomplete disclosure or deception, or prisoners 
__ No, requesting IRB approval to waive 
requirement for documentation of consentix 
__ Yes, via short form consent documentation (for 
non-English-speaking participants) 
_X_ Yes 

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Research Costs 
26. Will participation result in out of pocket expenses 
(including costs for cell phones used in research), co-
pays, 3rd party payer costs, or research-related injury 
costs?x 
_X_ No 
__ Yes, complete the following: 
What costs will participants or 3rd party cover? 
What costs will the researchers cover? 
What costs will the VA cover? 
What costs will the sponsor cover? 
Study Design/Research Methods 
Describe in non-technical terms. 
27. What is the background 
information that supports 
this research? (Summarize 
previous work and provide 
references.) 
Background: About 11% of the general population has social anxiety 
disorder, which is linked with reduced educational performance and 
quality of life, and increased rates of substance use, depression, and 
suicide attempts [1-4]. Furthermore, social anxiety is unlikely to remit 
without intervention [5], and Latinos with persistent social anxiety report 
higher levels of overall impairment relative to their white, non-Latino 
counterparts [6]. Exposure therapy, which involves repeated exposure to 
feared situations, is one of the most effective treatments for social anxiety 
[7]. However, even with this top-of-the-line treatment approach, only about 
25-50% of patients achieve full remission [8].  
 
Transcranial direct current stimulation (tDCS) targeting the medial 
prefrontal cortex (mPFC) may offer a low-risk and cost-effective pathway 
to improving outcomes from exposure therapy for social anxiety. Several 
lines of research point to the importance of mPFC activation in facilitating 
fear reduction. For example, findings from animal models have 
demonstrated that electrical stimulation of the mPFC facilitates fear 
extinction, the primary mechanism of exposure therapy [9]. Moreover, in 
clinical samples, response to exposure-based therapy for social anxiety is 
associated with increases in negative connectivity between regions of the 
mPFC and the amygdala (i.e., mPFC inhibition of limbic-driven emotional 
distress) [10,11]. tDCS is an especially promising strategy for facilitating 
mPFC response during therapy. This form of non-invasive 
neuromodulation is thought to enhance neuroplasticity, particularly after 
multiple sessions in healthy and clinical populations, with no known 
serious adverse effects [12]. This present study will therefore examine 
whether active (versus sham) tDCS targeting the mPFC during exposure 
therapy facilitates fear reduction in people with social anxiety. 
This study will also evaluate how two different ethnic/racial groups 
(Hispanic and non-Hispanic/Caucasian) respond to public speaking 
audiences that are either 75% matched or 75% unmatched to the 
participant’s own ethnicity.  
 
Findings will provide insight into whether tDCS can be used to improve 
outcomes from exposure therapy for social anxiety, a debilitating disorder 
that is particularly severe among Latinos. Findings will also provide insight 
into whether tDCS can be used to facilitate extinction toward more 
extinction resistant cues (e.g., public speaking audiences that are not 
matched to the participant’s own ethnicity),  
 

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Study Protocol and Statistical Analysis Plan (SAP).docx 
28. State the study purpose, 
research hypothesis, or 
research questions: 
Design: We will recruit participants with a fear of public speaking, the 
most commonly feared situation among individuals with social anxiety and 
among the general population [12-14]. Participants will be randomized to 
receive either active/anodal or sham tDCS stimulation targeting the 
vmPFC during one, 20 to 30-minute exposure therapy session delivered 
through virtual reality (VR). VR-based exposure therapy for public 
speaking anxiety is equally effective as in vivo/in life exposure therapy [8], 
but allows for greater consistency of the exposure environment between 
participants (e.g., consistency in listener facial expressions). During 
exposure therapy, participants will complete six, 3-minute public speaking 
trials. During each 3-minute public speaking trial, the audience will be 
comprised of either 75% Latino individuals/25% non-Latino Caucasian 
individuals, or 75% non-Latino Caucasian individuals/25% Latino 
individuals (gender of audience members will be equally distributed 
among each ethnicity group). Order of ethnicity matched and unmatched 
trials will be randomized.  
 
Severity of social anxiety will be assessed at baseline and 1-month follow 
up with (1) a validated battery of questionnaires (the Personal Report of 
Public Speaking Anxiety and the Self-Statements during Public Speaking 
Scale), and (2) two behavioral approach tests (BATs), each involving a 
short speech in virtual reality to either an ethnicity matched or ethnicity 
unmatched audience. Fear will be assessed during each BAT behaviorally 
(total duration of speech out of a 5-min maximum), physiologically 
(electrodermal response and heart rate variability), and subjectively (peak 
fear rating on a scale from 0 to 100). 
 
Study Aims:  
 
Test the hypothesis that augmenting exposure therapy with tDCS 
facilitates alleviation of social anxiety symptoms. If tDCS targeting the 
mPFC improves treatment response, we would expect to detect lower 
symptom scores in the active (versus sham) tDCS group on self-report 
and BAT measures at 1-month follow-up. If tDCS is ineffective, we 
anticipate observing no differences in symptom severity between the 
active and sham tDCS groups at one-month follow-up.  
 
Test the hypothesis that pairing exposure therapy with active (vs 
sham) tDCS facilitates extinction of fear response toward ethnic out-
group, public speaking audiences. If tDCS facilitates reduction of fear 
toward ethnic out-group individuals, we expect an interaction between 
tDCS group (active vs. sham; between-subjects variable) and public 
speaking audience (ethnic-matched vs. ethnic-unmatched; within subjects 
variable) on behavioral, physiological, and subjective indices of fear 
response during the BATs at one-month follow-up. We expect that the 
active tDCS group will show equally low fear response on ethnic-matched 
and ethnic un-matched BATs at one-month follow-up, and the sham tDCS 
group will show higher fear responding during the ethnic un-matched BAT 
relative to the ethnic-matched BAT at one-month follow-up. 
 
REFERECES (for # 27 & #28) 

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Study Protocol and Statistical Analysis Plan (SAP).docx 
1. 
Beesdo, K., Bittner, A., Pine, D. S., Stein, M. B., Höfler, M., Lieb, R., 
& Wittchen, H. U. (2007). Incidence of social anxiety disorder and the 
consistent risk for secondary depression in the first three decades of 
life. Archives of General Psychiatry, 64(8), 903-912. 
2. 
Olatunji, B. O., Cisler, J. M., & Tolin, D. F. (2007). Quality of life in the 
anxiety disorders: a meta-analytic review. Clinical Psychology 
Review, 27(5), 572-581. 
3. 
Stein, M. B., & Kean, Y. M. (2000). Disability and quality of life in 
social phobia: epidemiologic findings. American Journal of 
Psychiatry, 157(10), 1606-1613. 
4. 
Davidson, J. R., Hughes, D. L., George, L. K., & Blazer, D. G. (1993). 
The epidemiology of social phobia: Findings from the Duke 
Epidemiological Catchment Area Study. Psychological 
Medicine, 23(3), 709-718. 
5. 
Keller, M. B. (2006). Social anxiety disorder clinical course and 
outcome: Review of Harvard/Brown Anxiety Research Project 
(HARP) findings. The Journal of Clinical Psychiatry, 67, 14-19. 
6. 
Polo, A., Alegría, M., Chen, C. N., & Blanco, C. (2011). The 
prevalence, comorbidity, and age of onset of social anxiety disorder 
among US Latinos. The Journal of Clinical Psychiatry, 72(8), 1096. 
7. 
Butler, A. C., Chapman, J. E., Forman, E. M., & Beck, A. T. (2006). 
The empirical status of cognitive-behavioral therapy: a review of 
meta-analyses. Clinical Psychology Review, 26(1), 17-31. 
8. 
Anderson, P. L., Price, M., Edwards, S. M., Obasaju, M. A., 
Schmertz, S. K., Zimand, E., & Calamaras, M. R. (2013). Virtual 
reality exposure therapy for social anxiety disorder: A randomized 
controlled trial. Journal of Consulting and Clinical Psychology, 81(5), 
751-760.http://dx.doi.org/10.1037/a0033559 
9. 
Milad, M. R., Vidal-Gonzalez, I., & Quirk, G. J. (2004). Electrical 
stimulation of medial prefrontal cortex reduces conditioned fear in a 
temporally specific manner. Behavioral Neuroscience, 118(2), 389. 
10. Young, K. S., Burklund, L. J., Torre, J. B., Saxbe, D., Lieberman, M. 
D., & Craske, M. G. (2017). Treatment for social anxiety disorder 
alters functional connectivity in emotion regulation neural 
circuitry. Psychiatry Research: Neuroimaging, 261, 44-51. 
11. Goldin, P. R., Ziv, M., Jazaieri, H., Hahn, K., Heimberg, R., & Gross, 
J. J. (2013). Impact of cognitive behavioral therapy for social anxiety 
disorder on the neural dynamics of cognitive reappraisal of negative 
self-beliefs: Randomized clinical trial. JAMA Psychiatry, 70(10), 1048-
1056. 
12. Bikson, M., Grossman, P., Thomas, C., Zannou, A. L., Jiang, J., 
Adnan, T., ... & Brunoni, A. R. (2016). Safety of transcranial direct 
current stimulation: evidence based update 2016. Brain Stimulation: 
Basic, Translational, and Clinical Research in Neuromodulation, 9(5), 
641-661. 
13. Stein M. B., Torgrud, L. J., & Walker J. (2000). Social phobia 
symptoms, subtypes, and severity: Findings from a community 
survey.  Archives of General Psychiatry, 57, 1046- 1052 
14. Mannuzza, S., Schneier, F. R., Chapman T. F., Liebowitz  M.R., 
Klein  D. F., Fyer, A. J. (1995). Generalized social phobia: reliability 
and validity. Archives of General Psychiatry, 52, 230- 237 

Page 11 of 27 
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15. Pollard, C.A., & Henderson, J.G. (1988). Four types of social phobia 
in a community sample. Journal of Nervous and Mental Disease, 176, 
440- 445 
16.  
29. When appropriate (e.g., community-based 
participatory research, international research), how 
will you involve community members as advisors in 
the design/implementation of the research, and 
dissemination of results? 
_X_ N/A, not necessary/appropriate to involve 
community members 
Describe: 
30. Check all research methods/procedures that apply to this research: 
_X_ Psychological or behavioral interventions/treatments 
__ Educational activities/interventions 
_X_ Experimental-control group assignment 
__ Cross-over design 
__ Computerized simulations 
_X_ Equipment/devicesxi, specify: transcranial direct 
current stimulation; Empatica E4, ambulatory 
physiological recording; HTC Vive (virtual reality)  
__ Ethnographic research 
__ Needs assessment research 
__ Program evaluation research 
__ Observational research 
_X_ Surveys, interviews, focus groups 
__ Collection of data from records 
__ Retrospective 
__ Prospective 
__ Other, specify: 
31. Which of these methods/procedures are 
experimental (i.e., conducted to evaluate 
safety/efficacy or other outcomes)xii? 
Augmenting this exposure therapy with tDCS 
stimulation targeting the mPFC is experimental.  
32. Which of these methods/procedures are considered 
standard-of-care? 
 Using exposure-based therapy to treatment social 
anxiety is standard of care.  
33. Who will provide the standard treatment or care 
referenced above? 
__ N/A, research does not include usual 
care/standard treatment 
_X_ Study team 
__ Participant’s own health care provider 
__ Other, specify 
34. Why is group assignment necessary, and how will 
participants be assigned to treatment/experimental 
or control groups? 
__ N/A, research does not involve group assignment 
Justification/description: 
We will use a blocked randomization procedure and a 
random numbers generator to determine random 
assignment. Random assignment is necessary to 
provide an empirical evaluation of whether 
active/anodal tDCS improves outcomes relative to a 
placebo condition (sham tDCS stimulation).  
35. What will participants experience or be asked to do 
when assigned to the treatment / experimental group 
or to the control group? 
All participants will complete one session of exposure 
therapy for public speaking (six, 3-minute trials of 
exposure therapy). During exposure therapy, they 
will be engaging in public speaking in a VR-based 
environment. All participants will complete six, 3-
minute public speaking trials, each of which will be 
with an 75%-ethnicity matched or 75%-ethnicity 
unmatched public speaking audience (order of trials 
will be randomized).   
 

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Treatment-group specific tasks: During their public 
speaking exposure therapy, participants will receive 
either (a) active or (b) sham tDCS stimulation. In the 
active and sham tDCS stimulation groups, anodal 
tDCS will be applied to target the vmPFC (Hammerer 
et al., 2016). Participants in the active tDCS group will 
receive 2 mA anodal stimulation during the exposure 
therapy task, and participants in the sham group will 
receive sham tDCS stimulation for about 20-30 s at 
the beginning and ending of the task to mimic the 
sensation of active tDCS (Zhao et al., 2017). 
 
Additional information on tDCS procedures:  
 
The tDCS administration procedures will include the 
following steps:  
(1) The participant's head is measured for 
appropriate placement of the electrodes (following 
the 10-20 international EEG convention). A towel is 
draped over the participant to prevent any saline 
drips from the electrodes.  
(2) The 5 x 5 cm or 5 x 7 cm saline dampened 
electrodes are then placed on the participant's head 
and held in place with adjustable bands. Electrodes 
may be placed on a single cortical area and a ground 
site (e.g. right parietal, left cheek or orbitofrontal 
region), or on two cortical sites (e.g. right parietal, 
right frontal).  
(3) If it is an anodal session, tDCS stimulation is 
applied approximately 20-30 minutes at 2 mA. 
Stimulation ends at the programmed time. During 
sham sessions, the electrodes are attached, and a low 
current is supplied for approximately the first and last 
20-30 seconds to mimic the anodal tDCS experience. 
Electrodes are removed at the end of stimulation. 
Stimulation is  perceived by most people only at the 
onset and offset of stimulation. Participants describe 
the sensation as a slight tingling sensation. In most 
participants, there is no abnormal sensation during 
the bulk of the stimulation period.  
The experimenter directly administering the tDCS will 
be blind to the treatment condition (i.e., placebo vs 
active tDCS).  
 
Hämmerer, D., Bonaiuto, J., Klein-Flügge, M., Bikson, 
M., & Bestmann, S. (2016). Selective alteration of 
human value decisions with medial frontal tDCS is 
predicted by changes in attractor dynamics. Scientific 

Page 13 of 27 
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Reports, 6, 25160. 
 
Zhao, H., Qiao, L., Fan, D., Zhang, S., Turel, O., Li, Y., ... 
& He, Q. (2017). Modulation of brain activity with 
noninvasive transcranial direct current stimulation 
(tdcs): clinical applications and safety concerns. 
Frontiers in Psychology, 8, 685-703. 
 
36. Note the expected number/length of 
contacts/meetings, and time commitment for 
participation (include similar information in consent 
materials): 
2                 Expected number of contacts/meetings 
60-120 min Minutes/hours for each contact/meeting  
                     (estimated)  
1 visit          Duration of participation (in 
weeks/months) for intervention 
1 month 
Duration of participation (in 
weeks/months) for long-term follow-up 
Data Collection and Analysis 
37. List the information/specimens that researchers will 
obtain for this research xiii: 
Researchers will collect questionnaire and interview 
data related to social anxiety severity and 
potential moderators of treatment (see research 
instrument section), physiological data (skin 
conductance and heart rate) to assess for 
increases in anxiety, and behavioral data 
(behavioral performance measured in total 
duration of public speeches; and in total duration 
of eye contact with audience members as 
recoded by the VR program).  
38. How will research data be obtained?xiv 
Questionnaire/self-report and interview data will be 
collected in the laboratory. Participants will fill out 
questionnaires via Qualtrics. Research staff will 
administer the interviews and record responses in 
Qualtrics.  
 
Modifications to procedures due to COVID-19 
restrictions: “In the case of campus closure, follow-up self-
report data will be collected via an online survey. Participants will 
be emailed one-month after their first visit. The email will include 
a description of the modified procedures (i.e., online survey 
rather than in-person visit due to campus closure; reduced gift 
card compensation amount) and a link to the Qualtrics survey. 
Participants’ emails will be linked to the survey so that 
researchers can view when the survey has been completed and 
provide compensation. Reminder emails will be sent after the 
first email if the participants have not completed the surveys. 
 
Physiological data (skin conductance and heart rate) 
will be collected via an Empatica E4 wristband during 
behavioral avoidance tests.  
 

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Behavioral performance (e.g., speech duration) will 
be coded by research staff and by the output form 
the virtual reality program. Eye contact duration with 
audience members will be recorded via the virtual 
realty program. This information is labeled with 
time/date and will be stored in a study folder in 
Nevada box, labeled with the participant ID number 
(not with any identifying information).   
 
39. Identify each research instrument (e.g., diary, 
questionnaire, data collection log) and describe how 
its use relates to the study purposexv: 
Participants will complete a demographics 
questionnaire at baseline, along with an 
inclusion/exclusion criteria screening interview.  
 
Social Anxiety Questionnaires: Social Anxiety 
questionnaires include the Personal Report of Public 
Speaking Anxiety, the Self-Statements during Public 
Speaking Scale, and an interview for social anxiety 
disorder (the MINI International Neuropsychiatric 
Interview- Social anxiety section; see Appendix). 
Except for the interview, these are each Likert-style 
questionnaires that evaluate severity of social anxiety 
symptoms. These will be administered at baseline 
and one-month follow up.  
 
We will provide additional questionnaires that are all 
potential treatment moderators. These include (a) a 
Color of My Skin Interview (because the participant’s 
perception of their skin tone might moderate their 
response to public speaking audiences of different 
skin tones), (b) the intergroup contact questionnaire 
(because those with greater experience with the 
ethnic out-group may be less fearful when the 
audience is mostly ethnic out-group members), and 
(c) the intergroup anxiety scale (because those with 
lower intergroup anxiety may respond less fearfully 
when the audience is mostly ethnic out-group 
members).  
Immediately after participants are told about the 
treatment, they will also complete a treatment 
Credibility and Expectancy Questionnaire.  
 
After the VR and tDCS sessions we will also 
administer (a) the igroup Presence Questionnaire 
(because participants who find the VR experience 
immersive rather than ‘fake’ may demonstrate better 
outcomes), and (b) a side effects questionnaire (for 
monitoring possible adverse effects of tDCS and VR).  
 

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Study Protocol and Statistical Analysis Plan (SAP).docx 
Before and after exposure therapy, and before and 
after each behavioral avoidance test (BAT), 
participants will additionally self-report on their 
emotional state (e.g., fear levels) and beliefs (e.g., 
belief that public speaking practices will be/were 
harmful/negative). During exposure therapy, 
participant’s physiological responding will be 
recorded (heart rate and electrodermal skin 
response).  After exposure therapy is complete, 
participants will fill out a question indicating their 
best guess as to their treatment assignment (placebo 
or active tDCS). This question is to ensure that 
blinding was effective.  
 
Behavioral avoidance tests (BATs): Participants will 
be complete two behavioral avoidance tests. The 
BATs will involve providing two public speeches to an 
audience in virtual reality that is A) 75% matched to 
the participant’s ethnicity, and b) 75% un-matched to 
the participant’s ethnicity. Participant’s responding 
will be measured subjectively (with self report items), 
physiologically (with electrodermal skin response and 
with heart rate), and behaviorally (recording duration 
eye contact with audience members, and overall 
duration of the speech). The subjective, physiological, 
and behavioral measures of anxiety during the 
behavioral avoidance task provide a triangulated 
measurement of the construct of public speaking 
anxiety. The behavioral approach tests will be 
completed at baseline and 1-month follow up.  
 
Modifications to procedures due to COVID-19 
restrictions: For the online follow-up survey, only the 
following questionnaires will be included, due to participants’ 
completing the survey at home: Intergroup Anxiety Scale, 
Personal Report of Public Speaking Anxiety, Self-
Statements During Public Speaking, and a modified MINI – 
Social Anxiety interview so that participants can answer the 
questions without the presence of an interviewer. See 
Appendix- Questionnaires to view interviews that have been 
modified to questionnaires.  
 
40. How will researchers analyze the data?xvi 
Primary analyses will be ANCOVAs, evaluating the 
impact of tDCS group (active vs sham) on outcome 
measures (questionnaires, physiology,  
and behavior) at post-treatment and follow-up, 
controlling for baseline levels. The hypothesis is that 
participants with active (vs sham) tDCS will have 

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Study Protocol and Statistical Analysis Plan (SAP).docx 
lower symptom scores at post-treatment and follow 
–up (adjusting for baseline levels).  
 
We will also use a repeated-measures ANOVA to 
examine whether tDCS group (active vs 
sham; between-subjects variable) interacts with 
ethnic make-up of the public speaking audience 
(ethnicity- matched vs. ethnicity-unmatched; within-
subjects variable) to determine fear response on each 
index of fear reactivity (behavioral, physiological, and 
subjective fear response) at one-month follow-up. 
 
41. Will this research include records of participants’ 
voices or images?xvii  
_X_ No 
__ Yes, audio; describe and justify: 
__ Yes, video; describe and justify:  
__ Yes, photographs; describe and justify: 
Research Risks 
42. Describe how risks 
will be minimized 
through use of 
sound research 
design: 
__ N/A, minimal risk research 
 
Description:  
1) One risk is breach of confidentiality because we are collecting identifying information 
(name, phone number, email address). This risk is minimized by linking identifying data 
to the primary study dataset (i.e., data collected during all in person visits) only through 
a hard copy, linking document, which will be stored separately from the rest of the 
research data. This linking document will be stored in a locked file cabinet in the 
laboratory. For the pre-screening assessment, however, identifying data will need to be 
collected along with eligibility information (pre screening assessments), so that 
researchers can contact eligible participants to set up appointment times. Only 
researchers who are IRB-approved (on this protocol) will have access to the pre-
screening data set.  Furthermore, we have tried to minimize any collection of 
identifiable private information on the prescreening form by categorizing all health-
related conditions into one yes/no questions (so the participant does not need to 
identify any particular health condition they may have which would exclude them from 
the study, such as current pregnancy or a history of seizure or neurological condition).  
 
2) A second risk relates to the use of tDCS. There is risk of seizure, skin irritation 
(itching, tingling, redness, pain) and burning associated with the application of electrical 
current to the scalp. There is risk of headache and discomfort from the adjustible bands 
that hold the electrodes in place. Seizure activity is associated with symptoms of 
attention deficiency, nausea, mood changes, and changes in perception, thus, these 
symptoms are also monitored.   
 
However, to our knowledge, there have been no reported seizures associated with 
tDCS. Thus, symptoms associated with seizure activity (nausea, mood and perceptual 
changes) are unlikely. The stimulus parameters we propose are consistent with what 
has been safely used by other researchers and because of this we think that the 
likelihood of a serious event is very small.   

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Study Protocol and Statistical Analysis Plan (SAP).docx 
 
Our best estimate of other more minor symptoms comes from a recent publication. 
Poreisz et al., (2007) tested 102 participants in 567 tDCS sessions. In post-session 
questionnaires asking for ratings from 1(low) - 5 (high), a mild-tingling sensation 
occurred in 71% of participants and was given a mean rating of 1.74± .84. Other effects 
included moderate fatigue in 35% (rated 2.17 ± 1.11), itching under the electrode 
placement in 30% (rated 1.6 ± .72). More serious symptoms of burning sensations were 
reported in 22% (rated 1.59 ± .91) and pain in 16% (rated 1.41 ± .71). However, no 
participant asked to terminate a session. In our testing experience, participants describe 
a slight itching sensation when the stimulation begins and ends. We anticipate 
participants describing slight itching and tingling. If participants report burning and pain 
at any point during the session, we will ask them if they would like to end the testing 
session. If the symptoms are not resolved by ending stimulation, we will take the 
participant to the health center or call medical emergency services if needed. If the 
participant reports feeling extreme symptoms during stimulation in the 'Post-Study 
Questionnaire' we will speak with the participant to see if medical attention is needed. 
 
3) Additionally, completing procedures such as exposure therapy and the behavioral 
avoidance tests, can produce an increase in anxiety; during these procedures 
participants are engaging in a feared task on purpose (in this study, giving a public 
speech). However, this risk of psychological distress does not exceed what one might 
experience in daily life (e.g., when asked to provide a speech/presentation in a 
classroom setting). To provide participants resources for additional social anxiety 
treatment if desired, all participants who begin treatment will be provided a referral 
document, listing contacts for local mental health resources, at the end of the study.  
 
4) Finally, the use of immersive virtual reality (used to administer exposure therapy in 
our study) can occasionally lead to transient side effects such as motion sickness, 
dizziness, or headaches. Following procedures used by prior studies of VR-based 
exposure therapy for public speaking anxiety (Anderson et al., 2013), we will mitigate 
the risk of simulator sickness by limiting the virtual reality exposure therapy session to 
20-30 minutes. Participants will be allowed to request to stop VR sessions early, or take 
breaks during VR sessions, as needed if they are experiencing symptoms associated 
with simulator sickness.  
 
Anderson, P. L., Price, M., Edwards, S. M., Obasaju, M. A., Schmertz, S. K., 
Zimand, E., & Calamaras, M. R. (2013). Virtual reality exposure therapy for 
social anxiety disorder: A randomized controlled trial. Journal of Consulting and 
Clinical Psychology, 81(5), 751-760.http://dx.doi.org/10.1037/a0033559 
 
Poreisz, C., Boros, K., Antal, A., & Paulus, W. (2007). Safety aspects of transcranial 
direct current stimulation concerning healthy subjects and patients. Brain research 
bulletin, 72(4-6), 208-214. 
 
43. What precautions 
will researchers 
use to avoid 
unnecessarily 
Check all that apply: 
__ N/A, minimal risk research 
_X_ Using recognized standard practices 
__ Ensuring researcher expertise/credentialing 

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Study Protocol and Statistical Analysis Plan (SAP).docx 
exposing 
participants to 
risk? 
_X_ Researcher training 
__ Minimizing time required for procedures 
_X_ Using procedures that are already being performed (e.g., for education or 
treatment) – use of the tDCS  
_X_ Monitoring participants for adverse reactions 
__ Monitoring data for safety 
__ Other, specify: 
44. List the discomforts 
and physical harms 
that might result 
from participation 
in this research; 
assess the 
probability, 
severity, and 
duration of each 
discomfort/harm: 
 
1) Potential physical discomfort associated with tDCS:  
 There is risk of seizure, skin irritation (itching, tingling, redness, pain) and burning 
associated with the application of electrical current to the scalp. There is risk of 
headache and discomfort from the adjustible bands that hold the electrodes in place. 
Seizure activity is associated with symptoms of attention deficiency, nausea, mood 
changes, and changes in perception, thus, these symptoms are also monitored.  
However, there have been no seizures associated with tDCS. Symptoms associated with 
seizure activity (nausea, mood and perceptual changes) are unlikely. The stimulus 
parameters we propose (1-2 mA stimulation) are consistent with what has been safely 
used by other researchers and because of this we think that the likelihood of a serious 
event is very small.   
 
Our best estimate of other more minor symptoms comes from a publication on a large 
sample exposed to tDCS. Poreisz et al., (2007) tested 102 participants in 567 tDCS 
sessions. In post-session questionnaires asking for ratings from 1(low) - 5 (high), a mild-
tingling sensation occurred in 71% of participants and was given a mean rating of 1.74± 
.84. Other effects included moderate fatigue in 35% (rated 2.17 ± 1.11), itching under 
the electrode placement in 30% (rated 1.6 ± .72). More serious symptoms of burning 
sensations were reported in 22% (rated 1.59 ± .91) and pain in 16% (rated 1.41 ± .71). 
However, no participant asked to terminate a session. In our testing experience (in the 
Berryhill/co-PI lab), participants typically describe a slight itching sensation when the 
stimulation begins and ends. Therefore, we anticipate participants will likely describe 
slight itching and tingling, but that this effect will be transient.  
 
(2) Potential simulator sickness related to VR use:  
Probability of simulator sickness is reported by Gregg & Tarrier (2007): “In a series of 
experiments 80% of all participants reported an increase in sickness symptoms following 
immersions in a virtual environment (Cobb et al., 1999). For the majority this was a mild 
increase, which subsided after exiting the immersion. However, 5% could not complete the 
immersion because the effects were so aversive. Symptom onset typically occurred within 
15 min of starting. In repeated trials, symptoms were worse during the first immersion and 
were negligible by the third.”  
 
Thus, it is likely that a participant might experience a mild, but transient, increase in 
simulator sickness symptoms (e.g., slight nausea, headache, etc), but rare that the increase 
would be so significant that a participant would need to terminate an exposure therapy 
session. This risk is further mitigated in the present study due to little to no movement in 
position during the public speaking simulation.  
 
Cobb SVG, Nichols S, Ramsey A, Wilson JR (1999) Virtual reality induced symptoms and effects 

Page 19 of 27 
Study Protocol and Statistical Analysis Plan (SAP).docx 
(VRISE). Presence, 8,169–186.  
Gregg, L., & Tarrier, N. (2007). Virtual reality in mental health. Social psychiatry and psychiatric 
epidemiology, 42(5), 343-354. 
Poreisz, C., Boros, K., Antal, A., & Paulus, W. (2007). Safety aspects of transcranial direct current 
stimulation concerning healthy subjects and patients. Brain research bulletin, 72(4-6), 208-
214.  
 
45. List the social, 
legal, financial, 
emotional, or 
familial harms 
might result from 
participation in this 
research; assess 
the probability, 
severity, and 
duration of each of 
these harms: 
Emotional risk: Prior studies have estimated that exposure-based therapies lead to a 
temporary exacerbation in symptoms for approximately 10-20% of patients (Foa et al., 
2002; Larsen et al., 2016). However, those patients who experience exacerbation still 
experienced clinically significant improvements in symptoms by the end of treatment 
(Larsen et al., 2016). Thus the risk of temporary exacerbation of emotional symptoms is 
relatively unlikely, and exposure therapy seems very unlikely to have any long-term 
negative emotional effects.  
 
Foa, E. B., Zoellner, L. A., Feeny, N. C., Hembree, E. A., & Alvarez-Conrad, J. (2002). 
Does imaginal exposure exacerbate PTSD symptoms?. Journal of Consulting and 
Clinical Psychology, 70(4), 1022. 
 
Larsen, S. E., Stirman, S. W., Smith, B. N., & Resick, P. A. (2016). Symptom 
exacerbations in trauma-focused treatments: Associations with treatment outcome and 
non-completion. Behaviour Research and Therapy, 77, 68-77. 
 
46. Identify secondary 
and incidental 
findings (see Policy 
Manual 
Definitions) that 
are reasonably 
expected to result 
from this research. 
Explain the plans 
for whether the 
findings to 
participants or 
others will be 
disclosed: 
_X_ N/A, secondary/incidental findings not expected 
 
47. How will 
participants be 
referred to 
psychological, or 
other services that 
may be required as 
a consequence of 
participation in the 
research? 
__ N/A, need for referrals not anticipated 
Explanation: Participants are unlikely to need psychological referrals as a consequence 
of participating in the current research. However, participants may have a desire to 
continue exposure therapy (the dosage of exposure therapy provided in the study less 
than standard clinical care). Therefore, participants will receive a handout at the end of 
the study providing them with contact information for mental health resources/clinics 
in the Reno area.  
 
Physical side effects:  
If the participant feels physically unwell during the session, the session will be halted. It 
is anticipated that symptoms will cease once the electrodes are removed and when the 
VR head mounted display is removed. However, in the unlikely occurrence of a seizure, 

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Study Protocol and Statistical Analysis Plan (SAP).docx 
the emergency response team will be contacted immediately. Emergency contact 
numbers are posted in the lab for easy access. Research staff will contact 911 in the 
case of any medical emergency.  
 
If the participant reports a more minor medical condition - such as the slight tingling 
associated with tDCS or slight nausea due to VR, we will monitor the condition during 
the session. The post-Therapy questionnaire will be administered at the end of the 
treatment/exposure therapy session to monitor physical symptoms. During the Post-
Therapy Questionnaire, if a serious side-effect comes to light, we will ask the participant 
if emergency treatment is needed and we will either take the participant to the health 
center or call emergency services (911). There will be a first aid kit in the laboratory to 
provide care for any minor treatments. For example, the participant may request an ice 
pack to the area under electrodes if the skin is irritated. 
Safety Monitoring for Greater than Minimal Risk Research 
__ Check here if this is minimal risk research and safety monitoring is not required; skip to next section. 
48. Describe the plan to monitor data for safety. Include: 
• 
Who will monitor the data for safety concerns? 
• 
What data will be reviewed? 
• 
How often will the monitoring occur? 
• 
How often will cumulative data be reviewed? 
After the treatment session, participants will fill out a 
'Post-Therapy Questionnaire' to assess how he/she 
feels along a series of dimensions. These data will 
provide a formal record demonstrating any after 
effects of the stimulation. The research staff member 
running the study procedures will monitor/review 
this questionnaire each session before the participant 
leaves. The cumulative data on this will be reviewed 
upon the final analysis of the study data.  
49. Are there specific findings that would trigger an 
immediate suspension of the research? 
_X_ No 
__ Yes, specify: 
Research Benefits 
50. Are individual participants expected to benefit from 
being in this research? 
__ No 
_X_ Yes, specify: Participants with fears of public 
speaking could experience a reduction in these 
fears as a result of the exposure therapy 
intervention. It is possible that participants with 
tDCS augmentation could experience enhanced 
treatment benefits. Participants will also benefit 
from compensation via course credits or amazon 
gift cards.   
51. What is the potential value of the knowledge to be 
gained from this research? 
Outcomes of this study will shed light on the whether 
tDCS, a low-risk and cost-effective neuro-stimulation 
tool, can be used to improve outcomes of exposure 
therapy for individuals with symptoms of social 
anxiety.  
Protecting Participant Privacy 
52. Will Protected Personally Identifiable Information 
(PPII) be collected for this research (see Policy 
Manual Definitions)? 
__  No 
_X_ Yes, specify what PPII will be collected 
and why it is necessary to collect it: 
  

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Study Protocol and Statistical Analysis Plan (SAP).docx 
It is necessary for us to collect names and 
contact information (phone number and email) for 
our research participants so that we can 
schedule their study visits, and link their data 
together across multiple study visits. Data 
collected during the pre-screening process will be 
stored separately from the main study outcome 
data – however, it will be necessary to link these 
identifying data to prescreening information for 
the purpose of contacting participants to 
schedule study visits. Data collected during the 
primary (in-person) study visits (i.e., everything 
except prescreening) will be linked to a unique 
subject identifier (ID number) and not to 
personally identifiable information. We will link 
the ID number to identifiable information only in a 
hard copy linking document, which will be stored 
in the laboratory (MSS 120) in a locked filing 
cabinet. 
 
Modifications to procedures due to COVID-19 
restrictions: 
Until such time when normal daily functioning 
resumes on campus (i.e., all restrictions are lifted and 
we are able to return to campus), we will enact 
alternate procedures in order to collect follow-up 
data remotely. The participant’s one-month survey 
will be sent directly from qualtrics to their email 
address and they will report their name as a part of 
the survey form. This will be done to ensure that we 
can later link the correct study ID number to the one-
month follow up survey response. Data collected via 
this remote procedure will be downloaded and 
identifiable data will be deleted within 6 months of 
returning to campus and resuming normal study 
procedures. 
53. How will researchers protect the privacy of 
prospective participants during initial contact, and 
interventions or interactions? 
To protect privacy, participants will complete study 
procedures in the laboratory (with the exception of 
the pre-screening questionnaire assessment).  
 
Confidentiality will be protected in the following way: 
Data collected during the in-person study visits will 
be linked to a unique subject identifier (ID number) 
and not to personally identifiable information. We 
will link the ID number to identifiable information 
only in a hard copy linking document, which will be 

Page 22 of 27 
Study Protocol and Statistical Analysis Plan (SAP).docx 
stored in the laboratory (MSS 120) in a locked filing 
cabinet. 
 
On the pre-screening questionnaire (only 
questionnaire linked directly to identifying data) 
questions related to physical health (e.g., current 
pregnancy, history of concussion, etc) that could 
exclude one from using tDCS for this study will be 
asked within a single question. Therefore, 
participants will not be required to report on any 
specific medical condition (see Prescreening 
Questionnaire, item #7, in Appendix).   
 
Modifications to procedures due to COVID-19 
restrictions: 
The follow-up survey link will be sent to the email 
address provided by the participant in previous 
correspondence (study visit scheduling) and in 
the pre-screening form. The participant will report 
their name in the follow up survey as well. To 
protect privacy, we selected to use an email 
address the participant has provided the study 
staff with previously.  Additionally, the email 
subject and text will remain as generic as 
possible (e.g., “Center for FearLess Research 
Survey” rather than “Fear of Public Speaking 
Survey”) to limit references to private information. 
Further, data will be stored securely (via 
Qualtrics and NevadaBox), and only the research 
team will have access to the data collected.  
Finally, identifiers  (email address and name) will 
be removed from follow up data within 6 months 
of returning to campus and resuming original 
study procedures.  
54. What protections will be in place for investigators to 
access records generally considered private (e.g., 
education or personnel records? 
_X_ N/A, records generally considered private will not 
be accessed for the research 
__ Compliance with FERPA (for education records) 
__ Other, describe: 
55. Do any state laws for mandatory reporting apply to 
this research? (See IRB policy for applicable Nevada 
State Laws.) 
_X_ No 
__ Yes, specify and include in consent document: 
56. For researching involving the collection of identifiable 
information that may have legal ramifications (e.g. 
illegal drug use, criminal activity), will a Certificate of 
Confidentiality be obtained (see IRB CoC policy)? 
_X_ N/A, no such information will be collected 
__ N/A, identifiers not collected or not maintained 
__ No, explain why not: 
__ Yes, upon receipt of the COC, create a new 
package, and Add the certificate. 

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Study Protocol and Statistical Analysis Plan (SAP).docx 
Maintaining Data Confidentiality 
57. Identify the formats in which research records will be 
maintained by the PI: 
_X_ Paper 
_X_ Electronic 
__ Recorded media (e.g., audio/video, digital 
photos) 
__ Other, specify: 
58. Where will research records be maintained by the PI?xviii (Check all that apply.) 
_X_ Password-protected file on University/Affiliate server 
(e.g., UNRNAS) or secure VA network server 
(Downloaded datasets from Qualtrics and Empatica 
are stored here).  
__ In the UNR Med-hosted environment 
_X_ On an external cloud-based solution; Add Business 
Associate Agreement or ORD approval for VA 
research (Qualtrics surveys are maintained and 
stored on Qualtics, and the physiological data 
collected via an Empatica E4 is stored on their web-
based service. With the exception of the prescreening 
survey, these data are linked only to the date/time of 
survey administration and/or to a participant ID 
number – not to personal identifying information.) 
__ On a password-protected stand-alone desktop/laptop 
computer (must be encrypted) 
__ On a password-protected Electronic Portable Device 
(must be encrypted) 
_X_ In a locked file cabinet in the PI’s office or lab 
(master code sheet linking ID numbers to 
identifying information is stored here).  
__ In a locked or password-protected office or lab at 
the University, Affiliate site, or VASNHCS 
__ Off-site in a secure facility with password-
protected access, Add Business Associate 
Agreement 
__ VA research only, off-site in another VA facility, 
specify: 
__ VA research only, off-site in a secure non-VA 
facility with password-protected access, Add 
documentation of ORD approval 
__ Other location, specify: 
59. Who will have access to research records? 
NOTE: It is understood the US DHHS, and UNR RI and 
IRB will have access. 
Check all that apply: 
_X_ Principal Investigator 
_X_ Co-Investigators 
_X_ Research assistants 
__ Collaborating researchers, institutions or 
organizations, specify: 
_X_ Study sponsor 
__ VASNHCS or Affiliate Site Research Office 
__ Other federal agencies, specify: 
__ Other, specify:  
60. How will researchers protect against unauthorized 
disclosure of identifiable information about 
participants? 
__ N/A, data will be collected without identifiers 
__ Data will immediately be stripped of personal 
identifiers; no master code list 
_X_ Data will be coded; master code list will be stored 
securely and separately 
_X_ Other, specify: 
 
Modifications to procedures due to COVID-19 
restrictions: The data collected will be linked to 
the participant’s email address and name in 
qualtrics, which is only accessed via 
login/password. The online data will be accessible 

Page 24 of 27 
Study Protocol and Statistical Analysis Plan (SAP).docx 
only to members of the research team. Once 
normal in person research procedures resume, 
and we have access to the hard copy linking 
document (which is currently located in a locked 
filing cabinet in the laboratory, MSS 120), we will 
match the study ID number to each survey 
response and delete the identifying data from the 
database (email address and name). Identifiable 
data will be deleted within 6 months of returning 
to campus and resuming normal study 
procedures. 
61. Will web-based applications be used to obtain, 
record, or store data (e.g., online survey 
administrator or sponsor-portal)? 
__ No 
_X_ Yes, identify the server/applicationxix 
Qualtrics will be used to collect all self-report data for 
the study. Qualtrics data for the primary study data 
(i.e., everything except prescreening) will be attached 
to a de-identified participant code (a master code list 
attaching identifying information to the code will be 
stored separately). The pre-screening form will be 
used only to assess eligibility for the study, and will 
necessarily include contact/identifying information 
for the purposes of scheduling study visits.  
 
Empatica’s E4 system requires the data to be 
downloaded into a cloud service prior to analysis; 
physiological data will be stored at this location. The 
data will be downloaded, linked to a participant ID, 
and stored on a secure server university server.  
 
Modifications to procedures due to COVID-19 
restrictions: 
Until such time when normal daily functioning 
resumes on campus (i.e., all restrictions are lifted 
and we are able to return to campus), we will 
enact alternate procedures in order to collect 
follow-up data remotely. The participant’s one-
month survey will be sent directly from qualtrics 
to their email address and they will report their 
name as a part of the survey form. This will be 
done to ensure that we can later link the correct 
study ID number to the one-month follow up 
survey response. Data collected via this remote 
procedure will be downloaded and identifiable 
data will be deleted within 6 months of returning 
to campus and resuming normal study 
procedures. 

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Study Protocol and Statistical Analysis Plan (SAP).docx 
 
The Empatica E4 system will not be used for this 
modified procedure to collect data remotely.  
 
 
62. Will software provided by a 3rd party (e.g., sponsor) 
be used to record or transmit data? 
_X_ No 
__ Yes, identify the software and the source; 
summarize or Add data security policy: 
63. Will mobile devices be used to collect or record data 
for this project? 
_X_ No 
__ Yes, with FIPS 140-2 encryption standard 
__ Yes, with other security measures, specify: 
64. Will identifiable research records be transmitted or 
shipped to another location/institution? 
_X_ No 
__ Yes, describe how confidentiality will be 
maintained during transmission/shipping: 
65. How long will the PI store identifiable records? 
__ N/A, identifiers not collected or not kept 
__ N/A, data coded; master list will be destroyed 
before permanent storage 
__ Until the study closes 
_X_ Years after study closure (note number): 5 
__ Indefinitely  
__ Other, specify: 
66. What will happen to identifiable records after the storage period ends? (Check all that apply.) 
__ N/A, identifiable data not collected or not stored 
__ N/A, research data and records will be stored 
indefinitely (per VHA Records Control Schedule 10-1 
when applicable) 
__ Paper/electronic records will be destroyed. 
__ Audiotapes/videotapes will be erased or destroyed 
_X_ The master code list will be destroyed; de-identified 
data will be maintained by the Investigator 
indefinitely. 
__ Coded data will be placed in an existing 
repository; master code list will be destroyed 
__ Coded data will be placed in an existing 
repository; master code list will be maintained by 
the repository 
__ Data along with PPII will be maintained by the PI 
for future research purposes 
__ Other, describe: 
Transferring Research Data to a Bank or Repository for Future Uses 
_X_ Check here if this is data will not be transferred to a bank or repository; skip to next section. 
67. Will identifiable research data be transferred to a 
data bank or repository for future use? 
NOTE: Information about future uses must be in 
consent documents. 
__ No 
__ Yes, name the bank/repository, justify the 
retention of identifiers, and describe future uses: 
68. Specify the oversight mechanisms for future uses of 
identifiable data transferred to a bank/repository: 
__ N/A, identifiable data will not be transferred to a 
bank/repository 
__ Existing repository has appropriate oversight 
mechanisms in accordance with VHA Handbook 
1200.12. 
__ IRB of Record for the bank/repository is 
responsible for approval and oversight of 
research involving the records 
__ Other, specify: 

Page 26 of 27 
Study Protocol and Statistical Analysis Plan (SAP).docx 
Additional Requirements for VA Research 
_X_ Check here if this is not VA research; skip to next section. 
69. Check the employment category that applies to the 
Principal Investigator: 
__ VA employee, specify VA percentage of time in 
8ths: _____ 
__ VA WOC (Without Compensation) 
__ VA-contracted personnel 
__ Other, specify:  
70. How is this research relevant to Veterans? 
 
71. If the research involves non-Veteran participants, 
describe VA’s coverage of costs resulting from 
research-related injury: 
__ N/A, all participants will be Veterans 
Description: 
72. Will a non-VA entity (other than as disclosed above) 
have access to VA-Sensitive Information/Data (as 
defined in VA Handbook 6500, Appendix A)? 
__ No 
__ Yes, name the entities and check the type of 
agreement that will be in place, and Add a copy 
of the agreement: 
__ Data Use Agreement 
__ Cooperative Research and Development 
Agreement (CRADA) 
__ Other, specify: 
Informed Consent Documents/Materials 
__ Check here if you request IRB approval to waive the requirement for informed consent and skip section. 
73. What materials will be used to inform participants 
about the research?xx 
__ N/A, not obtaining consent 
__ Sponsor consent template, revised using Consent 
Checklist 
_X_ Consent form or information sheet based on a 
Consent Form Template from IRBNet 
_X_ Simplified info script, sheet, email, letter based 
on a Consent Information Script/Sheet Template 
from IRBNet (for prescreening only)  
__ Other, specify: 
74. Will participants in greater than minimal risk research 
be provided with the DHHS required basic and 
additional elements of informed consent (as specified 
at 45CFR46.116)?  
__ N/A, minimal risk research 
__ N/A, under IRB-Flex for greater than minimal risk 
research, elements that do not apply to the 
research are excluded 
_X_ Yesxxi 
__ Other: 
75. Will participants in minimal risk research that is 
conducted/supported by a federal agency, or that 
involves incomplete disclosure/deception or 
prisoners be provided with the DHHS required basic 
and additional elements of informed consent (as 
specified at 45CFR46.116)? 
_X_ N/A, greater than minimal risk research 
(addressed above) 
__ N/A, minimal risk research that does NOT involve 
federal funding, incomplete disclosure or 
deception, or prisoners 
__ N/A, PI requesting IRB approval for alteration of 
DHHS requirements for informed consentxxii 
__ Yes, using a Consent Form Template from IRBNet 
to create the consent document 

Page 27 of 27 
Study Protocol and Statistical Analysis Plan (SAP).docx 
Obtain the electronic signature of Principal Investigator to confirm the following PI assurances: 
University/Affiliate Principal Investigator Assurance 
My electronic signature certifies that I have read/prepared the project documents and agree to comply with the 
PI responsibilities in the IRB Policy Manual and applicable Affiliate policies. 
Obtain the electronic signature of a Responsible Official (RO) or Affiliate Representative. 
University/Affiliate Responsible Official Assurance 
My electronic signature certifies that I have read the project documents, and agree to comply with the RO 
responsibilities in the IRB Policy Manual and applicable Affiliate policies. 
 
 
i 
Add copies of collaborating IRB decisions, as Other 
ii 
Add copies of all recruitment materials, as Advertisements. 
iii NOTE: Data must be retained for VA research. 
iv Disclose in consent materials, gift value and odds of winning. 
v 
Disclose in consent materials, requirement for participant to provide PPII to receive payment. 
vi Add form Consent Waivers. 
vii Add form Population: Children to describe child assent and parental permission 
viii Add form Population: Persons with Cognitive Impairment 
ix Add form Consent Waivers. 
x 
Disclose costs to participants or 3rd-party payer in consent materials. 
xi For example: Retinal scans, skin galvanometers,  
xii NOTE: All research components that are experimental must be identified as such in consent materials. 
xiii  Include information that will be obtained from existing records, from activities/procedures performed solely 
for the research, or from activities/procedures performed as part of standard treatment/educational practice. 
xiv Include descriptions for obtaining data from existing records, prospectively from study procedures, or 
prospectively from procedures performed for standard treatment/educational practices. 
xv Add non-standard instruments as Questionnaire/Survey or Data Collection, as applicable. 
xvi For multi-site research specify if site-specific data will be analyzed separately. If data will be pooled, indicate if 
participant identifiers will be maintained and describe how findings will be shared among cooperating PIs. 
xvii ONLY for video or photographs, Add video/photo release form. (Release form not required for VA research.) 
xviii See University IT Data Management on the web for information about electronic data management/storage 
solutions. Additional requirements apply to storage of identifiable information outside of the University. 
Investigators planning to store Identifiable data on a cloud-based solution or off-campus, must contact the 
University Chief Information Security Officer in the University IT office for requirements. 
xix Add copies of the site’s privacy/data security policies. 
xx Add all consent materials. 
xxi Use either the Consent Checklist to revise sponsor consent templates or a Consent Form Template from IRBNet 
to create a consent document. 
xxii Add form Consent Waivers.