Efficacy of Using Real-Life Footage in Virtual Reality Exposure Therapy for Social Anxiety Disorder
Phase: NA
Conditions: Social Anxiety Disorder
Sponsor: Penn State University

Page 1 of 40 (V.04/27/2017)  
 
ClinicalTrials.gov: NCT04850989 
 
Unique Protocol ID: STUDY00010344 
 
Efficacy of Virtual Reality Exposure Therapy Scripts for Social 
Phobia 
 
Date: August 07, 2020 
 
 
 
 

Page 2 of 40 (V.04/27/2017)  
CONSENT FOR RESEARCH 
The Pennsylvania State University 
 
 
Title of Project:  Efficacy of Using Real-Life Footage in Virtual Reality Exposure Therapy for Social Anxiety Disorder 
 
 
Principal Investigator:  
 
Michelle G. Newman, PhD 
 
Address:  
371 Moore Building 
 
 
Pennsylvania State University 
 
 
State College, 16802-3103 
 
Telephone Number:  
(814) 863-1148 
 
Subject’s Printed Name: _____________________________ 
 
We are asking you to be in a research study.  This form gives you information about the research. 
Whether or not you take part is up to you. You can choose not to take part. You can agree to take part and later 
change your mind. Your decision will not be held against you. 
Please ask questions about anything that is unclear to you and take your time to make your choice. 
 
1.   Why is this research study being done?    
 
You are part of this study because you expressed interest in getting help for your social anxiety. This research is 
conducted to test if virtual reality technology is effective to help people face their social fears and promote the use of 
adaptive social skills in various settings. You will be immersed in a range of virtual reality environments and work with a 
research therapist to learn certain skills, such as managing fears of negative evaluation during job interviews, and 
interacting with peers in common social settings (e.g., classrooms, cafeterias).  
 
Approximately 300 people will take part in this research study at the Pennsylvania State University, University Park 
campus.  
 
2.   What will happen in this research study? 
 
You will attend a series of sessions for the purposes of conducting the initial assessment, treatment planning, assessing and 
adjusting treatment, as well as termination of treatment. Note that all treatment conducted in this study by the research 
therapist will be supervised by a licensed mental health provider and advanced clinical psychology graduate student. As 
such, each therapy session will be videotaped for quality treatment assurance and research purposes.  
 
Here is an overview of the activities you will undergo in this research study: 
 
• 
Step 1: Initial Assessment (approximately 140 minutes) 
o Complete a battery of self-report questionnaires. 
o A video-recorded clinical interview by research personnel to examine your study eligibility. 
o Assessment of your interest in the type of intervention you are willing to engage in. 
o If you are eligible for the study, you will be randomly assigned to either the immediate treatment or waitlist 
control condition. 

Page 3 of 40 (V.04/27/2017)  
 
After the baseline assessment visit, if you are eligible to continue in the research, you will go through the following 
procedures: 
 
• 
Step 2: Treatment Planning and Process 
o If you are allocated to the experimental condition, you will begin the virtual reality treatment soon after 
with a research therapist and do the following: 
§ 
An initial planning session to discuss your goals. 
§ 
Attend the 50-minute virtual reality treatment weekly for 8-10 sessions.  
§ 
Duration: approximately 50 x 10 = 500 minutes. 
o Research therapist will tailor your presenting problems to the treatment plan and process. 
o If you are assigned to the waitlist control condition, you will begin the virtual reality treatment in about 8 
weeks. 
 
• 
Step 3: Assessing and Adjusting Treatment 
o Complete the System Usability Scale questionnaire on the 1st, 4th, and last session. 
o Give feedback on the degree to which you find this treatment to be helpful. 
o Identify if there is a need to discontinue due to side effects (e.g., severe cybersickness).  
o Work with the research therapist to personalize the process to meet your needs. 
 
• 
Step 4: Between-Session Symptom Adjustment (approximately 15 minutes)  
o Complete between-session symptom assessments at regular intervals to monitor progress. 
o All participants assigned to either conditions will be completing this step. 
o There will also be between-session homework to practice the skills you are learning in treatment so that 
you benefit from using these skills in your daily experience. 
 
• 
Step 5: Termination  
o Work with the research therapist to determine treatment goals and monitor progress.  
 
• 
Step 6: Final Assessments at the 3-month and 6-month time points after treatment termination 
o Complete self-report measures either at the clinic or by phone based on preference. 
 
If any symptoms, feelings or thoughts arise that you would like to address with another mental health professional, feel free 
to call the Penn State Psychological Clinic at (814) 865-2191, Penn State Counseling and Psychological Services (CAPS) at 
(814) 863-0395, or the crisis intervention hotline, Center County Can Help at (800) 643-5432 to set up an appointment. 
 
3.   What are the risks and possible discomforts from being in this research study?   
 
This study is of minimal risk to those participating, yet participants may experience discomfort. You may feel distress 
with respect to the sensitivity of some of the questions being asked, but we wish to reiterate that you may decline to 
respond or discontinue at any time. There is a risk of loss of confidentiality if your information or your identity is 
obtained by someone other than the investigators, but precautions will be taken to prevent this from happening. The 
confidentiality of your electronic data created by you or by the researchers will be maintained to the degree permitted 
by the technology used. Absolute confidentiality cannot be guaranteed. Due to the nature of virtual reality, there is 

Page 4 of 40 (V.04/27/2017)  
potential for users to develop dizziness and physical symptoms associated with being immersed in a virtual 
environment. The risks involved in the assessment and therapy procedures are no more than those involved in other 
therapy settings. 
 
4.   What are the possible benefits from being in this research study?    
 
4a. What are the possible benefits to you? 
 
Possible benefits include learning to better understand your mental health concerns, equipping yourself with coping skills, 
reducing isolation from others, and reaching other individual goals set in conjunction with your study therapist. You may also 
experience some occupational success as you learn to better manage your job interview phobia and general social fears. To 
this end, this treatment aims to help you to effectively use the skills learned to succeed in interviews and other common 
social settings encountered in daily life.  
 
4b. What are the possible benefits to others? 
 
The field of psychology lags behind other disciplines with regard to incorporating technology into practice. This study will 
help to move the field forward by examining how technology can be incorporated to existing treatments. It is the plan of the 
researchers to use the results of this study to help establish best practices for including technology into therapy and to 
identify more specific research questions for future study. 
 
5.   What other options are available instead of being in this research study? 
 
You may decide not to participate in this research. 
 
6.   How long will you take part in this research study? 
 
If you agree to take part, the whole study takes about 6 months, including follow-up assessments (approximately a total 
of 600 minutes or 10 hours). You will be asked to return to the research site about 12 times.  
 
7.   How will your privacy and confidentiality be protected if you decide to take part in this research study? 
 
Efforts will be made to limit the use and sharing of your personal research information to people who have a need to 
review this information. A list that matches your name with your code number and other identifying information, including 
the videotaped initial clinical interview and weekly therapy sessions, will be kept in secure and encrypted files and servers at 
the Pennsylvania State University, University Park Campus. Only the study team members have access to these files. In the 
event of any publication or presentation resulting from the research, no personally identifiable information will be 
shared.  
 
We will do our best to keep your participation in this research study confidential to the extent permitted by law. However, it 
is possible that other people may find out about your participation in this research study. For example, the following 
people/groups may check and copy records about this research:  
• 
The Office for Human Research Protections in the U. S. Department of Health and Human Services;  
• 
The Institutional Review Board (a committee that reviews and approves research studies);  
• 
The Office for Research Protections;  
• 
Food and Drug Administration (FDA); 

Page 5 of 40 (V.04/27/2017)  
• 
Family Educational Rights and Privacy Act (FERPA); 
• 
Health Insurance Portability and Accountability Act (HIPAA). 
 
Some of these records could contain information that personally identifies you. Reasonable efforts will be made to keep the 
personal information in your research record private. However, absolute confidentiality cannot be guaranteed. 
            
8.   What are the costs of taking part in this research study? 
 
8a. What will you have to pay for if you take part in this research study?  
 
There are no economic costs for subjects in this study. Subject “costs” merely includes their time investment. 
 
8b. What happens if you are injured as a result of taking part in this research study? 
 
There are no foreseeable risks of physical injury in this treatment study. Despite the discomfort this may cause, this risk 
remains minimal as the procedures involved in the study are similar to those that individuals would encounter when 
engaging in any other mental health treatment. 
 
9. Will you be paid or receive credit to take part in this research study? 
 
If you are eligible for the treatment, you will be compensated up to $40 based on the degree to which you complete the 
research in the following way: You will be compensated $10 in cash after completing the initial assessment; $15 in cash 
for completing the post-study assessment which follows the 8-10 sessions of therapy; and $15 in cash for completing the 
three-month follow-up assessment.  
 
10. Who is paying for this research study? 
 
This study is funded by an Industry Sponsor, LIMBIX, Inc. (Grant Title: The use of Virtual Social Interactions to Treat Anxiety 
Disorders). 
 
11.  What are your rights if you take part in this research study? 
 
Taking part in this research study is voluntary.  
• 
You do not have to be in this research.  
• 
If you choose to be in this research, you have the right to stop at any time.  
• 
If you decide not to be in this research or if you decide to stop at a later date, there will be no penalty or loss of 
benefits to which you are entitled.  
 
You may be asked to stop participating in this study if you present with the following events:    
 
• 
If you no-show to 4 sessions in a row or 6+ sessions in a 2-month period. 
• 
If your symptoms increase to the point that more intensive care than can be provided through this study is 
required. This includes needing multiple sessions a week or an increase in suicidal ideation or self-harm behavior 
that necessitates hospitalization. 
 
In the unlikely scenario that this happens, we ask that you contact the Centre County Community Care Behavioral Health 
Organization at 1 (866) 878-6046 to uncover other appropriate behavioral health treatment services you can access. 
 
12. If you have questions or concerns about this research study, whom should you call?     
 
Please call the head of the research study (principal investigator), Dr. Michelle Newman at (814) 863-1148 or Hani Zainal at 
(814) 863-0115 if you:  

Page 6 of 40 (V.04/27/2017)  
• 
Have questions, complaints or concerns about the research. 
• 
Believe you may have been harmed by being in the research study.   
 
You may also contact the Office for Research Protections at (814) 865-1775, ORProtections@psu.edu if you:  
• 
Have questions regarding your rights as a person in a research study. 
• 
Have concerns or general questions about the research. 
• 
You may also call this number if you cannot reach the research team or wish to offer input or to talk to someone 
else about any concerns related to the research.  
 
 
 

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INFORMED CONSENT TO TAKE PART IN RESEARCH  
 
SIGNATURE OF PERSON OBTAINING INFORMED CONSENT 
 
Your signature below means that you have explained the research to the subject or subject representative and have 
answered any questions he/she has about the research. 
 
 
______________________________ 
 
_________ 
 
____________________ 
Signature of person who explained this research Date 
 
 
Printed Name 
 
(Only approved investigators for this research may explain the research and obtain informed consent.)   
 
Signature of Person Giving Informed Consent  
 
Before making the decision about being in this research you should have: 
• 
Discussed this research study with an investigator,  
• 
Read the information in this form, and 
• 
Had the opportunity to ask any questions you may have.  
 
Your signature below means that you have received this information, have asked the questions you currently have about the 
research and those questions have been answered. You will receive a copy of the signed and dated form to keep for future 
reference. 
 
SIGNATURE OF SUBJECT 
 
By signing this consent form, you indicate that you voluntarily choose to be in this research and agree to allow your 
information to be used and shared as described above.  
 
 
___________________________ 
 
__________ 
 
____________________  
Signature of Subject  
 
 
 
Date 
 
 
Printed Name 

Page 8 of 40 (V.04/27/2017)  
                                                                                        
 
HRP-591 - Protocol for  
Human Subject Research 
 
Protocol Title: 
Provide the full title of the study as listed in item 1 on the “Basic Information” page in CATS IRB (http://irb.psu.edu).  
 
Efficacy of Using Real-Life Footage in Virtual Reality Exposure Therapy for Social Anxiety Disorder 
 
Principal Investigator: 
 
Name:  Michelle G. Newman, PhD 
Department: Psychology 
Telephone: (814) 863-1148 
E-mail Address: mgn1@psu.edu  
Version Date: 
Provide the date of this submission. This date must be updated each time the submission is provided to the IRB office 
with revisions.   
Version 5 (Saturday, December 8, 2018) 
 
Clinicaltrials.gov Registration #: 
Provide the registration number for this study, if applicable. 
Not Applicable  
 
Important Instructions for Using This Protocol Template: 
1. 
Add this completed protocol template to your study in CATS IRB (http://irb.psu.edu) on the “Basic Information” 
page, item 7.  
2. 
This template is provided to help investigators prepare a protocol that includes the necessary information needed 
by the IRB to determine whether a study meets all applicable criteria for approval.  
3. 
Type your protocol responses below the gray instructional boxes of guidance language.  If the section or item is 
not applicable, indicate not applicable. 
4. 
For research being conducted at Penn State Hershey or by Penn State Hershey researchers only, delete the 
instructional boxes from the final version of the protocol prior to upload to CATS IRB (http://irb.psu.edu).  For all 
other research, do not delete the instructional boxes from the final version of the protocol. 
5. 
When making revisions to this protocol as requested by the IRB, please follow the instructions outlined in the Study 
Submission Guide available in the Help Center in CATS IRB (http://irb.psu.edu) for using track changes.  
 
If you need help… 
University Park and other campuses: 
Office for Research Protections Human Research Protection Program 
The 330 Building, Suite 205 
University Park, PA 16802-7014 
Phone: 814-865-1775 
Fax: 814-863-8699 
Email: irb-orp@psu.edu 
College of Medicine and Hershey Medical Center: 
Human Participants Protection Office 
90 Hope Drive, Mail Code A115, P.O. Box 855 
Hershey, PA 17033 
(Physical Office Location: Academic Support Building Room 1140) 
Phone: 717-531-5687 
Fax number: 717-531-3937 
Email: irb-hspo@psu.edu 

Page 9 of 40 (V.04/27/2017)  
 
Table of Contents 
1.0 
Objectives 
2.0 
Background 
3.0 
Inclusion and Exclusion Criteria 
4.0 
Recruitment Methods 
5.0 
Consent Process and Documentation 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
7.0 
Study Design and Procedures 
8.0 
Subject Numbers and Statistical Plan 
9.0 
Confidentiality, Privacy and Data Management 
10.0 
Data and Safety Monitoring Plan 
11.0 
Risks 
12.0 
Potential Benefits to Participants and Others 
13.0 
Sharing Results with Participants 
14.0 
Subject Stipend (Compensation) and/or Travel Reimbursements 
15.0 
Economic Burden to Participants 
16.0 
Resources Available 
17.0 
Other Approvals 
18.0 
Multi-Site Research 
19.0 
Adverse Event Reporting 
20.0 
Study Monitoring, Auditing and Inspecting 
21.0 
Future Undetermined Research: Data and Specimen Banking 
22.0 
References 
23.0     Appendix 
 
 
 

Page 10 of 40 (V.04/27/2017)  
1.0 
Objectives 
 
22.1 
Study Objectives 
Describe the purpose, specific aims or objectives.  State the hypotheses to be tested. 
 
The purpose of this study is to test the efficacy virtual reality videos to facilitate exposure therapy in 
social anxiety disorder (SAD). The exposure therapy videos are the focus of this experiment. Essentially, 
we are testing the efficacy of the Virtual Reality Exposure Therapy (VRET) scripts (i.e., virtual scenarios, 
people, and interactions that we expose socially anxious people to). To this end, the goal of the current 
study is to help people with social anxiety overcome their phobias. Individuals who experience a difficult 
time building social relationships, accomplishing everyday tasks, or pursuing interviews can practice 
those same behaviors in a controlled environment.  
 
The study hypotheses are as follows: 
1. Virtual reality exposure therapy intervention (vs. waitlist control condition) is effective for treating 
SAD symptoms. 
2. Participants who received the virtual reality exposure therapy will experience maintenance of 
treatment gains following 3-month and 6-month post-termination of treatment. 
3. Users of the virtual reality exposure therapy will demonstrate high amounts of acceptability of the 
treatment.  
 
22.2 
Primary Study Endpoints 
State the primary endpoints to be measured in the study.  Clinical trials typically have a primary 
objective or endpoint. Additional objectives and endpoints are secondary.  The endpoints (or outcomes), 
determined for each study subject, are the quantitative measurements required by the objectives.  
Measuring the selected endpoints is the goal of a trial (examples: response rate and survival). 
 
To answer these questions, the proposed study will use both qualitative and quantitative methods. 
Qualitative methods will include a semi-structured interview at the end of the study to gather 
information on the participant’s experience, as well as data collected throughout the therapy process. 
Quantitatively, the study proposes to use basic descriptive statistics to examine treatment outcomes 
and engagement with digital tools.  
 
 
 
This exploratory study will answer the following questions: 
1) Compared to the waitlist control condition, is the virtual reality exposure intervention more effective 
for treating symptoms of social anxiety disorder? 
2) Are there higher treatment gains maintained over time among participants who receive the virtual 
reality exposure therapy compared to the waitlist control condition? 
 
22.3 
Secondary Study Endpoints 
State the secondary endpoints to be measured in the study. 
 
3) To what degree does presence in the virtual reality environment impact the efficacy of the VRET 
scripts?  
4) How do users rate the acceptability of treatment delivered through virtual reality? 
2.0 
Background  
 
2.1 
Scientific Background and Gaps 
Describe the scientific background and gaps in current knowledge. 

Page 11 of 40 (V.04/27/2017)  
 
Social Anxiety Disorder (SAD) has a lifetime prevalence of 12.1% in the U.S. population of adults (Kessler 
& Wang, 2008). According to the Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5; 
American Psychiatric Association, 2013), SAD is characterized by an intense fear of social and 
performance situations or the fear of acting in an embarrassing way due to apprehension about 
negative evaluation by others. This can lead to marked avoidance of routine situations such as going to 
the grocery store, making appointments, or socializing with others resulting in significant impairment. 
SAD may also affect individual’s ability to succeed professionally. For individuals with job interview 
anxiety, it is well documented that high levels of anxiety may result in a low job interview score that 
negatively impacts an applicant’s chances of getting hired (McCarthy & Goffin, 2004). Cook, Vance and 
Spector (2000) provided evidence that it is more likely for individuals with a high level of job interview 
anxiety to receive significantly lower performance ratings and less likely to be offered a second-round 
interview and subsequent job offer. As a result, individuals with job interview anxiety may experience 
significant vocational impairment even when they may display superior on-the-job performance. To 
meet the needs of this population, the gold standard for treatment is exposure therapy. 
 
2.2 
Previous Data 
Describe any relevant preliminary data. 
 
Exposure therapy is an evidence-based treatment for social anxiety that has been shown to effectively 
target the fears of negative evaluation that is characteristic of SAD (Emmelkamp, 2005). Despite rates of 
success, there are logistical barriers of exposure therapy that limit treatment acceptability and 
accessibility (Olatunji, Deacon, & Abramowitz, 2009). Therefore, there is opportunity for growth and 
innovation for exposure therapy to expand the reach of treatment. 
 
Virtual reality has been shown to meet these increased demands. Through this technology, 
experimenters can control every variable presented in a given virtual social scenario, which is not 
feasible in the real world. Further, it is less cost prohibitive, as the user can virtually experience a large 
array of social situations, regardless of distance or financial means. Virtual reality exposure therapy 
(VRET) has been shown to be as effective, and in some cases marginally more effective, than real-life 
exposure therapy for anxiety disorders (Powers & Emmelkamp, 2008). Preliminary results from VRET 
studies have also been promising for treating social anxiety, with participants maintaining treatment 
gains at a one-year follow-up (Anderson et al., 2013). 
 
2.3 
Study Rationale 
Provide the scientific rationale for the research. 
 
There is a dearth of studies testing the efficacy of virtual reality exposure therapy scripts based on its 
level of realness. Our study attempts to fill this gap by making the interactions and scenes inside the 
virtual reality exposure therapy scripts as realistic to everyday encounters.  
 
The goal of the current study is to leverage the capabilities of this virtual reality technology to create a 
more immersive experience in social exposures. Individuals who experience a difficult time building 
social relationships, accomplishing everyday tasks, or pursuing interviews can practice those same 
behaviors in a controlled environment. The current study allows for a high degree of researchers’ 
control to effectively and repeatedly create “social mishap” exposures, which is generally not feasible in 
the real world. We are hopeful that this study will not only increase the accessibility and utility of social 
phobia treatment, but also contribute to the expanding evidence-base for digital mental health 
interventions. 
 
This study will focus on the effectiveness of the exposure therapy scripts to help people with social 
phobia. Individuals will be excluded if their symptoms would be best treated in a different setting, if we 

Page 12 of 40 (V.04/27/2017)  
are not equipped to offer needed treatment, or if the person is not able or interested to participate in 
treatment. 
3.0 
Inclusion and Exclusion Criteria 
Create a numbered list below in sections 3.1 and 3.2 of criteria participants must meet to be eligible for study 
enrollment (e.g., age, gender, diagnosis, etc.). Indicate specifically whether you will include any of the 
following vulnerable populations: (You may not include members of these populations as participants in your 
research unless you indicate this in your inclusion criteria.) Review the corresponding checklists to ensure that 
you have provided the necessary information. 
• 
Adults unable to consent 
o Review “CHECKLIST: Cognitively Impaired Adults (HRP-417)” to ensure that you have 
provided sufficient information. HRP-417 can be accessed by clicking the Library link in 
CATS IRB (http://irb.psu.edu). 
• 
Individuals who are not yet adults (infants, children, teenagers) 
o If the research involves persons who have not attained the legal age for consent to 
treatments or procedures involved in the research (“children”), review the “CHECKLIST: 
Children (HRP-416)” to ensure that you have provided sufficient information. HRP-416 
can be accessed by clicking the Library link in CATS IRB (http://irb.psu.edu). 
• 
Pregnant women 
o Review “CHECKLIST: Pregnant Women (HRP-412)” to ensure that you have provided 
sufficient information. HRP-412 can be accessed by clicking the Library link in CATS IRB 
(http://irb.psu.edu). 
• 
Prisoners 
o Review “CHECKLIST: Prisoners (HRP-415)” to ensure that you have provided sufficient 
information.  HRP-415 can be accessed by clicking the Library link in CATS IRB 
(http://irb.psu.edu). 
• 
Neonates of uncertain viability or non-viable neonates 
o Review “CHECKLIST: Neonates (HRP-413)” or “CHECKLIST: Neonates of Uncertain Viability 
(HRP-414)” to ensure that you have provide sufficient information.  HRP-413 and HRP-414 
can be accessed by clicking the Library link in CATS IRB (http://irb.psu.edu). 
 
3.1 
Inclusion Criteria 
List the criteria that define who will be included in your study. 
 
1) 
Be at least 18 years old. 
2)  
Meet criteria on the 15- to 25-minute MINI Neuropsychiatric Interview (Sheehan et al., 1997) for 
a social anxiety disorder. 
3)  
Not psychotic via the MINI. 
4)  
Not actively suicidal via the MINI (i.e. Participants who endorse suicidal intent and/or plan to 
commit suicide). 
5)  
Not actively homicidal via a single question (i.e., “Have you had the urge to hurt someone else 
within the past two weeks?”) 
6)  
Not needing immediate medical attention for ongoing alcohol or substance use via the MINI. 
7) 
Dual diagnoses apart from psychosis, alcohol or drug use disorders, are allowed. 
8)  
Not judged to have severe mental illness better treated through broader mental health services 
that can be offered through our clinic (for example, individuals who require more than once-
weekly sessions, individuals who require medical monitoring). 
9)  
Able to read, write, and understand English. 
 
3.2 
Exclusion Criteria 
List the criteria that define who will be excluded in your study. 

Page 13 of 40 (V.04/27/2017)  
 
1)  
Not interested in engaging in mental health treatment, or seeking mental health treatment for 
concerns unrelated to symptoms of social anxiety via two questions (i.e., “Are you currently 
interested in seeking mental health treatment to manage social anxiety symptoms better?” and 
“Are you currently interested in seeking mental health treatment to manage symptoms other 
than social anxiety?” 
2)  
Individuals not meeting criteria on the MINI Neuropsychiatric Interview (Sheehan et al., 1997) 
for a social anxiety disorder. 
3)  
Those who do not meet the inclusion criteria.  
 
3.3 
Early Withdrawal of Participants 
 
3.3.1 Criteria for removal from study 
Insert subject withdrawal criteria (e.g., safety reasons, failure of subject to adhere to protocol 
requirements, subject consent withdrawal, disease progression, etc.). 
 
1. If a participant no-shows to 4 sessions in a row or 6+ sessions in a 2-month period. 
2. If a participant’s symptoms increase to the point that more intensive care than can be 
provided through this study is required.  
 
3.3.2 
Follow-up for withdrawn participants 
Describe when and how to withdraw participants from the study; the type and timing of the 
data to be collected for withdrawal of participants; whether and how participants are to be 
replaced; the follow-up for participants withdrawn from investigational treatment. 
Participants are free to withdraw from the study at any point in time. Data will be collected up 
to the point the participant expresses his/her wish to withdraw. If a subject withdraws from the 
study, we will not ask participants to continue with study procedures (post and follow-up 
assessments). Further, as per FDA regulations, we will not remove study data collected up to 
the point of withdrawal. 
4.0 
Recruitment Methods 
 
4.1 
Identification of participants 
Describe the methods that will be used to identify potential participants or the source of the 
participants.  If not recruiting participants directly (e.g., database query for eligible records or samples) 
state what will be queried, how and by whom. 
StudyFinder:  If you intend to use StudyFinder (http://studyfinder.psu.edu) for recruitment purposes, 
please indicate this in section 4.1 along with any other methods for identifying participants. Note that 
information provided in this protocol should be consistent with information provided on the 
StudyFinder page in your CATS IRB study. 
 
For Penn State Hershey submissions using Enterprise Information Management (EIM) for recruitment, 
attach your EIM Design Specification form on the Basic Information page in CATS IRB 
(http://irb.psu.edu). See HRP-103 Investigator Manual, “What is appropriate for study recruitment?” for 
additional information. 
 
For participants we are planning to recruit from the PSU subject pool, we will identify potential 
participants by using the Social Phobia Diagnostic Questionnaire (“LIMBIX – Screening – SPDQ”) and the 
Beck Depression Inventory II (“LIMBIX – Screening – BDI-II”). Subject pool participants who screen 
positive (i.e., they scored >7.38 (85% specificity, sensitivity 82% (Bianca Lauria-Horner, 2016)) on the 

Page 14 of 40 (V.04/27/2017)  
SPDQ) and score above 20 on the BDI-II will be invited to an initial appointment to complete the 
baseline assessments and clinical interview.  
 
For participants we are planning to recruit from the Penn State Psychological Clinic, we aim to reach out 
to potential clients with social anxiety disorder through these means: (1) Advertising our study at the 
adult clinic waiting room (see flyer attached at the Appendix); (2) Clients will contact us if they are 
interested in participating; (3) Therapists will raise awareness to potential clients about our study by 
giving them the flyer and letting the client contact us if they are interested in participating. Once a client 
has expressed interest, we will schedule the initial visit comprising baseline assessments to determine 
their study eligibility. 
 
We also intend to recruit from StudyFinder and will ensure that the information written in this protocol 
is consistent with that provided on the StudyFinder page of our CATS IRB.  
 
4.2 
Recruitment process 
Describe how, where and when potential participants will be recruited (e.g., approaching or providing 
information to potential participants for participation in this research study). 
 
Participants will be identified through the current Pennsylvania State University Subject Pool, 
StudyFinder, and the Penn State Psychological Clinic.  
 
For participants recruited from the subject pool, contact information will be obtained from the subject 
pool and participants will be contacted through email (refer to “LIMBIX - Subject Pool Email”) and phone 
(refer to “LIMBIX - Screening Consent – Phone.docx”) to be invited to participate in the study.  
 
For participants recruited from the clinic, we will ask therapists to raise awareness of our study with a 
brief script (refer to “LIMBIX - Scripts - Therapists to Clients - V1.docx”) that enables potential 
participants to contact us.  
 
For participants recruited from Study Finder, we will use a distinct email (refer to “LIMBIX - StudyFinder 
Email”).  
 
Once a participant agrees to participate in this study after we do the pre-screening protocol, we will 
schedule for the in-person initial assessment session to determine whether or not the participant meets 
the study eligibility criteria. The participant will receive a hard copy of the informed consent form and 
will be given every opportunity to ask questions about the study along the way. 
 
4.3 
Recruitment materials 
List the materials that will be used to recruit participants. Add recruitment documents to your study in 
CATS IRB (http://irb.psu.edu) on the “Consent Forms and Recruitment Materials” page. For 
advertisements, upload the final copy of printed advertisements. When advertisements are taped for 
broadcast, attach the final audio/video tape. You may submit the wording of the advertisement prior to 
taping to preclude re-taping because of inappropriate wording, provided the IRB reviews the final 
audio/video tape. 
 
StudyFinder:  If you intend to use StudyFinder (http://studyfinder.psu.edu) for recruitment purposes, 
you do not need to upload a separate recruitment document for information placed on the StudyFinder 
site to your study in CATS IRB.  Necessary information will be captured on the StudyFinder page in your 
CATS IRB study. 
 
i. 
Psych Subject Pool: email and phone script;  

Page 15 of 40 (V.04/27/2017)  
Potential subject pool participants will be reached out via email ( “LIMBIX – Subject Pool Email”) 
and phone ( “LIMBIX – Screening Consent - Phone.docx”).  
 
ii. 
Psych Clinic: flyer, verbal script for therapist, phone script, email (this would be needed to send 
a copy of the consent form); 
The therapist will approach the potential participant with a pre-defined script (“LIMBIX - Scripts - 
Therapists to Clients - V1.docx”). 
The therapist will then give the advertisement (“LIMBIX - Clinic Study Ad.pdf”) and a copy of the 
consent form detailing the procedures of the study (“LIMBIX - Consent - In-Person Form - 
V2.docx”). 
Additionally, a flyer advertising our study (“LIMBIX - Clinic Study Ad.pdf”) will be placed in the 
waiting room. 
 
We will then live it up to the potential participant to contact us.  
 
iii. 
StudyFinder – StudyFinder email 
Participants who found our study via StudyFinder and expressed interest will contact us on our 
StudyFinder page in our CATS IRB study (refer to “LIMBIX – Study Finder Email”). 
 
 
 
4.4 
Eligibility/screening of participants 
If potential participants will be asked eligibility questions before obtaining informed consent, describe 
the process. Add the script documents and a list of the eligibility questions that will be used to your 
study in CATS IRB (http://irb.psu.edu) on the “Consent Forms and Recruitment Materials” page. 
 
StudyFinder:  If you intend to use StudyFinder (http://studyfinder.psu.edu) for recruitment purposes, 
any scripts (phone, email, or other) used when contacting StudyFinder participants as well as any 
eligibility screening questions must be added to your study in CATS IRB (http://irb.psu.edu) on the 
“Consent Forms and Recruitment Materials” page. 
 
Not applicable.  
5.0 
Consent Process and Documentation  
Refer to “SOP: Informed Consent Process for Research (HRP-090)”, for information about the process of 
obtaining informed consent from participants.  HRP-090 can be accessed by clicking the Library link in CATS IRB 
(http://irb.psu.edu). 
 
5.1 
Consent Process  
  
5.1.1 Obtaining Informed Consent 
 
5.1.1.1 Timing and Location of Consent 
Describe where and when the consent process will take place. 
 
 
 
 
 
 
Participants will first be contacted by phone (see “LIMBIX – Screening Consent - 
Phone.docx”). 
 
This initial assessment will take place within the research offices located at 378, 
380, 348A, and 381 Moore as well as the therapy rooms at the Penn State 
Psychological Clinic (PSU University Park Campus). At the start of the initial in-
person assessment session, the research therapist will present the written 

Page 16 of 40 (V.04/27/2017)  
consent form to the participant to ensure their understanding of the risks and 
benefits of the study. 
 
5.1.1.2 Coercion or Undue Influence during Consent 
Describe the steps that will be taken to minimize the possibility of coercion or 
undue influence in the consent process. 
 
All study personnel will let clients know they are free to decline to participate 
and/or drop out of the study at any time. They will hand the consent form to 
the client and remain present while the client is reading it and let them ask any 
questions they may have after reading the form. Participants will personally 
read (and keep) a copy of the informed consent. 
 
5.1.2 Waiver or alteration of the informed consent requirement 
If you are requesting a waiver or alteration of consent (consent will not be obtained, required 
information will not be disclosed, or the research involves deception), describe the rationale 
for the request in this section.  If the alteration is because of deception or incomplete 
disclosure, explain whether and how participants will be debriefed. Add any debriefing 
materials or document(s) to your study in CATS IRB (http://irb.psu.edu) on the “Supporting 
Documents” page.  NOTE: Review the “CHECKLIST: Waiver or Alteration of Consent Process 
(HRP-410)” to ensure you have provided sufficient information for the IRB to make these 
determinations. HRP-410 can be accessed by clicking the Library link in CATS IRB 
(http://irb.psu.edu).  
 
Not applicable. 
 
5.2 
Consent Documentation 
 
5.2.1 
Written Documentation of Consent 
Refer to “SOP: Written Documentation of Consent (HRP-091)” for information about the process 
to document the informed consent process in writing.  HRP-091 can be accessed by clicking the 
Library link in CATS IRB (http://irb.psu.edu). 
 
If you will document consent in writing, describe how consent of the subject will be documented 
in writing. Add the consent document(s) to your study in CATS IRB (http://irb.psu.edu) on the 
“Consent Forms and Recruitment Materials” page. Links to Penn State’s consent templates are 
available in the same location where they are uploaded and their use is required. 
 
Participants, from the current PSU Subject Pool, Penn State Psychological Clinic, and StudyFinder 
will sign a copy of the written consent from which will be obtained by the research team and 
kept in a locked room in the PSU Moore Building, as well as receive a copy of the form to keep 
themselves. See “Consent Forms and Recruitment Materials” Section for documentation.  
 
5.2.2 
Waiver of Documentation of Consent (Implied consent, Verbal consent, etc.) 
If you will obtain consent (verbal or implied), but not document consent in writing, describe how 
consent will be obtained. Add the consent script(s) and/or information sheet(s) to your study in 
CATS IRB (http://irb.psu.edu) on the “Consent Forms and Recruitment Materials” page. Links to 
Penn State’s consent templates are available in the same location where they are uploaded and 
their use is required. Review “CHECKLIST: Waiver of Written Documentation of Consent (HRP-
411)” to ensure that you have provided sufficient information. HRP-411 can be accessed by 
clicking the Library link in CATS IRB (http://irb.psu.edu). 

Page 17 of 40 (V.04/27/2017)  
 
If your research presents no more than minimal risk of harm to participants and involves no 
procedures for which written documentation of consent is normally required outside of the 
research context, the IRB will generally waive the requirement to obtain written documentation 
of consent. 
 
The research presents no more than minimal risk of harm to subjects and involves no procedures 
for which written documentation of consent is normally required outside of the research context. 
 
5.3 
Consent – Other Considerations  
 
5.3.1 
Non-English Speaking Participants 
Indicate what language(s) other than English are understood by prospective participants or 
representatives. 
 
If participants who do not speak English will be enrolled, describe the process to ensure that the 
oral and written information provided to those participants will be in that language. Indicate the 
language that will be used by those obtaining consent. 
 
Indicate whether the consent process will be documented in writing with the long form of the 
consent documentation or with the short form of the consent documentation.  Review the 
“SOP: Written Documentation of Consent (HRP-091)” and the “Investigator Manual (HRP-103)” 
to ensure that you have provided sufficient information. HRP-091 and HRP-103 can be accessed 
by clicking the Library link in CATS IRB (http://irb.psu.edu). 
 
Not applicable. 
 
5.3.2 
Cognitively Impaired Adults 
Refer to “CHECKLIST: Cognitively Impaired Adults (HRP-417)” for information about research 
involving cognitively impaired adults as participants. HRP-417 can be accessed by clicking the 
Library link in CATS IRB (http://irb.psu.edu). 
 
5.3.2.1 Capability of Providing Consent 
Describe the process to determine whether an individual is capable of consent. 
 
Not applicable. 
 
5.3.2.2 Adults Unable To Consent 
Describe whether and how informed consent will be obtained from the legally 
authorized representative.  Describe who will be allowed to provide informed 
consent. Describe the process used to determine these individual’s authority to 
consent to research. 
 
For research conducted in the state, review “SOP: Legally Authorized 
Representatives, Children and Guardians (HRP-013)” to be aware of which 
individuals in the state meet the definition of “legally authorized 
representative”. HRP-013 can be accessed by clicking the Library link in CATS IRB 
(http://irb.psu.edu). 
 
For research conducted outside of the state, provide information that describes 
which individuals are authorized under applicable law to consent on behalf of a 

Page 18 of 40 (V.04/27/2017)  
prospective participant to their participation in the procedure(s) involved in this 
research.  One method of obtaining this information is to have a legal counsel or 
authority review your protocol along with the definition of “children” in “SOP: 
Legally Authorized Representatives, Children, and Guardians (HRP-013).” HRP-
013 can be accessed by clicking the Library link in CATS IRB (http://irb.psu.edu). 
 
Not applicable. 
 
5.3.2.3 Assent of Adults Unable to Consent 
Describe the process for assent of the participants.  Indicate whether assent will be 
required of all, some or none of the participants.  If some, indicate which 
participants will be required to assent and which will not.  
 
If assent will not be obtained from some or all participants, provide an explanation 
of why not. 
 
Describe whether assent of the participants will be documented and the process to 
document assent.  The IRB allows the person obtaining assent to document assent 
on the consent document and does not routinely require assent documents and 
does not routinely require participants to sign assent documents. 
 
Not applicable. 
 
5.3.3 
Participants who are not yet adults (infants, children, teenagers)  
 
5.3.3.1 Parental Permission 
Describe whether and how parental permission will be obtained. If permission 
will be obtained from individuals other than parents, describe who will be 
allowed to provide permission.  Describe the process used to determine these 
individual’s authority to consent to each child’s general medical care. 
 
For research conducted in the state, review “SOP: Legally Authorized 
Representatives, Children and Guardians (HRP-013)” to be aware of which 
individuals in the state meet the definition of “children”. HRP-013 can be 
accessed by clicking the Library link in CATS IRB (http://irb.psu.edu). 
 
For research conducted outside of the state, provide information that describes 
which persons have not attained the legal age for consent to treatments or 
procedures involved in the research, under the applicable law of the jurisdiction 
in which research will be conducted.  One method of obtaining this information 
is to have a legal counsel or authority review your protocol along with the 
definition of “children” in “SOP: Legally Authorized Representatives, Children, 
and Guardians (HRP-013).” HRP-013 can be accessed by clicking the Library link 
in CATS IRB (http://irb.psu.edu). 
 
Not applicable. 
 
5.3.3.2 Assent of participants who are not yet adults 
Indicate whether assent will be obtained from all, some, or none of the children. If 
assent will be obtained from some children, indicate which children will be 

Page 19 of 40 (V.04/27/2017)  
required to assent. When assent of children is obtained describe whether and how 
it will be documented. 
 
As all participants are older than 18 years of age, assent will not be required from 
any of the participants. 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
This section is about the access, use or disclosure of Protected Health Information (PHI). PHI is individually 
identifiable health information (i.e., health information containing one or more 18 identifiers) that is transmitted 
or maintained in any form or medium by a Covered Entity or its Business Associate. A Covered Entity is a health 
plan, a health care clearinghouse or health care provider who transmits health information in electronic form.  
See the “Investigator Manual (HRP-103)” for a list of the 18 identifiers.  HRP-103 can be accessed by clicking the 
Library link in CATS IRB (http://irb.psu.edu). 
 
If requesting a waiver/alteration of HIPAA authorization, complete sections 6.2 and 6.3 in addition to section 
6.1. The Privacy Rule permits waivers (or alterations) of authorization if the research meets certain conditions. 
Include only information that will be accessed with the waiver/alteration.  
 
6.1 
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
Check all that apply: 
  
Not applicable, no identifiable protected health information (PHI) is accessed, used or 
disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable] 
 
 
Authorization will be obtained and documented as part of the consent process. [If this is the 
only box checked, mark sections 6.2 and 6.3 as not applicable] 
 
 
Partial waiver is requested for recruitment purposes only (Check this box if patients’ medical 
records will be accessed to determine eligibility before consent/authorization has been 
obtained). [Complete all parts of sections 6.2 and 6.3] 
 
 
Full waiver is requested for entire research study (e.g., medical record review studies). 
[Complete all parts of sections 6.2 and 6.3] 
 
 
Alteration is requested to waive requirement for written documentation of authorization 
(verbal authorization will be obtained). [Complete all parts of sections 6.2 and 6.3] 
 
6.2 
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
6.2.1 
Access, use or disclosure of PHI representing no more than a minimal risk to the privacy of the 
individual 
 
6.2.1.1 Plan to protect PHI from improper use or disclosure 
Include the following statement as written – DO NOT ALTER OR DELETE unless this 
section is not applicable because the research does not involve a waiver of 
authorization. If the section is not applicable, remove the statement and indicate 
as not applicable.  
 
Not applicable. 

Page 20 of 40 (V.04/27/2017)  
6.2.1.2 Plan to destroy identifiers or a justification for retaining identifiers  
Describe the plan to destroy the identifiers at the earliest opportunity consistent 
with the conduct of the research. Include when and how identifiers will be 
destroyed. If identifiers will be retained, provide the legal, health or research 
justification for retaining the identifiers. 
 
Not applicable. 
 
6.2.2 
Explanation for why the research could not practicably be conducted without access to and 
use of PHI 
Provide an explanation for why the research could not practicably be conducted without access 
to and use of PHI. 
 
Not applicable.  
  
 
6.2.3 
Explanation for why the research could not practicably be conducted without the waiver or 
alteration of authorization 
Provide an explanation for why the research could not practicably be conducted without the 
waiver or alternation of authorization. 
 
Not applicable.  
 
6.3 
Waiver or alteration of authorization statements of agreement 
By submitting this study for review with a waiver of authorization, you agree to the following statement 
– DO NOT ALTER OR DELETE unless this section is not applicable because the research does not involve a 
waiver or alteration of authorization. If the section is not applicable, remove the statement and indicate 
as not applicable. 
 
Not applicable.  
7.0 
Study Design and Procedures 
 
7.1 
Study Design 
Describe and explain the study design. 
 
We will compare exposure therapy via virtual reality technology to a waitlist control group across 8 to 10 
sessions with follow-up assessments after 3-month and 6-month post-termination of treatment.  
 
NOTE: While research procedures may be carried out in the Psych Clinic, no data will be entered into a 
medical record/student health record. Therefore, this data is strictly research data – it would not fall 
under the HIPAA or FERPA regulations.  
 
Further, involvement in this study will not have any impact of participants’ treatment options. 
Participants may seek other forms of professional mental healthcare elsewhere outside the context of 
clinical research during the course of this study.  
 
7.2 
Study Procedures 
Provide a description of all research procedures being performed and when they are being performed 
(broken out by visit, if applicable), including procedures being performed to monitor participants for 
safety or minimize risks.  Include any long-term follow-up procedures and data collection, if applicable.  

Page 21 of 40 (V.04/27/2017)  
 
Describe where or how you will be obtaining information about participants (e.g., medical records, 
school records, surveys, interview questions, focus group topics, audio or video recordings, data 
collection forms, and collection of specimens through invasive or non-invasive procedures to include the 
amount to be collected and how often). Add any data collection instruments that will be seen by 
participants to your study in CATS IRB (http://irb.psu.edu) in the “Supporting Documents” page. 
 
Step 1: Phone Screening 
 
Potential participants will first complete a brief phone screen to ensure they meet the basic criteria for 
the study. During the phone screen, the participant will be asked to provide a brief description of their 
presenting problem, as well as some basic information about their age to ensure they meet some of the 
inclusion criteria for the study (over the age of 18 and seeking help for social anxiety treatment). 
Researchers will administer the script before scheduling the initial assessment (see “LIMBIX – Screening 
Consent - Phone.docx” under recruitment materials). 
 
Step 2: Initial Assessment 
 
Those that appear to meet some of the criteria based on the phone screen will be scheduled for an in-
person initial assessment. The waiting period between the initial phone screen and appointment for the 
baseline assessment will depend on the availability of the participant and study team member 
conducting the baseline assessment.  
 
During the initial assessment visit, participants will review the study consent with a study team member 
(“LIMBIX - Baseline Assessment Script” done online). Once consent is obtained, participants will be 
instructed to complete the baseline self-report questionnaires using a tablet or computer in one of the 
clinic or laboratory rooms at the Moore building, which will link to the Qualtrics questionnaires. The self-
report assessments will take approximately 40 minutes.  
 
After self-report questionnaires are completed, participants will then complete the baseline clinical 
interview (paper version of “LIMBIX - Measure - MINI Neuropsychiatric Interview.pdf”) conducted by a 
study team member who is not the ultimate research therapist. The clinical interview will generally take 
about 15 to 25 minutes. This interview will be videotaped to conduct reliability assessment on the 
diagnoses. 
 
Participants who meet the study eligibility criteria will next be contacted by phone by another study 
team member within a week to receive their random assignment to either the virtual reality exposure 
therapy condition or the waitlist control condition and to schedule their treatment planning session 
Participants in the immediate treatment group will be invited to start treatment soon after the baseline 
assessments, whereas those in the waitlist control condition will be invited to start this treatment 8 
weeks later. The script “LIMBIX - Scripts - Study Therapist to Subject” will be used to facilitate this 
process.  
 
Within a day the intake assessor completes the initial assessment for an eligible participant, the 
coordinator will (1) randomly assign the eligible participant who had just completed the interview to 
their treatment condition, (2) call the participant to inform them of their study condition, and (3) inform 
their research therapist assigned to be in charge with conducting the 8 to 10 50-minute weekly 
treatment planning and therapy sessions.  
As participants assigned to the treatment condition will begin therapy immediately, the coordinator will 
communicate this message to the research therapist within a day of the initial assessment.  
 

Page 22 of 40 (V.04/27/2017)  
On the other hand, participants assigned to the waitlist control condition will begin therapy 8 weeks 
later, and the coordinator will communicate this message within a few weeks after the initial 
assessment visit.  
 
Once the research therapist receives the message from the coordinator to start scheduling treatment 
with a particular participant, he or she is expected to contact the participant and set up an appointment 
within the next one or two weeks depending on their availability.  
 
Step 3: Treatment Planning 
 
Once participants have been assigned their treatment condition and research therapist, they will be 
assessed for interest in beginning the specific job interview intervention or the general social settings 
intervention (“LIMBIX - Scripts - Treatment Selection - V1.docx”). Whereas the specific job interview 
intervention helps clients overcome their social phobia linked to job application situations, the general 
social settings interventions assists with helping clients overcome social fears across a variety of social 
situations (e.g., dating, ordering a cup of coffee at a cafeteria).  
 
All treatment offered within the context of the study will be supervised by a licensed mental health 
provider and an advanced graduate student (Dr. Michelle Newman and Hani Zainal), and treatment 
options will be based on current best practices and available evidence-based care. Treatment will be 
based on exposure therapy, which has been shown through prior research to be effective for social 
anxiety disorder (Powers & Emmelkamp, 2008). In addition, therapy may focus on helping the 
participant to build a set of adaptive coping and emotion regulation skills, such as self-monitoring, 
breathing training, and enhancing motivation to take interpersonal risks.  
 
The research therapist will determine if the intervention best matches the participant’s presenting 
concerns and goals and will record this on the treatment plan. The VR treatment is tailored to 
participants' presenting problems (general social anxiety or job interview phobia). These plans will first 
be reviewed in supervision to ensure participants are offered treatment based on current best practices 
and standards of care. Treatment plans will also be reviewed with the participant to ensure agreement 
on the treatment plan and to allow for collaborative changes to the plan, as needed. Considerations 
such as the participant’s digital literacy, comfort with technology, access to the tools, and participants’ 
stated preferences will be considered. 
 
Each 50-minute therapy session will be video recorded as part of the clinical supervision and research 
procedures to ensure that the research therapists adhere to the protocol of the virtual reality exposure 
therapy. The tapes will be coded by trained assessors to ensure quality of therapy and adherence. These 
videos will only be made available to the PI and study team members to maintain participants’ 
confidentiality.   
 
In each session, the participant will come in and be exposed to different social scenarios virtually. Each 
study team member follows a script for each session to direct them to the scenario (“LIMBIX - Scripts - 
Each Session - V1.docx”). The team member thus functions mainly as a facilitator who will ensure that 
the correct brief social scenario is presented to the participant for both the general social skills exposure 
therapy (“LIMBIX - Scripts - Phobia General Social Interactions.docx”) and job interview exposure 
therapy (“LIMBIX - Scripts - Phobia Job Interview.docx”). Note that there are seven social scenarios for 
both forms of exposure therapy. The social scenarios build on each other in terms of the level of 
difficulty. Therefore, we will continue with the next scenario only after the participant says he or she 
feels ready to expose themselves to the next scenario. After each scenario, the study team member 
records participants’ subjective units of distress using the “LIMBIX - In-session SUDS Ratings”. Ten 
minutes before the 50-minute session ends, the team member assigns homework in between the 

Page 23 of 40 (V.04/27/2017)  
weekly sessions using a standard script (“LIMBIX – Between Session Homework”).  Homework is meant 
to help participants generalize the skills they learn from this treatment to their everyday life situations.  
 
Step 4: Assessing and Adjusting Treatment  
 
We aim to ensure that each participant finds the intervention to be helpful and to identify the need to 
discontinue due to various reasons (e.g., participant finds the intervention is unhelpful, causes adverse 
side effects or severe cybersickness). Participants will thus complete the System Usability Scale on the 
first, fourth, and last week of the 8-10 session intervention. This will provide a measure of their 
experience and will help to facilitate a conversation with the therapist about their experience. Scores 
below a 70 (Bangor, Kortum, & Miller, 2009) would indicate that the usability of the tool was below 
average and will signify that further discussion is needed to identify if the use of the digital tool should 
be discontinued. Please note that efforts will be made to problem solve usability concerns with the 
participant when possible, as participants will have varying levels of technological comfort the therapist 
will work to personalize this process to the participants’ needs.  
 
During the session, some research personnel will assist with helping participants to respond if the 
participants have problems responding to the system (“LIMBIX - Scripts - RA Prompts If Participant Gets 
Stuck.docx”).   
 
Step 5: Between-Session Symptom Assessment  
 
To monitor treatment progress, participants will complete between-session symptom assessments at 
the end of each session (“LIMBIX - Measure - Between session symptom assessments.pdf”). Participants 
will also be asked to engage in practice of skills they learn in treatment between sessions (refer to 
“LIMBIX – Between-Session Homework”).  
 
This applies to participants in the treatment, but not waitlist, condition. For participants placed on the 
waitlist, this applies only once treatment has started. 
 
Step 6: Termination  
 
The research therapist will work with participants to determine therapy goals at the start of treatment, 
and will work with them to monitor progress on these goals throughout treatment. Generally, treatment 
length will span 8 to 10 sessions, depending on the participant’s symptoms, response to treatment, and 
therapists’ clinical judgment.  
 
Step 7: Final Assessments  
 
Participants will be asked to complete the follow-up questionnaire packet (see “LIMBIX - Measure - 
Follow-up questionnaire packet.pdf”). This packet will be provided to them prior to their final session, 
and the final interview (conducted online “LIMBIX - Measure - Final interview.pdf”) will be included in 
the termination session. The final interview session will be administered at the end of Session 10.  
 
Three and six months after treatment, participants will be contacted online to complete the 3-month 
and 6-month follow-up questionnaires (see “LIMBIX - Measure - 3-month post-treatment.pdf” and 
“LIMBIX - Measure - 6-month post-treatment.pdf” accordingly). At this time, participants will only 
complete self-report measures online.   
 
7.3 
Duration of Participation 
Describe the duration of an individual subject’s participation in the study. 

Page 24 of 40 (V.04/27/2017)  
 
We determined the length of time needed to complete the assessments. Based on this, it is predicted 
that the baseline assessments will be completed in 90 minutes, and the assessments at the end of 
treatment and 3- and 6-month post should take between 30 minutes to complete. In addition to time 
spent on assessments, participants will attend 8 to 10 sessions of weekly therapy sessions that will each 
be 50 minutes long. Note that the between-session measures are done at the end of each session. The 
frequency of treatment sessions will be determined by the participant’s presenting concerns, but the 
following presents a reasonable estimate for most clients with social anxiety disorder who meet the 
study eligibility criteria.  
 
Initial visit assessments: 
 
 
60 minutes 
3- month post-treatment assessments:  
15 minutes 
6- month post-treatment assessments:  
15 minutes 
8-10 treatment sessions: 
 
 
50 x 10 = 500 minutes  
Final visit assessments:  
 
 
10 minutes  
 
Total time (approximate): 
 
 
600 minutes 
8.0 
Participant Numbers and Statistical Plan 
 
8.1 
Number of Participants 
Indicate the total number of participants to be accrued.  
 
If applicable, distinguish between the number of participants who are expected to be enrolled and 
screened, and the number of participants needed to complete the research procedures (i.e., numbers of 
participants excluding screen failures.) 
 
750 participants 
 
8.2 
Sample size determination 
If applicable, provide a justification of the sample size outlined in section 8.1 – to include reflections on, 
or calculations of, the power of the study. 
 
The proposed study is focused on examining the efficacy, acceptability, feasibility, and the experience of 
the patient when using virtual reality in treating job interview phobia. The number of participants (300 
per intervention condition; 300 General Social Skills Training; 300 Job Interview Phobia; 150 Waitlist 
Control) was based on Kampmann et al. (2016) who conducted a virtual reality study with adults with 
social phobia and used similar primary outcome measures. In their study, their power calculations 
estimated that 300 participants/per intervention group would be sufficient to find significant differences 
(two sided-power, power= 80%, alpha -0.05, G*Power 3.2) based on an effect size of exposure therapy 
found in a meta-analysis (Powers et al., 2008). 
 
8.3 
Statistical methods 
Describe the statistical methods (or non-statistical methods of analysis) that will be employed. 
 
We will conduct a series of growth curve analyses to test for treatment efficacy. We will use the R 
packages ‘lme4’ (Bates, Maechler, & Bolker, 2012), ‘lmerTest’ (Kuznetsova & Brockhoff, 2014), and 
‘lavaan’ (Rosseel, 2012) to calculate the growth trajectories for each participants. We will test for the 
impact of time using participants’ scores at post-treatment, and at 6-month and 12-month follow-ups. 
We intend to perform separate models for each of the study outcome measures.  

Page 25 of 40 (V.04/27/2017)  
9.0 
Confidentiality, Privacy and Data Management  
For research being conducted at Penn State Hershey or by Penn State Hershey researchers only, the research 
data security and integrity plan is submitted using “HRP-598 – Research Data Plan Review Form Application 
Supplement”, which is available in the Library in CATS IRB (http://irb.psu.edu).  Refer to Penn State College of 
Medicine IRB’s “Standard Operating Procedure Addendum: Security and Integrity of Human Research Data”, 
which is available on the IRB’s website. In order to avoid redundancy, for this section state “See the Research 
Data Plan Review Form” in section 9.0 if you are conducting Penn State Hershey research and move on to 
section 10.  
 
For all other research, in the sections below, describe the steps that will be taken to secure the data during 
storage, use and transmission. 
 
9.1 
Confidentiality 
 
9.1.1 
Identifiers associated with data and/or specimens 
List the identifiers that will be included or associated with the data and/or specimens in any way 
(e.g., names, addresses, telephone/fax numbers, email addresses, dates (date of birth, 
admission/discharge dates, etc.), medical record numbers, social security numbers, health plan 
beneficiary numbers, etc.).   
 
If no identifiers will be included or associated with the data in any way, whether directly or 
indirectly, please indicate this instead.   
 
The identifiers include code numbers “VRET001, VRET 002, … VRET 00X, etc.” that will be linked 
with the participant’s name and email address in a password-protected master list code only 
accessible to the PIs and study team members of this project.  
 
To maintain confidentiality of video tapes recorded of the clinical interviews and for each 
therapy session, these tapes will be labeled with participant code numbers and session numbers 
(e.g., VRET001-Session 1, VRET001-Session 2, … VRET001-Session X). These tapes are also stored 
in a password protected, private, and secure PSU Box folder that is only available to the PIs and 
study team members of this project. This password protected server has a two-factor 
authentication feature for added security.  
 
9.1.1.1 Use of Codes, Master List 
If identifiers will be associated with the data and/or specimens (as indicated in 
section 9.1.1 above), describe whether a master record or list containing a code 
(i.e., code number, pseudonyms) will be used to separate the data collected from 
identifiable information, where that master code list will be stored, who will have 
access to the master code list, and when it will be destroyed.  
 
If identifiers are included or associated with the data as described in section 
9.1.1 above, but no master record or list containing a code will be used, it will be 
assumed by the IRB that the investigator plans to directly link the identifiers 
with the data.    
 
The master code list will be stored in a secure and password protected server 
online using PSU Box at the Newman Lab, PSU University Park campus. Only Dr. 
Michelle Newman, Nur Hani Zainal, and trained study team members will have 
access to the master code list and therapy video tapes. We plan to destroy the 
master code list that it is stored in a password protected and secure server that 

Page 26 of 40 (V.04/27/2017)  
minimizes the risk of breaching participants’ confidentiality after 5 years of 
completing the research study.   
 
9.1.2 
Storage of Data and/or Specimens 
Describe where, how and for how long the data (hardcopy (paper) and/or electronic data) 
and/or specimens will be stored. NOTE: Data can include paper files, data on the internet or 
websites, computer files, audio/video files, photographs, etc. and should be considered in the 
responses.  Refer to the “Investigator Manual (HRP-103)” for information about how long 
research records must be stored following the completion of the research prior to completing 
this section. HRP-103 can be accessed by clicking the Library link in CATS IRB 
(http://irb.psu.edu).  
 
Please review Penn State’s Data Categorization Project for detailed information regarding the 
appropriate and allowable storage of research data collected according to Penn State Policy 
AD71. Although the IRB can impose greater confidentiality/security requirements (particularly 
for sensitive data), the IRB cannot approve storage of research data in any way or using any 
service that is not permissible by Penn State Policy AD71.   
 
Paper data:  
 
Physical consent forms and MINI clinical interviews will be kept in a locked room in the Newman 
Laboratory (either rooms 378, 380, 348A, 348B, 348C, or 381 Moore) for a maximum period of 5 
years. These consent forms will be stored separately from the study data. 
 
Video recordings: 
 
We will use the computer webcams installed on the College of Liberal Arts computers in the 
Moore building to ensure treatment fidelity. Once these videos have been recorded, the 
research personnel will immediately upload it onto the encrypted, secure, and password 
protected PSU Box folder and the webcam version will be deleted. Videos stored in the safe and 
encrypted PSU Box folder will be destroyed 5 years after the close of the study. The videos will 
not be transcribed. 
 
Online data:  
 
Based on the policies of AD 95 (https://policy.psu.edu/policies/ad95 ) and AD 53 
(https://policy.psu.edu/policies/ad53 ), we will use moderate security control. We are planning 
to store data on Qualtrics for a maximum period of 5 years after the close of the study. The 
Qualtrics website is highly secure. All surveys hosted with Qualtrics are encrypted using 256-bit 
SSL Technology (Secure Socket Layer) that is equivalent to the industry standard for securely 
transmitting credit card information over the Internet. This technology encrypts BOTH the 
questions displayed to the participants and their responses. Thus, all responses are instantly 
encrypted and remain so until they are received at the Qualtrics database. Interception of data 
when it is being transmitted between the Internet browser (i.e., Internet Explorer, FireFox, 
Safari, Chrome) and the Qualtrics database is HIGHLY unlikely (consider the motivations of a 
person attempting to intercept research data over the internet vs. papers stored in an office vs. 
credit card information). However, should interception of encrypted data occur, that data could 
not be decoded without the unique encryption key that is held. 
 
Once research data is stored on a Qualtrics server, it is held in an isolated database that can only 
be accessed by a researcher with the correct username and password. Qualtrics employees do 
NOT examine customer data unless requested to do so by the account owner; additionally, 

Page 27 of 40 (V.04/27/2017)  
those employees are trained in the ethics of research involving human subjects.  Servers are 
housed in a secure data facility and are monitored 24 hours-per-day and 7 days-per-week by 
network operations personnel for all aspects of operational security. Biometric/intrusion 
sensors, card readers, personal identification numbers, and environmental sensors are used to 
ensure server integrity and safety. Redundant HVAC systems ensure an optimized operational 
environment. Server power is provided by a redundant, multi-stage, uninterruptible system. 
Even in the event of a catastrophic commercial power failure, diesel generators seamlessly 
provide backup power. A redundant, high-bandwidth, private transport network provides 
connectivity between our servers and the world. The local fiber connectivity is redundant with 
three fiber rings with dual entry points from Optical Carrier-12 (OC-12) hardware. This network 
has demonstrated 99.999% availability, which means that the network will be down no more 
than 5 minutes in one year. Qualtrics allows you to link two surveys together. Therefore, 
identifying information about participants and research data can be collected, stored, and 
accessed separately. If you need to collect identifying information at the same time you are 
collecting anonymous research data this method is, by far, the safest. 
 
9.1.3 
Access to Data and/or Specimens 
Identify who will have access to the data and/or specimens. This information should not conflict 
with information provided in section 9.1.1.1 regarding who has access to identifiable 
information, if applicable.    
 
Only Dr. Michelle Newman, Nur Hani Zainal, and trained study team members (i.e., research 
assistants) included on this IRB protocol will have access to data on the encrypted PSU Box 
folders. 
 
9.1.4 
Transferring Data and/or Specimens 
If the data and/or specimens will be transferred to and/or from outside collaborators, identify 
the collaborator to whom the data and/or specimens will be transferred and how the data 
and/or specimens will be transferred. This information should not conflict with information 
provided in section 9.1.1.1 regarding who has access to identifiable information, if applicable. 
 
Not Applicable. 
 
9.2 
Subject Privacy 
This section must address subject privacy and NOT data confidentiality. 
 
Indicate how the research team is permitted to access any sources of information about the participants.  
 
Describe the steps that will be taken to protect participants’ privacy interests. “Privacy interest” refers to 
a person’s desire to place limits on whom they interact with or to whom they provide personal 
information. 
 
Describe what steps you will take to make the participants feel at ease with the research situation in terms 
of the questions being asked and the procedures being performed. “At ease” does not refer to physical 
discomfort, but the sense of intrusiveness a subject might experience in response to questions, 
examinations, and procedures. 
 
All investigators will be asked to be aware of participant comfort and participants will be encouraged to 
ask questions or state concerns regarding privacy. Both prescreening measures and study procedures are 
designed to (and will be implemented in such a way that) preserves participant privacy. Phone calls and 
experimental sessions will take place in private rooms in the Moore building where participants can be 

Page 28 of 40 (V.04/27/2017)  
assured that the privacy of their information will not be compromised. Overall, participants will be able 
to address privacy concerns or questions at any time throughout the study by emailing or calling Nur Hani 
Zainal at 814-863-0115. 
 
10.0 Data and Safety Monitoring Plan 
This section is required when research involves more than Minimal Risk to participants. As defined in “SOP: 
Definitions (HRP-001)”, available in the Library in CATS IRB (http://irb.psu.edu), Minimal Risk is defined as the 
probability and magnitude of harm or discomfort anticipated in the research that are not greater in and of 
themselves than those ordinarily encountered in daily life or during the performance of routine physical or 
psychological examinations or tests.  For research involving prisoners, Minimal Risk is the probability and 
magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine 
medical, dental, or psychological examination of healthy persons. Please complete the sections below if the 
research involves more than minimal risk to participants OR indicate as not applicable.  
 
10.1 
Periodic evaluation of data 
Describe the plan to periodically evaluate the data collected regarding both harms and benefits to 
determine whether participants remain safe. 
 
Not Applicable. 
 
10.2 
Data that are reviewed 
Describe the data that are reviewed, including safety data, untoward events, and efficacy data. 
 
Not Applicable. 
 
10.3 
Method of collection of safety information 
Describe the method by which the safety information will be collected (e.g., with case report forms, at 
study visits, by telephone calls and with participants). 
 
Not Applicable. 
 
10.4 
Frequency of data collection 
Describe the frequency of data collection, including when safety data collection starts. 
 
Not Applicable. 
 
10.5 
Individuals reviewing the data 
Identify the individuals who will review the data. The plan might include establishing a data and safety 
monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the 
sponsor. 
 
Not Applicable. 
 
10.6 
Frequency of review of cumulative data 
Describe the frequency or periodicity of review of cumulative data. 
 
Not Applicable. 
 

Page 29 of 40 (V.04/27/2017)  
10.7 
Statistical tests 
Describe the statistical tests for analyzing the safety data to determine whether harms are occurring. 
 
Not Applicable. 
 
10.8 
Suspension of research 
Describe any conditions that trigger an immediate suspension of research. 
 
Not Applicable. 
11.0 Risks 
List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the participants related the 
participants’ participation in the research.  For each potential risk, describe the probability, magnitude, duration, 
and reversibility. Consider all types of risk including physical, psychological, social, legal, and economic risks. If 
applicable, indicate which procedures may have risks to the participants that are currently unforeseeable. If 
applicable, indicate which procedures may have risks to an embryo or fetus should the subject be or become 
pregnant. If applicable, describe risks to others who are not participants. 
 
Please keep in mind that loss of confidentiality is a potential risk when conducting human subject research and 
should be addressed as such.  
 
 
Possible risks:  
 
 
In the assessment process, it is possible that participants may experience some distress as they are reminded of 
difficult memories, asked to answer personal questions, and asked about past and current symptoms. In 
counseling, the process of therapy may increase distress over the short term, especially as the counseling 
provided in this study involves exposure to elicited anxiety around feared stimuli. The risks involved in the 
assessment and therapy procedures are no more than those involved in other therapy settings. 
 
The responses to questions concerning illegal drug use could be self-incriminating and harmful if they became 
known outside the study. Precautions will be taken to ensure the safety and security of participant’s personal 
information. 
 
It is also possible that participants experience physical distress, including muscle tension, upset stomach, or 
other somatic symptoms associated with anxiety and arousal. The risks involved in the assessment and therapy 
procedures are no more than those involved in other therapy settings. 
 
Due to the nature of virtual reality, there is potential for users to develop cybersickness. Cybersickness involves 
users feeling some dizziness, abdominal symptoms as a result of using virtual reality. However, the time within 
the virtual reality world in our study has been adapted (under 40 mins per use) to reduce eye strain and 
cybersickness (Bouchard, Loranger, Robillard, & Larouche, 2012). None of the participants in Bouchard and 
Wiederhold (2009) had to stop the immersion due to negative side effects. For 92% of the 157 adult users, the 
intensity of symptoms was rated as “slight”. 
 
The design of the virtual reality scripts has minimal unnecessary movement of the user within the virtual reality 
space, which is a high predictor for inducing cybersickness and, hence, limits the likelihood of users developing 
cybersickness. 
 
Additionally, there is social stigma attached to individuals who have a history of mental health diagnoses. Given 
this, precautions will be taken to ensure the safety and security of subject’s personal information. 
 

Page 30 of 40 (V.04/27/2017)  
For risks associated with mental health or physical discomfort the following precautions will be taken: 
 
• 
Participants will be informed of these risks in advance. 
• 
As part of treatment, participants will gain coping skills to better manage the distressing symptoms. 
• 
Treatment and assessments will be provided by doctoral students who have training in mental health 
treatment, and who can provide support to research participants. 
• 
Research therapists involved in the study will be supervised by a licensed psychologist or advanced graduate 
student therapist who can provide additional oversight and resources to either the research therapist or 
participant to ensure participants are getting appropriate treatment. 
• 
Each treatment session will be under 40 mins to minimize the likelihood of a user developing cybersickness. 
• 
Unwanted side effects of cybersickness are monitored using a well-established instrument (Simulator 
Sickness Questionnaire [SSQ]; Kennedy, Lane, Berbaum, & Lilienthal, 1993). If a user reports significant 
cybersickness, research therapist will problem solve with the user. If continuous cybersickness is reported, 
the user may not be a good fit for the intervention. 
 
For risks related to disclosure of information outside of the study, the following precautions will be taken: 
 
• 
Participants will be informed of these risks in advance. 
• 
All necessary steps, as dictated by law and the American Psychological Association ethics code will be 
followed to ensure the safety of participant’s data. 
• 
Only individuals who are directly involved with the research project will have access to the research 
information. 
 
Why this study is of minimal risk: 
 
Participants involved in this study will be asked to discuss difficult topics including current symptoms, past 
trauma, substance use, and psychiatric history. Despite the discomfort this may cause, this risk remains minimal 
as the procedures involved in the study are similar to those that individuals would encounter when engaging in 
any other mental health treatment. 
 
Circumstances under which the study will be ended to prevent future risk: 
 
The study will be ended if the protocol is shown to cause unnecessary harm to participants without any 
compensatory benefit. The Beck Anxiety Inventory (BAI; Beck & Steer, 1993) will be used to assess changes in 
symptoms every week. If no response, or negative response, (as operationalized as a 15% increase in severity on 
BAI scores for two consecutive sessions after initial adjustment to treatment has been made) continues for at 
least 5 participants, or if at least 5 participants are referred out due to requiring more care, the study will be 
stopped. This figure was chosen as controlled studies of single-diagnosis treatment trials often show that 5-10% 
of the study populations may exhibit an increase in symptoms while participating in a therapy study and 35- 40% 
report little benefit (Hansen, Lambert, & Forman, 2002). Given that the community population served by this 
study may be more complex than the populations seen in clinical trials the number was slightly increased. 
 
It is expected that some participants will see a temporary increase in symptoms over the course of treatment 
due to the need to discuss difficult emotional information in treatment. To help ensure that any of the 
participant’s concerns are addressed and that the treatment offered is responsive to the participant’s needs, 
ongoing symptom monitoring will assist with the identification of individuals who do not appear to be benefiting 
from treatment and adverse effects will also be monitored through the assessment process (i.e., through the 
use of the Negative Effects Questionnaire; Rozental, Kottorp, Boettcher, Andersson, & Carlbring, 2016). This 
monitoring will also allow for a collaborative discussion with study participants so that adjustments can be made 
in their treatment as needed. If an individual participant becomes an imminent risk to themselves or others, 
their participation in the study will end and they will be referred to an appropriate level of care. We will ask such 

Page 31 of 40 (V.04/27/2017)  
participants to contact the Centre County Community Care Behavioral Health Organization at 1 (866) 878-6046 
to uncover other appropriate behavioral health treatment services they can access. 
12.0 Potential Benefits to Participants and Others 
 
12.1 
Potential Benefits to Participants 
Describe the potential benefits that individual participants may experience from taking part in the 
research. If there is no direct benefit to participants, indicate as such. Compensation is not considered a 
benefit. Compensation should be addressed in section 14.0. 
 
Participants may experience some benefits from participation, this includes learning to better 
understand their mental health concerns, learning more about coping, reducing isolation from others, 
and reaching other individual goals set through with their research therapist. 
 
Participants may also experience some occupational success as they learn to better manage their job 
interview phobia and access the skills they have to succeed in job interviews. The treatment is aimed to 
target reducing job interview phobia, one of the potential obstacles to occupational attainment and 
advancement. 
 
Social anxiety has been linked to difficulties at work or in school and in social or romantic relationships. 
Therefore, a benefit of treating social interaction anxiety may be an increase in quality of life as 
individuals can more comfortably engage in daily situations in their personal and professional lives. A 
second benefit may be an increase in self-esteem. Social anxiety is also highly comorbid with depression. 
Therefore, treating the underlying source of distress that is rooted in social phobia may also yield 
additional gains when addressing multiple diagnoses. 
 
12.2 
Potential Benefits to Others 
Include benefits to society or others.  
 
The field of psychology lags behind many other disciplines with regard to incorporating technology into 
practice. This study will help to move the field forward by examining how technology can be 
incorporated to supplement existing treatments. It is the plan of the researchers to use the results of 
this study to help establish best practices for including technology into therapy and to identify more 
specific research questions for future study. 
13.0 Sharing Results with Participants 
Describe whether results (study results or individual participant results, such as results of investigational 
diagnostic tests, genetic tests, or incidental findings) will be shared with participants or others (e.g., the 
participant's primary care physicians) and if so, describe how it will be shared. 
 
Not Applicable. 
14.0 Subject Stipend (Compensation) and/or Travel Reimbursements 
Describe the amount and timing of any subject stipend/payment or travel reimbursement here. If there is no 
subject stipend/payment or travel reimbursement, indicate as not applicable.  
 
If course credit or extra credit is offered to participants, describe the amount of credit and the available 
alternatives. Alternatives should be equal in time and effort to the amount of course or extra credit offered. 

Page 32 of 40 (V.04/27/2017)  
If an existing, approved student subject pool will be used to enroll participants, please indicate as such and 
indicate that course credit will be given and alternatives will be offered as per the approved subject pool 
procedures.  
 
The following compensation mechanism will be used for all participants: Participants will be awarded a $40 gift 
card which will be reimbursed online via email within a week after they have completed the measures at 6-
month follow-up. The planned payment is appropriate and mutually beneficial. It maximizes the chances that 
participants will engage fully with treatment to benefit themselves and complete all of the study procedures. 
Participants are expected to spend about 10 hours to complete the assessment batteries and therapy sessions. 
The money is reasonable in compensating their time.  However, given that they are also receiving free 
treatment, we do not compensate them for time spent in therapy or homework from therapy. Further, this 
amount is not expected to cause undue coercion on the prospective research participants to partake in the 
study. 
15.0 Economic Burden to Participants 
 
15.1 
Costs  
Describe any costs that participants may be responsible for because of participation in the research. 
 
There are no economic costs for participants in this study. Participant “costs” merely includes their time 
of investment and thought. 
 
15.2 
Compensation for research-related injury 
If the research involves more than Minimal Risk to participants, describe the available compensation 
in the event of research related injury. 
 
If there is no sponsor agreement that addresses compensation for medical care for research 
participants with a research-related injury, include the following text as written - DO NOT ALTER OR 
DELETE: 
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Costs for the treatment of research-related injuries 
will be charged to participants or their insurance carriers.  
 
For sponsored research studies with a research agreement with the sponsor that addresses 
compensation for medical care for research-related injuries, include the following text as written - DO 
NOT ALTER OR DELETE: 
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Such charges may be paid by the study sponsor as 
outlined in the research agreement and explained in the consent form. 
 
Not applicable. 
16.0 Resources Available 
 
16.1 
Facilities and locations 
Identify and describe the facilities, sites and locations where recruitment and study procedures will be 
performed.  
 

Page 33 of 40 (V.04/27/2017)  
If research will be conducted outside the United States, describe site-specific regulations or customs 
affecting the research, and describe the process for obtaining local ethical review. Also, describe the 
principal investigator’s experience conducting research at these locations and familiarity with local 
culture. 
 
Study participation and recruitment will occur in Dr. Newman’s research lab [348B, 348C, 381, 380, 348A 
and 378 Moore Building] as well as the therapy rooms in the Psych Clinic [301-325 Moore Building] on 
Penn State University Park campus.  
 
The Newman Laboratory for Anxiety and Depression Research as well as PSU Psychological Clinic 
therapy rooms, located in the Moore Building, includes seating, desk space, and computers where 
participants will undergo the consenting process and experiment. Some research personnel will also be 
seated in the room to guide participants through the study. 
 
16.2 
Feasibility of recruiting the required number of participants 
Indicate the number of potential participants to which the study team has access.  Indicate the 
percentage of those potential participants needed for recruitment. 
 
During each semester, approximately 800 students are enrolled in the subject pool who are expected to 
accumulate up to 6 hours of research credits as a course requirement. We would thus have access to a 
large numbers of people who are willing and able to partake in the present study. The PSU Psychology 
Subject Pool is thus an abundant resource for the recruitment of study participants and many previous 
studies with larger social anxiety disorder samples have been conducted within this participant pool. It is 
feasible that the desired/required number of participants can be recruited based on previous experience 
with the subject pool. For the past two semesters of subject pool research over 200 students have met 
criteria for social anxiety disorder via the Social Phobia Diagnostic Questionnaire. 
 
Further, the Penn State Psychological Clinic is the best place for conducting this study primarily because 
the data is relatively unique to the clinic. The clinic is a rural outpatient community mental health clinic 
and will provide information generalizable to an understudied segment of outpatient clients.  
Furthermore, the use of structured clinical interviews as part of routine practice as well as the Practice-
Research Network (PRN) that has seamlessly been incorporated into the daily operations of the clinic 
allow the Psychological Clinic to provide both ecologically valid and empirically rigorous data 
(Castonguay, Locke, & Hayes, 2011).  These data will therefore be reliably generalizable to both the 
research and clinical community, particularly the U.S. community mental health centers. 
 
The StudyFinder which is customized and supported by the Pennsylvania State University Clinical and 
Translational Science Institute under grant UL1TR000127 is also another excellent resource to tap into. 
Participants from the community who have been struggling with high levels of social anxiety symptoms 
and tend to avoid multiple feared social situations experience less social and occupational opportunities 
in life. This research study offers such community adult participants the chance to break away from such 
avoidance patterns. To this end, interested participants via StudyFinder who identify with struggling 
with social anxiety are able receive diagnosis and treatment and thereby improve their quality of life. 
 
16.3 
PI Time devoted to conducting the research 
Describe how the PI will ensure that a sufficient amount of time will be devoted to conducting and 
completing the research. Please consider outside responsibilities as well as other on-going research for 
which the PI is responsible. 
 
This study's PI and project coordinator will devote all necessary research time to completing the study 
within the next eight semesters (August 2018 to August 2023).  The active time burden for study 
personnel, working with participants before data analysis, does not appear to amount to more than 10 

Page 34 of 40 (V.04/27/2017)  
hours per participant, ideally. With 75 participants per semester, the time investment would be 45,000 
hours per semester.   
 
16.4 
Availability of medical or psychological resources 
Describe the availability of medical or psychological resources that participant might need as a result of 
their participation in the study, if applicable. 
 
If desired, participants recruited from the subject pool may contact the Penn State Psychological Clinic 
at 814-865-2191 or Penn State Counseling and Psychological Services (CAPS) at 814-863-0395 for mental 
health services. Participants may also call the CAN Help phone line at 1-800-643-5432 after hours if 
necessary.  
 
16.5 
Process for informing Study Team 
Describe the training plans to ensure members of the research team are informed about the protocol 
and their duties, if applicable. 
 
The current study personnel have already been trained extensively in their duties. If a new individual 
joins the team, they will undergo a training session of approximately ten hours and—like everyone 
involved—will be monitored for adequate performance through the study’s duration. They will be 
required to read this IRB protocol for the study, the informed consent, each of the measures, the 
proposal for the study, and will be given every opportunity to ask questions. They will be walked 
through the virtual reality exposure therapy assignments, as well as each step of the study. The security 
measures of the locked room and the computers will be addressed. Last, there will be 0.5 to 1-hour 
weekly meeting between all study members to address any ongoing issues and track progress. 
17.0 Other Approvals 
17.1 
Other Approvals from External Entities 
Describe any approvals that will be obtained prior to commencing the research (e.g., from cooperating 
institutions, community leaders, schools, external sites, funding agencies). 
 
Not Applicable.    
 
17.2 
Internal PSU Committee Approvals 
 
Not Applicable.  
 
Check all that apply: 
  Anatomic Pathology – Hershey only – Research involves the collection of tissues or use of pathologic 
specimens. Upload a copy of HRP-902 - Human Tissue For Research Form on the “Supporting 
Documents” page in CATS IRB. This form is available in the CATS IRB Library.   
 
  Animal Care and Use – All campuses – Human research involves animals and humans or the use of 
human tissues in animals 
 
  Biosafety – All campuses – Research involves biohazardous materials (human biological specimens 
in a PSU research lab, biological toxins, carcinogens, infectious agents, recombinant viruses or DNA 
or gene therapy). 
 
  Clinical Laboratories – Hershey only – Collection, processing and/or storage of extra tubes of body 
fluid specimens for research purposes by the Clinical Laboratories; and/or use of body fluids that 

Page 35 of 40 (V.04/27/2017)  
had been collected for clinical purposes, but are no longer needed for clinical use. Upload a copy of 
HRP-901 - Human Body Fluids for Research Form on the “Supporting Documents” page in CATS IRB. 
This form is available in the CATS IRB Library.  
 
  Clinical Research Center (CRC) Advisory Committee – All campuses – Research involves the use of 
CRC services in any way. 
 
  Conflict of Interest Review – All campuses – Research has one or more of study team members 
indicated as having a financial interest. 
 
  Radiation Safety – Hershey only – Research involves research-related radiation procedures. All 
research involving radiation procedures (standard of care and/or research-related) must upload a 
copy of HRP-903 - Radiation Review Form on the “Supporting Documents” page in CATS IRB. This 
form is available in the CATS IRB Library. 
 
  IND/IDE Audit – All campuses – Research in which the PSU researcher holds the IND or IDE or 
intends to hold the IND or IDE. 
 
  Scientific Review – Hershey only – All investigator-written research studies requiring review by the 
convened IRB must provide documentation of scientific review with the IRB submission. The 
scientific review requirement may be fulfilled by one of the following: (1) external peer-review 
process; (2) department/institute scientific review committee; or (3) scientific review by the Clinical 
Research Center Advisory committee.  NOTE: Review by the Penn State Hershey Cancer Institute 
Scientific Review Committee is required if the study involves cancer prevention studies or cancer 
patients, records and/or tissues. For more information about this requirement see the IRB website 
at: http://www.pennstatehershey.org/web/irb/home/resources/investigator  
 
18.0 Multi-Site Research 
If this is a multi-site study (i.e., the study will be conducted at other institutions each with its own principal 
investigator) and you are the lead investigator, describe the processes to ensure communication among sites in 
the sections below. 
 
18.1 
Communication Plans 
Describe the plan for regular communication between the overall study director and the other sites to 
ensure that all sites have the most current version of the protocol, consent document, etc.  Describe the 
process to ensure all modifications have been communicated to sites. Describe the process to ensure 
that all required approvals have been obtained at each site (including approval by the site’s IRB of 
record).   Describe the process for communication of problems with the research, interim results and 
closure of the study. 
 
Not Applicable. 
 
18.2 
Data Submission and Security Plan 
Describe the process and schedule for data submission and provide the data security plan for data 
collected from other sites.  Describe the process to ensure all engaged participating sites will safeguard 
data as required by local information security policies. 
 
Not Applicable. 
 

Page 36 of 40 (V.04/27/2017)  
18.3 
Subject Enrollment 
Describe the procedures for coordination of subject enrollment and randomization for the overall 
project. 
 
Not Applicable. 
 
18.4 
Reporting of Adverse Events and New Information 
Describe how adverse events and other information will be reported from the clinical sites to the overall 
study director. Provide the timeframe for this reporting. 
 
Not Applicable. 
 
18.5 
Audit and Monitoring Plans 
Describe the process to ensure all local site investigators conduct the study appropriately. Describe any 
on-site auditing and monitoring plans for the study. 
 
Not Applicable. 
19.0 Adverse Event Reporting 
 
19.1 
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB 
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE:  
 
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) 
experienced by a participant or other individual, which in the opinion of the investigator is determined 
to be (1) unexpected; and (2) probably related to the research procedures. Harms (adverse events) will 
be submitted to the IRB in accordance with the IRB policies and procedures. 
20.0 Study Monitoring, Auditing and Inspecting 
 
20.1 
Auditing and Inspecting 
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE:  
 
The investigator will permit study-related monitoring, audits, and inspections by the Penn State quality 
assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all study related 
documents (e.g., source documents, regulatory documents, data collection instruments, study data, 
etc.).  The investigator will ensure the capability for inspections of applicable study-related facilities 
(e.g., pharmacy, diagnostic laboratory, etc.). 
21.0 Future Undetermined Research: Data and Specimen Banking 
If this study is collecting identifiable data and/or specimens that will be banked for future undetermined 
research, please describe this process in the sections below.  This information should not conflict with 
information provided in section 9.1.1 regarding whether or not data and/or specimens will be associated with 
identifiers (directly or indirectly). 
 
21.1 
Data and/or specimens being stored 
Identify what data and/or specimens will be stored and the data associated with each specimen. 
 

Page 37 of 40 (V.04/27/2017)  
Not applicable. 
 
21.2 
Location of storage 
Identify the location where the data and/or specimens will be stored. 
 
Not applicable. 
 
21.3 
Duration of storage 
Identify how long the data and/or specimens will be stored. 
 
Not applicable. 
 
21.4 
Access to data and/or specimens 
Identify who will have access to the data and/or specimens. 
 
Not applicable. 
 
21.5 
Procedures to release data or specimens 
Describe the procedures to release the data and/or specimens, including: the process to request a 
release, approvals required for release, who can obtain data and/or specimens, and the data to be 
provided with the specimens. 
 
Not applicable. 
 
21.6 
Process for returning results 
Describe the process for returning results about the use of the data and/or specimens. 
 
Not applicable. 
 
22.4 
Test Article(s) (Study Drug(s) and/or Study Device(s)) 
22.4.1 Description 
Provide a brief description of all test articles (drugs (including any foods and dietary 
supplements), devices and/or biologics used in the research including the purpose of their use 
and their approval status with the Food and Drug Administration (FDA). Include information 
about the form of the drug product (e.g., tablets, capsules, liquid). 
 
The VR kit is a technology that has been used in multiple research studies conducting exposure 
therapy to treat a range of psychiatric disorders. There have been no reports of participants 
being harmed in any way, shape, or form in the process. Further, VR technology has been 
around over the past two decades and has been used repeatedly in a wide range of settings. 
Therefore, it poses no safety concerns. 
 
22.4.2 Treatment Regimen 
Describe dose, route of administration and treatment duration. Include information about dose 
adjustments. 
 
For each participant, the VR kit will be used for 30 minutes per session.    
 

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22.4.3 Method for Assigning Subject to Treatment Groups 
Describe the randomization process and how the associated treatment assignment will be 
made. 
 
Using a random number generator with the “RAND” function on Microsoft Excel, the 
participants will be randomly allocated to either one of the two treatment conditions (General 
Social Skills training or Job Interview training) or waitlist condition.  
 
22.4.4 Subject Compliance Monitoring 
Insert the procedures for monitoring subject compliance. 
 
Study team members will track each participant’s progress every session with the following 
indicators: (1) Level of completion of homework; (2) Response to the scripts of the virtual reality 
exposure therapy during each session; (3) Other indicators mentioned above in the protocol.  
 
22.4.5 Blinding of the Test Article 
Describe how the test article is blinded. 
 
Not applicable. Study team members and participants will eventually know the assigned 
condition of each participant.  
 
22.4.6 Receiving, Storage, Dispensing and Return  
 
22.4.6.1 Receipt of Test Article  
Describe how the test article will be obtained and from what source. Describe 
how the study test article will be packaged along with amounts (e.g., number of 
tablets/capsules or volume of liquid) and labeling. If drug kits are used, describe 
all the contents of the kit and associated labeling. 
 
Not applicable – Researchers already have the VR equipment. We are waiting 
for IRB approval and the videos needed for the research study.  
 
22.4.6.2 Storage 
Describe the plans to store, handle the test article so they will be used only on 
subjects and only by authorized investigators. Describe storage temperature 
requirements and how temperature will be monitored and recorded. 
 
All the VR kits and the scripts will be stored in a locked room belonging to the 
Newman Laboratory in the Moore building.  
 
22.4.6.3 Preparation and Dispensing 
Describe how the test article will be assigned to each subject and dispensed. 
Describe the steps necessary to prepare the test article. Include where the test 
article preparation will be done and by whom. Fully describe how the study 
treatment is to be administered and by whom. 
 
The VRET is displayed on a mobile phone app mounted on a VR headset for a 
maximum of 30 minutes per session.  
 

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22.4.6.4 Return or Destruction of the Test Article 
Describe the procedures for final reconciliation of the test article supply at the 
end of the study and whether the test article is to be shipped back to a source 
or destroyed on site. 
 
Not applicable, the VR equipment was purchased and belongs to the University. 
 
22.4.6.5  Prior and Concomitant Therapy 
Describe what prior and/or concomitant medical therapy will be collected. 
Describe which concomitant medicines/therapies are permitted during the 
study. Describe which concomitant medicines are not permitted during the 
study. 
 
Not applicable.  
23.0 References 
List relevant references in the literature which highlight methods, controversies, and study outcomes. 
 
 
American Psychiatric Association. (2013). Diagnostic and Statistical Manual of mental Disorders (DSM-5). 
Washington, DC: American Psychiatric Association. doi: 10.1176/appi.books.9780890425596 
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, 751-760. doi:10.1037/a0033559 
Bangor, A., Kortum, P., & Miller, J. (2009). Determining what individual SUS scores mean: adding an 
adjective rating scale. J. Usability Studies, 4, 114-123.  
Bates, D., Maechler, M., & Bolker, B. (2012). lme4: Linear mixed-effects models using S4 classes.  
Beck, A. T., & Steer, R. A. (1993). Beck Anxiety Inventory manual. San Antonio, TX: Psychological 
Corporation.  
Bouchard, S., & Wiederhold, B. K. (2009). Side effects of immersions in virtual reality for people suffering 
from anxiety disorders. Journal of Cyber Therapy and Rehabilitation, 2, 127–137.  
Bouchard, S., Loranger, C., Robillard, G., & Larouche, S. (2012). Description of a Treatment Manual for in 
Virtuo Exposure with Specific Phobia: INTECH Open Access Publisher.  
Castonguay, L. G., Locke, B. D., & Hayes, J. A. (2011). The Center for Collegiate Mental Health: An Example 
of a Practice-Research Network in University Counseling Centers. Journal of College Student 
Psychotherapy, 25, 105-119. doi:10.1080/87568225.2011.556929 
Emmelkamp, P. M. G. (2005). Technological Innovations in Clinical Assessment and Psychotherapy. 
Psychotherapy and Psychosomatics, 74, 336-343.  
Hansen, N. B., Lambert, M. J., & Forman, E. M. (2002). The psychotherapy dose-response effect and its 
implications for treatment delivery services. Clinical Psychology: Science and Practice, 9, 329-343. 
doi:10.1093/clipsy.9.3.329 
Kennedy, R. S., Lane, N. E., Berbaum, K. S., & Lilienthal, M. G. (1993). Simulator Sickness Questionnaire: An 
Enhanced Method for Quantifying Simulator Sickness. The International Journal of Aviation 
Psychology, 3, 203-220. doi:10.1207/s15327108ijap0303_3 
Kessler, R. C., & Wang, P. S. (2008). The descriptive epidemiology of commonly occurring mental disorders in 
the United States. Annual Review of Public Health, 29, 115-129. 
doi:10.1146/annurev.publhealth.29.020907.090847 
Kuznetsova, A., & Brockhoff, P. B. (2014). Package ‘lmerTest’.  
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McCarthy, J., & Goffin, R. (2004). Measuring Job Interview Anxiety: Beyond Weak Knees and Sweaty Palms. 
Personnel Psychology, 57, 607-637. doi:doi:10.1111/j.1744-6570.2004.00002.x 
Olatunji, B. O., Deacon, B. J., & Abramowitz, J. S. (2009). The Cruelest Cure? Ethical Issues in the 
Implementation of Exposure-Based Treatments. Cognitive and Behavioral Practice, 16, 172-180. 
doi:10.1016/j.cbpra.2008.07.003 
Powers, M. B., & Emmelkamp, P. M. G. (2008). Virtual reality exposure therapy for anxiety disorders: A meta-
analysis. Journal of Anxiety Disorders, 22, 561-569. doi:10.1016/j.janxdis.2007.04.006 
Rosseel, Y. (2012). lavaan: An R Package for Structural Equation Modeling. Journal of statistical software, 48, 
1–36.  
Rozental, A., Kottorp, A., Boettcher, J., Andersson, G., & Carlbring, P. (2016). Negative Effects of 
Psychological Treatments: An Exploratory Factor Analysis of the Negative Effects Questionnaire for 
Monitoring and Reporting Adverse and Unwanted Events. PLoS ONE, 11, e0157503. 
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