Wiring Adolescents With Social Anxiety Via Behavioral Interventions (WASABI): a Closed-loop Mobile Intervention to Reduce Social Anxiety and Improve Social Skills
Phase: NA
Conditions: Social Anxiety
Sponsor: Posit Science Corporation

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Protocol 
 
 
WASABI: Wiring Adolescents with Social Anxiety Via Behavioral Interventions 
 
 
Protocol Number: PSC-1016-19 
 
 
NCT03990870 
 
 
Document Date: November 24, 2020 
 

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TITLE: Wiring Adolescents With Social Anxiety via Behavioral 
Interventions (WASABI): a closed-loop mobile intervention to reduce 
social anxiety and improve social skills 
 
Grant No: 1R43MH 121209-01 
 
 
Dated: November 24, 2020 
Revision 3 
Posit Science Corporation 

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Table of Contents 
 
Principal Investigator and Key Staff ............................................................................ 5 
Site Investigators and Study Locations ........................................................................ 5 
Overview ................................................................................................................... 6 
Specific Aims .............................................................................................................. 6 
Background ................................................................................................................ 6 
Pilot Trial Design and Procedures ............................................................................... 8 
General Study Design ................................................................................................. 9 
Study Population...................................................................................................... 11 
Inclusion/Exclusion Criteria ...................................................................................... 11 
Recruitment ............................................................................................................. 13 
Description of Informed Consent Process ................................................................. 15 
Screening Procedures ............................................................................................... 20 
Study Procedures/Research...................................................................................... 21 
Description of Assessments ...................................................................................... 23 
Description of Protocol Devices (Software Program) ................................................. 25 
Laboratory Specimens .............................................................................................. 33 
Sample Size Justification .......................................................................................... 33 
Data Analysis ........................................................................................................... 33 
Data Management ................................................................................................... 35 
Confidentiality ......................................................................................................... 37 
Disposition of Data ................................................................................................... 39 
Sharing Research Results .......................................................................................... 40 
Foreseeable Risks, Risk Management & Emergency Response ................................... 40 
Potential Benefits..................................................................................................... 43 
Study Personnel ....................................................................................................... 43 
Blinding ................................................................................................................... 45 
Research Monitor .................................................................................................... 46 
Withdrawal from the Protocol .................................................................................. 47 

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Modifications to the Protocol ................................................................................... 48 
Protocol Deviations .................................................................................................. 48 
Reporting of Serious Adverse Effects & Unanticipated Device Effects ........................ 48 
Continuing Review and Final Report ......................................................................... 49 
Surveys, Questionnaires and Other Data Collection Instruments ............................... 49 
References ............................................................................................................... 50 
Appendix I. Table of Assessments ............................................................................. 55 
Appendix II.  Sample Debit Card Information ............................................................ 56 
 

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Title 
Wiring Adolescents with Social Anxiety via Behavioral Interventions (WASABI): a closed-loop 
mobile intervention to reduce social anxiety and improve social skills 
 
Principal Investigator and Key Staff 
The trial is sponsored by Posit Science Corporation (PSC) and is funded exclusively by the 
National Institute on Mental Health (NIMH). Posit Science will serve as the coordinating and 
data monitoring and management center for this study. Key staff and site information may be 
found below: 
 
Principal Investigators 
 
Bruno Biagianti, MD, PhD 
 
 
 
 
Senior Scientist 
 
 
 
 
Posit Science Corporation 
 
 
 
 
160 Pine Street, Suite 200 
 
 
 
 
San Francisco, CA  94111 
 
 
 
 
Tel: (415) 689-6792 
 
 
 
 
Email: bruno.biagianti@positscience.com  
 
Site Investigators and Study Locations 
The University of Minnesota Child and Adolescent Anxiety Clinic and associated clinics will 
serve as the primary recruitment site for this study. The Site Principal Investigator, listed 
below, will oversee participant recruitment and enrollment for this clinical trial.   
 
Principal Investigator 
 
Prof. Gail Bernstein, MD 
University of Minnesota 
Department of Psychiatry & Behavioral Sciences 
F282/2AWest 
2450 Riverside Ave 
Minneapolis, MN 55454 
Tel: (612) 273-9721 
Email: berns001@umn.edu 
 
Clinical Research Coordinator  
University of Minnesota 
Study Tel: (612) 326-4228 
Study Email: wasabi@umn.edu 
 
 

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Overview 
This is a validation study to evaluate the acceptability, feasibility and impact of WASABI 
(Wiring Adolescents with Social Anxiety via Behavioral Interventions), a clinician-assisted, 
adjunct to treatment, mobile application employing a closed-loop technology, designed to 
augment the efficacy of digitally delivered Cognitive Behavioral Group Therapy (dCBGT). The 
goal of this study is to evaluate WASABI in adolescents with Social Anxiety and to prepare for 
a large-scale efficacy trial in this population. 
 
Specific Aims 
This study will employ an innovative and evidence-based mobile intervention that includes 
Ecological Momentary Assessments (EMAs) data collected from mobile devices, the WASABI 
closed-loop algorithm to detect exacerbation of social anxiety, and 1:1 and group-based 
videoconferencing and Instant Messaging with peers and providers. This study will test 
WASABI as an adjunct to dCBGT in adolescents with Social Anxiety (SA), in a parallel arm, 
double-blind, randomized, controlled clinical trial to assess feasibility and initial efficacy, to 
investigate the generalization of trained cognitive skills in the natural environment and ability 
to improve anxiety and social functioning, and to prepare for a large-scale efficacy trial in 
adolescents with Social Anxiety.  
 
Background 
Social Anxiety (SA) is characterized by fear of negative evaluation from others in social or 
performance situations.1 SA affects up to 9% of adolescents,2 with 75% of its extreme and 
persistent forms emerging by mid-adolescence with a median age of onset of 13 years.3,4 If left 
untreated, SA can follow a chronic course2 and lead to consequences such as depression,5 
suicidality,6 substance and alcohol dependence,7 academic under-performance, and increased 
social isolation.8 In addition, since peer interactions carry learning experiences, avoidance of 
social exchanges, used to cope with anxiety in social situations, is more disruptive during this 
time,9 and often results in an impaired development of social skills.10 With SA contributing to 
substantial burden for patients, their families, and to long-term societal costs, it is critical to 
intervene early.11,12 Among the psychological Evidence Based Treatments (EBTs) for 
adolescents with SA, Cognitive Behavioral Group Therapy (CBGT) is considered one of the 
most established, with numerous Randomized Controlled Trials (RCTs) over the last 20 years 
corroborating its efficacy for both adults and adolescents,13–17 and with a recent study showing 
equivalent efficacy after treatment and at one year follow-up between the individual and the 
group format in youth with anxiety disorders.18 However, full diagnostic recovery rate is only 
20.5% in CBGT,18 and up to 50% of patients remain symptomatic post-treatment,19,20 calling for 
treatment augmenters.21 Additionally, only 20% of those with SA seek this CBGT, and even 
fewer ultimately receive it.4,22–25 Certainly the nature of SA contributes to this delay in seeking 

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treatment, as in-person social interactions are required to access professional services.9 For 
those who do seek treatment, barriers to receiving it include geographic location, availability 
of trained therapists, long waiting lists, and the requirement to take time off from school for 
clinic visits.26,27 Therefore, remotely delivering CBGT through video calls (dCBGT) offers 
advantages, including ready accessibility, time flexibility, and convenience. While research 
shows that remotely delivering CBGT to adolescents with SA via digital platforms is 
adaptable, feasible, efficient, cost-effective, and equally efficacious,28–33 we believe that recent 
advances in mobile and communication technology can be harnessed to further improve 
dCBGT delivery for SA:   
1) Existing dCBGT is not informed by patient ecologically valid data on social role 
performance and generalization of trained cognitive skills in real-world settings. Although 
developmentally informed adaptations to dCBGT for adolescents were shown to reduce lab-
based measures of SA symptoms in this population,34 to date no improvements in social 
functioning have been reported. This is problematic, as the inability to behave as desired in 
social situations is the primary reason why most individuals seek treatment, and are of critical 
importance in the clinical presentation of SA, and in diagnostically determining its 
presence/absence.35 Although some authors argue that a patient’s perceived lack of social skills 
is a cognitive distortion that may seriously undermine confidence in social situations,36 this 
lack of effect could be due to the fact that dCBGT does not take place within an ecologically 
valid social context, despite exposure (i.e., repeated confrontation of anxiety-provoking social 
situations without escape/avoidance in order to facilitate extinction)37 being one of its founding 
principles. If integrating cognitive and exposure treatment components is critical to enhance 
social functioning in SA,28,29,38 then the first necessary step would be to collect real-time data 
from social situations at an individual level. Although Ecological Momentary Assessments 
(EMAs) have been shown to increase accuracy, minimize retrospective bias and highlight 
context-specific relationships of symptoms or behaviors,39 only a few studies to date have used 
these experience sampling methods in adolescents to capture manifestations of SA, and/or to 
measure the actual generalization of trained skills in real-world settings.40–42 
2) Existing dCBGT does not provide real-time support to adolescents with SA during stressful 
social situations.  
Importantly, these EMA data can be viewed in real time by CBGT clinicians via digital 
dashboards, and used not only to monitor symptoms and social functioning during the 
intervention, but also to guide the delivery of personalized care. In particular, communication 
methods such as 1:1 Instant Messaging (IM) can be embedded in the intervention to facilitate 
real-time remote communication, and extend the reach of the clinician within the environment 
of adolescents with SA. This was recently demonstrated to be an effective means to provide 
patients with opportunities, encouragement, and reinforcement for using the behaviors and 
skills learned and for receiving the appropriate rewards.43,44 Additionally, these methods help 

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consolidate therapeutic alliance and maintain inter-session continuity, with important 
implications for treatment engagement.45–47 Finally, the reach of peer-support can be extended 
beyond the clinical setting, by means of direct peer-to-peer 1:1 or group IM.43,44 This becomes 
an important source of nonprofessional to practice and improves skills in the everyday lives of 
patients.48 
Based on our expertise in the development of digital platforms that provide individualized 
monitoring and treatments,44,49 we designed WASABI (Wiring Adolescents With Social 
Anxiety via Behavioral Interventions)–a clinician-assisted, adjunct to treatment, mobile 
application. WASABI enriches dCBGT with a mobile solution that provides multi-modal 
monitoring through EMAs, detects via a closed-loop algorithm patterns of symptom 
exacerbation, and cues peers and providers to connect in via IM. WASABI is posited to 
augment the efficacy of dCBGT by promoting the generalization of trained skills in the 
environment of adolescents with SA, thus reducing anxiety and improving real-world social 
functioning.  
 
Pilot Trial Design and Procedures 
Participants will be recruited to join a pilot trial prior to the implementation of the parallel 
arm, double-blind, randomized, controlled clinical trial to assess feasibility and initial efficacy 
of WASABI as an adjunct to dCBGT in adolescents with Social Anxiety (SA). During the pilot 
trial, three focus groups will be organized with a group of three adolescents with SA and at 
least one clinician to refine WASABI and qualitatively evaluate its manageability, clinical 
utility, and acceptability. After the focus groups are completed, participants will be granted 
access to WASABI for two weeks to test its features and evaluate its usability. At the end of the 
2-week trial period, participants will offer feedback on the app through a 1:1 user interview 
with a member of the research team. It is expected that participants will be enrolled in the pilot 
trial for approximately 4 weeks.  
 
Participants must be between the age of 14 to 18 (inclusive) and have clinically significant 
Social Anxiety, as defined by a score of 25 or greater on the Social Phobia and Anxiety 
Inventory-Brief (SPAI-B) for Adolescents. Participants must have access to reliable Internet 
connection and must be willing to engage in remote and/or in-person activities to qualify for 
enrollment. 
 
Prior to initiating any pilot trial procedures, Site Study personnel will screen potential 
participants (either over the phone or in-person) using an IRB-approved screening 
questionnaire that assesses for inclusion and exclusion criteria. If the potential participant 
appears eligible, they and their parents/legal guardian(s), when appropriate, will be invited to 
a consent/assent discussion with a designated team member prior to enrollment 

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Consenting/assenting to research activities will take place remotely or in a private room at the 
Study Site.  During the consent/assent discussion, the qualified Site Study personnel 
authorized by the Site Principal Investigator and the potential participant and their 
parent/legal guardian will discuss the nature, purpose, and procedures of the pilot trial, the 
possible risks and benefits of participation, confidentiality, and the voluntary nature of 
participation in the pilot trial (emphasizing the participant’s right to withdraw from the focus 
group at any time). Participants will also be informed of the compensation procedures; 
specifically, participants will be paid $10 for completing the consent and screening procedures, 
$25 for participating in each focus group session, $25 for completing 2-weeks of WASABI app 
activities, and $15 for completing a 1:1 user interview. Participants that complete all activities 
will earn a total of $125. Compensation will be provided through CashPass, a reloadable debit 
card through a third-party vendor, CT Payer. Payment will be provided upon exiting from the 
pilot trial, following the completion of the 1:1 user interview. If a participant leaves early, for 
any reason, and does not complete all focus group activities, they will be paid only for 
activities they have completed. Upon agreeing to participate in the pilot trial and signing 
consent/assent documents, participants will be asked to complete the SPAI-B to confirm their 
eligibility for the study (a score of 25 or greater).   
 
Once three participants are deemed eligible and enrolled in the pilot trial, they will be 
scheduled for three focus group sessions that could occur in-person or remotely, to be 
completed over the course of approximately 2-weeks. Each session will last approximately 1 
hour and will be facilitated by the study clinician(s). After feedback from the focus group 
sessions is implemented into the app and dashboard design, the three adolescents will be 
granted access to the WASABI app and engage in a 2-week trial period, during which the 
predictive ability of the algorithm will be validated by the WASABI clinician, who will verify 
via 1:1 remote videocalls the actual presence of clinically-significant social anxiety whenever 
the WASABI clinician receives an alert. Additionally, this trial period will ensure that WASABI 
EMA data are timely evaluated by the clinician on the dashboard and meaningfully orient the 
delivery of individualized IM and weekly dCBGT content. At the end of the 2-week trial 
period of WASABI, participants will be asked to rate their enjoyment, ease of use, product 
quality, and perceived usefulness in a 1:1 user interview. Finally, we will submit these data 
from the trial period to our consultant to confirm that WASABI is suitable for the feasibility 
trial.  
 
General Study Design 
We will employ a standard prospective, parallel arm, double-blind, randomized, controlled 
clinical trial to assess the safety and efficacy of WASABI in adolescents with Social Anxiety 
(SA), and evaluate its potential in augmenting the efficacy of dCBGT in improving social 

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anxiety, social skills and social functioning. We will randomize adolescents with SA (ages 14-
18) to receive either 12 weeks of dCBGT+WASABI or dCBGT only. 
 
Approximately 32 participants will be consented to ensure the successful completion of 24 
participants (12 participants per treatment arm). A diagnostic interview will be performed to 
determine eligibility. Following inclusion and enrollment, participants will complete a set of 
assessments prior to the intervention to establish their baseline performance. Participants will 
then be randomized to dCBGT+WASABI or dCBGT only and spend up to 12 weeks engaged in 
their assigned intervention.  
 
Participants assigned to receive WASABI will complete at least 3 EMA sessions per week, 1 
hour of digitally delivered Cognitive Behavioral Group Therapy (dCBGT) per week, and 
weekly cognitive biases assessments and self-reports for 12 weeks. During the intervention, 
these participants will also have daily access to 1:1 and group chat Instant Messaging (IM) and 
may have weekly electronic check-ins with Site Study personnel (as needed). Participants in 
the control condition will be asked to attend 1 hour of digitally delivered Cognitive Behavioral 
Group Therapy (dCBGT) per week for 12 weeks and may have weekly electronic check-ins 
with Site Study personnel (as needed).  
 
For each arm, as soon as 3-6 participants have completed the baseline assessments and 
randomization, a cohort will be assembled. The Study Coordinator will meet with the 
participants to orient them to the study platforms and the WASABI Clinician will meet with 
each participant individually for a brief introduction and orientation prior to the 12-week 
intervention and will review of the Procedures and Guidelines to Group Therapy. The WASABI 
Coordinator and/or Clinician will create a virtual support group open only to cohort 
participants. The WASABI Clinician will explain her role, make group introductions, and will 
invite participants to attend weekly 1-hour group sessions (dCBGT+ WASABI or dCBGT only, 
depending on the treatment arm). For the treatment group (dCBGT + WASABI), between 
group sessions, the WASABI Clinician will spend approximately 30 min/day keeping the chat 
active during work hours, checking it approximately 3 times a day and may respond to 
messages participants leave, as appropriate. The WASABI Coordinator will be included in the 
support group chat and may monitor the chat content, and may be active in the chat in the 
absence of the WASABI Clinician. 
 
Participants will be re-evaluated again at the expected time of completion, immediately 
following the 12-week intervention, to evaluate changes in performance. Finally, participants 
will be asked to fill out an online exit survey to rate enjoyment, usability, perceived benefits, 
and ease of fit into schedule. 

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The protocol will be conducted in accordance with the protocol submitted to and approved by 
the reviewing Institutional Review Board and approval will be obtained prior to 
implementation.  
 
Study Population 
The study population is comprised of adolescents diagnosed with Anxiety Disorder, 
specifically those with clinically significant social anxiety. The study is open to all races, 
ethnicities, and genders.  
 
Inclusion/Exclusion Criteria 
We will use standard diagnostic criteria and classifications for Social Anxiety. Following 
informed consent, participants will be screened for the following inclusion/exclusion criteria.   
 
Inclusion Criteria 
1) Potential participant is between the age of 14 and 18 (inclusive) at the time of consent 
2) Potential participant has a clinical diagnosis of Anxiety Disorder, as confirmed using the 
Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID), a 
brief structured diagnostic interview using DSM-IV criteria  
3) Potential participant has clinically significant Social Anxiety, as defined by a score of 25 or 
greater on the Social Phobia and Anxiety Inventory-Brief version. 
4) Potential participant is clinically stable at time of screening as determined by the screening 
clinician/study team and the following criteria: 
- 
Potential participant has not experienced a psychiatric hospitalization within the 
4 weeks prior to screening 
- 
Potential participant on a medication for anxiety and psychiatric disorders must 
be on a stable medication regimen for ≥ 4 weeks prior to screening, based on self-
report.  
5) Potential participant has an IQ Score > 80 as determined by performance on the Wechsler 
Abbreviated Scale of Intelligence (WASI-II) 
6) Potential participant is a fluent English speaker, based on participant and/or parent/legal 
guardian self-report and as determined by the screening clinician, to ensure reasonable 
neuropsychological results on key assessments 
7) Potential participant has adequate sensorimotor capacity to perform the intervention and 
study activities, including visual capacity adequate to read from a computer screen or 
mobile device at a normal viewing distance, auditory capacity adequate to understand 
normal speech, and motor capacity adequate to control and use a mobile device and/or 
computer, based on participant and/or parent/legal guardian self-report and as determined 
by the screening clinician and/or study team  

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8) Potential participant has reliable access to wireless Internet connectivity 
9) Potential participant can use iOS mobile applications 
 
Exclusion criteria: 
1) Potential participant has a diagnosis of autism spectrum disorders, history of seizure 
disorder or seizure episodes within the last 2 years 
2) Potential participant is receiving psychotherapy at the time of randomization 
3) Potential participant has a history of mental retardation, pervasive developmental 
disorder, head trauma, traumatic brain injury, or other neurological disorder that impairs 
cognition 
4) Potential participant has medical illnesses deemed to interfere with participation in study 
activities and/or unstable and/or untreated conditions that may affect cognition, including 
substance abuse/dependence disorders, ongoing chemotherapy or other cancer treatment. 
5) Potential participant has history or current DSM-IV diagnosis of organic mental disorder, 
schizophrenia, schizoaffective disorder, delusion disorder, psychotic disorder NOS, bipolar 
disorder, substance dependence (<1 year), and/or mood congruent or mood incongruent 
psychotic features or disorders 
6) Potential participants had significant medication changes, including changes to anxiety 
medications or other psychiatric medications, in the 4 weeks prior to screening 
7) Potential adult participant scores less than a 14 (75%) on the University of California, San 
Diego Brief Assessment of Capacity to Consent (UBACC). Please note, this criteria applies 
only to adult participants, age 18, at the time of screening. 
8) Potential participants who have answered ‘yes’ to: 
a. Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the Columbia-
Suicide Severity Rating Scale (C-SSRS), or, 
b. Any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted 
attempt, preparatory act or behavior) on the C-SSRS “Suicidal Behavior” portion  
will be excluded from the study if the ideation or behavior occurred within 2 months from 
Participant’s date of consent (as recommended by the FDA for treatment trials.)  Participants 
excluded for this reason will be referred for appropriate treatment. Further, the C-SSRS 
form will also be administered to all participants at the follow-up visit.  Participants 
meeting these criteria at any time throughout the study will be asked to complete a final 
assessment, if appropriate, then withdrawn from the study and referred for appropriate 
treatment. 
9) Potential participants that show signs of intoxication or are under the influence due to 
current substance abuse (including alcohol and/or illegal drugs) during any in person visit 
or dCBGT session will be evaluated on a case-by-case basis.  Such participants may have 
that visit re-scheduled or may be asked to exit the dCBGT session, as appropriate. 

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Participants with this problem occurring more than once may be excluded and dropped at 
the discretion of the PI(s). 
10) Potential participant has problems performing assessments or comprehending or following 
spoken instructions, or participant displays behaviors during assessments visits or dCBGT 
sessions that, in the judgment of the clinician and study team, are likely to present 
significant problems for the Site Study personnel or other participants. 
11) Potential participant is enrolled in a concurrent clinical trial involving an investigational 
pharmaceutical, medical device, behavioral treatment, or any other clinical trial that could 
affect the outcome of this study. However, participation in standard treatments (e.g., 
occupational therapy) or use of prescribed medications is allowable. 
 
Recruitment 
Study participants will be recruited through several recruitment mechanisms in an effort to 
examine engagement and acceptability in a representative sample of patients with Social 
Anxiety. Following IRB approval, IRB-approved recruitment materials and information about 
the study aims and procedures may be posted on Youtube, Facebook, Craigslist, Reddit, 
Instagram, Tik Tok, newsletters, the study website, as well as other web-based recruitment and 
social media sites. In addition, efforts will be made to recruit participants through several 
community mental health and primary care clinics and/or referrals, school-based settings 
and/or referrals, community organizations, and publicly hosted information sessions and 
webinars. Following IRB approval, a WASABI recruitment video, which includes a brief 
description of the study and may include members of the study team, may be shared with 
potential participants, with identified recruitment sources, and the community for recruitment 
purposes and engagement. Patients may also contact the Site Study team directly via the 
phone or the internet (email, website, social media, etc.).  
 
The PI has extensive professional contacts and community clinician referrals. Thus, study 
participants may also be recruited through the patient network of the University of Minnesota 
Department of Psychiatry Child and Adolescent Anxiety Clinic and the University of 
Minnesota Physicians (UMP) Psychiatry Clinics. Potential participants may be identified by 
clinicians within the UMP Psychiatry Outpatient Clinics. Clinicians treating eligible patients in 
clinic may briefly introduce the study to their patients and/or the patient’s parents/legal 
guardians. To prevent perceived therapeutic benefit or other coercion for participation in this 
trial, principal investigators will not be involved in consent discussions and will be minimally 
involved in study procedures that involve direct participant contact. If the individual is 
interested, they will be introduced to a member of the Site Study personnel or the Psychiatry 
Research Recruitment Specialist to explain the study in greater detail.  
 

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The Department of Psychiatry & Behavioral Sciences at the University of Minnesota provides 
patients with the opportunity to indicate whether they are interested in being contacted to 
learn about research studies through enrollment into a recruitment registry. This is 
accomplished through provision of a secure electronic REDCap consent form. Access to the 
voluntary contact information is managed by the Department of Psychiatry & Behavioral 
Sciences and securely stored and accessed by the Institute for Health Informatics Data 
Warehouse (BPIC) at CTSI (UL1TR002494). The department’s Research Recruitment Specialist 
partners with BPIC to request a registry database for specific, IRB approved research. The 
Study Site intends to request permission to receive this contact information to recruit 
participants for the study.  
 
Additionally, this study may be advertised on the Psychiatry Department website and 
recruitment areas in the lobbies of the Child and Adolescent Anxiety Clinic and/or other 
University of Minnesota Physicians (UMP) Outpatient Clinics. Potential participants and/or 
their parents/legal guardians may self-identify to advertisements online or to advertisements 
(e.g. flyers, recruitment contact cards) posted in the recruitment areas in the lobbies of the 
UMP Psychiatry Clinics.  
 
The Site study team may host various information sessions and/or webinars within the 
Minnesota community in an effort to recruit participants.  The Site Study team may also 
contact schools and school personnel (e.g., teachers, nurses, counselors, etc.) and/or school-
related organizations within Minnesota to host a webinar or information session about the 
WASABI Study. These sessions may include discussions regarding approaches to identify 
students who may be experiencing social anxiety or have related concerns. The Site Study 
team may provide the school staff with resources to refer students of concern (e.g. flyers, the 
recruitment video and other recruitment materials).  
 
As the Sponsor, Posit Science will strictly serve as a coordinating and data monitoring and 
management site. The Posit Science study team will directly manage this study using standard 
and established methods. Site Study personnel will be invited to complete virtual training 
sessions conducted by Posit Science study team and/or the PI will visit the Study Site to 
engage in a hands-on orientation of the mobile application and clinician’s portal. Eligible 
patients undergoing treatment for Social Anxiety, with the exception of psychotherapy, that 
participate in the study will be able to continue with their treatment regime as planned. 
Potential participants receiving psychotherapy at the time of randomization will not be eligible 
for the study and will not be randomized and enrolled, per exclusion criteria. The intervention 
is designed to serve as adjunct to conventional care to remotely capture and document 
changes in anxiety, social anxiety, real-world social functioning and cognitive biases. 

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Enrollment and assessments will be performed by authorized Site Study personnel remotely 
and/or at the Study Site, the University of Minnesota. Participants will perform the 
intervention activities, either dCBGT+WASABI or dCBGT only, remotely in their place of 
residence. This project will employ established Sponsor- and Site-procedures for compliance, 
treatment delivery and communication to ensure standardization of all study procedures.  
 
The emphasis of the benefit will be on advancing science to assist others with Social Anxiety.  
Compensation will be described in appropriate terms that are not overemphasized relative to 
the remainder of the text.  No indication of “free medical treatment” will be communicated. 
All materials used for advertising or recruitment will have received IRB approval prior to 
implementation. The Site Study Coordinator will manage these efforts and contact 
individuals that express interest.  The aim of this discussion is to describe the study, answer 
any questions, and if the potential participant agrees, conduct a preliminary screening. Site 
Study personnel will conduct an interview with a screening questionnaire, over the phone or 
in person, in which potential participants will be asked about the presence of inclusion and 
exclusion criteria. If the participant appears eligible, they and their parents/legal guardians, 
when appropriate, will be invited to a consent discussion.   
 
All study team members are required to follow Good Clinical Practices and institutional best 
practices in the identification and recruitment of research participants. Volunteer selection will 
be equitable: all participants meeting Inclusion/Exclusion criteria will be offered the 
opportunity to participate in this study regardless of gender, race and/or ethnic origin. Basic 
demographic data will be collected from participants screened for participation but not 
meeting study eligibility requirements to ensure that the opportunity to participate in this 
research study has been extended to all potential participants in an equitable manner. 
 
Description of Informed Consent Process 
For participants that move forward following the initial screening, every effort will be made to 
send a copy of the consent form and HIPAA waiver via email ahead of their scheduled 
appointment. Assent/Consent forms for adults, minors (youth), and parents/legal guardians of 
minors will be written using appropriate vocabulary and language and will be accessible (non-
technical). As minors cannot give legal consent to participate in research, a parent or legal 
guardian must sign a consent form on their behalf. However, we will still obtain the minor’s 
written or electronic assent to ensure their voluntary participation in the research study. As 
with consent, the research study will be explained to them in language they will understand.  
 
To ensure that the potential adult participants have the capacity to provide informed consent, 
a modified version of the UCSD Brief Assessment of Capacity to Consent (UBACC) will be 

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administered. In the modified version of the UBACC, Question 10 was not included as the risk 
of hospitalization due to research is unlikely, and there is no corresponding information in the 
consent document. If the participant scores less than a 14 (75%) on the UBACC, the study staff 
obtaining consent may review the study details and re-administer the UBACC. If the 
participant is still unable to pass during the second administration, they will not be offered 
participation at this time. Participants may return for a consent visit in the future if, in the 
opinion of the clinical care provider and/or the PI, their status has improved and they may 
have regained capacity to consent to research. In addition, if at any point during the study the 
staff has reason to suspect that the individual’s capacity to provide consent has diminished 
(e.g., the participant has increased symptoms), the study staff may choose to conduct another 
consent discussion and/or re-administer the UBACC to confirm that the participant has 
capacity to provide ongoing consent. If the participant does not show capacity to consent, the 
PI will review their case and determine whether it would be best to withdraw the participant 
from the study or place their participation on a temporary hold until the participant is capable 
of providing informed consent. If the participant is placed on hold, they must successfully 
complete the UBACC prior to continuing with study procedures. 
 
Potential participants will meet with the designated team member for assent/consent and 
potential enrollment. Consenting to research activities will take place in a private room at the 
Study Site or electronic consent may be conducted remotely, by phone or videocall. During 
this visit, the qualified Site Study personnel authorized by the Site Principal Investigator and 
the potential participant and their parent/legal guardian will discuss the nature of the trial, the 
purpose of the research, the trial procedures, the possible risks and benefits of participation, 
confidentiality and the voluntary nature of participation in the trial (emphasizing the 
participant’s right to withdraw from the study at any time).  Site Study personnel obtaining 
consent will emphasize that the study will not influence that participant’s clinical care or their 
relationship to the University of Minnesota and/or Posit Science. 
 
Following this discussion, potential participants and their parents/legal guardians will be 
offered the opportunity and encouraged to ask any study-related questions and enroll by 
providing written assent/consent on the IRB-approved form. For remote consent discussions, 
participants and/or their parent/legal guardian will navigate to the electronic consent/assent 
form shared through REDCap. The electronic consent/assent form has been designed so that 
the participant and their parent/legal guardian are unable to complete the consenting process 
without completing the consenting process with a member of the research team. Participants 
and/or their parent/legal guardian will first receive a “Read Only” version of the consent. Only 
after the research coordinator has completed the informed consent discussion and determined 
the parent/legal guardian and/or participant fully understand all procedures and are capable 

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of informed consent will he/she sign the electronic consent form and deliver an “editable” 
version of the electronic consent form which the participants and/or their parent/legal 
guardian will be able to sign. For the electronic consent process to be considered complete, the 
consenting team member will access REDCap in real-time to confirm the parent/legal guardian 
and/or participant have signed the consent/assent form correctly.  
 
Participants will be allowed as much time as needed, with Site Study personnel or in private, 
to review the HIPPA waiver and consenting documents before making the decision to 
participate. Potential participants may invite a friend or family member to be present during 
the visit, to further discuss their decision to enroll and/or contact (e.g., phone call) a friend or 
family member that is not physically present for discussion before deciding to enroll.  At the 
potential participant’s request, Site Study personnel may be asked to ‘step-out’ of the room or 
end/mute the call during remote discussions, to provide privacy for such discussions. In 
addition, potential participants will be provided the option to defer their decision to allow 
them to review the consent form and other study information forms at their convenience, and 
later reconnect with the Site Study team remotely or return to the Study Site to enroll (i.e., 
complete the informed consent procedures).  No study activities will take place prior to 
completion of the consenting process.  
 
Participants will not be invited for consent discussions during periods of greater impairment. 
Participants must have been in outpatient status and on stable medications for 4 weeks prior to 
signing assent/consent. If a participant is hospitalized for psychiatric reasons during the study, 
they will be withdrawn from study activities. Additionally, consent to continue in the study 
will be addressed as needed throughout the study and the participant will be reminded that 
their participation in this study is completely voluntary and they do not have to continue 
unless they choose to.  
 
The consenting Site Study team member will inform participants about compensation for their 
participation in the study. Specifically, participants will be compensated $20 for completing 
the Screening assessment visit (V0), $25 for completing the Baseline (pre-intervention) 
assessment visit (V1),  $15 for completing the Program Set-up visit (V2), $10/week during the 
12-week intervention period, given participants complete their weekly dCBGT session, and 
$75 for completing the End of Study (post-intervention) assessment visit (V3). Participants that 
complete the study in its entirety will earn $255. Compensation will be provided through 
CashPass, a reloadable debit card through a third-party vendor, CT Payer.  For remote 
assessments, the CashPass card will be mailed to participants to a mailing address of their 
choice after the completion of the Screening assessment visit (V0). Compensation will not be 
provided to participants that complete the informed consent process but do not complete the 

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Screening assessment visit (V0). In the unlikely event that a participant must repeat an 
assessment visit due to administrative assessment or Site Study personnel errors, participants 
may be provided additional compensated for that session. Compensation during the 
intervention period will occur on a weekly basis and participants will be paid for attending 
their dCBGT treatment session that week. 
 
 
 
 
 
 
 
 
 
 
 
If, for any reason, e.g. technical or CT Payer vendor issues prevent the Site Study personnel 
from issuing the reloadable debit card, adding funds to the reloadable debit card, or making 
any other changes to the debit card, participants may be compensated through a gift card (e.g. 
Amazon eGift Card, Visa Gift Card, or similar vendor). In such cases, participants are expected 
to read the associated terms and conditions for the respective gift card. For Amazon eGift 
Cards, the participant must accept the eGift Card through their email; participants will be 
notified of this requirement prior to sending the payment, and will be asked to provide verbal 
consent to receiving payment in this method.  
 
If the participant does not complete the study or withdraws early for any reason, the 
participant will only be compensated for the study visits and/or treatment sessions they have 
completed.  
 
All participants will receive compensation for the Screening assessment visit (V0) after the end 
of the visit, regardless of eligibility. For participants who are loaned a mobile device for the 
duration of the intervention period, compensation for all study activities completed from V1 
through V3, including the intervention period, will occur after the participant returns the 
loaned device to the Site Study personnel. If participants are unable to meet with Site Study 
personnel in person to return the device, the participant will be sent a pre-paid label and box 
(if necessary) to return the mobile device at no cost to them. Participants who withdraw from 
the study will be compensated for all study visits they have completed once the loaned device 
has been returned to the Site Study personnel. For participants who do not return the device, 
Visit 
Compensation 
Screening 
$20 
Baseline 
$25 
Program Set-up 
$15 
Intervention Period 
($10/week for 12-weeks, 
up to $120) 
$120 
Post-Intervention 
$75 
Total Participant 
Compensation 
$255 

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all forms of appropriate means and communication (e.g. phone contact, email, mailed letters) 
will be used in an effort to retrieve the study device. The mobile device that is loaned out may 
have GPS enabled as part of the Find My Device feature that will allow the Site Study 
personnel to ping the device if the participant needs assistance with locating it. This feature 
will also be used to remotely deactivate a device so that the device is unusable, and/or erase 
the contents of the iPad, when necessary and if a loaned study device is not returned to the 
Site Study personnel at the end of the study. 
 
Participants who do not return the study device will receive their compensation after Site 
Study personnel have exhausted all means of contact in an attempt to return the device (a 
maximum of three months after the end of study participation). Participants will not face any 
legal or financial retribution for failure to return the study mobile device. 
 
During the consenting process, participants will also be requested to fill out an emergency 
contact form. This form will detail primary and secondary emergency contact information. If 
the participant agrees to fill this form out, the participant authorizes the Site Study personnel 
to contact the primary or secondary emergency contact in case of a study-related emergency. 
Participants will also be asked to sign a Site-specific Release of Information authorizing Site 
Study personnel to communicate with the participant’s clinical care provider to confirm and 
discuss their diagnosis, symptoms, treatment status, study participation, and to discuss any 
safety concerns that are discovered during the course of the study. Site Study personnel may 
request relevant records from the participant’s care team if there is a relevant health concern 
(e.g., hospitalization for psychiatric reasons). Participants will be notified before Site Study 
personnel contacts their care team for any reason.  
 
A copy of the informed assent/consent will be provided directly to the participant and/or 
parent/legal guardian, a fully-executed copy will be retained in a secure manner at the 
recruitment site and be available for inspection at the site upon the request of representatives 
of the reviewing Institutional Review Board or other relevant regulatory agencies. No study 
activities will take place prior to completion of the assent/consent process. The copy of the 
consent form provided to the participant will include telephone and email contact information 
for the Site Study Coordinator and the Site PI.  At any point during or after completion of the 
study, the participant may contact the Site Study Coordinator, Site PI or the reviewing 
Institutional Review Board to obtain additional information regarding his/her rights as a 
participant. No participant will be under legal commitment at the time of their consent or 
during their participation in the study. 
 

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Screening Procedures 
Following informed consent, potential participants will go through a set of structured 
interviews and short neuropsychological assessments and provide basic demographic 
information to evaluate their suitability for the study given the inclusion/exclusion criteria.  
The screening procedures include: 
 
• Clinical Evaluation: Clinical diagnosis of Anxiety Disorder will be assessed using 
the Mini International Neuropsychiatric Interview for Children and Adolescents 
(MINI-KID), a brief structured diagnostic interview using DSM-IV criteria. Clinically 
significant Social Anxiety will be assessed using the Social Phobia and Anxiety 
Inventory-Brief version, as defined by a score of 25 or greater.  
• Cognitive Status: the Wechsler Abbreviated Scale of Intelligence (WASI-II), 
specifically the Vocabulary and Reasoning subscales, will be used to assess 
participant IQ. Participants’ IQ score must be great than 80 to be eligible for 
enrollment. For adult participants, the UBACC will serve as an additional measure 
to assess cognitive status. Participants scoring less than a 14 (75%), may be indicative 
of compromised cognitive status.  Those that cannot pass the UBACC will not be 
eligible for enrollment 
• Participants will be asked to complete the Columbia-Suicide Severity Rating Scale 
(C-SSRS); potential participants that answer ‘yes’ to: 
o Question 5 (Active Suicidal Ideation with Specific Plan and Intent) or, 
o Any of the suicide-related behaviors (actual attempt, interrupted attempt, 
aborted attempt, preparatory act or behavior) on the “Suicidal Behavior” 
portion  
will be excluded from the study if the ideation or behavior occurred within two months 
from Participant’s date of consent (as recommended by the FDA for treatment trials.)  
Participants excluded for this reason will be referred for appropriate treatment. 
Further, participants meeting these criteria at any time throughout the study will be 
asked to complete a final assessment, if appropriate, then withdrawn from the study 
and referred for appropriate treatment 
• Demographics and Medical History: A structured clinical interview will be used to 
collect key demographic and medical history information, including medical 
diagnoses or conditions that may be grounds for exclusion (e.g., schizophrenia, 
ongoing or recent chemotherapy), current therapies (including enrollment in other 
clinical trials that may be grounds for exclusion), medications, as well as age. Those 
taking medications for anxiety and psychiatric disorders will not be excluded;  
instead, their treatment will be evaluated and entered as covariates in all statistical 
analyses. 

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Participants expressing interest in the study that do not meet certain eligibility criteria, e.g. 
have experienced a change in medication or have been hospitalized within the last 4 weeks, 
have an upcoming medical procedure, surgery or treatment that would interrupt their 
participation, have experienced suicidal ideation or behavior within two months or those with 
known future end dates to psychotherapy treatment, will be placed on hold and re-screened 
for appropriate eligibility criteria.  
 
Study Procedures/Research  
Study Procedures: Participants at the recruitment Site will flow through the study in the 
following manner: 
1. Informed Consent Discussion: Site Study personnel will discuss study goals, activities, and 
requirements with the parent/legal guardian and/or potential participant; complete the 
informed consent discussion, and if/when appropriate the potential participant will 
complete assent/consent to join study.  
Duration: ~30-60 minutes remotely or in-person at the Study Site. 
 
2. Initial Screening Visit (V0):  Following assent/consent, Site Study personnel will perform 
diagnostic assessments and interviews and assess inclusion/exclusion to determine if 
the participant is eligible for enrollment.  
Duration: ~2-3 hours remotely or in-person at the Study Site. The Informed Consent 
Discussion and the Initial Screening Visit (V0) may occur independently or may be 
combined in a single session. 
 
3. Baseline Assessment (V1): Following enrollment, the participant will perform all 
social/cognitive baseline characterization assessments and questionnaires prior to the 
intervention period. Duration: ~2 hours remotely or in-person at the Study Site. 
 
4. Randomization: Participants will be randomized into one of two treatment groups.  
 
5. Mobile device Set-Up and Proctored Application Use (V2): The participant will be oriented 
to the intervention activities and program application(s). Participants assigned to both 
WASABI and the active control arm will complete a series of mobile assessments during 
this visit (embedded baseline assessments via BrainHQ) .  
 
Participants with a compatible personal device that are willing to download the 
necessary application(s) for program use will have their device set-up at this visit. 
Participants in assigned to WASBAI will be guided to schedule reminders for 

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completing their study activities. Participants that do not have a compatible personal 
device, do not wish to use their personal device, or do not agree to configure their 
settings and download the necessary application(s) for program use will be loaned a 
mobile device for the duration of the Intervention and Program Use period. Participants 
will be asked to sign a form acknowledging they have been loaned a study device. The 
research team may attempt to complete this visit on the same day as Baseline Assessment 
(V1), but a separate visit may be scheduled, if necessary.   
Duration: ~30-60 minutes remotely or in-person at the Study Site. 
 
6. Intervention and Program Use: Participants will have a 1:1 orientation with the WASABI 
Clinician prior to engaging in their assigned group intervention activities. Site Study 
personnel will review the Procedures and Guidelines to Group Therapy and will ask the 
parent/legal guardian and/or participant to review and sign this form. After which, 
participants will remotely engage in the intervention for 12 weeks, completing 
approximately 12 hours of dCBGT in addition to other assigned study activities.   
 
7. Post-Intervention Assessment (End of Study Visit; V3): After the Intervention and Program 
Use period is completed, the participant will be asked to complete their final assessment 
visit, where they’ll repeat all assessments performed at baseline to assess changes in 
performance.  
Duration: ~2 hours remotely or in-person at the Study Site. 
 
Participants expressing interest in returning their device to its original settings will be 
instructed by Site Study personnel on how to delete study application(s) during this 
visit or at the time of study exit. Participants loaned a study device will be asked to 
return the loaned device at this visit.  
 
If participants were loaned a mobile device to complete study activities at home and no 
longer wish to participate in study activities, including their post-intervention 
interview, Site Study personnel will attempt to coordinate with the participant to return 
the device at a time that is convenient for the participant. If participants are patients at 
the Child and Adolescent Anxiety Clinic or associated UMP Psychiatry Clinics, Site 
Study personnel may attempt to meet them before or after a regularly scheduled clinic 
appointment to return the loaned device. If the participant cannot be reached, Site 
Study personnel will send them a letter asking them to return the device along with a 
box with a return label. Participants will be invited to come back for a follow up visit in 
this letter, but also reminded that they are free to no longer participate in the study. Site 
Study personnel may also send this letter to participants who completed all study 

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activities but forgot to return the device and are unable to coordinate with Site Study 
personnel to return it. 
 
8. Exit Survey (~10 minutes): Participants will be asked to fill out an online exit survey to 
rate enjoyment, usability, perceived benefits, and ease of fit into schedule. 
 
Assessments.  
The complete assessment battery will be performed at the pre-intervention assessment 
(Baseline Assessment, V1) visit and at the post-intervention assessment (End of Study, V3) visit. 
For a full list of all assessments and administration times, please direct your attention to the 
Description of Assessments or Appendix I. We will use assessments of functional abilities to 
determine the degree of transfer of benefit to real-world experience (e.g., symptoms, social 
functioning, quality of life). 
 
All assessments will be administered to all participants; alternate forms of the assessments will 
be used when available to mitigate test-retest effects. Performance on all measures will be 
scored, submitted into the study database, and monitored for accuracy and integrity. Any 
discrepancies in scoring will be resolved by referring to the raw data collected during the 
assessment visit(s).  
 
Description of Assessments 
 
Diagnostic Assessment 
Standard diagnostic criteria and classifications for Anxiety Disorder as defined by the Mini 
International Neuropsychiatric Interview for Children and Adolescents (MINI-KID), a brief 
structured diagnostic interview using DSM-IV criteria and standard diagnostic criteria and 
classifications for Social Anxiety, as defined by the Social Phobia and Anxiety Inventory-Brief 
version, as defined by a score of 25 or greater, will be used to assess eligibility. If information is 
gathered from self-report questionnaires, emergency contacts, the participant’s psychiatrist, 
therapist, and/or primary care physician, this may be used to corroborate and supplement the 
participant interview to assess eligibility. 
 
Clinical and Neuropsychological assessments and characterization 
The study will employ empirically validated assessment measures specific to anxiety and 
depression, and also adhere to recent NIH Toolbox recommendations.  Collectively, we have 
chosen a battery based on five key criteria (when possible), including 1) existing 
standardization, to ensure reliable data collection procedures, 2) sensitivity to the impairment 
typical of this study population, 3) normative data availability, 4) reasonable test-retest 

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stability (i.e., to control for potential participant improvement through strategy learning over 
repeated measures) for use in a treatment trial with two repeated measures, and 5) good 
sensitivity to change following remediation. Several measures will be used to provide gross 
clinical characterization. 
 
Cognitive Assessments 
Screening. Cognitive status will be assessed using WASI-II, specifically the Vocabulary and 
Reasoning subscales. Participants must score IQ > 80 to enroll in the study. Adult participants 
will undergo an additional cognitive assessment, the UBACC. Participants must score within 
the normal range; participants who cannot pass the UBACC will not be eligible for enrollment. 
 
Anxiety and Social Anxiety 
Clinician ratings of anxiety and social anxiety symptoms will be assessed through the 
Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA).50 Self-report 
inventories of social anxiety symptoms through the Social Phobia and Anxiety Inventory 
(SPAI)51 will be completed at the Baseline (V1) and End of Study (V3). Broad measure anxiety 
and potential generalization of treatment to other anxiety domains will be captured through 
the Multidimensional Anxiety Scale for Children 2nd Edition (MASC-2). 
 
Social Functioning  
We will assess social skills by administering the Social Skills Questionnaire (SSQ);52 and social 
functioning using the Adolescent Social Self-Efficacy Scale (ASSES).53 
 
Suicidality Assessment 
The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to screen for and assess 
suicidal ideation. Those that do not meet inclusion criteria for this assessment will not be 
enrolled in the study. Participants who do not meet this criteria but express interest in the 
study may be reengaged and reassessed following a 2-month period. The C-SSRS will be 
repeated at the End of Study (V3) Visit to screen for any changes in suicidal ideation over the 
course of the study. The C-SSRS may be re-administered during the intervention period, as 
needed, should there be any concerns for safety or increasing symptoms. 
 
Intervention Embedded Assessments 
Cognitive Biases. Participants in both the WASABI and active control arm will complete 
embedded assessments immediately before and after the 12-week intervention. Additionally, 
for participants assigned to WASABI, during the intervention and program use period, 
WASABI weekly collects performance data on two cognitive assessments that capture 
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receive WASABI will also complete a weekly SPAI-B assessment. Performance on these 
assessments will be modeled longitudinally to examine if these measures can serve as 
potential moderators and mediators of treatment efficacy.  
 
The primary outcome measures, including assessment adherence, dCBGT and IM 
engagement, EMA, SPAI-B and overall program completion rates, reported adverse effects, 
usability ratings and clinician burden, will be used to assess feasibility, acceptability and 
usability of WASABI.  
 
Secondary outcomes include clinical ratings of anxiety and social anxiety symptoms (LSAS-
CA), self-report inventories of social anxiety symptoms (SPAI), broad measures of anxiety 
(MASC-2), as well as measures that capture social skills (SSQ), and social functioning (ASSES).  
 
Description of Protocol Devices (Software Program) 
This study employs two mobile-device delivered interventions: the treatment intervention 
(dCBGT+WASABI) and an active control (dCBGT). Participants will be asked to use their 
assigned program activities over the course of the 12-week Intervention and Program Use period.  
Participants will be asked to complete 12 weekly 1-hour group sessions (dCBGT) led by a Site 
Study Clinician (WASABI Clinician). Participants assigned to the treatment intervention 
(WASABI) will be asked to complete at least 3 EMA sessions per week and weekly cognitive 
assessments, in addition to dCBGT. Several elements of flexibility are allowed in the schedule 
to accommodate the challenges that adolescents with Social Anxiety may face: 
• Location of Use: Some participants may experience barriers to receiving treatment, 
including geographic location, availability of trained therapists, long waiting lists, and 
the requirement to take time off from school for clinic visits. This intervention is a 
remote intervention that allows participants to access the intervention and program 
activities remotely. Every effort will be made to schedule the weekly group therapy 
sessions at a time that is most convenient for the participant. EMAs and weekly 
cognitive assessments are mobile-accessible, allowing participants to complete them at 
different locations, as convenient. 
• Variable Number of Total Sessions: Given fatigue (common in this population), 
commitments to non-study activities, health issues and/or re-integration into school, 
work and home life, we expect that some participants will not be able to complete the 
weekly dCBGT sessions for 12 weeks. To accommodate this, we will be understanding 
of their circumstances, recommend that participants complete as many sessions as their 
schedule permits, and explain that the results of the trial may benefit from frequent and 
consistent involvement in group sessions. Similarly, participants granted access to daily 
EMAs and weekly cognitive assessments will be encouraged to complete at least 3 

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sessions per week and the weekly cognitive assessments. Participants will be informed 
that the study will work if the participant is unable to commit to recommended 
minimum EMA sessions per week and weekly cognitive assessments. The Site Study 
Coordinator may offer their support to work with the participant on a schedule that is 
feasible, given participant’s current life circumstances, as appropriate. To ensure a time-
bounded study commitment, after 12 weeks such participants will perform their post-
intervention assessment (End of Study, V3) visit, given that they have met the minimum 
number of sessions required to complete this visit.   
• Extra Time: : Under special circumstances, dCBGT session(s) may be paused for 1 or 
more weeks. This may occur if the WASABI Clinician is unable to conduct the session 
and no alternate WASABI Clinician is available to conduct the session. In such cases, 
the intervention will be extended by the number of weeks it has been placed on hold. 
Participants will resume the assigned dCBGT session such that all 12 sessions intended 
for the 12-week intervention are delivered to participants. Similarly, participant access 
to BrainHQ app will be extended by the same number of weeks. While the intervention 
is on hold, access to BranHQ may be revoked and participants will not be asked to 
completed BrainHQ study activities until dCBGT sessions resume. Access to other 
study applications, such as Google Apps, Google Meet and Chat, may be available until 
the final dCBGT session is completed, but participants will not need to engage with 
these activities while the intervention is on hold and participants will be informed the 
WASABI Clinician will not be monitoring or engaging in the group chat.   
• Cessation of Program Use While Continuing Participation in the Study: In some cases, a 
participant may wish to stop or minimize use of the program, while remaining in the 
study.  Potential reasons for this decision might include changes in school or work 
circumstances, changes in residence, health issues, family/personal issues, or a lack of 
interest in program activities.  While the participant will be encouraged to meet their 
weekly goals, in such cases, after discussion with the Site Study Coordinator, the 
participant will be permitted to cease using the program and undergo the post-
intervention assessment (End of Study, V3) visit, given they have met the minimum 
number of sessions required to complete this assessment.  
• Emergency: All participants will be told how to contact the appropriate Site Study 
personnel in the case of an emergency. 
 
Several of these options in aggregate are likely to lead to variation within a group and between 
groups with regard to the total number of sessions completed, and may cause an imbalance 
between the number of sessions completed within and between groups. Although this is not 
ideal, we believe that this is the correct approach given that such flexibility will allow more 
participants to join the study (compared to no program use flexibility), and may produce less 

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drop-out.  In addition, this approach has the value of more closely mimicking real-world use 
of the program, increasing the prospective validity of the study.  We will continuously monitor 
the distribution of completed sessions and will consider modifications to the protocol (see 
Modifications to the Protocol) if it appears that this flexibility is causing meaningful 
differences to emerge.  The data analysis plan is generally robust to variations in number of 
sessions completed (see Data Analysis Plan).  
 
Each study participant will be remotely supervised by a Site Study Coordinator. The Site 
Study Coordinator will inform participants of designated office hours that the Site Study 
Coordinator will be available in real-time. Participants will be able to contact Site Study 
Coordinator by email or by phone and may leave a message outside of designated office 
hours. Participants may be contacted once per week by a member of the Site Study team to 
discuss lack of engagement with the study apps or intervention activities, and contact may be 
adjusted depending on each participant’s needs. Based on our previous experiences with in-
residence trials, we have developed protocols and training that will allow the Site Study 
Coordinator and WASABI Clinicians to establish rapport with participants, identify and tend 
to any barriers to program use or compliance (such as establishing reminders to complete 
assessments or reducing distracters in the environment), and to provide feedback and support 
around performance.  The Site Study Coordinator and WASABI Clinician will also be 
specifically trained to deal with specific issues that might arise with individuals with Social 
Anxiety.  
 
Experimental Treatment Intervention (dCBGT+WASABI): The Experimental Treatment Intervention 
is a mobile-delivered and clinically-supervised adjunct to treatment composed of three 
primary treatment tools. Participants will be asked to 1) attend 12 weekly, 1-hour, group 
dCBGT sessions and complete “homework” associated with traditional dCBGT; 2) complete 3 
EMA sessions per week, weekly standardized SA self-report, and weekly cognitive 
assessments; 3) use IM for 1:1 and group conversations. At the beginning of each treatment 
cohort, the WASABI Clinician will create a group text open only to cohort participants, explain 
their role, and make introductions. Between group sessions, the WASABI Clinician will spend  
approximately 30 min/day keeping the chat active during work hours, checking it 
approximately 3 times a day and responding to any messages participants leave, as 
appropriate. The WASABI Clinician will also receive notifications whenever the WASABI 
algorithm detects SA symptom exacerbation, and engage participants in synchronous or 
asynchronous IM. In absence of alerts, the WASABI Clinician will monitor the WASABI 
dashboard the day before each dCBGT session to customize the delivery of targeted content 
during the videocall. 
 

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- 
Digitally delivered Cognitive Behavioral Group Therapy (dCBGT). Participants are 
expected to join weekly, hour-long, group-video calls to complete dCBGT 
sessions using the Google Meet application. The WASABI Clinician uses EMAs 
and weekly assessment and self-report data completed by participants to 
calibrate and personalize the delivery of weekly dCBGT structured sessions 
through videoconferencing. Sessions replicate the protocol described in 
“Cognitive-behavioral group therapy for social phobia in adolescents,”54 with 12 
weekly sessions that center CBT content around the young person’s 
developmental context, needs, and capacities, and adapt it to the unique 
developmental issues characteristic of adolescence (e.g. ascendancy of the peer 
group, identify formation, propensity towards limit testing). Sessions 1-4 focus 
on psychoeducation on recognizing and understanding social anxiety symptoms 
(e.g., avoidance cycle that maintains anxiety over time; rationale for exposure to 
overcome avoidance cycle). Sessions 5-6 implement cognitive restructuring 
(focusing on the identification/modification of dysfunctional thoughts) and social 
skills training. Session 7-8 include instruction in exposure principles and role-
play/modeling of exposure exercises. Sessions 9-11 focus on in vivo exposure to 
anxiety provoking situations. In vivo exposure during these sessions focuses on 
anxiety provoking situations that can be created within the social setting of the 
video chat, such as a person giving a speech or singing a song, members 
engaging in “small talk” with each other, or people altering their appearance in a 
socially conspicuous way (e.g., messy hair, wearing silly attire). Session 12 
focuses on how to avoid personal pitfalls and relapse. Adjustments may be made 
to the dCBGT treatment protocol described in “Cognitive-behavioral group 
therapy for social phobia in adolescents” during COVID-19 to allow for a more 
appropriate treatment given current shelter-in-place and distance-learning 
procedures that may not allow for replication of the traditional protocol. 
Participants are assigned “homework” focused on practicing specific skills in 
anxiogenic, in vivo situations to promote skills generalization and anxiety/fear 
extinction learning. Finally, content of the group-therapy sessions and 
“homework” assignments are personalized on the basis of the EMAs data each 
user has provided during the week.  
- 
EMAs. Participants will be asked to complete at least three sessions of mobile-
based self-report questionnaires of social anxiety and social role performance 
(EMAs Thoughts, Feelings, and Goals) per week. EMAs will be available daily for 
those who wish to complete more than the minimum recommendation. In the 
EMA Thoughts questionnaires, participants are asked to rate 1-7 how closely ten 
example cognitive distortions relate to their current thoughts. These 10 example 

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cognitive distortions are related to 10 overarching cognitive distortion categories 
(emotional reasoning, mental filter, magnification, disqualifying, all or nothing, 
jumping to conclusions, overgeneralization, personalization, labelling, should 
statements). In the EMA Feelings questionnaires, participants are asked to rate how 
closely they are feeling certain negative and positive emotions (comfort, relax, 
excited, serenity, confidence, gratitude, reward, hope, courage, joy, upset, 
dissatisfaction, 
annoyance, 
resentment, 
pessimism, 
guilt, 
powerlessness, 
disappointment, discouragement, fear, shame). In the Goals questionnaires, 
participants are asked to fill out short-term goals and rate their confidence of goal 
completion.  
- 
Standardized Self-Report Questionnaires. WASABI includes standardized self-
reports of social anxiety (SPAI-B), and weekly assessments that implicitly evaluate 
core cognitive operations known to be impaired in social anxiety (e.g., attention 
bias, interpretation bias). The SPAI-B consists of 16 items using a 5-point Likert 
scale (1–5). It assesses the cognitive, somatic, and behavioral symptoms (triple-
response-system) and captures interactional and performance-provoking socially 
anxious situations. In the attention bias assessment, neutral and negative faces are 
presented for a limited time, followed by a letter that is displayed in the region of 
the screen where the neutral face was. Participants need to identify the letter as 
quickly as possible. In the interpretation bias assessment, a series of ambiguous 
images is presented for a limited time (for example, a situation in which one friend 
walks past another without acknowledgement), followed by a screen where three 
images with clear emotional valence are concurrently presented. Participants need 
to choose the image that captures the emotion that best explains the ambiguity of 
the previous images. The rationale behind the assessment is that participants with 
interpretation bias may develop expectations that ambiguous situations are more 
likely to end negatively.  
- 
WASABI Alerts. If WASABI detects clinically-significant social anxiety through 
EMA metrics (EMA Thoughts, EMA Feelings, EMA Goals), cognitive biases 
assessments, and the Social Phobia and Anxiety Inventory-Brief (SPAI-B), the 
monitoring clinician will receive an alert that cues them to connect via Instant 
Messaging with the participant. The algorithm will be used to alert the WASABI 
clinician when a trial participant reaches clinically significant social anxiety, so 
that symptom exacerbation can be addressed over Instant Messaging.  
 
EMAs, cognitive biases assessments and self-reports are meant to support standard clinical 
care by providing additional structured tools for an individual to use to address cognitive 
biases that often co-occur with anxiety. To complete these activities, a participant opens a 

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standard application (BrainHQ) on an Internet-connected iOS device and goes to a general log-
in screen. The participant then logs into the experimental treatment program platform through 
the BrainHQ application (using a study provided username that contains no personally 
identifiable information). Participants are directed to their assigned EMAs, cognitive biases 
assessments, or self-report questionnaire and perform their assigned activities over the course 
of a session. 
 
Participant will use Google Meet and Chat, a HIPAA-compliant videoconferencing and instant 
messaging application on an Internet-connected iOS mobile device and goes to a general log-in 
screen. The participant then logs in using a study provided account. Participants assigned to 
the WASABI are expected to join 12, 1 hour-long dCBGT sessions using the Google Meet 
application. These will be scheduled and facilitated by the WASABI Clinician. 
 
Active Control Program (dCBGT): Given the nature of the augmentation study, it’s expected that 
participants in the control condition may spend less time, overall, on study activities as 
compared to the Experimental Treatment Intervention (dCBGT+WASABI). In an effort to equate 
time spent in the intervention and control for the effects of mobile device use, contact with 
personnel, monetary payments, and nonspecific engagement, participants in the control 
condition will be asked to attend 12 weekly, 1-hour, group dCBGT sessions and complete 
“homework” associated with traditional dCBGT. 
Digitally delivered Cognitive Behavioral Group Therapy (dCBGT). The WASABI Clinician will lead 
weekly dCBGT structured sessions through videoconferencing. Sessions replicate the protocol 
described in “Cognitive-behavioral group therapy for social phobia in adolescents”,54 with 12 
weekly sessions that center CBT content around the young person’s developmental context, 
needs, and capacities, and adapt it to the unique developmental issues characteristic of 
adolescence (e.g. ascendancy of the peer group, identify formation, propensity towards limit 
testing). Sessions 1-4 focus on psychoeducation on recognizing and understanding social 
anxiety symptoms (e.g., avoidance cycle that maintains anxiety over time; rationale for 
exposure to overcome avoidance cycle). Sessions 5-6 implement cognitive restructuring 
(focusing on the identification/modification of dysfunctional thoughts) and social skills 
training. Session 7-8 include instruction in exposure principles and role-play/modeling of 
exposure exercises. Sessions 9-11 focus on in vivo exposure to anxiety provoking situations. In 
vivo exposure during these sessions focuses on anxiety provoking situations that can be 
created within the social setting of the video chat, such as a person giving a speech or singing a 
song, members engaging in “small talk” with each other, or people altering their appearance in 
a socially conspicuous way (e.g., messy hair, wearing silly attire). Session 12 focuses on how to 
avoid personal pitfalls and relapse.  Adjustments may be made to the dCBGT treatment 

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described in “Cognitive-behavioral group therapy for social phobia in adolescents” during 
COVID-19 to allow for a more appropriate treatment given current shelter-in-place and 
distance-learning procedures that may not allow for replication of the traditional protocol. 
Participants are assigned “homework” focused on practicing specific skills in anxiogenic, in 
vivo situations to promote skills generalization and anxiety/fear extinction learning.  
 
Participants in the active control will complete two sessions of embedded assessments, one  
immediately before and one after the 12-week intervention. The embedded assessments 
include two cognitive assessments—an attention bias assessment and interpretation bias 
assessment—and the SPAI-B assessment.  
 
The active control program is designed to: 1) be a face-valid approach to remediation in 
anxiety disorders, to ensure that participants remain blind to group affiliation, and match the 
experimental treatment program in halo or expectation-based influence on performance in 
outcome measures; 2) match the experimental treatment program in overall dCBGT session 
intensity, time-spent attending, and overall engagement; and 3) provide a comparison group 
that matches the experimental treatment group on the aforementioned attributes, but without 
the adjunct to treatment component, WASABI. 
 
To use the active control, a participant opens Google Meet, a HIPAA-compliant 
videoconferencing and instant messaging application on an Internet-connected iOS mobile 
device and goes to a general log-in screen. The participant then logs in using a study provided 
account). Participants assigned to the active control are expected to join 12, 1 hour-long dCBGT 
sessions using the Google Meet application. These will be scheduled and facilitated by the 
WASABI Clinician. To complete the BrainHQ embedded assessments, a participant opens a 
standard application (BrainHQ) on an Internet-connected iOS device and goes to a general log-
in screen. The participant then logs into the experimental treatment program platform through 
the BrainHQ application (using a study provided username that contains no personally 
identifiable information). 
 
Application Security 
 
BrainHQ: All usage and progress data collected through the BrainHQ application is encrypted 
then transmitted to a central server.  Data is encrypted in transit and at rest, and access is 
limited and audited. Data collected through the BrainHQ platform will not include geographic 
information. IP address data is stored only in memory and in request logs, and is used for 
technical support and troubleshooting, but not persisted with the participant's data. However, 
data as it relates to dates that assessments are completed is collected and stored. The EMA 

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questionnaires include open text boxes for participants to include their goals, thoughts, and 
feelings. Participants will be aware that research team members at the University of Minnesota 
and Posit Science will have access to the questionnaires and that any personally identifying 
information voluntarily shared on this platform will be viewed by staff at both the University 
of Minnesota and Posit Science. On the server, the data are available for review by the un-
blinded WASABI Clinician, Study Coordinator, Posit Science study team, and/or other study 
personnel through a secure web portal. The WASABI Clinician in particular will use the secure 
web portal to regularly check on usage and progress of each active participant to customize 
their weekly phone/in-person and dCBGT discussions to provide helpful guidance and 
coaching. 
 
G-Suite Google Chat and Meet: This platform allows participants to communicate with others 
via the app without having to share their full name, mobile phone number or email to do so. 
Participants also have the opportunity to personalize their profile, by entering a short bio and a 
picture of their choice. In order to access the Google Meet and Chat apps, participants will have 
a unique username/login that contains no personally identifiable information. Once logged in, 
they will be operating within the Google Meet and Chat HIPAA-compliant digital environment, 
and data that are produced, transmitted, and shared among users will be exclusively 
visible/readable to the research participants and authorized University of Minnesota and Posit 
Science staff. These data will include personally identifiable information–such as faces, first 
names or aliases, biographical and medical information–similar to what happens during all in-
person group therapy sessions. The Google Meet and Chat API will allow participants to 
exchange end-to-end encrypted instant and group messages, as well as make end-to-end 
encrypted group voice and video calls. Participants will be aware that research team members 
at the University of Minnesota and Posit Science will have access to the group chat history and 
will be monitoring its contents throughout the intervention period. As such, participant are 
informed that any personally identifying information voluntarily shared on this platform will 
be viewed by staff at both the University of Minnesota and Posit Science. Google Meet and Chat 
use end-to-end encryption for voice and video calls, as well as instant messages. Google Meet 
and Chat's voice calls are encrypted with DTLS and SRTP, its video calls with RTP, and its 
instant messages with RTP. In addition to this, client-server communication is protected 
by Transport Layer Security.  More information about how Google Meet and Chat protects 
privacy can be found here: https://support.google.com/a/answer/3407054 
 
Participants assigned to the Active Control condition will not be asked to use the Google Chat  
app, as it is unique to the  WASABI intervention. Participants in both groups will be able to 
download other Google apps associated with their deidentified study assigned G-Suite account, 
such as Google Calendar and Gmail, to facilitate communication with the Site Study team and 

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set reminders for weekly dCBGT sessions and study activities. The Site Study Coordinator will 
assist participants in downloading these apps, as needed. Participants loaned a study-device 
will have these applications available on the study device. 
 
Laboratory Specimens 
 
There are no laboratory specimens collected for this study. 
 
Sample Size Justification 
Within-group effect sizes (Cohen’s d) will be computed using the mean change scores for 
primary quantitative outcomes (post-intervention minus baseline) and the change score SDs. 
With 24 participants fully evaluated, we will not have enough power to detect a treatment 
augmentation effect ascribable to WASABI. However, data from this pilot RCT will suggest 
whether there is feasibility, acceptability and usability of WASABI, as well as an incremental 
difference in secondary outcomes between groups, with greater improvement in the 
WASABI+dCBGT arm, and will be used to power a pivotal RCT in Phase II. To test whether 
WASABI induced greater improvements in social anxiety ratings compared to the active 
control condition, we will conduct the analysis based on the pre-intervention (baseline) and 
post-intervention data. Finding a significance level of p < 0.05 on the outcome measures will 
support the statement that the intervention improves social anxiety in the population.  
 
Data Analysis 
Standard data quality procedures will be used, including double-scoring and random spot-
checking of cognitive assessments, electronic data capture, and external data monitoring. 
Acceptability of the program will focus on the functional effectiveness of the program 
(validation that it functions as intended). Evaluation of the actual acceptability of WASABI will 
be based on adherence rates, engagement patterns, EMA completion rates, SPAI-B completion 
rates, overall program completion rates, usability ratings (exit survey data), clinician burden, 
and reported adverse effects. Rate of referral to enrollment and average program completion 
rate will be used to evaluate adherence rates. Assessment adherence (percentage of assessment 
sessions attended) refers to assessments completed by all participants who have participated 
in the minimum required intervention activities (attended at least 2 group calls, completed 
EMAs at least five times). We expect successful data collection of baseline and post-
intervention outcome measures for ≥90% of participants. Engagement with the digitally delivered 
Cognitive Behavioral Group Therapy (dCBGT) and with group Instant Messaging (IM) refers to the 
number of group sessions attended and number of messages sent per week on the group chat. 
We hypothesize WASABI+dCBGT will participate in 80% of the dCBGT sessions, and send at 
least 8 messages/week in the group chat. 

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We do not anticipate dCBGT within WASABI being associated with greater adherence rates 
and engagement patterns compared to the control condition. Due to the inter-individual 
differences in participant engagement found in the pilot study, we will also use bivariate 
correlations to test whether changes in outcome measures correlate with engagement metrics. 
If so, we will use repeated measures linear mixed modeling to determine whether changes in 
outcome measures were mediated by engagement with the intervention. Finally, enjoyment, 
usability, perceived benefits, and ease of fit into schedule, and qualitative user feedback will 
also be evaluated. Based on our previous findings, we hypothesize exit survey ratings of at 
least ≥4.5 ±1.5 on the 7-point Likert scale items.  
 
We hypothesize that the innovative features of WASABI will improve the quality of treatment 
delivery and facilitate the generalization of trained skills into real-world settings. The 
measures collected to determine the efficacy of the program for this trial are clinical ratings of 
anxiety and social anxiety symptoms (LSAS-CA), self-report inventories of social anxiety 
symptoms (SPAI), broad measures of anxiety (MASC-2), self-report inventories of social skills 
(SSQ), and self-report inventories of social functioning (ASSES). To test this hypothesis, we 
will use a linear mixed model approach. We will first compare treatment and active control 
groups in the ITT population to determine if any differences in baseline demographic, 
characterization, outcomes variables, or total program use time remain after the randomization 
process. Any such factors that show trend level significant differences (p < 0.1) will be noted 
and used as covariates in the linear mixed model analysis. The criterion for statistical 
significance is p < 0.05. Results with p < 0.1 will be described as trends. 
 
Performance on the attention bias and interpretation bias assessments will be modeled 
longitudinally to examine if these measures can serve as potential moderators and mediators. 
To test if the attenuation of attention and interpretation biases mediates improvements in 
outcome measures, we will use repeated-measures linear mixed modeling to test in the active 
group the effects of WASABI on LSAS-CA, SPAI, SSQ and ASSES, and then model outcomes 
as a function of performance improvements on the attention bias and interpretation bias 
assessments.  
 
Because we are interested in examining the ecological validity of WASABI, we will not restrict 
the analyses only to participants who adhered to all intervention requirements. Within-group 
effect sizes (Cohen’s d) will be computed using the mean change scores (post-intervention 
minus baseline) and the change score SDs. 
 

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These measures will be analyzed to power the pivotal study proposed for Phase II. For the 
FDA, we will collect data documenting that WASABI meets its design requirements when 
used in the field by clinicians and patients, and that clinicians deem its risk/benefit ratio as 
acceptable and view it as adequate/appropriate for the target population. 
 
Data Management 
Data collected in this study may include paper forms for consent/assent forms and some 
assessments from clinician- or psychometrician-administered structured interviews, 
neuropsychological or functional assessments. Other assessments will be administered 
remotely and collected electronically through REDCap servers (hosted on HIPAA compliant 
UMN servers) or the program platform (hosted on Posit Science servers). Fully executed 
consent/assent forms completed by Site Study personnel and securely stored at the Study Site 
will not be shared with Posit Science. With the exception of dates that assessments are 
completed, personally identifying information collected by UMN Site Study personnel will not 
be collected or stored with study assessment or performance data on the BrainHQ app on Posit 
Science Servers and will not be shared with Posit Science. Personally identifying information 
voluntarily disclosed by participants on BrainHQ (EMA questionnaires) and the Google Meet 
and Chat platforms during the intervention will be accessible to the Posit Science research 
team. Participants are informed that both the UMN and Posit Science research teams will be 
monitoring their chat history on the Google Meet and Chat platforms. Prior to entering the 
participant’s study record, direct identifiers (names, email addresses) will be redacted. De-
identified, study-related data collected on paper and shared with Posit Science will be 
recorded into a secure, web-based electronic case report form (eCRF). This system meets all 
relevant privacy and security standards for electronic clinical trial data entry and storage, as 
well as the Health Insurance Portability and Accountability Act (HIPAA) standards for 
confidentiality and privacy.  
 
Following consent, each participant will be assigned a standardized Participant Identification 
Number (PIDN) composed of digits to identify the study and 3 digits to identify the 
participant.  The digits will begin with “001” for the first consented participant and ascend 
thereafter.  All eCRF data entry will be de-identified, using the PIDN only and not the 
participant name, but will include the date of the assessment administration.  
 
Study personnel will transcribe and upload de-identified data and de-identified source 
documentation into the study database for the purpose of data monitoring. PSC data entry 
personnel and Site Study personnel will interact frequently throughout the study to 
accomplish the quality goals of the data management process through the below process.  
 

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Participants may email Site Study personnel with questions or concerns, or to make 
arrangements for study visits. If deemed significant and relevant to the participant’s study 
record, de-identified emails may be saved to the participant’s study file. To de-identify emails, 
all direct identifiers (name, email address, date of birth, etc.) will be redacted from the email in 
PDF format. Site Study personnel will place black bars over any directly identifying 
information. The redaction will be verified by a secondary staff member for accuracy and 
completion to ensure patient privacy prior to being uploaded for permanent storage at the Site 
and shared with Posit Science. The dates of communication will be maintained in the emails to 
provide context for the conversation. 
 
Periodic analysis of the data will be performed in order to examine the expected distributions 
of data, and to identify outliers for possible data mistakes.  PSC data management personnel 
and Site Study personnel will interact frequently throughout the study to accomplish the 
quality goals of the data management process through the below process. 
 
Periodic analysis of each data field (across all cases) will be performed in order to examine the 
expected distributions of data, and to identify outliers for possible data mistakes. Particular 
attention will be paid to the following: 
• Data Cleaning:  All eCRFs are automatically reviewed to check for omitted data and data 
inconsistencies.  These deficiencies are required to be resolved at the point of data entry 
to prevent errors from entering the system. 
• Data Editing:  Each data record is evaluated on a regular interval.  Any discovered error 
is then referred to the clinical site Investigator Designee within the Electronic Data 
Management (eCRF) System via the Data Monitor.  The Investigator Designee will 
review the queries and make the corrections through the eCRF system.  All such 
changes are automatically logged to allow a complete audit trail and recovery to any 
point in the change log if required. 
• Data Update:  The cycle of data editing will be ongoing until all the data are clean. If 
further data entry or source documentation errors are discovered during review, the 
corrections will be made at that time through the eCRF system. 
• Data Back-up:  The eCRF system employs an automatic continuous replication system to 
ensure that all data including change logs and access logs are replicated to two 
independent remote servers.  At any point, the system is capable of emitting the entire 
store of eCRFs as paper CRFs for offsite storage or auditing if required. 
 
We will take all standard and appropriate steps to protect the privacy and confidentiality of 
participants in this trial.  At enrollment participants will be assigned a PIDN as described 
above, and all study data collection derived from that participant will be coded by PIDN.  All 

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eCRF pages, including those with demographic as well as assessment data, will have the PIDN 
on them rather than the participants name. No personally identifying information will be 
shared with Posit Science, with the exception of dates that assessments are completed and date 
of birth. However, personally identifying information voluntarily disclosed by participants on 
the BrainHQ (EMA questionnaires) and Google Meet and Chat platforms during the 
intervention will be accessible to the Posit Science research team. Prior to entering the 
participant’s study record, direct identifiers (names, email addresses) will be redacted. 
Accurate and complete study records will be maintained and stored in a confidential manner 
so as to protect the confidentiality of participant information. 
 
The eCRF system runs on remote servers not physically accessible to any study staff (including 
PSC staff); all electronic access to the eCRF system is logged and regularly reviewed for any 
inappropriate access.  All study related paper materials will be stored in locked file cabinets 
inside of locked rooms when not in use.  During remote procedures, study personnel may 
shred the original paper documents after Posit Science has completed the data monitoring and 
reconciliation process and approved shredding of documents. Until documents are ready for 
shredding, they will be stored by the respective study personnel with limited access until the 
documents are shred or transferred to the Study Site. All participant use of the BrainHQ 
program will use a login based on the PIDN, and study programs will not collect or store any 
personally identifiable information, with the exception of any volunteered information 
included in EMA questionnaires, on the laptop or on PSC servers, with the exception of dates 
that assessments are completion. Participants will choose whether to use their first name or an 
alias for the Google Meet account. 
 
We note this protocol does collect sensitive information, i.e. when assessing suicidal ideation, 
that may result in a reporting requirement to state or local authorities. The Study Site is 
expected to follow standard institutional policies in such cases to ensure the protection of 
participants and proper reporting.  If Site Study personnel become aware of specific issues 
outside of the ordinary data collection procedures (e.g., child abuse) they will follow 
established institutional procedures already in place as appropriate for their local jurisdiction 
to report such knowledge. 
 
Confidentiality 
 
Participation in research may involve a potential loss of privacy.  All records and documents 
pertaining to participation in this study will be handled as confidentially as possible.  
However, absolute confidentiality cannot be guaranteed.   
 

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All information, if collected on paper, will be kept in areas of limited access available to 
approved study personnel only.  Any physical records will be maintained in locked cabinets in 
locked offices, until the appropriate time at which documents may be shredded. Access to 
these cabinets will be limited to the study team. During remote procedures, study personnel 
may shred the original paper documents after Posit Science has completed the data monitoring 
and reconciliation process and approved shredding of documents. Until documents are ready 
for shredding, they will be stored by the respective study personnel with limited access until 
the documents are shred or transferred to the Study Site. 
 
Electronic data will be password protected and securely stored.  The servers maintained by 
both Posit Science and UMN are HIPAA compliant, secure servers, that will require 
permissions from the study team to access. 
  
Absolute confidentiality in therapy groups is difficult to achieve irrespective of the delivery 
method (in-person, video-conference, etc.), as there is no guarantee that other group members 
will maintain confidentiality about sensitive information. However, in order to decrease the 
likelihood of breaches of confidentiality among group members, we will 1) provide informed 
consent about confidentiality; 2) educate group members about confidentiality; and 3) make the 
discussion of confidentiality an ongoing process. 
• First, study participants will learn about confidentiality during the informed consent 
process. The consent form will clearly describe the roles and responsibilities of all parties 
and the limits of confidentiality.  
• Second, individual sessions will be held between the Site Study Coordinator and/or 
WASABI Clinician and each participant to educate them regarding confidentiality prior 
to entering the intervention. Participants will be informed that 1) they have the right to 
choose an alias rather than their first name and decide at any point what information they 
choose to disclose; 2) the WASABI Clinician will respect the patients’ ability to choose 
what they disclose, and keep the promises of faithfulness and loyalty to all participants, 
including not revealing information participants disclose; 3) the WASABI Clinician 
cannot promise that other group members will maintain confidentiality; 4) the WASABI 
Clinician may have a legal obligation to break confidentiality in certain circumstances 
(e.g., child abuse), and those circumstances will be fully explained. The WASABI 
Clinician will follow established procedures appropriate for their local jurisdiction to 
report such knowledge; 5) the UMN and Posit Science research teams will be monitoring 
the BrainHQ (EMA questionnaires) and Google Meet and Chat contents, including chat 
history, throughout the intervention and as such any volunteered information that may 
be personally identifying will be available to both UMN and Posit Science monitors. 

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• Third, participants will be asked to read, sign and agree to be bound by a modified 
version of the American Psychological Association procedures and guidelines for group 
therapy 
(http://www.apadivisions.org/division-49/publications/newsletter/group-
psychologist/2011/04/group-procedures.aspx), adapted for the target population, while 
in the intervention.  
• Finally, during the first group therapy session, the WASABI clinician will encourage 
group members to embrace the concept of confidentiality, making it their own rather than 
a mandatory rule.  
 
Given that one of the goals of WASABI is to enhance social functioning in people with social 
anxiety, we will not discourage group members from sharing contact information and 
befriending other study participants. Research shows that peer-to-peer interactions occur 
naturally on social media platforms and serve many purposes, such as establishing new 
relationships, maintaining relationships, reconnecting with people, disclosing personal 
experiences of living with social anxiety, seeking and sharing information related to symptoms 
and medications.  
 
Representatives of the Sponsor, the reviewing Institutional Review Board, and the National 
Institute on Aging will be permitted to audit study-related data and related materials. 
Personally identifiable information will not be used in any study reports or publications; data 
contained in these will only be presented or published in aggregate form. 
 
Disposition of Data 
 
The following study records will be retained by the Study Site for minimum of two years 
following the conclusion of the study: 
1. signed participant informed consent forms (securely held at UMN and stored with 
limited access), 
2. patient medical records, including all significant diagnostic reports, 
3. supporting documentation of all adverse events, 
4. completed eCRFs, and; 
5. study related correspondence and study reports. 
 
Paper records from this study must be stored in locked areas of limited access. During remote 
procedures, documents will be stored by the respective study personnel in a safe location with 
limited access until the documents can be shred or transferred to the Study Site.  Electronic 
data must be securely held with restricted access available to personnel on a need-to-know 

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basis only. Google Team Drive access will be restricted to authorized study personnel by 
invitation only. 
 
Research staff will comply with the requirements of UMN (i.e., the enrolling institution) data 
storage and disposition policies at the conclusion of the record retention period. 
 
Sharing Research Results 
 
Overall study results will be available to participants through ClinicalTrials.gov and when 
such results are completed and accepted for publication. At enrollment, information is 
collected that, if appropriate, we will share with the participant to ensure they are receiving 
appropriate health care (i.e. suicidality) as assessed by the C-SSRS. Any participant presenting 
a safety concern for any of these medical issues will be referred to ensure they are receiving 
appropriate treatment. We do not intend to share individual assessment data with 
participants, as the assessment battery is not intended to be the type of comprehensive battery 
a rehabilitation psychologist would use to guide treatment.  Any participant interested in such 
comprehensive assessment will be referred to an appropriate clinician. 
 
Foreseeable Risks, Risk Management & Emergency Response 
 
Participation in the study presents minimal risk. The probability and magnitude of harm or 
discomfort anticipated in this research study are not greater than those ordinarily encountered 
in daily life or during the performance of routine physical or psychological examinations or 
tests. 
 
Serious adverse effects from prior studies of the treatments under study have not been 
reported. The protocol details potential risks related to study participation and includes 
assessments of increased risk of suicidality. 
 
The following foreseeable risks will be discussed with potential participants during the 
enrollment visit, as will the following measures taken to minimize such risks: 
• Diagnostic interview and self-report measures. Participants may feel uncomfortable or 
embarrassed due to sensitive questioning about their psychiatric condition and medical 
history during the diagnostic interview or on self-report measures. Participants will be 
reminded during each appointment that their participation in the study is voluntary and 
that as such, they are not required to complete any assessments and may skip individual 
questions or assessments entirely.  

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• Discomfort During Assessments: Assessments may be fatiguing for some individuals, 
particularly for those with persistent cognitive symptoms. To minimize this potential 
discomfort, breaks are encouraged and scheduled within the session. In the event that a 
participant appears to be under undue strain, test sessions are discontinued. 
• Lack of Assessment Feedback:  Participation in this study does not include feedback to 
participants on their individual assessment results.  Though participants are informed 
of this policy during consent, some participants may find the lack of feedback to be 
frustrating. 
• Discomfort During Intervention/Program Use:  The following risks may be reasonably 
anticipated as the result of intervention and/or program use: fatigue, mood complaint, 
headache, tremor, eye strain, neck/shoulder discomfort, leg/hip discomfort, arm/wrist 
discomfort, back discomfort, headache and sleep difficulty.  To minimize the fatigue 
participants are encouraged to sit ergonomically correctly while completing study 
activities on their device. The program is also designed to be entertaining and 
enjoyable. In addition, assessment and self-report sessions may be paused at any time 
and participants are encouraged to take breaks.   
• Other Risks:  Although it has not been previously documented, it is possible that the use 
of the investigational program or participation in the study activities may cause 
symptoms to worsen.  There may also be risks related to the use of the computer program 
that are unknown at this time. 
• Loss of Privacy: The most significant risk to the participants are those that would follow a 
breach of confidentiality and the disclosure of clinical information. Participation in any 
research study, including this one, may involve a loss of privacy, and absolute 
confidentiality cannot be guaranteed. Procedures designed to maintain data 
confidentiality include (1) formal protocol training sessions for all study team members 
emphasizing the importance of confidentiality, (2) adherence to specific procedures 
developed to protect participants’ confidentiality, and (3) formal mechanisms limiting 
access to information that can link data to individual participants. One reason for 
breaking confidentiality is that the study personnel are required by law to report cases of 
physical or sexual abuse to local law authorities; and another is that despite all 
procedures, an error may occur. To mitigate this risk, data forms that include identifying 
information, with the exception of dates assessments are completed, date of birth, and 
dates associated with other data collected, and personally identifying information 
volunteered by participants in the BrainHQ (EMA questionnaires) and Google Meets chat 
forum, will be kept in locked cabinets or secure servers at the study site, accessible only 
to authorized site study personnel, and will not be shared with Posit Science. Only the 
unique ID number, assigned by the study coordinator, will represent participants during 
participation in the study. In the Google Meet platform, participants will have the choice 

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to self-identify with their first name or an alias. To facilitate tracking, a password-
protected computer file will be maintained containing the identity of participants, their 
ID numbers, and contact information. This file, however, will contain no clinical data. 
Electronic data will be password protected and stored on a secure network. All data keys 
will be stored separately and securely. Only study personnel (specifically, the PSC study 
steam, study site collaborator, and Data Management designee) will have access to the 
study data. No participant names will be used in study reports or publications. 
• Risks of Email Communication: This study will rely on the use of email communication 
between Site Study personnel and research participants as part of their participation in 
the intervention. Site Study personnel may expected to email participants about their 
upcoming appointments, provide weekly updates on program usage, or communicate 
other important study information. Participants may also ask questions of Site Study 
personnel using email. There are risks associated with email communication, and these 
risks increase when emails are sent without an encryption service. Risks of sending or 
receiving unencrypted emails include, but are not limited to:  
• Others can intercept messages 
• If messages are sent or received on an employer-owned device, the 
employer may have the right to save and read the messages. The internet or 
cell-phone provider may also have the right to save and read email 
messages 
• A copy of the message may be saved on a device or computer system, even 
if it is deleted 
• If an email address is not typed correctly, it can be sent to the wrong person 
• Emails can spread computer viruses 
• Others may be able to access messages on devices that were lost, stolen, or 
thrown away 
• If a participant changes emails without notifying study personnel, they 
may miss communications.  
Participants will be encouraged to report any adverse effects occurring during the duration of 
the study to the Site Study point of contact.   
 
PSC does not provide compensation for research-related injuries and will not reimburse or pay 
medical expenses for the treatment of research-related injuries. 
 
Although there is little chance for a study-related emergency, Site Investigators and Site Study 

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personnel are required to following institutional standard operating procedures for obtaining 
emergency care or treatment for adverse effects requiring such.  This study has adequate 
personnel and equipment to respond to expected adverse effects, and maintains working 
knowledge of the nearest treatment facilities available to patients enrolled into this study. 
 
Potential Benefits 
Two levels of benefit will be described to participants: 
 
1. Benefit to Science: Results from this study will directly benefit the applied science in social 
anxiety disorders. Understanding if the scientific design principles of WASABI drive superior 
outcomes to current evidence-based treatments will provide considerable insight to scientists 
and clinicians working in social anxiety disorders. 
 
2. Benefit to Participants: This study has the potential to directly benefit the participant, in terms 
of symptom alleviation and improved social functioning. We will emphasize that this is the level 
of benefit that is most speculative in this study, and that potential participants in any 
randomized controlled trial should join if the benefits to participants like them and to science 
from the overall trial results are compelling to them, and should not expect that the trial provides 
treatment benefits as such. 
 
Study Personnel 
PSC will serve as the coordinating and data management center for this clinical trial.   
 
Key study personnel at PSC include: 
• Principal Investigator (Bruno Biagianti): responsible for the overall design of the 
study protocol and data analysis plan as well as the eventual publication of the 
result (with input and authorship from all investigators). He is also responsible for 
the execution of the study protocol, and coordinating activities with all PSC and 
UMN staff participating in the trial. Additionally, Dr. Biagianti will monitor, flag 
and/or remove inappropriate content on the Google Meet chat and report and 
discuss the content with the appropriate team members, including the WASABI 
Clinician(s). 
• Sponsor Study Coordinator is responsible for assisting the PI with the execution of 
the study protocol and for data management.  She will also be responsible for 
monitoring all submitted data for consistency and integrity, monitoring, flagging, 
removing and/or discussing the Google Meet chat content with the appropriate 
team members, including the WASABI Clinician(s). The Sponsor Study 
Coordinator will also be responsible for discussing all qualifying criteria with Site 

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Study personnel, leading virtual training sessions, and holding meetings and with 
the Site Study personnel. S/he will be responsible for ensuring that the Site meets 
regulatory compliance requirements and executes the protocol, as IRB approved.  
• Sponsor Clinical Trials Manager will provide oversight, advise on regulatory 
procedures, and support the sponsor study coordinator with her responsibilities, as 
needed. 
 
Dr. Biagianti and research staff at PSC disclose a conflict of interest: all are paid employees of 
PSC and may be shareholders, and could benefit if this intervention for Social Anxiety is 
shown to be an effective treatment in this trial.   
 
This conflict will be mitigated by ensuring that the complete investigator team, including Dr. 
Biagianti, other PSC study personnel, and UMN Site personnel have joint and overlapping 
responsibility for the design of the protocol, the execution of the protocol, the a priori design of 
the data analysis plan, the execution of the data analysis plan, the interpretation of the study 
results, and the authorship of publications emerging from the study.  In addition, this conflict 
of interest will be disclosed to all study participants, and through standard mechanisms for all 
publications. 
 
Key study personnel at UMN include: 
 
• Principal Investigator (Gail Bernstein): responsible for the overall execution of the 
study protocol at the Study Site, including overseeing participant recruitment, 
enrollment and intervention delivery in conjunction with the Site Study team for 
this clinical trial.  She will provide support and coordinate activities between PSC 
and UMN staff participating in the trial. She will be involved in the data analysis as 
well as the eventual publication of the result (with input and authorship from all 
investigators). Additionally, she will ensure that the Site meets regulatory 
compliance requirements and executes the protocol, as IRB approved. Dr. Bernstein 
will be blinded to participant randomization assignments.  
• Site Clinical Research Coordinator is responsible for assisting the Site PI with the 
execution of the study protocol, recruiting, screening, enrolling and monitoring 
participant progress when active in the study. She will also be responsible for 
entering data into REDCap, reviewing data for consistency and integrity, 
reconciling data queries, and may randomize participants. She may serve as a back-
up WASABI clinician and may be responsible for removing and/or discussing the 
Google Meet chat content with the appropriate team members, including other 
WASABI Clinician(s) and the Posit Science research team. Additionally, she will 

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assist in ensuring that the Site meets regulatory compliance requirements and 
executes the protocol, as IRB approved.  
• Site Clinical Assessor will serve as the blinded psychometrician and clinical rater. 
She will conduct eligibility and clinical assessments with participants and will be 
blinded to their randomization assignment. S/he may assist with conducting 
preliminary screening interviews with participants and conducting consent 
discussions, as needed. The assessor may assist with connecting with different 
community organizations, clinics, schools or other sources of recruitment. 
• Site WASABI Clinician will lead the group CBT sessions, for treatment and control. 
She will monitor the Google Meets forum and may be responsible for removing 
and/or discussing the Google Meet chat content with the appropriate team 
members, WASABI Clinician(s) and the Posit Science research team. For 
participants assigned to the WASABI treatment, she will manage the clinician 
dashboard, and engage participants in ecologically valid interactions. The WASABI 
Clinician  may assist with connecting with different community organizations, 
clinics, schools or other sources of recruitment. 
• Volunteers may be recruited to assist Study Coordinator with study activities, 
including, but not limited to, recruiting, contacting and conducting a preliminary 
screening of participants.  
• Site Regulatory Study Monitor may be required to access study documents and 
data capture systems to conduct study monitoring visits to ensure adherence to 
institutional requirements. 
 
Blinding 
 
Un-blinded Site Roles: At each site, WASABI Clinicians are un-blinded in order to provide lead 
dCBGT sessions and support for participants using their assigned programs.  They will be 
distinct from staff administering and scoring follow-up assessments. Additionally, designated 
personnel that are un-blinded may not participate in the assessment and evaluation at follow-
up assessments (V3) of study participants. 
 
Blinded Site Roles:  All site staff responsible for the administration and scoring of participant 
assessments visits conducted after randomization will remain blinded to participant treatment.  
Site Principal Investigators will be required to complete a Delegation of Authority Form, 
indicating which activities individual site research team members will be authorized to 
complete. Site Principal Investigator will also remain blinded. 
 

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Depending upon the extent to which they are responsible for data collection and/or entry, 
Clinical Research Coordinators may or may not remain un-blinded to participant treatment.  This 
will be clarified on a site-by-site basis and will be noted on the Site Principal Investigator 
Delegation of Authority Form.   
 
To prevent un-blinding, the following controls will occur at the site level: 
 
1. The treatment condition and the control condition will be identified as “two forms of 
dCBGT.” 
2. Participants will be reminded not to discuss details related to treatment with blinded 
psychometricians and/or clinical evaluators during the informed consent process as 
well as prior to initiation, and at the conclusion of, each assessment visit; 
3. Site personnel will be instructed to not discuss details of either treatment arm during 
open participant groups or forums outside of the assigned dCBGT sessions or cohort 
discussions; 
4. Sites will be required execute the protocol in a manner that minimizes the possibility of 
accidental un-blinding of psychometricians or clinical evaluators (e.g. unintended 
viewing of treatment sessions). 
 
Research Monitor 
 
This is a minimal risk protocol.  There is no significant risk to using either of the web-based 
programs in this study, beyond the minor discomfort and tedium risks noted above.  Previous 
studies in healthy aging, schizophrenia, and spatial neglect have not noted any significant 
adverse events arising from program use.  Nonetheless, to follow best practices for treatment 
trials in medical indications, we will employ a central Research Monitor to review all 
unanticipated problems involving risk to participants, serious adverse effects, and any 
participant deaths associated with the protocol, and provide an unbiased written report of the 
event within ten calendar days.  The research monitor will comment on the outcomes of the 
adverse event and relationship of the event to the protocol or test article.  The research monitor 
will also indicate whether they concur with the details of the report provided by the PI. 
Reports for events determined by either the PI or Research Monitor to be possibly or definitely 
related to participation, and reports of events resulting in death will be promptly forwarded to 
the IRB. 
 
 
 
 

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Withdrawal from the Protocol 
 
Study participants may withdraw from the study at any time, for any reason, or for no stated 
reason.  We anticipate that a common reason for study withdrawal will be the time required to 
complete the intervention.  For participants seeking to withdraw for that reason, we will offer 
the alternative of discontinuing the intervention and scheduling and completing the post-
intervention assessment (End of Study, V3) visit, given they have met the minimum sessions 
required to complete the post-assessment visits.  The data analysis plan is structured so that 
their data will be valuable even if they do not complete the intended number of sessions. 
Participants who still wish to withdraw following that option will withdraw.  Other than time 
required to use the program, we do not anticipate any common reasons for withdrawal that 
we will plan for in advance. 
 
In rare cases, a Principle Investigator may decide to prematurely discontinue a participant’s 
involvement in the study for any of the following reasons:   
a) Safety, 
b) Participant non-compliance, 
c) A change in circumstance that would prevent completion of protocol-required 
assessments, 
d) Participant relocation to an area that, due to great distance, would prohibit a participant 
from receiving follow-up at the study site, 
e) Participant displays inappropriate behavior toward study staff members or other 
participants, 
f) Participant is hospitalized for psychiatric reasons; 
g) Loss of funding, or; 
h) A clinical determination, by the Principal Investigator, that continuation in the study is 
not in the participant’s best interests. 
 
Across all reasons for withdrawal, we will ensure an orderly end to the participant’s 
involvement in the study by arranging for the Site Study Coordinator or WASABI Clinician to 
recover the mobile device (if it has been issued to the participant), conducting an informational 
interview with the participant to understand the reasons for study withdrawal and identify 
any issues with study conduct or adverse events that are relevant, and arrange study 
compensation for sessions that the participant completed. 
 
 
 

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Modifications to the Protocol 
 
Any significant changes to the protocol, including changes to inclusion/exclusion criteria, 
changes to assessments, changes to recommended intervention and/or program use, changes 
that could potentially increase risk to study participants, and additions or removals of key 
personnel and/or recruitment sites will have to be approved by the grant-recipient and 
Sponsor PI, Dr. Bruno Biagianti, PSC. Changes requiring approval by the Institutional Review 
Board will be submitted for review in the form of a protocol amendment or revision prior to 
implementation. 
 
Protocol Deviations 
 
Protocol deviations will be noted and recorded by Staff (PI, Clinical Coordinator, Study 
Coordinator, Psychometrician, or WASABI Clinician) if they detect the deviation, or the Study 
Data Monitor if they detect the deviation during a site visit. All protocol deviations will be 
reviewed by the Study PI (Bruno Biagianti) on a monthly basis and must be signed off by the 
Study PI; any such deviations suggesting systematic problems with the protocol procedures as 
implemented by the site will be reviewed and corrective action determined and implemented 
by the site.   
 
Reporting of Serious Adverse Effects & Unanticipated Device Effects  
 
The intervention activities and WASABI-program assessments are conducted remotely and 
primarily computerized. The WASABI protocol has minimal risk, and previous studies of 
similar approaches in psychiatric populations have not reported significant adverse events 
arising from intervention and program use. Additionally, computerized treatment studies using 
Posit Science software in healthy aging, schizophrenia, and TBI have never reported adverse 
events attributable to study activities. Nonetheless, to follow best practices for treatment trials 
in medical indications, we will employ a central Medical Research Monitor to review all 
unanticipated problems involving risk to participants, serious adverse events, and any 
participant deaths associated with the protocol, and provide an unbiased written report of the 
event within ten calendar days. The Medical Research Monitor will comment on the outcomes 
of the adverse event and relationship of the event to the protocol or test article. The Medical 
Research Monitor will also indicate whether they concur with the details of the report provided 
by the Site Study staff member. Reports for events determined by designated study personnel,  
i.e. Medical Research Monitor, to be possibly or definitely related to participation, and reports 
of events resulting in death will be promptly forwarded to Western IRB. Further, serious adverse 
events attributable to study activities and/or the intervention and/or program use, will be 

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documented and reported immediately to the Western IRB. An event that is serious must be 
recorded on the case record and requires expeditious handling to comply with regulatory 
requirements. In the event that a patient becomes ill or injured as a direct result of participation 
in the project, necessary medical care will be made available. 
The Site Study Coordinator and WASABI Clinician will ask about any deterioration in 
symptoms during each contact with participants, and will be alert to any volunteered episodes 
of suicidality. All events of this nature will be documented on a standardized form and will be 
classified by the PI to their degree of seriousness and their relationship to the study protocol. 
Participants will be referred to appropriate clinical care should there be any concerns for safety 
or increasing symptoms. If deemed clinically necessary, the PI may elect to remove 
participants from the study if they find that it is no longer in the participant’s best interests to 
continue participation in the study.   
Finally, we will also conservatively follow guidelines for medical devices (i.e., 
computerized assessments) in the reporting of adverse events in this trial, which defines 
unanticipated adverse device effects (UADEs) in The Code of Federal Regulations in 21 CFR 
812.3(s) as any serious adverse effect on health or safety associated with, a device. 
 
Continuing Review and Final Report 
 
In accordance with NIA SBIR guidelines, a continuing review report(s) as well as a Final report 
will be submitted via eRA Ccommons.  
 
The knowledge of any pending compliance inspection/visit by the FDA, Department of Health 
and Human Services Office for Human Research Protection, or other Government agency 
concerning clinical investigation or research, the issuance of Inspection Reports, FDA Form 
483, warning letters, or actions taken by any Regulatory Agencies, including legal or medical 
actions, and any instances of serious or continuing noncompliance with the regulations or 
requirements will also be reported. 
 
 Surveys, Questionnaires and Other Data Collection Instruments 
*Complete paper versions are available upon request. 
 
Diagnostic Assessment 
MINI-KID  
https://eprovide.mapi-trust.org/instruments/mini-international-neuropsychiatric-interview-for-children-
and-adolescents 
 
 

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Cognitive Status 
WASI-II 
https://www.pearsonassessments.com/store/usassessments/en/Store/Professional-
Assessments/Cognition-%26-Neuro/Wechsler-Abbreviated-Scale-of-Intelligence-%7C-Second-
Edition/p/100000593.html 
 
Anxiety and Social Anxiety  
SPAI-B 
https://www.mhs.com/MHS-Assessment?prodname=spai 
LSAS-CA 
Masia-Warner, C. et al. The Liebowitz Social Anxiety Scale for Children and Adolescents: An Initial 
Psychometric Investigation. Journal of the American Academy of Child & Adolescent Psychiatry 42, 
1076–1084 (2003). 
MASC-2 
https://www.mhs.com/MHS-Assessment?prodname=masc2 
 
Social Functioning  
ASSES 
Connolly, J. Social self-efficacy in adolescence: Relations with self-concept, social adjustment, and 
mental health. Canadian Journal of Behavioural Science/Revue canadienne des sciences du 
comportement 21, 258–269 (1989). 
SSQ  
Nelson, W. Social Skills Training – Enhancing Social Competence With Children and Adolescents, S.H. 
Spence; U.K.; NFER Nelson; 1995; Kit; $160.00 (ACER). Australian Journal of Guidance and 
Counselling 6, 102–103 (1996). 
 
 
Suicidality  
C-SSRS 
https://cssrs.columbia.edu/the-columbia-scale-c-ssrs/cssrs-for-research/ 
 
Case Report Forms: this study employs both an electronic case report form system and a 
paper-based case report form system (i.e., source documentation records to support the EDC 
System). 
 
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57. Gleeson, J. F. et al. Safety and Privacy Outcomes From a Moderated Online Social Therapy for 
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Appendix I. Table of Assessments  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assessment 
Screening 
V1 
V3 
Informed Assent/Consent 
X 
 
 
Demographics 
X 
 
 
Medical History Questionnaire and Screening 
X 
 
 
Mini International Neuropsychiatric Interview 
for Children and Adolescents (MINI-KID) 
X 
 
 
Social Phobia and Anxiety Inventory-Brief 
version 
X 
 
 
Wechsler Abbreviated Scale of Intelligence 
(WASI-II) 
X 
 
 
C-SSRS, Baseline 
X 
 
 
Medications, Baseline 
X 
 
 
Liebowitz Social Anxiety Scale for Children 
and Adolescents (LSAS-CA) 
 
X 
X 
Social Phobia and Anxiety Inventory (SPAI)  
 
X 
X 
Multidimensional Anxiety Scale for Children 
2nd Edition (MASC-2) 
 
X 
X 
Adolescent Social Self-Efficacy Scale (ASSES) 
 
X 
X 
Social Skills Questionnaire (SSQ) 
 
X 
X 
Medications, Since Last Visit 
 
X 
X 
C-SSRS, Since Last Visit 
 
X 
X 
Adverse Effects 
 
X 
X 
Unanticipated Adverse Effects 
As needed 
Study Exit  
As needed 

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Appendix II.  Sample Debit Card Information 
Attached separately.