Brief Enhanced Anxiety Sensitivity Treatment: A Pilot Study
Phase: NA
Conditions: Anxiety Sensitivity, Functional Impairment
Sponsor: VA Office of Research and Development

Version 5 4/12/2023 
 
 
 
 
 
 
 
Brief Enhanced Anxiety Sensitivity Treatment: A Pilot Study 
Funding Agency: HSR&D 
Principal Investigator: Nicholas Allan, Ph.D 
 
 
 
 

 
Page 2 of 25 
 
Abstract 
 
The impact of the COVID-19 pandemic on behavioral health and associated functional 
impairment is well-documented. Based on data from past national/regional crises, the impact on 
emotional distress and functional impairment will continue unabated for many people. Yet, the 
increased use of telehealth and mobile apps in the Veterans Healthcare Administration (VHA) 
provides an unprecedented opportunity to quickly and efficiently ameliorate extreme emotional 
distress through brief evidence-based interventions. Anxiety sensitivity, or fear of anxiety 
sensations, amplifies the experience of emotional distress. People high in anxiety sensitivity fear 
that bodily sensations associated with anxiety are catastrophic, setting up a vicious positive 
feedback loop leading to increased distress and/or avoidance of anxiety-provoking situations 
and ultimately functional impairment. There is robust evidence that anxiety sensitivity 
contributes to increased emotional distress and functional impairment during the COVID-19 
pandemic. 
 
Cognitive behavioral therapy (CBT)-based interventions for anxiety sensitivity have 
demonstrated efficacy in reducing anxiety sensitivity. However, this efficacy has not translated 
to effective delivery of these interventions. Anxiety sensitivity interventions either require many 
in-person sessions with a trained clinician making them costly and time-intensive or are online 
self-help programs which results in deficits in treatment uptake and reports of patient 
disengagement. We have developed Brief Enhanced Anxiety Sensitivity Treatment (BEAST) as 
a brief one-session intervention that can be delivered effectively by a clinician via telehealth and 
augmented with a mobile app. BEAST includes psychoeducation, cognitive bias modification, 
and interoceptive exposure exercises designed to reduce sensitivity to anxiety-provoking stimuli, 
delivered virtually with a CBT-trained clinician. 
 
The proposed study will be the first to provide preliminary data for BEAST among Veterans with 
elevated anxiety sensitivity reporting functional impairment. The study’s first aim will be to adapt 
an existing brief intervention for anxiety sensitivity for virtual delivery within the VA and 
augmentation via mobile app to increase homework adherence and treatment gains. The 
second aim will be to assess the feasibility, acceptability, and usability of BEAST among 15 
Veterans with elevated anxiety sensitivity and functional impairment. It is expected that, upon 
completion, an intervention will be developed that effectively reduces functional impairment due 
to anxiety through reducing sensitivity to anxiety. Conducting this preliminary study establishes 
the feasibility, acceptability, and usability of BEAST using pre-existing VHA infrastructure to 
deliver the intervention (i.e., telehealth, mobile app). This study directly addresses RX-22-003 in 
that we aim to aid in the recovery from functional impairment in Veterans with elevated anxiety. 
Based on results of this study, we will propose a fully-powered effectiveness randomized control 
trial. 
 

 
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List of Abbreviations 
BEAST – Brief Enhanced Anxiety Sensitivity Treatment 
CBT – Cognitive Behavioral Therapy 
CoE – VISN 2 Center of Excellence for Suicide Prevention 
CPG – Clinical Practice Guidelines 
ITT – Intent-to-treat 
MAR – Missing at random 
PROMIS – Patient Reported Outcome Measures Information System 
 
 

 
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Contents 
Study Protocol............................................................................................................................ 5 
Protocol Title:  Telehealth CBT to increase engagement in pain treatment… ............................. 5 
1.0 
Study Personnel .............................................................................................................. 5 
2.0 
Introduction ..................................................................................................................... 6 
3.0 
Objectives ....................................................................................................................... 8 
4.0 
Resources and Personnel ............................................................................................... 8 
5.0 
Study Procedures ............................................................................................................ 9 
5.1 Study Design .................................................................................................................... 9 
5.2 Recruitment Methods.......................................................................................................12 
5.3 Informed Consent Procedures .........................................................................................13 
5.4 Inclusion/Exclusion Criteria ................................................ Error! Bookmark not defined. 
5.5 Study Evaluations ............................................................................................................14 
5.6 Schedule of Assessments ................................................. Error! Bookmark not defined. 
5.7 Data Analysis ..................................................................................................................16 
5.8 Withdrawal of Subjects ....................................................................................................19 
6.0 
Protection of Human Subjects ........................................................................................19 
7.0 
References .....................................................................................................................23 
 
 
 

 
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Study Protocol 
Protocol Title:   
1.0 
Study Personnel 
Principal Investigator: 
Nicholas P. Allan, PhD 
Health Science Specialist 
Center of Excellence for Suicide Prevention 
VA Finger Lakes Healthcare System 
Nicholas.Allan@va.gov 
Co-Investigators: 
Tracy Stecker, PhD 
Co-Research Director 
Center of Excellence for Suicide Prevention 
VA Finger Lakes Healthcare System 
Tracy.stecker@va.gov 
 
Lisham Ashrafioun, PhD 
Health Science Specialist 
Center of Excellence for Suicide Prevention 
VA Finger Lakes Healthcare System 
Lisham.ashrafioun@va.gov 
Hugh Crean, PhD 
Health Science Specialist 
Center of Excellence for Suicide Prevention 
VA Finger Lakes Healthcare System 
Hugh.Crean@va.gov 
Research Staff: 
Park Bogan 
Project Coordinator 
Center of Excellence for Suicide Prevention 
VA Finger Lakes Healthcare System 
park.bogan@va.gov 
 
Anne Zahradnik 
Research Assistant 
Center of Excellence for Suicide Prevention 
VA Finger Lakes Healthcare System 
anne.zahradnik@va.gov 
 
Samantha Daruwala  
Center of Excellence for Suicide Prevention  
VA Finger Lakes Healthcare System 
Samantha.daruwala@va.gov 
 
Sponsor: HSR&D  
Sites: 
Center of Excellence for Suicide Prevention/Canandaigua VA Medical Center

Version 5 4/12/2023 
2.0 
Introduction 
 
Veterans with anxiety are likely to suffer disproportionately and unnecessarily following 
the COVID-19 pandemic because of anxiety sensitivity. The death toll and economic impact 
of the COVID-19 pandemic are staggering. Unaddressed, a mental health crisis will follow.1 
Prior natural, manmade or biological disasters have spurred long-lasting mental health impacts; 
already, longitudinal data on the wellbeing of people during the COVID-19 pandemic support an 
emerging mental health crisis. Fear and anxiety about the COVID-19 virus itself, the economic 
impact, and the uncertain timeline are driving the mental health impacts of COVID-19, with 45% 
of Kaiser Family Foundation poll respondents reporting that the coronavirus has had a negative 
impact on their mental health.2 For Veterans already experiencing heightened anxiety, the 
duress experienced during the pandemic will exacerbate pre-existing difficulties in everyday 
functioning (i.e., work/school, family, household obligations). Anxiety sensitivity is an ideal target 
to efficiently restore functioning in this population. Anxiety sensitivity, a highly researched risk 
factor represented in the DSM-
5 and NIMH’s RDoC matrix, is 
defined as the fear of 
catastrophic outcomes due to 
anxiety sensations.3 Anxiety 
sensitivity is associated with a 
broad array of anxiety, mood, 
and substance use pathology 
as well as suicidal thoughts and 
behaviors.4–8 Experimental 
studies have verified that 
anxiety sensitivity exacerbates 
the experience of anxiety;9–12 
Individuals high on anxiety 
sensitivity misinterpret and 
overreact to stress, anxiety 
symptoms, and bodily sensations. Theoretical models posit that short- and long-term stressors, 
such as those experienced during the pandemic exacerbate the experience of negative 
emotions that individuals with elevated anxiety sensitivity already experience (see Figure 1).13,14 
Functional impairment during COVID-19 is common and anxiety sensitivity has been 
implicated as a risk factor. Anxiety sensitivity exacerbates the experience of negative 
emotions and increases the likelihood of maladaptive coping behaviors, including avoidance of 
role responsibilities, resulting in increased functional impairment. Preliminary studies we have 
conducted during the pandemic support this hypothesized model of anxiety sensitivity. Across 
three samples (Ns = 249, 368, 435), anxiety sensitivity was significantly and strongly associated 
with increased functional impairment related to the COVID-19 pandemic (rs = .58-.69, R2 = .34-
.48) as well as increased anxiety severity (rs = .67-.68, R2 = .45-.46). Further, Veteran status 
moderated these relations such that these effects were more pronounced in Veterans compared 

 
Page 7 of 25 
 
to civilians. Manning and colleagues15 reported that anxiety sensitivity moderates the 
association between anxiety and distress experienced during the COVID-19 pandemic and 
functional impairment in a sample of 563 adults. In a sample of 645 community adults we 
collected data on from May to October 2020, mean anxiety sensitivity levels exceeded clinical 
cutscores for moderate-to-severe anxiety sensitivity (M = 21.40, SE = 0.67), remained elevated 
at six-month follow-up (M = 19.61, SE = 0.75), and were significantly correlated across 
timepoints, R2 = .89. Another study found anxiety sensitivity during the early stages of the 
pandemic predicted functional impairment one month later.16 These studies demonstrate that 
regardless of the progression of the pandemic through recovery, a large minority of Veterans 
will retain functional impairment driven by anxiety sensitivity barring intervention. 
 
Anxiety sensitivity can be reduced using brief CBT techniques. There is robust evidence 
that anxiety sensitivity is malleable using CBT techniques. Brief CBT is an ideal treatment 
modality to increase treatment access efficiently. Brief, computerized interventions targeting 
anxiety sensitivity have been shown to be efficacious and to reduce functional impairment.17–23 
However only self-help interventions are available. Pilot studies in the VA and elsewhere 
suggest this may not be optimal for delivery of a brief anxiety sensitivity intervention. In a study 
focused on dissemination of a brief computerized self-help anxiety sensitivity intervention, only 
57% reported that the intervention was more than “moderately helpful” and 41% indicated they 
would be very likely to use the information/techniques learned during the intervention.24 In an 
acceptability/feasibility trial of the same brief anxiety sensitivity self-help intervention in 22 
Veterans experiencing a mild TBI and elevated anxiety sensitivity,25 Veterans provided multiple 
recommendations for improvement. Relevant to the low percentage of treatment uptake when a 
computerized intervention was delivered, Veterans requested more opportunities to practice the 
skills learned during the intervention, a therapist to assist in comprehension, and inclusion of 
interoceptive exposure (IE) exercises. Concerns raised were consistent with the treatment 
literature: treatment uptake and outcomes are increased substantially when homework is 
completed, when a therapist is included, and when IE is practiced.26–29  We directly address 
these barriers through iterative development of Brief Enhanced Anxiety Sensitivity Treatment 
(BEAST), a one-session intervention that can be delivered effectively by a clinician via 
telehealth and supplemented with a mobile app to provide opportunities to practice the skills 
learned in the face-to-face session. 
 
To enhance the efficacy and ease of dissemination of BEAST, we propose two crucial 
improvements to our prior protocol. First, prior brief anxiety sensitivity interventions have 
been self-guided. BEAST is delivered via telehealth, which retains the accessibility of other brief 
anxiety sensitivity interventions while increasing Veteran engagement. BEAST will be delivered 
in a one-hour intervention by a master’s level or above therapist who has experience in CBT 
and telehealth. Second, as practicing skills outside the session improves treatment outcomes,30 
the intervention will likely be more impactful if opportunities to practice skills learned during the 
telehealth session are provided. Adding ecological momentary intervention (EMI),31 delivered 
via ecological momentary assessment (EMA), to the treatment will remind participants to apply 
skills they learned in the face-to-face session in a variety of real-life situations and practice IE at 
different times and mental states. EMI delivers the intervention remotely in real-time and in 

 
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natural settings, providing better learning through deeper processing.32 Recent studies on 
depression, anxiety, and stress as outcomes indicate a medium effect size improvement 
through inclusion of EMI.33–35 We expect inclusion of these elements not to impact the feasibility 
and acceptability of the trial compared to brief self-help interventions while translating to 
enhanced efficacy and ease of dissemination in our future fully-powered trials of BEAST. 
3.0 
Objectives 
  
Dr. Allan was involved in the development and testing of prior computerized self-help 
interventions for anxiety sensitivity.18,21,31 Since the onset of the pandemic in the summer of 
2020, our group has worked with populations of anxious adults reporting distress and 
impairment due to the COVID-19 pandemic to create BEAST and other brief transdiagnostic 
treatment modules (i.e., intolerance of uncertainty, social isolation). We recently completed 
several focus groups in 12 adults reporting elevated anxiety sensitivity or intolerance of 
uncertainty. We also completed a focus group with three PhD-level therapists who use CBT as 
part of their daily patient regimen. Participants and therapists reported the content of the 
intervention was accessible, easily understood, and highly relevant to distress. Participants and 
therapists thought inclusion of EMA/EMI would improve participant engagement and reported 
they would not perceive completion of multiple surveys daily to be a burden. Participants also 
believed personalized content would increase engagement and assisted in developing a 
protocol to collect this content. Participants made several suggestions to improve delivery of the 
intervention, including a therapist modeling the use of the mobile app, check-ins on mobile app 
completion, and creating a set of questions to determine which facet of anxiety sensitivity is 
driving anxiety. This pilot one-arm trial will test the acceptability, feasibility, and usability of 
BEAST to reduce anxiety sensitivity and functional impairment in Veterans.  
 
We are proposing the following aims: 
 
Aim 1: Adapt an existing brief intervention for anxiety sensitivity for virtual delivery 
within the VA and augmentation via mobile app to increase homework adherence and 
treatment gains. We will use a Delphi method to engage Veterans with elevated anxiety 
sensitivity and functional impairment into the design and evaluation of BEAST. We will also 
partner with the VA Center for Mobile Apps Research and Resources to incorporate design 
changes directly into the app. 
 
Aim 2: Assess the feasibility, acceptability, and usability of BEAST among 15 Veterans 
with elevated anxiety sensitivity and functional impairment. We will assess (1) treatment 
satisfaction and acceptability, (2) participant recruitment and retention, (3) participant treatment 
adherence, (4) therapist fidelity, and (5) assessment fidelity. Further refinement will occur based 
on feedback. 
4.0 
Resources and Personnel 
Drs. Allan and Stecker will train the research team to administer verbal consent and 
administer and score the assessment measures through instruction and observed role play. 
Interventionists with at least a master’s degree and prior CBT training will deliver BEAST. Drs. 
Stecker and Allan will train the interventionists using the PowerPoint slide deck. We will monitor 
treatment fidelity (i.e., adherence and competence) by audio-recording intervention sessions 

 
Page 9 of 25 
 
(via Teams or Webex) and reviewing them in weekly supervision meetings. Weekly meetings 
will be provided by Drs. Allan and Stecker. The meetings will focus on all of the issues involved 
in study tasks including: a) recruiting participants, b) conducting interviews, c) coding interview 
data, d) communicating between research staff and interventionists, e) contacting participants 
for follow-up assessment; f) completing documentation, and g) storing and safeguarding data. 
To maintain blinding, separate meetings among interventionists and the coordinator will be done 
as needed. The interventionist will complete intervention sheets electronically to track beliefs 
identified. These will be monitored, in addition to the recorded sessions, during ongoing 
supervision.  
 
PI Allan will train the project staff in coordination with Co-Is Ashrafioun and Stecker. Dr. Allan 
will train the Project Coordinator to track recruitment and retention as well as data fidelity. Dr. 
Allan will supervise and train the Project Coordinator to address IRB and grant-related 
documentation and to monitor the data stream from the mobile app and contact participants as-
needed when compliance issues for completion of surveys via mobile app arise.   
 
Therapists with at least a master’s degree in a counseling/health-related field and prior CBT 
experience will deliver BEAST. Drs. Allan and Stecker will train the therapists using the 
PowerPoint slide deck. Initial training will consist of lecture, role play “rehearsal” techniques, and 
coding of pre-recorded practice sessions for delivery of intervention content. Ongoing 
supervision will also be provided by Drs. Allan and Stecker throughout the study. Treatment 
fidelity will be monitored by recording all intervention sessions, having research assistants code 
each session for fidelity, and reviewing these tapes and sheets in weekly supervision practice. 
Adherence scores will be given by transforming the total number of points into a percentage of 
content delivered. Based on existing measures, we will measure quality of intervention delivery 
by: (1) Pacing/focus, (2) Communication skills, (3) Therapeutic skills, and (4) 
Flexibility/Tailoring/Continuity. Each item will be rated on a 5-point Likert scale by the research 
team. Coding team members will be assigned independent rating of sessions with a 20% 
overlap of sessions as well as randomly reinserting previously coded sessions to continue to 
assess interrater reliability.6,7 Consensus meetings will be held for all double-coded sessions. 
Interrater reliability (κ)  below at least moderate levels, in the overlapping sessions and/or for 
previously coded sessions will result in immediate retraining of all coders until κ suggests 
substantial agreement. Coders who continue to perform poorly will be replaced.8 
 
Weekly meetings will be conducted to focus on monitoring: a) recruitment, b) conducting 
interviews, c) coding interview data, d) communication between research staff, e) retention; f) 
completeness of documentation, and g) storing and safeguarding data.  
5.0 
Study Procedures 
5.1 Study Design 
Aim 1 Study Design 
Study sample and Screening: We will recruit 6 therapists with experience in telehealth 
and CBT treatment of Veterans with anxiety and 6 Veterans who meet study eligibility for Aim 2 
through the Canandaigua, NY VA. 
 

 
Page 10 of 25 
 
Assessments and Intervention: Stakeholders (masters-level or higher therapists and 
Veterans meeting eligibility criteria) will be enrolled following consent. Separate consent forms 
have been developed for the initial session and the second session. The framework for BEAST 
exists and will be refined based on feedback received from stakeholders. BEAST comprises two 
components: face-to-face virtual sessions delivered via telehealth and EMI based on the skills 
acquired in session, delivered via mobile app. Stakeholders will be asked a series of open- and 
close-ended questions about the intervention (see Appendix) using an evidence-based expert 
consensus method for refining the intervention and tailoring the protocol for Veterans. 
Stakeholders will evaluate the final product after we have completed the one-arm trial and 
compiled and organized the exit interview information. Final modifications will be incorporated 
again through seeking consensus with stakeholders. 
 
The study team will work with the Center for Mobile Applications Research Resources & 
Services (CMARRS) to refine the mobile app and therapist dashboard that will be used to 
deliver the EMA/EMI components of the intervention. The initial development will occur with the 
study team using the Mobile App Rating Scale, a multi-dimensional scale assessing an apps 
engagement, functionality, aesthetics, information, and subjective quality as well as items 
assessing the perceived impact of the app on the target audience’s knowledge, attitudes, 
intentions to change and likelihood of changing.40 Ratings across scales range from 1 
(“inadequate”) to 5 (“excellent”). We will proceed with our app once it receives consensus 
scores of 4 or higher across all scales among the study team. In the unlikely event that 
consensus ratings are not achieved, we will resolve through a study team meeting and a simple 
majority being used to select consensus.  
 
Veteran participants will receive compensation for their participation in the study. The 
compensation amount will be based on the following: 
 
 
Prior to Pilot Study  
 
 
 
$50  
 
Completion of Pilot Study 
 
 
$50 
 
Payments will be made via direct deposit, check, or debit card following each study procedure 
listed above. Participants who do not complete the entire study for any reason will receive 
compensation for the components that were completed per the above schedule of payments. 
 
VA Clinicians recruited for Aim 1 will not be compensated, instead providing their effort in kind.  
 
Aim 2 Design 
Study Sample and Screening: We will recruit 15 Veterans with elevated anxiety sensitivity 
(i.e.,SSASI > 9 ) and moderate or higher functional impairment (12-item World Health 
Organization Disability Assessment Schedule 2.0 > 59). Additional criteria include English-
speaking and 18 years of age or older. Veterans do not need to meet diagnostic criteria for an 
anxiety disorder to benefit from BEAST and therefore the presence of an anxiety disorder is not 
an inclusionary criterion. Further, because BEAST targets a construct that is non-overlapping 
with constructs targeted in traditional CBT, Veterans are eligible regardless of current treatment 
status. The Project Coordinator will conduct all screening and assessments by phone or video 
call following a script. Potential participants will provide verbal consent to complete the 
screening measures. Veterans meeting eligibility and interested in participating will be 
scheduled for a consent and baseline assessment appointment. 
 

 
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Assessments and Intervention: Veterans will be enrolled following informed consent. 
Veterans will next complete the baseline assessment. At the baseline assessment, Veterans 
meet with the Project Coordinator by phone or virtually to complete a consenting process, 
guidance on the video software being used, and set-up and guidance of the mobile app. 
Research team member will reach out to the Veteran the following day to address any issues 
with using the app. Veteran will complete assessment surveys for approximately 1 week. At the 
baseline appointment, participants will be scheduled to receive the face-to-face virtual 
intervention followed by two weeks of EMA/EMI via mPRO. At the end of the two weeks, 
Veterans will complete a post-intervention assessment appointment. Follow-up assessment 
appointments will be completed at the 1-month and 3-month follow-ups. The post-intervention 
assessment includes an exit interview for participants to provide additional feedback regarding 
acceptability of the intervention. The research staff will read the measures to the Veteran who 
will verbally provide their answers; we have found this improves data reliability and 
completeness immensely compared to mailing packets/sending survey links. 
BEAST contains two components: First, there is a single session face-to-face virtual 
intervention delivered by the counselor or therapist, delivered via VA Video Connect software. 
Second, a mobile app (mPRO) is used for EMA and to deliver EMI components.  
Face-to-face session. The face-to-face session is a one-hour manualized intervention that 
uses interactive content to enhance participant learning of critical intervention components. The 
session includes 1) psychoeducation regarding the role of anxiety sensitivity in exacerbating 
anxiety sensations, 2) practice identifying and challenging maladaptive thoughts about anxiety, 
and 3) an IE activity. Psychoeducation is first provided, focusing on the body’s alarm system 
with a goal of normalizing bodily sensations associated with anxiety. Following 
psychoeducation, the participant and therapist discuss sensations the participant experiences 
when they are anxious and the thoughts about these sensations that serve to maintain them. 
The participant and therapist explore challenges to any strongly held beliefs about the danger of 
anxiety sensations. Finally, the IE consists of: repeated trials of hyperventilation given evidence 
that this challenge is among the most anxiety-provoking for individuals with panic disorder and 
our experience using this IE exercise in prior RCTs,10–12 as well as repeated trials of another 
selected interoceptive exposure activity. To aid in personalization, Veterans assist in choosing 3 
key takeaways that summarize what they learned from the intervention regarding anxiety 
sensations as benign. Common summaries from past participants include: Anxiety sucks, but it 
is harmless; I’ve been anxious before, no big deal! These summary phrases are incorporated 
into the EMI. Participants are also asked to complete one set of IE exercises daily for the next 
two weeks.  
EMA. EMA will be collected from baseline to post-intervention and for one week after 
completing each follow-up. This measurement burst design allows for ratings of functional 
impairment and anxiety to be calculated disambiguated from state level influences. In our future 
RCT, this will provide additional power to explore the mechanisms at play. Consistent with best-
practice recommendations13 we will employ a mixture of fixed time-based sampling, experience 
sampling, and event-based sampling strategies. In the morning, participants will receive a fixed 
time-based survey that will include a short battery of questions that will take approximately 2 

 
Page 12 of 25 
 
minutes to complete. Experience sampling will be used to deliver three surveys, distributed 
quasi-randomly over the remainder of the day (each take 30s to 1 minute to complete). Pulses 
are randomized such that they are never less than 3 hours and never more than 8 hours apart. 
Finally, event-based sampling will be used for tracking IE exercise completion.  
5.2 Recruitment Methods 
 
Aim 1 Recruitment and retention procedure for Clinical Psychologists: We aim to recruit 6 
VA clinical psychologists who self-report experience in CBT, anxiety, and in treating Veterans. 
We will recruit through emails to colleagues who work with VA clinical psychologists.  
Recruitment and retention procedure for Veterans (Aims 1 & 2): We aim to recruit 6 eligible 
Veterans for Aim 1 and 15 eligible Veterans for Aim 2 from the Canandaigua VA. A two-pronged 
recruitment strategy will be employed: 1) VA healthcare providers will be able to refer potentially 
eligible participants by placing the investigators as additional signers on notes using the VA’s 
electronic medical record. To facilitate recruitment, we will present on the intervention at staffing 
meetings held at various clinics. 2) Veterans with anxiety disorder diagnoses, identified using 
ICD codes, who are enrolled at the study site will be identified using structured queries of VA 
administrative datasets. Potential participants will be mailed a personalized letter describing the 
study and providing a toll-free number so that they can contact study staff if they are interested 
in participating as well as opt out of future contact. A study flyer will be included with this letter. 
There will be a QR code on this flyer directing participants toward our screener on Qualtrics that 
potential participants can complete instead of contacting study staff. We will use several 
procedures known to promote retention in longitudinal studies.1-4  
Web-based study screening:   
One mode for determining study eligibility will be Qualtrics (www.qualtrics.com), a web-based 
survey platform. Qualtrics is a popular tool for collecting survey data online with the ability to 
implement sophisticated study designs. People interested in completing the screening form via 
Qualtrics will scan the QR code on the flyer which will direct participants to several brief 
screening questions to ascertain study eligibility, made up of IRB-approved study measures. If 
eligible and interested, participants can request to be contacted by study staff. All respondents 
are encouraged to call the toll-free number with any questions/comments /concerns prior to 
enrolling in the study. 
Screening Data. Participants will be asked several questions to confirm eligibility and asked to 
answer several multiple-choice questions in Qualtrics (or by phone). The information will be 
stored separately from study data in a password-protected database. Data will be encrypted and 
stored behind the VA firewall. To enhance data security, access to study data will be limited to 
IRB approved study personnel. None of these data will be linked to research data. 
Self-Report Survey. Data collected for this project will be obtained by online survey. No 
identifiable data will be included in the limited data set, and a unique identifier will be assigned 
to each of the records to be used for analysis. Data will then be encrypted stored behind the VA 
firewall for cleaning and analysis in VINCI. To enhance data security, access to study data will 
be limited to IRB approved study personnel. 

 
Page 13 of 25 
 
Any recruitment, screening, or payment-related documents will be stored separately (in ‘access 
restricted’ file) from study data when received by VA behind VA firewall. 
 
5.3 Informed Consent Procedures 
There are three phases where informed consent could be obtained, when stakeholders are 
reviewing the intervention (Aim 1), when completing the screening for eligibility and when 
enrolling into the study following the screening and if eligibility criteria are met (Aim 2). Verbal 
consent to participate will be obtained for all participants. Informed consent will be obtained by 
study personnel trained in human subjects’ protections requirements and how to obtain and 
document informed consent. Further, questions are embedded at the end of the consent form 
requiring potential participants to demonstrate comprehension of what they are being asked to 
do.   
 
5.4 Inclusion/Exclusion Criteria 
Aim 1 Eligibility Criteria 
Eligibility Criteria for 6 Veterans: 
 
Inclusion criteria: Participants will include men and women Veterans who: 
• 
Are English-speaking  
• 
Are 18 years of age or older 
• 
Score > 9 on the SSASI indicating elevated anxiety sensitivity 
• 
Score > 5 on the 12-Item WHODAS 2.0 
Exclusion criteria: Veterans will be excluded on the basis of: 
• 
Veterans with cognitive impairment as measured scoring > 11 on the Blessed 
Orientation-Memory-Concentration Test 
• 
Veterans without access to a smartphone 
• 
Veterans with significant medical or psychiatric conditions that may limit participation, 
including severe documented schizophrenia, an ongoing active psychotic or manic 
state, or an imminent suicide crisis will be excluded from our study and provided the 
appropriate referral. 
 
Eligibility Criteria for 6 therapists 
Inclusion criteria: Participants will include masters-level or higher therapists who: 
• 
Are English-speaking  
• 
Are 18 years of age or older 
• 
Report experience in telehealth 
• 
Report experience in CBT treatment of Veterans with anxiety 
Aim 2 Eligibility Criteria: 
Inclusion criteria: Participants will include men and women Veterans who: 
• 
Are English-speaking  
• 
Are 18 years of age or older 

 
Page 14 of 25 
 
• 
Score > 9 on the SSASI indicating elevated anxiety sensitivity 
• 
Score > 5 on the 12-Item WHODAS 2.09 
Exclusion criteria: Veterans will be excluded on the basis of: 
• 
Veterans with cognitive impairment as measured scoring > 11 on the Blessed 
Orientation-Memory-Concentration Test14,43 
• 
Veterans without access to a smartphone 
• 
Veterans with significant medical or psychiatric conditions that may limit participation, 
including severe documented schizophrenia, an ongoing active psychotic or manic 
state, or an imminent suicide crisis will be excluded from our study and provided the 
appropriate referral. 
 
Pregnant women will not be excluded from this study as no invasive medical procedures are 
being performed and there is no known risk to the mother or the fetus of the proposed 
interventions. The study will not include prisoners or institutionalized veterans. 
 
5.5 Study Evaluations 
Consistent with recommendations for determining acceptability and feasibility in the context of 
intervention development, multiple program aspects will be evaluated with the aim of refining 
BEAST for larger-scale implementation.15–17 Feasibility of BEAST will be indexed via participant 
retention, average homework completion, and percentage of EMA sessions completed. 
Acceptability will be measured using an adaptation of the Program Satisfaction Questionnaire 
(PSQ), a 14-item measure that assesses both general program satisfaction (usefulness, 
acceptability) and perceived utility of program components (psychoeducation, EMA/EMI 
schedule).18 Measures selected were well-validated, have been administered to Veterans, 
and/or have been administered via telehealth. 
Assessments completed via research staff: 
Program Satisfaction Questionnaire (PSQ). Acceptability will be measured using an 
adaptation of the PSQ, a 14-item measure that assesses both general program satisfaction 
(usefulness, acceptability) and perceived utility of program components (psychoeducation, 
EMA/EMI schedule).18 
Blessed Orientation-Memory-Concentration Test (BOMC). The BOMC will be used to screen 
for cognitive impairment (i.e., > 11). 19 
Short Scale Anxiety Sensitivity Index (SSASI).20 The SSASI is a 5-item self-report measure 
assessing fear of negative consequences of anxiety-related symptoms. Scores > 9 on the 
SSASI are eligible.  
The Anxiety Sensitivity Index-3 (ASI-3).21 The ASI-3 is an 18-item self-report measure 
assessing fear of negative consequences of anxiety-related symptoms.  
The Intolerance of Uncertainty Scale-12 (IUS-12).22 The IUS-12 is a 12-item self-report 
measure assessing fear of uncertainty.  

 
Page 15 of 25 
 
12-Item World Health Organization Disability Assessment Schedule (WHODAS) 2.0. The 
12-item version of the WHODAS 2.0 assesses functional impairment across six domains: 1) 
understanding and communication, 2) self-care, 3) mobility, 4) interpersonal relationships, 5) 
work and household roles, and 6) community and civic roles.23  
PROMIS Profile-2924. Used to assess the following domains: anxiety, depression, physical 
function, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain 
interference. 
 
Functional Impairment Due to COVID (FIDC).25 A 7-item measure adapted from the 
WHODAS 2.0 to capture difficulties in functioning due to the COVID-19 pandemic, developed 
and validated by PI Allan and colleagues. 
 
COVID-19 Impact Battery (CIB) Worries.25 An 11-item scale measuring distress and worry 
due to the COVID-19 pandemic. 
 
COVID-19 Impact Battery (CIB) Behaviors.25 A 12-item scale assessing avoidance 
behaviors in relation to the COVID-19 pandemic. 
 
Depressive Symptom Index – Suicidality Subscale (DSI-SS). A 4-item measure assessing 
suicidality within the previous two weeks. 
 
Demographics. At screening, we will assess participants’ gender, age, educational 
background, employment, income, race, ethnicity, marital status, and socioeconomic status. 
Exit Interview. The exit interview will assess overall impressions, impact of treatment, 
relationship with the therapist, and ways to improve the treatment. Acceptability will be 
measured using an 11-item adaptation of the Program Satisfaction Questionnaire (PSQ) that 
assesses both general program satisfaction (usefulness, acceptability) and perceived utility of 
program components (psychoeducation, EMA/EMI schedule).18  The exit interview and PSQ will 
inform further refinement of the intervention as needed with our stakeholders. The exit interview 
will also consist of a number of open ended questions, including prompts to ask for more 
information, to collect worthwhile feedback on the study procedures, intervention, and their 
overall feelings toward the intervention.  
EMA Measures: 
State Short Scale Anxiety Sensitivity Inventory; SSASI20: measures anxiety sensitivity. 
State Penn State Worry Questionnaire; PSWQ51: measures anxious apprehension. 
State Anxiety Depression Distress Inventory-27; ADDI-27: measures anxious arousal 
The PSWQ and ADDI-27 have been validated as measures of general anxious apprehension 
and anxious arousal, respectively, reflecting the two core anxiety dimensions underlying anxiety 
disorders.26,27 Participants will also rate their impairment across functional domains using the 

 
Page 16 of 25 
 
12-item WHODAS 2.0. Visual analog scale (VAS) ratings from 1-100 will be used to assess 
anxiety, stress, and depression four times daily. ASI-3 items, revised to capture in-the-moment 
beliefs, will also be completed. Three items will be randomly selected from an ideographically 
developed pool of items the participant rates as impacting them “much” or “very much.” Thus, 
the pool of items to be drawn to potentially deliver EMI will differ by individual. 
 
5.6 Schedule of Assessments  
Participants will complete virtual baseline, post-intervention, and 1- and 3-month followups. 
Participants will receive compensation for their participation in the study but not for the 
intervention session. The compensation amount and sessions attended will be based on the 
following: 
 
 
Baseline Assessment  
 
 
$40  
 
Face-to-face session  
 
 
NA 
Post-Intervention Assessment 
 
$40 
 
1-month Assessment   
 
 
$30 
 
3-month Assessment  
 
 
$30 
 
Weekly EMA Data Collection  
 
$30 per week 
 
> 80% of EMA Weekly Surveys 
 
$10 per week 
 
Therefore, the total compensation for completing all the study components would be $340. 
Payments will be made following each study procedure listed above. Participants who do not 
complete the entire study for any reason, will receive compensation for the components that 
were completed per the above schedule of payments. 
5.7 Data Analysis 
General. To enhance methodological rigor and to allow for accurate dissemination of our 
findings, we will follow CONSORT guidelines in the design, analysis, and reporting of this study.  
Data Management. Dr. Allan, with the assistance of Drs. Ashrafioun and Stecker, will supervise 
data management using the following services: Enrollment, randomization, tracking of 
interviews, and auditing of data. A single enrollment and randomization document will be 
developed to assign identification codes to participants during the pre-enrollment period to track 
their eligibility status, and randomly assign participants. Similar to our prior studies, a tracking 
system will be developed to assist research personnel in managing follow-up interviews. This 
information will be covered during weekly staffing meetings involving Drs. Allan, Stecker, and 
Ashrafioun as well as the research personnel. Data will be audited for: a) data quality control (% 
of scales returned for corrections after auditing); b) rate of data entry; and c) backlog of data 
that has not been entered. All scales will be audited for identifiers, item completeness, and 
consistency of major clinical indicators. We will store and manage data at the VA with access 
limited to pertinent study personnel. During the study, we will maintain a dialogue on the technical 
integrity of our procedures and on conceptual aspects of our project. 
Data analysis for Aim 1: Develop expert consensus for our intervention components using a 
modified Delphi method. Specifically, a modified Delphi Method will facilitate the incorporation of 
expert and stakeholder feedback to reach consensus.38,39 We will present to our stakeholders 
the results of our study and any proposed changes as-needed after we complete Aim 2 (one-
arm trial). Experts and stakeholders will rate each component as: a) acceptable as is, b) 

 
Page 17 of 25 
 
acceptable with minor changes, or c) unacceptable. For each component, our intervention will 
be considered ready for Aim 2 if at least 4 of 6 clinicians and 4 of 6 veterans meeting eligibility 
criteria rate it to be acceptable as is and two rate it as acceptable with changes. If any member 
rates the content as unacceptable, we will meet with these participants individually to discuss 
why they rated the intervention as such. Experts and stakeholders will again evaluate any 
component of the intervention that did not meet eligibility criteria after the initial round of review. 
determine if the change would invalidate the intervention. If so, the team will agree not to make 
the suggested change. Correspondence with the expert panel will be done via email and virtual 
meetings. A final meeting regarding the summarized findings from the second round of 
feedback will be held by the investigative team to finalize the protocol. We will meet with our 
stakeholders to resolve any disagreements between the investigative team and our 
stakeholders. 
Data analysis for Aim 2: Assess the feasibility, acceptability, and usability of BEAST.  We will 
track the number of Veterans who are recruited per month. We will calculate the percentage of 
participants who complete the protocol and follow-ups to calculate acceptability. Treatment 
acceptability will be assessed with the exit interview. Therapist fidelity scores for the individual 
session will be assessed as the percentage of the content delivered. Interrater reliability for 
fidelity and competence will be assessed using intraclass correlation coefficients. When 
incorporating information from the exit interview, raters will provide perspectives, discuss their 
summarized responses, and reach consensus on different factors (e.g., format, receptivity, 
feasibility).  
The PI will check the work of the raters and chart the data to further examine the domains, core 
ideas, and categories that describe the themes. Means and standard deviations for outcomes 
will be calculated at each assessment, including change scores and correlations across 
timepoints. We expect large standard errors due to sample size. Distribution of scores will be 
examined to better evaluate how to analyze these data in future studies. For continuous 
outcomes, Hedge’s g will be calculated to identify a range of the pre-post effect size. Although 
such calculations are of limited benefit in determining the effect of the intervention, they are 
helpful in identifying outcomes for which the intervention may be less effective.  
For data quality and handling of missing data, descriptive statistics will help identify out of range 
values and outliers. The assessment battery will be considered acceptable if no questionnaires 
are missing in full in more than 25% of the participants and if reliability is higher than 0.70. 
Acceptability of EMA procedures will be assessed through calculating the percentage of EMA 
surveys completed as well as completion patterns. BEAST will also be considered feasible and 
acceptable if > 70% of the EMA sessions are completed by > 80% of participants, consistent 
with prior rates in studies conducted and reviewed by Dr. Allan. Acceptability will also be 
measured using an adaptation of the PSQ, an 11-item measure that assesses both general 
program satisfaction (usefulness, acceptability) and perceived utility of program components 
(face-to-face sessions, EMA/EMI).18 Finally, an average PSQ general satisfaction score of > 4 
(on a 5-point scale) and an average PSQ mobile app score > 4 (on a 5-point scale) will provide 
support for the feasibility and acceptability of BEAST. The research team and stakeholders will 

 
Page 18 of 25 
 
meet and discuss the intervention regarding benchmarks of acceptability and feasibility as well 
as the information gathered during the exit interviews.  
Power analysis. As this is a pilot trial, we did not conduct a formal power analysis when 
selecting the sample size. Rather, we used stepped rules of thumb to optimize the overall 
sample size for the pilot and main effects study.28 Based on these stepped rules of thumb and 
an expectation of clinical effect sizes in the medium range on primary and secondary outcomes 
of the RCT, 15 participants is considered adequate.  
Future trial. Findings from this pilot trial will provide the necessary infrastructure and 
demonstration of feasibility to allow us to expeditiously conduct a fully powered RCT and then 
disseminate through the VA. At the completion of this study, we will have refined the treatment 
manual, the mobile app design and schedule, and the study protocol/pipeline. Therefore, it is 
expected we will be well-positioned to pursue a MERIT award to provide evidence of efficacy of 
BEAST. 
Data storage, security, and confidentiality. Several procedures for protecting participant 
confidentiality will be implemented to reduce the risk of revealing participant identity. All 
informed consent forms will contain identifying information. To ensure confidentiality, each 
consent form will be labeled with a numeric identifier and will be stored in a double-locked file. 
These will be stored in separate double-locked files from other study materials. 
The VA Informatics and Computing Infrastructure (VINCI) will be used for the storage of study 
data. VINCI is a major informatics initiative of the Department of Veterans Affairs (VA) that 
provides a secure, central analytic platform for performing research and supporting clinical 
operations activities. It is a partnership between the VA Office of Information Technology (OI&T) 
and the Veterans Health Administration Office of Research and Development (VHA ORD). 
VINCI includes a cluster of servers for securely hosting suites of databases integrated from 
select national VA data sources. VINCI servers for data, applications. and virtual sessions are 
physically located at the VA Austin Information Technology Center (AITC), located in Austin, 
Texas. This secure enclave with 105 high-performance servers and 1.5 petabytes of high-speed 
data storage has multiple layers of security and disaster recovery to prevent data loss. 
Study data will be kept in accordance with the Department of Veterans Affairs Record Control 
Schedule 10-1 (RCS 10-1). Storage and transfer of any Personally Identifiable Information (PII) 
or Protected Health Information (PHI) must be done in accordance with applicable VA and VHA 
policies and directives, state and federal regulations, and applicable statutes including the 
Health Insurance Portability and Accountability ACT (HIPAA). Unless explicitly requested and 
approved by data stewards, all sensitive patient data must remain on VINCI project servers and 
only aggregate data without PII / PHI may be transferred from VINCI. At the completion of the 
study, disposition of records will also follow guidelines of RCS 10-1 in accordance with VA, 
VHA, and HIPAA policies and directives as mentioned previously. 
Prior to being uploaded to VINCI for analysis, data will be stored on a secure VA server, which 
is password protected, and to which only IRB approved VA research personnel have access. 
Should any identifiable information need to be shared between research sites, research teams 

 
Page 19 of 25 
 
will utilize a secure, SharePoint site or electronic communication with PKI encryption. Any 
identifiable paper data will be stored in two separate locked file cabinets (one for informed 
consents and the other for paper questionnaire data) in the offices of the Center for Excellence 
for Suicide Prevention at the Canandaigua VAMC and VA Center for Integrated Healthcare at 
the Buffalo VAMC. After a participant completes the study, any identifiers will be removed from 
the paper questionnaire data immediately. Data analysis will occur in the VINCI framework. 
5.8 Withdrawal of Subjects 
Participants who wish to withdraw may do so at any time without affecting their medical care or 
participation in any other study. Participants will be informed of any new information throughout 
the duration of the study which may affect their condition or influence their willingness to 
continue in this study. Finally, based on decisions made by the Principal Investigator, 
participants may be taken out of the study because of unanticipated circumstances such as 
extreme distress. That is, they may be withdrawn from the study if we judge that participating is 
not in their best interest. 
6.0 
Protection of Human Subjects 
 
Human Subjects Involvement and Characteristics. The purpose of this study is to assess the 
acceptability, feasibility, and usability of an intervention designed to reduce anxiety sensitivity 
and functional impairment among Veterans with elevated anxiety sensitivity experiencing 
functional impairment. A total of 15 participants will be recruited through the Canandaigua VA 
and receive Brief Enhanced Anxiety Sensitivity Treatment (BEAST) through telehealth and 
supplemented via a mobile app.  
 
Source of Materials. Study materials will include self-report questionnaires. The materials will 
be collected for study purposes only. Information collected will be stored in a locked filing 
cabinet in a locked office at the study sites that can only be accessed by members of the study 
team. All electronic data will be stored on VINCI project servers. Only approved study team 
personnel who will be involved in data entry, management and analyses will be granted access 
to this data. All computers are password protected.  
Recruitment and Informed Consent.  
All research staff conducting recruitment and informed consent will have completed appropriate 
and up-to-date training in research, research ethics and the proper conduct of research that 
includes common issues related to recruitment and informed consent.  
 
Veterans will be identified using structured queries of VA administrative datasets. Research staff 
will use these lists to identify potentially eligible participants and to enhance the number of 
Veterans at high risk, women and/or minorities recruited into the study. Research staff will mail 
an IRB-approved letter describing the study to the Veteran. Research staff will call all patients 
who receive a letter unless the patients call a number to opt out. These are Syracuse VA IRB-
approved procedures that are used by researchers at the Center of Excellence for Suicide 
Prevention and Syracuse VAMC. There is no more than minimal risk to the participants and the 
rights of the participants, or their welfare, will not be adversely affected. Recruitment and 
informed consent procedures were designed to ensure patients do not feel like participation is 
required. Patients unable to understand the informed consent process will be excluded from 
participating. Screening interviews will be completed initially over the telephone (using a script) 

 
Page 20 of 25 
 
to assess eligibility criteria. Verbal consent will be obtained at this time to complete the 
screening. Participants screening positive for exclusion criteria will not be included in the study. 
Veterans who report suicidal intent with a plan will be transferred to the Veteran’s Crisis Line (as 
detailed below in Protection Against Risk). For eligible and interested participants, a research 
assistant will review the consent form and complete a brief questionnaire to ensure the potential 
participant understands the study. 
 
Participants will receive compensation for their participation in the study due to the time 
commitment required. The compensation amount will be based on the schedule that follows per 
aim, also found earlier in this protocol: 
 
Aim 1: 
 
 
Prior to Pilot Study  
 
 
 
$50  
 
Completion of Pilot Study 
 
 
$50 
 
Stakeholders will be provided compensation prior to the pilot study when feedback is given, as 
well as after the pilot study has been completed for a total of $100 as compensation for their 
time. 
 
Aim 2: 
 
 
Baseline Assessment  
 
 
$40  
 
Post-Intervention Assessment 
 
$40 
 
1-month Assessment   
 
 
$30 
 
3-month Assessment  
 
 
$30 
 
Weekly EMA Data Collection  
 
$30 per week 
 
> 80% of EMA Weekly Surveys 
 
$10 per week 
 
Therefore, the total compensation for completing all the Aim 2 study components would be 
$340. Payments will be made following each study procedure listed above. Participants who do 
not complete the entire study for any reason, will receive compensation for the components that 
were completed per the above schedule of payments. 
 
Protection Against Risk.  
Anticipated risks to the participants from assessment procedures and therapy are minimal; 
however, participants may experience psychological distress, frustration, and/or fatigue. The 
semi-structured interviews, assessments associated with the intervention, and therapy sessions 
encourage participants to recall personal events and life stressors that may evoke distress. 
Participants will be told they can withdraw from the study at any time. Participation or withdrawal 
from the study will not affect any benefits to which they are otherwise entitled. Special 
precaution will be taken to safeguard confidentiality.  
 
All assessors and interventionists will have a specific protocol to follow regarding emergency 
care and will have the clinical back-up of Drs. Allan, Stecker, and Ashrafioun. This study will use 
safety procedures that have been previously approved by the IRB in several of our protocols. All 
research staff will be thoroughly trained on these procedures. These include written procedures 
for handling emergencies, a written procedure for conducting a full suicide risk assessment 
whenever suicidality is endorsed, procedures for participants endorsing a suicidal plan or intent 
(including staying with a patient until they are connected with a mental health provider or 911 

 
Page 21 of 25 
 
help), and a written warm-handoff guideline to connect Veterans to the National 
Veterans/Military Crisis Line (VCL).  
 
In any of the above instances, the research staff member will read (or paraphrase) the following 
statement to the participant at the end of the call:  
 
I am concerned about your safety and so at this time I am going to transfer you to speak 
with one of our mental health clinicians at the Veterans/Military Crisis Line. There will be 
a moment of silence as I connect you.  If for some reason we get disconnected please 
dial 1-800-273-8255 and press #1 to reach the Lifeline. I will stay on the line with you 
until the transfer is complete. I am now going to transfer you.  Please stay on the line.   
 
The researcher will briefly summarize the participant’s situation to orient the VCL responder to 
the nature of the call (the participant will hear a moment of silence at this time, and then the 
participant will be transferred to the VCL).  
 
If the participant hangs up or becomes disconnected, the researcher will call the VCL 
immediately, and the VCL staff will take necessary actions as appropriate according to the VCL 
safety protocol and/or direct the researcher what actions to take.  These actions may include 
initiating a “rescue” that involves calling 911 at the participant’s local jurisdiction and having 
emergency personnel come to the participant’s home to ensure their safety.  The VCL staff 
performs rescues every day, and all rescues are done in collaboration with a supervisor.    
We have ongoing collaborations with the VCL and have substantial experience working with 
responders and supervisors.  Our approach to participant safety will be applied to all 
participants including control participants and is guided by ongoing clinical and research 
experience in suicide prevention, including our Center Director’s affiliation with the VCL.   
 
We will collaborate closely with the VCL during the study start-up phase to review these safety 
protocol steps. As a reminder, the VCL, which was established in 2007 at the Canandaigua 
VAMC, can be reached anytime by calling 1-800-273-8255.  The VCL has grown to be one of 
the largest in the world, with a full-time staff of more than 600 full-time responders. VCL 
responders are paid professional staff and nearly all have a Master’s degree in a relevant field 
(e.g., mental health counseling), distinguishing the VCL from others in the U.S. that are staffed 
primarily with volunteers.   
 
VCL resources will be available as back-up at all times during study sessions. VCL responders 
are arguably the foremost experts in managing acute suicidal crises via telephone. They have in 
place protocols for locating suicidal individuals, identifying the closest police and emergency 
medical services, and monitoring and documenting “rescues.”  Moreover, VCL responders have 
the ability to look up call histories based on callers’ phone numbers, a capability that since 
implemented has greatly aided the ability of responders to rapidly assess callers’ needs.   
 
All participants will be provided the VCL phone number at the end of each baseline assessment 
and at each follow-up assessment and encouraged to call the number should they become 
suicidal, simply wish to talk with someone, or would like assistance in obtaining a referral for 
mental health treatment.  In situations in which potential suicide risk is identified during a phone 
call, we plan to use two levels of response: 1) researcher transfers the individual to the VCL 
(used in acute crises requiring emergency intervention or “rescue”); 2) researcher offers the 
participant a transfer to the VCL, but does not perform the transfer if he/she does not wish to be 
transferred (used in non-emergency situations).    
 

 
Page 22 of 25 
 
Breach of Confidentiality. Statistical data files will be kept on VINCI project servers maintained 
by VINCI OI&T personnel and only summarized data without protected health information (PHI) 
will be downloaded from VINCI to local storage media. Research staff will use an audited VINCI 
download utility to move summarized data for reports, presentations and publications from 
VINCI servers to local storage media. The VINCI download utility provides an audit path 
including a copy of the downloaded material. The data extraction tool will be adapted for use 
with software directly available on the VINCI platform (e.g. Microsoft Word and Excel) and study 
data will be stored and maintained on VINCI. All study team personnel with access to sensitive 
patient data will stay current on their VA approved information security training and VA 
approved privacy policy training.  
 
Adverse Events (AE). All research staff will participate in an intensive training to help them 
understand the importance of reducing the risk for participants and learning how to recognize 
and report any AE or SAE. AEs may include, but are not limited to: worsened physical or mental 
health, or inadvertent disclosure of confidential research information. Serious Adverse Events 
(SAE) may include: death, hospitalization due to worsening psychiatric symptoms or suicidal 
ideation, or all life threatening or disabling/incapacitating events among research participants. 
Per IRB regulations, SAEs, any event resulting in a deviation from the study protocol (e.g., 
emergency hospitalization to address suicidal behaviors) or death will be reported to the PI 
within 24 hours and to the IRB in 48 hours. He will make a decision whether there is sufficient 
evidence to suspend data collection, allow for further IRB review, modify the protocol, or make 
other changes to reduce potential risk to participants. The study will resume based on 
agreement of the PI, and an IRB member (the chair will recuse himself because he is a co-I on 
the study). Immediate evaluation will occur to determine if any extra steps can be taken to 
minimize the likelihood of that type of AE occurring again. If changes can be made, a 
report/amendment will be written and submitted to the IRB. AEs that involve temporary distress 
will be noted by interviewers and provided to the IRB in an annual report. 
 
Confidentiality of Records:  Numerous protections are in place to reduce the likelihood of loss 
of confidentiality. All research data will be kept in locked filing cabinets in secure areas, absent 
of identifying information, and coded by research number only. Files containing consent forms 
and other items with identifying information will also be kept in locked filing cabinets, but these 
will be separate from cabinets containing data from this study. Social security numbers (SSNs) 
may be collected based on the participant’s preferred payment methods. These SSNs would 
only be used as part of fiscal forms needed for payment, and these payment vouchers would be 
stored within protected electronic folders for documentation purposes only. 
 
Potential Benefits of Research to Participants and Others. There may be direct and/or 
indirect benefits of study participation. Participants may benefit from receiving the intervention 
as it is designed to reduce sensitivity to anxiety. Participation in this intervention will benefit 
future Veterans as we can identify if these interventions can reduce anxiety and improve 
functional impairment in Veterans experiencing elevated anxiety sensitivity. Dissemination of the 
findings from the study will contribute to the extant literature and will inform future 
implementation efforts.  
 
Importance of Knowledge to be Gained. This study is important to science and society 
because there is an urgent need for brief interventions to help individuals that experience 
anxiety and anxiety sensitivity. This study represents an important step towards making these 
interventions more accessible. Ultimately, this intervention could be an efficient means to 
reduce anxiety in Veterans.  

 
Page 23 of 25 
 
 
Data Safety & Monitoring Plan 
 
Data Safety. To ensure safety of participants in the study proposed and validity and integrity of 
data collected, the PI (Allan) will oversee all data and safety monitoring functions and the 
research team will be advised that he will be the primary contact overseeing these activities. 
The investigators will meet regularly to monitor study progress and discuss the implementation 
of monitoring procedures. The PI will also meet regularly with the research coordinator and staff 
to review monitoring procedures and ensure all efforts are being taken to minimize risks to 
participants. As indicated above, the PI will track all negative outcomes and incidents as well as 
conduct interim data analysis every 12 months after the study has started. The study design will 
be significantly modified if the study is creating potential harm to our participants.  
 
The PI and Dr. Stecker will regularly oversee all aspects of the study, including participant 
recruitment, informed consent, data collection, management, and analysis, as well as regularly 
assess the risk/benefit ratio associated with participation in the study.  
 
As part of a standard practice, the PI will supervise the implementation of one audit within 4 
months after study recruitment and one regularly per year afterwards of the materials collected 
and produced as part of the study at each site to ensure proper confidentiality and compliance 
with ethical principles, including informed consents, questionnaire data, and to make sure that 
the research staff are following established protocols. The PI will provide an annual summary 
report of all AEs to the IRB as part of the annual review. If no adverse events have occurred, the 
report will state, “No adverse events affecting human participants have occurred during this 
project year.”    
 
Data Monitoring. To ensure adequate participant recruitment and enrollment, each week, the PI 
will discuss the current number of participants contacted, screened, and enrolled from each site 
and compare those numbers to the expected based on our preliminary data. If after the first 4 
months, it appears we are not reaching our expected number of participants, the PI will discuss 
potential barriers/obstacles and solutions with the research team and we will enact contingency 
plans as needed.  
 
 
 
 
 
 
7.0 
References 
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