Mobile Health to Monitor Risk for COVID-19 and Improve Mental Health During the Pandemic
Phase: NA
Conditions: Anxiety Depression
Sponsor: University of Houston

FULL PROTOCOL TITLE: Mobile Health to Monitor Risk for COVID-19 and Improve 
Mental Health during the Pandemic 
 
ClinicalTrials.gov Identifier: NCT05074693  
 
DOCUMENT DATE: October 13, 2023 
 

FULL PROTOCOL TITLE: Mobile Health to Monitor Risk for COVID-19 and Improve 
Mental Health during the Pandemic 
 
 
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Table of Contents 
1.0 
Objectives ............................................................................................................................ 3 
2.0 
Background .......................................................................................................................... 3 
3.0 
Inclusion and Exclusion Criteria .......................................................................................... 6 
4.0 
Vulnerable Populations ........................................................................................................ 8 
5.0 
Number of Subjects.............................................................................................................. 8 
6.0 
Recruitment Methods ........................................................................................................... 8 
7.0 
Multi-Site Research Communication ................................................................................... 9 
8.0 
Study Timelines ................................................................................................................. 10 
9.0 
Study Endpoints ................................................................................................................. 11 
10.0 Procedures Involved........................................................................................................... 11 
11.0 Setting ................................................................................................................................ 20 
12.0 Risks to Subjects ................................................................................................................ 20 
13.0 Potential Benefits to Subjects ............................................................................................ 21 
14.0 Withdrawal of Subjects ...................................................................................................... 22 
15.0 Costs/Payments to Subjects ............................................................................................... 22 
16.0 Confidentiality ................................................................................................................... 22 
17.0 Provisions to Protect the Privacy Interests of Subjects ...................................................... 22 
18.0 Informed Consent Process ................................................................................................. 23 
19.0 Process to Document Consent in Writing .......................................................................... 23 
20.0 Data Management .............................................................................................................. 24 
21.0 Sharing of Results with Subjects ....................................................................................... 26 
22.0 Resources ........................................................................................................................... 26 
23.0 Additional Approvals ......................................................................................................... 27 
 
 
 

FULL PROTOCOL TITLE: Mobile Health to Monitor Risk for COVID-19 and Improve 
Mental Health during the Pandemic 
 
 
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1.0 
Objectives 
1.1 The proposed research is directly relevant to public health because it aims to target 
health disparities in access to behavioral health care during the COVID-19 pandemic 
among Black, Hispanic, and American Indian (BLAI) individuals via testing an 
adaptation of an established, initially validated, low-cost, mobile application (‘app’) 
designed to reduce ongoing mental health concerns among BLAI individuals with 
elevated anxiety and/or depressive symptoms (Easing Anxiety Sensitivity for Everyone 
[EASE] App). Using a precision medicine approach, EASE targets anxiety sensitivity, a 
transdiagnostic individual difference factor implicated in the etiology, maintenance, and 
progression of anxiety and depressive symptoms. EASE includes COVID-19 symptom 
monitoring, exposure management skills, and psychoeducation on COVID-19-related 
stress and the impact of stress on susceptibility to infection and disease progression; if 
successful, this study will provide evidence that the EASE app-based intervention can 
address the public health concerns of anxiety and depressive symptoms among BLAI 
during the COVID-19 crisis. Aim 1. To compare the effect of EASE with COVID-19 
specific elements (n = 420) to a standard-of-care digital intervention with educational 
material covering stress reduction, and anxiety and depression symptom management and 
COVID-19 specific elements (n = 420). To evaluate the efficacy of the experimental 
intervention across each race/ethnic group. Aim 2. To identify the therapeutic 
mechanisms of EASE, including theoretically driven mediators (i.e., anxiety sensitivity, 
subsequent changes in COVID-19 related stress and fear) and moderators (i.e., perceived 
racial discrimination, social support, and socioeconomic status).  
1.2 H1: Those assigned to EASE will show greater reductions in anxiety and depression 
symptoms, and greater reductions in functional impairment in daily responsibilities (e.g., 
work performance, household maintenance, and social interactions, and relationships) 
relative to the control group. H2: Effectiveness of EASE will be similar across 
racial/ethnic groups.  H3: Intervention effects on study outcomes will be mediated by 
reductions in anxiety sensitivity and changes in COVID-19 related stress and fear. H4: 
Perceived discrimination (worse intervention outcomes), social support (better 
intervention outcomes), and socioeconomic status (SES; lower SES associated with 
worse outcomes) will be examined as potential moderators of the EASE effects. 
 
2.0 
Background 
 
COVID-19 Racial/Ethnic Disparities. Significant racial/ethnic health disparities have emerged in the 
United States (US)5 related to the novel 2019 SARS2-Coronavirus disease (COVID-19).17 Black and 
Hispanic persons experience significantly higher rates of COVID-19 relative to their proportion in the 
general population (19.9% and 31.4%, respectively),18 and the rate of COVID-19 cases is 2.6 and 2.8 
times higher among Black and Hispanic persons, respectively, relative to Non-Hispanic White (NLW) 
persons.19 American Indian persons are 2.8 times more likely to contract COVID-19 relative to NLW 
individuals19 and are approximately 5.2 times more likely to be hospitalized from COVID-19 relative 
to NLW persons.5,8 Similarly, Black and Hispanic individuals are 4.7 times more likely to be 
hospitalized20 relative to NLW persons. Indeed, proportionate prevalence rates of COVID-19-related 
hospitalizations are highest among American Indian, Black, and Hispanic persons and lowest among 

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Mental Health during the Pandemic 
 
 
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NLW populations.20 Death from COVID-19 is 2.1 times higher among Black, 1.1 times higher among 
Hispanic, and 1.4 times higher among American Indian relative to NLW individuals.19 These data 
highlight the disproportionate, over-representation of BLAI individuals in COVID-19 infection rates, 
hospitalizations, and death relative to NLW individuals. Preexisting inequities related to social 
determinants of health and the effects of racism have likely contributed to these disparities.21 
BLAI individuals are more likely to be affected by COVID-19-related stress relative to NLW 
persons.9,10,22 Current rates estimate that 42.6% of Black and 46.3% of Hispanic individuals reported 
symptoms of an anxiety or depressive disorder between July 16-21, 2020.7 These estimates are in stark 
contrast to the estimated 11.3% of Black and 10.3% of Hispanic individuals who reported symptoms of 
an anxiety or depressive disorder from January - July 2019.23 Although NLW individuals experience 
comparable, albeit slightly lower, rates of anxiety or depression (38.8%), the racial/ethnic disparity gap 
for mental health outcomes is widening. To illustrate, data from 2019 found 0.2-1.2% difference in 
elevated anxiety or depressive symptoms between NLW and Black and Hispanic persons, with NLW 
individuals evincing a higher prevalence rate (11.5%).23 The inverse pattern is now true with Black and 
Hispanic persons reporting higher rates of these symptoms by 4-8 percentage points.7, 23 These data 
offer valuable insight into the potential mental health disparities that are developing from the pandemic. 
Additionally, although post-pandemic onset mental health data for American Indians in the US is 
lacking, American Indian community leaders have expressed continued concern for the mental health 
of their constituents given their propensity for worse physical health outcomes if infected with COVID-
19 and generally worse mental health outcomes, including high rates of substance use and suicide.24,25 
Further, BLAI populations have lower access to mental health treatments and are less likely to engage 
with mental health treatments,12,26 which may compound the severity of emerging COVID-19-related 
mental health disparities.9,10 The pandemic has revealed changing mental health symptom patterns 
between BLAI and NLW, and emerging COVID-19 disparities in mental health symptoms are likely to 
widen without proper early intervention tactics. 
 
Chronic Stress and Health Disparities. Impediments to care for BLAI individuals (e.g., racism, 
discrimination, mistrust of medical providers) and social determinants of health that make BLAI 
communities vulnerable to worse health outcomes (e.g., housing, income, access to healthcare) are 
known factors for chronic stress. Stressors are events or conditions that threaten, or are perceived to 
threaten, psychobiological equilibrium.27 From a psychophysiological perspective, stress activates the 
Hypothalamic-Pituitary-Adrenal (HPA) axis.28 The HPA axis’ main function is to regulate the stress 
response. Continued and prolonged stress may disturb the HPA axis to the extent that negative 
feedback mechanisms are disrupted and may contribute to poorer health outcomes.29 This perspective 
is in line with the allostatic load theory, suggesting that continued stress can be associated with negative 
physical and mental health outcomes.30 Notably, BLAI individuals are at increased risk for high stress 
levels and greater chronicity of stress relative to NLW individuals, which accounts for a substantial 
portion of racial/ethnic health disparities.31,32 In the US, People of Color are more likely than NLW 
adults to report stress related to contracting COVID-19 (71% vs. 59%), accessing healthcare (59% vs. 
46%), and meeting basic needs (61% vs. 47%).33 Chronic or repeated activation of the HPA axis often 
corresponds to prolonged or seemingly inescapable stressors, such as the present pandemic.34 As such, 
the additive effect of COVID-19-related disease and stress burden exerted on stress responses systems 
saturated with pre-existing chronic stress is likely to amount in worse short- and long-term mental 
health outcomes among BLAI communities. 
  
COVID-19 Stress Burden and Mental Health. Exposure to COVID-19 stress likely influences the 

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Mental Health during the Pandemic 
 
 
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development, or exacerbation, of psychological and neurobiological processes that confer vulnerability 
to multiple types of psychopathology, including anxiety and depression.3,4 Anxiety and depression 
represent two of the most commonly experienced mental health conditions across race/ethnicity.35 In 
the following section, we describe a central stress-based, transdiagnostic mechanism that may underlie 
the link between COVID-19 stress and psychopathology, particularly anxiety and depression.36 Taking 
a transdiagnostic approach allows the identification of core psychological and neurobiological 
processes that underlie multiple forms of psychopathology.37 COVID-19 stress burden (accumulated 
impact of stress) may have a particularly pernicious influence when it happens among persons already 
struggling with greater stress exposure and pre-existing psychopathology. Specifically, higher degrees 
of COVID-19 stress can influence patterns of social, emotional, and neurobiological development in 
ways that facilitate the rapid detection of potential threats,38 and by extension, may increase risk for 
multiple forms of psychopathology.  
 
Importance of Stress and Stress Reactivity. Adverse life events increases the risk of 
psychopathology, particularly disorders of emotion.39-41 Indeed, alterations in stress- and threat-
response systems may compromise emotion-and attention-regulatory systems.42 These data have often 
been used to explain the heightened risk for behavioral and affective disorders following exposure to 
adverse stressors in life.43,44 This transdiagnostic theoretical framework also is at the crux of the 
assertion that increased rates of emotional disorders are an inevitable consequence of the pandemic.45 
After repeated exposure, a threat processing system involving a rapid appraisal-response system 
develops that is capable of orchestrating rapid reactions with little processing.46 Thus, individual 
differences in the tendency to be ‘stress reactive’ (i.e., appraise threat rapidly) provide a fertile 
theoretical and clinical basis for understanding the nature of COVID-19 stress on emotional disorders 
among BLAIs specifically (see A.4.b).  
 
Anxiety Sensitivity. Research in affective science has identified anxiety sensitivity (AS) as an ‘affect 
amplifier’ because it represents a fundamental threat appraisal process.47 Specifically, AS refers to the 
fear of anxiety symptoms, including bodily sensations, which results from beliefs about the harmful 
social, psychological, or physiological consequences of such symptoms.48 AS has consistently been 
identified as a malleable risk factor for the onset of panic attacks, panic disorder, generalized anxiety, 
depression, and posttraumatic stress, in prospective studies of adults across race/ethnicity.49-52 
Specifically, AS has been found to predict the development of panic attacks and has been linked to 
panic-like symptoms, anxiety, fear, and clinical anxiety and depressive disorders across a range of 
diverse community and clinical samples.52-56 It is important to note that AS predicts anxiety symptoms 
above and beyond trait anxiety, demonstrating the incremental validity of this construct.52,57 AS also 
has demonstrated strong racial/ethnic invariance across a range of samples, including BLAI 
groups.14,54,55,58 Individuals with high AS may be more likely to attend to bodily sensations that are 
associated with anxiety, such as respiratory symptoms, stomach distress, fatigue, and body aches, and 
to misinterpret these symptoms as dangerous or catastrophic.59,60 These interpretations of bodily 
sensations can lead to increased anxiety and perpetuate a cycle of increased attention to and 
misinterpretation of bodily cues. This process may eventually lead to avoidance and increased 
symptoms of anxiety, stress, and depression, and it has the potential to exacerbate stress on the body 
systems, which, in turn further compromises the immune system and places individuals at risk.61 This 
maladaptive cycle may be particularly relevant to BLAI populations during the pandemic given their 
increased likelihood of COVID-19 exposure, challenges with enacting behaviors to reduce the 
likelihood of infection, concerns about the increased likelihood of worse outcomes if infected, and 

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Mental Health during the Pandemic 
 
 
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greater pandemic-related stress (e.g., job loss, income reduction, childcare needs). Further, because 
some BLAI populations experience psychological distress somatically,62-64 AS is particularly relevant 
to these groups because it amplifies threat response to somatic perturbation. 
 
AS Relevance for BLAI Individuals. AS is highly theoretically relevant to BLAI individuals based on 
several lines of work. First, BLAI individuals have increased awareness of the negative outcomes of 
physical symptoms and illnesses.65-69 Second, BLAIs experience more somatic symptoms, and are 
more distressed by these symptoms compared to NLW persons. Third, BLAI individuals are more 
often diagnosed with comorbid psychiatric disorders than NLWs.70-72 Finally, affective disturbances are 
associated with an increased prevalence of comorbid medical diseases, such as chronic pain, arthritis, 
and cardiovascular disease, and many of these chronic medical conditions disproportionately affect 
BLAIs.73-75 Thus, interrelated lines of work suggest that BLAI populations may be more apt to react to 
interoceptive symptoms with heightened anxiety76,77 and mood disturbances. Yet, past work has not 
leveraged the potential of AS to better address mental health inequalities in the context of the pandemic 
which represents a unique and unprecedented period that may contribute to increased mental health 
disparities.78-81  
 
AS: Precision Medicine Treatment Target. Approaches to break the link between AS-
anxiety/stress/depression have been developed and have demonstrated strong efficacy.82-84 Indeed, AS 
is malleable in response to psychosocial intervention,85 making it a prime mechanistic agent to target in 
prevention/intervention programs. Reductions in AS improve clinical outcomes among general clinical 
and nonclinical populations, highlighting the relevance of this construct within the general 
population.85,86 AS reduction treatment can be distilled in as few as 1-4 treatment sessions both in-
person or via computer, with equal success.83,87,88 AS treatment decreases AS by providing 
psychoeducation about the true dangers of anxiety related bodily sensations; cognitive restructuring of 
catastrophic appraisals of anxiety related bodily sensations and life experiences; and by helping 
individuals develop greater tolerance to these sensations through interoceptive and in vivo exposure 
exercises. Such decreases, in turn, result in reduced anxiety, depression, and related conditions (e.g., 
stress burden).89 Thus, a cognitive-behavioral approach that targets maladaptive cognitions about 
bodily symptoms (i.e., AS) may have significant clinical utility in decreasing anxiety and depressive 
symptoms in the context of COVID-19. Indeed, COVID-19 stress and associated beliefs for exposure 
and health-risk associated with COVID-19, which is likely to be elevated among BLAI persons, may 
motivate vigilance to internal sensations. COVID-19 may thus serve as a context in which individuals 
learn to fear bodily sensations because such sensations could potentially have harmful consequences.90 
Yet, intervention work to address the impact of AS on mental health outcomes among BLAI 
individuals has not been leveraged in the context of COVID-19 stress.  
 
3.0 
Inclusion and Exclusion Criteria 
Table 1. Inclusion and Exclusion Criteria 
 
Eligibility Criteria: 
Exclusion Criteria: 
1.  ≥ 18 years of age 
  2. Self-identify as Black, Hispanic, American Indian, or NLW  
3. Clinically significant anxiety and/or depressive symptoms as evinced by a score of 8 
or higher on the Overall Anxiety Severity and Impairment Scale (OASIS)122 and/or 
Overall Depression Severity and Impairment Scale (ODSIS)123  
4. Reside in the United States 
1. Not fluent in English 
2. Lifetime or significant 
cognitive impairment 
 

FULL PROTOCOL TITLE: Mobile Health to Monitor Risk for COVID-19 and Improve 
Mental Health during the Pandemic 
 
 
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Participants will be recruited online via social media and internet outlet (e.g. Craigslist, 
Facebook) advertisements that target residents of the United States. Individuals who click our 
ads will read the study description and complete a brief study screener in REDCap. Further, we 
will utilize Qualtrics Panels Recruitment as a method of recruiting new participants. Qualtrics 
will reach out to individuals who express interest in participating in order to determine eligibility 
of recruited individuals, Qualtrics will have access to identifiable information to include the 
following: (1) Full name, (2) Phone number, (3) Phone number (secondary), (4) Email address, 
(5) Age, (6) Date of birth, (7) Ethnicity, (8) Race, (9) Gender assigned at birth. The Qualtrics 
survey will also utilize the Overall Anxiety Severity and Impairment Scale and the Overall 
Depression Severity and Impairment Scale. Additionally, we will be recruiting participants using 
university and online LISTSERV services. Also, we will be recruiting American Indian 
participants through BuildClinical.BuildClinical will direct individuals to their own platform 
where they will receive more information about the study. They will also be able to take our pre-
screener survey through BuildClinical and we will be able to download a list of pre-eligible 
participants. This program will have access to the following information: (1) Full name, (2) 
Phone number, (3) Phone number (secondary), (4) Email address, (5) Age, (6) Date of birth, (7) 
Ethnicity, (8) Race, and (9) Gender assigned at birth. BuildClinical will create all recruitment 
materials for use on their platform once recruitment through BuildClinical is approved by the 
University of Houston Institutional Review Board.Those who initially meet the study inclusion 
criteria will complete a phone call with study staff after completing the REDCap screener. 
During this call, study staff will verify that individuals meet the study inclusion criteria.  
The REDCap screener will include assessment of demographics, anxiety (OASIS), depression 
(ODSIS), and state of current residency. Demographic-Treatment History Questionnaire will 
assess sex, age, race and ethnicity, occupation, and current monthly income. The OASIS is a 5-
item measure that has demonstrated strong psychometric properties to identify those with 
clinically significant anxiety. The ODSIS is a 5-item measure that has demonstrated strong 
psychometric properties to identify those with clinically-significant depression. Potentially 
eligible participants will be asked to upload a picture to confirm their identity (such as a photo 
ID). If their identification photo information does not fully match (e.g. last name change), the 
participant can provide a secondary form of identification to confirm their identity. At the phone 
screener, a trained research assistant will obtain informed consent, confirm the state of residency 
by requesting participant address and current location, assess literacy, evaluate cognitive 
impairment using the Six Item Cognitive Impairment Test (6CIT), and assess English literacy. 
The trained research assistant will also obtain U.S. residency status, date of birth, and social 
security number. To be in compliance with IRS regulations, the University of Oklahoma must 
collect residency status for all participants and all payments are required to be reported as 
outlined in this policy. Further, participant name, tax identification number (SSN or ITIN), 
address, amount paid and source of funding for the payment will be collected. The full 
participant payment policy for the Oklahoma University Health Sciences Center can be found 
here: https://www.ouhsc.edu/policy/#19931991-section-557---participant-payment-policy. We 
would like to stress that U.S. citizens, Permanent Residents, Resident Aliens, and Non-Resident 
5. Willing/able to complete EMAs on study provided or personal smartphone for 6-
month study period 
6. Willing and able to complete the 3- and 6-month follow-up assessments via InsightTM 
app and over the phone (i.e., qualitative interview) 
7. Score ≥ 4 on the REALM-SF indicating > 6th grade English literacy level (needed to 
complete EMAs) 
4. Identifying as a race/ethnicity 
for which the corresponding 
study cell has been filled 

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Mental Health during the Pandemic 
 
 
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Aliens will receive equal compensation for their participation. Per the Oklahoma Taxpayer and 
Citizen Protection Act of 2007, undocumented immigrants are prohibited from receiving 
payment, and thus will be excluded from this study. The informed consent procedure will be 
completed by phone and REDCap (i.e., participants will use REDCap to review the informed 
consent document along with research staff, REDCap will be used to obtain signatures). The 
REALM-SF138 will be employed to assess literacy. 
Economically disadvantaged persons will be included in the study as research suggests 
that a significant portion of BLAI individuals are low income.  
 
None of the following populations will be specifically recruited: 
• 
Adults unable to consent 
• 
Individuals who are not yet adults (infants, children, teenagers) 
• 
Pregnant women 
• 
Prisoners 
• 
Students for whom you have direct access to/influence on grades 
 
4.0 
Vulnerable Populations 
N/A 
5.0 
Number of Subjects 
 
STUDY-WIDE: Taking failed screeners and participant attrition into account, we expect to 
consent 1300 participants. We anticipate randomizing a total of 880 participants (N = 880; 220 
Black, 220 Hispanic, 220 American Indian, and 220 NLW; Intervention group, n=440, control 
group, n=440). 
 
6.0 
Recruitment Methods 
 
STUDY WIDE:  
Participants will be recruited online via social media and internet outlet (e.g. Craigslist, Facebook) 
advertisements that target residents of the United States. Individuals who click our ads will read the 
study description and complete a brief study screener in REDCap. We will also utilize university and 
online LISTSERV services to recruit participants, as well as Qualtrics Panels Recruitment to gather 
basic demographic information to assess primary eligibility. Also, we will be recruiting American Indian 
participants through BuildClinical. BuildClinical is a data-driven platform that helps academic researchers 
recruit participants for research studies more efficiently using social media, software, and machine 
learning.BuildClinical will direct individuals to their own platform where they will receive more 
information about the study. They will also be able to take our pre-screener survey through BuildClinical 
and we will be able to download a list of pre-eligible participants. This program will have access to the 
following information: (1) Full name, (2) Phone number, (3) Phone number (secondary), (4) Email 
address, (5) Age, (6) Date of birth, (7) Ethnicity, (8) Race, and (9) Gender assigned at birth. BuildClinical 

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does not interact with data outside of sending the data to the University of Houston. BuildClinical’s 
Secure Socket Layer (SSL) software encrypts all inputted information and keeps the information private 
and compliance. BuildClinical will create all recruitment materials for use on their platform once 
recruitment through BuildClinical is approved by the University of Houston Institutional Review Board.  
Those who initially meet the study inclusion criteria will complete a phone call with study staff after 
completing the REDCap screener. During this call, study staff will verify that individuals meet the 
study inclusion criteria and staff will review study details with each individual. We will also post flyers 
in the community and around the UH and OU campuses as permitted (flyer attached). Additionally, we 
will recruit residents specifically from OK and TX through various media outlets (e.g. TV, Radio). 
Finally, we will utilize community organizations (e.g. Legacy Health, Lone Star clinic) for recruitment 
purposes as well. 
 
 
7.0 
Multi-Site Research Communication  
To facilitate communication, we have budgeted for face-to-face meetings of the PIs and the 
larger team and will include site-specific investigators at each of the local meetings. We hold 
weekly lab meetings and monthly conference calls across sites for all investigators to review 
recruitment progress, assessment issues, and discuss publications. Other informal conferencing 
occurs between the PIs, who routinely speak at least weekly and much more frequently by 
electronic means. This organizational structure has been in place for the past 5 years and 
functions efficiently and without major difficulties. We have collaborated for many years and 
conflicts have not arisen. Should a conflict arise, Dr. Zvolensky has final say on administrative 
and fiscal issues, and on issues related to treatment development. Dr. Businelle has final say on 
issues related to his budget components (e.g., staffing) and issues related to technology 
development and adaptation. In the unlikely event that the PIs are unable to resolve an issue, it 
would be put forward for discussion with the investigative team and a vote would be taken 
among the 9 participants. Dr. Zvolensky and Businelle would accede to the voting results. In the 
unlikely event that the investigative team cannot resolve the issue, it will be referred to the Data 
Safety and Monitoring Board (DSMB) who will review the matter and determine an equitable 
and binding decision. The full DSMB plan is located on page 25 of the grant under the heading, 
“Data and Safety Monitoring Plan”. 
 
The UH study team, under the supervision of the contact PI, will provide services to: 
• Coordinate communications with partnering sites 
• Request and receive information and documentation from partnering sites 
• Develop template materials for review by the UH IRB and for limited modification by 
participating sites 
• Submit materials from all sites to the UH IRB and coordinate responses to any IRB queries 
• Provide documentation to participating sites 
 
Participating sites will follow local procedures to coordinate, collect and verify information such 
as: 
• Local context 
• Site variations in areas such as recruiting, informed consent, HIPAA, populations 
• Conflict of Interest disclosure and management 
• Completion of ancillary reviews 

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• Training and qualifications of study team 
• Continuing Review or Closure information 
• Reportable Events 
 
The contact PI will maintain a copy of this communication plan and any other communication 
plans that are developed. Copies will be made available to the participating sites as appropriate.  
 
Before initiating the study, each participating site will execute a reliance agreement with the IRB 
which will clarify the roles and responsibilities of the sIRB and the site. 
 
The Insight app encrypts all data as it is collected. This data is synced with   Azure servers up to 
four times per day. Study data are available through Insight’s encrypted web portal (i.e., the 
content management system). Each individual member of the research team has a STRONG 
password. Only team members that require access to study data will be granted the ability 
download data directly to their encrypted university computer. Given both sites are able to 
download study data directly, there is not a need to transmit it across study sites. Research data 
will be encrypted and saved to the study phones or through REDCap.  
 
As required by NIH, we will provide de-identified data from this project to interested individuals 
one year following achievement of the aims of the project (i.e., publication of the main outcome 
papers). These data will be provided in digital format (i.e., disk) with clear labels for all 
variables. Data will be de-identified and released directly by the investigators that provide 
evidence of their institutional IRB approval for planned analyses of the data. Our team will be 
available to address queries. 
 
8.0 
Study Timelines 
The present study will include a baseline assessment, a 3-month intervention period, a 3-month 
continued assessment period (with access to intervention materials), and 3- and 6-month post-
baseline assessments that includes a qualitative interview for selected participants via phone or 
online platform (e.g., Zoom). The qualitative interviews will be recorded and securely stored for 
qualitative analysis (or completed by the participant via REDCap survey if a medical condition 
prevents them from being able to speak for long periods of time).  Recordings will be transcribed 
by internal staff, Microsoft Transcribe, or by approved contractors. When using Microsoft 
Transcribe, all transcriptions will be reviewed by study staff.  Hence, the total duration of an 
individual subject’s participation in the study will be 6 months. We expect each study 
appointment will take approximately 30-60 minutes to complete.  
 
Baseline timeline: All study assessments as well as all EMAs will be conducted remotely 
through the Insight app. Participants who do not have a mobile phone will be mailed one. The 
InsightTM app will be downloaded and activated during the baseline session using a unique 
activation code provided by the research team. All interactions with the Insight and EASE app will be 
date, time, and Geolocation (GPS) stamped and app feature use will be recorded for future analysis. After 
downloading the Insight app, participants will use the app to complete the baseline assessment. 
We expect participants will take approximately 30-minutes to complete all baseline assessment 
measures (please refer to section 10.0 procedures involved for a detailed list of measures 
participants will be prompted to complete). Following completion of the baseline assessment, the 

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app will request a code. This code will be used to ensure that the participant is placed in their 
randomly assigned study condition (EASE or Control). Upon entering this code, the app will 
automatically begin prompting twice daily EMAs for 6-months (please refer to section 10 below 
and Table 3 for a list of EMA assessments and more detailed information). 
 
Follow-up timeline: Participants will complete follow-up assessments at 3- and 6-months 
following the baseline assessment, which will also be completed using the Insight app, in the 
same manner as the baseline assessment. Assessments to be conducted have been detailed below 
(please see 10.0 procedures involved). We expect the 3- and 6-month follow up assessment 
sessions will each take participants approximately 30 minutes to complete. Moreover, during the 
time between the baseline and 6-month follow-up assessments (6-month continuous assessment 
period) participants will continue to receive daily EMAs and will have access to all intervention 
materials included in the app.  
 
Project Timeline. Year 1 will focus on obtaining IRB approval (i.e., submit application, respond 
to reviewers, and re-submit), hiring and training research staff, and beginning the enrollment. 
Year 2 will focus on recruitment, enrollment, and collecting follow-up data. Year 3 will focus on 
collecting follow-up data, data cleaning/analysis, and manuscript preparation and dissemination, 
including presenting findings at professional conferences and community-based events. For the 
present study, we expect approximately 50% of participants who click on our advertisement to 
be eligible; 75% of those who complete the phone screener to be eligible; and 95% of those to 
consent to participate. Weighted compensation schedule and reminder calls will be utilized to 
minimize subject dropout. Based on our ongoing work, we expect to enroll 39 participants each 
month, on average, across the 21-month enrollment period. We expect to retain 80-90% of 
subjects at each follow-up assessment points. 
 
 
9.0 
Study Endpoints 
The primary study endpoint will be recruitment of all study subjects at the end of the study 
enrollment period. The secondary study endpoint will be the collection of study data from all 
participants following the 6-month follow-up.    
 
10.0 Procedures Involved 
All study data (both survey data and EMAs) will be collected through the Insight app which 
participants will be asked to download during their baseline assessment, with the only exception 
being the study screener, consent process, and qualitative follow-up interviews for selected 
participants which will be completed through REDCap and phone call. Qualitative interviews will 

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be recorded and transcribed for analysis. All data being collected from research participants will 
be input into the Insight app by participants themselves. 
 
Participants will be recruited online via social media and internet outlet (e.g. Craigslist, Facebook) 
advertisements that target residents of the United States. Individuals who click our ads will read the 
study description and complete a brief study screener in REDCap. Participants will also be recruited 
through Qualtrics Panels Recruitment which will gather basic demographic information to assess 
eligibility. Also, we will be recruiting American Indian participants through BuildClinical. BuildClinical 
is a data-driven platform that helps academic researchers recruit participants for research studies more 
efficiently using social media, software, and machine learning.BuildClinical will direct individuals to 
their own platform where they will receive more information about the study. They will also be able to 
take our pre-screener survey through BuildClinical and we will be able to download a list of pre-eligible 
participants. This program will have access to the following information: (1) Full name, (2) Phone 
number, (3) Phone number (secondary), (4) Email address, (5) Age, (6) Date of birth, (7) Ethnicity, (8) 
Race, and (9) Gender assigned at birth. BuildClinical does not interact with data outside of sending the 
data to the University of Houston. BuildClinical’s Secure Socket Layer (SSL) software encrypts all 
inputted information and keeps the information private and compliance. BuildClinical will create all 
recruitment materials for use on their platform once recruitment through BuildClinical is approved by the 
University of Houston Institutional Review Board. Additionally, participants will be recruited via 
university and online LISTSERV services. Those who initially meet the study inclusion criteria will 
complete a phone call with study staff within one week of completing the REDCap screener. During 
this call, study staff will verify that individuals meet the study inclusion criteria, staff will review study 
details with each individual; and interested individuals will complete the informed consent process 
(signatures will be collected digitally via REDCap) and begin the screening assessment. Participants 
who are found to be eligible during the screening process will then be instructed to download the 
INSIGHT app onto their smartphone to complete the Baseline assessment. If a participant requires a 
study phone, they will be mailed one and scheduled to complete the baseline assessment once the 
phone has been received. Participants who report they are not the only users of their phone will be 
mailed a study phone for the study. 
 
Baseline assessment:  
During the baseline assessment, all participants will be asked to download the Insight app. Upon 
downloading Insight, participants will be provided with a unique activation code which they will enter 
onto Insight to gain access to the Baseline assessment. Upon completion of the Baseline assessment, 
the app will request a second code that will be used to place participants in the correct group.  
 
Though participants will be assigned to different mobile interventions, all participants will use the 
Insight app to answer the baseline, follow-up, and EMA surveys. We will be using the Insight app to 
collect all of the study data (with the exception of the study screener, consent, and qualitative 
interviews which will be obtained via phone call and REDCap). Below is a detailed list of all study 
measures which will be administered to participants during their baseline session, via the Insight app: 
 
Baseline measures: 
Sociodemographic variables will be assessed using a standard form we have used in many prior 
studies. SES will be measured as income and education.  
AS will be assessed using the 5-item SSASI we developed, which has excellent psychometric 
properties. Research has supported using a cut-off score of 5 to identify moderate to high AS 

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individuals (reflecting top 1/3rd of distribution).  
The Sheehan Disability Scale (SDS)152 is a psychometrically sound, brief, 5-item self-report tool that 
assesses functional impairment in work/school, social life, and family life.16  
The Social Support Questionnaire-Short Form (F-SozU K-6) List141 is a well-validated 6-item measure 
of social support.  
The PEG scale is ultra-brief 3-item measure derived from the brief pain inventory and validated in 
ambulatory care settings.143 It demonstrates strong properties to detect change in pain.153  
The Everyday Discrimination Scale139 is a 6-item, validated measure of discrimination.  
The Coronavirus Racial Bias Scale (CRBS)140 is a 4-item Likert scale designed to assess disparities in 
COVID-19, including likelihood of contracting COVID-19, lack of appropriate healthcare, as well as 
negative social medial posts against certain racial groups.  
The Fear of COVID-19145 scale is a 6-item, validate measure to assess emotional fear and somatic 
expression of fear related to COVID-19.  
The 4-item Perceived Stress Scale (PSS-4) is a 4-item global measure of perceived stress. The Patient 
Health Questionnaire (PHQ-4) is a 4-item measure that combines the two-item measure (PHQ–2), 
consisting of core criteria for depression, as well as a two-item measure for anxiety (GAD–2), both of 
which have independently been shown to be good brief screening tools. The Health-Related Quality of 
Life (HRQOL) is used to assess physical and mental health.  
The MacArthur Scale of Subjective Social Status (MSSS) is a self-rating scale on which a person 
indicates where they believe they fall on a 10-rung ladder that represents the levels that a person 
may occupy within society. Two versions of the ladder will be included, one linked to traditional 
SES indicators (the SES ladder) and the second linked to standing in one's community (the 
community ladder).  
The COVID 19 Vaccine Hesitancy Survey will measure hesitancy to take the COVID vaccine. 
The Financial Strain Questionnaire (FSQ) includes 9-items rated on a scale from one to four that 
assess level of financial strain currently being experienced.  
The Behavioral Risk Factor Surveillance System (BRFSS) Inadequate Sleep Questionnaire is a 5-item 
measure used to detect sleep problems that result in health burden. Frequency of Attendance at 
Religious Services is a two item measures that asks individuals to indicate the frequency of their 
attendance at religious services.  
The Discrimination Burden measure contains 4-items that assess perceptions of discrimination. The 
Self-Rated Heath (SRH) questionnaire is a 32-item measure of current health and health behavior. The 
Employment Status measure is used to assess the effect of the COVID-19 pandemic on participant 
employment status.  
The COVID-19 Psychological Impact Survey is a 3-item self-report measure of the psychological 
impacts of COVID-19 and associated risk factors. The Daily Activities measure contains three 
statements asking participants to rate the extent to which they feel impaired in their daily activities. The 
COIVD-19 Substance Use measure contains 4 items that ask about changes in substance use (i.e. 
alcohol, marijuana, e-cigarettes, and cigarettes) from before the pandemic, to now. 
The Alcohol Use Disorder Identification Test-Concise (AUDIT-C) is a 3-item brief alcohol screening 
instrument that reliably identifies persons who are hazardous drinkers or have active alcohol use 
disorders (including alcohol abuse or dependence).  
The Abbreviated Multidimensional Acculturation Scale is a 12-item measure that assesses an 
individual's level of acculturation to a host culture. 
The Life Events Checklist for the DSM-V (LEC-5) and the Primary Care PTSD Screen (PC-PTSD) 
will be used to screen for potentially traumatic events in a participant’s lifetime. 

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The Distress Tolerance Scale – Short Form is a 3-item measure used to measure a respondent’s ability 
to tolerate feelings of distress. Change in Fast Food Consumption during COVID-19 will be assessed 
using a single item measure.  
Items assessing Marijuana/Cannabis Use Behavior were selected from a statewide study on medical 
and recreational cannabis use (Public Health Impact of and Attitudes About Medical Marijuana 
Legalization in Oklahoma).  
The Three-item Loneliness Scale is a 3 item scale for large-scale social surveys regarding how 
individuals feel about different aspects of their life. 
The OASIS122 and ODSIS123 also will be administered at baseline. 
The Mindful Attention and Awareness Scale (MAAS) is a 15-item measure used to measure conscious 
mindfulness. 
 
Follow-up assessments:  
Following completion of the baseline assessment, the app will automatically begin prompting twice 
daily EMAs for 6-months. Participants will complete two scheduled daily ecological momentary 
assessments (EMAs) during the intervention and continued assessment periods that will guide a just-in-
time approach to immediate, personalized behavioral health care (please see EMA types section 
below). Assessments will be completed remotely and no in-person study visits will be required.  
 
Moreover, Participants will complete follow-up assessments at 3- and 6-month post-baseline (i.e., end-
of-treatment and end of 3-month continued monitoring period) using the InsightTM app. These 
assessments will include a qualitative interview for selected participants. The follow-up surveys will be 
distinguishable from EMAs (i.e., a new “Follow-up” button will appear on the app home screen (both 
groups) 3- and 6-month post-baseline and participants will click this button to initiate the assessment). 
Participants will receive a daily alert from the app to click the “Follow-up” button until the assessment 
is completed. Like the baseline, the follow-up assessments will include the PSS-4, PHQ-4, HRQOL, F-
SozU K-6, MSSS, Covid-19 Vaccine Hesitancy Survey, Additional Aim 1 Measures, FSQ, 
BRFSS, Frequency of Attendance at Religious Services, Discrimination Burden, SRH, 
Employment Status, COVID-19 Psychological Impact Survey, Daily Activities, Change in Fast 
Food Consumption, Three-item Loneliness Scale, COVID-19 Substance Use, AUDIT-C, 
Marijuana/Cannabis Use Behavior, EDS, CRBS, SDS, , PEG Scale, , , , SSASI, OASIS, ODSIS, and 
Fear of COVID-19 (see above for description of measures). Additionally, the 10-item System Usability 
Scale156 will be incorporated to assess perceptions of the usability of the apps (i.e., intervention and 
control). Lastly, the 6-month follow-up assessment only will include two demographic questions taken 
from the Demographic/Background Information Questionnaire. 
 
If a participant does not respond to the app prompts to complete the follow-up assessment, he/she will 
be contacted via call, text, and email to remind them. Selected participants will complete a qualitative 
interview (i.e., phone call or Zoom) to collect qualitative data on the utility of EASE and the control 
app and methods for improvement for a next generation (Note: the date and time of this call will be 
scheduled at baseline and will appear at the top of the app home screen). We will use an interview 
structure and open-ended response style, like our previous studies. Further, we will use a modified 
quota sampling strategy. Specifically, 20-30 participants from each racial/ethnic group within the 
intervention and control conditions across a sampling time frame will be interviewed. This sampling 
strategy distributes interviews evenly across the project to minimize selection bias within each 
category. If participation is less than 100%, the sampling strategy will be accommodate depending on 

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response rate. We anticipate a high response rate based on our previous projects. This protocol has been 
successful in our previous research (e.g., 83% app-based follow-up completion and remote qualitative 
interviews in a 6-month smartphone-based intervention). Sample size is estimated based on the depth 
of data collection with individual participants, the diversity of participants, and project objectives. 
Qualitative experts advise estimating 20-30 participants per group which can be revised based on data 
quality. In this sequential explanatory mixed methods study, the qualitative data will complement the 
in-depth longitudinal quantitative data which is the primary focus of the project. The objectives for the 
qualitative data will be to make recommendations for future mHealth research, and compare 
experiences of participants from different race/ethnic backgrounds. The brief qualitative interviews will 
be recorded and transcribed following completion and read to monitor data quality. If the early 
interviews result in more complex data than anticipated, the sample size and density of the sampling 
strategy will be revised (e.g., oversampling racial/ethnic minority groups that reveal unique app 
experiences). The qualitative interviews will be recorded and securely stored for qualitative 
analysis (or completed by the participant via REDCap survey if a medical condition prevents 
them from being able to speak for long periods of time).  Recordings will be transcribed by 
internal staff, Microsoft Transcribe, or by approved contractors. When using Microsoft 
Transcribe, all transcriptions will be reviewed by study staff. All participants, regardless of 
treatment condition, will be compensated for completing the baseline assessment ($20), 3- and 6-month 
follow-up assessments and qualitative interviews if selected ($50 each), for referring new participants 
($10 per eligible and randomized participant up to $50), and daily EMAs (on a weighed schedule 
described below). 
 
At the conclusion of the study, participants who were loaned smartphones will be provided a pre-paid 
padded envelope to return the phone and charger. There will be no consequences to participants who do 
not return their study phone to the research team at the end of the study. Participants that lose study 
phones will be offered a second study phone. At the conclusion of the study, resources will be provided 
to those who are interested in getting a smartphone for reduced rates- we will connect participants with 
the Lifeline program, which offers discounted telecommunications service to low-income individuals. 
(for more information, please visit https://www.fcc.gov/general/lifeline-program-low-income-
consumers) 
 
Assessment Schedule:  
Table 3. MEASURES for Phase 1 
MEASURE 
ITEMS 
 
 
FULL BATTERY ASSESSMENTS 
EMA ASSESSMENTS 
 
Screen 
 
Base 
 
3- and 6- Month FU 
 
MEASURE 
EASE Measures 
 
Descriptive Variables and Moderators 
Morning Daily Diary 
Demographics-Treatment History Questionnaire 
(DTHQ; descriptive) 
24 
24 
 
 
 Sleep (4) 
Alcohol Consumption 
Additional Phone Screener Items 
4 
4 
 
 
Cigarette Consumption 
6CIT (eligibility) 
7 
7 
 
 
Marijuana Use 
Rapid Estimate of Adult Literacy in Medicine-Short 
Form138 (eligibility) 
9 
9 
 
 
Fast food consumption 
Demographic/Background Information Questionnaire 
21 
 
21 
2 
(6- Month FU Only) 
Other Substance Use 
SSASI (2) 
Sheehan Disability Scale (SDS)16 ( A.1: H1) 
4 
 
4 
4 
 Prescription Medication Consumption 
System Usability Scale (A.3) 
10 
 
 
10 
Discrimination Experience (3) 
4-item Perceived Stress Scale 
4 
 
4 
4 
Affect (15) 
Everyday Discrimination Scale (EDS)139 (A.2: H3) 
6 
 
6 
6 
Pain Level 

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EASE App Features and Treatment Components. See Table 2 for app components. EASE offers  
Coronavirus Racial Bias Scale (CRBS)140 (A.2: H3) 
4 
 
4 
4 
Ability to Cope with Stress 
The Patient Health Questionaire-4 (PHQ-4) 
4 
 
4 
4 
Social Support  
Health Related Quality of Life (HRQOL) 
3 
 
3 
3 
Location 
The Perceived Social Support Questionnaire (F-SozU 
K-6) (A.2: H3) 
6 
 
6 
6 
Evening Daily Diary 
MacArthur Scale of Subjective Social Status (A.2: 
H.4) 
2 
 
2 
2 
Physical Activity (2) 
COVID 19 Vaccine Hesitancy Survey 
15 
 
15 
15 
News 
Additional Aim 1 Measures 
4 
 
4 
4 
Money 
Financial strain questionnaire 
9 
 
9 
9 
Hours Away from Home 
Behavioral Risk Factor Surveillance System 
(BRFSS) Inadequate Sleep Questionnaire 
5 
 
5 
5 
Course of your day (2) 
Frequency of Attendance at Religious Services 
2 
 
2 
2 
Amount eaten 
PEG Scale143 (A.3) 
3 
 
3 
3 
Argument 
Affect Constructs 
Affect (15) 
Overall Anxiety Severity and Impairment Scale 
(OASIS)122 (A.1: H1) 
5 
5 
5 
5 
Pain Level 
Overall Depression Severity and Impairment Scale 
(ODSIS)123 ( A.1: H1) 
5 
5 
5 
5 
Ability to Cope with Stress 
SSASI171 (A.2: H3) 
5 
 
5 
5 
Location 
Discrimination Burden (A.2: H.4) 
4 
 
4 
4 
Sunday Morning Diary 
Self-Rated Health Questionnaire 
33 
 
33 
21 
Self-rated health questionnaire 
Employment Status (A.3.b)  
3 
 
3 
3 
Optimism towards the future 
Fear of COVID-19145 (A.2: H3) 
5 
 
5 
5 
App Quality (3) 
COVID-19 Psychological Impact Survey 
3 
 
3 
3 
OASIS (5) 
Daily Activities (A.1: H.1) 
3 
 
3 
3 
SSASI (5) 
Change in Fast Food Consumption during COVID-19 
1 
 
1 
1 
PSI (8) 
COVID-19 Substance Use (A.3.b) 
4 
 
4 
4 
ODSIS (5) 
AUDIT-C 
3 
 
3 
3 
Report Distress 
Marijuana/Cannabis Use Behavior 
6 
 
6 
6 
Affect (15) 
Abbreviated Multidimensional Acculturation Scale  
(A.2) 
15 
 
15 
15 
Location 
LEC5 &  PCPTSD-5 
6 
 
6 
6 
Pain Level 
Ability to Cope with Stress 
Three-item Loneliness Scale 
3 
 
3 
3 
 
Mindful Attention Awareness Scale (MAAS)  
15 
 
15 
15 
Report COVID-19 Symptoms 
Total items  
273 
54 
209 
188 
Current Symptoms 
Exposure to someone with COVID 
Loss of taste/sense of smell 
Note. Screen = REDCap or Phone Screener; Base = Baseline; 3- and 6-Month FU = 3- and 6-Month Post-Baseline Follow-up. *Indicates items that are only collected 
during the morning EMA. **Indicates items that are only collected during the evening EMA. Please see EMA types below for more information. 
Table 2. Comparison of EASE and Control 
conditions 
App Components 
EASE Control 
EMA 
X 
X (add on 
for this 
study) 
COVID-19 monitoring 
and intervention 
X 
X (add on 
for this 
study) 
AS psychoeducation 
X 
 
On demand tips and 
exercises 
   Coping with mood 
   Coping with stress 
   Interoceptive exposure 
   Guided relaxation 
   Inspirational messages 
   Challenge Automatic  
 
 
X 
X 
X 
X 
X 
X 
 
 
X 
X 
 
X 
 

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clinical grade care by integrating standard CBT 
with a transdiagnostic treatment for AS reduction. 
Individuals randomized to the EASE group will 
receive: 1) scheduled treatment, 2) scheduled and cued interoceptive exposure sessions, 3) on-demand 
intervention content (i.e., how to cope with symptoms of anxiety and depression; cognitive 
restructuring exercises; guided relaxation videos), and 4) tailored treatment messages based on 
responses to EMA items. Information about frequency of resource use and length of time spent viewing 
EASE intervention content will be collected through InsightTM.  
Scheduled Treatment. During the baseline call, participants will indicate the best times for 18 3-7 
minute treatment videos that focus on AS reduction (adapted from traditional AS reduction 
treatments)89 and relaxation training videos to manage negative affective states (from our previous 
studies). Two videos will be delivered through the EASE app during each of the first 9-10-weeks of the 
intervention (e.g., 6:00 pm on Monday and Wednesday). Sessions will be cued at the participant 
selected scheduled time and 3 additional times (i.e., every 15 minutes) if the cue is not acknowledged. 
Participants will have the option to delay/reschedule videos or watch them before the scheduled 
day/time (see EASE home screen in Figure 2). Videos can be re-watched if desired (Insight will record 
the date/time when each video is watched, both initiation and completion). Eight of the 18 brief (3-7 
minute) videos provide psychoeducation on: the role of AS in interoceptive stress; the CBT model of 
anxiety/depression and interoceptive stress; procedures for each intervention module; coping 
mechanisms to avoid experiencing negative emotions (e.g., chronic stress due to sociocultural 
stressors); fear-avoidance hierarchy for specific stressors (e.g., bodily stress or stress burden due to 
experiences of racism or discrimination); and interoceptive exposure techniques. Six 
videos focus on the relation between COVID-19 and anxiety/depression and the role 
of AS in these relations as well as utilizing AS-reduction strategies to mitigate the 
impact of COVID-19 related stress on mental health. Each video also presents 
known disparities regarding COVID-19 and the potential impact on mental health 
disparities. Four videos focus on relaxation training to help mitigate the impact of 
stress related to discrimination, general life events, and COVID-19-specific stressors 
on heightened symptoms of anxiety and depression. The final 2 weeks of treatment 
conclude with provided response-prevention prompts to remind participants to use 
and practice skills learned, as well as redirecting and reminding them to review 
specific intervention content. 
Exposure sessions. Internet- and smartphone-based interoceptive exposure are well 
tolerated, acceptable, and effective.107,131,132 We will target AS through graduated 
exposure to anxiety and distress-provoking situations and response prevention. These 
exposure exercises were originally created for a previous app-based treatment 
developed by our team for AS-reduction (e.g., over-breathing, straw breathing, 
running in place, chair spinning, and head rush). The EASE app will cue the 
participant to begin the exposure session at the designated time and then the app will 
guide participants through exposure exercises. Participants will learn to manage 
negative affect and stress during elevated distress states without acting on acute motivation to supress 
distress. In the exercises, the app guides the participant through interoceptive exposures by explaining 
the activity, normalizing the physical symptoms experienced during the exercise, and relating this 
experience to the increasing tolerance of physical symptoms (e.g., anxiety, depression), as well as 
helping to cope with experiences of discrimination. When the participant is ready to begin, the app will 
assess level of distress (0-100 scale), begin a countdown for a specified amount of time for the 
      Thoughts 
Tailored treatment 
messages in real-time 
X 
 
Figure 2 

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exposure, and re-assesses level of distress (0-100 scale) once the countdown has expired. This is 
immediately repeated to ensure habituation to feared sensations. Participants will complete brief 
questions about the length, engagement, and usefulness of the exposure, and they will be encouraged to 
continue practicing these exposures daily (i.e., “Practice Stress Management” option on the app home 
screen). Exposures will incorporate graduated elements to safely elicit strained breathing, racing heart, 
dizziness, and mild disorientation. These exposures were selected to elicit symptoms that may increase 
worry about potential COVID-19 infection, particularly among racial/ethnic minority populations.  
EMAs with tailored real-time treatment messages. During the 3-month intervention period, a message 
will be delivered at the end of each EMA (2 per day). When participants provide a pattern of responses 
that are suggestive of heightened emotional distress (e.g., answering, “neutral, agree, or strongly agree” 
when asked to rate how much they agree with the statement, “Right now, I feel depressed” using a 5-
point Likert scale.), they will be prompted to complete an on-demand exercise (e.g., cognitive 
restructuring, guided relaxation video). The type of message that is delivered (e.g., coping with 
depression, coping with anxiety, coping with COVID-19 related anxiety) will be recorded in the 
database, so we may determine if the message attenuated the targeted symptom (assessed during the 
next EMA). Maladaptive automatic thoughts will be assessed in EMAs. EMAs will capture 
participants' beliefs about internal and/or physical sensations experienced. When participants endorse 
maladaptive cognitive processes, EASE will use response skip patterns to encourage challenging of 
maladaptive thoughts and to develop more balanced responses. Interactive exercises to guide the 
participant through the process of challenging dysfunctional thoughts are to be also available ‘on 
demand.’ Additionally, participants will be instructed to review and practice interoceptive exposure 
exercises to further normalize symptoms of anxiety and depression as well as consider the uniqueness 
of these symptoms relative to COVID-19 symptoms.  
On demand features. We have created a menu of on demand intervention content that is available 
through clicking buttons on the EASE home screen. Specifically, participants can use the Coping 
toolkit button to access: 1) tips on coping with stress and anxiety, 2) relaxation exercises, 3) help with 
challenging unhelpful thoughts, 4) coping with COVID-19, 5) coping with loss and grief, 6) coping 
with discrimination, 7) coping with sadness and depression, and 8) distraction exercises. Participants 
are instructed to click the Treatment Videos button to access educational content on how to cope with 
stress, anxiety, and depression. In addition, they will be instructed to click the Stress Management 
training button to complete exercises that are designed to help overcome the negative feelings of stress. 
Further, participants will receive a coping focused message at the completion of the participant-initiated 
“Report Distress” EMAs. Finally, participants are instructed to click a “Report COVID-19 Symptoms” 
button to report any COVID-19 symptoms they are experiencing to research staff at any time 
throughout the study. 
 
Instructions on how to use app functions will be available to participants in the home screen (i.e., App 
Instructions) which will be accessible at all times. Moreover, participants will also be able to contact 
the research staff when needed using the “Call Staff” function of the insight app if they have any 
questions. The Insight platform respects users display settings and participants will also be able to make 
font sizes bigger if needed. 
 
Standard-of-Care Control. Participants randomized to the control condition will be prompted to 
download the InsightTM app and enter a unique activation code provided by the research team. Upon 
entering this code, participants will be granted access to the baseline assessment. Upon completion of 
the baseline assessment, the app will ask for a code. Participants will receive the code for the control 

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app from the research team. The control app was built using the Insight platform. Participants assigned 
to the control app will have access to: 1) a series of educational videos that discuss meditation 
techniques, mindfulness exercises, and stress reduction exercises, 2) a feature that allows participants to 
report when they are experiencing heightened stress, anxiety or depression, and 3) a “Report COVID-
19 Symptoms” button that allows participants to report any COVID-19 symptoms they are 
experiencing to research staff at any time throughout the study. If a symptom cluster consistent with 
COVID-19 is detected, an encrypted email will be sent to the research team and they will work with the 
participant to help them find a local testing center. Instructions on how to use the app will be available 
to participants on the home screen, and will accessible at all times. Additionally, participants will be 
able to call study staff by pressing the “Call Staff” button on the study home screen. Participants will 
receive 2 daily EMAs during which they will be prompted to watch aforementioned educational videos 
twice per week. Following the intervention period, participants will be encouraged to continue to 
practice the meditation, mindfulness, and stress reduction techniques they have learned, report 
moments of heightened stress, depression, or anxiety, and report any COVID-19 symptoms they 
experience.   
 
Ecological Momentary Assessments (EMA). EMAs are currently the most accurate way to measure 
phenomena in real-time, natural settings.158,159 EMA items will identify fluctuations in key variables 
that predict study outcomes with less bias than traditional in-person assessments. EMA data will be 
used to identify moments of distress (e.g., anxiety/depression), tailor EASE treatment, and identify 
treatment mechanisms.  
 
App Configuration. The mHealth Shared Resource (Businelle is the founding director) at the 
OUHSC and NCI Designated Stephenson Cancer Center (SCC) has developed the InsightTM mHealth 
Platform which enables researchers to RAPIDLY create studies (e.g., most studies are created within 
1-2 weeks) that can use EMA and sensor data (i.e., activity monitor) to identify environmental, 
cognitive, affective, physiological, and behavioral antecedents of health risk behaviors (e.g., smoking, 
heavy alcohol use, inactivity / obesity) and deliver context-specific adaptive interventions in real-time 
(see more about InsightTM here: 160). The mHealth resource currently employs 11 individuals, including 
7 senior programmers (computer scientists/engineers) who develop and maintain our cross-platform 
InsightTM app and relational databases. To date, the mHealth resource has supported 65 studies 
including 35 with funding from the NIH. Across studies, thousands of participants have used the 
InsightTM app. EASE Intervention adherence will be objectively assessed by examining components 
used by each participant (e.g., videos watched, completed exposure exercises). To access perceived 
engagement with EASE and control intervention, participants will answer questions about app features 
used and time, in total, spent using the app each week during the Sunday morning EMA assessment. 
Similar methods have been used to assess app engagement in past work.133 
EMA Types: The EMA methodology for this study will be similar to what we have used in our 
previous studies, and by other researchers.109,110,114,121,161-170 Each EMA will ask about current 
emotional, physical, and behavioral symptoms, as well as COVID-19 symptoms, and will take 
approximately two minutes to complete. Two types of EMAs will be used: time-based sampling (i.e., 
daily diary) and event sampling. Time-based EMAs will be prompted and initiated by the phone two 
times per day during the 6-month study period (we have had great success with this type of EMA 
schedule in previous trials, e.g., ~70% EMA compliance over 6 months; see Table 3 for EMA 
constructs). Also, participants will be instructed to self-initiate event sampling EMAs to record Distress 
and new COVID-19 symptoms. All EMAs will be date and time stamped for future analyses.  
 
Time-Based Sampling EMAs: Daily diary EMAs will be prompted by the smartphone twice per 

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day (i.e., morning daily diary 30 minutes after the participant’s pre-set wake time; end of day daily 
diary 75 minutes before the participant’s pre-set bedtime). The phone will ring and vibrate to cue these 
EMAs for 5 minutes (i.e., alternating between 30 second alerting and silence periods). If the participant 
does not respond to the daily diary prompts, the EMA will be automatically rescheduled (up to 2 
additional times) 15 minutes later. Questions ask about current symptoms of anxiety and depression, 
medication use, current thoughts/affect/behaviors, social support, discrimination experiences, sleep 
quality/quantity, fear of COVID-19, daily activities, fast food consumption, and current COVID-19 
symptoms. Participants will rate their emotional state by indicating the extent to which they agree or 
disagree with each of 15 statements (using a 5-point scale from strongly disagree to strongly agree): I 
feel stressed, happy, angry, tired, afraid, relaxed, sad, bored, worried, lonely, calm, depressed, 
overwhelmed, energetic, and anxious (from the circumplex model of affect).171 Participants also will 
indicate current environment/social setting. During the weekly Sunday Morning EMAs participants 
will answer questions about their health behaviors, optimism towards the future, quality of the app, 
their levels of anxiety and depression, and COVID-19 related items (see Table 3).  
 
Event Sampling EMAs: All participants will be asked to initiate “Report Distress” EMAs and 
answer Core EMA items when they perceive a heightened level of depression and/or anxiety (see Table 
3). Participants will be instructed to answer questions based upon immediate thoughts/feelings. EASE 
participants will receive unique intervention content when they report elevated depression and/or 
anxiety symptoms. Intervention/coping messages and video content will be different each time the 
“Report Distress” button is clicked (this component is consistent with 8 of our previous trials on 
various topics including relapse prevention [e.g., Smart-T, Smart-T Alcohol, Phoenix, MASP, M-
ICART] and mood management interventions [e.g., Persist]). Additionally, all participants will be 
asked to initiate a survey (by clicking the “Report COVID-19 Symptoms” button in the app) if any new 
COVID-19 symptoms arise between the morning and evening daily diaries. NOTE: Our previously 
developed COVID-19 risk detection algorithm will advise participants to get a test for COVID-19 
when elevated risk is detected. The app will immediately trigger an automated and encrypted email to 
study staff to call the participant and assist with obtaining a COVID-19 test (if desired by the 
participant). 
The EASE app content was created by Dr. Businelle and Dr. Zvolensky. Moreover, all 
EASE app content in this study will be accessed through the Insight platform, which is 
owned by the Oklahoma University Health Sciences Center (OUHSC). The EASE app 
will only be available to research participants.  
The control app used in the control condition was created by Dr. Businelle and Dr. 
Zvolensky. All content found in the control app for this study will be accessed through 
the Insight platform, which is owned by the Oklahoma University Health Sciences Center 
(OUHSC). The control app will only be available to research participants.  
11.0 Setting 
Participants will be screened for eligibility via phone and data will be entered into REDCap. All 
screening data will be will be collected online via REDCap. The study investigators will be the 
only ones who have access to the data collection portal. Qualitative interviews will be recorded and 
transcribed for analysis. 
 
12.0 Risks to Subjects 

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Participation in this study poses minimal risk to participants. However, one potential, although 
unlikely, risk to participants is loss of confidentiality. The severity of harm in the case of loss of 
confidentially may range from mild to severe depending upon the individual and the specific 
circumstances. However, the risks of participation in the study are similar to participation in 
usual in person mental health clinic care, as loss of confidentially may be experienced in either 
case. Other possible adverse events might include compromised data security and discomfort 
related to being asked study questions. The research team will monitor this risk and the others 
listed below and report adverse events immediately to the IRB. 
 
Each participant will be assigned an identification number that will be utilized in place of names 
in all electronic data files. The sheet or datafile containing the links between participant names 
and identifiers will be kept in locked filing cabinet and/or password protected digital files on 
encrypted university computers and will be destroyed 12 months after data collection has been 
completed. All electronic data (with names omitted) will be maintained on the investigator’s 
computers, and all computers and electronic files will be encrypted and password protected. 
Identifiable participant information will not be released to any party outside the research team at 
any time.  
 
In the unlikely event that a participant experiences severe symptoms while participating in the 
study, a protocol has been developed to address this concern. If a participant experiences severe 
symptoms, mental health referral information for providers within a 50-mile radius of their home 
location will be provided to participants. The potential for discomfort associated with being 
asked personal questions regarding thoughts and behaviors will be minimized in the following 
ways: 
i. By informing participants of the nature of questions to be asked, 
participants will not be caught unaware by the topics covered and can 
decline participation if such topic areas are known to be personally 
uncomfortable. 
ii. Only measures that have been validated or used in prior studies will be 
used. None of the proposed instruments have been known to evoke serious 
emotional reactivity. 
iii. Participants will be consistently reminded that they are free to skip any 
baseline/follow-up questions they do not wish to answer, without penalty. 
iv. All participants will be reminded during consent they may contact study 
staff with any questions or concerns that arise during the survey.  
 
Lastly, the time commitment to participate in the study may be burdensome to participants. 
However, participants will be informed that they can leave the research at any time it will not be 
held against them.  
 
13.0 Potential Benefits to Subjects 
First, the overall cost/benefit ratio is highly favorable for participants. All participants will have 
the opportunity to examine and improve their ability to effectively manage their mood and stress 
through the intervention program. Second, the costs of completing the study have been 
minimized through our use of procedures for maintaining confidentiality, and minimizing the 
risk of adverse study reactions. Third, the societal benefits of the proposed research are better 

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understanding how to develop a mobile mental health intervention that is personalized and 
focused on improving anxiety and depression. Fourth, the implementation of smartphone-based 
interventions to address anxiety and depression could have a positive impact on public health 
policy for minorities (e.g., American Indians, Hispanic, African Americans). Further, it is 
possible that EMAs will identify key factors that predict mental health symptom exacerbation, 
and this information may be used to improve future COVID-19-specific mental health 
interventions for White, African Americans, Hispanic, and American Indians. Finally, all 
participants, regardless of group assignment, will complete a daily COVID-19 screener. This 
information will have access to a COVID-19 symptom screener and when our previously 
developed algorithm indicates heightened risk, participants will be notified and assisted (if 
desired) with scheduling a COVID-19 test. 
 
14.0 Withdrawal of Subjects 
There are no anticipated circumstances under which subjects will be withdrawn from the 
research without their consent.  
 
15.0 Costs/Payments to Subjects 
In addition to compensating participants for completing the Baseline (i.e., $20), and 3- 
and 6-month post-baseline assessments, which will include a qualitative interview over 
the phone for selected participants (i.e., $50 each), participants will be compensated for 
completing daily EMAs for 6-months. Specifically, those who complete 50%-74% of 
prompted EMAs each month (2 per day x 30 days = 60 monthly EMAs) will receive $20, 
those who complete 75%-89% of assessments will receive $30, and those who complete 
90% or more of their EMAs will receive a total of $40 for that month. Additionally, 
participants will have the ability to earn up to $50 for referring people to our study. 
Participants will have the ability to earn $10 for each person they refer who is deemed 
eligible and randomized into the study, up to $50. Participants will be compensated 
through a reloadable Greenphire MasterCard. These cards can be used anywhere 
MasterCard is accepted and participants may use these cards to withdraw their 
compensation from a bank. This convenient and auditable method of payment is 
preferred by participants and study staff. Cards will be purchased by the study team and 
mailed to participants following their baseline assessment and reloaded monthly based 
upon compensation earned. 
16.0 Confidentiality 
Consent forms with identifying information will be completed via RedCap, encrypted, and stored 
on university computers. A password protected computer file will contain information linking 
participant names to their assigned numbers. Only the researchers will have access to this 
information. 
 
17.0 Provisions to Protect the Privacy Interests of Subjects 
Participants will be consistently reminded that they are free to skip any baseline/follow-up 
questions they do not wish to answer, without penalty. Participants will not need to answer any 
questions that they find intrusive to their privacy.  
 

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Participants will answer questions in a location and time of their choosing. Upon receipt, study 
phones that are returned by participants will be factory reset. Phones will not be mined or 
reviewed for non-study related data. 
 
18.0 Informed Consent Process 
The informed consent process will be completed via phone. During this call, study staff will 
verify that each individual meets the study inclusion criteria, staff will review study details with 
each individual; and interested individuals will complete the informed consent process 
(signatures will be collected digitally via REDCap). 
The information to be provided to the participants over the phone will be that which is included 
in the uploaded consent document (please refer to consent form uploaded to the Local Site 
Documents). The consent document will be displayed to participants over REDCap and 
participants will be able to read and review all information while on the phone with a research 
assistant who will ensure the participant understands the research and has no questions. Thus, all 
participants will be provided with written information describing the research to be provided to 
the subject 
The research will present no more than a Minimal Risk of harm to subjects and will not involve 
procedures for which written consent is normally required outside of the research context. 
Participants will be informed that qualitative data collected through the qualitative interview will 
be transcribed through transcription company Civicom. Accordingly, Civicom will readily 
review and accept clients and partners ensuring that PHI shared with them will not be 
compromised, as they are committed to confidentiality and the protection of health information 
for individuals, clients, customers and partners. Moreover, we will ensure participants are aware 
the only data being shared with Civicom is the audio recording of qualitative interviews, and as 
such, no personal information will be shared with Civicom unless this information is mentioned 
during the interview process. 
 
19.0 Process to Document Consent in Writing 
The consent form will be reviewed with the participant by a member of the study staff via 
phone. Participants who choose to take part in the research study will sign consent forms 
electronically via REDCap.  
REDCap is a secure, web-based platform which allows for safe, secure and easy sharing 
of collected data within and across institutions for multicenter trials as it requires user 
authentication and can assign data access rights based on user role, allows for field-level 
data validation, and has mechanisms for ensuring data quality and integrity. It offers a 
digital method to acquire and store participant consent by implementing the study’s 
consent form through an online survey that will display a PDF copy of the consent 
document (please refer to uploaded consent form in local site documents) that can be 
accessed by the participant through a computer, mobile phone, or tablet. Participants will 
be able to read and review the consent form virtually and will do so while on the phone 
with a research assistant who will ensure the participant understands the study procedures 
and who will answer any questions the participant may have.  

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Participants who would like to participate will be able to ‘sign’ their consent form 
electronically by typing in their name or by utilizing REDCap’s ‘Signature’ field type on 
the survey. Signed documents will be protectively stored to our server and participants 
will not need to email any signed documents to the research team. Participants will be 
mailed a signed copy of the consent form. 
 
20.0 Data Management 
Data Management Organizational Structure. Confidentiality is assured by several factors. Most 
importantly, participants will be identified on only by participant identification number (names 
and ID numbers will be stored in encrypted and password protected data files on the 
investigators firewalled computers). Additional measures to ensure the confidentially of study 
data include the following: access to databases (REDCap and InsightTM) will require complex 
passwords. When data are accessed, the user id, password, date, and time are logged. Each user 
of the systems will be assigned unique user-IDs. 
 
 
Our study procedures prevent potential fraudulent surveys, as they consist of speaking with 
participants on the phone before they are enrolled, and all participants will need an activation 
code from the research team in order to participate in the study. Additionally, participants will 
need to provide a valid address, social security number, and date of birth in order to receive 
Greenphire cards.  
 
The Insight app encrypts all data as it is collected and this data is synced to our secure servers up 
to four times per day. Thus, the research team can still access data collected through Insight even 
when a phone is not returned and may be retrieved if a phone is lost. Participant data will be 
collected through Insight, REDCap, and qualitative interviews will be recorded and transcribed.  
Recordings of transcribed interviews will be deleted within 12 months of transcription. All data 
will be stored in password protected and encrypted computers. The Insight app is encrypted 
within the smartphone. 
 
A copy of the collected data will be stored for at least 3 years following completion of the 
research study.  Study data will be stored to university owned encrypted computers. Consistent 
with NIH requirements, we will provide de-identified data from this project to interested 
individuals one year following achievement of the aims of the project (i.e., publication of the 
main outcome papers). These data will be provided in digital format (i.e., disk) with clear labels 
for all variables. Requested data will be released directly by the investigators providing evidence 
of their institutional IRB approval for planned analyses of the data. Our team will be available to 
address queries. The Insight app works through an encrypted shared content management system 
which allows researchers from both sites to download data directly to university owned 
encrypted computers. Both sites are able to download study data directly. Study data collected 
through Insight will be saved to our laboratory drive which is set up by the UH Psychology 
Department’s IT team. Study data will be password protected. 
 
For recruitment through BuildClinical, they will be collecting their own data when advertising 
our study to participants and sharing data with the University of Houston and University of 
Oklahoma study teams. Data collection will be through our pre-screener link. Collected data will 

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include: (1) Full name, (2) Phone number, (3) Phone number (secondary), (4) Email address, (5) Age, (6) 
Date of birth, (7) Ethnicity, (8) Race, and (9) Gender assigned at birth. BuildClinical does not interact 
with data outside of sending the data to the University of Houston and the University of Oklahoma. 
BuildClinical’s Secure Socket Layer (SSL) software encrypts all inputted information and keeps the 
information private. All of BuildClinical’s systems are HIPPA-compliant and have been approved by the 
Office of Veterans Affairs and the National Institutes of Health. Study teams will not be sharing data 
with BuildClinical that will need to be protected by the 3rd party. Upon request, BuildClinical 
can remove data from their platform. 
 
Qualitative data collected through the qualitative interview will be transcribed through 
transcription company Civicom. Civicom acts as a Business Associate of Covered Entities as 
defined under HIPAA. Accordingly, Civicom will readily review and accept clients and partners 
ensuring that PHI shared with them will not be compromised. Moreover, Civicom is committed 
to confidentiality and the protection of health information for individuals, clients, customers and 
partners. Their data policies ensure that privacy and security of any health information is 
protected in all forms, with particular care in controlling the confidentiality, storage and access to 
electronic Protected Health Information. They have achieved this by implementing security 
standards, administrative, technical, and physical safeguards, organizational requirements, and 
requirements for documentation, policies and procedures. Civicom standards are maintained and 
improved by continuous review and audit of internal processes and business agreements, with the 
aid of external consultants and specialized staff dedicated to data privacy. Additionally, Civicom 
provides training to all members of its workforce on policies and procedures with respect to PHI, 
as necessary and appropriate for them to carry out their job responsibilities. Moreover, it must be 
noted that the only data being shared with Civicom is the audio recording of qualitative 
interviews, and as such, no personal information or PHI will be shared with Civicom unless this 
information is mentioned during the interview process of any participants. 
 
Data analysis overview: Hypotheses for Aims 1 and 2 will be examined using latent growth 
models (LGM),172 multilevel structural equation models173 (MSEM) and latent difference 
score174 models using MPlus 8.0.175 To simplify subsequent sections, an overview of the 
common data analysis elements is presented first. Data will first be examined for multivariate 
normality and outliers to determine the most appropriate estimator. The maximum likelihood 
(ML) estimator will be used if data are approximately normal. Robust maximum likelihood 
(MLR) will be used if the data are not multivariate normal. We anticipate some participant 
attrition during the trial. Missing data will be handled in all analyses using direct ML techniques 
within MPlus under a missing at random (MAR) assumption.176 Modern missing data 
techniques such as direct ML increase statistical power and provide more accurate estimates of 
model parameters and standard errors and are the recommended intent-to-treat approach for 
clinical trials. LGM will generally be used to model outcomes collected at major assessments. 
MSEM will be used to further examine the longitudinal course of outcomes and hypothesized 
mechanisms of action as MSEM is ideally suited for disentangling within and between individual 
variance in order to more precisely estimate main effects, lagged effects, and indirect effects in 
intensive longitudinal designs. Evaluation of model fit in the LGM/MSEM models will be 
examined using fit diagnostics (i.e., standardized residuals) and common fit statistics (i.e., root 
mean square error of approximation) following the associated cutoff criteria recommended by 
Hu & Bentler.177 We will assess the equivalence of the treatment groups on key baseline 

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variables (demographics and psychological variables); variables on which the groups differ will 
be used as covariates in the final analyses. We will also examine attrition from the study as a 
dichotomous outcome and use logistic regression to determine if treatment assignment predicts 
attrition.  
 
 
21.0 Sharing of Results with Subjects 
Study results will not be shared with participants. 
22.0 Resources  
Dr. Zvolensky has published over 750 peer-reviewed articles and books/book chapters on the co-
occurrence of anxiety and stress-related psychopathology with substance use disorders, health 
behavior problems, and physical illness. He has utilized a variety of methodological tactics in his 
research program, including community-based participatory research (CBPR), laboratory studies, 
epidemiologic-field (cross-national and prospective), Ecological Momentary Assessment 
(EMA), and randomized clinical trials. He has developed culturally tailored interventions in past 
projects for racial and ethnic minority groups. A large percentage of his recent work has focused 
specifically on smoking among African American and Latino populations. He has been involved 
in over 60 NIH grants as PI, Co-PI, or co-investigator, and therefore, has extensive experience 
leading large and multi-team projects.  
 
Dr. Garey’s research employs advanced methodological designs to elucidate risk and protective 
factors of addictive behavior and treatment outcomes. Dr. Garey has published over 115 peer-
reviewed articles and books/book chapters on topics within her area of research and served as PI 
on several federally and privately funded grants, including a stage I trial of a technology-based 
intervention for mood and substance use. Many aspects of her research program focus on health 
behavior change models, including elucidating biopsychosocial determinants of substance use 
and mental health. She has collaborated with Drs. Zvolensky, Businelle, Vujanovic, and 
Gallagher. Dr. Garey assisted extensively with the refinement of the current research idea and 
proposal and will serve as the project coordinator.  
 
Dr. Gallagher has published over 110 peer-reviewed articles and book chapters primarily 
focusing on transdiagnostic treatments, mechanisms of change, and resilience factors for 
emotional disorders. Dr. Gallagher’s training and expertise is in both clinical and quantitative 
psychology, and he has extensive experience with the proposed methods of data analysis, 
particularly the examination of outcomes and mechanisms of change in clinical trials and EMA 
studies, including work expressly focused on tobacco. He has served as both co-investigator and 
biostatistician on NIH, VA, DOD, and foundation grants focusing on clinical trials for emotional 
disorders and experimental psychopathology work examining how factors such as anxiety 
sensitivity contribute to the development and maintenance of depression and anxiety disorders. 
He has multiple ongoing collaborations with Dr. Zvolensky that have resulted in publications and 
grants and has successfully collaborated with Drs. Businelle, Garey, and Vujanovic on peer-
reviewed articles in collaboration with Dr. Zvolensky. He will have primary responsibility for 
overseeing the data analyses for this project, will oversee the randomization, and will also advise 
on any statistical or other methodological issues that arise during the trial.  
 

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Dr. Vujanovic has published over 160 peer-reviewed articles and book chapters primarily 
focusing on trauma, stress, and substance misuse among high-risk populations (e.g., first 
responders, human trafficking victims). Dr. Vujanovic’s expertise offers a unique and 
complementary addition to the team, as she has long-standing clinical and scholarly experience 
with the socioenvironmental contexts of low SES African Americans and other underrepresented 
groups. Across both clinical and research contexts, she has extensive experience in the 
application of cognitive-behavioral approaches for the treatment of psychiatric conditions, 
namely traumatic stress, and substance use. Further, she has frequently recruited and retained 
populations who identify as racial/ethnic minorities in intensive treatment work on addictive 
disorders. She has multiple ongoing collaborations with Dr. Zvolensky that have resulted in 
publications and grants and has successfully collaborated with Drs. Gallagher and Garey on peer-
reviewed articles in collaboration with Dr. Zvolensky. She will have primary responsibility for 
overseeing the retention of the sample and will also advise on other methodological issues that 
arise during the trial.  
Dr. Michael Businelle is the primary investigator in charge of the TSET Health Promotion 
Research Center in Oklahoma. Dr. Michael Zvolensky is the primary investigator for all subsites. 
23.0 Additional Approvals 
N/A