Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans (COR 19-490)
Phase: NA
Conditions: Suicide
Sponsor: VA Office of Research and Development

Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans 
NCT04881903 
Study Protocol and Statistical Design 
3/27/2023 

Mobile Intervention for Suicide Cognitions 
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PROTOCOL TITLE: Developing a Mobile Intervention to Reduce Suicidal Cognitions in 
Veterans 
 
PRINCIPAL INVESTIGATOR: Kirsten H. Dillon, Ph.D. 
 
SPONSOR/FUNDING SOURCE: HSR&D SPRINT Planning Grant  
 
Purpose 
The goal of this research is to develop, refine, and pilot-test a mobile interpretation bias 
modification intervention to reduce cognitions that contribute to elevated suicide risk and 
to assess the impact of reductions in suicide cognitions and hostile interpretation bias 
on suicide risk and functioning. 
 
Background and Significance 
According to the fluid vulnerability theory, suicide risk fluctuates as a function of chronic 
and acute vulnerability factors.1 One of the factors that contributes to persistent 
vulnerability is what is known as a “suicidal belief system”.1 This belief system is made 
up of several well-studied, cognitive constructs, such as hopelessness2, thwarted 
belongingness, perceived burdensomeness 3,4 unlovability, unbearability, and 
unsolvability4,5. Each of these constructs have been associated with suicide-related 
outcomes.6 For example, suicide cognitions have been prospectively associated with 
subsequent suicide attempts among military personnel.5 In another study, suicide 
cognitions were stronger predictors of future suicide attempts than current suicidal 
ideation or prior suicide attempts.4 In fact, thwarted belongingness, unlovability, and 
unbearability were uniquely related to prospective attempts over a two-year period, 
above and beyond other well-established risk factors.4 Suicide cognitions are 
conceptualized as enduring, chronic vulnerability factors that predispose individuals to 
suicidal crises. Therefore, modification of these beliefs may reduce suicidal thoughts 
and behaviors.  
 
In addition to suicide cognitions, another potentially modifiable risk factor for suicide is 
anger. Recent research (including from our team) has demonstrated a strong, 
consistent relationship between anger and suicidal thoughts and behaviors in civilian 
and veteran samples.7-9 For example, in a longitudinal, nationally-representative 
sample, anger was prospectively associated with subsequent suicidal ideation and 
attempts, even after adjusting for well-established risk factors.7  
 
Interpretation bias modification techniques have been used in recent years to modify 
cognitive biases that cause and maintain psychiatric disorders.10 Interpretation bias 
modification is delivered via computer, tablet, or smart phone and essentially helps 
participants to adopt more adaptive interpretational styles through repeated practice. Dr. 
Dillon has developed an app to deliver her hostile interpretation bias modification 
intervention with ~10 minute treatment session delivered 5-7 times per week for 4 
weeks. The current project will use this paradigm to develop a similar intervention to 
reduce suicidal cognitions for Veterans. The impact of this intervention as well as the 
hostile interpretation bias intervention on suicide risk and daily functioning will be 
examined.  

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Aims 
Aim 1(a). Develop a mobile interpretation bias modification intervention entitled 
Mobile Intervention for Suicidal Thoughts (MIST) to reduce cognitions that 
contribute to elevated suicide risk. We will develop content to target cognitive factors 
that contribute to suicide risk and program this content into a mobile application similar 
to an existing app developed by the team to target hostile interpretation bias, entitled 
MIRA.  
 
Aim 1(b). Use a successive cohort design to refine the MIST intervention among 
Veterans with PTSD, problematic anger, and elevated suicidal ideation. To refine 
the intervention developed in Aim 1(a), the app will be tested in two cohorts (each n = 5) 
of Veterans with problematic anger, and suicidal ideation. After each cohort uses the 
MIST application for four weeks, a quantitative and qualitative evaluation will be 
conducted with each Veteran. Revisions will be conducted before the next cohort is 
treated. Then, a third cohort (n = 4) will be recruited to test a web-based version of the 
MIST intervention delivered via Qualtrics. 
 
Aim 2. Assess the impact of reductions in suicide cognitions and hostile 
interpretation bias on suicide risk and functioning. After using the MIST intervention 
for four weeks, participants will use the MARI intervention for another four weeks. For 
the duration of the study (all eight weeks of treatment), EMA data will be collected to 
evaluate the impact of both interventions on suicide risk and daily functioning.  
Design 
The proposed research project has two aims: 1) to develop and refine the MIST mobile 
intervention; and 2) to assess the impact of reductions in suicide cognitions and hostile 
interpretation bias on suicide risk and functioning among Veterans with problematic 
anger, and elevated suicidal ideation. The project has been designed in order to 
complete both aims simultaneously. The first step is to develop training scenarios for the 
MIST intervention. Dr. Dillon has already started developing these scenarios to fit into 
specific themes of types of cognitions that have been theoretically and empirically linked 
to suicide: unbearability (I can’t tolerate being this upset), unlovability (I am unworthy of 
love), unsolvability (Nothing can solve my problems), thwarted belongingness (I do not 
belong), perceived burdensomeness (Others are better off without me), and 
hopelessness about the future (Things will not improve). Unique scenarios will be 
developed for 28 treatment sessions (daily sessions for four weeks). When the 
scenarios have been developed, they will be reviewed by a team of experts (i.e., 
doctoral level psychologists with experience working with this Veteran population) who 
will rate them on how relevant they are for the Veteran population. They will also share 
comments and suggestions for refining these scenarios. Each scenario will be reviewed 
by at least one expert. Scenarios with low relevance will be revised before inclusion in 
the app. These are the same procedures used to develop the content for the MARI app.  
 
In order to refine the MIST mobile intervention, a successive cohort design11 will be 
used. Successive cohort design utilizes an iterative process for by which psychosocial 
treatments in the early stages of development are systematically refined and modified. 
Qualitative and quantitative data collected by providing the treatment to these small 

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cohorts is used to inform these revisions. Accordingly, we will be refining the treatment 
approach with two successive cohorts of n= 5 Veterans with problematic anger, and 
elevated suicide risk. After the first cohort uses the application, a qualitative and 
quantitative evaluation will be conducted. Revisions will then be made based on these 
evaluations before another cohort of n = 5 Veterans is treated. Again, following 
treatment an evaluation will be completed and further revisions will be made to the 
treatment. This same method was used successfully to develop the MARI app. 
 
Following completion of the second cohort, we will be testing a third cohort (n=4) using 
the web-based version of the MIST intervention delivered via Qualtrics. This intervention 
will include the same MIST treatment scenarios and EMA questionnaires delivered via 
Qualtrics links directly to the Veterans’ phones. 
 
Procedures: All study procedures can be completed remotely using video conferencing 
services and mailings to minimize potential COVID-19 exposure. Participant will provide 
informed consent and HIPAA authorization via mail or with DocuSign where available. 
At an initial assessment, after establishing that they meet study criteria, they will 
complete a battery of baseline self-report questionnaires.  They will then be instructed 
on how to complete the MIST treatment sessions and diary entries via their phone 
through Qualtrics. Four weeks later, each participant will complete a post-MIST 
interview during which they will provide detailed feedback on their experience using the 
MIST intervention and some self-report questionnaires. These semi-structured 
interviews will assess how helpful they found the intervention. They will be asked to 
elaborate upon what aspects of the intervention they think are most and least helpful 
and to provide suggestions on how it could be improved. They will also be shown a list 
of 100 random MIST treatment scenarios and asked to provide feedback and 
suggestions on the content and wording of these scenarios. 
 
They will then be instructed to complete the MARI treatment sessions and diary entries 
via Qualtrics for another period of four weeks.  
 
Following the completion of each cohort, quantitative and qualitative data will be 
analyzed. Based upon results, the intervention structure and content will be revised. 
The content that will be subject to revisions includes IBM content (e.g., topics and 
themes of scenarios). After the final cohort is completed, the MIST intervention will be 
finalized.  
 
Measures: The following self-report measures will be administered at pre-treatment, 
post-MIST, and post-MARI assessments: suicide cognitions will be assessed with the 
Suicide Cognitions Scale4, Beck Hopelessness Scale12, Interpersonal Needs 
Questionnaire13; hostile interpretation bias will be assessed with the Word Sentence 
Association Paradigm-Hostility14; suicide risk will be assessed with the C-SSRS15 and 
the Beck Scale for Suicidal Ideation; anger will be assessed with the Dimensions of 
Anger Reactions16; functioning and quality of life will be assessed with the Brief 
Inventory of Psychosocial Functioning (IPF)17 and WHOQOL-BREF18. Participants will 
also complete the PTSD Checklist for DSM-5, the Patient Health Questionnaire-9, and a 

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brief questionnaire to assess their self-efficacy at managing suicidal thoughts and 
anger. On a 1-5 Likert scale they will be asked to rate: “how confident are you with your 
ability to cope with suicidal thoughts?” and “how confident are you with your ability to 
cope with anger?”. At the post-MIST and post-MIRA assessments, they will complete 
the Client Satisfaction Questionnaire. 
 
EMA assessments will also be conducted for the duration of the time that participants 
are engaged in the MIST and MARI interventions (8 weeks). There will be one random 
alarm-prompted diary entry during the day and a nightly diary using established 
procedures from our team.19,20 The EMA diary will include assessments of: suicidal 
ideation; and functioning and health related quality of life using the brief IPF21 and items 
from the WHOQOL-BREF18. EMA entries will also ask about affect and alcohol and 
substance use. 
 
Demographics and Background Measures 
Time 
(min) 
Baseline 
Post-MIST 
Post-MIRA 
Demographics 
2 
● 
 
 
Traumatic Life Events Questionnaire (TLEQ) 
10 
● 
 
 
Diagnostic Interviews 
 
Structured Clinical Interview for DSM-5 
60 
● 
 
 
Feasibility and Acceptability Measures 
 
Participant Recruitment 
-- 
● 
 
 
Treatment Retention 
-- 
 
● 
● 
Withdrawals 
-- 
● 
● 
● 
App Utilization 
-- 
 
● 
● 
Client Satisfaction Questionnaire (CSQ) 
5 
 
● 
● 
Post-MIST Interview 
30 
 
● 
 
Clinical Measures 
 
Interpersonal Needs Questionnaire (INQ) 
5 
● 
● 
● 
Suicide Cognitions Scale (SCS) 
5 
● 
● 
● 
Beck Hopelessness Scale 
5 
● 
● 
● 
Word Sentence Association Paradigm-
Hostility (WSAP-H) 
10 
● 
● 
● 
Columbia-Suicide Severity Rating Scale 
5 
● 
● 
● 
Beck Scale for Suicide Ideation 
5 
● 
● 
● 
Dimensions of Anger Reactions (DAR) 
5 
● 
● 
● 
Brief Inventory of Psychosocial Functioning 
5 
● 
● 
● 
WHOQOL-BREF 
5 
● 
● 
● 
Patient Health Questionnaire-9 (PHQ-9) 
5 
● 
● 
● 
PTSD Checklist for DSM-5 (PCL-5) 
10 
● 
● 
● 
 
Mobile Device Use 
Study participants will access the MIST, MARI, and EMA interventions and 
assessments using their personal mobile devices. They will receive Qualtrics links to 
access the treatment sessions and EMA diary entries. These data will be collected via 
the VA instance of Qualtrics.   
 
Risk/Benefit Assessment 

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Participation is completely voluntary and participants are informed that they are free to 
refuse to answer any items on the questionnaires or questions from the interview that 
they do not wish to answer. They are also informed that they are free to decline 
participation in any procedure and can withdraw from the study at any time. Regarding 
qualitative data, participants will be informed that all published results will be 
anonymized, including any mention of city/medical center/clinic to protect the identity of 
participants. 
 
Potential risks will be minimized by carefully screening potential participants according 
to the inclusion/exclusion criteria, closely monitoring symptom levels, and following 
established laboratory procedures. To ensure confidentiality, all records will be identified 
by the participant’s identification number, not by name. All raw hard copy data will be 
kept in a locked file cabinet in a locked room. Data files will be stored on secure, 
password-protected computers. Finally, all project staff will complete educational units 
required by the Durham VAHCS IRB.  
 
While participants may benefit from using the mobile intervention, there are no 
guaranteed benefits to the individual participant and no immediate benefits of the 
proposed research to others. There are potential benefits to others from the information 
generated that potentially will be helpful in increasing reach of treatments to target 
suicidal ideation and anger and developing more effective interventions for Veterans 
with suicidal ideation, PTSD, and problematic anger. In our opinion, the anticipated 
benefits of this study outweigh the potential risks. 
 
Selection of Subjects 
We will screen up to 30 participants for the project for a desired total sample size of 14.  
 
Inclusion/Exclusion Criteria 
Veterans must meet all inclusion criteria: 
Veterans who meet any one of the 
exclusion criteria will be excluded:              
 Report a score of ≥12 on the 5-item 
Dimensions of Anger Reactions Scale  
 Can read at least 6th grade level 
material 
 Report a score of 1-3 (indicating 
ideation without intent) on the Columbia-
Suicide Severity Rating Scale (C-SSRS) 
 Are engaged in mental health treatment 
and regularly attending appointments 
with a provider (e.g., therapy, 
counseling, medication management) at 
least every 3 months. 
 
 Currently in a period of active 
psychosis or mania. 
 Current moderate or severe alcohol 
or substance use disorder, 
established via SCID-5* 
 Current imminent suicide risk or 
homicidal ideation requiring 
immediate intervention. 
 
 
* SCID-5 interviews will be administered by trained lab personnel who have been 
trained using standardized training, which consists of review of interview manuals, 

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training videotapes, and co-rating training with an experienced rater. Across previous 
studies, interrater reliability based on videotapes of participant interviews has been 
excellent (kappa = .96). 
 
Subject Recruitment 
Participants will be recruited using a Data Access Request Tracker (DART) request to 
identify Veterans with PTSD diagnoses from Regional and/or Corporate Data 
Warehouse. Potential participants will be sent an introductory letter that describes the 
study and informs them that they will be called regarding participation. In the letter, 
potential participants will be given an “opt-out” number to call in order to decline 
participation and/or further contact regarding participation. Seven business days after 
the mailing, Veterans who have not called the toll-free number to decline participation 
will be contacted by a study team member to request their participation in the research 
study.  
 
We will also recruit veterans from the Traumatic Stress and Health Laboratory’s 
“Contact Database,” IRB #1080; this database contains information about previous lab 
study participants who have agreed to be contacted about other studies for which they 
may qualify.  
 
Clinicians in clinics throughout the medical center will be provided information about 
study eligibility and basic procedures (see brochure), and will be asked to refer 
potentially eligible veterans. Clinicians have reported that Veterans often indicate that 
they prefer that their names and contact information be provided directly to study staff.  
We’d like to make it easy for interested Veterans to get involved in research, while 
protecting the privacy of those Veterans who are not interested in research. Towards 
that end, we would like to allow a clinician to refer a participant directly to our clinic by 
adding the study PI or study coordinator as a co-signer to a note in CPRS in which the 
clinician has documented that the participant wishes to be contacted about participation. 
 
Any Veteran who contacts or is contacted by the study team will be told that their 
participation is voluntary, and they may choose not to answer any questions that they 
find too sensitive. Also, Veterans will be told that their participation will not affect their 
care at the VA. The study team member will explain the study in detail, including 
compensation. No study procedures will begin until formal, written informed consent and 
HIPAA authorization have been obtained.  
 
Study Interventions 
Two interventions will be studied in the current project, the MARI and the MIST 
interventions. The MARI intervention has already been developed by Dr. Dillon (IRB # 
2168). The MIST intervention is going to be developed in a similar manner. The 
interventions will be very similar except for the content of the treatment sessions. Below, 
we explain the layout of the MARI intervention and then the changes that will be made 
for the MIST intervention. 
 

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MARI Intervention.  
The IBM intervention. The IBM 
treatment works as follows (see Figure 
6). Participants are shown ambiguous, 
anger-relevant scenarios and instructed 
to imagine themselves in the described 
situation. For example, “You speak to 
someone and they do not respond.” 
Next, another sentence appears that 
offers a benign, non-threatening 
interpretation of the scenario. For 
example, the sentence following this 
particular scenario reads, “This person 
is unaw_re.” The participants fill in the 
missing letter of the word, forming the 
word “unaware,” and assigning the benign interpretation. This interpretation is then 
reinforced by requiring the participants to correctly answer “yes” or “no” to a 
comprehension question (i.e., “Did this person hear you?”). In this example, they must 
answer “no” to proceed. Across treatment sessions, unique scenarios are presented 
(i.e., participants do not see the same scenario twice). Scenarios have been developed 
to capture a wide range of different themes that are likely to be anger-provoking. 
Themes include: physical aggression, driving situations, irritating traits of 
others, thinking you are being ignored by others, feeling argued with or 
criticized, thinking someone is stealing from you, having people block you, thinking that 
others have hostile feelings, feeling disrespected, thinking that people will not help 
you, thinking that others do not appreciate you, and thinking that situations are unfair. 
See Figure 7 for an example of a training scenario in the MARI app.  
 
We will be 
delivering the 
intervention 
daily for 4 
weeks. It will 
include 28 
treatments 
sessions that 
will each take 
approximately 
10 minutes to 
complete. Each 
session will 
include 42 
training 
scenarios. No 
scenario will be 
repeated across these sessions. To this end, 1,176 unique training scenarios have been 
developed. Scenarios have been reviewed by 9 PTSD experts in the field and 

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individuals with PTSD to confirm the content is relevant to this patient population. 
Additionally, the reading level has been assessed using an online readability calculator 
(“Readability Formulas”) and all scenarios are at a 6th grade reading level or less. 
Qualtrics will time stamp use by the participants so that treatment time and completion 
for each participant can be calculated. 
 
 
 
MIST Intervention 
The MIST intervention will be identical to the MARI intervention. The only difference is 
that the treatment sessions will include the scenarios that are being developed (see 
Design section) to target suicide cognitions.  For example, “You make a mistake.” Next, 
another sentence appears that offers a resolution to the scenario that is incompatible 
with the suicide cognition being targeted (in this example, unsolvability). The sentence 
following this particular scenario reads, “It can be fi_ed.” The participants fill in the 
missing letter of the word, forming the word “fixed,” and resolving the scenario in a way 
to change the targeted suicidal cognition. This is then reinforced by requiring the 
participants to correctly answer “yes” or “no” to a comprehension question (i.e., “Are 
things permanently damaged?”). In this example, they must answer “no” to proceed. 
 
Staff Readiness to Handle Potential Disruptive Behavior 
Principal investigators in the Traumatic Stress and Health Research Laboratory have 
been working with Veterans with PTSD since the mid-1990s, and much of their clinical 
and research work has involved providing anger interventions to these Veterans. Our 
laboratory currently has three other studies in which we provide anger interventions to 
Veterans with PTSD (IRB #s 1731, 2063, and 2168). Over the course of those studies, 
we have not had any need to report any disruptive behaviors or contact VA police. Dr. 
Dillon, recently completed a pilot study of the computer-based hostile interpretation bias 
intervention (IRB # 2136) and is currently conducting another study of the mobile hostile 
interpretation bias intervention (IRB # 2168). She has not had any Veterans express 
anger regarding the intervention.  
 
Senior staff members are well trained in utilization of counseling techniques such as 
active listening, which helps to minimize the likelihood of angry outbursts. Study staff 
members are asked to attend levels 2 and 3 of the VA’s Prevention and Management of 
Disruptive Behavior (PMDB) training, which is the VA’s workplace violence prevention 
program. This level of training is the highest offered to VA employees in outpatient 
settings. Finally, office areas that are used for clinical interventions, interviews, etc. are 
equipped with panic alarms, and staff are trained in how/when to use the alarms.  
 
Costs and/or Payments to Subjects 
The study involves up to three visits. Participants who are screened and found ineligible 
for the study will receive $40 for their time. Eligible participants will receive $100 for 
completing the first visit, $50 for completing the post-MIST visit, $25 for providing 
feedback on the 100 MIST scenarios, and $50 for completing the post-MIRA visit. They 
will also be paid for completing the EMA monitoring for the 8-week duration of the study. 

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They will receive $30 for each week that they do the EMA monitoring (8 weeks total) 
plus a $20 compliance bonus each week that they complete at least 2/3rds of the 
prompted diaries. Participants can receive up to $625 for completion of the study.  
 
Data and Safety Monitoring 
The PI and study staff will be responsible for data safety and monitoring. There will be 
several ongoing mechanisms for monitoring and reporting of AEs: 1) ongoing participant 
contact via study personnel, 2) a toll-free number provided to participants to report 
concerns related to study participation; 3) weekly meetings between the PIs and study 
personnel. Study-related serious adverse events (SAEs) for participants in this project 
are not expected, but should they occur, they will be reported to the Durham VA Health 
Care System Institutional Review Board in accordance with local human protections 
program guidelines. 
 
The PI will meet at least weekly with study personnel to discuss participants’ reactions 
to the intervention, proper delivery of the intervention, and any adverse events or 
unanticipated problems. Monthly meetings between the investigators and the project 
manager will allow for ongoing progress reports, including the number of participants 
currently involved in the study, attrition rates, and scheduled data collection from 
participants, as well as notification and review of any AEs. Safety monitoring for AEs will 
be conducted in real time by the PI and/or project manager. The following information 
about adverse events will be collected: 1) the onset and resolution of the AE, 2) an 
assessment of the severity or intensity (use existing grading scales whenever possible), 
3) an assessment of the relationship of the event to the study (definitely, probably, 
possibly or not related), and 4) action taken (e.g., none, referral to physician, start or 
increase concomitant medication). The PI will determine the severity of the event, will 
assign attribution to the event, and will monitor the event until its resolution. Any 
adverse events will be reported to the IRB in accordance with the local Human 
Research Protection Program’s Standards of Practice. All research projects conducted 
at the Durham VAHCS are required to have yearly IRB review. Reports of non-serious 
AEs are required as part of these progress reports. Additionally, any changes to the 
project between review periods must be application by the IRB prior to fielding. 
 
Withdrawal of Participants 
The PI may withdraw participants due to inability, or unwillingness, to complete study 
procedures or attend appointments. 
 
COVID-19 Temporary Study Procedures 
The informed consent process will occur over the phone or via an approved telehealth 
platform. Potential participants will be mailed the consent and HIPAA authorization, and 
a study staff member will call them to discuss the consent and HIPAA. Participants will 
be asked to return the signed consents by mail/UPS.  
 
Study visits will be completed via an approved telehealth platform, with phone as a 
back-up measure. If the study staff member has access to Audacity via 
CAG,he/she/they will record the interviews (think-aloud and post-treatment qualitative 

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interview) directly to the VA secured server (in lieu of videorecording with an external 
device). If telehealth visits are done using VA’s instance of WebEx, audiorecordings will 
be done to the VA WebEx cloud and moved as soon as possible to the VA secured 
server. Questionnaires will be completed orally, by mail, and/or via MyHealthyVet.  
 
We would like to ask participants to complete measures related to stress, trauma, and 
coping strategies during the pandemic. New participants will complete these measures 
at their first visit, and ongoing participants will complete them at their next study visit. 
We are adding the CAIR Pandemic Impact Questionnaire (Lang, 2020; 
https://www.nlm.nih.gov/dr2/CAIR-PIQ_scoring.pdf), and another measure, COVID 
Core Questions, with variables of interest. If a participant endorses any item marked 
with an asterisk on the COVID Core Questions measure, we will ask them to complete a 
PTSD Checklist 5 related to that specific event. Because these are temporary measures 
to be used only during the COVID-19 pandemic, we have not added them to the 
consent form. Instead, participants will be informed verbally re: the measures, and will 
be told that they can refuse to answer them. 
 
Safety Concerns. Study therapists will be informed that prior to beginning interviews 
participants will need to identify an emergency contact for the participant to be used 
only in true emergencies (e.g., medical crisis, high risk suicidal ideation). If any 
participant expresses suicidal or homicidal ideation (SI and HI, respectively), study staff 
will respond using a standard of practice that has been used successfully in our lab’s 
past telehealth-based trials. The study staff member responsible for the call will be 
instructed to gather more information from the participant, including information about 
plan, means, intent, intended victim (in the case of HI) and history of suicidal and 
homicidal behavior. Any participant who expressed SI will be provided with the suicide 
hotline number. The participant will be informed that the PI may contact him/her to talk 
more about his/her SI or HI. The study coordinator will obtain current contact 
information for the participant and inform the PI, who will contact the participant as 
necessary to ensure participant safety. In cases of imminent homicidality or suicidality, 
which are not anticipated, we will seek guidance from the Psychiatric Emergency Clinic 
on best strategies for follow-up, which could include, but is not limited to, self-
presentation at the VA’s emergency room with the help of an emergency contact, calling 
911, or calling local police for a wellness check.  
 
Study Communication. For any participant who indicates that they are willing to 
receive study communications via email, we will use Azure to send secure 
communications to them re: appointment scheduling, missed appointments, etc. 
Content from the study’s IRB-approved letters will be included in the emails. 
Data Analysis and Statistical Considerations 
Rapid turn-around analysis of the qualitative interviews will be conducted according to 
methods described by Hamilton.23 Participant impressions of the MIST app, feedback 
on the content of the scenarios, usability of the app, perceived strengths and 
weaknesses, and suggestions for improvement will be compiled and used to make 
modifications to the app content and design. 

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Recognizing that it is inappropriate to examine efficacy in a small pilot trial, we will focus 
on feasibility and acceptability objectives.24 As appropriate for this stage of treatment 
development and evaluation, analysis and interpretation will focus on describing the 
primary outcomes: acceptability of the intervention and feasibility of the trial approach. 
Additionally, although we will not be able to statistically analyze changes in suicide 
cognitions and hostile interpretation bias, we will describe the changes including 
whether they were observed in the expected directions. 
 
Data will be analyzed using SAS. In the event that required SAS modules are not 
available at VINCI, deidentified data will be moved to Duke University Medical Center 
for analysis. Any data movement outside the protected VA environment will be 
accomplished using a VA-issued and owned FIPS-140-2 encrypted thumb drive loaned 
to a VA study staff member. Data will be stored at Duke on a protected server to which 
only Dr. Dillon and her study staff have access; data are encrypted at rest. 
 
Multilevel modeling (MLM) will be used to analyze the EMA data. MLM is a technique 
for analyzing repeated observations of data across multiple individuals. Unlike repeated-
measures ANOVA, MLM can incorporate time-varying and time-invariant predictors to 
model between-person differences in within-person relationships. MLM can also 
accommodate imbalanced data and unequal variances. To examine the association 
between app use on suicide risk and functioning (Aim 2), three models will be analyzed 
in which each of the continuous outcome variables recorded during EMA will be 
modeled via MLM during each of the 4-week intervention periods as a function of 
frequency of app use. 
 
Privacy, Confidentiality, and Information Security 
1. Lists of Data Reviewed and/or Collected for Screening/Recruitment and 
Conduction of Study:  
The Personal Health Information that will be obtained, used, and/or shared for this study 
includes:   
Identifier(s) 
Source(s) of Health Information 
 Names 
 Medical history & physical exam 
information 
 All geographic subdivisions smaller than 
a State, including street address, city, 
county, precinct, and zip code.  Describe: 
Participants’ addresses will be collected 
during the study in order to pay them for 
participation. 
 Photographs, videotapes, audiotapes, 
or digital or other images 
 All elements of dates (except year) for 
dates directly related to an individual, 
including birth date, admission date, 
discharge date, visit or treatment dates, etc.; 
and all ages over 89,  Describe: Date of 
participation will be collected. In addition, 
treatment records, laboratory results, etc. 
 Biologic specimens (e.g., blood, 
tissue, urine, saliva). Describe: 

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Identifier(s) 
Source(s) of Health Information 
will be collected. 
 Telephone numbers 
 Progress notes 
 Fax numbers 
 Diagnostic / Laboratory test results 
 Electronic mail addresses 
 Operative reports 
 Social Security Numbers 
 Imaging (x-ray, CT, MRI, etc.) 
 Medical record numbers 
 Discharge summaries 
 Health plan beneficiary numbers 
 Survey / Questionnaire responses 
 Account numbers 
 Billing records 
 Certificate and/or license numbers  
 HIV testing or infection records 
 Vehicle identifiers and serial numbers, 
including license plate numbers  
 Sickle cell anemia information 
 Device identifiers and serial numbers 
 Alcoholism or alcohol use information 
 Web Universal Resource Locators 
(URLs) 
 Drug abuse information 
 Internet Protocol (IP) address numbers 
 Mental health (not psychotherapy) 
notes 
 Biometric identifiers, including finger & 
voice prints 
 Psychological test results 
 Full-face photographic images and any 
comparable images 
 Genetic testing 
 Any other unique identifying number, 
linked study ID, characteristic, or code, 
describe:   
 Other, describe:        
 
2. Data and/or Specimen Acquisition:   
Data for this study will be collected through (check all that apply): 
  Prospective data and/or specimen collection obtained from participants.  Provide 
description of processes:  Data will be obtained through self-report questionnaires, 
semi-structured interviews, and app utilization.  
  Retrospective data collection and/or specimens obtained from medical chart 
review/data access.  Describe how data will be obtained (e.g., fileman, CDW, etc.):  In 
accordance with a Waiver or Alteration of HIPAA Authorization, names, addresses, 
telephone numbers, social security numbers, and diagnostic information of potential 
participants will be obtained from the VA’s Regional Data Warehouse. 
  Retrospective data collection and/or specimens obtained from an IRB-approved 
data and/or specimen repository.  Indicate the repository source including name, VA 
location, and IRB number:       . 
Note:  for data and/or specimens obtained from a VA approved data repository, a Data 
Use Agreement (DUA) must be executed prior to obtaining data and/or specimens.  See 
VHA Handbook 1200.12 for further information. 
 
3. Level of Data:   
The following level(s) of data will be acquired/maintained for this study (check all that 
apply): 
  Identified (e.g., names, addresses or other identifiers included)  

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  Coded (direct and/or all identifiers removed, but study code/ID included)  
  De-Identified (all HIPAA 18 and study ID/code removed): 
  Verified Statistically  
 
OR 
  Verified by Absence or Removal of HIPAA 18 and study ID  
  Limited Data Set 
  Other: Describe:        
 
4. Location of Data and/or Specimens, and Data Retention Plan:   
A. Data and/or Specimen Location: Data will be stored electronically in 
\\VHADURFPC02B\groups1\Nicotine Research\Study Information\Study 
Logbooks\Kirsten SPRINT and \\VHADURFPC02B\groups1\Nicotine Research\Study 
Information\Study Databases\Kirsten SPRINT. Data that will be stored electronically 
include name, address, phone number, social security number, amount of study 
payment earned, and date of visits (in Study Logbooks location). The study logbook will 
contain the key connecting PHI and the study identification number. Paper records of 
data include study consent form and HIPAA authorization (identified), questionnaire 
responses, and interview notes (coded). Audio recordings will be made using Audacity 
or WebEx. Any recordings made using WebEx will be transferred from the cloud to the 
“Study Logbooks” location listed above for long term storage, audio recordings may be 
moved to an encrypted DVD that is password-protected. Any encrypted DVDs will be 
stored in a locked filing cabinet in a locked office.  Transcriptions from the study 
interviews will be stored electronically at the Study Logbooks location listed above. Data 
will also be stored within VA Qualtrics, which is FedRAMP approved for collection and 
storage of PHI and sensitive information, and has an Authority to Operate (ATO) within 
VA. Data will be moved from Qualtrics \\VHADURFPC02B\groups1\Nicotine 
Research\Study Information\Study Databases\Kirsten SPRINT for permanent storage.  
  Data will be also be placed at the VA Informatics and Computing Interface (VINCI; 
http://vaww.vinci.med.va.gov/vincicentral/VINCIWorkspace.aspx). The VA Informatics 
and Computing Infrastructure is a partnership between the VA Office of Information 
Technology and the Veterans’ Health Administration Office of Research and 
Development.  Researchers and operations staff can use VINCI to access data and 
statistical analysis tools in a virtual working environment through a certified VHA 
network computer using the VA Intranet or Virtual Private Network (VPN).  
B. Data Retention Plan 
 Research records will be maintained and destroyed according to the National 
Archives and Records Administration, Records Schedule Number:  DAA-0015-2015-
0004.  Records destruction, when authorized, will be accomplished using the then 
current requirements for the secure disposal of paper and electronic records.  Currently, 
destruction of research records (see DAA-0015-2015-0004, section 7.6 “Research 
Investigator Files” for materials included in research records) is scheduled for 6 years 
after the cut-off (the cut-off is the completion of the research project) and may be 
retained longer if required by other federal agencies.  Records will not be destroyed 
without pre-notification to the facility records manager. 
  Other data retention plan, describe:        
 

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5. 
Data Access and Data Recipients:  Only members of our DVAMC research team 
will have access to identifiers and coded data. In order for data analysis to occur using 
SAS software, a de-identified dataset will be uploaded to VINCI for analysis. 
 
All VA research personnel who have access to VHA records are instructed, in 
accordance with VA policy, on the requirements of Federal privacy and information laws 
and regulations, VA regulations and policies, and VHA policy. All study personnel who 
are VA employees working within the VA system have fulfilled all required HIPAA and 
other VA security and privacy policy training requirements and have agreed to follow 
guidelines pertaining to the protection of patient data. All research staff sign VA Rules of 
Behavior, and all study staff are up-to-date with VHA Privacy Policy Training and the VA 
Office of Cyber and Information Security Awareness Training Course. The data security 
and privacy procedures summarized in that course include logging off or locking the 
computer when walking away from it; no sharing of access codes, verify codes or 
passwords; not allowing anyone else to use the computer under one’s password; and 
disposing of sensitive information using VA-approved methods (e.g., shredder bins). 
Access to study data will be removed for all study personnel when they are no longer 
part of the research team.  
 
Study visits will either be conducted at the main VA Hospital or at the MIRECC at 
Croasdaile, based on participant preference and space availability. Data that is 
transported between the main hospital and Croasdaile offices will be secured in a 
lockable briefcase. 
 
6. Data and/or Specimen Transportation and/or Transmission for all data and/or 
specimens involved in the study:   
I. 
  Data and/or specimens will not be transported or transmitted outside of 
Durham VAMC environment. 
II. 
  Data and/or specimens will be transported BETWEEN sites that are under 
the auspices of the Durham VA Medical Center.   
III. 
   Data and/or specimens will be transmitted to other VA sites using the 
following method(s): 
A. Data 
  Data are de-identified and thus will be sent via unencrypted e-mail or 
unencrypted disk (encryption is optional). 
  Data are coded or contain identifiers and thus will be sent  
  Other, describe:        
B. Specimens 
  Specimens are de-identified and thus will be sent via standard carrier 
(tracking is optional). 
  Specimens are coded or contain identifiers and thus will be sent via VA-
authorized carrier with tracking.   
  Other, describe:        
IV. 
  Data and/or specimens will be transported to non-VA/VHA sites (e.g., 
academic affiliates, laboratories, etc.) using the following method(s): 
A. Data 

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  Data are de-identified and thus will be sent via unencrypted e-mail or 
unencrypted CD. 
  Data are coded or contain identifiers and thus will be sent via <chose 
method of transfer such as FIPS 140-2 encrypted CD or FIPS 140-2 
encrypted hard drive/flash drive> using VA—approved carrier with tracking.   
  Data are coded or identified and will be uploaded to sponsor website 
using electronic case report form (eCRF) <insert information including 
sponsor name and URL and the encryption the site uses.> 
 Other, describe:       
B. Specimens 
  Specimens are de-identified and thus will be sent via standard carrier 
(tracking is optional) or will be hand-delivered by research study personnel.  
Specify method of delivery:        
  Specimens are coded and thus will be sent via VA-approved carrier with 
tracking or will be hand-delivered by research study personnel.  Specify 
method of delivery:        
In accordance with the HIPAA and the Privacy Act, for any coded or identifiable data or 
specimens released from the Durham VAMC (with the exception of Limited Data Sets), 
an Accounting of Disclosure (AOD) will be maintained (e.g., in a database or 
spreadsheet) that includes the participant’s name, date of the disclosure, description of 
the nature of the Individually Identifiable Information (III) disclosed, purpose of each 
disclosure, and the name and address of the person/agency to whom the disclosure 
was made. 
C.      
 Local DVAMC memorandum “Authorization to Use, Process, Store, or 
Transmit VA Sensitive Information Outside VA Owned or Managed Facilities” has 
been pre-filled out for each study team member who may transport the data 
and/or specimens off-site.  This (these) forms are included with the IRB 
materials.  
 
D. 
  Containers (e.g., briefcase, bin) are labeled with the following notice (label 
placed on the outside of container) in accordance with VHA Directive 6609: 
NOTICE!!! 
Access to these records is limited to: AUTHORIZED PERSONS ONLY. 
Information may not be disclosed from this file unless permitted by all applicable 
legal authorities, which may include the Privacy Act; 38 U.S.C. §§ 5701, 5705, 
7332; the Health Insurance Portability and Accountability Act; and regulations 
implementing those provisions, at 38 C.F.R. §§ 1.460 – 1.599 and 45 C.F.R. 
Parts 160 and 164. Anyone who discloses information in violation of the above 
provisions may subject to civil and criminal penalties. 
 
7. Risk Mitigation Strategies:   
  Data are fully de-identified (stripped of HIPAA 18 and study ID/code) before being 
shared outside of Durham VAMC. 
  Specimens are fully de-identified (stripped of HIPAA 18 and study ID/code before 
being shared outside of Durham VAMC. 

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  Direct identifiers will be maintained separately from data and or specimens by using 
a code to “identify” subjects.  In a separate database (i.e., a “linking” or “cross-walk” 
database) this code will be linked to identifying subject information.   
  Other, specify:        
 
8. Suspected Loss of VA Information: 
Should any incident such as theft or loss of data, unauthorized access of sensitive data 
or non-compliance with security controls occur it will be immediately reported according 
to VA policy. All incidents regarding information security/privacy incidents will be 
reported to the ISO and PO within 1 hour of acknowledgement of issue and done so 
using the VHADUR Research Events Report e-mail group 
(VHADURResearchEventReport@va.gov). 
 
9. Reporting of Results:   
  Reporting of results, such as in scientific papers and presentations, will never 
identify individual subjects.  Data will be presented in aggregate and individual-level 
data will not be published. 
  Other results reporting plan, describe:       
 
10. Future Use of Data: 
  Data will be retained for future use.  This is described elsewhere in the protocol and 
is noted in the HIPAA authorization. 
 
  Future Use of data is optional (i.e., not required by the research subject). 
  Future Use of data is required for participation in the study. 
  No future use of data is currently planned. 
 
11. Use of Mail Merge Technology 
  Mail merge programs will be used to generate letters and/or address labels for 
mailings to potential or already enrolled research subjects. The study team is aware that 
to reduce risk of mail merge related privacy incidents, use of mail merge programs 
requires a 25% accuracy check to verify that (potential) research subject name and 
mailing address are properly “matched”.  If discrepancies are found, a 100% accuracy 
check is required before letters may be mailed.   
 
12. Use of Non-Standard Software 
 I do NOT intend to use any new specialized software (i.e. Software that’s not already 
approved OR installed) in this study. 
 
 I intend to use specialized software that has not already been installed and it has 
been approved for use by the VA Technical Reference Model (TRM) Group.  
(Note: All new software must be approved by TRM before it can be installed on VA 
systems.) 
 
 I intend to use previously installed software on my VA computer.  
 
13. Use of Cloud Computing Services 

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 Cloud computing services will NOT be used in this study. 
 
 Cloud computing services WILL be used in this study as described below and have 
been approved nationally by the VA Chief Information Officer (CIO).  (Note: ONLY cloud 
computing services that have been approved nationally may be used.) If telehealth 
study visits are performed using VA’s instance of WebEx, the visits may be audio-
recorded to the VA’s WebEx cloud, as has been previously approved by VA.  
 
 
 
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