Pilot Testing a Virtual Mindfulness-Based Intervention Aimed at Improving Reintegrating Veterans' Health Outcomes
Phase: NA
Conditions: Depression
Sponsor: VA Office of Research and Development

NCT ID: NCT05975008 
 
 
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Pilot Testing a Virtual Mindfulness-Based Intervention Aimed at Improving Reintegrating Veterans' Health 
Outcomes 
IRB #15934 
Principal Investigator 
Sarah Shue, PhD, Research Scientist, Center for Health Information and Communication, Roudebush VA Medical 
Center, Indianapolis, IN 
Co-investigators and study staff 
Annie Do, BA, Project Manager/Research Assistant, Center for Health Information and Communication, Roudebush VA 
Medical Center, Indianapolis, IN 
Marianne Matthias, PhD, Co-Investigator, Research Scientist, Center for Health Information and Communication, 
Roudebush VA Medical Center, Indianapolis, IN 
a) Research Scientist, Regenstrief Institute, Indianapolis, IN 
b) Indiana University School of Medicine 
Matthew Bair, MD, Co-Investigator, Research Scientist, Center for Health Information and Communication, Roudebush 
VA Medical Center, Indianapolis, IN 
a) Research Scientist, Regenstrief Institute, Indianapolis, IN 
b) Indiana University School of Medicine 
Jayme Brosmer, DPT, Consultant, Physical Therapist, Roudebush VA Medical Center, Indianapolis, IN 
Stanley Taylor, Data Manager, Center for Health Information and Communication, Roudebush VA Medical Center, 
Indianapolis, IN 
Stephanie Dickinson, Biostatistician/VA WOC appointment, Center for Health Information and Communication, 
Roudebush VA Medical Center, Indianapolis, IN 
a) Executive Director, Biostatistics Consulting Center, Department of Epidemiology & Biostatistics, School of 
Public Health, Indiana University, Bloomington, IN 
 
Lilian Golzarri Arroyo, Biostatistician/VA WOC appointment (pending), Center for Health Information and 
Communication, Roudebush VA Medical Center, Indianapolis, IN  
a) Biostatistician, Biostatistics Consulting Center, Department of Epidemiology & Biostatistics, School of 
Public Health, Indiana University, Bloomington, IN 
 
Funding 
VA HSR&D Merit Review Award Pilot Project Program (I21), Office of Research & Development (ORD) 
VA only / Non-Collaborative Research:  
This project is not collaborative with another entity/institution/outside investigator. VA is the only institution, and all 
PIs/personnel are affiliated with and appointed by the VA. This is an RLR Indy VA Veteran participant only (identified 
via VA CDW), single VA personnel only, and VA HSRD salary supported study utilizing VA approved technology 
systems for/such as: VA encrypted Azure email, VA audio visual platform, VA approved recording devices, VA medical 
record access, with VA data collection tools and data analysis tools within the VA network and stored only on the VA 
network. All visits occur virtually. 
1.0 
Background 
Community reintegration is a critical period of transition for post-9/11 Veterans that is rife with challenges.1-3 Separating 
from military service and reintegrating into civilian life is often characterized by a range of psychosocial stressors and 
adjustment difficulties, such as social isolation and challenges establishing a new personal identity.4,5 Reintegration 

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becomes further complicated if the Veteran is returning to civilian life with a service-related condition.1,6 Of particular 
concern is depression, which is one of the most costly and common mental health diagnoses among the post-9/11 Veteran 
cohort.7,8 Prior research has demonstrated that depression is strongly associated with poor psychosocial outcomes and 
reintegration challenges among Veterans.6,8 Successful community reintegration requires programming that effectively 
promotes and addresses post-9/11 Veterans' mental health needs, particularly depression.2 
2.0 
Rationale and Specific Aims 
If not properly addressed, Veterans' reintegration challenges can place a tremendous burden on Veterans, their families, 
communities, and healthcare systems.9-11 Despite the well-documented needs of post-9/11 Veterans and numerous 
resources, Veterans continue to report inadequate support for the transition from military to civilian life.4,10,12-16 Moreover, 
many Veterans do not use available services.17,18 As such, reintegration services must address Veterans' mental health care 
needs using approaches that increase the likelihood of Veteran engagement. Mindfulness-based reintegration services are 
a promising approach for reducing post-9/11 Veterans' symptoms of depression and are supported by previous research 
that demonstrates (1) beneficial effects of mindfulness meditation in reducing depression;19-22 (2) the potential of 
mindfulness to mitigate self-stigma, which is a key barrier to seeking mental health care among Veterans;18,23 and (3) 
Veterans' interest in the use of mindfulness to help manage depression.24-26 The appeal of mindfulness-based reintegration 
services may be further enhanced by virtual delivery.24 
The overarching goal of the proposed project is to use mindfulness practices to reduce depression and improve 
community reintegration among post-9/11 Veterans. This proposal focuses on the REconnecting to Civilian Life using 
Activities that Improve Mindfulness (RECLAIM) intervention. RECLAIM is a virtual multi-component, mindfulness-
based intervention developed by our study team in collaboration with VA clinicians, post-9/11 Veterans, and stakeholders 
and guided by the VA Whole Health framework.27,28 The proposed project builds on preliminary pilot work and a Small 
Award Initiative for Impact (SWIFT) pilot project funded by our VA HSR&D Center of Innovation. In the SWIFT pilot, 
we refined the RECLAIM content and tested the feasibility of virtual delivery with a small sample (N=18) using a single 
arm pre/post-test design. The proposed pilot project builds on preliminary work by (1) testing the refined intervention in a 
randomized controlled design to assess feasibility of recruitment for a randomized trial, (2) randomization, (3) retention in 
both study arms, and (4) intervention acceptability. Findings from the proposed project will support a HSR&D 
Investigator Initiated Research Merit award application that will assess the effectiveness of RECLAIM while 
simultaneously planning for implementation in a Hybrid Type I trial.29 The following are the specific aims for this pilot 
project. 
Aim 1: Conduct a randomized controlled pilot study to assess feasibility of the RECLAIM intervention. We 
will conduct a two-arm randomized pilot study. Veterans (N=48) will be randomized to either the intervention arm (i.e., 
virtually delivered RECLAIM) or a control arm (i.e., psychoeducation materials). We will assess intervention feasibility, 
including recruitment, randomization, administration and completion of outcome assessments, treatment engagement, and 
retention in both the intervention and control study arms. 
Aim 2: Conduct qualitative interviews to assess acceptability of RECLAIM. A purposefully sampled subgroup 
(i.e., based on attendance) of RECLAIM participants (i.e., Veterans from the intervention arm; N=16) will engage in a 
qualitative interview to explore experiences in RECLAIM, including perceived strengths and suggestions for future 
improvements. 
Aim 3: Refine and finalize the RECLAIM intervention. As findings emerge from the Aim 1 pilot test and Aim 2 
interviews with Veteran participants, we will iteratively update the RECLAIM protocol manual and testing procedures 
(i.e., randomization, control group materials). We will consult with the Patient Advisory Council of the Indianapolis 
VAMC to gather Veteran feedback on the revised RECLAIM protocol manual, as well as partners (e.g., Patient Centered 
Care and Cultural Transformation). These actions will help refine the study methods, design, and intervention in 
anticipation of a larger trial. 
3.0 
Study Plan, Experimental Design, and Methodology 
Aim 1: We will conduct a two-arm randomized controlled pilot study to assess feasibility of (1) recruitment using VA 
electronic medical record data (in contrast to primarily networking and word of mouth in our preliminary pilot study), (2) 
the randomization strategy, (3) retention in both study arms, (4) participant engagement in the intervention, and (5) 
outcome assessment administration (e.g., time to complete, proportion completed, attrition). 

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Aim 2: We will conduct qualitative interviews with Aim 1 pilot study participants who were randomized to the 
RECLAIM arm. We will use principles of rapid analysis to analyze the qualitative data.30,31  
Aim 3: Consistent with the intervention mapping approach32 used to design RECLAIM, as findings emerge from this 
project - the Aim 1 pilot test and Aim 2 interviews with Veteran participants - we will iteratively update RECLAIM 
content in the protocol manual. Intervention protocol manuals are necessary to facilitate rigorous and systematic 
evaluation of interventions and are useful for translating effective intervention strategies across settings.33 We will also 
refine the procedures for testing the RECLAIM intervention (e.g., recruitment strategies, control group materials). 
4.0 
Inclusion/Exclusion Criteria 
To be eligible for this study, Veterans must be between the ages of 18 and 44. Majority of post-9/11 Veterans fall into this 
age range, as do the highest rates of depression in this Veteran cohort.34,35 Veterans must have also served (a) active duty 
and/or (b) in the National Guard/Reserves after October 2001. Potential participants can still be in the National Guard or a 
Reservist. Veterans must be enrolled in VHA care. Veterans must also endorse at least a mild level of depression. We will 
use the Patient Health Questionnaire (PHQ-9)36 to assess the presence and severity of depressive symptoms among 
potential Veteran participants. Mild depression is defined as a score of at least 5 on the PHQ-9. Finally, Veterans must 
also endorse at least a little difficulty adjusting to civilian life to be eligible for participation. Difficulty adjusting to 
civilian life will be assessed using the Military to Civilian Questionnaire (M2C-Q).37 For this study, "a little" difficulty 
will be defined as a mean M2C-Q score of 1 (i.e., a 1 indicates "a little difficulty" on the M2C-Q).  
Mental health screening: As previously mentioned, we will use the Patient Health Questionnaire36 (PHQ-9) to 
screen participants for depressive symptoms. Veterans who present with a score of 20 or greater (i.e., severe depression) 
or endorse the 9th item (i.e., suicidal ideation) on the PHQ-9 will then complete the Columbia Suicide Severity Rating 
Scale (C-SSRS)39 to determine if the Veteran is currently experiencing suicidal ideation and needs further evaluation by a 
VA provider. Veterans will not be immediately excluded from participation in the study; the study team will consult with 
the Roudebush Suicide Prevention Team and/or the Veterans' care provider to determine whether continued study 
participation is appropriate. If a Veteran is experiencing active suicidal ideation, the following steps, aligned with the 
Indianapolis VAMC policy (116-05), will be taken: Veterans who are experiencing active suicidal ideation will be 
immediately connected to the Veterans Crisis Line. If the warm transfer to the Veterans Crisis Line fails, the study team 
member will attempt to call the Veteran back immediately. If the Veteran cannot be located, then the study team member 
will call the Veterans Crisis Line to provide them with the Veteran’s information and receive guidance on next steps. If 
the Veterans Crisis Line decides not to pursue follow up to locate a Veteran caller, the study team member will then 
contact the local suicide prevention team (i.e., the team located at the facility that the patient is receiving healthcare 
services). In either of these scenarios, the Suicide Prevention Team will initiate suicide risk management protocol, 
documentation, and follow up plans. The complete protocol for screening and referring Veterans needing additional care 
was developed in collaboration with the Roudebush Suicide Prevention Team). Screening measures will be collected prior 
to the baseline assessment and collected during each outcome assessment. 
5.0 
Recruitment/Enrollment/Randomization 
Under an IRB approved HIPAA Authorization Waiver for recruitment, we will request a list of Veterans and their contact 
information based on the study inclusion criteria (e.g., age and service area) via CDW. Eligibility criteria included in this 
CDW request will also seek a depression diagnosis, but participation is not solely contingent upon any health conditions 
(i.e., potential participants may still present mild depression symptoms without a formal depression diagnosis). The 
research assistant will mail a recruitment brochure and letter to eligible Veterans. Study staff will then contact these 
eligible Veteran participants (who were initially contacted by mail) by phone and/or email to recruit them for the study. 
Veterans who enroll will be emailed using VA compliant methods (VA Azure encrypted email). Word-of-mouth and 
snowballing techniques will also be used to identify eligible Veteran participants.  
Other methods of study referral: Preliminary work for the RECLAIM intervention established a network of VA staff and 
providers and VA stakeholders (e.g., Tricia Parker, M2VA Case Management program) who are willing to refer Veterans 
to the study. During recruitment, to ensure the representation of minoritized and women Veterans, we will contact the 
Minority Veterans Program and the Women's Clinic to discuss the proposed project and ask for staff and clinician 
assistance for study referral. Finally, participants will be recruited through word-of-mouth and snowballing techniques. 

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Recruitment and retention strategies: Based on findings in our preliminary studies,27 the following strategies will be used 
to maximize recruitment and retention: (1) Use recruitment and program materials with clear and transparent messaging 
(based on preliminary findings from Veterans to avoid vague language); (2) Gather multiple forms of contact information; 
(3) Establish Veterans' preferred contact method (email or phone) and contact time preferences (e.g., morning or evening); 
(4) Offer incentives for outcome assessments and interviews; (5) Send recap emails following sessions that contain 
overviews of session topics and discussion, and a reminder for the upcoming session; (6) Reminder call day of RECLAIM 
session. 
If target recruitment numbers are not being met, we will (1) consult with our operational and clinical partners (e.g., 
Office of Mental Health and Suicide Prevention; Tricia Parker, Military2VA Case Management program) for suggestions 
on identifying potential participants; (2) call and send letters to VA staff and providers and community-based Veteran 
service organizations to explain the study and ask for referrals; (3) present information about the study and preliminary 
findings to VA staff and providers and local organizations; (4) follow up with VA staff and providers and organizations 
who referred Veterans to the study to capitalize on good sources of referrals; and (5) use VA-approved social media to 
recruit Veterans. 
6.0 
Study Procedures 
Aim 1 Procedures 
Veterans who consent to participate in the pilot study will complete the eligibility screening over the phone or using VA-
approved teleconferencing software. Eligible Veterans must (1) be between the ages of 18 and 44, (2) have served active 
duty and/or in the National Guard/Reserves after October 2001, (3) endorse a mild level of depression (i.e., at least a score 
of 10 on the PHQ-9, and (4) at least some difficulty with their community reintegration (i.e., a mean M2C-Q score of 2). 
Veterans will receive a copy of the consent form, which will include information such as potential risk and benefits and 
contact information if issues should arise. A request to VA ORD (Office Research Development) will be made and ORD 
permission provided, under VA’s contracted use of DocuSign, to allow participants to sign the HIPAA Authorization 
electronically with DocuSign envelopes. Eligible Veterans will also complete baseline outcome assessments. These 
assessments will be completed again at the 2-month follow-up. Randomization: After completing the informed consent 
and baseline assessments, Veteran participants will be randomized to one of two study arms: (1) virtually delivered 
RECLAIM arm, or (2) the control arm. Randomization will occur using the block randomization method, which balances 
the number of participants in each study group across time. 
Intervention arm: Veterans randomized to the intervention arm (n=24) will participate in the 8-week RECLAIM 
intervention after 12 Veterans (i.e., a cohort) have been randomized. Delivery of RECLAIM: The RECLAIM intervention 
is comprised of (1) four 60-minute sessions that are delivered bi-weekly in a virtual group setting and (2) four bi-weekly 
coaching calls. Participants will also be offered an introductory session (i.e., Session 0) that will serve as a technical 
assistance session to ensure that participants can access Microsoft Teams and to try and mitigate connection challenges 
prior to the start of the intervention. The bi-weekly coaching calls will happen in the weeks between the virtual 
intervention sessions. Delivery of the bi-weekly intervention virtual sessions will be led by Dr. Jayme Brosmer, who is a 
study consultant and an expert in mindfulness (e.g., certified as a Mindfulness Based Meditation for Pain Relief 
practitioner) and co-facilitated by Dr. Shue. Each RECLAIM session is structured with the following components to 
achieve this purpose: (1) an overview and discussion of the weekly topic, which is a domain of community reintegration; 
(2) a brief mindfulness practice (approximately 10 minutes); (3) reflection and discussion of the topic and mindfulness 
practice; (4) journal prompt and brief discussion; and (5) a discussion of ways to effectively engage in independent 
mindfulness practice(s). RECLAIM participants will be invited, but not required, to participate in optional check-in 
sessions which will occur between the regularly scheduled weekly RECLAIM sessions. The bi-weekly coaching calls will 
be conducted by the project manager (Annie Do) or Dr. Shue.  
Control arm: The inclusion of a control group in the proposed pilot project will allow us to test aspects of and 
procedures for the control group in preparation for the larger scale study.40 We will also assess feedback from the control 
arm participants to determine whether our approach is feasible for inclusion in a future fully powered randomized 
controlled trial (RCT). We will use an attention control group design. Participants in the control arm will not receive the 
RECLAIM intervention but will receive some similar RECLAIM activities. They will not be the same in intensity, time, 
and/or contacts as the intervention activities.41 We will provide Veterans randomized to the control arm with 
psychoeducational materials (i.e., a list of suggested readings) that will also be received by the intervention arm. Control 

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arm participants will receive the psychoeducational materials in the same week that the intervention arm is scheduled to 
begin RECLAIM. Psychoeducational materials will be sent to the intervention and control arm using unencrypted email. 
Use of unencrypted emails for sending these materials has been approved by the Roudebush VAMC Privacy Office (see 
PO Request document). 
Aim 2 Procedures:  
A subset of participants from the intervention arm of the Aim 1 pilot study (n=16) will be invited to complete a single, 
individual qualitative semi-structured program experience and impact interview. Selection: Participants will be 
purposively sampled to take part in a qualitative interview based on their RECLAIM participation (i.e., participants who 
attended the most and fewest sessions). In each of the four cohorts, we will invite four participants to participate in a 
qualitative interview. This will provide a sample size of 16 interview participants. This sample size is consistent with 
published recommendations and our own experience to achieve saturation (i.e., when additional data do not provide new 
insights).42-45  
Aim 3 Procedures: 
At the conclusion of each study pilot cohort, the project team will review and refine the protocol manual. As we complete 
these iterative refinements, we will consult with the Patient Advisory Council of the Indianapolis VAMC (see letter of 
support) to gather Veteran feedback on the revised RECLAIM protocol manual. In addition, we will consult with partners 
from the VA Office of Patient Centered Care and Cultural Transformation and the Indianapolis Military 2VA Case 
Management Team (see letters of support). Refining the methods, design, and RECLAIM intervention will prepare us to 
submit a fully powered Hybrid Type I randomized controlled trial (RCT),29 which we plan to submit as a HSR&D 
Investigator Initiated Research (IIR) Merit grant application. 
7.0 
Data Collection & Storage 
Aim 1 Data Collection: 
Data will be collected to assess feasibility of screening, recruitment, randomization, and retention. We will also assess 
intervention engagement, treatment fidelity, and administration and completion of the outcome measures. These are 
described in greater detail below. 
Intervention engagement: We will measure three indicators of participants' engagement with the intervention: (1) 
attendance at RECLAIM sessions; (2) attendance at optional check-in sessions; and (3) amount of independent/at-home 
practice. To assess independent/at-home practice, all participants randomized to the RECLAIM intervention arm will be 
provided an electronic mindfulness practice log sheet at the start of the study to track their engagement. Specifically, 
between RECLAIM sessions, participants will be asked to record how many days in the past week and approximately how 
many minutes per day they practiced mindfulness. They will also be asked to document any successes or difficulties that 
occurred. Practice log sheets will also ask participants to indicate how often they access the VA-approved cloud-based file 
storage application (e.g., Box) to use intervention materials (e.g., scripts, recordings). [Note: The VA-approved cloud-
based file storage application will allow participants do access and download materials. The application will not allow 
participants to revise materials, upload their own materials, or provide any personal information (i.e., this application will 
not be used for data collection).] The practice log sheet can be completed electronically, or participants can print their log 
sheets to be completed manually. Participants can submit their practice logs to a member of the study staff via email. 
Additionally, at the beginning of each RECLAIM session, we will provide an electronic survey within the 
teleconferencing software that will match the questions/prompts on the participants' practice logs. This will provide 
participants another opportunity to submit their mindfulness practice information if they have not done so by email. 
Practice feedback: At the start of each weekly session, we will engage in a discussion about participants' independent 
practice (e.g., successes and challenges) and engage in discussion on strategies to maximize facilitators and overcome 
barriers. We will do weekly reminder calls to make sure participants are completing their logs and this will be another 
opportunity to provide any additional information or feedback to assist participants' independent mindfulness practice. 
Treatment fidelity: Intervention fidelity has been defined as the degree to which an intervention was delivered as 
conceived and planned.46-50 Fidelity of the RECLAIM intervention will be evaluated by the Principal Investigator (PI), Dr. 
Shue, who will be co-facilitating the RECLAIM sessions, and the Project Manager, who will observe the eight RECLAIM 
sessions across all four cohorts. Fidelity will be assessed using a checklist, which will be iteratively refined throughout the 
Aim 1 pilot. The checklist will capture intervention content elements (e.g., presentation of reintegration challenges, 

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mindfulness practices), as well as unplanned components (e.g., discussion questions and participant responses). The 
fidelity checklist for RECLAIM will facilitate the larger prepare for the planned Hybrid Type I trial,111 which will assess 
the effectiveness of RECLAIM while simultaneously planning for implementation. 
Administration of outcome measures: Part of our feasibility assessment will be to determine the acceptability of 
measures administered, time for outcome measure completion, number of items missing, and follow-up rates. We will 
administer assessments after a Veteran has consented to study participation to measure (1) depression, (2) general 
difficulty adjusting to civilian life, (3) anxiety, (4) quality of life, (5) mindfulness, and (6) pain. Participants will complete 
outcome assessments at two timepoints: baseline and 2-month follow-up. Participants will receive a $25 gift card for each 
outcome assessment they complete, for a possible total of $50. 
1. Depression severity: The Patient Health Questionnaire (PHQ-9) is a reliable and valid 9-item measure of 
depression severity used to screen, diagnose, monitor, and measure the severity of depression.36 It is one of the 
most widely used, reliable, and validated measures of depressive symptoms.36 
2. General difficulty adjusting to civilian life: The Military to Civilian Questionnaire (M2C-Q) is an empirically 
validated self-report scale that measures general difficulty in readjusting to civilian life by assessing important 
indicators of reintegration challenges over the past 30 days including social/health behaviors, specifically 
interpersonal relationships; productivity at school, work, or home; community participation; self-care; leisure; and 
perceived meaning in life.37 Research supports the construct and factor validity of scale scores and indicates high 
internal consistency (Cronbach’s alpha = .92).37 
3. Anxiety: The Generalized Anxiety Disorder Scale (GAD-7) is a brief 7-item measure for assessing generalized 
anxiety disorder.51 The GAD-7 uses some of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) 
diagnostic criteria to assess generalized anxiety disorder. Scores classify respondents as having minimal, mild, 
moderate, or severe anxiety. The GAD-7 has good reliability and validity.51 
4. Quality of life: The Veterans RAND Health Survey (VR-12) is a brief, self-administered health survey primarily 
used to measure health related quality of life.52-54 The VR-12 is one of the most widely used functional status 
measures and has been shown to be highly reliable and valid.52 
5. Mindfulness: The Five Facet Mindfulness Questionnaire (FFMQ) is a 15-item scale to measure five factors of 
mindfulness: (1) Observing; (2) Describing; (3) Acting with awareness; (4) Non-judging of inner experience; and 
(5) Non-reactivity to inner experience.55 The FFMQ has strong psychometric properties, including good reliability 
for all facets (i.e., aspects) of mindfulness.37,56,57 
6. Pain: The PEG (pain intensity, interference with enjoyment of life, interference with general activity) is an ultra-
brief measure that contains 3 items to assess pain levels on average, pain interference with enjoyment of life, and 
pain interference with general activity.58 The PEG demonstrates strong reliability and validity. 
Aim 2 Data Collection: 
Interviews will take place using VA-approved teleconferencing software or over the phone. The Project Manager will 
conduct the interviews with pilot study participants. Purpose: Interviews will explore participants' experiences in the 
RECLAIM intervention. Interviews will also explore participants' perceived strengths of the intervention, suggestions for 
future improvements, and barriers and facilitators that impacted participation in RECLAIM. Interviews will take 
approximately 60 minutes to complete. Participants who engage in an interview will receive a $50 gift card. 
Aim 3 Data Collection: 
No new data collection will occur in Aim 3. We will use data from Aims 1 & 2 to inform RECLAIM revisions. 
8.0 
Data Analysis/Statistical Considerations 
Aim 1 analyses. The feasibility assessments in Aim 1 will be determined by using raw count numbers and percentages. 
Descriptive statistics will be calculated for all baseline demographic data. Frequencies and percentages will be reported 
for categorical variables; means, standard deviations, medians, minimums, and maximums will be reported for continuous 
variables. We will explore the data collected from the outcome assessments (for feasibility purposes) to examine any 
trends on the outcomes of interest that could be informative for future trials. Study groups will be compared on baseline 
characteristics using standardized difference tests to understand their initial comparability.59 
Aim 2 Qualitative analysis. Interview data will be analyzed using the principles of rapid qualitative inquiry (RQI), which 
is an "intensive, team-based qualitative inquiry using triangulation, iterative data analysis, and additional data to quickly 

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develop a preliminary understanding of a situation from the insider's perspective."30 As outlined by Hamilton31 we will 
conduct the following steps to rapidly analyze the qualitative data: (1) create a neutral domain that corresponds with each 
interview question; (2) create a summary template to capture the interview and observation data; (3) pilot test the template 
(i.e., assess usability, relevance) among a set of transcripts; (4) divide transcripts among the qualitative analysis team 
(Drs. Shue and Matthias, and the Project Manager, Ms. Do), who will code using the summary template; and (5) use a 
matrix to display summary points. This rapid assessment process will allow for a quick understanding of the major 
findings from the qualitative data in Aim 2 and will facilitate iterative refinement to the RECLAIM manual to be 
completed during the proposed project. 
9.0 
Reporting of Adverse Events or Unanticipated Problems Involving Risk to Participants or Others 
Due to the nature of this study, there are no anticipated adverse events. However, local IRB guidelines for reporting 
adverse events will be followed.  
• The PI will determine if an event is an adverse event (AE) or a serious adverse event (SAE) by assessing if it is 
1) unexpected, 2) related or possibility related to study participation, AND 3) suggests that the research places 
subjects or others at a greater risk of harm than was previously known. Serious adverse events must be determined 
by the PI as both unanticipated and related to the research study.  
• Upon becoming aware of a serious adverse event, which was both unanticipated and related to the research, the 
study team will immediately (within 24 hours) notify the IRB via verbal notification. A written notice to the IRB 
will be submitted within 5 business days following the event.  
• Data collection on AEs and SAEs will begin at the time participants have been provided the Study Information 
Sheet and will be kept on a tracking log by the program manager.  
Additionally, this study will adhere to VA and university regulations in conducting studies with human subjects. Adverse 
psychosocial reactions by participants and risks to confidentiality and data security (detailed in section 12.0 below) will be 
minimized through: informing potential participants in advance of the nature of the project, the nature of the questions to 
be asked, and the individual's right to decline to answer any or all questions; providing full and proper training to research 
staff; never sharing research findings about one participant with another participant; keeping paper documents in locked 
cabinets in locked offices; and ensuring that compensation is non-coercive. 
If there is a suspected or confirmed loss of information, the PI will ensure that the event is reported to the IRB according 
to IRB policy and to the VA Privacy Officer. 
10.0 
Study Withdrawal/Discontinuation 
Participants will receive a copy of the Study Information Sheet form for their records and they will be reminded that 
participation is strictly voluntary and that they may withdraw at any time. Additionally, if at any time participants wish to 
skip a question or discontinue their participation study altogether, they will be permitted to do so. 
11.0 
Study Risks 
There are no anticipated physical, social, or legal risks to participants in this study. Loss of confidentiality is a risk with 
protection measures described below. 
12.0 
Protection against Risks 
The researcher will be responsible for the implementation of any and all reasonable steps to minimize disclosure of 
identifiable patient information. A study specific VA Information Security Officer (ISO) checklist has been provided to 
the VA information security officer and a VA Privacy Checklist form 10-250 provided to the VA privacy officer for 
review as requested by the local VA Research Administration office.  
The following policies will be enforced to ensure that subject privacy and confidentiality is protected: 
• 
All staff will be required to complete formal training regarding patient privacy and confidentiality of clinical 
information. Provisions for disciplinary action (including termination of employment) in case of unauthorized 
disclosure are included as policy and are covered in the formal training process. 

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• 
Access to identifiable information will be limited to people who require such access to perform the stated 
research. Any patient data held by research staff (whether identifiable or not) will be held in strictest confidence, 
with the need for confidentiality taking precedence over considerations of economy or convenience. Research 
staff will use, disclose, or request protected health information to the minimum amount necessary required to 
perform their specific job function and to accomplish the intended research purpose. 
• 
The research team will participate in annual security awareness training which identifies the information security 
risks associated with their activities and their responsibilities in complying with policies and procedures designed 
to reduce those risks. 
13.0 
Privacy/Confidentiality 
The study data will reside with the VA firewall to ensure appropriate protection. Primary data will be collected via 
outcome measures and interviews, which will be entered into and stored electronically in VA REDCap and within the 
secured research folder. Qualitative transcripts (i.e., interview data) will be uploaded into VA-approved computer assisted 
qualitative software for organization and analysis. All other computerized files will be protected by the electronic firewall 
at the Indianapolis VAMC, will be kept in locked areas accessible only by authorized persons (i.e. locked offices/filing 
cabinets), and will be password protected. All data will only be accessible to the PI and research staff. Procedures will be 
put in place which successfully minimize this risk:  
• All stored electronic data will be de-identified and placed behind the VA firewall.   
• All study assessments will be conducted in private locations.  
• All audio video recordings will be conducted and saved in a secure study folder on a password-protected secure 
server.  
• Participants’ names will not appear on any of the data collected, including audio recordings. All participants’ 
responses will be matched with a code number only. The key to this code number will be stored in a password 
protected computer file, separate from other data, locked behind closed office doors accessed by the research team 
for this study only. 
14.0 
VA Record Retention 
This study will last for approximately 18 months. Data collected throughout the duration of the study will be 
stored on a password-protected secure server. Research records will be maintained per the VA Records Retention 
Policy and will be maintained by the investigator for 6 (six) years following the federal fiscal year end 
(September 30) after the study has been closed by the VA in accordance with the VHA Records Control Schedule 
or longer if required by other Federal regulations. 
 
 

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