Mission Reconnect: Delivering a Mobile and Web Based Self Directed Complementary and Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD
Phase: NA
Conditions: PTSD, Chronic Musculoskeletal Pain
Sponsor: VA Office of Research and Development

PI: Jolie Haun, PhD EdS 
IRB Study Protocol #: Pro-000035440 
NCT #: 03593772 
Funding Source: Rehabilitation Research and Development Service RX002775 
 
Study Title: 
Mission Reconnect: Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD  
 
Combined documents include: 
• 
Protocol V18_06.13.2023 
• 
Verbal Consent for Veteran V10_01.11.2021 
• 
Verbal Consent for Partner V10_01.11.2021 
• 
Social Consent for Veteran V9_01.11.2021 
• 
Social Consent for Partner V9_01.11.2021 
 
 

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RESEARCH PROTOCOL 
 
Protocol Title: 
"Mission Reconnect: Delivering a Mobile and Web Based Self Directed Complementary 
and Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD" 
PI:Jolie Haun, PhD EdS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ABSTRACT 
 
 
OBJECTIVES: The VA Secretary of Health Strategic Priorities and the emerging VA Whole 
Health Program identify access to complementary and integrative health (CIH) for pain and 
self-care management as a priority to achieve optimal Veteran health. To be responsive to 
these priorities the 2016 VA State-of-the-Art Conference (SOTA) and Comprehensive Addiction 
Recovery Act (CARA) mandated VA’s commitment to conduct rigorous research to integrate 
non-pharmacological and CIH approaches into care, with emphasis on pain management. This 
proposal is also responsive to the VA’s Opioid Safety Initiative (OSI) and Pain Care Mission 
which prioritize the need for nonpharmacological treatment options for pain.  
This project is specifically responsive to RR&D’s current special areas of interest for non-
pharmacological activity-based interventions for chronic pain impacting pain reduction, 
function and quality of life. This project aligns with the VA mandate for complementary and 
integrative health (CIH) care for Veterans and their families. CIH complements traditional care 
for Veterans managing chronic conditions, such as chronic pain and PTSD. Mission Reconnect 
(MR) is a user-driven, dyadic, CIH self-care management program delivered remotely that 
teaches techniques that Veteran/partner dyads can use to reduce pain, anxiety and stress, 
promote well-being and improve relationship quality. The research goal is to evaluate MR as an 
approach to manage chronic pain and PTSD symptoms, for potential subsequent 
implementation. The short-term goal of this study is to determine the effects of MR on (1) 
chronic pain, PTSD and related outcomes and (2) relationship outcomes for Veterans and their 
partners. The long-term goal is to determine the effectiveness and sustainability of using CIH 
self-care management programs like MR to improve outcomes for Veterans with chronic pain 
and PTSD, and their partners. This study will possibly provide a model for establishing remote 
access and sustainable implementation of CIH within VA. 

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RESEARCH DESIGN: This study is a four-year mixed-methods randomized controlled trial of 
MR with two arms (treatment intervention arm & wait-list control arm) in a clinical sample of 
Veterans with comorbid pain and symptoms of PTSD, and their partners (e.g., spouse, 
significant other, caregiver, friend, or family). The study will evaluate the effectiveness and 
perceived value of the MR program in relation to physical and psychological symptoms, global 
health, and social outcomes. 
METHODOLOGY: The specific aims are to: (Aim 1) Determine MR effectiveness for physical 
(pain, sleep), PTSD (intrusion, arousal, avoidance, numbing), and psychological (depression, 
stress, anxiety) symptoms, and global health (quality of life); (Aim 2) Determine MR 
effectiveness for social (relationship satisfaction, compassion for self/others) outcomes among 
Veterans and their partners; and (Aim 3) Describe Veteran and partner perceived value of MR 
in a sub-sample of participants. The sample will consist of Veteran and partner dyads (N = 
600).  Aim 1 & 2 data collection will include self-report assessment of 4-data points over a 4-
month period to evaluate physical, psychological, and social outcomes. Eight weekly reports 
will also be collected for the first two months of MR use to assess MR utilization, and pain and 
stress levels. Aim 3 data collection will include telephone interviews from a selected sub-
sample of 84 individuals to examine MR user experiences, study experiences, and to collect 
their suggestions for making MR useful for Veterans and their partners. 
CLINICAL RELEVANCE: In a community-based trial in a non-clinically defined sample of 
Veterans, MR was associated with significant reductions in pain and PTSD-related symptoms. 
In the proposed study we will test MR’s effects in a clinically defined population as a 
complement to clinical services. This program evaluation is needed to determine MR’s 
appropriateness for implementation within the VA for clinically defined populations.  

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Aim 1: Determine MR effectiveness for physical (pain, sleep), PTSD (intrusion, arousal, 
avoidance, numbing), and psychological symptoms (depression, stress, anxiety), and global 
health (quality of life). 
H1.1. Veterans who use MR will report significantly greater improvement in physical 
pain compared to those in the control group. (Primary Outcome) 
H1.2. Veterans who use MR will report significantly greater improvement in PTSD and 
psychological symptoms, sleep and quality of life compared to those in the control 
group. (Secondary Outcomes) 
Aim 2: Determine MR effectiveness for social (relationship satisfaction, compassion for 
self/others) outcomes among Veterans and their partners. 
H2.1. Veterans and partners who use MR will report significantly greater improvement 
in social outcomes compared to the control group. (Secondary Outcomes) 
Aim 3: Describe Veteran and partner perceived value of MR in a sub-sample of participants. 
RQ3.1. What are the experiences of participants and their partners using MR? 
RQ3.2. What recommendations do participants have for promoting use of MR? 
Impact. Currently there is no self-directed evidence-based CIH mobile application for a 
clinically defined population of Veterans and their partners to improve outcomes. This study 
will catalyze a program of research focused on MR, a multi-dimensional non-pharmacological 
intervention, to allow potential subsequent evaluation of service utilization, cost, outcomes 
(e.g., opioid use and suicide risk) and implementation. This study will also potentially provide a 
model for establishing remote access and sustainable implementation of CIH within VA. 
 
 
 
 
 

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Contents 
Rationale ....................................................................................................................................................................... 8 
Background .................................................................................................................................................................. 9 
Research Plan (work proposed) ...................................................................................................................... 12 
Research Design and Methods ..................................................................................................................... 14 
Sampling ................................................................................................................................................................ 16 
Sample .................................................................................................................................................................... 17 
Data Collection Procedures ........................................................................................................................... 19 
Data Analysis ....................................................................................................................................................... 22 
Data Management and Quality..................................................................................................................... 23 
Dissemination Plan ........................................................................................................................................... 25 
Project Management Plan .............................................................................................................................. 26 
Resources and Specific Location of Study ................................................................................................... 27 
Probable Duration of the Project .................................................................................................................... 29 
Privacy and Information Security Information ......................................................................................... 29 
References ................................................................................................................................................................. 40 
 

 
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ABBREVIATIONS  
 
AE  
 
 
Anticipated Event 
AMSUS  
Association of Military Surgeons of the 
United States  
ANCOVA  
Analysis of Covariance  
BDI  
Beck Depression Inventory  
CARA  
Comprehensive Addiction and Recovery Act  
CARF  
Commission on Accreditation of 
Rehabilitation Facilities  
CBOC  
Community Based Outpatient Clinic  
CCO  
Connected Care Office  
CIH  
 
Complementary and Integrative Health  
 
  
 
CLC  
Community Living Center  
COS  
Compassion for Others Scale  
CSS  
Compassion for Self-Scale  
DART  
Data Access Request Tracker  
DCG  
Diagnostic Cost Group  
DOD  
Department of Defense  
DSS-NDE  
Decision Support System – National Data 
Extracts  
DV  
Dependent Variable  
HCC  
Hierarchical Condition Category  
HIT  
Health Information Technology  
HSR&D  
Health Services Research and Development 
Service  
 IV  
Independent Variable  
IRB  
Institutional Review Board  
JAH  
James A. Haley Veterans’ Hospital  
LL  
Log Likelihood  
LR  
Likelihood Ratio  
MedSAS  
VHA Medical SAS Datasets  
MR  
Mission Reconnect  
NRS  
Pain Numeric Rating Scale  
NSI  
Neuro-behavioral Symptom Inventory  
OEF/OIF/OND  
Operation Enduring Freedom/ Operation 
Iraqi Freedom/Operation New Dawn  
OPCCCT  
Office of Patient Centered Care and Cultural 
Transformation  
OSI  
Opioid Safety Initiative  
P  
Partner  
PCL-C  
Posttraumatic Checklist-Civilian  
POQ-VA  
Pain Outcomes Questionnaire – for Veterans 
  

 
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ABBREVIATIONS CONTINUED 
 
R&DS  
 
 
 
 
         Research and Development Service 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Rationale 
The VA Secretary of Health Strategic Priorities and the emerging VA Whole Health Program 
identify access to CIH for pain and self-care management as a priority to achieve optimal 
Veteran health. To be responsive to these priorities the 2016 VA State-of-the-Art 
Conference (SOTA) and Comprehensive Addiction Recovery Act (CARA) mandated VA’s 
commitment to conduct rigorous research to integrate non-pharmacological and CIH 
approaches into care, with emphasis on pain management. This proposal is also responsive 
to the VA’s Opioid Safety Initiative (OSI) and Pain Care Mission which prioritize the need 
for nonpharmacological treatment options for pain.  
 
This project is responsive to RR&D’s current special areas of interest for non-
pharmacological activity-based interventions for chronic pain impacting pain reduction, 
function and quality of life. This project aligns with the VA mandate for complementary and 
integrative health (CIH) care for Veterans and their families. CIH complements traditional 
care for Veterans managing chronic conditions, such as chronic pain and PTSD. Mission 
Reconnect (MR) is a user-driven, dyadic, CIH self-care management program delivered 
remotely that teaches techniques the Veteran/partner dyad can use to reduce pain, anxiety 
and stress, promote well-being and improve relationship quality. The research goal is to 
evaluate MR as an approach to manage chronic pain and PTSD symptoms, for potential 
subsequent implementation. This study will possibly provide a model for establishing 
remote access and sustainable implementation of CIH within VA. 
 
The short-term goal of this study is to determine the effects of MR on (1) chronic pain, 
PTSD and related outcomes and (2) relationship outcomes for Veterans and their partners.  
The long-term goal is to determine the effectiveness and sustainability of using CIH self-
care management programs like MR to improve outcomes for Veterans with chronic pain 
and PTSD, and their partners. We propose a four-year mixed-methods randomized 
controlled trial of MR with two arms (treatment & wait-list control) in a clinical sample of 
Veterans with comorbid pain and PTSD, and their partners (e.g., spouse).  
 
The specific aims are to:  
 
Aim 1:  Determine MR effectiveness for physical (pain, sleep), PTSD (intrusion, arousal, 
avoidance, numbing), and psychological symptoms (depression, stress, anxiety), 
and global health (quality of life). 
H1.1. Veterans who use MR will report significantly greater improvement in 
physical pain compared to those in the control group. (Primary Outcome)  
H1.2. Veterans who use MR will report significantly greater improvement in PTSD 
and psychological symptoms, sleep and quality of life compared to those in the 
control group. (Secondary Outcomes) 

 
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Aim 2:  Determine MR effectiveness for social (relationship satisfaction, compassion for 
self/others) outcomes among Veterans and their partners. 
H2.1.  Veterans and partners who use MR will report significantly greater 
improvement in social outcomes compared to the control group. (Secondary 
Outcomes) 
Aim 3:  Describe Veteran and partner perceived value of MR in a sub-sample of 
participants. 
RQ3.1. What are the experiences of participants and their partners using MR?  
RQ3.2. What recommendations do participants have for promoting use of MR? 
 
Aim 1 & 2 data collection will include self-report assessment of 4-data points over a 4-
month period to evaluate physical, psychological, and social outcomes. Eight weekly 
reports will also be collected for the first two months of MR use to assess MR utilization, 
and pain and stress levels.  
 
Aim 3 data collection will include telephone interviews from a selected sub-sample of 84 
individuals to examine MR user experiences, study experiences, and to collect their 
suggestions for making MR useful for Veterans and their partners. 
Background  
The impact of chronic pain. Chronic pain is a highly prevalent condition among Veterans 
(81.5%).1 Musculoskeletal ailments are some of the most frequent reasons that Veterans 
seek care at the VA.2 In addition to discomfort and mood and sleep disturbances associated 
with pain, Veterans with chronic pain have a high co-prevalence of medical, mental health 
and substance use disorders.3 Veterans with pain have higher prescribed opioid doses 
which is associated with risk of accidental poisoning death and suicide death.4 In sum, 
chronic pain is a high priority area in the VA due to its prevalence and severity of impact on 
quality of life for Veterans and their families.  
 
The compounded impact of chronic pain and comorbid PTSD on outcomes. We chose 
to address chronic pain and PTSD due to their prevalence, compounded impact, and their 
priority in the VA. As many as 70% of Veterans with chronic pain treated in the VA have 
PTSD, and up to 80% of those with PTSD have pain.2 Prevalence of PTSD is higher in patients 
with chronic pain.5,6 Patients with both PTSD and chronic pain generally present with more 
complicated clinical profiles7 and patients with these comorbidities report lower quality of 
life than their Veteran counterparts.8 Chronic pain and PTSD are associated with high rates 
of depression, anxiety and fatigue, 9–13 which detrimentally impact work, social functioning, 
relationships, independent living, and ability to enjoy life.14–16 Effectiveness of 
pharmacotherapy is limited and can result in other negative consequences, such as substance 
use disorders.17 Further, Veterans with PTSD receive more frequent and higher-dose 
opioids for pain diagnoses than Veterans without PTSD.4 Innovative CIH approaches are 
needed to help Veterans and their families cope with chronic pain and PTSD without the 
side effects and adverse events associated with pharmacological management.18–20  
 

 
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Theoretical Mechanisms Connecting Pain and PTSD. The biopsychosocial model 
represents the complex inter-relationships between physical, psychological, and social 
factors.21,22 Within the context of our research, the application of the biopsychosocial model 
will center around the bi-directional relationship between pain and PTSD. Psychological 
trauma induces change in biological substrates, which in turn alter pain transduction 
pathways and pain processing mechanisms in the brain, intensifying pain experience in 
individuals with PTSD.2 Neurologically, PTSD is characterized by hyperactivation of the 
amygdala and hippocampus, and lower activation and imbalance in the medial prefrontal 
cortex. The amygdala integrates nociceptive information and plays a dual faciliatory and 
inhibitory role in the modulation of emotional pain behavior.2 Therefore, interventions that 
ameliorate pain may be expected to reduce symptoms of PTSD23 and vice versa.2 On the 
basis of this bi-directional biopsychosocial model, we propose a multi-dimensional CIH 
intervention to support positive multi-factorial outcomes associated with comorbid 
chronic pain and PTSD.  
 
Veterans’ chronic conditions can affect their families’ well-being. In alignment with the 
biopsychosocial model we contend the complexity of comorbid chronic pain and PTSD does 
not end with the Veteran. We recognize the critical role of the Veteran’s family in 
supporting Veterans’ well-being. Chronic conditions, such as comorbid pain and PTSD, can 
have substantial impacts on personal relationships. Studies have linked unhealthy family 
responses to poorer outcomes in the person with pain.24 Maladaptive patterns of interaction 
may reinforce disability, fear of activity, and dependency in the patient, thereby inhibiting their 
recovery, rehabilitation and treatment outcomes. Family members or other support partners 
may respond in a manner that is solicitous, thereby unintentionally reinforcing the sick role 
and disabled lifestyle of the person with pain.24 Though partners often serve as a protective 
factor through social support and advocacy, problematic effects of caregiver burden are 
common.25,26 Family/loved ones’ involvement in treatment can help to support positive 
outcomes.27,28   
 
Partner-family-assisted interventions. Including partners-family in treatments has been 
conceptualized in four ways: (1) partner-assisted interventions, (2) disorder-specific 
interventions, (3) general therapy, and (4) education facilitated engagement.29,30 MR 
qualifies as a partner-family assisted intervention, as MR is not disorder-specific, nor a 
focused couples therapy, nor primarily educational; rather it involves providing guidance 
and encouragement to the partners or family members so they can support the Veterans’ 
engagement in and experience of MR. The majority of family-partner focused interventions 
focus on mental health and couples-family therapy. 29,30 MR is unique in its conjoint 
approach to supporting the Veteran through the use of partnered CIH. A Veteran-partnered 
sample participated in a multimodal intervention to address PTSD symptoms using CIH 
modalities for stress reduction and resource building; findings indicate significant 
reduction in PTSD symptoms and benefits to their family members.31 Though current 
research in partner-assisted CIH based programs is limited, these programs hold potential 
for supporting Veterans with chronic conditions and their partners/families.  
 

 
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Introduction of an Innovative Partnered-family-assisted CIH Intervention. Mission 
Reconnect (MR) provides a novel CIH approach that supports Veterans’ symptom 
management using evidence-based CIH modalities (i.e., massage, meditation, positive 
psychology) presented in a self-paced partnered-family-assisted program that can be 
accessed remotely.  
 
MR is distinctive in its:  
(1) Approach to treating chronic pain using a non-pharmacological CIH approach to 
managing chronic pain that has been shown successful in a community-based non-clinically 
defined cohort.32  
(2) Use of CIH therapy skills education teaching massage techniques as a home-based, 
interpersonal skill between Veterans and their selected partners.  
(3) Focus on the Relationship dyad as the unit of intervention. The proposed partner-
family-assisted intervention directly applies the biopsychosocial model, engaging Veterans 
in their natural social contexts rather than relying solely on a clinical setting. Targeting the 
dyad leverages the natural resources of the relationship—trust, commitment, compassion, 
and mutual reinforcement of participation.  
 
CIH impact on pain and PTSD outcomes. Massage is the most preferred CIH modality of 
all complementary health approaches, indicating broad appeal among Veterans.33 Research 
indicates 82% of Veterans with chronic pain reported use of at least one CIH therapy and 
nearly all (99%) were willing to try such approaches.33 These findings are consistent with 
military treatment facilities that report CIH is most often used use for pain and mental 
health conditions.34 The preference for massage is intuitive given evidence suggesting the 
therapeutic benefits of massage including reduction of pain, stress, depressive symptoms, 
anxiety and improvement of sleep across diverse populations.32,35–39 A 2016 VA Evidence-
based Synthesis report identified 21 high-quality systematic reviews on massage for pain. 
Findings described potential benefits of massage, but evidence strength is limited due to 
methods used in reviewed studies.40 An independent meta-analysis of RCTs addressing 
pain concluded massage effectively reduced pain compared to sham, and active 
comparators, and improved mood and health-related quality of life compared to active 
comparators, and concluded massage is a viable pain management option.41 A limited 
number of massage studies have shown results on PTSD, but many studies have 
demonstrated results on related symptoms such as anxiety, stress, and 
depression.42,43,36,44,38 
 
Though limited research connects the impact of massage on PTSD outcomes, a secondary 
analysis of four trials with Veterans with PTSD suggests mindfulness based stress 
reduction, another MR component, is a viable mechanism of treatment.45 Mindfulness 
reduces pain for Veterans with chronic pain,46 and improves anxiety, depression and 
suicidal ideations.47Based on a VA review of the current evidence and best practices, 
VA/DOD PTSD clinical practice guidelines suggest though CIH is not indicated as primary 
treatment it holds promise to improve wellness and promote recovery.48Even with these 
clinical guidelines, it is noted that study limitations leave current evidence inconclusive.48 

 
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Another systematic review of CIH among veterans and military personnel indicated 
benefits from mind-body modalities; however the quality of most RCTs was rated poorly.49 
The evidence base regarding the effectiveness of CIH interventions40  for reducing pain and 
PTSD symptoms in Veterans is inconclusive; this study will fill this gap in this area of 
research.50This project will contribute to the knowledge base of this field of research by 
using strong methodology related to sample size, contextual specificity of the target 
population, RCT design and measurement of long term outcomes.  
 
Research Plan (work proposed) 
Conceptual Framework 
 
In our conceptual model 
(Figure 1), deployment 
impacts on Veterans and 
their families are 
summarized in the left box 
while target biopsychosocial 
outcomes in the boxes on 
the right are the expected 
effects of the proposed MR 
intervention, while 
controlling for previous and 
current treatment history 
(non-MR). MR has potential 
to provide a critically 
needed CIH option to 
manage deployment-related 
impacts, such as pain 
symptoms, sleep issues, and relationship issues.  
 
Hypothesized Mechanisms of Mission Reconnect. The biopsychosocial model was 
proposed to encourage exploration into categories of human distress that did not neatly fit 
the physiology only biomedical concept of disease, and the processes by which disease 
developed.51 Now, the biopsychosocial view is accepted, which provides mechanisms that 
account for interactions between the comorbid physical, emotional and cognitive 
symptoms that appear in patients, particularly those with pain.22 The biopsychosocial 
model supports interdisciplinary programs that combine intervention components at the 
biological, psychological and social levels.21,22 MR leverages the mechanisms of action of 
multiple evidence-based CIH approaches, offering users multiple pathways to achieve 
clinical benefit. Users can benefit from the discrete therapies themselves but also the 
synergy of diverse therapies that mutually reinforce each other's effects. The primary 
modalities taught in MR - cognitive and behavioral approaches such as activation of 
mindfulness, gratitude and compassion, and massage - have very rich evidence bases for 

 
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reducing pain and anxiety. Finally, the interpersonal support conferred by collaborative 
participation in MR makes possible the buffering effects of social support while reinforcing 
practice activities.52 Impacts of MR participation on pain have been demonstrated in both 
the Phase I and Phase II trials.53 
 
Study Context 
The primary site is James A. Haley VA Hospital in Tampa, FL and is one of the largest VHA 
hospitals. The Tampa VA system includes one hospital and four CBOCs. Furthermore, the 
Tampa system includes urban and rural facilities to provide diversity based on geographic 
locality.  
 
Significance 
Chronic pain and PTSD are highly prevalent comorbid conditions in the Veteran 
population, and present a challenge for traditional interventions.1,54 Pharmacological 
options have potential consequences of opioid use disorder and overdose.4 The VA’s Opioid 
Safety Initiative (OSI) and the U.S. Department of Health and Human Services 2016 
National Pain Strategy prioritize the need for nonpharmacological pain treatment options 
that leverage self-management.17,55 The VA is invested in providing virtual services to 
improve Veteran and family member access to care that promotes self- management and 
improves patient outcomes. The VHA currently views touch-based therapies as 
interventions requiring professional delivery. Massage costs approximately $60/hour,56 its 
primarily an out-of-pocket expense, and is often not affordable. Massage is not currently 
widely available in the VA, however with the emerging Whole Health initiative, massage 
and other mind-body modalities will be in increasing demand. Simply put, the VA will not 
be able to meet the increasing demand for massage services. MR provides a potentially low 
cost, accessible and sustainable intervention for Veterans in home settings. Need for low-
cost interventions to support well-being and optimal functioning among Veterans and their 
families is clear.3 Furthermore, the VHA's Secretary for Health’s Critical Priorities for 
Strategic Action identified access, pain management, and putting Veterans first to achieve 
Veteran health. To be responsive to these priorities the 2016 VA State-of-the-Art 
Conference (SOTA) and VA CARA mandate,50 indicate VA’s commitment to conduct 
rigorous research to integrate non-pharmacological and CIH approaches into care at every 
level, with emphasis on pain management. To support these priorities, the Office of Patient 
Centered Care and Cultural Transformations’ (OPCCCT) Whole Health Program, provides 
an innovative approach to integrative care that leverages CIH and family participation. 
Finally, the Connected Care Office (CCO) seeks to support self-care management and health 
care using mobile technology. 
 
Severity of outcomes, cost of care, and initiatives prioritizing access to CIH and whole 
health care warrant the need for a multi-dimensional approach, such as MR. The proposed 
research will advance science by: (1) testing a safe self-directed sustainable CIH approach 
for treating a clinically defined high-risk population of Veterans diagnosed with chronic 
pain and PTSD-related symptoms to improve psychological and physical outcomes; (2) 
introducing a non-pharmacologic chronic pain management program option for Veterans; 

 
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(3) testing the usefulness of MR as a remotely delivered internet/mobile program 
delivered in the users’ natural environment; (4) leveraging a partnered approach (e.g., 
spouses or family members) to implementing interventions that address the 
biopsychosocial aspect of wellness; and (5) conducting longitudinal repeated-measures 
analyses, which are not common in CIH research. 
 
Research Design and 
Methods  
 
Study Design and 
Overview. This four-year 
randomized controlled 
trial with one 
intervention arm and one 
wait-list control arm will 
utilize mixed methods to 
evaluate the effectiveness 
and perceived value of 
the MR program in 
relation to physical and 
psychological symptoms, 
global health, and social outcomes. An underpinning of the MR program is that it is 
intended to be adjunctive (complementary) to conventional evidence-based modalities for 
treatment of pain and PTSD (i.e. usual care). This is consistent with the previous MR trial 
conducted in a non-VA setting and different patient population whereby usual care served 
as the comparator group.  
 
Therefore, a waitlist control condition has been selected as the comparator for the 
proposed trial. This will allow assessment of the MR program above and beyond the effects 
of usual care being received. In addition, the relatively brief waitlist control period insures 
that all subjects will ultimately be offered the MR program. We believe this will be an 
incentive for both recruitment and retention of study subjects for this new recruitment 
setting. We will test MR using a randomized control trial with concurrent mixed methods 
data collection. We will recruit Veteran and partner (e.g., spouse or family member) dyads. 
Study flow for each site is shown in Figure 2.  
 
Aim 1 & 2 assessment data will be collected from 600 Veteran/partner dyads (up to 200 
per site, 100 dyads per arm) via a secure project website at baseline, 1, 2, and 4 months to 
assess primary and secondary outcomes. MR utilization and pain ratings will be assessed 
weekly for the first eight weeks of the intervention. This data collection plan will allow 
assessment of acute changes, rate of change with repeated measures over two months and 
sustained changes.  
 
MR 
n= 
100  
dyads 
Control 
n= 100  
dyads 
 
Interview Sub-
sample n=~28 
individuals 

 
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In Aim 3, a sub-sample of 84 individuals assigned to the intervention arm (n= 84 
individuals, approximately 28 individuals/site) will be purposively selected (e.g., high or 
low MR utilization groups) to participate in telephone interviews to evaluate their 
experiences using the program. All consenting participants will be randomly assigned in a 
1:1 ratio using a permuted variable block design to one of two arms (treatment vs. control). 
Participants will receive study information, instructions on how to complete the online 
data collection, and contact information in case they experience an adverse event. 
Participants will provide preferred contact information for data collection reminders. We 
will have contact information for each participant’s primary care provider to ensure 
contact in the case of an adverse event and follow our established protocol for such events.  
 
Treatment Arm: MR is a user-driven, dyadic, self-care management program developed 
with NIMH funding (R43/44) for use by Veterans and their selected partners, individually 
or together, to reduce pain and distress and support physical, mental, and relationship 
health. MR was designed for Veterans who face obstacles accessing formal mental health 
services. It can also be used to complement formal services. MR is a patient-centered 
intervention, allowing users to determine the pace at which to proceed in each program 
component.  
 
MR Content. The program provides video and audio instruction in a set of 11 evidence-
based wellness activities in three thematic categories: Connecting with Yourself, Connecting 
with Quiet, and Connecting with Your Partner. All instruction is accessible via the program 
website (MissionReconnect.com) and mobile device apps. Video content totals 91 minutes 
and was produced by filming two days of workshops to teach the practices to 
Veteran/partner dyads. The Program Overview video (54 min.) introduces the MR 
instructional sequences accompanied by commentary by workshop participants. Detailed 
massage instruction is presented in the separate Massage Instruction video (34 min.) and 
Massage Video Supplement (3 min.) addressing use with home furniture. Users are 
encouraged to give and receive at least one massage per week. Audio content totals 67 
minutes and was recorded in studio, with nine instructional audios ranging from one to 22 
minutes. Users are encouraged to listen, learn the practices, and then use each technique 
with or without the guided instruction as they wish. Support materials. A Massage 
Instruction Booklet and illustrated Massage Reminder Handout are downloadable from the 
website. A What if? feature enables users to access advice on how to apply program 
techniques in challenging situations such as experiencing problems with sleep, focus and 
concentration. Users can submit questions and suggestions for future content through the 
What if? interface. Optional Audios give users choice of audio gender voice. A Resources 
section provides links to hotlines, Vet Centers and VA Facilities.  
 
Users will be instructed to (1) try all the practices at least once during the first two weeks, 
and thereafter (2) do at least one exchange of massage per week with their partner, and (3) 
practice other methods of their choice at least 3 to 4 times per week. Dyads will be 
informed that greater use may result in greater benefit to reinforce practice.  
 
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control 

 
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arm to ultimately offer all participants exposure to the MR intervention. Dyads in the 
control arm will participate in all assessments like those in the intervention group, 
however, they will be asked to agree to not access the public web site during their 
participation. Wait-list control participants will be instructed to seek advice about 
treatment from their providers. Other than this initial advice, there will be no attempt by 
study personnel to influence condition management unless an issue (i.e., suicidal ideation) 
arises. The control condition will account for potential temporal effects that occur from 
passage of time (brief), and expectation effects associated with anticipation of MR 
participation.  While dyad randomization suggests primary physicians will have 
intervention and control patients in their practices, numerous effectiveness trials have 
shown there is little spillover of the intervention to usual care patients. The control group 
will receive access to MR after they complete data collection. 
 
Sampling: We will use a four-step process to purposively recruit study participants (see 
Figure 2). First, using an IRB approved procedure with a waiver of consent process; a 
secondary administrative data query of the ICD-9-10 conditions for chronic pain and PTSD 
will identify a sample pool of Veterans in the previous fiscal year. Cross-examination of the 
pain and PTSD cohorts for FY 2016 indicates a sample of 5,508 in Tampa who will be 
potential participants [Source: VSSC, Diagnosis Pyramid Analytics Report: Accessed 
08/27/2017]. With our access levels and expertise, this process should take two weeks. 
Second, we will recruit from providers using signed letters from the PI. The provider will 
give the recruitment letter to the patient for him/her to follow up with the study team 
member to inquire about participating in the study. Study team members will mail the 
same recruitment letters to cohorts who have been identified in step one of the recruitment 
process to reduce burden of clinical partners and to reach those Veterans who don’t often 
attend VA medical appointments. This helps provide a way to reach out to those Veterans 
with this type of diagnoses who are less likely or don’t regularly receive care intervention. 
Potential participants who contact study staff after receiving a recruitment letter will be 
presented with information about the study to help them determine whether they’d like to 
participate in the study and provide a verbal consent and HIPPA authorization.  Potential 
participants who have not responded to the letter may be contacted by their healthcare 
team for follow-up. Based on our previous projects the process from initial sampling to 
recruitment and randomization should conservatively take three months.  
 
Screening interviews will assess the occurrence of chronic pain (pain for 6 months or more 
during the prior year) and symptoms of PTSD (diagnosed, treated or experienced 
symptoms of PTSD in the past 6-months); assess if they have visual, hearing, or other 
cognitive impairments; assess for previous diagnosis of moderate or severe TBI; recent 
history of psychosis; and determine availability of a partner and the dyad’s interest in 
participation. Additional details on pain treatment history, severity and treatments of PTSD 
symptoms, potential TBI exposure, and recent use of complementary and alternative 
therapies for pain will be captured from the baseline data collection forms. In tandem, the 
fourth step (with waiver of consent) will allow chart review if needed for interested 
potential participants to: (1) confirm comorbid conditions (chronic pain and PTSD), (2) 

 
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determine substance use disorder treatment status, and (3) determine TBI diagnosis and 
severity to exclude individuals with moderate or severe TBI.  
 
Eligible Veterans will be invited to participate after screening, be consented, and receive 
information to access the data collection site and determine their group assignment. This 
information will be provided at the completion of baseline data collection. Veterans and 
their partners will receive separate stipends  for their time.  
 
Sample: The sample will consist of 400 participants drawn from 200 dyads over 
approximately 4 months (MR Intervention Group) or approximately 4 months for (MR 
Control Group) at the Tampa VA. Women and minorities recruitment numbers will mirror 
site distribution based on sex and race, as this study is not powered to examine differences 
by race and sex. We anticipate considerable racial variability due to having three 
geographically diverse sites with markedly different census profiles. We anticipate a 
considerable representation of female participants with our invested partnership with 
women’s physician Dr. Paykel, who has estimated the ability to recruit approximately 10% 
(n=25) of the overall sample at the Tampa site alone. This will make a considerable 
contribution to the knowledge of female Veterans which is often lacking in VA studies.  
 
Inclusion criteria will be: 18 years or older, English-speaking Veterans with chronic 
musculoskeletal pain57 as initially identified through secondary administrative data query 
of the ICD-9-10 conditions for chronic pain. In the initial query, musculoskeletal pain is 
present if the Veteran meets either of two validated criteria (See Appendix 5): (1) 2+ 
occurrences of any of targeted musculoskeletal ICD-9-CM codes “likely to represent chronic 
pain” identified by Tian et.al58 recorded at visits separated by at least 30 days within past 
six months; or (2) high impact chronic pain = 2+ occurrences of targeted musculoskeletal 
ICD-9-CM codes (adapted from Goulet et al.3) separated by at least 30 days within the past 
six months previous to study recruitment and two or more pain scores greater than or 
equal to 4 separated by at least 30 days within past six months.58 For pain scores, we will 
use the 0-10 numeric pain rating scale that is routinely collected at the VA. We will count 
two ICD-9-CM codes or pain scores recorded on the same day as one code/score.  
 
Previous history of PTSD will be present if the Veteran has a flag in medical record 
indicating confirmed condition by the VA Compensation and Benefits program, has at least 
two outpatient visits in the year with the primary diagnosis being listed as PTSD (ICD-9-CM 
code 309.81) and/or had PTSD listed on the problem list.  
 
Confirmation of chronic pain for more than 6-months in the past year and diagnosis, 
treatment, or symptoms of PTSD in the past 6 months will be confirmed by the telephone 
screening interview and use of CPRS if needed for further confirmation. 
 
To participate in the study, the Veteran must also have ability to access and use an 
electronic platform (e.g. Mobile device, internet, DVD) for MR delivery, with a willing 
partner to participate in the study and MR program.  
 

 
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Exclusion criteria will be: Moderate to severe TBI, diagnosis or documented treatment for 
psychosis in previous 6 months, currently in high-intensity substance use disorder 
treatment, non-English speaking; visual, hearing, cognitive impairment that prevent 
participation or ability to consent, self-report history of partner/family member physical 
abuse in the past year, and/or lack of access to internet service. These individuals will be 
excluded due to medical, language, and technology access issues that would prevent safe 
and full study participation.  As stated above, potential participants who screen for 
aggression or violence will also be excluded from study.     
 
Randomization: Participants (dyads) will be randomized to treatment (MR) or control 
using a per site variable block randomization method (blocks of 6 and 8) to facilitate a 
balance in treatment and control group sizes per site and over time. Variable blocks of 6 
and 8 per site will be randomly used so that no one will know for sure the next random 
assignment.  Dyad is the unit of randomization; this ensures that members of the same 
couple receive the same intervention. The randomization will be stratified by whether or 
not the veteran is currently receiving, or has received in the past 2 weeks, a Level 1 
evidence-based treatment for pain and/or PTSD, per current VA-DoD treatment guidelines.  
 
This will facilitate subgroup analyses of the effect of the MR intervention in the presence 
versus absence of concomitant first-line evidence-based treatment for pain and PTSD. A 
computer-generated random allocation sequence will be generated by the study 
biostatistician (separately for each site/era of service combination to ensure balance 
across sites, that is, control for site effects by design).  Dr. Alman and Dr. French will be 
responsible for monitoring participant (dyad) assignment. Participant dyads randomized 
to the treatment group will receive a link, and PIN to access the MR site and will be 
instructed to create personal user accounts. Control group members will receive access to 
MR after completing data collection. 
 
Participants will complete the informed consent and HIPAA authorization for the study 
either in-person or over-the-telephone. Research team members will review the consent 
and HIPAA content with participants, to ensure review and comprehension. Since both 
partners will be full and equal participants in the study, both will be individually screened 
and consented by individual interview. We will employ three self-report items (Appendix 
6) to address physical threat to and by partner, and fear reprisal. We will use a standard 
protocol advised and utilized in VA Family Services in its couples/family therapy: (1) Initial 
brief – individual consent/self-report; (2) Identify urgent need; (3) provide follow up call, 
and referral for community resources; (4) exclude from study.  
 
Participants will be provided an option to receive a printed copy of their informed consent 
and HIPAA authorization for review to ensure their understanding. Communication, such 
as informed consent explanations, will be supplemented using the telephone to provide 
respondents opportunities for questions and clarification as needed. This is an effective 
means of communication for studies evaluating electronic health services such as Mission 
Reconnect. These remote methods of communication and consent have been effectively 
used in other studies conducted by the PI. These forms of communication: (1) reduce 

 
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participant burden; (2) conserve resources; and (3) leverage electronic communication 
devices which support and promote virtual care. 
 
Sample Size Power Analysis: Aim 1&2, H1.1-H1.2 & H2.1 estimates of statistical power 
are based on Aim 1 and initially the primary outcome of pain. Whereas dyad is the unit of 
randomization, we assess power based on separate analyses for Veterans and partners 
(one approach used). There are 4 major intervals of assessment (baseline, 1, 2, and 4-
months).  At the beginning of this study, we estimated attrition based off of a previous MR 
trial that had less than 5% attrition. Based on early recruitment at the primary site, we 
have adjusted recruitment goals to allow for approximately 33% attrition, and uneven 
recruitment across the three study sites. Assuming within-subject (outcome measurement) 
correlation of 0.5, the proposed sample size will provide 80% power (2-sided type I error 
rate of 0.05) to detect a “small-to-medium” effect size of 0.38 (Cohen’s d). For analyses 
stratified by site (in addition to evaluation by random effect assessment), the study will 
provide 80% power to detect a “medium-to-large” effect size of 0.66. By way of 
comparison, the pilot data presented above describes large effect sizes (d = 0.81 for pain 
symptom reduction).  While this effect size was based on a relatively small sample of 
comparable patients (n<15) and within-subject assessment (paired t-test), it provides good 
assurance that the proposed sample size is sufficient to detect realistic, medium size effects 
should they exist with the MR program. For secondary outcomes, we will use a type I error 
rate of 0.01 for multiple comparisons.  For the sample and our described assumptions, this 
will provide 80% power to detect a “medium” effect size of 0.45.59 
 
Sample Size: Qualitative- Aim 3 sample size relies on the quality and richness of 
information obtained.60 Conceptual saturation is the goal of qualitative research, and 
depends on data to support interpretations. Saturation has been noted to occur within the 
first 12 interviews.60,61 Our team has extensive experience in evaluating electronic 
technologies, and have found recruiting high and low volume users provides the richest 
dataset. To ensure representative data, we will conduct telephone interviews with a 
purposive (e.g., high or low MR utilization group) sub-sample of up to 84 individuals to 
achieve representation at each site (approximately 28 individuals/site).  
 
Data Collection Procedures. Data will be collected using (1) self-report surveys; and 
(2) telephone interviews. 
 
(1) Self-reported Survey Data.  
 
To test Aim 1 & Aim 2, survey data will be collected using Qualtrics, a resource that has 
demonstrated capacity for remotely and securely collecting participant data in other 
studies conducted within the VA system. Qualtrics is a secure platform for the creation 
and distribution of online surveys and recording of response data, including quality 
control features such as range checks, skip patterns, and completeness of data entry. 
Qualtrics ensures protection and reliability of client data with high quality firewall 
systems, regular vulnerability scans, nightly complete backups, and annual complete 

 
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penetration tests. Qualtrics services will allow control of individual permissions for 
accounts and surveys. Qualtrics accounts are password protected, and all data are 
replicated in real-time. The participants will be assigned a unique PIN and will receive 
email messages with a link to prompt participant dyads to access the site and complete 
data collection. Upon access to Qualtrics, participants will be required to enter their PIN 
as the first entry into the system. Similarly, access to the online Mission Reconnect 
content will require entry of the same PIN. The PIN selected by each participant will be 
maintained in a cross-walk file with their randomly assigned study ID number.  The 
Qualtrics measures will be compiled into a single survey format and collected at 
baseline, 1, 2, and 4 months. The rationale for this schedule is to formally assess initial, 
short-term, and sustained effects that may occur with the MR intervention. MR will 
utilize an outcome measure named Self-Assessment of Change62,63. This tool was 
uniquely designed to assess a wide range of shifts in well-being across complementary 
and alternative medicine (CAM), therapeutic modalities and conditions.  MR use and 
satisfaction, pain, tension and stress items will be conducted weekly for the first 8-
weeks of data collection. This more frequent schedule of data collection will permit 
short-term dose-response analyses (i.e. dose of MR utilization) in relation to major 
symptoms of pain and PTSD.  Measures and psychometric properties are illustrated in 
Table 1. 
  Table 1: Veteran and Partner Measures and Psychometric Properties 
Construct 
Measure 
Description 
Min. Time point 
Veteran Eligibility Variable 
TBI 
Exposure 
OHIO TBI 
Exposure 
Screen64 
8-items designed to elicit self- or proxy-
reports of TBI occurring over a person’s 
lifetime. Can provide measures of the extent of 
exposure to TBI including the current injury. 
5 
Pre-
screening   
Veteran and Partner Independent Variables 
Demo- 
graphics 
Participant  
Survey 
15-items assess age, gender, ethnicity/race, 
education, income levels, religion, marital 
status, relationship length, military 
service/status/grade, deployments, 
computer/internet use.  
5  
Baseline 
Veteran Independent Variable – Covariate 
Other 
Treatments   
Concurrent 
treatments 
2 items asking Veterans to report concurrent 
pain and PTSD treatment(s) and CIH 
modalities to account for dual intervention 
effects.    
1 
Baseline, 
months 1, 
2, 4 
Veteran Dependent Variables   
Quality of 
Life 
Self-
Assessment 
of Change62,63 
16-item word pairing scale to assess a variety 
of shifts in well-being across a broad range of 
therapeutic modalities and conditions. 
5 
months 1, 
2, 4 

 
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Quality of 
Life 
Quality of Life 
SF1265 
12-items to assess quality of life using physical 
status and mental health distress. 
3 
Baseline, 
months 1, 
2, 4 
Pain 
 
Defense and 
Veterans Pain 
Rating Scale66  
 10-point scale to measure “usual” pain 
intensity over the last week and 4 pain 
functionality (past month) items.  
3  
 
Pain 
Outcomes 
Questionnair
e- Short Form 
VA67 
20-items assess pain-related domains, 
including pain intensity, interference with 
activities and mobility, negative affect, vitality, 
pain-related fear; and improbable pain-related 
symptoms.  
5  
 
 
 
 
 
Pain 
Single item 
scale 
One item will assess pain using a 0 to 5-point 
Likert-type scale.  
1 
Baseline, 
weeks 1-8;  
months 1, 
2, 4 
Stress and 
Tension 
Single item 
scales 
Two items will assess stress and tension using 
a 0 to 5-point Likert-type scale.  
1 
PTSD & 
Related 
Psychological 
Symptoms 
PTSD: 
Posttraumatic 
Checklist68 
20-item measure of the DSM-V PTSD 
symptoms with scales related to stress, 
anxiety, & emotional numbing.  
4  
Baseline, 
months 1, 
2, 4 
Depression: 
Beck 
Depression 
Inventory69 
21-items, a widely used instrument for 
measuring depression. Respondents are asked 
to rate their symptoms and attitudes using a 4-
point scale.  
5 
Stress: 
Perceived 
Stress Scale70 
10 Likert-scaled items, validated and widely 
used, to determine perceived stress levels. 
3 
Sleep Quality: 
Pittsburg 
Sleep Quality 
Index71 
19 self-rated questions from which 7 
component scores are calculated and summed 
into a global score to assess sleep quality in 
the past month.  
4 
Veterans and Partner Independent Variable – Covariate 
MR Program 
Utilization 
(Treatment 
and Control 
group) 
Utilization 
survey 
Treatment group: weekly report 11-items will 
assess frequency of use and compliance of the 
MR mind/body & massage practices.  
Control group: weekly report 4-items with 
descriptive activities to obtain descriptive data 
on their utilization of any personal strategies 
to address stress coping, physical pain, partner 
relationship support, and sleep quality.  
3 
weeks 
1-8; 
months 1, 
2, 4 
Veterans and Partner Dependent Variables 
Relationship 
Satisfaction 
Revised Dyadic
Adjustment 
Scale72-
Adapted 
14-item Likert-scaled instrument is reliable 
and valid and contains subscales for dyadic 
consensus, dyadic satisfaction, and dyadic 
cohesion. 
3 
Baseline, 
months 1, 
2, 4 

 
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Compassion 
Compassion 
for Self and 
Others 
Scales73,74 
26- (CSS) and 21- item (COS) measures, five-
point Likert-scaled measures self-compassion 
and compassion for others.  
5 
Program 
Satisfaction  
(Treatment 
Only)  
MR Program 
Satisfaction 
Items 
11 ten-point Likert-type items assess 
satisfaction using MR components, whether 
they would recommend MR, and massage 
satisfaction. 
1 
Weeks 1-8;  
months 1, 2, 
4 
 
(2) Telephone interviews.  
To address Aim 3, telephone interviews (~30 min) will be conducted with a sub-sample of 
84 individuals. Only treatment group members will be recruited for this data collection. 
Prospective interviewees will be purposively selected (e.g., high or low MR utilization 
groups) to participate in telephone interviews to evaluate their experiences using the 
program. MR utilization will be calculated at the dyadic level. Both Veteran and partner 
members of dyads assigned to the treatment arm will be contacted for qualitative 
interviews, however interviews will be conducted with Veterans and their partners 
separately. We will explain the interview purpose and ask permission to audio-record and 
use the interview script to ensure that all topics are covered. An audio voice consent must 
be completed and voice recorded at the time of the telephone interview process. The 
participant will be informed they will be recorded and need to state on the recorded 
telephone interview when asked if they agree to participate prior to the start of the 
telephone interview.  
Interviewers will solicit respondents’ attitudes, opinions, and reports about their 
preferences and the pros and cons of MR and/or participating in the practice groups, 
including their perceptions of usefulness. We will use standard communication techniques 
to stimulate discussion, with prompts (e.g., “tell me more”), summarizing statements, and 
silence. We have used these methods in several previous studies to gather data effectively. 
Additionally, in an effort to understand the factors that contribute to study attrition, a 
maximum of ten individuals who did not complete study activities may be contacted for a 
brief 15-minute voluntary telephone interview. These interviews will solicit respondents’ 
experiences with the study and any difficulties that they experienced. Only participants 
who were lost to follow up and who had been assigned to the treatment arm will be 
contacted for these attrition interviews. Participants who officially withdrew from the 
study will be excluded from the pool of prospective interviews.  
A total of 84 interviews (n=84 individuals), including participants lost to follow up and 
participants who have successfully completed the study, will be performed. We will 
attempt to interview both members of dyads to obtain conceptual saturation.  
Data Analysis: The intention to treat principle will be used for all analyses irrespective of 
the extent of protocol compliance or dropout.90 Whereas randomization is anticipated to 
balance both study arms on presenting demographic and clinical characteristics, including 

 
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within sites and by concomitant receipt of first line pain and/or PTSD treatment, 
continuous variables will be compared by student t-tests or Wilcoxon tests (depending on 
distributional properties); categorical variables will be compared by chi-square analyses.  
 
Hypotheses Aims 1 & 2. All outcome measures (primary and secondary) under Aim 1 will be 
collected at baseline, 1, 2, and 4 months and are continuous variables. Therefore, general 
linear mixed models will be used with main effects terms for GROUP (MR vs. waitlist) and 
TIME (4-time points) and a GROUP x TIME interaction term (for rate of change). The 
models will also include site as a random effect. To assess whether the rate of change is 
curvilinear (i.e., the rate of change differs between time points), a quadratic parameter will 
be tested. Different correlation structures and functional forms of the effects of the MR 
program will be assessed using the information criteria and a final parsimonious model 
will be determined for final statistical inference. Initial effects of the MR program (baseline 
to 1-month) will be evaluated by analysis of covariance (ANCOVA). For H1.1, the primary 
outcome measure for pain will be total score on the 19-item POQ. For H1.2., the primary 
outcome measure for PTSD will be total score on the 20-item PCL-5. Subgroup analyses will 
be explored using similar methods and examination of severity of baseline pain and PTSD 
scores. These analyses will provide insight into subgroups in whom the MR program may 
be particularly beneficial. In a similar realm, analyses will be stratified by baseline median 
level of relationship satisfaction, as derived from total score on the 14-item RDAS. This will 
permit assessment of the effect of the MR intervention on potential improvement in 
relationship satisfaction among a cohort of dyads with presumably troubled relationships 
at entry. Moreover, using the weekly reports (8 weeks) of MR use and satisfaction with the 
MR program, the MR sample will be split above versus below the median for these two 
measures, and compared separately against the waitlist control condition at 2-months. This 
approach approximates a “per protocol” analysis in terms of recommended use of the MR 
program. In addition, especially for Aim 2 outcomes, we seek to examine whether dyads 
appear to show mutual benefits from the MR program. Therefore, multilevel models will be 
fit using an over-time dyadic model78 in which individuals are nested within dyads and 
time is crossed with dyads (i.e., both Veteran and partner are assessed at the 4 time points). 
This analysis accounts for the non-independence due to the correlation between dyad 
members’ general levels on outcomes averaged over time, as well as the time-specific 
correlation between their outcomes (e.g., similarity caused by time-specific events).    
 
Data Management and Quality. All data will be password protected and made 
accessible only to our research team members. Most consent and data collection will occur 
on a VA approved secure website (i.e. Qualtrics). However, a secure drive folder will be 
available to each site team.  
 
Self-reported data: Participants’ survey data will be remotely collected using Qualtrics, a VA 
approved secure survey assessment center and located on a secure VA network server 
database. Location tracking services will be disabled. 
 
Interview data. Interview recordings will be collected on a VA-approved encrypted 
recorder with a telephone interview adaptive device. These recordings will be downloaded 

 
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and stored on a secure network server at the R&DS. Recorded documents will be remotely 
retrieved, transcribed and returned for analysis by the Salt Lake City Transcription Center. 
Interview data will be managed using Atlas Ti91 and analyzed by at least two experienced 
qualitative researchers. Transcripts will be time stamped, reviewed, compiled, and 
standardized. 
 
Research Questions RQ3.1. & 3.2. Interview transcript data will be managed using 
descriptive content analytical methods to identify domains and taxonomies related to 
participants’ experiences with MR use.44 Categories will be compared and contrasted, and 
relationships among them will be identified. As coding schemas are developed to create 
domains and taxonomies, data samples will be extracted and coded by research team 
members and evaluated for inter-rater reliability and credibility. Descriptive and 
comparative matrices, which identify the patterns of regularities (shared) and 
inconsistencies (unique or varied) will then be constructed for the Veteran and partner 
participants. Comparative matrices enable identification of the most relevant, shared, and 
perhaps representative components, thereby enhancing the potential representation of the 
findings. Finally, a complex cross-case data display or matrix will be developed to 
summarize the significant taxonomic outcome structures identified within and between 
Veterans and their partners. This process of descriptive and comparative matrix analysis 
will allow discernment of the most salient and representative components identified by 
Veterans and their partners. 
 
Data Use 
• Data will be stored and maintained in accordance with the VA approved Record 
Control Schedule. 
 
• Final de-identified data sets underlying publications resulting from the proposed 
research will be available outside VA in an electronic format, through email upon 
request, after results are published. Data sets will be available for collaborators and 
other investigators upon request prior to publication (expected time period: 30 days 
post request). The extent of the data will be de-identified aggregate data only. 
 
• De-identified data will be publicly shared through publications and scientific 
presentations at meetings with adequate detail to permit validation of results. 
Publications/presentations will be made available to the public through the 
National Library of Medicine PubMed Central website within one year upon request. 
The current project will not generate any identifiable human data. 
 
In general, data will be stored on a R&DS secure network server or on a VINCI server.  
 
• De-identified information will be stored and shared in password-protected files and 
accessible only to research team members with VHA Privacy Policy training on VA 
approved secure server behind VA firewall.  
 

 
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• Data for means of analysis will be backed up to a hard drive, maintained, and 
secured in the PI’s VA office. 
 
• Interview data will be collected on VA encrypted recorders. After being stored, 
recorded documents will be remotely retrieved and transcribed for analysis. De-
identified interview data will be managed using Atlas Ti77 by experienced qualitative 
researchers.  
 
• To ensure quantitative data quality, we will identify and correct errors in 
coding/data entry. De-identified quantitative data cleaning will begin during data 
collection to allow detection and correction of systematic errors. Measures of 
frequency, central tendency, and dispersion will be used to identify errors. 
Statistical data will be managed using SAS statistical software suite.78 
 
Missing data. Missing data will be tabulated by treatment arms and by assessment waves; 
comparison tests between arms will be conducted to assess potential attrition bias and to 
examine the missing data mechanism (e.g. missing at random). If missing rate is less than 
10%, analyses with list wise deletion (missing values dropped from the analysis) will be 
performed (due to minimal concern over bias). Participants who are lost to follow-up and 
missing on post randomization outcome assessments will be included in additional 
comparison analyses that utilize multiple imputations of missing data to minimize bias due 
to differences between those with complete and incomplete data. 
 
Dissemination Plan. Dissemination efforts will be led by the PI along with the VA 
operational (e.g. OPCCCT and CCO), clinical stakeholders (e.g. mental health and pain 
clinicians), and the Tampa R&DS VEC. We will publish findings in peer-reviewed journals 
and present findings at national and international meetings including Medicine 2.0, the 
international conference for internet-based health research (Haun) and Association of 
Military Surgeons of the United States (AMSUS) Annual Continuing Education Meeting. 
Dissemination activities will inform VHA operational initiatives and clinical practice (Table 
2). The deployment of Whole Health models of care nationally will provide a natural setting 
for dissemination. The Tampa VEC will support dissemination efforts to Veterans, their 
families, and to Veteran Service Organizations.  
 
Table 2.  Dissemination Plan 
Format 
Target Audience 
Potential Use or Outcomes 
1. Mission Reconnect for Veterans and their partners 
Briefing 
Clinicians in Mental Health and 
Pain Clinics, VEC   
• MR as an option for non-pharmacological 
self-care management for chronic pain  
2. Linking study findings to operational and clinical initiatives 
Reports/Oral 
Presentation 
Office of Mental Health 
• Guidelines for using MR to support clinical 
care  
• Support operational mission and provide 
insight on usability and application of MR 
Connected Care Office  
Office of Patient Centered Care & 
Cultural Transformation & 

 
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Flagships 
• Lessons learned and MR use strategies 
3. Mission Reconnect in the VA for self-care management  
Marketing  
Materials   
Veterans and family members, 
Veteran Service Organizations, 
VEC 
• Increased motivation to actively use MR for 
non-pharmacological self-care management 
4. System-wide presentation of in-service and marketing of implementation strategies  
TMS/EES  
VHA Employees 
• Present findings and increase awareness of 
MR 
• Lessons learned, recommendations, and MR 
use strategies 
Presentation VISN PACT Leads & Virtual Care 
Coordinators 
5.  Cyber Seminar 
Oral 
Presentation 
VA Researchers & 
Administrators 
• Present findings and increase awareness of 
MR 
• Lessons learned and MR use strategies 
Project Management Plan  
This team has established effective mechanisms for communication and collaboration 
leveraging technology across sites. The Tampa based team, led by Dr. Haun, will direct 
overall coordination of the project. Dr. Haun will work with co-investigators to refine and 
implement data collection and analyses, and ensure the project is achieving study 
benchmarks. Dr. Alman will lead randomization and quantitative data analyses for Aims 1 
& 2. PI and study team will lead qualitative activities for Aim 3. Drs. Paykel, Scott, and 
Murphy will provide clinical expertise and recruitment support at the Tampa site.  
Table 3. GANTT Chart of Study Benchmarks. 
 
 
YEAR 1       
 (2019-2020) 
YEAR 2       
(2020-2021) 
YEAR 3         
(2021-2022) 
YEAR 4       
 (2022-2023) 
Project activity 
Q1 
Nov 
’18  
Q2 
Feb 
‘19 
Q3 
May 
Q4 
Aug 
Q1 
Nov 
Q2 
Feb 
‘20 
Q3 
May 
Q4 
Aug 
Q1 
Nov 
Q2 
Feb 
‘21 
Q3 
May 
Q4 
Aug 
Q1 
Nov 
Q2 
Feb 
‘22 
Q3 
May 
Q4 
Aug 
Start-up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment Screening and Randomization, 
Qualtrics development and validation  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment (3-4 dyads/month per site) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Primary Data Collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Conduct Interviews  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Interview Transcription 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Interview Data Analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prepare & Stage Primary Data 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Primary Data Analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Interpretation and Triangulation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Finalize Data Reports/Manuscripts 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Develop Materials for Dissemination  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prepare/Submit Subsequent Proposal  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Disseminate Materials to Audiences 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Resources and Specific Location of Study 
 
Primary Study Site: James A. Haley Veterans’ Hospital, Tampa, FL. James A. Haley 
Veterans' Hospital (JAHVH) is a tertiary care facility classified as a Clinical Referral Level 1 
Facility. It was the first VA hospital—and is one of 342 VA and private hospitals 
worldwide—to receive the prestigious designation as a Magnet Hospital. JAHVH Main 
Hospital has 415 beds, with an additional 118 beds in the onsite Nursing Home Care Unit. 
JAHVH was recently designated the VISN 8 Complementary and Integrative Health (CIH) 
Center, this designation comes with substantial funding to support CIH implementation 
and evaluation, to support roll-out efforts throughout VISN 8 and ultimately the VA 
nationally.  
 
JAHVH is a teaching hospital, providing a full range of patient care services, with state-of-
the-art technology as well as education and research. Comprehensive health care is 
provided through primary, tertiary, and long-term care in areas of medicine, surgery, 
psychiatry, physical medicine and rehabilitation, spinal cord injury, neurology, oncology, 
dentistry, geriatrics, and extended care. JAHVH consists of five Veterans Health 
Administration facilities located in Tampa serving four counties in Central Florida; with 
four Community Based Outpatient Clinics in New Port Richey, Zephyrhills, Lakeland and 
Brooksville. The proposed study includes three groups within JAHVH: (1) The Center of 
Innovation on Disability and Rehabilitation Research; (2) Mental Health Outpatient Clinic; 
and (3) Polytrauma Rehabilitation Center.  
 
R&DS Resources  
Investigators include health services researchers and data managers with experience in 
measurement, survey and qualitative methodologies, and use of VA administrative 
databases for research, and five anthropologists with qualitative research expertise. We 
have dedicated servers located behind the VA firewall. We have developed server 
technologies to securely host a virtual environment to give researchers the ability to 
securely access data along with reporting and analysis tools. Resources available in the 
Tampa server include: computing infrastructure; shared research environment; protected 
development environment; secure and controlled access to data; and tools for analysis and 
publication. The Tampa server uses a VMware Server driver model and virtualization 
components. The virtualized environment allows cluster shared volume support and 
expanded processor and memory support for host systems. The virtual environment 
includes two VMware server nodes to be collectively configured as a clustered system 
hosting all the Tampa servers in a virtual fashion. Utilizing a shared SAN (or Storage Area 
Network), these hosts are to share storage resources providing failover, disaster recovery, 
as well as high performance to ensure optimal operability for Tampa server resources. The 
Tampa computing infrastructure contains multiple servers and more than 1 TB of storage. 
The virtual system is designed to handle more than 200 concurrent users, with more than 
50 users at any given time.  
 
R&DS Veteran Engagement Council  

 
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The purpose of the R&DS Veteran Engagement Council (VEC) is to improve rehabilitation 
research through a trusted partnership among Veterans’ communities and R&DS 
investigators. The VEC mission is to incorporate the Veteran and family voice into all 
phases of R&DS research projects. The ten Veterans and/or caregivers VEC members 
represent the Air Force, Marines, Army, Navy, National Guard and the Vietnam, pre-9/11, 
post-9/11-3, Persian Gulf War and Iranian Hostage conflicts. There are 5 males and 5 
females. The race/ethnicity representation is white (50%), African American (40%), and 
American Indian and Hispanic (10%). The VEC members’ role is to bring their unique 
military background, health conditions, and health consumer perspective to the research 
arena. At each of the monthly meetings, an investigator volunteers to present their 
research and ask one to three questions of the members to focus the discussion. By using 
focusing questions, researchers can engage VEC members at any point of the research 
process, e.g., from topic generation to data collection, to dissemination of results. R&DS VEC 
members have the option of working of working on individual R&DS projects. On this 
proposed project, the VEC has reviewed the proposed project to support recruitment and 
dissemination activities, to support the successful recruitment of Veteran participants and 
the spread of study findings.  
 
VA Informatics and Computing Infrastructure (VINCI)  
Data analysis for many R&DS projects will be conducted using VINCI. VINCI is a partnership 
between the VA Office of Information Technology (OI&T) and the Veterans Health 
Administration's Office of Research and Development (VHA ORD). Supporting 
Transformation for the 21st Century Initiative #13, VINCI aims to provide researchers a 
nation-wide view of high value VA patient data. While VINCI brings together data sources 
and provides the analytical environment for performing studies, VHA National Data 
Services (NDS) authorizes research access to patient data. New research projects are 
granted access to snapshots of data that can be updated as needed. In addition to data 
storage, VINCI includes a cluster of servers set aside for tasks like analysis, data processing, 
and information extraction from text. This means VA researchers will have access to the 
data and applications they need to select, transform, and analyze patient data in a central, 
secure location accessible from the VA intranet. Data are maintained on the VINCI servers 
behind the VA firewall.  
 
Use of VINCI is governed by the following practices:  
• Data will be accessed by authorized members of the research team via a secured 
remote computing environment using TLS 1.0 to encrypt the connection between 
the RDP client and the TS Gateway server. The remote computing environment will 
enable data analysis to be done directly on CDW-VINCI servers located at the Austin 
Information Technology Center. The transferred data will not be transmitted to local 
PC hard drives by any of the participating investigators.  
• Data will be retained and destroyed according to VA and VHA policy.  
• Database and file monitoring tools and reports will be generated to monitor 
database and file systems access and use.  
 

 
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(2) Outpatient Mental Health Clinic, Tampa, FL. The off-site mental health service 
facility at James A. Haley Veterans’ Hospital provides consultation, evaluation and 
treatment for a variety of issues impacting emotional well-being. Staff psychologist Dr. 
Jennifer Murphy (Co-I), is a research team member and employee of the mental health 
clinic. Dr. Murphy will act as the primary mental health consultant for any mental health 
queries that study members may have. 
 
(3) Polytrauma Rehabilitation Center, Tampa, FL. Under the leadership of Dr. Steven 
Scott (research team Co-Investigator), Tampa has the largest of five designated Polytrauma 
Rehabilitation Centers in the VHA. The program includes a Polytrauma Network Service, a 
mild TBI program, a Disorders of Consciousness Program, and a 10-bed transitional living 
unit. The Tampa VA is one of four VAMCs in the collaborative Defense and Veterans Brain 
Injury Center (DVBIC), designed to ensure that all military and Veterans receive TBI 
specific evaluation, treatment, and follow-up, while collecting standardized patient 
outcome data to compare the relative efficacy of various treatment and rehabilitation 
strategies. Tampa also participates in the VA/TBI Model Systems collaborative and collects 
comparable data on Veterans. Researchers at the Tampa R&DS and the clinical staff at the 
Tampa Polytrauma Rehabilitation Centers (PRCs) have a 10-year history of strong 
collaboration as evidenced by joint publications and co-investigator status on HSR&D and 
RR&D-funded studies. Polytrauma Rehabilitation System of Care provides specialized 
rehabilitation for Veterans and Service Members with polytrauma and TBI to restore 
multiple skills and facilitates the transfer of those skills from the hospital setting to daily 
life. VA’s PRCs provide the most intensive, specialized and comprehensive rehabilitation 
care for Veterans and Service members with complex and severe polytrauma. Polytrauma 
injuries involve more than one physical region or organ system, one of which may be life 
threatening, and which results in physical, cognitive, psychological, or psychosocial 
impairments and functional disability. The PRCs embrace an interdisciplinary team 
approach to plan and administer an individually tailored rehabilitation plan to help the 
patient recover to the fullest extent possible. Each PRC is accredited by the Commission on 
Accreditation of Rehabilitation Facilities and serves as a resource to develop educational 
programs and best practice models for other facilities across the system.  
 
Probable Duration of the Project 
The projected study period to complete this research is four years. The anticipated start date will 
occur by November 1, 2018. The PI and study team will conduct a continuing review for approval 
annually and comply with required reporting based on risk associated with the study. See Table 3 
for the GANTT study timeline.  
Privacy and Information Security Information 
1. Risk to Subjects  
A) Human Subjects Involvement and Characteristics 
 

 
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In Aims 1-2 we estimate a recruitment sample size of 600 dyads, with approximately 33% 
over-sampling for attrition. We will recruit a sample of up to 200 Veteran/partner dyads 
(total 600 dyads) at each of the three sites to allow even numbers of dyads to be assigned 
to treatment and control arms. We will use a four-step process to purposively recruit study 
participants (see Figure 2). First, using a standard IRB approved procedure with a waiver 
of consent; a secondary administrative data query of the ICD9/10 conditions for chronic 
pain and PTSD will identify a sample pool of Veterans in the previous fiscal year. Cross-
examination of the pain and PTSD cohorts for FY 2015 indicate a sample of 5,508 in Tampa 
who will be potential participants [Source: VSSC, Diagnosis Pyramid Analytics Report: 
Accessed 04/27/2017]. With our access levels and expertise, this process should take two 
weeks. Second, we will recruit from providers using signed letters from the PI. The 
provider will give the recruitment letter to the patient for him/her to follow up with the 
study team member to inquire about participating in the study. Study team members will 
mail the same recruitment letters to cohorts who have been identified in step one of the 
recruitment process to reduce burden of clinical partners and to reach those Veterans who 
don’t often attend VA medical appointments. This helps provide an effective way to reach 
out to those Veterans with this type of diagnoses who are less likely or don’t regularly 
receive care intervention.  Potential participants  who contact study staff after receiving a 
recruitment letter will be presented with information about the study to help them 
determine whether they’d like to participate in the study and provide a verbal consent and 
HIPPA authorization.  Potential participants who have not responded to the letter may be 
contacted by their healthcare team for a follow-up. This procedure has been approved in 
other studies and provides an effective way to reach out to those Veterans with this type of 
diagnoses who are less likely or don’t regularly receive care intervention. Based on our 
previous projects the process from initial sampling to recruitment and randomization 
should conservatively take three months.  
 
Screening interviews will be conducted to assess the occurrence of chronic pain and PTSD; 
assess if they have visual, hearing, or other cognitive impairments; and determine 
availability of a partner and the dyad’s interest in participation. Fourth, eligibility will be 
confirmed through review of all questions from the screening interview and use of CPRS if 
needed for further confirmation. The initial secondary administrative data query of the 
ICD9/10 conditions will be conducted to: (1) confirm comorbid conditions (chronic pain 
and PTSD), [Veteran is considered to have chronic pain if he or she has documented 
chronic pain and/or treatment listed. Veteran is considered to have chronic 
musculoskeletal pain if he or she meeting either of two validated criteria: (1) Having 2+ 
occurrences of any of targeted musculoskeletal ICD-9-CM codes “likely to represent chronic 
pain” identified by Tian et.al63 recorded at visits separated by at least 30 days within past 
six months; or (2) Having high impact chronic pain = 2+ occurrences of targeted 
musculoskeletal ICD-9-CM codes (adapted from Goulet et al.19) separated by at least 30 
days within the past six months previous to study recruitment and two or more pain scores 
greater than or equal to 4 separated by at least 30 days within past six months.63 For pain 
scores, we will use the 0-10 numeric pain rating scale that is routinely collected at the VA. 
We will count two ICD-9-CM codes or pain scores recorded on the same day as one 
code/score. Veteran is considered to have previous history of PTSD if he or she has a flag in 
his/her record indicating confirmed condition by the VA Compensation and Benefits 

 
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program, has at least two outpatient visits in the year with the primary diagnosis being 
listed as PTSD (ICD-9-CM code 309.81) and/or has PTSD listed on the problem list]. After 
screening, eligible Veterans will be invited to participate and receive information necessary 
to access the data collection site and determine their group assignment. 
 
Though we have developed a strong recruitment plan that has worked effectively in past 
studies, in the event we experience recruitment issues identifying eligible participants we 
will rely on our strong team of collaborators to support recruitment efforts. We will also 
gain IRB approval to collaborate with the Tampa R&DS Veteran Engagement Council to 
recruit Veteran participants using other recruitment means such as referrals and 
advertisements (e.g. poster, brochures, flyers). We will also distribute flyers and brochures 
in approved VA designated areas of the hospital, outpatient PCA clinic and local Veteran 
service organizations. Additionally, due to the strong research interest in PTSD 
populations, we are working with the Tampa VA Physical Medicine and Rehabilitation 
research committee to support successful recruitment while accounting for dual 
enrollment in other studies. JAHVAH will not be the data coordinating center. 
 
In Aim 3 we will select a sub-sample of 84 individuals from the intervention arm 
(approximately 28 individuals per site) to complete a single telephone interview to collect 
qualitative data about their perceived value of MR and recommendations. 
 
Study Inclusion and Exclusion Criteria. Inclusion criteria will be: Participants must be 
adults, 18 years of age or older, and English-speaking Veterans with chronic 
musculoskeletal pain. Veteran is considered to have chronic musculoskeletal pain if he or 
she meeting either of two validated criteria: (1) Having 2+ occurrences of any of targeted 
musculoskeletal ICD-9-CM codes “likely to represent chronic pain” identified by Tian et.al 
recorded at visits separated by at least 30 days within past six months; or (2) Having high 
impact chronic pain = 2+ occurrences of targeted musculoskeletal ICD-9-CM codes 
(adapted from Goulet et al.) separated by at least 30 days within the past six months 
previous to study recruitment and two or more pain scores greater than or equal to 4 
separated by at least 30 days within past six months. For pain scores, we will use the 0-10 
numeric pain rating scale that is routinely collected at the VA. We will count two ICD- 9-CM 
codes or pain scores recorded on the same day as one code/score. Presence of chronic pain 
for 6-months in the past year will be confirmed in the screening interview and use of CPRS 
if needed. 
 
Veteran is considered to have a history of PTSD if he or she has a flag in his/her record 
indicating confirmed condition by the VA Compensation and Benefits program, has at least 
two outpatient visits in the year with the primary diagnosis being listed as PTSD (ICD-9-CM 
code 309.81) and/or had PTSD listed on the problem list], Veteran must also have PTSD 
(defined by PTSD diagnosis-ICD-9-CM 309.81). Presence of diagnosis, treatment, or 
symptoms of PTSD in the past 6-months will be confirmed in the screening interview and 
use of CPRS if needed. 
 
All participants must have, the ability to access and use an electronic platform (e.g. Mobile 
device, internet, DVD) for MR delivery, with a willing partner to also participate in the 

 
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study and MR program. Exclusion criteria will be: Moderate to severe TBI, diagnosis or 
treatment for psychosis in previous 6 months, currently in formal substance use disorder 
treatment program, non-English speaking; visual, hearing, cognitive impairment that 
prevent participation or ability to consent, and/or lack of access to internet service. These 
individuals will be excluded due to medical, language, and technology access issues that 
would prevent safe and full study participation. Potential participants who screen for 
aggression or violence will also be excluded from study. 
 
B) Sources of Materials 
 
We will not collect any specimens or biological samples. We will collect data during 
assessments at baseline and follow-up. Data will be collected for research purposes and 
stored, per VA protocol, behind the VA firewall and on the secure VA server as data is 
entered. Data collection for this project will include: (1) self-report survey assessment data; 
and (2) telephone interview data.  
 
For Aims 1 & 2, Self-report survey assessment data and weekly reports will be collected 
using Qualtrics, a secure electronic survey data collection service. Weekly reports about MR 
use and pain and stress outcomes will be collected weekly for the first eight weeks. Full 
assessment data measures will be compiled into a single survey format and collected at 
baseline, 1, 2, and 4 months.  
 
For Aim 3 we will audio-record telephone interviews with Veterans and their partners to 
identify their views on the value of MR and possible recommendations for implementation 
in the VA system. 
 
C) Potential Risks 
 
The potential risks for participating in this study are minimal. No pharmacological 
therapies are used in this study. This study will be approved for adherence to Human 
Subjects Protection by the Institutional Review Board and R&D committees at both study 
sites. Subjects will be issued a coded identifier, which will be known only to the PI, project 
manager, and data manager; all records and the informed consent documents will be 
retained in locked files in the PI’s or project manager’s office. All computer data will be 
encrypted to protect patient confidentiality. HIPAA regulations will be strictly adhered to. 
Data will be secure on a networked computer system behind VA firewalls, and access will 
be restricted and password protected. 
 
Participants will be assured that their participation is voluntary and they can choose not to 
answer any question. Participants will also be assured that they can choose not to 
participate in the study at any time. There is an intervention being offered in this study; 
there are no alternative options available for participants beyond standard of care 
treatment. The proposed study poses minimal risk to participants. As this intervention is 
palliative in nature with non-intrusive data collection, this is a minimal risk study. There is 
a risk that some patient participants may: 
 

 
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1. Feel uncomfortable reporting about their comorbid condition symptoms, specifically 
their PTSD; 
2. Emotional and/or physical discomfort as a result of engaging in the MR activities 
3. Experience agitation/distress during the intervention and/or data collection. 
 
Unauthorized access to data is also a risk in all research studies. Based on our prior 
research, we believe that it is unlikely that these adverse events will occur, however we 
will implement several protective strategies to protect participants and their data. 
Should any behavioral or relationship issues arise during treatment, participants will have 
information to contact their providers and the research team for support. The research 
team will follow up directly with the Veterans’ identified provider (at onset of 
participation) to ensure the Veteran has mental health support. All unanticipated incidents 
will be documented and reported in alignment with VA and Institutional Review Board 
regulations. 
 
 
2. Adequacy of Protection from Risk  
 
All study staff are up-to-date with VA Privacy and Information Security and Rules of 
Behavior training.   
A) Recruitment and Informed Consent and HIPAA Authorization: 
 
Prior to recruitment, we will obtain IRB and VA R&D Scientific Review Committee approval 
to conduct this proposed research.  
 
Recruitment. We will obtain a HIPAA authorization waiver for recruitment purposes. 
Identified patients will be sent a letter via mail or from their provider on behalf of the PI 
explaining the study and asking if patients would be willing to participate in the study. 
Veteran will contact the study team member by telephone and at that time team member 
can gauge Veterans willingness and appropriateness to participate. This recruitment 
method has been successfully used in previous studies conducted by this team and other 
R&DS projects. Recognizing the potential limitation of this strategy given the 
inclusion/exclusion criteria we will also gain IRB approval to collaborate with the Tampa 
R&DS Veteran Engagement Council and co-investigators to recruit Veteran participants 
using other recruitment means such as referrals and advertisements (e.g. poster, 
brochures, flyers). As described under Sampling on page 23 of these potential participants 
who contact study staff or who are contacted by study staff will be presented with 
information about the study to help them determine whether they’d like to participate in 
the study and give verbal consent and HIPPA authorization.  If we do not get an adequate 
recruitment response, we will implement the snowball recruitment technique that involves 
asking participants to inform and encourage friends, colleagues, and other peers to 
participate. 
  
Informed Consent. A waiver of informed consent process for recruitment purposes 
(medical record review), and a waiver of consent for a Verbal Consent Document for 

 
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participant phone screening will occur. Please note, the study team will also be utilizing a 
Written Consent Document or verbal consent via telephone. Participants will have an 
option to complete the informed consent and HIPAA authorization for study, in person or 
over-the-telephone. During recruitment contact and calls, research team members will 
review the consent and HIPAA content with participants, to ensure review and 
comprehension. Since both partners will be full and equal participants in the study, both 
will be individually screened and consented by individual interview.  
 
We will employ three self-report items to address physical threat to and by partner, and 
fear reprisal. We will use a standard protocol advised and utilized in VA Family Services in 
its couples/family therapy: (1) Initial brief – individual consent/self-report; (2) Identify 
urgent need; (3) provide follow up call, and referral for community resources; (4) exclude 
from study. When participants go to the study site to join the study, they will be provided 
an option to print a copy of their informed consent and HIPAA authorization for review to 
ensure their understanding. Communication, such as informed consent explanations, will 
be supplemented using telephone to provide respondents opportunities for questions and 
clarification as needed. This is an effective means of communication for studies evaluating 
electronic health services such as Mission Reconnect. These remote methods of 
communication and consent have been effectively used in other studies conducted by the 
PI. These forms of communication: (1) reduce participant burden; (2) conserve resources; 
and (3) leverage electronic communication devices which support and promote virtual 
care.  
 
PTSD Specific Training and Protocol. This study sample is inclusive of Veterans with 
PTSD, a chronic mental health condition that can put Veterans at risk. As such, at the onset 
of funding the study team members will receive a formal training session on the risks and 
outcomes associated with PTSD as well as an in-depth review of the protocol to address the 
specific needs of Veterans with PTSD and steps to take to be responsive to the behavioral 
health needs that may arise for Veterans during their study participation. As appropriate, 
team members will be provided with the action plan to respond to Veterans behavioral 
health needs in the unlikely event that a participant and/or partner becomes agitated or 
distressed during the intervention or data collection process. In this case, team members 
will be directed to contact and inform the project manager, site PI (if in Ann Arbor or Puget 
Sound) and study PI immediately. They will also be instructed to provide each participant 
with: (1) the contact information of the participant’s provider (collected at onset of study 
participation for referral as appropriate (i.e., mental health), if indicated; (2) the PI’s 
contact information; and (3) the national crisis hotline number for Veterans. The project 
manager and or PI/site PI will also follow up personally with the participant to address 
resolution of the incident. The participant may be formally excluded from further 
participation to ensure the individual’s safety.  
 
Data Collection. Care will be taken to ensure that sufficient backup procedures are in 
place. To assure intact data files, we will copy the raw data file into a data file for 
computation and analysis so that if there are computational errors or computer problems, 
the raw data will remain unchanged. All hard copies of data documents will be kept in a 
locked file cabinet in the project manager’s office that is kept locked when unoccupied. VA 

 
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Policy regarding retention of research records will be stored for6 years once the study is 
completely closed at R&DC and all subcommittees, in accordance with VHA’s Records 
Control Schedule (RCS10-1), applicable FDA and DHHS regulations, or as described in VHA 
Handbook 1200.5, section 7.j. At the end of the retention period, the hard copy and 
electronic source data records will be destroyed in accordance with VA Policy. All 
identifiable computer data will be encrypted to protect patient confidentiality. VA and 
other Federal privacy, confidentiality and HIPAA regulations will be strictly adhered to. 
Electronic data will be secured on a networked computer system behind two firewalls, and 
access to data folders will be password protected and restricted to study personnel who 
have a need. Self-report survey data will be collected using Qualtrics, a secure electronic 
survey data collection service. Qualtrics has been successfully used to remotely collect 
Veteran data in other studies conducted by R&DS. Telephone interview data will be audio 
recorded with participant’s permission. We will ask them to avoid using their names, 
others’ names, and personally identifying information, however, if they divulge such 
information, we will scrub the transcribed files of personally identifying or sensitive 
information before data analysis  
Data Storage. Original informed consent forms will be stored at the study site and kept in a 
locked file cabinet in site PI or project manager’s office at all times. Electronic survey, audio 
recordings and electronic files (e.g., assessment data, notes, transcripts, data analyses) will 
be stored on the secure server behind a VA firewall. 
 
B) Protection Against Risk 
 
Interviews. 
 
In Aims 3, interview recordings will be collected on a VA-approved encrypted recorder 
with a telephone interview adaptive device. These recordings will be downloaded and 
stored on a secure network server at the R&DS behind the VA firewall. Once the data 
quality is verified, files on the recorders will be erased. Recorded documents will be 
remotely retrieved, transcribed and returned for analysis by the Salt Lake City 
Transcription Center in accordance with IRB regulations. Qualitative data will be 
transcribed at the Salt Lake City Transcription Center under the supervision of Dr. 
Zickmund. Lastly, participants will be instructed that they may refuse to answer any 
question that they are uncomfortable answering. In addition, participants may withdraw 
from the study at any time without any repercussions to their healthcare. 
 
Interview Field Notes. 
In Aims 1-3, handwritten interview notes will be transcribed and electronic files will be 
handled in the same way described for interview transcripts.  Electronically recorded field 
notes will be saved in an encrypted file (either on a VA issued laptop or thumb drive), 
transported to the R&DS, and entered and uploaded as soon as possible to the secure VA 
server. Once verified, the original file will be deleted. We anticipate these efforts will 
provide adequate protection against risk. 
 
Data Storage Location. 

 
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In Aims 1-3, Original informed consent forms will be stored at the local sites and kept in a 
locked file cabinet at the R&DS in the project manager’s office at all times. Audio recordings 
and electronic files (e.g., notes, transcripts, survey data, data analyses) will be stored in 
secure folders on the secure server behind a VA firewall. We anticipate these efforts will 
provide adequate protection against risk. All paper forms with PII will be stored with R&DS 
staff at 8900 Grand Oak Way, Tampa, FL 33647, in Room 196. 
 
Audio Recordings and Transcription. Approved Tampa R&DS staff or approved VA staff 
from the VA HSR&D Centralized Transcription Services Program will transcribe the audio 
files. Transcription staff will be given access to a sub-folder within study’s secure project 
folder.  The transcriptionist will transcribe each interview and save the completed 
transcript in the sub-folder using the same de-identified code. The audio files and 
completed transcripts will be maintained and saved behind the VA firewall in the study 
secure shared project folders. No data will leave the R&DS secured research server. 
 
 
 
Secure Messaging Secondary, Interview, and Survey/Evaluation Form Data. 
 
In Aims 1-3, care will be taken to ensure that sufficient backup procedures are in place. To 
assure intact data files, we will copy the raw data file into a data file for computation and 
analysis to safeguard raw data against computational errors or computer problems. All hard 
copies of data documents will be kept in a locked file cabinet in the PI’s office, which is kept 
locked office when unoccupied. Retention of research records will be in accordance with 
VHA’s Records Control Schedule (RCS10-1), applicable FDA and DHHS regulations, or as 
described in VHA Handbook 1200.5, section 7.j. At the end of the retention period, the hard 
copy and electronic source data records will be destroyed in accordance with VA policy. All 
identifiable computer data will be encrypted to protect participant confidentiality. We will 
strictly adhere to VA and other federal privacy, confidentiality, and HIPAA regulations.  
Electronic data will be secured on a networked computer system behind two firewalls, and 
access to data folders will be password protected and restricted to study personnel who 
have a need to review these data. We anticipate these efforts will provide adequate 
protection against risk. 
 
In Aims 1 and 2, survey data will be collected using Qualtrics, a resource that has 
demonstrated capacity for remotely and securely collecting participant data in other 
studies conducted within the VA system. Qualtrics is a secure platform for the creation and 
distribution of online surveys and recording of response data, including quality control 
features such as range checks, skip patterns, and completeness of data entry. Qualtrics 
ensures protection and reliability of client data with high quality firewall systems, regular 
vulnerability scans, nightly complete backups, and annual complete penetration tests. 
Qualtrics services will allow control of individual permissions for accounts and surveys. 
Qualtrics accounts are password protected, and all data are replicated in real-time. 
 
3) Potential Benefits of Research to Subjects and Others 
 

 
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Participants may receive direct benefit for participating in this study as a result of engaging 
in the proposed intervention. Participants randomized to the control group who receive 
access to MR after they complete data collection, may also receive benefit from engaging in 
the proposed intervention. Additionally, this research may benefit the Veteran population 
and their partners in the future if the intervention is found to be effective and subsequently 
disseminated to Veterans and their partners throughout the VA system. Potential benefits 
are those anticipated by the completion and dissemination of our research efforts to 
support Veterans-centered, patient-driven care through the use of CIH.     
 
Compensation 
Compensation to participants include reimbursement for their time: Consistent with other 
funded HSR&D studies, each participant will receive $5 for providing weekly MR reports on 
utilization and pain ratings for the first 8 weeks of their participation in the study (total, 
$40). As an incentive to complete the study each participant will also receive $20 each time 
they provide assessment data at each time point (4) for a 4-month period (total, $80). 
Individuals participating in the telephone interview will receive an additional $20. 
Participants will not be paid for surveys that are not completed by the study end period  
(up to 4 months). These four time-points were selected to collect baseline for comparison, 
weekly to examine immediate effects, at 2-months to examine post intervention effects, and 
at 4-months to examine sustained intervention effects. The total possible incentive for 
participants is up to $140. 
 
4) Importance of Knowledge to be Gained 
Advancing the science of implementing complementary and integrative health services into 
the VA system of care for Veterans and their partners is an important aspect of providing 
Veteran-centered care. VHA recognizes the need to develop a holistic approach to create a 
patient-centered experience for Veterans with comorbid conditions such as chronic pain 
and PTSD. This data will support the development of a Veteran-centric self-management 
intervention for Veterans and their partners (e.g. spouse, life partner) within the VA system 
of care. 
 
5) Data and Safety Monitoring Plan 
Risk of harm from this study is less than minimal risk. The principal investigator will be 
responsible for monitoring the safety and efficacy of the study, executing the data and 
safety monitoring plan and complying with the reporting requirements. The PI and project 
manager will provide a summary as part of the grant’s progress report. The report will 
include participant’s socio-demographic characteristics, expected versus actual 
recruitment rates, any quality assurance or regulatory issues that occurred during the past 
year, summary of adverse events, and any actions or changes with respect to the protocol. 
The research team will be trained in protecting the safety of the study participants and the 
scientific credibility of the project. We will also work with VA clinical psychologists, and 
Chief of PM&R Steven Scott, DO, to ensure our protocol is appropriate for Veterans with 
comorbid chronic pain and PTSD, as well as other conditions participants might have 
including substance abuse disorders and TBI. The team will coordinate to respond to any 
individual needs participants and their partners may present throughout the study.  
 

 
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The team will meet regularly to plan and report on the selection, recruitment and retention 
of participants, their management, and the procedures for data management and quality 
control. The PI and team will monitor success of recruitment, assess data integrity, and 
monitor for adverse events. In the occurrence of adverse events, the team will report to 
local R&D and IRB within the regulated timeframe. Risks to study participants relate mostly 
to misinterpretation of what is research and loss of confidentiality. Appropriate measures 
will be taken to protect participants and their data. All aspects of data collection and data 
storage will be carefully monitored to ensure rapid detection of errors, inconsistencies or 
other problems. Study personnel involved in data collection will follow a strict written 
protocol that describes study measures for protecting data privacy, clearly explains to 
study participants that they have the right to refuse to participate or refuse to answer any 
individual question that they wish to not answer and emphasizes reporting as accurately 
and truthfully as possible. The principal investigator and co-investigators are experienced 
in training study staff in handling sensitive and confidential data, and in the storage and 
processing of such data. 
 
Entity conducting monitoring of the study: The Institutional Review Board (IRB) and 
Tampa, Ann Arbor and Puget Sound R&D committees will review the protocol and 
procedures for the proposed study prior to implementation. The IRB, Tampa, Ann Arbor 
and Puget Sound R&D committees and the principal investigator will continue to monitor 
the project. All changes to the study protocol and procedures will be submitted to the IRB 
and Tampa, Ann Arbor and Puget Sound R&D committees for approval prior to 
implementation.  
 
What is monitored: The following aspects of the study and study conduct are monitored: 
all procedures to ensure conformity with the approved study protocol; unforeseen 
circumstance that might arise and affect participant safety; all reports of serious adverse 
events (SAE) as defined in 38 CFR 46 (death, new or prolonged hospitalization, persistent 
or significant disability or incapacity; congenital anomaly or birth defect); other significant 
adverse events that lead to participant dropout, participant termination by the principal 
investigators, or termination of participation in the project activities within the VAMC 
clinics.  
 
Adverse or Serious adverse events: Any adverse event (AE) that: (1) results in illness or 
death; (2) is life-threatening (places the subject at immediate risk of death from the event 
as it occurred); (3) results in inpatient hospitalization or prolongation of existing 
hospitalization; (4) results in a persistent or significant disability/incapacity; (5) results in 
a congenital anomaly/birth defect; or (6) based upon appropriate medical judgment, may 
jeopardize the subject’s health and may require medical or surgical intervention to prevent 
one of the other outcomes listed in this definition.  
Since the study is utilizing a non-invasive palliative intervention and social-behavioral 
methods including surveys and telephone interviews, it is unlikely that recruiting 
participants in the described activities will cause an “adverse event” among the study 
population. However, it is possible that a Veteran participant and/or partner will become 
agitated or experience an adverse emotional/psychological response during the 
intervention and/or the data reporting process. In the event of an adverse event the project 

 
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manager and PI will follow regulated protocol. Then they will follow procedure to report 
the adverse event to the IRB. In anticipation of the unlikely event that a participant and/or 
partner might become agitated or distressed during the intervention or data collection 
period, each participant will be provided: (1) the PI’s contact information; and (2) the 
national crisis hotline number for Veterans. The contact information of the Veteran’s 
provider will be collected at onset of study participation for referral as appropriate (i.e., 
mental health), if indicated. 
 
The participant may be formally excluded from further participation to ensure the 
individual’s safety.  
 
We are including an established process for responding to adverse events of suicide 
ideation. We provide resources for suicide ideation in all of the surveys that the 
participants take. Furthermore, when the participant responds affirmatively to the suicide 
ideation question in the online survey, they are immediately prompted to seek professional 
help through the VA crisis hotline. The VA crisis hotline provides 24 hour, 7 days a week 
free and confidential assistance with adverse events.  
 
Additionally, a designated team member will contact the participant’s current mental 
health provider, or, in the case they do not have a mental health provider, their primary 
care provider in a timely manner to report the incident and request immediate follow-up. 
The use of a local clinical psychologist will be unfeasible for this nation-wide participant 
population. Also, the decision to utilize the mental health or primary care provider that the 
Veteran has an established relationship with is ethical and Veteran-centric.  
 
After participant’s provider is notified, a designated study team member will follow up 
with the provider to ensure communication has occurred.  In the case of participants who 
recurrently experience adverse events (e.g., responding to survey question with suicidal 
ideation if they ‘had a chance’) during the data collection period, study team members will 
continue to notify participant’s provider until agreed upon by all parties (i.e., participant, 
provider, study team member) to desist on notifications. 
 
If the participant does not have a designated mental health provider or primary care 
provider, we will escalate the issue to the local VA office’s Suicide Prevention Team.   
 
We have added language to the verbal informed consent, and also in the copy of the 
consent that is mailed to the study participants, that in the case of an AE or SAE, 
confidentiality may be breached by escalating the issue to the necessary health authorities, 
in order to protect the safety of the study participant and others.  
 
Reporting: It is unlikely that any of the study procedures will cause an AE or SAE. Should 
an AE or SAE occur, study staff is trained to immediately report AEs connected to 
implementation of the study to the project manager, and Drs. Haun (PI), Alexander (Site 
PI), and Hebert (Site PI). They will also be escalated, in the case of suicide ideation, to the 
mental health provider or primary health care provider. The study project manager will 
keep a log of AEs and SAEs. In the event of an SAE, we will file a report with VA Tampa R&D 

 
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and the IRB. As part of this process the IRB will determine if the event is directly related to 
project procedures, so that It can be determined if project procedures should be modified. 
Information about all AEs and SAEs will be provided in annual progress reports. 
 
 
  
6) Inclusion of Women, Minorities, and/or Children 
 
The proposed study involves a population of: (1) Veteran patients receiving services at the 
Tampa VA for chronic pain and PTSD; and (2) Veteran participants’ selected partners (e.g. 
spouse, life partner).  
Women and minorities recruitment numbers will mirror site distribution based on sex and 
race, as this study is not powered to look at race/sex issues; however, we anticipate greater 
racial variability due to having three geographically diverse sites. We also anticipate 
increased recruitment of females with our focused efforts to recruit within the women’s 
health centers in partnership with Dr. Paykel at the Tampa site. 
References  
 
1. Lew, H. L. et al. Prevalence of chronic pain, posttraumatic stress disorder, and persistent 
postconcussive symptoms in OIF/OEF veterans: polytrauma clinical triad. J. Rehabil. Res. 
Dev. 46, 697–702 (2009). 
2. Kip, K. E. et al. Accelerated Resolution Therapy for treatment of pain secondary to 
symptoms of combat-related posttraumatic stress disorder. Eur. J. Psychotraumatology 5, 
24066 (2014). 
3. Goulet, J. L., Kerns, R. D., Bair, M., Becker, W. C. & et al. The musculoskeletal diagnosis 
cohort: examining pain and pain care among veterans. Pain 157, 1696–1703 (201AD). 
4. Seal, K. H. et al. Association of mental health disorders with prescription opioids and high-
risk opioid use in US veterans of Iraq and Afghanistan. JAMA 307, 940–947 (2012). 
5. Kessler, R. C., Chiu, W. T., Demler, O., Merikangas, K. R. & Walters, E. E. Prevalence, 
severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity 
Survey Replication. Arch. Gen. Psychiatry 62, 617–627 (2005). 

 
Page 41 of 49 
June 13, 2023 
Version 18           
6. Hickling, E. J. & Blanchard, E. B. Post-traumatic stress disorder and motor vehicle 
accidents. J. Anxiety Disord. 6, 285–291 (1992). 
7. Sharp, T. J. & Hanery, A. G. Chronic pain and posttraumatic stress disorder: Mutual 
maintenance. Clin. Psychol. Rev. 21, 857–877 (2001). 
8. Department of Veterans Affairs. Chronic pain and PTSD: A guide for patients. (2007). 
9. Tsang, A. et al. Common chronic pain conditions in developed and developing countries: 
gender and age differences and comorbidity with depression-anxiety disorders. J. Pain Off. J. 
Am. Pain Soc. 9, 883–891 (2008). 
10. Clark, M. E., Walker, R. L., Gironda, R. J. & Scholten, J. D. Comparison of pain and 
emotional symptoms in soldiers with polytrauma: unique aspects of blast exposure. Pain 
Med. Malden Mass 10, 447–455 (2009). 
11. Smeeding, S. J. W., Bradshaw, D. H., Kumpfer, K. L., Trevithick, S. & Stoddard, G. J. 
Outcome evaluation of the Veterans Affairs Salt Lake City Integrative Health Clinic for 
Chronic Nonmalignant Pain. Clin. J. Pain 27, 146–155 (2011). 
12. Shi, L., Liu, J. & Zhao, Y. Comparative Effectiveness in Pain-Related Outcomes and Health 
Care Utilizations between Veterans with Major Depressive Disorder Treated with Duloxetine 
and Other Antidepressants: A Retrospective Propensity Score-Matched Comparison. Pain 
Pract. 12, 374–381 (2012). 
13. Lang, K. P., Veazey-Morris, K. & Andrasik, F. Exploring the role of insomnia in the relation 
between PTSD and pain in veterans with polytrauma injuries. J. Head Trauma Rehabil. 29, 
44–53 (2014). 

 
Page 42 of 49 
June 13, 2023 
Version 18           
14. Kupersmith, J., Lew, H. L., Ommaya, A. K., Jaffee, M. & Koroshetz, W. J. Traumatic brain 
injury research opportunities: results of Department of Veterans Affairs Consensus 
Conference. J. Rehabil. Res. Dev. 46, vii–xvi (2009). 
15. Bosco, M. A., Murphy, J. L. & Clark, M. E. Chronic Pain and Traumatic Brain Injury in 
OEF/OIF Service Members and Veterans. Headache J. Head Face Pain n/a–n/a (2013). 
doi:10.1111/head.12172 
16. Schnurr, P. P. & Lunney, C. A. Work-related outcomes among female veterans and service 
members after treatment of posttraumatic stress disorder. Psychiatr. Serv. Wash. DC 63, 
1072–1079 (2012). 
17. Westanmo, A., Marshall, P., Jones, E., Burns, K. & Krebs, E. E. Opioid Dose Reduction in a 
VA Health Care System--Implementation of a Primary Care Population-Level Initiative. 
Pain Med. Malden Mass 16, 1019–1026 (2015). 
18. Walker, R. L., Clark, M. E. & Sanders, S. H. The “Postdeployment multi-symptom 
disorder”: An emerging syndrome in need of a new treatment paradigm. Psychol. Serv. 7, 
136–147 (2010). 
19. Ohye, B. Y. et al. Three-generation model: A family systems framework for the assessment 
and treatment of veterans with posttraumatic stress disorder and related conditions. Prof. 
Psychol. Res. Pract. 46, 97–106 (2015). 
20. Capehart, B. & Bass, D. Review: Managing posttraumatic stress disorder in combat veterans 
with comorbid traumatic brain injury. J. Rehabil. Res. Dev. 49, 789 (2012). 
21. Engel, G. L. The clinical application of the biopsychosocial model. Am. J. Psychiatry 137, 
535–544 (1980). 

 
Page 43 of 49 
June 13, 2023 
Version 18           
22. Gatchel, R., Peng, Y., Peters, M., Fuchs, P. & Turk, D. The biopsychosocial approach to 
chronic pain: scientific advances and future directions. Psychol. Bull. 133, 581–624 (2007). 
23. Geisser, M. E., Roth, R. S., Bachman, J. E. & Eckert, T. A. The relationship between 
symptoms of post-traumatic stress disorder and pain, affective disturbance and disability 
among patients with accident and non-accident related pain. Pain 66, 207–214 (1996). 
24. Raichle, K. A., Romano, J. M. & Jensen, M. P. Partner responses to patient pain and well 
behaviors and their relationship to patient pain behavior, functioning, and depression. Pain 
152, 82–88 (2011). 
25. Nelson, B. S. & Wright, D. W. Understanding and Treating Post-Traumatic Stress Disorder 
Symptoms in Female Partners of Veterans with Ptsd. J. Marital Fam. Ther. 22, 455–467 
(1996). 
26. Verbosky, S. J. & Ryan, D. A. Female partners of Vietnam veterans: stress by proximity. 
Issues Ment. Health Nurs. 9, 95–104 (1988). 
27. Keefe, F. J. et al. Spouse‐assisted coping skills training in the management of osteoarthritic 
knee pain. Arth Rheum 9, 279–291 (1996). 
28. Abbasi, M. et al. Spouse‐assisted training in pain coping skills and the outcome of 
multidisciplinary pain management for chronic low back pain treatment: A 1‐year 
randomized controlled trial. Eur J Pain 16, 1033–1043 (2012). 
29. Baucom, D. H., Shoham, V., Mueser, K. T., Daiuto, A. D. & Stickle, T. R. Empirically 
supported couple and family interventions for marital distress and adult mental health 
problems. J. Consult. Clin. Psychol. 66, 53–88 (1998). 

 
Page 44 of 49 
June 13, 2023 
Version 18           
30. Monson, C. M., Macdonald, A. & Brown-Bowers, A. Couple/family therapy for 
posttraumatic stress disorder: review to facilitate interpretation of VA/DOD Clinical Practice 
Guideline. J. Rehabil. Res. Dev. 49, 717–728 (2012). 
31. Church, D. & Brooks, A. J. CAM and energy psychology techniques remediate PTSD 
symptoms in veterans and spouses. Explore N. Y. N 10, 24–33 (2014). 
32. Kahn, J. R., Collinge, W. & Soltysik, R. Post-9/11 Veterans and Their Partners Improve 
Mental Health Outcomes with a Self-directed Mobile and Web-based Wellness Training 
Program: A Randomized Controlled Trial. J Med Internet Res 18, e255 (2016). 
33. Denneson, L. M., Corson, K. & Dobscha, S. K. Complementary and alternative medicine use 
among veterans with chronic noncancer pain. J. Rehabil. Res. Dev. 48, 1119–1128 (2011). 
34. Herman, P. M., Sorbero, M. E. & Sims-Columbia, A. C. Complementary and Alternative 
Medicine Services in the Military Health System. J. Altern. Complement. Med. N. Y. N 23, 
837–843 (2017). 
35. Evidence Brief: The Comparative Effectiveness of Selected Complementary and Integrative 
Health (CIH) Interventions for Preventing or Reducing Opioid Use in Adults with Chronic 
Neck, Low Back, and Large Joint Pain. Available at: 
http://www.hsrd.research.va.gov/publications/esp/cihopioid.cfm. (Accessed: 5th May 2016) 
36. Haun, J., Graham-Pole, J. & Shortley, B. The Physiological and Psychological Effects of 
Massage Therapy on Children with Cancer and Blood Diseases. Int. J. Ther. Massage 
Bodyw. 2, 7–14 (2009). 
37. Cherkin, D. C. et al. Randomized trial comparing traditional Chinese medical acupuncture, 
therapeutic massage, and self-care education for chronic low back pain. Arch. Intern. Med. 
161, 1081–1088 (2001). 

 
Page 45 of 49 
June 13, 2023 
Version 18           
38. Moyer, C. A., Rounds, J. & Hannum, J. W. A meta-analysis of massage therapy research. 
Psychol. Bull. 130, 3–18 (2004). 
39. Tsao, J. C. I. Effectiveness of Massage Therapy for Chronic, Non-malignant Pain: A 
Review. Evid.-Based Complement. Altern. Med. ECAM 4, 165–179 (2007). 
40. Evidence-based Synthesis Program (ESP) Center. Massage for Pain: An Evidence Map. 
(2016). 
41. Crawford, C. et al. The Impact of Massage Therapy on Function in Pain Populations-A 
Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part I, Patients 
Experiencing Pain in the General Population. Pain Med. Malden Mass (2016). 
doi:10.1093/pm/pnw099 
42. Sharpe, P. A., Williams, H. G., Granner, M. L. & Hussey, J. R. A randomised study of the 
effects of massage therapy compared to guided relaxation on well-being and stress 
perception among older adults. Complement. Ther. Med. 15, 157–163 (2007). 
43. Moraska, A., Pollini, R. A., Boulanger, K., Brooks, M. Z. & Teitlebaum, L. Physiological 
adjustments to stress measures following massage therapy: a review of the literature. Evid.-
Based Complement. Altern. Med. ECAM 7, 409–418 (2010). 
44. Haun, J., Patel, N., Schwartz, G. & Ritenbaugh, C. Evaluating the use of gas discharge 
visualization to measure massage therapy outcomes. J. Complement. Integr. Med. 12, 231–
239 (2015). 
45. Stephenson, K. R., Simpson, T. L., Martinez, M. E. & Kearney, D. J. Changes in 
Mindfulness and Posttraumatic Stress Disorder Symptoms Among Veterans Enrolled in 
Mindfulness-Based Stress Reduction. J. Clin. Psychol. 73, 201–217 (2017). 

 
Page 46 of 49 
June 13, 2023 
Version 18           
46. Garland, E. L. et al. Mindfulness-oriented recovery enhancement for chronic pain and 
prescription opioid misuse: results from an early-stage randomized controlled trial. J. 
Consult. Clin. Psychol. 82, 448–459 (2014). 
47. Serpa, J. G., Taylor, S. L. & Tillisch, K. Mindfulness-based stress reduction (MBSR) reduces 
anxiety, depression, and suicidal ideation in veterans. Med. Care 52, S19-24 (2014). 
48. Department of Veterans Afairs; Department of Defense. VA/DOD Clinical Practice 
Guideline for the Management of Posttraumatic Stress Disorder and Acute Stress Disorder. 
Available at: 
https://www.healthquality.va.gov/guidelines/MH/ptsd/VADoDPTSDCPGFinal082917.pdf.  
49. Elwy, A. R., Johnston, J. M., Bormann, J. E., Hull, A. & Taylor, S. L. A systematic scoping 
review of complementary and alternative medicine mind and body practices to improve the 
health of veterans and military personnel. Med. Care 52, S70-82 (2014). 
50. Complementary and Integrative Health Expanding Research, Education, Delivery and 
Integration of Complementary and Integrative Health Services into the Health Care Services 
Provided to Veterans. (2017). 
51. Engel, G. L. The need for a new medical model: a challenge for biomedicine. Science 196, 
129–136 (1977). 
52. Cohen, S. & Wills, T. A. Stress, social support, and the buffering hypothesis. Psychol. Bull. 
98, 310–357 (1985). 
53. Collinge, W., Kahn, J. & Soltysik, R. Promoting Reintegration of National Guard Veterans 
and Their Partners Using a Self-Directed Program of Integrative Therapies: A Pilot Study. 
Mil. Med. 177, 1477–1485 (2012). 

 
Page 47 of 49 
June 13, 2023 
Version 18           
54. Veterans Health Administration. Analysis of VA health care utilization among Operation 
Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) 
Veterans. (2013). 
55. Office of the Assistant Secretary for Health at the U.S. Department of Health and Human 
Services. National Pain Strategy: A Comprehensive Population Health-Level Strategy for 
Pain. (2016). 
56. Fritz, S. Mosby’s Fundamentals of Therapeutic MassageMosby’s Fundamentals of 
Therapeutic Massage. (2013). 
57. Persistent pain and well-being: a World Health Organization Study in Primary Care. - 
PubMed - NCBI. Available at: http://www.ncbi.nlm.nih.gov/pubmed/9669787. (Accessed: 
27th April 2016) 
58. Tian, T. Y., Zlateva, I. & Anderson, D. R. Using electronic health records data to identify 
patients with chronic pain in a primary care setting. J. Am. Med. Inform. Assoc. JAMIA 20, 
e275-280 (2013). 
59. Cohen, J. Statistical power analysis for the behavioral sciences. (Routledge, 1988). 
60. Strauss, A. C. & Corbin, J. M. Basics of Qualitative Research: Second Edition: Techniques 
and Procedures for Developing Grounded Theory. (Sage Publications, Inc, 1998). 
61. Sandelowski, M. Sample size in qualitative research. Res. Nurs. Health 18, 179–183 (1995). 
62. Ritenbaugh, C. et al. Developing a patient-centered outcome measure for complementary 
and alternative medicine therapies I: defining content and format. BMC Complement. Altern. 
Med. 11, 135 (2011). 

 
Page 48 of 49 
June 13, 2023 
Version 18           
63. Thompson, J. J. et al. Developing a patient-centered outcome measure for complementary 
and alternative medicine therapies II: Refining content validity through cognitive interviews. 
BMC Complement. Altern. Med. 11, 136 (2011). 
64. Corrigan, J. D. & Bogner, J. Initial Reliability and Validity of the Ohio State University TBI 
Identification Method. J. Head Trauma Rehabil. 22, 318 (2007). 
65. Busija, L. et al. Adult measures of general health and health-related quality of life: Medical 
Outcomes Study Short Form 36-Item (SF-36) and Short Form 12-Item (SF-12) Health 
Surveys, Nottingham Health Profile (NHP), Sickness Impact Profile (SIP), Medical 
Outcomes Study Short Form 6D (SF-6D), Health Utilities Index Mark 3 (HUI3), Quality of 
Well-Being Scale (QWB), and Assessment of Quality of Life (AQOL). Arthritis Care Res. 
63, S383–S412 (2011). 
66. Polomano, R. C. et al. Psychometric Testing of the Defense and Veterans Pain Rating Scale 
(DVPRS): A New Pain Scale for Military Population. Pain Med. Malden Mass 17, 1505–
1519 (2016). 
67. Clark, M. E., Gironda, R. J. & Young, R. W. Development and validation of the Pain 
Outcomes Questionnaire-VA. J. Rehabil. Res. Dev. 40, 381–395 (2003). 
68. Bovin, M. J. et al. Psychometric Properties of the PTSD Checklist for Diagnostic and 
Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in Veterans. Psychol. Assess. 
(2015). doi:10.1037/pas0000254 
69. Beck, A. T., Steer, R. A., Ball, R. & Ranieri, W. F. Comparison of Beck Depression 
Inventories-IA and-II in Psychiatric Outpatients. J. Pers. Assess. 67, 588–597 (1996). 
70. Cohen, S., Kamarck, T. & Mermelstein, R. A Global Measure of Perceived Stress. J. Health 
Soc. Behav. 24, 385 (1983). 

 
Page 49 of 49 
June 13, 2023 
Version 18           
71. Buysse, D. J., Reynolds, C. F., 3rd, Monk, T. H., Berman, S. R. & Kupfer, D. J. The 
Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. 
Psychiatry Res. 28, 193–213 (1989). 
72. Busby, D. M., Christensen, C., Crane, D. R. & Larson, J. H. A Revision of the Dyadic 
Adjustment Scale for Use with Distressed and Nondistressed Couples: Construct Hierarchy 
and Multidimensional Scales. J. Marital Fam. Ther. 21, 289–308 (1995). 
73. NEFF, K. D. The Development and Validation of a Scale to Measure Self-Compassion. Self 
Identity 2, 223–250 (2003). 
74. Sprecher, S. & Fehr, B. Compassionate love for close others and humanity. J. Soc. Pers. 
Relatsh. 22, 629–651 (2005). 
75. Ten Have, T. R. et al. Intent-to-Treat vs. Non-Intent-to-Treat Analyses under Treatment 
Non-Adherence in Mental Health Randomized Trials. Psychiatr. Ann. 38, 772–783 (2008). 
76. Kenny, D., Kashy, D. & Cook, W. Dyadic Data Analysis. (The Guilford Press, 2006). 
77. ATLAS.ti: The Qualitative Data Analysis Software. Available at: http://www.atlasti.com/. 
(Accessed: 7th April 2011) 
78. Statistical Analysis Software, SAS/STAT | SAS. Available at: 
http://www.sas.com/technologies/analytics/statistics/stat/index.html. (Accessed: 7th April 
2011) 
 
 
 

Updated Statistical Analysis Plan 
Under Aim 1, data for PRO (Patient Reported Outcomes) will be collected at Baseline,  
Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 16. Pain, Stress, and Tension will be collected as a single-item 
scale measures, alongside intervention utilization, intervention satisfaction, and waitlist control 
pain/PTSD symptom mitigation activities weekly. All other PROs will be collected at Weeks 4 
(Month 1), 8 (Month 2), and 16 (Month 4) (see Table 1: Veteran and Partner Measures and 
Psychometric Properties in Protocol for further details). General linear mixed models will be 
used with main effects terms for GROUP (MR vs. waitlist-control), TIME (continuous time 
measure from days from activation in protocol) and a GROUP x TIME interaction term (for rate 
of change).  
Different correlation structures and functional forms of the effects of the MR program 
will be assessed using the information criteria and a final parsimonious model will be 
determined for final statistical inference. For H1.1, the primary outcome measure for pain will 
be the total score on the 19-item POQ, and its subscales. Additional analyses will be performed 
on the DVPRS, and the weekly 5-point Likert-scale Pain item. For H1.2, the primary outcome 
measure for PTSD will be total score on the 20-item PCL-5. For H1.2, the outcome measure for 
psychological symptoms is PSS; the outcome measure of sleep is PSQI; and the outcome 
measure for QOL is the SF12 and BDI.  For H2.1, the outcome measure for relationship 
satisfaction is the RDAS. Additional analyses will be performed on the COS and CSS measures, 
the weekly 5-point Likert-scale Stress item, and the weekly 5-point Likert-scale Tension item. 
Qualitative data analysis followed Inductive and deductive coding methods. A 
qualitative code book, consisting of known constructs from the literature and those that 
emerged inductively from the data, was created. Two trained qualitative researchers coded the 
data using the qualitative analysis software program, ATLAS.ti v. 22. To establish intercoder 
reliability at 80%, two qualitative researchers coded 20% of the interviews (initially every 5th 
transcript then randomly to ensure coding consistency) separately then compared codes to 
determine percent of agreement. Coded text in ATLAS.ti v. 22 was exported and further 
analyzed in Excel spreadsheets to develop themes. To enhance credibility, initial findings were 
presented during quarterly stakeholder meetings to provide input and facilitate refinement of 
findings.  
 

Verbal Consent Script for Informed Consent-Veteran
Mission Reconnect: Delivering a Mobile and Web Based Self Directed 
Complementary and Integrative Health Program to Veterans and Their Partners 
to Manage Pain and PTSD– VA R&DS
_________________________________________________________________
1
__________________________________________________________________________________
Pro00035440                    Verbal Consent Script, V.10                       Date:  01/11/2021
Hello:  My name is____________.
I am a study team member for the research study called: “Mission Reconnect: Delivering a 
Mobile and Web Based Self Directed Complementary and Integrative Health Program to 
Veterans and Their Partners to Manage Pain and PTSD”?
[Proceed to read consent]
Overview of the Study:  Researchers at the James A. Haley Veterans Hospital study many topics.  
We are asking you to take part in “Mission Reconnect: Delivering a Mobile and Web Based Self 
Directed Complementary and Integrative Health Program to Veterans and Their Partners to 
Manage Pain and PTSD”, IRB Study #Pro00035440
Study Staff: This study is being led by Dr. Jolie Haun,  Co-Core Director for Implementation & 
Dissemination, Health Services Research and Development Service, Research & Development 
Service (R&DS) at the James A. Haley Veterans Hospital (JAHVH), Tampa, FL.  This person is 
called the Principal Investigator or PI. Other approved research staff may act on behalf of the PI.
Study Details:  This study is being conducted at JAHVH-Tampa R&DS and is supported by 
Rehabilitation Research and Development. This project is responsive to Rehabilitation and 
Research and Development current special areas of interest for non-pharmacological activity 
based interventions for chronic pain impacting pain reduction, function and quality of life. This 
project aligns with the VA mandate for complementary and integrative health (CIH) care for 
Veterans and their families. CIH complements traditional care for Veterans managing chronic 
conditions, such as chronic pain and PTSD. Mission Reconnect (MR) is a user-driven, dyadic, 
CIH self-care management program delivered remotely that teaches techniques the Veteran and 
family-partner can use to reduce pain, anxiety and stress, promote well-being and improve 
relationship quality. The research goal is to evaluate MR as an approach to manage chronic pain 
and PTSD symptoms, for potential subsequent implementation. This study will possibly provide 
a model for establishing remote access and sustainable implementation of CIH within VA. 
Inclusion criteria : You must an adult, 18 years or older. English-speaking Veterans with chronic 
musculoskeletal pain. Musculoskeletal pain is present if the Veteran meets either of two 
validated criteria (1) two or more occurrences of any of targeted musculoskeletal diagnoses 
recorded at visits separated by at least 30 days within past six months; or (2) high impact chronic 
pain (two or more occurrences of targeted musculoskeletal diagnoses separated by at least 30 
days within the past six months previous to study recruitment and two or more pain scores 
(greater than or equal to 4 separated by at least 30 days within past six months). 
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Verbal Consent Script for Informed Consent-Veteran
Mission Reconnect: Delivering a Mobile and Web Based Self Directed 
Complementary and Integrative Health Program to Veterans and Their Partners 
to Manage Pain and PTSD– VA R&DS
_________________________________________________________________
2
__________________________________________________________________________________
Pro00035440                    Verbal Consent Script, V.10                       Date:  01/11/2021
Exclusion criteria : Moderate to severe TBI, diagnosis or documented treatment for psychosis in 
previous 6 months, currently in substance use disorder treatment, non-English speaking; visual, 
hearing, cognitive impairment that prevent participation or ability to consent, and/or lack of 
access to internet service. These individuals will be excluded due to medical, language, and 
technology access issues that would prevent safe and full study participation. Pain and PTSD 
treatment will not be factored as an inclusion/exclusion criterion but will be evaluated as 
covariates. Potential participants who screen for aggression or violence will also be excluded 
from study.    
Participants:  You are being asked to take part because you are a patient at JAHVH. You will 
receive a copy of the full consent form.
You will be asked to spend several approximately 4 months in the study. The study will last that 
length of time because we want to 1) Determine MR effectiveness for physical (pain, sleep), 
PTSD (intrusion, arousal, avoidance, numbing), and psychological symptoms (depression, stress, 
anxiety), and global health (quality of life), 2) Determine MR effectiveness for social 
(relationship satisfaction, compassion for self/others) outcomes among Veterans and their 
partners,  (ie. spouse, significant other, caregiver, friend or family member) 3) Describe Veteran 
and partner perceived value of MR in a sub-sample of participants. As a study participant you 
may be asked to participate in the following activities. You will not necessarily participate in 
every activity.
Treatment Group: The treatment group will be asked to review all MR content. The MR program 
provides video and audio instruction in a set of 11 evidence-based wellness activities in three 
thematic categories: Connecting with Yourself, Connecting with Quiet, and Connecting with 
Your Partner. All instruction is accessible via the program website (MissionReconnect.com) and 
mobile device apps. Video content totals 91 minutes and was produced by filming two days of 
workshops to teach the practices to Veteran/partner dyads. The Program Overview video (54 
min.) introduces the MR instructional sequences accompanied by commentary by workshop 
participants. Detailed massage instruction is presented in the separate Massage Instruction video 
(34 min.) and Massage Video Supplement (3 min.) addressing use with home furniture. Users are 
encouraged to give and receive at least one massage per week. Audio content totals 67 minutes 
and was recorded in studio, with nine instructional audios ranging from one to 22 minutes. 
Treatment group participants will be instructed to seek advice about treatment from your 
provider. There will be no attempt by study personnel to contact your provider unless an issue 
(i.e., suicidal ideation) arises. Confidentiality may be breached by escalating the issue to the 
necessary health authorities, in order to protect the safety of the study participant and others.
Usual Care Waitlist Control Arm: Study subjects in the control arm will participate in all 
assessments like those in the treatment group, however, will be asked to agree to not access the 
public web site during their participation. Wait-list control participants will be instructed to seek 
advice about treatment from your provider. There will be no attempt by study personnel to  
contact your provider unless an issue (e.g., suicidal ideation) arises. Confidentiality may be 
breached by escalating the issue to the necessary health authorities, in order to protect the safety of 
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Verbal Consent Script for Informed Consent-Veteran
Mission Reconnect: Delivering a Mobile and Web Based Self Directed 
Complementary and Integrative Health Program to Veterans and Their Partners 
to Manage Pain and PTSD– VA R&DS
_________________________________________________________________
3
__________________________________________________________________________________
Pro00035440                    Verbal Consent Script, V.10                       Date:  01/11/2021
the study participant and others. The control condition will account for potential temporal effects 
that occur from passage of time (brief), and expectation effects associated with anticipation of 
MR participation. The control group will receive access to MR after completion of data 
collection.
Data will be collected using (1) self-report surveys; and (2) telephone interviews. 
(1) Self-reported survey data will be collected using online surveys. Participants will receive 
email messages with a link to prompt participants to access the MR website and complete data 
collection. The survey should take no longer than 30 minutes. Study measures will be compiled 
into a single survey format and collected at baseline, 1, 2, and 4 months. Survey data will be kept 
confidential and stored in a secured network for study personnel for the duration of the study.   
(2) Telephone interviews will be conducted with only treatment group members. If selected for a 
phone interview, you may be contacted at a later date after the initiation of the study to 
participate in the interview. The interview will last no longer than 30 minutes. Interviewers will 
request respondents’ attitudes, opinions, and reports about their preferences and the pros and 
cons of MR and/or participating in the practice groups, including their perceptions of usefulness. 
The interviews will be audio recorded with the participant permission on a VA approved digital 
recorder and will be kept confidential and stored in a secured network for study personnel for the 
duration of the study. An audio voice consent will be completed and verbal permission at the 
time of the telephone interview  process. 
About 400 people will take part in this study at JAHVH.  
Participants will receive $5 for providing weekly MR reports on utilization and pain ratings for 
the first 8 weeks of their participation in the study; a total of $40. Participants will receive $20 
each time you provide assessment data over a 4-month period (4 time points); a total of $80. 
Each treatment group member participating in the telephone interview will receive an additional 
$20. The total possible incentive for participants is up to $140. To be paid for your participation 
in the study, you will need to complete Form 1099 which will be provided to you. Please be 
aware for all surveys not completed by the study end period WILL NOT receive payment.   
Voluntary Participation:  Your participation is voluntary.  You do not have to participate and 
may stop your participation at any time.  There will be no penalties or loss of benefits or 
opportunities if you do not participate or decide to stop once you start.  
Benefits, Compensation, and Risk:  We do not know if you will receive any benefit from your 
participation. There is no cost to participate. You will be compensated for your participation in 
the study. This research is considered minimal risk.  Minimum risk means that study risks are the 
same as the risks you face in daily life. Subject participation involves completing interviews over 
the telephone or in person with no invasive procedures. Although unlikely, protocol will be 
followed if there is an adverse event. The project manager will report the adverse event to the PI 
and the event will subsequently be reported to the Institutional Review Board (IRB). If the 
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Verbal Consent Script for Informed Consent-Veteran
Mission Reconnect: Delivering a Mobile and Web Based Self Directed 
Complementary and Integrative Health Program to Veterans and Their Partners 
to Manage Pain and PTSD– VA R&DS
_________________________________________________________________
4
__________________________________________________________________________________
Pro00035440                    Verbal Consent Script, V.10                       Date:  01/11/2021
participant becomes agitated, the research assistant will ask if the participant would like to stop 
the interview and the assistant will discuss this immediately with the PI to determine if any 
further action is indicated. The most likely adverse event to occur would be unauthorized access 
to data. 
Participants in the audio-recorded telephone conversations will not be identified by name. The 
participants will be told in advance of their participation that you may decline to participate at 
any time. 
Again, there are no known risks to those who take part in this study. If you have any study-
related problems, please call the PI at 813-558-7622. Throughout the study, the researchers may 
notify you (via telephone or in person at a scheduled visit) of any new information that may 
become available and which might affect your decision to remain in the study.
If a participant is deemed at high risk for harm/suicide; the study personnel will do the following:
- Stay with patient until you can be referred to appropriate medical staff member.
- If the patient is an outpatient, this will involve taking the patient to the Emergency Room for 
evaluation.  
 - If the patient is an inpatient, this will involve calling the patient’s primary treatment team 
and/or escorting the patient to such providers.
All study personnel who work directly with research participants will be given the names and 
phone numbers of the patient’s medical care team.  After the patient has been referred to the 
appropriate staff, the PI will be alerted.
Confidentiality:  Even if we publish the findings from this study, we will keep your study 
information private and confidential.  Anyone with the authority to look at your records must 
keep them confidential.  While we are doing this research, we cannot let you see or copy the 
research information we have about you.  After the research is done, you have a right to see and 
copy the information about you, as allowed by JAHVH policies.
Confidentiality of data collected by audio recordings, online surveys, and other communication 
with study participants will be maintained, unless an issue arises that poses a risk to the health 
or well-being of the study participant or others (e.g., suicidal ideation). Confidentiality may be 
breached by escalating the issue to the necessary health authorities, in order to protect the safety 
of the study participant and others.
The VHA complies with the requirements of the Health Insurance Portability and Accountability 
Act of 1996 and its privacy regulations and all other applicable laws that protect your privacy.  
We will protect your information according to these laws.  Despite these protections, there is a 
possibility that your information could be used or disclosed in a way that it will no longer be 
protected.  Our Notice of Privacy Practices (a separate document) provides more information on 
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Verbal Consent Script for Informed Consent-Veteran
Mission Reconnect: Delivering a Mobile and Web Based Self Directed 
Complementary and Integrative Health Program to Veterans and Their Partners 
to Manage Pain and PTSD– VA R&DS
_________________________________________________________________
5
__________________________________________________________________________________
Pro00035440                    Verbal Consent Script, V.10                       Date:  01/11/2021
how we protect your information.  If you do not have a copy or would like a copy of the Notice, 
the research team will provide one to you.
Breach of data confidentiality will be minimized by maintaining research records in
accordance with VHA’s Records Control Schedule (RCS10-1), applicable FDA and DHHS
regulations, or as described in VHA Handbook 1200.5, section 7.j. We will strictly adhere
to VA and other federal privacy, confidentiality, and HIPAA regulations.
We must keep your study records as confidential as possible. We may publish what we learn 
from this study. If we do, we will not let anyone know your name. We will not publish anything 
else that would let people know who you are.  However, certain people may need to see your 
study records.  By law, anyone who looks at your records must keep them completely 
confidential.  The only people who will be allowed to see these records are:
•
The research team, including the PI, and all other research staff.
•
Certain government and university persons who need to know more about the study.  For 
example, individuals who provide oversight on this study may need to look at your 
records.  This is done to make sure that we are doing the study in the right way.  They 
also need to make sure that we are protecting your rights and your safety. 
•
The University of South Florida IRB and the staff that work for the IRB. Other 
individuals who work for USF that provide other kinds of oversight may also need to 
look at your records.
•
The Department of Health and Human Services  
•
RR&D 
It is possible that unauthorized individuals could gain access to your responses. Confidentiality 
will be maintained to the degree permitted by the technology used. No guarantees can be made 
regarding the interception of data sent via the Internet. However, your participation in this online 
survey involves risks similar to a person’s everyday use of the Internet. 
Interviews will be audio recorded using Veterans Health Administration approved equipment.  
Recordings will be stored on VHA computers behind password protected firewalls in secure 
password protected folders.  Data will be stored for the duration of the study and in accordance 
with the Veterans Health Administration (VHA) Records Control Schedule.
USE OF YOUR INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION 
Your individually identifiable health information is information about you that contains your 
health information and information that would identify you such as your name, date of birth, or 
other individual identifiers. VHA is asking you to allow the VA (PI and/or the VA research team 
members to access and use your past or present health information in addition to new health 
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Verbal Consent Script for Informed Consent-Veteran
Mission Reconnect: Delivering a Mobile and Web Based Self Directed 
Complementary and Integrative Health Program to Veterans and Their Partners 
to Manage Pain and PTSD– VA R&DS
_________________________________________________________________
6
__________________________________________________________________________________
Pro00035440                    Verbal Consent Script, V.10                       Date:  01/11/2021
information they may collect for the study named above. The investigators of this study are 
committed to protecting your privacy and the confidentiality of information related to your 
health care. However, your authorization (permission) is necessary to
participate in this study. Your treatment, payment, enrollment, or eligibility for VA benefits will 
not be affected, whether or not you agree with this authorization. Your individually identifiable 
health information used for this VA study includes the information below:

Information from your VA Health Records such as diagnoses, progress notes, 
medications, lab or radiology findings

Demographic Information such as name, age, race

Questionnaire, Survey, and/or Subject Diary
USE OF YOUR DATA FOR OTHER RESEARCH: 

Not Applicable - No Data or Specimen Banking for Other Research
DISCLOSURE: The VA research team may need to disclose the information listed above to 
other people or institutions that are not part of VA. VA/VHA complies with the requirements of 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Privacy Act of 1974 
and all other applicable federal laws and regulations that protect your privacy. The VHA Notice 
of Privacy Practices (a separate document) provides more information on how
we protect your information. If you do not have a copy of the Notice, the research team will 
provide one to you. Giving your permission by signing this authorization allows us to disclose 
your information to other institutions or persons as noted below. Once your information has been 
disclosed outside VA/VHA, it may no longer be protected by federal laws and regulations and 
might be re-disclosed by the persons or institutions receiving the information.

Non-VA Institutional Review Board (IRB): USF

Study Sponsor/Funding Source: RR&D 

Compliance and Safety Monitors: Research Compliance Officer

Other Federal agencies required to monitor or oversee research : The Office of Human 
Research Protections, the Government Accountability Office, the Office of the Inspector 
General, the VA Office of Research Oversight, our local Research and Development 
Committee, may look at any portion of your record.
Access to your Individually Identifiable Health Information created or obtained in the course of 
this research. You will not have access to your research related health records.
This will not affect your VA healthcare including your doctor's ability to see your records as part 
of your normal care and will not affect your right to have access to the research records after the 
study is completed.
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Verbal Consent Script for Informed Consent-Veteran
Mission Reconnect: Delivering a Mobile and Web Based Self Directed 
Complementary and Integrative Health Program to Veterans and Their Partners 
to Manage Pain and PTSD– VA R&DS
_________________________________________________________________
7
__________________________________________________________________________________
Pro00035440                    Verbal Consent Script, V.10                       Date:  01/11/2021
If you revoke (take back) your permission, you will no longer be able to participate in this study 
but the benefits to which you are entitled will NOT be affected. If you revoke (take back) your 
permission, the research team may continue to use or disclose the information that it has already 
collected before you revoked (took back) your permission which the research team has relied 
upon for the research. Your revocation is effective as soon as it is received by the study's 
Principal Investigator.
EXPIRATION: Unless you revoke (take back) your permission, your authorization to allow us to 
use and/or disclose your information will expire at the end of this research study PI. 
CERTIFICATE OF CONFIDENTIALITY:
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. This means that the researchers cannot release or use information, documents, or samples 
that may identify you in any action or suit unless you say it is okay. They also cannot provide 
them as evidence unless you have agreed.  This protection includes federal, state, or local civil, 
criminal, administrative, legislative, or other proceedings. An example would be a court 
subpoena.
 
There are some important things that you need to know.  The Certificate DOES NOT stop 
reporting that federal, state or local laws require. Some examples are laws that require reporting 
of child or elder abuse, some communicable diseases, and threats to harm yourself or 
others.  The Certificate CANNOT BE USED to stop a sponsoring United States federal or state 
government agency from checking records or evaluating programs. The Certificate DOES NOT 
stop disclosures required by the federal Food and Drug Administration (FDA).  The Certificate 
also DOES NOT prevent your information from being used for other research if allowed by 
federal regulations.
 
Researchers may release information about you when you say it is okay. For example, you may 
give them permission to release information to insurers, medical providers or any other persons 
not connected with the research.  The Certificate of Confidentiality does not stop you from 
willingly releasing information about your involvement in this research. It also does not prevent 
you from having access to your own information.
 
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Verbal Consent Script for Informed Consent-Veteran
Mission Reconnect: Delivering a Mobile and Web Based Self Directed 
Complementary and Integrative Health Program to Veterans and Their Partners 
to Manage Pain and PTSD– VA R&DS
_________________________________________________________________
8
__________________________________________________________________________________
Pro00035440                    Verbal Consent Script, V.10                       Date:  01/11/2021
CONSENT FOR PRODUCTION AND USE OF VERBAL OR WRITTEN 
STATEMENTS, PHOTOGRAPHS, DIGITAL IMAGES, AND/OR VIDEO OR AUDIO 
RECORDINGS BY VA
 
NOTE: The execution of this verbal consent does not authorize production or use of materials 
except as specified below. The specified material may be produced and used by VA for 
authorized purposes identified below, such as education of VA personnel, research activities, or 
promotional efforts. It may also be disclosed outside VA as permitted by law and as noted below. 
If the material is part of a VA system of records, it may be disclosed outside VA as stated in the 
“Routine Uses” in the "VA Privacy Act Systems of Records" published in the Federal Register.
The purpose of this verbal consent is to document your consent to the Department of Veterans 
Affairs' (VA) request to obtain, produce, and/or use a verbal or written statement or a 
photograph, digital image, and/or video or audio recording containing your likeness or voice. By 
verbally agreeing, you are authorizing the production or use only as specified below. 
You are NOT REQUIRED TO CONSENT TO VA's REQUEST to obtain, produce, and/or use 
your statement, likeness, or voice. Your decision to consent or refuse will not affect your access 
to any present or future VA benefits for which you are eligible. 
You may rescind your consent at any time prior to or during production of an audio recording, or 
before or during your provision of a verbal or written statement. You may rescind your consent 
after production is complete if the burden on VA of complying with that request is not 
unreasonable considering the financial and administrative costs, the ease of compliance that 
number of parties involved.
The audio recording will be produced while you are participant in the study "Mission Reconnect: 
Delivering a Mobile and Web Based Self Directed Complementary and Integrative Health 
Program to Veterans and Their Partners to Manage Pain and PTSD" USF IRB number #PRO-
35440.
If you have any questions about this study, you can contact  Dr. Jolie Haun at (813) 558-7622.  If 
you have question about your rights as a research participant please contact the USF IRB at (813) 
974-5638 or by email at RSCH-IRB@usf.edu. 
Would you like to participate in this study?  [PI or study team member will record if verbal 
consent is given. ]
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Verbal Consent Script for Informed Consent-Partner
Mission Reconnect: Delivering a Mobile and Web Based Self Directed 
Complementary and Integrative Health Program to Veterans and Their Partners 
to Manage Pain and PTSD– VA R&DS
_________________________________________________________________
1
__________________________________________________________________________________
Pro00035440                    Verbal Consent Script, V10                       Date:  01/11/2021
Hello:  My name is____________.
I am a study team member for the research study called: “Mission Reconnect: Delivering a 
Mobile and Web Based Self Directed Complementary and Integrative Health Program to 
Veterans and Their Partners to Manage Pain and PTSD”.
[Proceed to read consent]
Overview of the Study:  Researchers at the James A. Haley Veterans Hospital study many topics.  
We are asking you to take part in “Mission Reconnect: Delivering a Mobile and Web Based Self 
Directed Complementary and Integrative Health Program to Veterans and Their Partners to 
Manage Pain and PTSD”, IRB Study #Pro00035440.
Study Staff: This study is being led by Dr. Jolie Haun, Co-Core Director for Implementation & 
Dissemination, Health Services Research and Development Service, Research and Development 
Service (R&DS) at the James A. Haley Veterans Hospital (JAHVH), Tampa, FL.  This person is 
called the Principal Investigator or PI. Other approved research staff may act on behalf of the PI.
Study Details:  This study is being conducted at JAHVH-Tampa R&DS and is supported by 
Rehabilitation Research and Development. This project is responsive to Rehabilitation Research 
and Development’s current special areas of interest for non-pharmacological activity-based 
interventions for chronic pain impacting pain reduction, function and quality of life. This project 
aligns with the VA mandate for complementary and integrative health (CIH) care for Veterans 
and their families. CIH complements traditional care for Veterans managing chronic conditions, 
such as chronic pain and PTSD. Mission Reconnect (MR) is a user-driven, dyadic, CIH self-care 
management program delivered remotely that teaches techniques the Veteran and family-partner 
can use to reduce pain, anxiety and stress, promote well-being and improve relationship quality. 
The research goal is to evaluate MR as an approach to manage chronic pain and PTSD 
symptoms, for potential subsequent implementation. This study will possibly provide a model for 
establishing remote access and sustainable implementation of CIH within VA. 
Inclusion criteria: You must an adult, 18 years or older. English-speaking Veterans with chronic 
musculoskeletal pain. Musculoskeletal pain is present if the Veteran meets either of two 
validated criteria (1) two or more occurrences of any of targeted musculoskeletal diagnoses 
recorded at visits separated by at least 30 days within past six months; or (2) high impact chronic 
pain, two or more occurrences of targeted musculoskeletal diagnoses separated by at least 30 
days within the past six months previous to study recruitment and two or more pain scores 
(greater than or equal to 4 separated by at least 30 days within past six months). 
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Verbal Consent Script for Informed Consent-Partner
Mission Reconnect: Delivering a Mobile and Web Based Self Directed 
Complementary and Integrative Health Program to Veterans and Their Partners 
to Manage Pain and PTSD– VA R&DS
_________________________________________________________________
2
__________________________________________________________________________________
Pro00035440                    Verbal Consent Script, V10                       Date:  01/11/2021
Exclusion criteria: Moderate to severe TBI, diagnosis or documented treatment for psychosis in 
previous 6 months, currently in substance use disorder treatment, non-English speaking; visual, 
hearing, cognitive impairment that prevent participation or ability to consent, and/or lack of 
access to internet service. These individuals will be excluded due to medical, language, and 
technology access issues that would prevent safe and full study participation. Pain and PTSD 
treatment will not be factored as an inclusion/exclusion criterion but will be evaluated as 
covariates. Potential participants who screen for aggression or violence will also be excluded 
from study.    
Participants:  You are being asked to take part because you are a partner (i.e. spouse, significant 
other, friend, caregiver, or family member) of a patient at JAHVH. You will receive a copy of 
the full consent form.
You will be asked to spend approximately 4 months in the study. The study will last that length 
of time because we want to 1) Determine MR effectiveness for physical (pain, sleep), PTSD 
(intrusion, arousal, avoidance, numbing), and psychological symptoms (depression, stress, 
anxiety), and global health (quality of life), 2) Determine MR effectiveness for social 
(relationship satisfaction, compassion for self/others) outcomes among Veterans and their 
partners, 3) Describe Veteran and partner perceived value of MR in a sub-sample of participants. 
As a study participant you may be asked to participate in the following activities. You will not 
necessarily participate in every activity.
Treatment Group: The treatment group will be asked to review all MR content. The MR program 
provides video and audio instruction in a set of 11 evidence-based wellness activities in three 
thematic categories: Connecting with Yourself, Connecting with Quiet, and Connecting with 
Your Partner. All instruction is accessible via the program website (MissionReconnect.com) and 
mobile device apps. Video content totals 91 minutes and was produced by filming two days of 
workshops to teach the practices to Veteran/partner dyads. The Program Overview video (54 
min.) introduces the MR instructional sequences accompanied by commentary by workshop 
participants. Detailed massage instruction is presented in the separate Massage Instruction video 
(34 min.) and Massage Video Supplement (3 min.) addressing use with home furniture. Users are 
encouraged to give and receive at least one massage per week. Audio content totals 67 minutes 
and was recorded in studio, with nine instructional audios ranging from one to 22 minutes.
Usual Care Waitlist Control Arm: Study subjects in the control arm will participate in all 
assessments like those in the treatment group, however, you will be asked to agree to not access 
the public web site during their participation. Wait-list control participants will be instructed to 
seek advice about treatment from their providers. Other than this initial advice, there will be no 
attempt by study personnel to influence condition management unless an issue (e.g., suicidal 
ideation) arises. The control condition will account for potential temporal effects that occur from 
passage of time (brief), and expectation effects associated with anticipation of MR participation. 
The control group will receive access to MR after completion of data collection.
Data will be collected using (1) self-report surveys; and (2) telephone interviews. 
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Verbal Consent Script for Informed Consent-Partner
Mission Reconnect: Delivering a Mobile and Web Based Self Directed 
Complementary and Integrative Health Program to Veterans and Their Partners 
to Manage Pain and PTSD– VA R&DS
_________________________________________________________________
3
__________________________________________________________________________________
Pro00035440                    Verbal Consent Script, V10                       Date:  01/11/2021
(1) Self-reported survey data will be collected using online surveys. Participants will receive 
email messages with a link to prompt participants to access the MR website and complete data 
collection. The survey should take no longer than 30 minutes. Study measures will be compiled 
into a single survey format and collected at baseline, 1, 2, and 4 months. Survey data will be kept 
confidential and stored in a secured network for study personnel for the duration of the study.   
(2) Telephone interviews will be conducted with only treatment group members. If selected for a 
phone interview, you may be contacted at a later date after the initiation of the study to 
participate in the interview. The interview will last no longer than 30 minutes. Interviewers will 
request respondents’ attitudes, opinions, and reports about their preferences and the pros and 
cons of MR and/or participating in the practice groups, including their perceptions of usefulness. 
The interviews will be audio recorded with participant permission on a VA approved digital 
recorder and will be kept confidential and stored in a secured network for study personnel for the 
duration of the study. An audio voice consent will be completed and verbal permission recorded 
at the time of the telephone interview process. . 
About 400 people will take part in this study at JAHVH.  
Participants will receive $5 for providing weekly MR reports on utilization and pain ratings for 
the first 8 weeks of their participation in the study; a total of $40. Participants will receive $20 
each time you provide assessment data over a 4-month period (4 time points); a total of $80. 
Each treatment group member participating in the telephone interview will receive an additional 
$20. The total possible incentive for participants is up to$140. To be paid for your participation 
in the study, you will need to complete Form 1099 which will be provided to you. Please be 
aware for all surveys not completed by the study end period WILL NOT receive payment.  
Voluntary Participation:  Your participation is voluntary.  You do not have to participate and 
may stop your participation at any time.  There will be no penalties or loss of benefits or 
opportunities if you do not participate or decide to stop once you start.  
Benefits, Compensation, and Risk:  We do not know if you will receive any benefit from your 
participation. There is no cost to participate. You will be compensated for your participation in 
the study. This research is considered minimal risk.  Minimum risk means that study risks are the 
same as the risks you face in daily life. Subject participation involves completing interviews over 
the telephone or in person with no invasive procedures. Although unlikely, protocol will be 
followed if there is an adverse event. The project manager will report the adverse event to the PI 
and the event will subsequently be reported to the Institutional Review Board (IRB). If the 
participant becomes agitated, the research assistant will ask if the participant would like to stop 
the interview and the assistant will discuss this immediately with the PI to determine if any 
further action is indicated. The most likely adverse event to occur would be unauthorized access 
to data. 
Participants in the audio-recorded telephone conversations will not be identified by name. The 
participants will be told in advance of their participation that you may decline to participate at 
any time. 
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Verbal Consent Script for Informed Consent-Partner
Mission Reconnect: Delivering a Mobile and Web Based Self Directed 
Complementary and Integrative Health Program to Veterans and Their Partners 
to Manage Pain and PTSD– VA R&DS
_________________________________________________________________
4
__________________________________________________________________________________
Pro00035440                    Verbal Consent Script, V10                       Date:  01/11/2021
Again, there are no known risks to those who take part in this study. If you have any study-
related problems, please call the PI at 813-558-7622. Throughout the study, researchers may 
notify you (via telephone or in person at a scheduled visit) of any new information that may 
become available and which might affect your decision to remain in the study.
If a participant is deemed at high risk for harm/suicide; the study personnel will do the following:
- Stay with patient until you can be referred to appropriate medical staff member.
- If the patient is an outpatient, this will involve taking the patient to the Emergency Room for 
evaluation.  
 - If the patient is an inpatient, this will involve calling the patient’s primary treatment team 
and/or escorting the patient to such providers.
All study personnel who work directly with research participants will be given the names and 
phone numbers of the patient’s medical care team.  After the patient has been referred to the 
appropriate staff, the PI will be alerted.
Confidentiality:  Even if we publish the findings from this study, we will keep your study 
information private and confidential.  Anyone with the authority to look at your records must 
keep them confidential.  While we are doing this research, we cannot let you see or copy the 
research information we have about you.  After the research is done, you have a right to see and 
copy the information about you, as allowed by JAHVH policies.
Confidentiality of data collected by audio recordings, online surveys, and other communication 
with study participants will be maintained, unless an issue arises that poses a risk to the health 
or well-being of the study participant or others (e.g., suicidal ideation). Confidentiality may be 
breached by escalating the issue to the necessary health authorities, in order to protect the safety 
of the study participant and others.
The VHA complies with the requirements of the Health Insurance Portability and Accountability 
Act of 1996 and its privacy regulations and all other applicable laws that protect your privacy.  
We will protect your information according to these laws.  Despite these protections, there is a 
possibility that your information could be used or disclosed in a way that it will no longer be 
protected.  Our Notice of Privacy Practices (a separate document) provides more information on 
how we protect your information.  If you do not have a copy or would like a copy of the Notice, 
the research team will provide one to you.
Breach of data confidentiality will be minimized by maintaining research records in
accordance with VHA’s Records Control Schedule (RCS10-1), applicable FDA and DHHS
regulations, or as described in VHA Handbook 1200.5, section 7.j. We will strictly adhere
to VA and other federal privacy, confidentiality, and HIPAA regulations.
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Verbal Consent Script for Informed Consent-Partner
Mission Reconnect: Delivering a Mobile and Web Based Self Directed 
Complementary and Integrative Health Program to Veterans and Their Partners 
to Manage Pain and PTSD– VA R&DS
_________________________________________________________________
5
__________________________________________________________________________________
Pro00035440                    Verbal Consent Script, V10                       Date:  01/11/2021
We must keep your study records as confidential as possible. We may publish what we learn 
from this study. If we do, we will not let anyone know your name. We will not publish anything 
else that would let people know who you are.  However, certain people may need to see your 
study records.  By law, anyone who looks at your records must keep them completely 
confidential.  The only people who will be allowed to see these records are:
•
The research team, including the PI, and all other research staff.
•
Certain government and university persons who need to know more about the study.  For 
example, individuals who provide oversight on this study may need to look at your 
records.  This is done to make sure that we are doing the study in the right way.  They 
also need to make sure that we are protecting your rights and your safety. 
•
The University of South Florida IRB and the staff that work for the IRB. Other 
individuals who work for USF that provide other kinds of oversight may also need to 
look at your records.
•
The Department of Health and Human Services  
•
RR&D 
It is possible that unauthorized individuals could gain access to your responses. Confidentiality 
will be maintained to the degree permitted by the technology used. No guarantees can be made 
regarding the interception of data sent via the Internet. However, your participation in this online 
survey involves risks similar to a person’s everyday use of the Internet. 
Interviews will be audio recorded using Veterans Health Administration approved equipment.  
Recordings will be stored on VHA computers behind password protected firewalls in secure 
password protected folders.  Data will be stored for the duration of the study and in accordance 
with the Veterans Health Administration (VHA) Records Control Schedule.
USE OF YOUR INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
Your individually identifiable health information is information about you that contains your 
health information and information that would identify you such as your name, date of birth, or 
other individual identifiers. VHA is asking you to allow the VA PI and/or the VA research team 
members to access and use your past or present health information in addition to new health 
information they may collect for the study named above. The investigators of this study are 
committed to protecting your privacy and the confidentiality of information related to your 
health care. However, your authorization (permission) is necessary to
participate in this study. Your treatment, payment, enrollment, or eligibility for VA benefits will 
not be affected, whether or not you agree with this authorization. Your individually identifiable 
health information used for this VA study includes the information below:
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Verbal Consent Script for Informed Consent-Partner
Mission Reconnect: Delivering a Mobile and Web Based Self Directed 
Complementary and Integrative Health Program to Veterans and Their Partners 
to Manage Pain and PTSD– VA R&DS
_________________________________________________________________
6
__________________________________________________________________________________
Pro00035440                    Verbal Consent Script, V10                       Date:  01/11/2021

Information from your VA Health Records such as diagnoses, progress notes, 
medications, lab or radiology findings

Demographic Information such as name, age, race

Questionnaire, Survey, and/or Subject Diary
USE OF YOUR DATA FOR OTHER RESEARCH: 

Not Applicable - No Data or Specimen Banking for Other Research
DISCLOSURE: The VA research team may need to disclose the information listed above to 
other people or institutions that are not part of VA. VA/VHA complies with the requirements of 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Privacy Act of 1974 
and all other applicable federal laws and regulations that protect your privacy. The VHA Notice 
of Privacy Practices (a separate document) provides more information on how
we protect your information. If you do not have a copy of the Notice, the research team will 
provide one to you. Giving your permission by signing this authorization allows us to disclose 
your information to other institutions or persons as noted below. Once your information has been 
disclosed outside VA/VHA, it may no longer be protected by federal laws and regulations and 
might be re-disclosed by the persons or institutions receiving the information.

Non-VA IRB: USF

Study Sponsor/Funding Source: RR&D 

Compliance and Safety Monitors: Research Compliance Officer

Other Federal agencies required to monitor or oversee research: The Office of Human 
Research Protections, the Government Accountability Office, the Office of the Inspector 
General, the VA Office of Research Oversight, our local Research and Development 
Committee, may look at any portion of your record.
Access to your Individually Identifiable Health Information created or obtained in the course of 
this research. You will not have access to your research related health records.
This will not affect your VA healthcare including your doctor's ability to see your records as part 
of your normal care and will not affect your right to have access to the research records after the 
study is completed.
If you revoke (take back) your permission, you will no longer be able to participate in this study 
but the benefits to which you are entitled will NOT be affected. If you revoke (take back) your 
permission, the research team may continue to use or disclose the information that it has already 
collected before you revoked (took back) your permission which the research team has relied 
upon for the research. Your revocation is effective as soon as it is received by the study's PI.
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Verbal Consent Script for Informed Consent-Partner
Mission Reconnect: Delivering a Mobile and Web Based Self Directed 
Complementary and Integrative Health Program to Veterans and Their Partners 
to Manage Pain and PTSD– VA R&DS
_________________________________________________________________
7
__________________________________________________________________________________
Pro00035440                    Verbal Consent Script, V10                       Date:  01/11/2021
EXPIRATION: Unless you revoke (take back) your permission, your authorization to allow us to 
use and/or disclose your information will expire at the end of this research study. 
CERTIFICATE OF CONFIDENTIALITY:
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. This means that the researchers cannot release or use information, documents, or samples 
that may identify you in any action or suit unless you say it is okay. They also cannot provide 
them as evidence unless you have agreed.  This protection includes federal, state, or local civil, 
criminal, administrative, legislative, or other proceedings. An example would be a court 
subpoena.
 
There are some important things that you need to know.  The Certificate DOES NOT stop 
reporting that federal, state or local laws require. Some examples are laws that require reporting 
of child or elder abuse, some communicable diseases, and threats to harm yourself or 
others.  The Certificate CANNOT BE USED to stop a sponsoring United States federal or state 
government agency from checking records or evaluating programs. The Certificate DOES NOT 
stop disclosures required by the federal Food and Drug Administration (FDA).  The Certificate 
also DOES NOT prevent your information from being used for other research if allowed by 
federal regulations.
 
Researchers may release information about you when you say it is okay. For example, you may 
give them permission to release information to insurers, medical providers or any other persons 
not connected with the research.  The Certificate of Confidentiality does not stop you from 
willingly releasing information about your involvement in this research. It also does not prevent 
you from having access to your own information.
CONSENT FOR PRODUCTION AND USE OF VERBAL OR WRITTEN 
STATEMENTS, PHOTOGRAPHS, DIGITAL IMAGES, AND/OR VIDEO OR AUDIO 
RECORDINGS BY VA
 
NOTE: The execution of this verbal consent does not authorize production or use of materials 
except as specified below. The specified material may be produced and used by VA for 
authorized purposes identified below, such as education of VA personnel, research activities, or 
promotional efforts. It may also be disclosed outside VA as permitted by law and as noted below. 
If the material is part of a VA system of records, it may be disclosed outside VA as stated in the 
“Routine Uses” in the "VA Privacy Act Systems of Records" published in the Federal Register.
The purpose of this verbal consent is to document your consent to the Department of Veterans 
Affairs' (VA) request to obtain, produce, and/or use a verbal or written statement or a 
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Verbal Consent Script for Informed Consent-Partner
Mission Reconnect: Delivering a Mobile and Web Based Self Directed 
Complementary and Integrative Health Program to Veterans and Their Partners 
to Manage Pain and PTSD– VA R&DS
_________________________________________________________________
8
__________________________________________________________________________________
Pro00035440                    Verbal Consent Script, V10                       Date:  01/11/2021
photograph, digital image, and/or video or audio recording containing your likeness or voice. By 
verbally agreeing, you are authorizing the production or use only as specified below. 
You are NOT REQUIRED TO CONSENT TO VA's REQUEST to obtain, produce, and/or use 
your statement, likeness, or voice. Your decision to consent or refuse will not affect your access 
to any present or future VA benefits for which you are eligible. 
You may rescind your consent at any time prior to or during production of a audio recording, or 
before or during your provision of a verbal or written statement. You may rescind your consent 
after production is complete if the burden on VA of complying with that request is not 
unreasonable considering the financial and administrative costs, the ease of compliance that 
number of parties involved.
The audio recording will be produced while you are a participant in the study "Mission 
Reconnect: Delivering a Mobile and Web Based Self Directed Complementary and Integrative 
Health Program to Veterans and Their Partners to Manage Pain and PTSD" USF IRB number 
#PRO-35440.
If you have any questions about this study, you can contact Dr. Jolie Haun at (813) 558-7622.  If 
you have question about your rights as a research participant, please contact the USF IRB at 
(813) 974-5638 or by email at RSCH-IRB@usf.edu. 
Would you like to participate in this study?  [PI or study team member will record if verbal 
consent is given.]
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
Informed Consent to Participate in Research: Social and Behavioral
Research
University of South Florida, the IRB of record for the James A. Haley Veterans’ Hospital
Information to Consider Before Taking Part in this Research Study 
IRB Study #Pro00035440
Researchers at the James A. Haley Veterans’ Hospital study many topics. Our goal is to find better ways 
to help treat patients. To do this, we need the help of people who agree to take part in a research study.
We are asking you to take part in a research study that is called:
Mission Reconnect: Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD
The person who is in charge of this research study is Dr. Jolie Haun. This person is called the Principal 
Investigator. However, other research staff may be involved and can act on behalf of the person in 
charge. The person explaining the research to you may be a study staff member other than the Principal 
Investigator.
The research will be done at James A. Haley Hospital, Primary Care Annex, and the four surrounding 
Community Based Outpatient Clinics (CBOCs) Brooksville, CBOC, Lakeland CBOC, New Port Richey 
CBOC, Zephyrhills CBOC.
This research is being paid for by Veterans Health Administration (VHA), Rehabilitation Research and 
Development (RR&D) Merit grant program.
Should you take part in this study?
This form tells you about this research study. This form explains:
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 1
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673

Why this study is being done.

What will happen during this study and what you will need to do.

Whether there is any chance you might experience potential benefits from being in the study.

The risks of having problems because you are in this study.
Before you decide:

Read this form.

Have a friend or family member read it.

Talk about this study with the person in charge of the study or the person explaining the study. 
You can have someone with you when you talk about the study.

Talk it over with someone you trust.

Find out what the study is about.

You may have questions this form does not answer. You do not have to guess at things you don’t 
understand. If you have questions, ask the person in charge of the study or study staff as you go 
along. Ask them to explain things in a way you can understand.

Take your time to think about it.
It is up to you. If you choose to take part in this study, you will need to sign this consent form. If 
you do not want to take part in this study, you should not sign the form.
Why is this research being done?
We want to examine the effects of a Complementary Integrative Health (CIH) intervention using Mission 
Reconnect (MR), an online self-care management program and mobile application. MR teaches
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 2
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
techniques that Veterans and significant others can use individually, AND together to reduce pain, 
promote well-being and improve their relationship.
You have been selected for this study (inclusion criteria) because:

You are at least 18 years old

You are an English-speaking Veteran with chronic musculoskeletal pain

You have a diagnosis of Post-traumatic stress disorder (PTSD) in your VA health record
In order to participate, you must also have the ability to access and use the Mission Reconnect program 
via internet or mobile device.
You are not eligible to take part in this study (exclusion criteria) if:

You have moderate to severe Traumatic Brain Injury (TBI)

You have had documented treatment for severe mental disorder in previous 6 months

You are currently in an in-patient high intensity substance use disorder treatment program

You are non-English speaking

You have visual, hearing, or cognitive impairment that prevents participation or ability to consent

You lack access to internet service
Potential participants who screen for aggression or violence will also be excluded from this study.
Why are you being asked to take part?
We are asking you to take part in this study because you are a patient at James A. Haley Hospital with 
chronic musculoskeletal pain and PTSD. We want to learn more about your experiences using CIH 
modalities to improve pain and PTSD-related outcomes.
What will happen during this study?
You will be asked to spend several months in this study, about 4 months (treatment group) or about 4-8 
months (control group). The study will last that length of time because we want to 1) Determine MR 
effectiveness for physical (pain, sleep), PTSD (intrusion, arousal, avoidance, numbing), and 
psychological symptoms (depression, stress, anxiety), and global health (quality of life), 2) Determine 
MR effectiveness for social (relationship satisfaction, compassion for self/others) outcomes among 
Veterans and their partners, (i.e. spouse, significant other, caregiver, friend or family member). 3) 
Describe Veteran and partner perceived value
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 3
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
of MR in a sub-sample of participants. As a study participant you may be asked to participate in the 
following activities. You will not necessarily participate in every activity.
Aim 1: screening interview to assess the occurrence of chronic pain and PTSD
Aim 2: self-report survey assessment data and weekly reports collected using electronic survey 
Aim 3: complete an audio-record single telephone interview to collect qualitative data
Mission Reconnect: Mission Reconnect (MR) provides support for Veterans’ pain and PTSD symptom 
management using CIH modalities (i.e., massage, meditation, positive psychology) that can be accessed 
electronically (via Internet or mobile application).
Treatment Group: The treatment group will be asked to review all MR content. The MR program 
provides video and audio instruction in a set of 11 evidence-based wellness activities in three thematic 
categories: Connecting with Yourself, Connecting with Quiet, and Connecting with Your Partner. All 
instruction is accessible via the program website (MissionReconnect.com) and mobile device apps. Video 
content totals 91 minutes and was produced by filming two days of workshops to teach the practices to 
Veteran/partner dyads. The Program Overview video (54 min.) introduces the MR instructional sequences 
accompanied by commentary by workshop participants. Detailed massage instruction is presented in the 
separate Massage Instruction video (34 min.) and Massage Video Supplement (3 min.) addressing use 
with home furniture. Users are encouraged to give and receive at least one massage per week. Audio 
content totals 67 minutes and was recorded in studio, with nine instructional audios ranging from one to 
22 minutes. Treatment group participants will be instructed to seek advice about treatment from your 
provider. There will be no attempt by study personnel to contact your provider unless an issue (i.e., 
suicidal ideation) arises. Confidentiality may be breached by escalating the issue to the necessary health 
authorities, in order to protect the safety of the study participant and others.
Usual Care Waitlist Control Arm: Study subjects in the control arm will participate in all assessments like 
those in the treatment group, however, you will be asked to agree to not access the public web site during 
their participation. Wait-list control participants will be instructed to seek advice about treatment from 
your provider. There will be no attempt by study personnel to contact your provider  unless an issue (i.e., 
suicidal ideation) arises. Confidentiality may be breached by escalating the issue to the necessary health 
authorities, in order to protect the safety of the study participant and others. The control condition will 
account for potential temporal effects that occur from passage of time (brief), and expectation effects 
associated with anticipation of MR participation. The control group will receive access to MR after 
completion of data collection.
Data will be collected using (1) self-report surveys; and (2) telephone interviews.
Subject’s Name:   
_______________________________
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 4
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
(1) Self-reported survey data will be collected using online surveys. Participants will receive email 
messages with a link to prompt participants to access the MR website and complete data collection. The 
survey should take no longer than 30 minutes. Study measures will be compiled into a single survey 
format and collected at baseline, 1, 2, and 4 months. Survey data will be kept confidential and stored in a 
secured network for study personnel for the duration of the study.
(2) Telephone interviews will be conducted with only treatment group members. If selected for a phone 
interview, you may be contacted later after the initiation of the study to participate in the interview. The 
interview will last no longer than 30 minutes. Interviewers will request respondents’ attitudes, opinions, 
and reports about their preferences and the pros and cons of MR and/or participating in the practice 
groups, including their perceptions of usefulness. The interviews will be audio recorded, and will be kept 
confidential and stored in a secured network for study personnel for the duration of the study. An audio 
voice consent must be completed in addition to the verbal and/or written consent documentation.
How many other people will take part?
About 400 people will take part in this study at James A. Haley Veterans’ Hospital.
What other choices do you have if you decide not to take part?
If you decide not to take part in this study, that is okay. Participation in this research study is entirely 
voluntary. In other words, you do not have to participate in this study. If you do not want to participate 
in this study, the rights and health care benefits you are entitled to will not change (i.e., including VA 
benefits and access to standard medical care). Any new significant findings developed during the study 
that may change your decision about participating will be provided to you. Instead of being in this 
research study you can choose not to participate.
Will you be paid for taking part in this study?
Participants will receive $5 for providing weekly MR reports on utilization and pain ratings for the first 8 
weeks of their participation in the study; a total of $40. Participants will receive $20 each time you 
provide assessment data over a 4-month period (4-time points); a total of $80. Each treatment group
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 5
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
member participating in the telephone interview will receive an additional $20. The total possible 
incentive for participants is up to$140. To be paid for your participation in the study, you will need to 
complete Form 1099 which will be provided to you. Please be aware for all surveys not completed by 
the study end period WILL NOT receive payment.
What will it cost you to take part in this study?
It will not cost you anything to be part of the study. As a VA patient, there may be co-payment costs for 
some of the non-research procedures for which the VA may not pay even if these occur while you are 
participating in this research. Some veterans are required to pay co-payments for medical care and 
services provided by the VA. These co-payment requirements will continue to apply to medical care and 
services provided by the VA that are not part of this study and that you would receive as part of your 
regular medical care.
What are the potential benefits if you take part in this study?
The potential benefits to you are:
Participants may or may not receive direct benefit for participating in this study because of engaging in 
the proposed intervention. Participants randomized to the control group who receive access to MR after 
you complete data collection, may also receive benefit from being in the study. Additionally, this research 
may benefit the Veteran population and their partners in the future if the study is found to be effective and 
subsequently disseminated to Veterans and their partners throughout the VA system.
What are the risks if you take part in this study?
There are no known risks to those who take part in this study. If you have any study-related problems, 
please call the PI at 813-558-7622. Throughout the study, the researchers may notify you (via telephone 
or in person at a scheduled visit) of any new information that may become available and which might 
affect your decision to remain in the study.
If a participant is deemed at high risk for harm/suicide; the study personnel will do the following:
- Stay with patient until you can be referred to appropriate medical staff member.
- If the patient is an outpatient, this will involve taking the patient to the Emergency Room for evaluation.
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 6
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
- If the patient is an inpatient, this will involve calling the patient’s primary treatment team and/or 
escorting the patient to such providers.
All study personnel who work directly with research participants will be given the names and phone 
numbers of the patient’s medical care team. After the patient has been referred to the appropriate staff, 
the PI will be alerted.
What if you are injured while you are in the study?
You are participating in a research project approved by a Research and Development Committee and 
conducted under the supervision of one or more VA employees. Every reasonable safety measure will be 
used to protect your well-being. If you are injured because of your participation as a research subject in 
this research study, the VA medical facility will provide you with necessary medical treatment. 
If you need emergency care:

Go to your nearest hospital or emergency room right away. Call 911 or for help. It is 
important that you tell the doctors at the hospital or emergency room that you are participating in a 
research study. If possible, take a copy of this consent form with you when you go.

Call the person in charge of this study as soon as you can. You will need to know that you are 
hurt or ill. Call Dr. Jolie Haun at 813-558-7622.
If you need emergency care in a private hospital, have a friend or family member contact the VA 
immediately at (813) 972-2000, extension 6197 or 6198, and your study doctor so that you can coordinate 
care with a private hospital. If an eligible veteran requires admission to a non-VA hospital because of an 
emergency, the Department of Veterans Affairs will not be responsible for the cost incurred unless the 
Department of Veterans Affairs is involved immediately.
If it is not an emergency, and you get hurt or begin to feel bad: Go to your regular doctor. Tell your 
doctor that you are taking part in this study. If you can, take a copy of this consent form with you.
If you are harmed while taking part in the study:
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 7
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
If you believe you have a medical concern related to this study, or have been hurt or became sick because 
of something that is done during the study, you should call the person listed below immediately.
DURING THE DAY:
Dr.  Jolie Haun, PhD
Telephone number: 813-558-7622
AFTER HOURS:
Dr. Jolie Haun, PhD
Telephone number: 813-558-7622
Emergency and ongoing medical treatment will be provided as needed.
Compensation for Research-Related Injuries
Financial compensation for research-related injuries, lost wages, discomfort or disability may be 
available. You do not give up any of your legal rights and you do not release the VA from any liability by 
signing this form.
What happens if you decide not to take part in this study?
You should only take part in this study if you want to volunteer. You should not feel that there is any 
pressure to take part in the study to please the study Principal Investigator or the research staff.
If you decide not to take part:

You will not be in trouble or lose any rights you normally have.
What if you join the study and decide you want to stop later on?
You can decide after signing this informed consent document that you no longer want to take part in this 
study. We will keep you informed of any new developments which might affect your willingness to 
continue to participate in the study. However, you can decide you want to stop taking part in the study
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 8
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
for any reason at any time. If you decide you want to stop taking part in the study, tell the study staff as 
soon as you can.

We will tell you how to stop safely. We will tell you if there are any dangers if you stop suddenly.
Are there reasons we might take you out of the study later on?
Even if you want to stay in the study, there may be reasons we will need to take you out of it. You 
may be taken out of this study if:

We find out it is not safe for you to stay in the study. For example, your health may worsen.

You are not coming for your study visits when scheduled.

Study inclusion/exclusion criteria are not met.
Informed Consent Process for Online Survey Based Research
It is possible that unauthorized individuals could gain access to your responses. Confidentiality will be 
maintained to the degree permitted by the technology used. No guarantees can be made regarding the 
interception of data sent via the Internet. However, your participation in this online survey involves risks 
similar to a person’s everyday use of the Internet.
Interviews will be audio recorded using Veterans Health Administration approved equipment. Recordings 
will be stored on VHA computers behind password protected firewalls in secure password protected folders. 
Data will be stored for the duration of the study and in accordance with the Veterans Health Administration 
(VHA) Records Control Schedule.
Confidentiality of data collected by audio recordings, online surveys, and other communication with study 
participants will be maintained, unless an issue arises that poses a risk to the health or well-being of the 
study participant or others (e.g., suicidal ideation). Confidentiality may be breached by escalating the issue 
to the necessary health authorities, in order to protect the safety of the study participant and others.
Your Rights:
You can refuse to sign this form. If you do not sign this form:

You will not be able to take part in this research.
While we are doing this research, we cannot let you see or copy the research information we have about 
you. After the research is done, you have a right to see and copy the information about you, as allowed by 
James A. Haley Veterans’ Hospital policies.
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 9
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
The VHA complies with the requirements of the Health Insurance Portability and Accountability Act of 
1996 and its privacy regulations and all other applicable laws that protect your privacy. We will protect 
your information according to these laws. Despite these protections, there is a possibility that your 
information could be used or disclosed in a way that it will no longer be protected. Our Notice of Privacy 
Practices (a separate document) provides more information on how we protect your information. If you 
do not have a copy or would like a copy of the Notice, the research team will provide one to you.
Breach of data confidentiality will be minimized by maintaining research records in 
accordance with VHA’s Records Control Schedule (RCS10-1), applicable FDA and DHHS 
regulations, or as described in VHA Handbook 1200.5, section 7.j. We will strictly adhere 
to VA and other federal privacy, confidentiality, and HIPAA regulations.
USE OF YOUR INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION (IIHI):
Your individually identifiable health information is information about you that contains your health 
information and information that would identify you such as your name, date of birth, or other individual 
identifiers. VHA is asking you to allow the VA Principal Investigator (PI) and/or the VA research team 
members to access and use your past or present health information in addition to new health information 
you may collect for the study named above. The investigators of this study are committed to protecting 
your privacy and the confidentiality of information related to your health care. However, your 
authorization (permission) is necessary to participate in this study. Your treatment, payment, enrollment, 
or eligibility for VA benefits will not be affected, if you agree with this authorization. Your individually 
identifiable health information used for this VA study includes the information below:
•
Information from your VA Health Records such as diagnoses, progress notes, medications, lab or 
radiology findings
•
Demographic Information such as name, age, race
•
Questionnaire, Survey, and/or Subject Diary 
USE OF YOUR DATA FOR OTHER RESEARCH:
•
Not Applicable - No Data or Specimen Banking for Other Research
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
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Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
DISCLOSURE:
The VA research team may need to disclose the information listed above to other people or institutions 
that are not part of VA. VA/VHA complies with the requirements of the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA), Privacy Act of 1974 and all other applicable federal laws and 
regulations that protect your privacy. The VHA Notice of Privacy Practices (a separate document) 
provides more information on how we protect your information. If you do not have a copy of the Notice, 
the research team will provide one to you. Giving your permission by signing this authorization allows us 
to disclose your information to other institutions or persons as noted below. Once your information has 
been disclosed outside VA/VHA, it may no longer be protected by federal laws and regulations and might 
be re-disclosed by the persons or institutions receiving the information.
•
Non-VA Institutional Review Board (IRB): USF
•
Study Sponsor/Funding Source: RR&D
•
Compliance and Safety Monitors: RCO
•
Other Federal agencies required to monitor or oversee research (such as FDA, OHRP, GAO): The 
Office of Human Research Protections, the Government Accountability Office, the Office of the 
Inspector General, the VA Office of Research Oversight, our local Research and Development 
Committee, may look at any portion of your record.
Access to your Individually Identifiable Health Information created or obtained during this research. You 
will not have access to your research related health records.
This will not affect your VA healthcare including your doctor's ability to see your records as part of your 
normal care and will not affect your right to have access to the research records after the study is 
completed.
REVOCATION:
If you sign the HIPPA authorization you may change your mind and revoke or take back your permission 
at any time. You must do this in writing and must send your written request to the Principal Investigator 
for this study. If you revoke (take back) your permission, you will no longer be able to participate in this
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
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In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
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Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
study but the benefits to which you are entitled will NOT be affected. If you revoke (take back) your 
permission, the research team may continue to use or disclose the information that it has already collected 
before you revoked (took back) your permission which the research team has relied upon for the research. 
Your written revocation is effective as soon as it is received by the study's Principal Investigator.
EXPIRATION:
Unless you revoke (take back) your permission, your authorization to allow us to use and/or disclose your 
information will expire at the end of this research study.
CERTIFICATE OF CONFIDENTIALITY:
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means 
that the researchers cannot release or use information, documents, or samples that may identify you in any 
action or suit unless you say it is okay. They also cannot provide them as evidence unless you have 
agreed.  This protection includes federal, state, or local civil, criminal, administrative, legislative, or other 
proceedings. An example would be a court subpoena.
 
There are some important things that you need to know.  The Certificate DOES NOT stop reporting that 
federal, state or local laws require. Some examples are laws that require reporting of child or elder abuse, 
some communicable diseases, and threats to harm yourself or others.  The Certificate CANNOT BE USED to 
stop a sponsoring United States federal or state government agency from checking records or evaluating 
programs. The Certificate DOES NOT stop disclosures required by the federal Food and Drug Administration 
(FDA).  The Certificate also DOES NOT prevent your information from being used for other research if 
allowed by federal regulations.
 
Researchers may release information about you when you say it is okay. For example, you may give them 
permission to release information to insurers, medical providers or any other persons not connected with the 
research.  The Certificate of Confidentiality does not stop you from willingly releasing information about 
your involvement in this research. It also does not prevent you from having access to your own information.
You can get the answers to your questions, concerns, complaints or issues.
If you have any questions, concerns or complaints about this study, call Dr. Jolie Haun at 813-558-7622.
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 12
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
If you have questions about your rights, general questions, complaints, or issues as a person taking part in 
this study, call the USF IRB at (813) 974-5638 or contact by email at RSCH-IRB@usf.edu.
If you would like to contact someone independent of the research study, or cannot reach the research staff, 
you may contact the James A. Haley Veterans’ Hospital Research Compliance Officer at 813-903-4274.
Statement of Participation in Research
It is up to you to decide whether you want to take part in this study. If you want to take part, please read 
the statements below and sign the form if the statements are true.
I freely give my consent to take part in this study and authorize that my health information as 
agreed above, be collected/disclosed in this study. I understand that by signing this form I am agreeing 
to take part in research. I have received a copy of this form to take with me.
Signature of Person Taking Part in Study
Date
Printed Name of Person Taking Part in Study
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
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Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
Statement of Person Obtaining Informed Consent / Research Authorization
I have carefully explained to the person taking part in the study what he or she can expect.
I hereby certify that when this person signs this form, to the best of my knowledge, he or she understands:

What the study is about.

What procedures/interventions/investigational drugs or devices will be used.

What the potential benefits might be.

What the known risks might be.

How the information collected about the person will be used.
I also certify that he or she does not have any problems that could make it hard to understand what it 
means to take part in this research. This person speaks the language that was used to explain this 
research.
This person reads well enough to understand this form or, if not, this person is able to hear and understand 
when the form is read to him or her.
This person does not have a medical/psychological problem that would compromise comprehension and 
therefore makes it hard to understand what is being explained and can, therefore, give informed consent.
This person is not taking drugs that may cloud their judgment or make it hard to understand what is being 
explained and can, therefore, give informed consent.
Signature of Person Obtaining Informed Consent / Research Authorization
Date
Printed Name of Person Obtaining Informed Consent / Research Authorization
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
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Page 14
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
Informed Consent to Participate in Research: Social and Behavioral
Research
University of South Florida, the IRB of record for the James A. Haley Veterans’ Hospital
Information to Consider Before Taking Part in this Research Study 
IRB Study #Pro00035440
Researchers at the James A. Haley Veterans’ Hospital study many topics. Our goal is to find better ways 
to help treat patients. To do this, we need the help of people who agree to take part in a research study.
We are asking you to take part in a research study that is called:
Mission Reconnect: Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD
The person who is in charge of this research study is Dr. Jolie Haun. This person is called the Principal 
Investigator. However, other research staff may be involved and can act on behalf of the person in 
charge. The person explaining the research to you may be a study staff member other than the Principal 
Investigator.
The research will be done at James A. Haley Hospital, Primary Care Annex, and the four surrounding 
Community Based Outpatient Clinics (CBOCs) Brooksville, CBOC, Lakeland CBOC, New Port Richey 
CBOC, Zephyrhills CBOC.
This research is being paid for by Veterans Health Administration (VHA), Rehabilitation Research and 
Development (RR&D) Merit grant program.
Should you take part in this study?
This form tells you about this research study. This form explains:
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 1
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673

Why this study is being done.

What will happen during this study and what you will need to do.

Whether there is any chance you might experience potential benefits from being in the study.

The risks of having problems because you are in this study.
Before you decide:

Read this form.

Have a friend or family member read it.

Talk about this study with the person in charge of the study or the person explaining the study. 
You can have someone with you when you talk about the study.

Talk it over with someone you trust.

Find out what the study is about.

You may have questions this form does not answer. You do not have to guess at things you don’t 
understand. If you have questions, ask the person in charge of the study or study staff as you go 
along. Ask them to explain things in a way you can understand.

Take your time to think about it.
It is up to you. If you choose to take part in this study, you will need to sign this consent form. If 
you do not want to take part in this study, you should not sign the form.
Why is this research being done?
We want to examine the effects of a Complementary Integrative Health (CIH) intervention using Mission 
Reconnect (MR), an online self-care management program and mobile application. MR teaches 
techniques that Veterans and significant others can use individually, AND together to reduce pain, 
promote well-being and improve their relationship.
You have been selected for this study (inclusion criteria) because:

You are at least 18 years old

You are an English-speaking Veteran with chronic musculoskeletal pain*
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 2
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673

You have a diagnosis of Post-traumatic stress disorder (PTSD) in your VA health record*
*Veteran partner has diagnosis
In order to participate, you must also have the ability to access and use the Mission Reconnect program 
via internet or mobile device.
You are not eligible to take part in this study (exclusion criteria) if:

You have moderate to severe Traumatic Brain Injury (TBI)

You have had documented treatment for severe mental disorder in previous 6 months

You are currently in an in-patient high intensity substance use disorder treatment program

You are non-English speaking

You have visual, hearing, or cognitive impairment that prevents participation or ability to consent

You lack access to internet service
Potential participants who screen for aggression or violence will also be excluded from this study.
Why are you being asked to take part?
We are asking you to take part in this study because you are a partner of a patient at James A. Haley 
Hospital with chronic musculoskeletal pain and PTSD. We want to learn more about your experiences 
using CIH modalities to improve pain and PTSD-related outcomes.
What will happen during this study?
You will be asked to spend several months in this study, about 4 months (treatment group) or about 4-8 
months (control group). The study will last that length of time because we want to 1) Determine MR 
effectiveness for physical (pain, sleep), PTSD (intrusion, arousal, avoidance, numbing), and 
psychological symptoms (depression, stress, anxiety), and global health (quality of life), 2) Determine 
MR effectiveness for social (relationship satisfaction, compassion for self/others) outcomes among 
Veterans and their partners, (i.e. spouse, significant other, caregiver, friend or family member) .3) 
Describe Veteran and partner perceived value of MR in a sub-sample of participants. As a study 
participant you may be asked to participate in the following activities. You will not necessarily participate 
in every activity.
Aim 1: screening interview to assess the occurrence of chronic pain and PTSD
Aim 2: self-report survey assessment data and weekly reports collected using electronic survey
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
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Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
Aim 3: complete an audio-record single telephone interview to collect qualitative data
Mission Reconnect: Mission Reconnect (MR) provides support for Veterans’ pain and PTSD symptom 
management using CIH modalities (i.e., massage, meditation, positive psychology) that can be accessed 
electronically (via Internet or mobile application).
Treatment Group: The treatment group will be asked to review all MR content. The MR program 
provides video and audio instruction in a set of 11 evidence-based wellness activities in three thematic 
categories: Connecting with Yourself, Connecting with Quiet, and Connecting with Your Partner. All 
instruction is accessible via the program website (MissionReconnect.com) and mobile device apps. Video 
content totals 91 minutes and was produced by filming two days of workshops to teach the practices to 
Veteran/partner dyads. The Program Overview video (54 min.) introduces the MR instructional sequences 
accompanied by commentary by workshop participants. Detailed massage instruction is presented in the 
separate Massage Instruction video (34 min.) and Massage Video Supplement (3 min.) addressing use 
with home furniture. Users are encouraged to give and receive at least one massage per week. Audio 
content totals 67 minutes and was recorded in studio, with nine instructional audios ranging from one to 
22 minutes.
Usual Care Waitlist Control Arm: Study subjects in the control arm will participate in all assessments like 
those in the treatment group, however, you will be asked to agree to not access the public web site during 
their participation. Wait-list control participants will be instructed to seek advice about treatment from 
their providers. Other than this initial advice, there will be no attempt by study personnel to influence 
condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account 
for potential temporal effects that occur from passage of time (brief), and expectation effects associated 
with anticipation of MR participation. The control group will receive access to MR after completion of 
data collection.
Data will be collected using (1) self-report surveys; and (2) telephone interviews.
(1) Self-reported survey data will be collected using online surveys. Participants will receive email 
messages with a link to prompt participants to access the MR website and complete data collection. The 
survey should take no longer than 30 minutes. Study measures will be compiled into a single survey
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
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Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
format and collected at baseline, 1, 2, and 4 months. Survey data will be kept confidential and stored in a 
secured network for study personnel for the duration of the study.
(2) Telephone interviews will be conducted with only treatment group members. If selected for a phone 
interview, you may be contacted later after the initiation of the study to participate in the interview. The 
interview will last no longer than 30 minutes. Interviewers will request respondents’ attitudes, opinions, 
and reports about their preferences and the pros and cons of MR and/or participating in the practice 
groups, including their perceptions of usefulness. The interviews will be audio recorded and will be kept 
confidential and stored in a secured network for study personnel for the duration of the study. An audio 
voice consent must be completed in addition to the verbal and/or written consent documentation.
How many other people will take part?
About 400 people will take part in this study at James A. Haley Veterans’ Hospital.
What other choices do you have if you decide not to take part?
If you decide not to take part in this study, that is okay. Participation in this research study is entirely 
voluntary. In other words, you do not have to participate in this study. If you do not want to participate 
in this study, the rights and health care benefits you are entitled to will not change (i.e., including VA 
benefits and access to standard medical care). Any new significant findings developed during the study 
that may change your decision about participating will be provided to you. Instead of being in this 
research study you can choose not to participate.
Will you be paid for taking part in this study?
Participants will receive $5 for providing weekly MR reports on utilization and pain ratings for the first 8 
weeks of their participation in the study; a total of $40. Participants will receive $20 each time you 
provide assessment data over a 4-month period (4-time points); a total of $80. Each treatment group 
member participating in the telephone interview will receive an additional $20. The total possible 
incentive for participants is up to $140. To be paid for your participation in the study, you will need to 
complete Form 1099 which will be provided to you. Please be aware for all surveys not completed by 
your study end period WILL NOT receive payment.
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
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Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
What will it cost you to take part in this study?
It will not cost you anything to be part of the study. As a VA patient, there may be co-payment costs for 
some of the non-research procedures for which the VA may not pay even if these occur while you are 
participating in this research. Some veterans are required to pay co-payments for medical care and 
services provided by the VA. These co-payment requirements will continue to apply to medical care and 
services provided by the VA that are not part of this study and that you would receive as part of your 
regular medical care.
What are the potential benefits if you take part in this study?
The potential benefits to you are:
Participants may or may not receive direct benefit for participating in this study because of engaging in 
the proposed intervention. Participants randomized to the control group who receive access to MR after 
you complete data collection, may also receive benefit from being in the study. Additionally, this research 
may benefit the Veteran population and their partners in the future if the study is found to be effective and 
subsequently disseminated to Veterans and their partners throughout the VA system.
What are the risks if you take part in this study?
There are no known risks to those who take part in this study. If you have any study-related problems, 
please call the PI at 813-558-7622. Throughout the study, the researchers may notify you (via telephone 
or in person at a scheduled visit) of any new information that may become available and which might 
affect your decision to remain in the study.
If a participant is deemed at high risk for harm/suicide; the study personnel will do the following:
- Stay with patient until you can be referred to appropriate medical staff member.
- If the patient is an outpatient, this will involve taking the patient to the Emergency Room for evaluation.
- If the patient is an inpatient, this will involve calling the patient’s primary treatment team and/or 
escorting the patient to such providers.
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
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Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
All study personnel who work directly with research participants will be given the names and phone 
numbers of the patient’s medical care team. After the patient has been referred to the appropriate staff, 
the PI will be alerted.
What if you are injured while you are in the study?
You are participating in a research project approved by a Research and Development Committee and 
conducted under the supervision of one or more VA employees. Every reasonable safety measure will be 
used to protect your well-being. If you are injured because of your participation as a research subject in 
this research study, the VA medical facility will provide you with necessary medical treatment.
If you need emergency care:

Go to your nearest hospital or emergency room right away. Call 911 or for help. It is 
important that you tell the doctors at the hospital or emergency room that you are participating in a 
research study. If possible, take a copy of this consent form with you when you go.

Call the person in charge of this study as soon as you can. You will need to know that you are 
hurt or ill. Call Dr. Jolie Haun at 813-558-7622.
If you need emergency care in a private hospital, have a friend or family member contact the VA 
immediately at (813) 972-2000, extension 6197 or 6198, and your study doctor so that you can coordinate 
care with a private hospital. If an eligible veteran requires admission to a non-VA hospital because of an 
emergency, the Department of Veterans Affairs will not be responsible for the cost incurred unless the 
Department of Veterans Affairs is involved immediately.
If it is not an emergency, and you get hurt or begin to feel bad: Go to your regular doctor. Tell your 
doctor that you are taking part in this study. If you can, take a copy of this consent form with you.
If you are harmed while taking part in the study:
If you believe you have a medical concern related to this study, or have been hurt or became sick because 
of something that is done during the study, you should call the person listed below immediately.
DURING THE DAY:
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
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Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
Dr. Jolie Haun, PhD
Telephone number: 813-558-7622
AFTER HOURS:
Dr. Jolie Haun, PhD
Telephone number: 813-558-7622
Emergency and ongoing medical treatment will be provided as needed.
Compensation for Research-Related Injuries
Financial compensation for research-related injuries, lost wages, discomfort or disability may be 
available. You do not give up any of your legal rights and you do not release the VA from any liability by 
signing this form.
What happens if you decide not to take part in this study?
You should only take part in this study if you want to volunteer. You should not feel that there is any 
pressure to take part in the study to please the study Principal Investigator or the research staff.
If you decide not to take part:

You will not be in trouble or lose any rights you normally have.
What if you join the study and decide you want to stop later on?
You can decide after signing this informed consent document that you no longer want to take part in this 
study. We will keep you informed of any new developments which might affect your willingness to 
continue to participate in the study. However, you can decide you want to stop taking part in the study 
for any reason at any time. If you decide you want to stop taking part in the study, tell the study staff as 
soon as you can.

We will tell you how to stop safely. We will tell you if there are any dangers if you stop suddenly.
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 8
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
Are there reasons we might take you out of the study later on?
Even if you want to stay in the study, there may be reasons we will need to take you out of it. You 
may be taken out of this study if:

We find out it is not safe for you to stay in the study. For example, your health may worsen.

You are not coming for your study visits when scheduled.

Study inclusion/exclusion criteria are not met.
Informed Consent Process for Online Survey Based Research
It is possible that unauthorized individuals could gain access to your responses. Confidentiality will be 
maintained to the degree permitted by the technology used. No guarantees can be made regarding the 
interception of data sent via the Internet. However, your participation in this online survey involves risks 
similar to a person’s everyday use of the Internet.
Interviews will be audio recorded using Veterans Health Administration approved equipment. Recordings 
will be stored on VHA computers behind password protected firewalls in secure password protected folders. 
Data will be stored for the duration of the study and in accordance with the Veterans Health Administration 
(VHA) Records Control Schedule.
Confidentiality of data collected by audio recordings, online surveys, and other communication with study 
participants will be maintained, unless an issue arises that poses a risk to the health or well-being of the study 
participant or others (e.g., suicidal ideation). Confidentiality may be breached by escalating the issue to the 
necessary health authorities, in order to protect the safety of the study participant and others.
Your Rights:
You can refuse to sign this form. If you do not sign this form:

You will not be able to take part in this research.
While we are doing this research, we cannot let you see or copy the research information we have about 
you. After the research is done, you have a right to see and copy the information about you, as allowed by 
James A. Haley Veterans’ Hospital policies.
The VHA complies with the requirements of the Health Insurance Portability and Accountability Act of 
1996 and its privacy regulations and all other applicable laws that protect your privacy. We will protect 
your information according to these laws. Despite these protections, there is a possibility that your 
information could be used or disclosed in a way that it will no longer be protected. Our Notice of Privacy
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 9
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
Practices (a separate document) provides more information on how we protect your information. If you 
do not have a copy or would like a copy of the Notice, the research team will provide one to you.
Breach of data confidentiality will be minimized by maintaining research records in 
accordance with VHA’s Records Control Schedule (RCS10-1), applicable FDA and DHHS 
regulations, or as described in VHA Handbook 1200.5, section 7.j. We will strictly adhere 
to VA and other federal privacy, confidentiality, and HIPAA regulations.
USE OF YOUR INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION (IIHI):
Your individually identifiable health information is information about you that contains your health 
information and information that would identify you such as your name, date of birth, or other individual 
identifiers. VHA is asking you to allow the VA Principal Investigator (PI) and/or the VA research team 
members to access and use your past or present health information in addition to new health information 
you may collect for the study named above. The investigators of this study are committed to protecting 
your privacy and the confidentiality of information related to your health care. However, your 
authorization (permission) is necessary to participate in this study. Your treatment, payment, enrollment, 
or eligibility for VA benefits will not be affected, if you agree with this authorization. Your individually 
identifiable health information used for this VA study includes the information below:
•
Information from your VA Health Records such as diagnoses, progress notes, medications, lab or 
radiology findings
•
Demographic Information such as name, age, race
•
Questionnaire, Survey, and/or Subject Diary 
USE OF YOUR DATA FOR OTHER RESEARCH:
•
Not Applicable - No Data or Specimen Banking for Other Research 
DISCLOSURE:
The VA research team may need to disclose the information listed above to other people or institutions 
that are not part of VA. VA/VHA complies with the requirements of the Health Insurance Portability and
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 10
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
Accountability Act of 1996 (HIPAA), Privacy Act of 1974 and all other applicable federal laws and 
regulations that protect your privacy. The VHA Notice of Privacy Practices (a separate document) 
provides more information on how we protect your information. If you do not have a copy of the Notice, 
the research team will provide one to you. Giving your permission by signing this authorization allows us 
to disclose your information to other institutions or persons as noted below. Once your information has 
been disclosed outside VA/VHA, it may no longer be protected by federal laws and regulations and might 
be re-disclosed by the persons or institutions receiving the information.
•
Non-VA Institutional Review Board (IRB): USF
•
Study Sponsor/Funding Source: RR&D
•
Compliance and Safety Monitors: RCO
•
Other Federal agencies required to monitor or oversee research (such as FDA, OHRP, GAO): The 
Office of Human Research Protections, the Government Accountability Office, the Office of the 
Inspector General, the VA Office of Research Oversight, our local Research and Development 
Committee, may look at any portion of your record.
Access to your Individually Identifiable Health Information created or obtained during this research. You 
will not have access to your research related health records.
This will not affect your VA healthcare including your doctor's ability to see your records as part of your 
normal care and will not affect your right to have access to the research records after the study is 
completed.
REVOCATION:
If you sign the HIPPA authorization you may change your mind and revoke or take back your permission 
at any time. You must do this in writing and must send your written request to the Principal Investigator 
for this study. If you revoke (take back) your permission, you will no longer be able to participate in this 
study but the benefits to which you are entitled will NOT be affected. If you revoke (take back) your 
permission, the research team may continue to use or disclose the information that it has already collected 
before you revoked (took back) your permission which the research team has relied upon for the research. 
Your written revocation is effective as soon as it is received by the study's Principal Investigator.
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 11
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
EXPIRATION:
Unless you revoke (take back) your permission, your authorization to allow us to use and/or disclose your 
information will expire at the end of this research study.
CERTIFICATE OF CONFIDENTIALITY:
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means 
that the researchers cannot release or use information, documents, or samples that may identify you in any 
action or suit unless you say it is okay. They also cannot provide them as evidence unless you have 
agreed.  This protection includes federal, state, or local civil, criminal, administrative, legislative, or other 
proceedings. An example would be a court subpoena.
 
There are some important things that you need to know.  The Certificate DOES NOT stop reporting that 
federal, state or local laws require. Some examples are laws that require reporting of child or elder abuse, some 
communicable diseases, and threats to harm yourself or others.  The Certificate CANNOT BE USED to stop a 
sponsoring United States federal or state government agency from checking records or evaluating programs. 
The Certificate DOES NOT stop disclosures required by the federal Food and Drug Administration 
(FDA).  The Certificate also DOES NOT prevent your information from being used for other research if 
allowed by federal regulations.
 
Researchers may release information about you when you say it is okay. For example, you may give them 
permission to release information to insurers, medical providers or any other persons not connected with the 
research.  The Certificate of Confidentiality does not stop you from willingly releasing information about your 
involvement in this research. It also does not prevent you from having access to your own information.
You can get the answers to your questions, concerns, complaints or issues.
If you have any questions, concerns or complaints about this study, call Dr. Jolie Haun at 813-558-7622.
If you have questions about your rights, general questions, complaints, or issues as a person taking part in 
this study, call the USF IRB at (813) 974-5638 or contact by email at RSCH-IRB@usf.edu.
If you would like to contact someone independent of the research study, or cannot reach the research staff, 
you may contact the James A. Haley Veterans’ Hospital Research Compliance Officer at 813-903-4274.
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 12
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673
Statement of Participation in Research
It is up to you to decide whether you want to take part in this study. If you want to take part, please read 
the statements below and sign the form if the statements are true.
I freely give my consent to take part in this study and authorize that my health information as 
agreed above, be collected/disclosed in this study. I understand that by signing this form I am agreeing 
to take part in research. I have received a copy of this form to take with me.
Signature of Person Taking Part in Study
Date
Printed Name of Person Taking Part in Study
Statement of Person Obtaining Informed Consent / Research Authorization
I have carefully explained to the person taking part in the study what he or she can expect.
I hereby certify that when this person signs this form, to the best of my knowledge, he or she understands:
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 13
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021

Department of Veterans Affairs
VA RESEARCH CONSENT FORM
Social and Behavioral Research
Title of Study:
Delivering a Mobile and Web Based Self Directed Complementary and 
Integrative Health Program to Veterans and Their Partners to Manage Pain and 
PTSD
Principal Investigator:
Dr. Jolie Haun, PhD, EdS
VAMC:
Tampa-673

What the study is about.

What procedures/interventions/investigational drugs or devices will be used.

What the potential benefits might be.

What the known risks might be.

How the information collected about the person will be used.
I also certify that he or she does not have any problems that could make it hard to understand what it 
means to take part in this research. This person speaks the language that was used to explain this 
research.
This person reads well enough to understand this form or, if not, this person is able to hear and understand 
when the form is read to him or her.
This person does not have a medical/psychological problem that would compromise comprehension and 
therefore makes it hard to understand what is being explained and can, therefore, give informed consent.
This person is not taking drugs that may cloud their judgment or make it hard to understand what is being 
explained and can, therefore, give informed consent.
Signature of Person Obtaining Informed Consent / Research Authorization
Date
Printed Name of Person Obtaining Informed Consent / Research Authorization
Subject’s Name:   
Subject’s Last 4 digits of SS# required:   
Informed Consent Version 9
Revision date 01/11/2021
In lieu of VA FORM 10-1086   template dated  07-06-2017     IRB Number: #Pro00035440
Page 14
Study ID: Pro00035440_MOD000014 Date Effective: 1/13/2021