I CARE for Vets: InCreasing Activity & REcovery for Veterans With PTSD
Phase: PHASE1
Conditions: Stress Disorders, Post-Traumatic
Sponsor: VA Office of Research and Development

i 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
I CARE for Vets: InCreasing Activity & REcovery for Veterans with PTSD 
 
 
 
 
Study Protocol Version 2.6, 10/20/21 
 
Funding Agency: VA RR&D 
 
Principal Investigator: Wei (Denise) Duan-Porter, MD, PhD 
 
 
 
 

ii 
 
ABSTRACT 
Impacts: This project will be a key step forward in fulfilling the mission of VA RR&D to restore 
function and enable social reintegration for Veterans. Development of an intervention to increase 
physical activity may improve physical functioning for Veterans with posttraumatic stress disorder 
(PTSD), thus addressing an important gap in existing care. If demonstrated to be efficacious in a 
future randomized trial, this intervention could be implemented throughout VHA to improve quality 
of life and enable a full recovery for many Veterans with PTSD. Results from this study may also 
advance our understanding of how to optimally incorporate mobile health technology (mHealth) 
with more traditional types of patient contacts, such as in-person visits and telephone calls. 
Effective use of mHealth may offer greater flexibility for VHA clinics looking to implement new 
programs. Incorporation of mHealth may also increase access to clinical services for Veterans 
who reside far from VHA facilities. 
 
Background: One in ten Veterans seen in Veterans Health Administration (VHA) primary care 
clinics has PTSD. Individuals with PTSD are more likely to report impairments in physical 
functioning, including health-related limitations in climbing stairs or performing common 
household tasks. As an essential component of overall functioning and quality of life, physical 
functioning is an independent predictor of risk for adverse health outcomes, including mortality. 
Mechanisms underlying the association of PTSD and poor physical functioning are multifactorial, 
but a key contributing factor is likely persistent low levels of physical activity. Barriers to engaging 
in physical activity may include low perceived behavioral control for making positive long-term 
lifestyle changes and personal attitudes about the harms (vs. benefits) of physical activity. Those 
with PTSD have reduced self-efficacy for behavioral change and less ability to cope with setbacks, 
leading to greater difficulty with initiating and maintaining new health behaviors. Individuals with 
PTSD are also more likely to have ongoing pain and fatigue, which may contribute to beliefs about 
harmful effects of physical activity and lead to avoidance of activity. Current VHA outpatient 
programs are primarily focused on addressing physical activity in the context of specific medical 
conditions (eg, obesity or cardiovascular disease), and there is a paucity of programs specifically 
tailored to the unique needs of Veterans with PTSD. Development of effective programs to 
increase physical activity for Veterans with PTSD may therefore improve their physical functioning 
and represent an important contribution to VHA efforts to enhance health and recovery for this 
population. 
 
Objectives/Aims: The overall objectives of this study are to develop and pilot test a novel 
intervention aimed at initiating and maintaining higher levels of physical activity for Veterans with 
PTSD. 
Aim 1: Adapt graded exercise therapy (GET) and incorporate motivational interviewing and 
mHealth to increase physical activity and improve physical functioning for Veterans with PTSD. 
Aim 2: Conduct a pilot study to examine feasibility and acceptability of the intervention for a 
future randomized controlled trial.  
 
Methods. To increase physical activity for Veterans with PTSD, this project will combine GET, 
motivational interviewing, and mobile health technology (mHealth) to address attitudinal and 
behavioral barriers particularly relevant for this group. First, we will work collaboratively with our 
Veteran Engagement Panel to adapt GET protocols effective for non-PTSD populations (eg, 
adults with chronic pain or fatigue), and incorporate motivational interviewing and mHealth. We 
will then pilot test the intervention in 3 consecutive groups of 6-8 participants (total n=18-24) and 
use concurrent mixed-methods to examine feasibility and acceptability. Quantitative measures 
will include recruitment (proportion enrolled out of total eligible); attendance (proportion who 
attend 75% of in-person visits); and retention (proportion who complete data collection post-
intervention). Qualitative assessments will involve semi-structured interviews on acceptability of 

iii 
 
intervention components (eg, session formats and topics, usability of mHealth), and barriers and 
facilitators to attendance. At baseline, during and post-intervention, we will also assess overall 
and physical functioning using Veterans RAND 36-item, 6-minute walk, and 30-second sit to 
stand, and collect additional data (PTSD symptoms, depression, pain,fatigue, and sleep quality) 
to inform a future randomized trial. 
 

iv 
 
List of Abbreviations 
CCDOR........................................................ Center for Care Delivery & Outcomes Research 
CBT ............................................................. Cognitive Behavioral Therapy 
Co-I .............................................................. Co-Investigator 
ED ................................................................ Emergency Department 
GET ............................................................. Graded Exercise Therapy 
HSRD .......................................................... Health Services Research and Development 
IRB ............................................................... Institutional Review Board 
mHealth ....................................................... Mobile Health Technology 
MVAHCS ..................................................... Minneapolis VA Health Care System 
NIH .............................................................. National Institutes of Health 
PACT ........................................................... Patient Aligned Care Team (VA primary care staff) 
PCMHI ......................................................... Primary Care Mental Health Integration 
PCL-5 .......................................................... PTSD symptom checklist for the DSM-5 
PC-PTSD-5 .................................................. Primary Care Screen for PTSD for DSM-5 
PEG ............................................................. Brief 3-item Scale on Pain Intensity & Interference 
PHQ-9 .......................................................... Patient Health Questionnaire-9 
PI ................................................................. Principal Investigator 
PSQI ............................................................ Pittsburgh Sleep Quality Index 
PTSD ........................................................... Posttraumatic Stress Disorder 
PT ................................................................ Physical Therapist 
RR&D .......................................................... Rehabilitation Research and Development 
UMN ............................................................ University of Minnesota 
VA ................................................................ Department of Veterans Affairs 
VHA ............................................................. Veterans Health Administration 
VINCI ........................................................... VA Informatics and Computing Infrastructure 
VR-36 .......................................................... Veterans RAND 36-item Health Questionnaire 
WRAP…………………………………………..Wearables Research and Analytics Platform  

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TABLE OF CONTENTS 
1.0 
Study Personnel .............................................................................................................. 1 
2.0 
Introduction ..................................................................................................................... 1 
A. 
Overview & Conceptual Model ........................................................................................ 2 
B. 
Rationale for Intervention Components............................................................................ 2 
1. Graded exercise therapy (GET) ...................................................................................... 2 
2. Motivational interviewing and mobile health technology (mHealth) .................................. 2 
C. 
Significance & Innovation ............................................................................................. 3 
3.0 
Objectives ....................................................................................................................... 3 
4.0 
Resources and Personnel ............................................................................................... 4 
A. 
Research Site: Minneapolis VA Health Care System (MVAHCS) .................................... 4 
B. 
Principal Investigator ....................................................................................................... 4 
5.0 
Study Procedures ............................................................................................................ 4 
A. 
Study Design ................................................................................................................... 4 
B. 
Development of Physical Activity Intervention.................................................................. 4 
1. 
Development of intervention manual and training procedures ...................................... 4 
2. 
CCDOR Veteran Engagement Panel for PTSD research ............................................. 5 
3. 
Adaptation of GET and integration with motivational interviewing ................................ 5 
4. 
Mobile health technology (mHealth) ............................................................................. 6 
C.     Pilot Study to Evaluate Feasbility & Acceptability ............................................................ 8 
1. 
Human Subjects Involvement & Characteristics. .......................................................... 8 
2. 
Recruitment Procedures .............................................................................................11 
3. 
Inclusion/Exclusion Criteria .........................................................................................12 
4. 
Informed Consent Procedures ....................................................................................12 
5. 
Quantitative Data & Analyses (Table 4) ......................................................................12 
6. 
Qualitative Data & Analyses (Table 4).........................................................................13 
7. 
Withdrawal of Subjects ...............................................................................................14 
6.0 
Reporting ........................................................................................................................14 
7.0 
References .....................................................................................................................15 
Appendices ...............................................................................................................................20 
 

1 
 
1.0 
STUDY PERSONNEL 
 
Principal Investigator/Study Chair:  
1. Wei (Denise) Duan-Porter, MD, PhD; wei.duanporter@va.gov, 612-467-5845 
 
2.0 
INTRODUCTION 
 
One in ten Veterans seen in VHA primary care clinics has posttraumatic stress disorder 
PTSD.1, 2 Individuals with PTSD are more likely to report impairments in physical functioning, 
including health-related limitations in climbing stairs or performing common household tasks.1, 3, 4 
As an essential component of overall functioning and quality of life,5, 6 physical functioning is an 
independent predictor of risk for adverse health outcomes, including mortality.7, 8 Although those 
with PTSD have higher prevalence of chronic medical conditions (eg, diabetes and heart disease) 
that may lead to limitations in physical functioning, these comorbidities do not account for the 
association between PTSD and poor physical functioning.1, 3, 4 Mechanisms underlying the 
association of PTSD and poor physical functioning are multifactorial, but a key contributing factor 
is likely persistent low levels of physical activity.9-11 Development of effective programs to 
increase physical activity for Veterans with PTSD may therefore improve their physical functioning 
and represent an important contribution to VHA efforts to enhance health and recovery for this 
population.  
 
Individuals with PTSD have low levels of physical activity,9-11 and face unique and 
substantial barriers to increasing physical activity, compared to those without PTSD. Lack of 
physical activity leads to deconditioning and risk for further declines in physical functioning.12, 13 
In applying the Theory of Planned Behavior,14, 15 we posit that barriers to engaging in physical 
activity for those with PTSD include low perceived behavioral control for making positive long-
term lifestyle changes and personal attitudes about the harms (vs. benefits) of physical activity. 
Those with PTSD have reduced self-efficacy for behavioral change and less ability to cope with 
setbacks,16, 17 leading to greater difficulty with initiating and maintaining new health behaviors. 
Individuals with PTSD are also more likely to have ongoing pain and fatigue,18-21 which may 
contribute to beliefs about harmful effects of physical activity and lead to avoidance of activity. 
Current VHA outpatient programs are primarily focused on addressing physical activity in the 
context of specific medical conditions (eg, obesity or cardiovascular disease). These programs 
were not designed for the particular challenges faced by those with PTSD and participation rates 
are lower for this group. For example, Veterans with PTSD were 20% less likely to participate in 
VHA MOVE program (for weight loss) at recommended levels.22 Among participants who attended 
sessions as recommended, achieving 6-month goals was less likely for Veterans with vs. without 
PTSD.23 Despite these findings, a paucity of programs targeting physical activity have been 
specifically tailored to the unique needs of Veterans with PTSD. The few existing pilot studies of 
physical activity interventions for PTSD utilized mostly group exercises and did not show 
increased activity levels at home or improved functioning.24-26 Therefore, our long-term goal is to 
develop and implement effective interventions to increase physical activity, improve physical 
functioning, and reduce risk for adverse health outcomes for Veterans with PTSD.  
 
 

2 
 
A. Overview & Conceptual Model  
 
We will adapt GET and incorporate motivational interviewing and mHealth in a new 
intervention to increase physical activity (Aim 1), and conduct a pilot study to evaluate intervention 
feasibility and acceptability (Aim 2). The intervention applies GET to enhance perceived 
behavioral control, and motivational interviewing and mHealth components to address unhelpful 
personal attitudes that are barriers to physical activity (Figure 1). GET provides individualized 
assessments and instructions to build knowledge, and emphasizes setting small achievable 
increases in activity goals to boost confidence in ability to engage in physical activity. Together, 
these elements of GET lead to 
increased behavioral control for 
physical activity. Motivational 
interviewing in a small group 
setting 
helps 
participants 
examine attitudinal barriers to 
engaging in activity and provides 
social 
support. 
mHealth 
components include wearable 
devices to reinforce positive 
attitudes 
about 
physical 
activity 
through 
real-time 
feedback 
on 
meeting 
individualized goals.  
 
B. Rationale for Intervention Components 
1. Graded exercise therapy (GET) 
 
Randomized trials of GET have demonstrated efficacy for improving physical functioning 
for adults with chronic pain and/or fatigue symptoms.27, 28 Often delivered by physical therapists 
(PT), GET protocols involve individualized assessment of exercise capacity; coaching about 
appropriate types of physical activity; and collaborative decision-making between therapists and 
participants to set achievable goals for increasing activity (usually 10-20% per week, focusing first 
on longer duration). Some interventions have included cognitive behavioral therapy (CBT) to 
directly address negative cognitions about physical activity (eg, pain after exercise means 
damage is occurring to the body) and problematic behavioral patterns (eg, cycles of intense 
activity followed by long periods of inactivity in response to increased symptoms).29-32 CBT 
sessions often focused on time-based pacing, appropriate responses to bodily symptoms, and 
coping skills. 
 
 
Some elements of existing GET interventions will be directly applicable to Veterans 
with PTSD, due to the high prevalence of pain and fatigue symptoms among those with PTSD. 
However, there may be certain barriers particularly relevant to individuals with PTSD (eg, 
avoidance of outdoor activities due to hypervigilance) that are not addressed by current GET 
protocols. Additionally, past protocols required substantial clinic resources for weekly (or more 
frequent) in-person visits over several months, which limit feasibility for broad implementation. 
Extended duration of in-person visits may also reduce acceptability and uptake among those with 
PTSD. Therefore, GET protocols need to be adapted for Veterans with PTSD and modified to 
improve feasibility for implementation in outpatient settings. 
2. Motivational interviewing and mobile health technology (mHealth) 
Motivational interviewing has been used to address a variety of health behaviors and can be 
effectively delivered both in-person  (individually and in groups) and by telephone.33-37 It focuses 
on eliciting personal reasons and motivations for behavioral change and engages with participants’ 
ambivalence about change using a nonjudgmental stance. Recent studies have also shown that 
Figure 1. Conceptual Model of Intervention Components 
and Effects on Physical Activity and Physical Functioning. 
Physical 
Activity
Perceived 
Behavioral 
Control
Personal 
Attitudes
Physical 
Functioning
mHealth
Motivational 
Interviewing
Graded Exercise 
Therapy (GET)

3 
 
mHealth (eg, wearable devices and smart-phone applications), combined with financial incentives, 
is effective for increasing physical activity.38, 39 Wearable devices enable remote collection of 
physical activity data, asynchronous follow-up by staff (via text messages or telephone calls), and 
individualized goal-setting. Thus, mHealth components may improve acceptability among 
participants and feasibility for implementation in busy outpatient clinical settings, due to decreased 
need for in-person visits. mHealth and financial incentives to increase physical activity are realistic 
for implementation by VHA clinical services, as they would build on existing VHA investments in 
mHealth (eg, for mental health treatment and smoking cessation40, 41) and recent nationwide 
efforts to incorporate financial incentives in support of treatment for substance use disorders (ie, 
contingency management with financial rewards for abstinence and attendance of treatment 
sessions42, 43).  
 
C. Significance & Innovation 
 
Successful completion of this study will result in a tailored intervention to increase 
physical activity, and thereby improve physical functioning, for Veterans with PTSD. If 
demonstrated to be effective, this intervention may also reduce risk for adverse health outcomes, 
including cardiovascular events and mortality. Thus, this project will be highly significant for 
advancing VHA clinical care by contributing to development of effective outpatient programs that 
improve health and quality of life for Veterans with PTSD. This will be a critical next step towards 
fulfilling VA RR&D’s mission to restore function and enable recovery for Veterans.  
 
Results from this project will also advance our understanding of how to optimally 
incorporate mHealth components with traditional patient contacts (in-person visits and telephone 
calls). Effective use of mHealth may offer greater flexibility for VHA clinics to implement new 
programs and increase access to these services for Veterans. Thus, this work will expand the 
applicability of VHA’s current investments in mHealth for clinical care. 
 
This novel program may also help participants build confidence about their general ability 
to make positive changes related to health, thus increasing the likelihood they will engage in (and 
adhere to) mental health treatments. If such synergy is ultimately demonstrated, it will open a new 
direction for VA RR&D and VHA clinical care by indicating that interventions focusing on physical 
activity need to be more closely integrated with mental health services.  
 
To address potential challenges with recruitment, acceptability and/or retention (often 
encountered by randomized trials evaluating new interventions44, 45), this study incorporates a 
novel patient engagement model. Stakeholder engagement can improve the relevance of 
research to end-users and uptake of findings.46, 47 Patient engagement is also thought to increase 
the quality of assessment instruments and effectiveness of recruitment  strategies.48 We adapted 
an existing model of patient engagement49, 50 to address several noted barriers to effective 
stakeholder engagement.51 Our panel consists of Veterans with lived-experience of PTSD who 
participate in project-focused meetings. A core group of experienced investigators and research 
staff at CCDOR organize and facilitate meetings to ensure they are focused and effective for both 
project investigators and Veteran stakeholders. Completion of this project will help establish the 
utility of our model of Veteran engagement for rapidly developing effective interventions with 
improved feasibility and acceptability.  
3.0 
OBJECTIVES 
 
The overall objectives of this study are to develop and pilot test a novel intervention 
aimed at initiating and maintaining higher levels of physical activity for Veterans with PTSD. 
 
Aim 1: Adapt GET and incorporate motivational interviewing and mHealth to increase 
physical activity and improve physical functioning for Veterans with PTSD. We will develop 
treatment manuals, training procedures for physical therapists (as interventionists), and 
processes for fidelity assessment.  

4 
 
 
Aim 2: Conduct a pilot study to examine feasibility and acceptability of the intervention 
for a future randomized controlled trial. We will pilot test the intervention in 3 consecutive 
groups of 6-8 participants (total n=18-24) and use concurrent mixed-methods to examine 
feasibility and acceptability.  We expect 75% attendance and retention, based on results from 
pilot studies of group exercise interventions for PTSD (eg, retention of 76-82%).25, 26 
4.0 
RESOURCES AND PERSONNEL 
A. Research Site: Minneapolis VA Health Care System (MVAHCS) 
Center for Chronic Disease Outcomes Research, MVAHCS, Minneapolis, MN. Activities 
that take place at this site include the following: 
1. 
Data extraction  
2. 
Recruitment, obtaining informed consent, and data collection, including interviews 
by trained staff, who are the study coordinator and co-investigators  
3. 
Intervention administration/delivery 
4. 
Data analysis  
 
B. Principal Investigator 
Wei Duan-Porter, MD, PhD 
a. Will have access to protected health information  
b. Will be involved in recruiting subjects; obtaining informed consent; 
supervising and administering interview procedures/conduct of interviews,  
training and supervising providers in intervention delivery, and performing 
data analysis  
5.0 
STUDY PROCEDURES 
A. Study Design 
 
This will be a 2-year study. During the first 6 months, we will develop the intervention by 
adapting GET and incorporating motivational interview and mHealth components. In the next 18 
months, we will conduct a single-arm pilot with 3 groups (6-8 participants per group) to evaluate 
feasibility and acceptability.  
 
Table 1. Project Timeline 
 
Year 1 
Year 2 
Planned Activities  
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Aim 1: Adapt GET and incorporate motivational interviewing & mHealth  
Develop session formats, topics, and materials 
X 
X 
X 
 
 
 
 
 
Work with CCDOR Veteran Engagement Panel to refine 
treatment manual, materials, and recruitment procedures 
 
X 
 
 
 
 
 
 
Develop training procedures and fidelity assessments 
 
 
X 
 
 
 
 
 
Establish processes for mHealth components and data  
 
 
X 
 
 
 
 
 
Aim 2: Conduct pilot study to examine feasibility and acceptability 
Develop recruitment procedures with primary care and PCMHI 
staff  
X 
X 
X 
 
 
 
 
 
Conduct groups 1-3 (6-8 participants per group) 
 
 
 
X 
X 
X 
X 
X 
Examine recruitment, attendance, retention, and acceptability  
 
 
 
X 
X 
X 
X 
X 
Collect data on physical activity, physical functioning, PTSD 
symptoms, depression, pain, fatigue, and sleep quality 
 
 
 
X 
X 
X 
X 
X 
B. Development of Physical Activity Intervention 
1. Development of intervention manual and training procedures 

5 
 
 
The investigators will develop treatment manuals, training procedures for interventionists, 
and processes for fidelity assessment.  During months 1-3 of the project, we will elaborate session 
content and format. We will then present topics, formats, and communications materials to the 
Minneapolis VA Center for Care Delivery & Outcomes Research (CCDOR) Veteran Engagement 
Panel for PTSD research (see below).  In months 4-6, we will incorporate Engagement Panel 
input, and develop protocols for training PT to deliver the intervention. Training procedures may 
include didactic sessions, role playing and mock video-conferencing sessions. 
   The 
proposed 
4-
month 
intervention 
will 
focus on initiation (months 
1-2) 
and 
maintenance 
(months 
3-4) 
of 
higher 
physical 
activity 
levels 
(Figure 2). In month 1, 
sessions will employ GET 
and 
motivational 
inter-
viewing to  provide intensive, 
personalized 
counseling, 
thereby over-coming barriers 
to initiation. In  month 2, 
further gains in physical 
activity will be supported by 
weekly telephone contacts. Wearable devices will be incorporated to reinforce benefits of 
achieving activity goals, and in months 3-4, support maintenance of higher physical activity levels. 
 
2. CCDOR Veteran Engagement Panel for PTSD research  
 
Our Engagement Panel is adapted from a previously developed model of patient 
engagement,49, 50 and is comprised of 12 Veterans who have lived-experience with PTSD, 
including 6 men and 6 women of diverse race and ethnicity, 25-67 years old. The panel meets 
quarterly and more often, as requested to support ongoing projects. Meetings of 2-3 hours are 
organized by the CCDOR Engagement Workgroup, with input from project teams on topics and 
goals. Meetings begin with a brief investigator presentation on overall project goals and 2-3 key 
questions for panel members to address. Workgroup staff facilitate meetings, take detailed notes 
during meetings and review themes with project teams immediately afterwards. Investigators are 
also provided written summaries of key feedback. Co-Investigator Meis will lead collaboration with 
the Veteran Engagement Panel on session formats and topics (eg, additional barriers to address), 
communication materials (eg, brochures and worksheets for activity planning), and recruitment 
procedures. 
3. Adaptation of GET and integration with motivational interviewing 
We will combine GET and motivational interviewing in individual meetings and group 
sessions to be delivered by a trained PT. 
  
At the first individual meeting, participants will complete in-person baseline assessments, 
learn about intervention rationale and components, discuss their values and goals, describe 
preferences for types of physical activity (eg, walking), and be introduced to mHealth components.    
Weekly group sessions in month 1 will involve closed cohorts of 6-8 participants and be conducted 
by video-conferencing (see Section 4b below). Based on our experience with motivational 
interviewing, chronic pain rehabilitation, and PTSD psychotherapies, the group format should 
optimize development of relationships and support between participants, while also permitting 
personalized attention to motivations and barriers. Additionally, groups may be particularly 
beneficial for individuals with PTSD, who are often isolated and have greater difficulty making  
Figure 2. Timeline of Intervention Components and  
Activity Goals. 
GET & Motivational 
Interviewing
Activity Goal:
Telephone Follow-up
X X
X
X
X
X
X
0
X
Wearable Devices
Maintenance
Initiation
1 mo
2 mo
3 mo
4 mo

6 
 
use of existing social supports.52 Group sessions have been effective in previous studies of GET 
interventions for non-PTSD populations.31 Each session will have 2 main discussion topics, and 
incorporate approximately 30 minutes of group exercises. Proposed group session topics include 
time-based pacing, attitudes related to pain and/or fatigue after activity, improvement of sleep, 
and strategies to address other personal barriers.  At the end of group sessions, participants will 
develop individualized plans for physical activity at home. Physical activity goals will take into 
account participants’ baseline levels of activity and exercise capacity, with gradual increases of 
10-20% per week, focusing first on extending duration and then increasing intensity.  
 
Additional individual follow-up will occur between weeks 1 and 2; between weeks 2 and 3; 
and after week 4. By video-conferencing or telephone, PT will assess progress with increasing 
activity, apply motivational interviewing techniques and tools (eg, amplifying change talk and 
readiness rulers), and provide personalized troubleshooting as needed. PT will continue to use 
motivational interviewing in weekly follow-up telephone calls during month 2. 
Table 2. Goals and Content of Individual Meetings and Group Sessions 
 
 
4. Mobile health technology (mHealth)  
 
a. Wearable fitness devices 
 
Wearable devices will provide daily feedback to participants on their physical activity and 
help improve personal attitudes about activity (Figure 1). Principal Investigator Duan-Porter and 
Co-Investigator Erbes will lead the incorporation of wearable fitness devices (ie, Garmin 
Vivosmart 4) and financial incentives. Wearable devices will be introduced to participants at the 
first individual meeting with PT, providing time for participants to troubleshoot technical issues 
before the first group session. We will encourage participants to consistently wear the device on 
either right or left wrists (per their preference), and calibrate stride lengths. 
 
Participants will receive financial incentives to support their engagement with the wearable 
device and to add motivation for increasing their physical activity (see section below on 
incentives). During month 1, participants will determine their physical activity goals at the end of 
group sessions and we will assist them with setting these goals in their devices. In month 2, goals 
will be set during weekly telephone calls. In months 3-4, wearable devices (and financial 
incentives) will continue with no scheduled participant contacts or further increases in activity 
levels (Figure 2).  

7 
 
 
To access physical activity and sleep data from wearable devices, we will work with a VA-
approved contractor (RTI International, Inc). Device companies routinely obtain and store these 
data in their databases, as part of standard service to users. RTI will use dummy email identifiers 
to 
create 
and 
maintain 
online 
accounts 
through 
the 
device 
company 
(eg, 
"icare001@gowrap.org"). Participants will use the dummy email address to register their devices 
with the company. Cross-referencing with identifying information is known only to VA study staff. 
Participant data will be accessed through these accounts, and after the study concludes, 
participants will disconnect their devices from the study accounts and no further data will be 
collected or accessed. Participants may choose to share other data through their devices, but RTI 
will only access physical activity (eg, step counts and minutes of moderate intensity activity) and 
sleep data. No other data (eg, participant name or location) will be obtained by RTI. All RTI staff 
with data access have been trained in HIPAA security and ethics of human subjects research.  
RTI will provide weekly data to the VA study team, and once obtained, these data will be 
stored behind the VA firewall (see section below on protection of participant privacy for full 
description of information security procedures). VA study staff may review participants' physical 
activity and sleep data via the company website, in order to provide feedback to participants on 
their progress. RTI will also assist with generating weekly activity summary progress reports for 
participants. These will include physical activity data to provide updates on participants’ progress 
towards their activity goals (eg, minutes of walking or biking per day). The reports may display 
physical activity data using graphs and other figures available through the device company 
accounts (see Appendix 1). Additionally, reports will include messages of encouragement that are 
tailored to the participants’ progress that week (Table 3). Finally, we will provide a short summary 
statement of financial incentives they should expect (eg, “You met your goals on 3 days during 
this past week. This means you will receive $6.”). In all communications with RTI (and materials 
sent by them), participants will be referred to by their dummy email & device identifier. RTI will 
not have access to any identifiable participant information. 
 
Table 3. Examples of Tailored Messages 
Group 1:  Meeting daily 
activity goals ≥ 5 days 
per week 
Group 2:  Meeting daily 
activity goals 3-4 days 
per week 
Group 3:  Meeting daily 
activity goals 0-2 days 
per week 
You are on the right track! 
. You will be on your way to 
a healthier new you! 
New activities can be 
challenging to do. Take it 
one day at a time! 
You are on your way to a 
healthier new you! 
We know this is tough but 
keep at it! 
We know it is not easy, but 
it is worth it! Tell a friend 
what you look forward to 
most! 
 
 
b. Video-conferencing 
 
Due to the COVID-19 pandemic and higher risk for group activities, we will conduct all 
group sessions and some individual meetings (see Appendix 2) via videoconferencing on Zoom, 
a VA and HIPAA compliant videoconferencing platform. VA ORD permits group meetings via 
platforms that are approved by the ISSO. Zoom is included in the VA Technical Reference Model 
(TRM), a list of VA-approved technologies. We will audio-record some sessions to assess 
intervention fidelity.  
 
We will generate unique Zoom meeting links for each participant's individual sessions and 
for group sessions. Participants will be required to log into the videoconferencing platform with 
the unique link. Meeting invitations will be sent from a study-specific VA email address. The 

8 
 
waiting room feature will be enabled for all meetings, so each participant will be let into a meeting 
by a study team member with host capabilities. No PHI will be included in the subject line and 
recipents will only see their own email address.  
 
c. Financial incentives 
 
Financial incentives for participants are tied to physical activity data from their wearable 
devices. After their baseline visit and before group session 1, they will receive $2 for each day 
that their devices record at least 500 steps. This is to help participants develop the routine of 
consistently wearing their devices, syncing data, charging and other maintenance. After 
participants begin setting activity goals (eg,  group sessions 1-4), they will receive $2 for each day 
that they meet their daily activity goal, giving a maxium of $14 each week. Participants may need 
to record the activity on their wearable device to obtain the incentives. However, if an unforeseen 
device problem arises that prevents the participant from using the device, the participant will 
receive the incentives during the period of the device issue. Participants will have the option to 
receive incentives via direct deposit or debit card.  
 
C. Pilot Study to Evaluate Feasbility & Acceptability 
 
We propose to conduct a pilot study of 3 groups with 6-8 participants each (total n=18-
24). Based on our clinical and research experience with piloting group interventions, and number 
of participants in the active arm of recent pilot studies of group exercise interventions for PTSD,25, 
26 we expect that 3 groups will provide sufficient data on feasibility and acceptability to inform a 
larger study.  A control group will not be enrolled as examining efficacy is not appropriate at this 
stage,53, 54 and our main goal is to evaluate feasibility and acceptability of the active intervention. 
Co-Investigator Vogsland will be the PT interventionist conducting in-person assessments, video-
conferencing sessions, and telephone calls. We will use a concurrent mixed-methods approach 
to assess feasibility and acceptability, and anticipate making protocol modifications as 
appropriate. Data on physical activity, functioning, and symptoms will also be collected, to 
determine feasibility of outcomes assessments for a future randomized trial.  
 
1. Human Subjects Involvement & Characteristics. 
 
We will screen Veterans being seen in-person or having virtual care appointments at 
MVAHCS primary care clinics for PTSD (ie, ≥3 on Primary Care Screen for PTSD-5) and self-
reported health-related limitations in mobility (ie, climbing several flights of stairs or walking 
several blocks). Exclusion criteria include ongoing suicidal ideation or psychosis; medical 
contraindications to exercise (eg, complete paraplegia); high degree of disability (ie, impairments 
in ≥2 basic activities of daily living); plans to move out of the area permanently within 4 months; 
major neurocognitive impairment (eg, dementia), schizophrenia; acute mental health crisis within 
the past 3 months (requiring an ED visit or hospitalization); and routinely completing 150 minutes 
or more of moderate to vigorous activity per week. We will not recruit prisoners, institutionalized 
individuals, or children. Our goal is to conduct 3 groups of 6-8 participants each (18-24 total). 
 
Study participants will be asked to attend group and individual sessions during the first 
month, to address attitudinal and behavioral barriers to increasing physical activity. Most of these 
will occur by video-conferencing (see Section B). Participants will be encouraged to safely and 
gradually increase their daily physical activity. At the baseline in-person visit, participants will be 
interviewed about personal goals and motivations for increasing physical activity, beliefs about 
pain and fatigue related to activity, and specific barriers they have encountered in attempting to 
increase activity. Participants will also undergo assessments of physical functioning, PTSD and 
depressive symptoms, pain, fatigue, and sleep. During and after the intervention, participants will 
be interviewed to evaluate feasibility and acceptability of intervention components. 
 
 
 

9 
 
a. Data sources 
 
There will be 3 sources of data for this study: 1) existing VA electronic medical record 
(EMR) data (from the VA Corporate Data Warehouse [CDW]) to confirm lack of medical 
contraindications to exercise and to capture baseline health status; 2) physical activity and sleep 
data collected by wearable devices and accessed via RTI’s Wearables Research and Analytics 
Platofrm (WRAP); and 3) participant assessments, including interviews on acceptability, self-
reported data (on physical activity, functioning, mental health symptoms, pain, fatigue, and sleep), 
6-minute walking distance, and 30-second sit to stand test. No biological specimens will be 
involved. To obtain EMR information from CDW for potential participants, we will use social 
security numbers (SSN) and full names. Participant interviews will be audiorecorded and 
transcribed by the VA Health Services Research & Development (HSR&D) Transcription Core at 
the Salt Lake City VA. No protected health information will be shared with non-VA entities. 
 
b. Potential risk to participants 
 
The pilot study proposed in Aim 2 will pose minimal risk to subjects, as the therapeutic 
risks are no greater than what may occur in routine clinical care. Individual attitudinal and 
behavioral barriers discussed during intervention sessions are less likely to be of a sensitive 
nature, compared with therapy sessions for mental health conditions. There is a small risk of 
injury for participants as they increase their physical activity, but we anticipate 
recommendations will mainly be for low-intensity activity (eg, walking) that are well within the 
range of normal functioning. Some participants may experience skin irritation related to 
wearing the fitness device. The main research risks are breach of confidentiality, lost time, and 
inconvenience associated with participating in a research study. There are no economic risks 
and minimal social or psychological risks of participating. Participants could potentially feel 
some stress or discomfort during interviews or responding to surveys, but most questions are 
not of an especially sensitive nature.  
 
c. Adequacy of protection from risks 
 
The risk of psychological harm is minimal, as described above. Participants will be 
informed that they do not have to answer any question that makes them uncomfortable. Should 
participants report moderate to severe symptoms of depression or PTSD, we will discuss these 
results with participants and if they are not engaged in treatment, we will refer them to mental 
health resources at the Minneapolis VA. Intervention sessions will be conducted by an 
experienced PT who will also be trained in motivational interviewing techniques and tools. 
Risks associated with physical activity will be minimized, beginning with a thorough 
assessment of baseline activity levels and exercise capacity conducted by PT. The PT 
interventionist will also instruct participants on proper form and technique for physical activity, 
to help prevent injuries. Additionally, Veterans with clear medical contraindications to exercise 
will be excluded from participation. We will teach and reinforce good practices for cleaning the 
wearable device and protecting skin (eg, do not wear too tightly, dry devices as soon as 
possible after exercise). We will also follow all Minneapolis VA Research protocols related to 
COVID-19 precautions, including screening of participants via telephone before in-person 
assessments. 
 
d. Confidentiality and protection of participant privacy 
 
All study data will be stored behind the VA firewall on Minneapolis VA servers and on the 
VA Informatics and Computing Infrastructure (VINCI) in accordance with VA-approved data 
security standards. The servers are accessible only to designated, security-cleared, and trained 
personnel, and data are limited in terms of protected health information to the greatest extent 
possible. Data on both VINCI and CCDOR specific servers are organized by projects within 
designated folders for each principle investigator. Only personnel on the study team for a given 

10 
 
project have access to a specific project folder. Approved study personnel must use Windows 
authentication or Personal Identity Verification (PIV) card to access project data. Thus, all data 
housed on these servers are secure, and access by unauthorized persons is highly unlikely. 
 
 
All participants will be assigned randomly generated unique study identifiers that do not 
contain names or other personal identifying information. The crosswalk linking participants to 
their identifiers will be stored on secure VA servers (behind the VA firewall), and restricted to 
approved analysts who are part of the CCDOR Data Team and study team. Electronic data (eg, 
CDW data, scanned surveys, interview transcripts) will be stored on secure VA servers and de-
identified as quickly as is feasible. 
 
Physical activity and sleep data will be collected remotely from wearable devices (eg, 
number of steps taken, number of minutes of physical activity, and number of minutes of sleep 
per day for each participant). These data are transmitted to databases maintained by the wearable 
device company, per their established protocols for all device users. We will work with a VA-
approved contractor, RTI, to access only the data specified above. No other data (eg, participant 
name or location) will be obtained by the contractor or stored in their databases. Also contractor 
staff with access to data have been trained in HIPAA security and ethics of human subjects 
research. Physical activity data will be linked via dummy email identifiers, and cross-referencing 
with identifying information is known only to VA study staff. Data for each participant will be 
retrieved weekly by RTI and sent to VA study staff. Once obtained, activity data will be stored on 
secure VA servers behind the VA firewall, using the same procedures as noted above for other 
participant data.  
 
 
Emails with meeting information will be sent from a study-specific VA email address. 
Recipients will not see other email addresses and will be asked not to reply to invitation emails. 
Encrypted emails with activity summary reports will be sent to each participant separately. In all 
communications with RTI, participants will be referred to by their dummy email or device 
identifier.  
 
e. Potential benefits of research to subjects and others 
 
Veterans participating in this study have the potential to increase their physical activity 
and improve their physical functioning. This may have additional significant health benefits, 
including reducing their risk for cardiovascular events. If this intervention is subsequently found 
to be effective, it will lead to improved functioning for many Veterans enrolled in VHA who have 
PTSD and limitations in functioning. Veterans participating in the pilot study will also have the 
potential to receive up to a total of $277 for financial incentives tied to meeting daily physical 
activity goals and for completing the final post-intervention assessments. 
 
The proposed work will be an important step forward in fulfilling the mission of VA RR&D 
to restore function and enable social reintegration for Veterans. Development of an intervention 
to improve physical functioning for Veterans with PTSD will address an important gap in existing 
care. If eventually shown to be effective, this new intervention could be implemented throughout 
VHA to improve quality of life and enable a full recovery for many Veterans with PTSD. Results 
from the proposed work may also advance our understanding of how to optimally incorporate 
mHealth with more traditional types of patient contacts (ie, in-person visits and telephone calls). 
Effective use of mHealth may offer greater flexibility for VHA clinics looking to implement new 
programs. Incorporation of mHealth may also increase access to clinical services for Veterans 
who reside far from VHA facilities. 
 
f. Data and safety monitoring plan 
 
Safety Monitoring: We do not expect any injuries or safety events to occur during the pilot 
study, as we will be encouraging increased physical activity after a thorough evaluation by an 
experienced PT interventionist. However, as safeguards, study staff will inquire about any new 
injury or health problem that may affect participants’ ability to engage safely in physical activity, 

11 
 
at regular intervals during the intervention. Participants will also be instructed to contact study 
staff if any change in health status occurs in between scheduled study follow-ups. The 
investigative team includes general internal medicine physicians, in addition to the PT 
interventionist, who will help assess the full range of concerns regarding any changes in 
participant health status. If an injury is thought to be potentially related to the study, we will follow 
appropriate MVAHCS IRB policy for reporting and care of participants. 
 
 
Accuracy and Integrity of Data—Secure Data Infrastructure: VINCI is an HSR&D 
Resource Center that provides researchers a national view of VA patient data. VINCI is a 
research and development partnership and operational platform for health services research, 
epidemiology, decision support, and business intelligence. Partners include VA Office of 
Informatics and Analysis, and Office of Information and Technology (OIT) Business Intelligence 
Service Line. VINCI brings together data sources and the analytical environment for performing 
studies, along with the expertise of data stewards such as VHA National Data Systems (NDS) 
and VA Information Resource Center (VIReC). New research projects are granted access to 
dynamic views or data snapshots that can be updated as needed. In addition to data storage, 
VINCI includes a cluster of servers with dedicated software for analysis, data processing, and 
extracting information from text. VINCI is accessible from the VA intranet, providing VA 
researchers with a central, secure location to access data and the applications they need to 
select, transform, and analyze patient data. 
 
CCDOR also maintains several of its own secure virtual data servers that are protected 
behind the VA firewall. All individuals with administrative access privileges to the CCDOR servers 
have been screened and assigned a security clearance to work with patient level data. OIT 
Administrative access to the data is strictly limited to backing up server data, which prevents 
catastrophic loss of data. Backups of these servers occur regularly and are stored in a secure 
location.  
 
2. Recruitment Procedures 
 
Data collection and recruitment will take place at MVAHCS. We will rely primarily on 2 
methods of identifying potentially eligible Veterans: 1) primary care staff referral and 2) self-
referral.  
 
Staff Referral: Referrals from primary care staff, including Primary Care Mental Health 
Integration (PCMHI), will provide our first-line recruitment source, as this will closely model how 
the patients would receive referrals in typical clinic care. We will make announcements about 
the study in multiple settings and forums (eg, announcements at team meetings, presentations 
at grand rounds). We will provide flyers and brochures to staff and discuss the study with them. 
We will ask primary care staff to provide potentially eligible Veterans (ie, positive on PTSD 
screen and without suicidal ideation, see detailed inclusion and exclusion criteria below) with 
brochures about the pilot study. If a Veteran demonstrates interest, primary care staff will either 
encourage Veteran to directly call study coordinator (information in brochure) or ask for 
permission to share their name and telephone number with the coordinator.  
 
Self-Referral: To facilitate self-referral, we will use study fliers and brochures 
strategically placed in appropriate clinic locations and make announcements to inform primary 
care staff about the study. Individuals who are self-referred to the study will reach out to study 
staff to express their interest directly.  
 
Active Outreach: Due to decreased in-person visits during the COVID pandemic (which 
limit opportunities for staff and self-referrals), we will  identify potentially eligible Veterans who 
have a positive screen for PTSD in the past 2 months through an administrative data pull and 
recruit these Veterans through mailed letters and telephone calls. We will send out letters 
introducing the study and providing contact information for individuals to opt out of further 
contacts. Starting 10 days after the letter is sent, we will make up to 3 calls (on at least 2 

12 
 
different days) to provide more information about the study and conduct eligibility screening, 
for those who are interested.  
 
3. Inclusion/Exclusion Criteria 
 
To identify Veterans with PTSD symptoms and poor physical functioning who may benefit 
from the intervention, eligibility criteria are as follows (Error! Reference source not found.): 
 
Inclusion: 1) ≥18 years old; 2) patient in primary care at MVAHCS; 3) score ≥3 on Primary 
Care PTSD Screen (PC-PTSD-5), which is routinely administered during primary care 
appointments (95% sensitivity and 85% specificity for PTSD diagnosis55); 4) “yes” to any of 3 
questions about health-related limitations from the Veterans RAND 36-Item Health Survey (VR-
36),56, 57 as an indicator of impaired functioning; 5) has access to device (smart phone, tablet, or 
computer) that enables participation in videoconferencing; 6) has a smartphone or tablet that can 
support Garmin application; 7) has internet access for videoconferencing. 
 
Exclusion: 1) active suicidal ideation or psychosis; 2) medical contraindication to 
participation (eg, complete paraplegia); 3) self-reported impairments in 2 or more activities of daily 
living (ADLs); 4) plans to move out of area permanently within next 4 months; 5) major 
neurocognitive impairment (e.g., dementia); 6) schizophrenia; 7) acute mental health crisis within 
the past 3 months (requiring an ED visit or hospitalization); and 8) routinely completing 150 
minutes or more of moderate to vigorous activity per week. Individuals meeting these criteria may 
be unable to safely increase physical activity at home or not have a need for this program.  
 
For Veterans referred by primary care and PCMHI staff, the study coordinator and/or 
principal investigator will conduct further eligibility screening using the following sources: 1) review 
of medical records for exclusion criteria (recent episodes of psychosis and medical 
contraindications to physical activity); 2) discussion with primary care provider for clarification 
about potential contraindications, as needed; and 3) telephone call to administer questions on 
mobility limitations, other health problems, and ADL impairments. For Veterans who self-refer, the 
study coordinator will first complete the PC-PTSD-5 and screening questions for suicidal ideation. 
After completing screening for eligibility, the study coordinator will schedule Veterans for a phone 
call to obtain informed consent and provide additional information on the intervention.  
 
4. Informed Consent Procedures 
 
The study coordinator will schedule a telephone call with Veterans to go over the informed 
consent form, HIPAA authorization form, and enrollment forms for financial incentives. We will 
also include other materials to describe the study (eg, FAQ document, expectations for 
confidentiality and privacy during group meetings, and troubleshooting Zoom). We will mail 
potential participants these materials ahead of the phone call, instructing them not to sign any 
forms until the call. During the call, the study coordinator will provide a thorough overview of study 
participation, risks, benefits, alternatives, protections, and IRB and study staff contact information. 
We will emphasize the voluntary nature of study participation and provide the opportunity for 
questions about the study. The consent process will be conducted by the study coordinator, who 
is trained in the ethics of human subject research. Those who agree to participate will mail back 
signed informed consent and HIPAA authorization forms via prepaid stamped envelopes. Signed 
informed consent and HIPAA authorization forms will be received by the study team before 
collection of any participant data. 
 
5. Quantitative Data & Analyses (Table 4) 
 
Feasibility will be quantitatively assessed as recruitment (proportion enrolled out of total 
identified as eligible), attendance (proportion who attend ≥ 75% of in-person visits), and 
retention (proportion who complete post-intervention assessments). To determine feasibility, we 
will first evaluate recruitment and time needed to enroll participants. We anticipate approximately 

13 
 
20 Veterans per month may be eligible (based on preliminary data noted above), and with 20% 
recruitment, we expect to complete enrollment for each group in 4-6 weeks. We have set 
attendance and retention benchmarks at 75%, which are realistic estimates based on recent pilot 
studies of group exercise interventions for PTSD (participants attended an average of 78-82% of 
sessions and overall retention were 76-82%).25, 26  
 
Data on participant physical activity will be collected using both wearable devices and 
self-reported activity dairies. Physical functioning will be measured at baseline and post-
intervention using VR-36, 6-minute walk,58, 59 and 30-second sit to stand.59, 60 Based on our clinical 
experience, these latter 2 tests can be feasibly administered to detect small but clinically relevant 
improvements in endurance and lower body strength. We will also assess PTSD symptoms 
(PTSD Checklist for DSM-5 [PCL-5])61, 62; depression (Patient Health Questionnaire-9 [PHQ-
9])63; pain (brief 3-item scale on intensity and interference [PEG])64, fatigue (PROMIS 4-item 
short form)65; sleep quality (PROMIS sleep disturbance and impairment)66, 67; self-efficacy 
(PROMIS general 4-item68 and one item specific to physical activity); and social support for 
physical activity (1 item). We will compare physical activity data from wearable devices and self-
reported diaries, for consistency and data quality for these different methods. For measures of 
physical functioning, PTSD and other symptoms, we will refine procedures for administering 
assessments and also confirm consistency and data quality. 
 
Table 4. Assessments during Pilot Study. 
  
 
6. Qualitative Data & Analyses (Table 4) 
 
Qualitative assessments will involve semi-structured interviews at the end of month 2 and 
post-intervention, to address acceptability of intervention components, including session formats 
and topics and usability of wearable devices. Month 2 interviews will also elicit barriers and 
facilitators to attendance. Interviews will be audiorecorded and transcribed. We will use 
triangulation to integrate qualitative interview data with quantitative measures of attendance and 
retention. First, Drs. Duan-Porter and Spoont will apply an established rapid approach for 
qualitative analysis to identify key themes.69 This involves reviewing transcripts for the initial 3-4 
interviews to develop templates that are then applied to summarizing subsequent transcripts. 
Summary information will be further reviewed and analyzed using matrices to identify major 
themes for each main topic (eg, acceptability of mHealth components). Then, a matrix will be 
Baseline
During 
Intervention
Post-
intervention
Feasibility & Acceptability
Recruitment, Attendance & Retention
X
X
Acceptability of intervention components 
(semi-structured interviews)
X
X
Barriers & facilitators to attendance (semi-
structured interviews)
X
Physical Activity & Functioning
Wearable device physical activity & sleep data
X
Self-reported physical activity diaries
X
X
X
VR-36, 6-minute walk, 30-second sit to stand
X
X
Medical Conditions & Symptoms
Medical diagnoses, medications (EMR)
X
PTSD symptoms (PCL-5)
X
X
Depressive symptoms (PHQ-8)
Pain (PEG)
X
X
Fatigue (PROMIS 4-item)
X
X
Sleep Disturbance & Impairment (PROMIS)
X
X
Self-efficacy
X
X
Social support for physical activity
X
X
EMR=Electronic Medical Record; PCL-5=PTSD Checklist for DSM-5; PEG=3-item scale on pain 
intensity and interference; PHQ-9=Patient Health Questionnaire-9; PROMIS=Patient Reported 
Outcomes Measurement Information System; PSQI=Pittsburgh Sleep Quality Index; VR-
36=Veterans RAND 36 Item Health Survey 

14 
 
developed to compare themes for those who attended 75% of in-person visits with those who did 
not. A similar matrix will compare themes for those who completed post-intervention assessments 
and those who did not. 
 
7. Withdrawal of Subjects 
 
Participants can withdraw from the study at any point in time and for any reason by 
contacting study personnel in person, by telephone, or by mail, and requesting to withdraw. We 
anticipate termination of participation if: 
1. The participant becomes ineligible to participate 
2. The participant does not follow instructions from the researchers 
3. The study is unexpectedly suspended or canceled. 
6.0 
REPORTING 
 
Any change in a participant’s ability to engage in the physical activity program will be 
immediately reported by the PT interventionist to Dr. Duan-Porter, the Principle Investigator and 
communicated to the participant’s primary care team. If suicidal ideation is found upon initial 
eligibility screening by the study staff, they will immediately notify Dr. Duan-Porter, who will 
undertake appropriate evaluations and clinical referrals. If participants are noted to have severe 
or worsening PTSD and/or depression symptoms, they will be offered referrals for mental health 
treatment at MVAHCS. Notably, given the additional clinical expertise of Co-Investigators in 
rehabilitation medicine and mental health, this study team is well prepared to handle any potential 
health concerns that may arise.  
 
 
 

15 
 
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20 
 
APPENDICES 
 
Appendix 1: Example I CARE Participant weekly activity summary report 
 
 
 
 
 
 
 

21 
 
Appendix 2: Detailed Outline of Topics and Goals for Sessions 
 
Week 
Content and Goals 
0 
Baseline In-Person Visit (95 min) 
• 
Assessments (30 min) 
o 
Survey—Functioning, mental health symptoms, sleep, pain, & fatigue*  
o 
Physical Performance—6-minute walk, 30-second sit to stand, range of motion screen, 
strength screen, & 4-stage balance test 
• 
Introduction to rationale & I CARE schedule (20 min) 
o 
Rating of perceived exertion (handout) 
• 
Motivational interviewing (20 min) 
o 
Identify values & beliefs about physical activity 
o 
Develop discrepancy between current behavior and values 
o 
Readiness rulers—confidence & importance 
• 
Introduction to device, activity logs & financial incentives (20 min)  
o 
Set up Garmin Vivosmart 4 & Garmin Connect Application 
o 
Instruct on completing activity logs & mailing back 
• 
Closing (5 min) 
0.5 
Tech Prep Call (Virtual via Zoom, 30 min) 
• 
Mock session to introduce and troubleshoot Zoom platform issues 
 
1  
Group Session #1 (Virtual via Zoom, 90 min) 
• 
Discussion #1 (30 min) 
o 
Introductions, establish ground rules for group meetings (Expectations & Guidelines 
Handout) 
o 
Elicit participant goals for physical activity & health (Readiness Rulers) 
• 
Group exercise (25 min) 
• 
Discussion #2 (15 min) 
o 
Participant experiences with group exercise, rating of perceived exertion 
o 
Graded steps to increase activity, time-based pacing (Graded Steps Handout)  
o 
I CARE video playlist, elicit other exercise options 
• 
Home exercise plan (15 min) 
o 
Plan for week #1 (Home Exercise Worksheet; Readiness Rulers) 
o 
Share goals with group  
o 
Closing (5 min) 
1.5 
Individual Session #1 (Virtual via Phone, 10-15 min) 
• 
MI: 
o 
Readiness ruler 
o 
Self-efficacy, develop discrepancy 
o 
Amplify change talk, roll with resistance 
• 
Troubleshooting home activity plan 
o 
Review safe space in home 
o 
Address level of activity, correct positions, etc. 
2 
Group Session #2 (Virtual via Zoom, 90 min) 
• 
Discussion #1 (30 min) 
o 
Elicit experiences with home activity goals (Self-Reflection Worksheet) 
o 
Physical activity, pain & fatigue (Activity, Pain & Fatigue Handout) 
• 
Group exercise (25 min) 
• 
Discussion #2 (15 min) 
o 
Participant experiences with group exercise 
o 
Brainstorm strategies to address challenges, emphasize change talk  

22 
 
• 
Home exercise plan (15 min) 
o 
Plan for week #2 (Home Exercise Worksheet; Readiness Rulers) 
o 
Share goals with group  
o 
Closing (5 min) 
2.5 
Individual Session #2 (Virtual via Phone, 10-15 min) 
• 
Troubleshooting home plan 
• 
MI: Self-efficacy, amplify change talk, roll with resistance 
3 
Group Session #3 (Virtual via Zoom, 90 min)  
• 
Discussion #1 (15 min) 
o 
Elicit experiences with home activity goals (Self-Reflection Worksheet) 
• 
Group exercise (25 min) 
• 
Discussion #2 (30 min) 
o 
Participant experiences with group exercise 
o 
Physical activity and sleep (Better Sleep Guidelines and Worksheet) 
• 
Home exercise plan (15 min) 
o 
Plan for week #3 (Home Exercise Worksheet; Readiness Rulers) 
o 
Share goals with group  
o 
Closing (5 min) 
4 
Group Session #4 (Virtual via Zoom, 90 min)  
• 
Discussion #1 (20 min) 
o 
Elicit experiences with home activity goals (Self-Reflection Worksheet) 
o 
Elicit experiences with sleep changes (Better Sleep Worksheet) 
• 
Group exercise (25 min) 
• 
Discussion #2 (20 min) 
o 
Participant experiences with group exercise 
o 
Review physical activity, pain, fatigue, and sleep concepts 
• 
Home exercise plan (15 min) 
o 
Plan for next 4 weeks (Home Exercise Worksheet; Readiness Rulers) 
o 
Share goals with group  
• 
Closing statements (10 min) 
4.5 
Individual Session #3 (Virtual via Phone, 10-15 min) 
• 
Troubleshooting home activity plan for next month  
• 
MI: Self-efficacy, amplify change talk, roll with resistance 
 
5-8 
Individual Sessions #4-7 (Virtual via Phone, 10-15 min, weekly) 
• 
Troubleshooting home activity plan 
• 
Gradually increase activity goals 
• 
MI: Self-efficacy, amplify change talk, roll with resistance 
16 
Final In-Person Assessment (60 min) 
• 
Post-intervention Assessments: 
o 
Physical functioning (VR-36,56,57 6-minute walk,58,59 and 30-second sit to stand59,60)  
o 
Other study measures* 
• 
Disconnect Garmin Vivosmart 4 device from I CARE Study account 
*PTSD symptoms (PTSD Checklist for DSM-5 [PCL-5]61,62); depressive symptoms (Patient Health 
Questionnaire-8 [PHQ-8]63); pain (brief 3-item scale on intensity and interference [PEG]64); fatigue 
(PROMIS 4-item fatigue short form65); sleep quality (PROMIS sleep disturbance and impairment)66, 67; self-
efficacy (PROMIS general 4-item68 and one item specific to physical activity); and social support for 
physical activity (1 item).