Feasibility and Acceptability of Stress Induction, Physiological Data Collection, and Mindfulness-Based Stress Reduction Among Combat Veterans With PTSD
Phase: NA
Conditions: Ptsd
Sponsor: Oregon Health and Science University

DOCUMENT DATE (IRB A P P ROVAL): 
 
NCT NUMBER: 
 
OFFICIAL S T UDY T IT LE:  
 
INVESTIGATOR NAME:  
 
ORGANIZATION: 
Oregon Health & Science University 
Template Version 20201222 
ClinicalTrials.gov Document Upload 
03-Jan-2024
Josh Kaplan, PhD, MCR
Feasibility and acceptability of stress induction, physiological 
data collection, and Mindfulness-Based 
Stress Reduction among combat veterans with PTSD
NCT05938816

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1) 
Protocol Title 
Feasibility and acceptability of stress induction, physiological data collection, and Mindfulness-Based 
Stress Reduction among combat veterans with PTSD 
 
2) 
Objectives 
Objectives are to gather feasibility and acceptability of key study elements (e.g., stress induction 
via cognitive stressor, physiological data collection including respiration, blood pressure, and 
heart rate, and the target intervention Mindfulness-Based Stress Reduction) among combat 
veterans experiencing PTSD symptoms to support a future K23 grant resubmission. Specific Aims 
are as follows: 
 
Aim 1: Assess feasibility and participant acceptability of intervention and randomization procedures. 
Aim 1A: Examine acceptability of MBSR via qualitative data gathered during a post-intervention focus 
group. 
 
Aim 1B: Assess feasibility of recruiting and acceptability of randomizing participants to an MBSR or 
active control condition. Recruitment, differential retention, and home practice completion rates will be 
examined.  
 
Aim 2: Assess feasibility and participant acceptability of concurrent stress induction and physiological 
data collection (i.e., systolic [SBP] and diastolic [DBP] blood pressure) procedures. 
Aim 2A: Evaluate feasibility of stress induction via significant change in BP from baseline to stressor. 
Aim 2B: Examine acceptability of physiological data collection concurrent with stressor task via focus 
group.  
 
Aim 3:  Evaluate sensitivity and responsiveness to change of outcome measures. Examining these 
qualities and pre-post changes in physiological and psychological resilience and PTSD symptoms will 
provide crucial information regarding relationships between the intervention and changes in relevant 
variables.  
 
 
3) 
Background 
Posttraumatic stress disorder (PTSD) is a significant public health concern1 that negatively impacts 
quality of life and functioning,1-3 is associated with increased mortality,4 and poses an economic burden.5  
 
Despite a need for effective interventions, front-line treatments are limited.6-8 VA/DOD Clinical 
Practice Guidelines9 recommend cognitive processing therapy (CPT) and prolonged exposure (PE). 
Although research supports these treatments,10-12 they present significant shortcomings: (1) they may 
not be acceptable for all patients,13 (2) they show attrition as high as 40%,14-16 and (3) they often result 
in residual symptoms.7,8 Symptoms such as higher physiological arousal17,18 and stress reactivity17-19 are 
related to dropout. Despite this relationship, status quo treatment approaches do not account for 
physiological factors related to PTSD.20,21 Due to these limitations, alternative interventions and 
treatment targets for PTSD are warranted.  
 
Mindfulness-Based Stress Reduction (MBSR) is a promising alternative.1,22,23 MBSR is a mindfulness-
based intervention (MBI) and shows promise for treating PTSD in veterans.20,22,24-26 MBSR improves PTSD 
symptoms and benefits physiological systems related to PTSD symptoms20 such as the autonomic 

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nervous system.27 Despite promising findings, mechanisms by which MBSR may benefit PTSD are less 
understood.28,29 
 
Increased resilience may be the primary mechanism in MBSR for PTSD. Resilience is the ability to cope 
with, adapt to, or overcome exposure to stress.30 Psychological resilience is conceptualized as a trait31-33 
or a teachable skill.34-37 Psychological resilience is negatively associated with the likelihood of PTSD.38-40 
MBIs may reduce avoidance of trauma-related stressors, thereby increasing psychological resilience and 
reducing PTSD symptoms.41 MBIs effectively increase psychological resilience high-stress groups,42,43 and 
increased psychological resilience mediates improvements in stress disorders.44 
 
Physiological resilience is another promising mechanism, and is defined as the capacity of a biological 
system to avoid shifting away from baseline (e.g., “reactivity”) or to return to baseline (e.g., 
“recovery”).45 The sympathetic nervous system (SNS) has served as an indicator of physiological 
resilience among veterans.46-48 Specifically, physiological resilience is indicated by the magnitude of 
peripheral vasoconstriction,48 directly related to blood pressure (BP).49 BP has been conceptualized as an 
indicator of physiological resilience to negative health outcomes.50 Combat veterans with PTSD exhibit 
low physiological resilience via exaggerated BP reactivity to acute stress.51,52 Other research has found 
that trauma is predictive of lower physiological resilience.53 MBSR54-58 and resilience-based59 
interventions reduce BP, improve physiological resilience,60,61 including among military personnel.62 Prior 
to conducting a fully-powered mechanistic RCT, central research methods such as intervention, stress 
induction, and physiological data collection must be validated.  
 
Feasibility and acceptability must be established. Although some studies have conducted RCTs of MBSR 
among veterans with PTSD,23 feasibility and acceptability limitations remain. A systematic review 
currently under review by the PI found that MBIs for PTSD showed an average attrition rate of 21.3%; 
much higher than the general population.63 The reason for this difference is unknown. A recent meta-
analysis called for increased efforts to improve the feasibility and acceptability of MBIs.63 Similarly, a 
recent review reported that data regarding adherence in MBSR (e.g. at-home meditation practice) is 
underreported in most studies.64 No studies have evaluated the feasibility and acceptability of these 
facets of MBSR among veterans with PTSD. Further, no study has evaluated the feasibility and 
acceptability of a stressor task and concurrent physiological data collection in veterans. These aspects of 
feasibility require further study, as recent research has emphasized the need for stress induction tasks 
that are feasible and reproducible.65 Given the novelty of these procedures in this population, and the 
potential impact of the PI’s line of research among veterans underserved by status quo interventions, 
this KL2 application essential. To support this line of research, this KL2 will inform the resubmission of 
the PI’s K23 proposal and forthcoming VA CDA.  
 
The long-term goal of this research is to use mechanisms identified via a fully-powered mechanistic RCT 
funded by NIH K23 or VA CDA to optimize a resilience-based, trauma-informed MBI. In order to secure 
funding and conduct this mechanistic RCT, feasibility and acceptability of the stressor paradigm and 
concurrent physiological data collection, as well as the MBSR and randomization procedures must be 
established. 
 
4) 
Study Design  
The design of this study is a randomized controlled interventional study. All participants will complete 
three in-person lab visits, consisting of computerized questionnaires, physiological data recording, and 
completion of a stressor paradigm. Following completion of computerized questionnaires at the 
baseline visit, participants will be randomized at a 1:1 ratio using covariate adaptive randomization. 
 

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Participants will be randomized to receive Mindfulness-Based Stress Reduction (MBSR; active 
intervention condition) or Health and Wellness Education (HWE; control condition). Both interventions 
include 8 weekly in-person group sessions with an additional extended session after week 8. 
 
5) 
Study Population 
a) Number of Subjects 
This is a single center study. We will screen approximately 40 patients of which we expect to enroll 20 
participants, all of whom will be veterans experiencing PTSD symptoms (PTSD symptoms will be 
confirmed during telephone screen). Therefore, 20 participants will sign the consent form and be 
included in this study. 
 
b) Inclusion and Exclusion Criteria 
Participants will be screened over phone to determine eligibility.  Subjects will 
be aged 18-85 years. Subjects older than 85 years of age will be excluded due to their decreased 
ability to tolerate the experimental procedures because of potential cognitive decline and inability to 
sustain the attention needed for the Portland Arithmetic Stress Task (PAST), as well as the 
decreased ability to remain still during the intervention conditions due to musculoskeletal aches and 
pains and decreased flexibility frequently seen in aging. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
* Severe cognitive impairment will be determined by a score ≤ 20 on the Telephone Interview for Cognitive Status; active suicidality 
will be determined by endorsement of item 9 on the Patient Health Questionnaire. 
 
† Alcohol use will be determined by a score ≥ 8 on the Alcohol Use Disorders Identification Test (AUDIT-C); excessive cannabis use 
will be determined by a score ≥ 7 on the Cannabis Abuse Screening Tool; excessive nicotine use will be determined by a score ≥8 on 
the Fagerstrom Nicotine Dependence Scale. 
 
 If a participant does not consent, or is excluded for any other reason (e.g. screen-failed), data already 
collected (e.g., demographic; screening data) will be retained for the purpose of characterizing 
individuals who made contact, as well as collecting and presenting feasibility and acceptability data to 
the VEG at the conclusion of this study. The reason for not enrolling will be noted. 
 
c) Vulnerable Populations 
No vulnerable populations will be recruited as part of this study. 
 
Inclusion criteria 
Exclusion criteria 
Adult (18-85 years) 
Pregnancy 
Military veteran  
 Severe untreated depression, 
cognitive impairment, or active 
suicidality* 
 Experiencing PTSD symptoms 
  Life-threatening or severely disabling 
medical conditions 
Reading and speaking in English 
  Excessive use of alcohol, nicotine, or 
cannabis† 
Be able to travel to OHSU for three 
two-hour lab visits, 8 weekly 
intervention sessions and one long 
extended session, and a two- hour 
focus group 
   

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d) Setting 
This is a single site study. All research activities, including interventions, will take place at OHSU with 
the exception of some recruitment procedures that will take place at the Portland VA (e.g., presenting 
study materials to clinics). 
 
e) Recruitment Methods 
A multi-dimensional recruitment strategy will be used to achieve target enrollment numbers. We will 
use OHSU approved recruitment tools such as Epic Reporting Workbench, Slicer Dicer, Research Data 
Warehouse (RDW), etc., to query OHSU electronic medical records.  This study will use Epic MyChart® to 
recruit potential participants. Researchers will use OHSU approved search tools as mentioned above to 
identify potential study participants. Potential participants will be sent a MyChart® recruitment message 
asking them to participate. There is no risk of duplicate invitations as it is based on MyChart® accounts 
combined with Epic records and no duplication is possible.  
Social media advertising and community outreach and snowball methods (e.g. word of mouth) will also 
be utilized as avenues for participant recruitment. With the approval of OHSU clinical providers and the 
OHSU IRB (with the support of the mentorship team), additional outreach will take place at OHSU using 
clinic lists of patients who have opted into research opportunities. Only passive recruitment will occur at 
the VAPORHCS. Specifically, VA clinic staff may provide approved flyer with OHSU study contact to any 
interested Veteran who in turn may reach out to the PI or study team with questions if interested. A 
potential participant may then call the study team at the number on the flyer to schedule a phone call to 
be screened for eligibility. Dr. Kaplan may also provide OHSU IRB approved flyer (including study contact 
information) to VAPORHCS clinicians not affiliated to the study team to provide to any veterans who 
elect not to initiate, or who discontinue traditional PTSD treatments (e.g., Cognitive Processing Therapy 
(CPT) or Prolonged Exposure (PE) prior to completion. In addition to these recruitment efforts through 
VAPORHCS and OHSU, flyers will be posted via online outlets such as Facebook and Craigslist, and 
recruitment materials will be distributed to veterans with the Multnomah County Veterans’ Services. 
OHSU also hosts online search engines that allows potential participants to filter research participation 
opportunities based on certain criteria (e.g., compensation, time commitment). Dr. Kaplan will also 
present information about this study to veteran community resources, including Veterans of Foreign 
Wars (VFW) groups. Finally, Dr. Kaplan will engage in quarterly meetings with the Veterans Engagement 
Group (VEG) through VAPORHCS.  
 
Veterans Engagement Group (VEG). The VEG is a 7-10 member group comprised entirely of veterans 
who are VAPORHCS patients, former employees, and clinicians. This group provides investigators with 
feedback throughout the research process. The VEG regularly assists researchers in maximizing their 
recruitment and retention efforts, as well as providing feedback on aspects such as qualitative data 
collection and analysis as presented in this proposal. Dr. Kaplan has been invited to attend regular VEG 
meetings in order to ensure the effectiveness of recruitment methods, and to discuss alternative 
strategies in the event of slow recruitment. VEG will not have access to any patient data or identifier.  Dr. 
Kaplan may present aggregate recruitment/enrollment data to VEG in case there are problems and seek 
their advice to improve enrollment.   
 
Interested veterans will contact the research team to be screened for eligibility and to be informed of the 
purpose and procedure of the study. They may reach out by seeing the online flyers on social media 
platforms or hearing about the study during clinic visits or being handed a flyer. As a secondary strategy, 
upon identification of Veterans through OHSU approved recruitment tools, we will send a letter via US 
postal service or an email to explain the study. A study team member’s name and contact information 
will be provided in the letter so that the potential participant can call in to express interest or learn more 
about the study. Participants will also have the option to opt-out by calling or emailing the study team if 

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they wished not to be contacted. But if no response from the potential participant, the study team will 
call the Veterans who were sent the letters to discuss this study opportunity.    
 
Participants will be screened for eligibility by phone using a standardized list of inclusionary and 
exclusionary questions (Initial phone contact). The study and the participants’ right in research and 
compensation plan will be explained.  Those who are eligible will be invited to a second phone screening 
which will be scheduled according to a time convenient to the participant. During the second screening 
visit, eligible participants will be asked some questions related to demographics and will be required to 
complete some survey questionnaires to gauge their quality of life, cognitive status, etc. (see table below). 
If the participant qualifies screening, someone from the team will contact the participant and inform them 
of their eligibility and next steps. Participant’s name and contact information (phone number, mailing 
address, email address), age will be obtained to contact for the follow-up appointment and/or to initiate 
study participation. These identifiers will be kept in a separate database on the secured OHSU network 
drive or on OHSU acceptable cloud storage location.  
 
 
Participants will be given modest financial compensation for attending study visits and intervention 
sessions: $20 gift cards will be given at each study visit and post-intervention focus group interview (4 
total), and $5 will be added for each intervention session attended (9 total) for a total possible 
compensation amount of $125 per participant.  Compensation will be provided at the completion of each 
visit via ClinCard which will be reloaded following each visit.   The amount compensated is comparable to 
the compensation provided in similar research studies and should adequately compensate for the time 
and travel involved without constituting undue pressure or influence on, or coercion of, the prospective 
research participants to volunteer for or continue participation in the research study. 
 
 
 
Consent Process 
Participants will be informed about their rights at the beginning of the telephone screening. The 
telephone screening confirms that adults are competent in reading and speaking English. It also confirms 
that adults are cognitively capable of consent through administration of the Telephone Interview for 
Cognitive Status. A HIPAA waiver of authorization (WOA) will allow for the collection of identifiable data 
before obtaining full consent in person. Information to be collected during screening are as follows:  
  
 
 
 
 
Upon arrival at the research lab in Hatfield Research Center (HRC) for the first study visit, study personnel 
will review the study consent form with the participant and solicit questions. Once the subject verbally 
confirms understanding and interest in participation, they will be asked to sign consent forms and will be 
provided copies prior to leaving the HRC building. All research activities, including interventions, will take 
place at OHSU. Data collection and analysis will take place in the Oken Lab in OHSU’s Hatfield Research 
Building, and interventions will take place at OHSU’s Kohler Pavilion. 
  Subjects will be encouraged to ask questions throughout the duration of participation.   
Screening Measures 
Abbreviated Posttraumatic Stress Disorder Checklist (PCL-6), depression (PHQ-9), suicidality 
(PHQ-9 item 9), substance use (Alcohol Use Disorders Identification Test; Cannabis Abuse 
Screening Tool; Fagerstrom Nicotine Dependence Scale), medical history, self-reported 
medication history, current mindfulness practice, historical mindfulness experience. 
Demographics 
Age, gender, sex, ethnicity, BMI, marital status, education, income, employment status, 
military branch, era of service, years enlisted.  

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Modifications to the Consent Process  
In this study, Veterans will primarily be recruited when they see a flyer and contact the study team.  The 
PI will not be accessing the VA electronic medical record to identify a potential patient.  Once a potential 
participant reaches out to the PI and study from the contact information provided in the flyer, the PI or 
a delegated study team member will review the initial phone script to understand if the participant 
meets eligibility and shows interest in participation.  If the veteran is interested, the study team will call 
the participant at an agreed upon time to conduct screening procedures over phone.  If the participant 
is eligible, the participant will be invited to sign the OHSU informed consent form prior to randomizing 
to the study intervention (MBSR or HWE).   
We believe that requesting the participant to sign the consent form after screening will not adversely 
affect the patient as we will have a waiver to store this information in the secure network drive at OHSU. 
We have carefully selected the data elements as the minimum necessary in order to identify and recruit 
potentially eligible Veterans into this study without placing undue burden on the veterans. This is a 
minimal-risk study. Patients can avoid an unnecessary visit at OHSU to sign the consent form if they are 
ultimately determined to be not eligible after screening.   
  
Non-English Speaking Subjects 
English language reading and speaking are inclusion criteria for this study. Certain elements of the 
protocol such as the stressor task (Portland Arithmetic Stress Task) are not validated in other languages 
and would therefore not be able to be applied uniformly. 
Assent of Children and Parent Permission 
This is a study on Veterans so children will not be included.  
 
Adults Unable to Consent/Decisionally Impaired 
No decisionally-impaired adults will be recruited, and cognitive status will be determined during the 
phone screen. 
 
6) 
Procedures 
Aim 1 – Quantitative data: Recruitment and retention rates will be collected, compared between 
conditions, and evaluated in relation to previous research on MBSR recruitment and attrition. 
Correlations between rates of home practice completion (e.g., self-guided meditation practice) and 
attrition rates per condition will be examined for relationships. This quantitative data will be used to 
guide focus group prompt development. 
Aims 1&2 – Qualitative data: Focus groups will be conducted in accordance with guidelines for 
maximizing impact of qualitative research in feasibility studies.66 Broad topics will cover: 1) intervention 
content, 2) trial design and process (including stress induction and concurrent physiological data 
collection), 3) outcomes, and 4) measures. These discussion topics will be tailored to fit combat veterans 
with PTSD symptoms via consultation with the Veteran’s Engagement Group (VEG; see Human Subject 
Considerations for a description of the VEG; see also Matsumoto LOS). A thematic analysis approach67 
will explore participant experiences to understand feasibility, acceptability, and impact of assessments, 
protocol, and interventions. Analysis process will consist of: 1) familiarization, 2) initial coding, 3) 
creating themes, 4) reviewing themes, 5) defining and naming themes, and 6) data interpretation. The PI 
will work with Dr. Christopher (co-mentor) who has experience conducting thematic analysis of 
qualitative data in feasibility studies, and a trained RA to independently review focus group data. 
Emerging themes will help develop a coding scheme that the team will apply independently the finalized 
code structure. The team will meet regularly to review coding and discrepancies to ensure inter-rater 
reliability.  
Aim 2 – Physiological data: We will assess feasibility and effectiveness of stress induction by analyzing 
change in blood pressure (BP) between baseline and a cognitive stressor (see Stress induction paradigm 

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section below). BP will be collected via Caretaker Medical VitalStream™ device, which accurately and 
wirelessly measures vital signs. The VitalStream™ uses an automated readout inflatable finger cuff and is 
connected via Bluetooth to a tablet. Within-participants baseline-to-stressor task t-tests will evaluate 
feasibility of stress induction. Significant increases in BP from baseline to stressor will constitute 
effective stress induction. Quantitative analyses will be conducted in SPSS v.28,68 and qualitative will 
be conducted in NVivo.69 
 
Stress induction: 1. Baseline: The Simple Reaction Task (SRT) will serve as a baseline for the stressor 
task. Participants press a key each time a number appears on the screen. The SRT has been used as a 
baseline for cognitive stressors in prior Oken lab studies; 2. Stress induction: The Portland Arithmetic 
Stress Task (PAST)70 is a cognitive stressor comprised of arithmetic problems titrated in difficulty. It has 
an adaptive failure algorithm, maintaining an error rate of ~40%. It has been shown to induce 
physiological stress across groups.70-72 
 
Aim 3 – Quantitative data will be collected on paper and entered in REDCap by a study team member 
on an Oken lab computer and in-person clinical interview (i.e., Clinician-Administered PTSD Scale for 
DSM-5 [CAPS-5]). Using this data, we will examine sensitivity and responsiveness to change of outcomes. 
This Aim will be conducted in accordance with best practice guidelines,73,74 CONSORT 
recommendations,75 and previous research.76,77 Sensitivity in both groups will be analyzed via relative 
efficiency; dividing the F-statistic for each physiological (systolic and diastolic BP) and self-report 
(psychological resilience and PTSD symptoms) by the largest F-statistic among outcomes (see Table 
below for measures).77,78 This process will clarify which outcomes are most sensitive to MBSR. To 
generate F-statistics for relative efficiency, we will conduct repeated measures ANOVAs for each 
outcome in both groups. This statistical approach focuses on the degree to which measures are 
sensitive, not whether change is significant. Responsiveness to change over time will be assessed in the 
MBSR group for physiological and self-report outcomes by: 1) calculating and comparing standardized 
mean response by subtracting baseline mean response from post-intervention mean response, and 
dividing by standard deviation of change74,79,80 and 2) examining zero-order correlations between a 
global impression of change measure (post-intervention) and change scores (baseline to post-
intervention) for self-report outcomes.81-83 
Primary measures to be collected are listed below: 
 
Method 
Variable 
Measurement Tool 
Timepoints 
Paper>REDCap  
Psychological resilience 
Brief Resilience Scale (BRS) 
Pre, mid, post 
Paper>REDCap 
PTSD symptoms 
PTSD Symptoms Checklist for DSM-5 (PCL-5) 
Pre, mid, post 
Paper>REDCap 
Mindfulness 
Five Facet Mindfulness Questionnaire (FFMQ-15) 
Pre, mid, post 
Paper>REDCap 
Perceived stress 
Perceived Stress Scale (PSS-10) 
Pre, mid, post 
Paper>REDCap 
Loneliness 
UCLA Loneliness Scale 
Pre, mid, post 
Paper>REDCap 
Distress 
Distress tolerance scale 
Pre, mid, post 
Clinical interview 
PTSD symptoms 
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) 
Pre, mid, post 
CareTaker™ 
Physiological resilience 
Blood pressure (BP) 
Pre, mid, post 
 
 
Stress induction: 1. Baseline: The Simple Reaction Task (SRT) will serve as a baseline for the stressor 
task. Participants press a key each time a number appears on the screen. The SRT has been used as a 
baseline for cognitive stressors in prior Oken lab studies; 2. Stress induction: The Portland Arithmetic 
Stress Task (PAST)70 is a cognitive stressor comprised of arithmetic problems titrated in difficulty. It has 
an adaptive failure algorithm, maintaining an error rate of ~40%. It has been shown to induce 
physiological stress across groups.70-72 
 
Interventions: 
Mindfulness-Based Stress Reduction consists of weekly two-hour sessions for eight weeks, and a 7 hour 
retreat after Lab visit 3/week 8. The MBSR intervention will be facilitated by an experienced and 

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certified MBSR teacher. MBSR curriculum strongly encourages completion of home practice assignments 
(~30 minutes daily) to help integration of concepts into daily life. Participants will receive audio CDs and 
a DVD to help guide home practice.  
 
Health and Wellness Education (HWE) Intervention is a didactic-based group intervention designed as 
an active comparator for randomized-controlled trials of MBSR. HWE provides instruction to participants 
regarding improving their emotional and physical health. In contrast to MBSR, there are no attempts to 
train participants’ breathing, movement, or meditation habits or practices. HWE is administered in 8 
weekly 2.5-hour classes with home practice to be completed between sessions (matched to MBSR for 
amount and effort). HWE also features one extended 7hour retreat, similar to MBSR.84 Dr. Autumn 
Gallegos (consultant) has conducted trials of MBSR among veterans with PTSD using a control group 
based on similar materials, and will provide mentorship to the PI in administering the control 
intervention. Dr. Kaplan and a trained RA will facilitate HWE. 
 
 
CareTaker VitalStream™. The CareTaker VitalStream™ is comprised of a lightweight wrist pack attached 
via Velcro, which is connected via thin tube to a small Velcro finger cuff that contains a low-pressure 
sensor. All materials used in the VitalStream™ are medical grade. VitalStream™ measures continuous 
pulse pressure waveforms for processing via Pulse Decomposition Analysis™ (PDA™). The PDA™ 
technology includes algorithms to calculate and continuously monitor hemodynamic-related parameters 
by analyzing reflective pulsewave morphology within the arterial system. The VitalStream™ allows for 
secure wireless monitoring via a real-time mobile application, or remote monitoring via a Cloud Portal. 
For the purposes of the study, we will monitor participant data via mobile application on an encrypted 
Android tablet in a room adjacent to the testing room during the laboratory stressor task. Dr. Kaplan (PI) 
designed and executed a pilot RCT using a previous version of CareTaker. Through this study Dr. Kaplan 
gained familiarity with the equipment and software, and developed relationships with key CareTaker 
Medical personnel. 
Blood pressure. The VitalStream™ measures and records systolic, diastolic, and mean arterial pressure 
(MAP) using FDA-approved PDA™ technology. These algorithms have been validated in comparison to 
invasive central aortic measurement.  
Heart rate. The VitalStream™ measures heart rate via low-pressure finger sensor, with accuracy 
validated in comparison to 3-lead ECG measurement.  
Respiration rate. The VitalStream™ accurately measures respiration rate (breaths per minute) non-
invasively by extrapolating pulsewave morphology via PDA™. The VitalStream™ calculates respiration 
rate in this fashion with equivalent accuracy to ECG-derived respiration using a 3-lead ECG electrode. 
 
Potential participants will be sent a MyChart recruitment invitation and a follow-up (as applicable) via an 
email notification, as below, with the Subject “New Research Study” instructing them to log into 
MyChart to learn more and respond.  The text of this invitation is included in the eIRB submission. The 
link in the MyChart invitation will take the potential participant to their MyChart homepage with a link 
to a description of the study.  Potential participants will express interest or decline by pressing the 
associated buttons in MyChart, or they will not respond.  If the potential participant indicates interest, 
they are automatically associated to the study in Epic with a status of “interested;” the study remains 
listed on the patient’s Research Studies page in MyChart, and the study team immediately receives an 
in-basket notification in Epic so that they can follow up with the patient.  If the patient clicks “No, Thank 
You” this study will no longer appear on their Research Studies page in MyChart, and the patient is 
automatically associated to the study in Epic with a status of “declined.”  When the participant 
expresses interest, the study team will call the participant to schedule the initial phone call for an initial 
review of eligibility and a second screening phone call before the participant is enrolled on study. Details 
of the initial and second phone call are included under “recruitment methods” section. 
 

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Please see below for a description of the study schedule.  All survey data will be captured in paper 
surveys from study participants and will be directly entered in the REDCap database by a study team 
member.   
 
 
 
 
 
Study Schedule:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
a. 
Screening measures will include: PTSD (PCL-5), depression (PROMIS), suicidality (PHQ-9), substance abuse (Alcohol Use Disorders Identification 
Test, Cannabis Abuse Screening Tool, Fagerstrom Nicotine Dependence Scale) in addition to review of eligibility 
b. 
Demographic information includes age, gender, sex, ethnicity, BMI, marital status, education, income, employment status, military branch, era 
of service, years enlisted.  Medical and medication history, current and historical mindfulness experience are captured during screening 
c. 
Questionnaires include Brief Resilience Scale, PTSD Symptoms Checklist for DSM-5 (PCL-5,6), UCLA Loneliness Scale, CAPS-5, Five Facet 
Mindfulness Questionnaire (FFMQ-15), Perceived Stress Scale (PCL-10), Distress tolerance scale (DTS) 
d. 
Participants are randomized at visit 1 to either MBSR or HWE. All participants have 30-minute practice assignments to be carried out every day 
at home.  
e. 
Week 1 of the interventions will occur within one week of completing Lab Visit 1 for all participants.  
Participants may be withdrawn from this study without their consent in order to protect them from 
excessive risk (e.g., if they demonstrate unsafe elevated blood pressure), or in order to maintain the 
integrity of the study and data (e.g., a participant is not following study procedures and/or may be 
deliberately providing false information).  
 
7) 
Data 
Handling of Data  
Data collected will include computer-based and physiological recordings listed above, as well as 
demographic data such as age and gender. Data will also include health status information, such as 
Visits 
Initial 
phone 
call 1 
Screening 
phone call 
Lab visit 
1  
Wk
1e 
 
Wk
2 
Wk
3 
Wk
4 
Wk5/
Lab 
visit 2 
Wk
6 
Wk
7 
Wk8/
Lab 
visit 3  
 
Retreat 
Post-
interventi
on Wk9 
Study overview 
and eligibility 
review 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Screening 
questionnairesa 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Demographics b 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Informed 
consent 
 
 
X 
 
 
 
 
 
 
 
 
 
 
MBSR/HWEd 
intervention 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Study Visit 
Questionnairesc 
 
 
X 
 
 
 
 
X 
 
 
X 
 
 
Clinical 
interview 
(Clinician 
administered 
PTSD scale for 
DSM-5 (CAPS-5) 
 
 
X 
 
 
 
 
X 
 
 
X 
 
 
CareTaker 
VitalStream™ 
(physiologic 
data collection, 
BP) 
 
 
X 
 
 
 
 
X 
 
 
X 
 
 
Lab Stressor  
 
 
X 
 
 
 
 
X 
 
 
X 
 
 
Focus group 
Qualitative 
interview 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Approximate 
total time 
15 mins 
30 mins 
120 mins 
150 
mins 
150
mins 
150 
mins 
150
mins 
270 
mins 
150 
mins 
150 
270 
mins 
7 hours 
120 mins 

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medical conditions and prescription medications for use in determining eligibility. All data will be stored 
on a restricted OHSU network drive in a limited access folder or in a REDCap database, and the study PI 
and designee will be responsible for storage and transmission of the data. Following this study, all data 
will be transferred and stored indefinitely in repository IRB #7436. No specimens will be collected as 
part of this study.  
 
a) Sharing of Results with Subjects 
Participants will be given the opportunity to view their heart rate and blood pressure when it is taken in 
the lab during the baseline condition, unless they would prefer not to. Participants will not be shown 
their physiological data during the stressor condition due to the expected increases resulting from 
cognitive stress. Besides this, participants will not have access to any other data collected as a part of 
this study. If participants demonstrate pathological blood pressure during the course of the study, they 
will be notified and referred to their PCP and/or urgent care. If blood pressure reaches hypertensive 
crisis (180/110) the participant will be referred immediately to the emergency department. No data will 
be used for clinically decision-making, nor will it be entered into participants’ medical records. Referrals 
will be made based on generic critical blood pressure values only. 
 
b) Data and Specimen Banking 
If data or specimens will be banked in a repository for future use as part of this protocol submission, 
describe here (or in a separate repository protocol document) where they will be stored, how long they 
will be stored, how they may be accessed, and who will have access to the specimens.  Describe the 
procedures to release data or specimens, including: the process to request a release, approvals required 
for release, who can obtain data or specimens, and the data to be provided with specimens. 
Data will be sent to a repository maintained separately from this study. They will be stored indefinitely 
in repository IRB #7436.  Participants will be requested to consent to sharing data in the repository 
which will be optional. The repository investigator and members of the Oken Cognitive Neuroscience 
Laboratory are allowed to access the data and will have requisite HIPAA and other trainings.  Please see 
repository protocol for details related to that study.  
 
8) 
Data Analysis 
Quantitative data: 
Recruitment and retention rates will be collected, compared between conditions, and evaluated 
in relation to previous research on MBSR recruitment and attrition. Correlations between rates of 
home practice completion (e.g., self-guided meditation practice) and attrition rates per condition 
will be examined for relationships. 
 
Within-participants baseline-to-stressor task t-tests will evaluate feasibility of physiological stress 
induction. Significant increases in BP from baseline to stressor will constitute effective stress 
induction. 
 
Sensitivity in both groups will be analyzed via relative efficiency; dividing the F-statistic for each 
physiological (systolic and diastolic BP) and self-report (psychological resilience and PTSD 
symptoms) by the largest F-statistic among outcomes (see Table above for measures).77,78 This 
process will clarify which outcomes are most sensitive to MBSR. To generate F-statistics for 
relative efficiency, we will conduct repeated measures ANOVAs for each outcome in both groups. 
This statistical approach focuses on the degree to which measures are sensitive, not whether 
change is significant. Responsiveness to change over time will be assessed in the MBSR group for 
physiological and self-report outcomes by: 1) calculating and comparing standardized mean 
response by subtracting baseline mean response from post-intervention mean response, and 
dividing by standard deviation of change74,79,80 and 2) examining zero-order correlations between 

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a global impression of change measure (post-intervention) and change scores (baseline to post-
intervention) for self-report outcomes.81-83 
 
Qualitative data: 
A thematic analysis approach67 to qualitative data will explore participant experiences to 
understand feasibility, acceptability, and impact of assessments, protocol, and interventions. 
Analysis process will consist of: 1) familiarization, 2) initial coding, 3) creating themes, 4) 
reviewing themes, 5) defining and naming themes, and 6) data interpretation. 
 
9) 
Privacy, Confidentiality and Data Security 
Standard institutional practices will be followed as described in the OHSU Information Security Directives 
(http://www.ohsu.edu/xd/about/services/integrity/policies/ips-policies-info-sec-directiv.cfm#results) to 
maintain the confidentiality and security of data collected in this study. Study staff will be trained with 
regard to these procedures.  Any staff that will be involved in these research activities will have completed 
the requisite Human Subject Protection Training as required by the IRB prior to engagement. 
Documentation of training will be held on secure password protected computers at OHSU. Prior to 
implementation of any protocol changes, amendments will be submitted to the OHSU Institutional Review 
Board for approval. Dr. Kaplan will be responsible for continuous data and safety monitoring of all 
participants, and discussion of any data or safety monitoring concerns will be a routine topic of 
mentorship and consultation meetings. In the event there are AEs/SAEs that require medical intervention, 
Dr. Oken, a board-certified neurologist, will be available to review events and refer them as needed.   
 
 
Paper files will be stored in locked filing cabinets in restricted access offices at OHSU and will not leave 
the Oken lab facility. Electronic data is stored on restricted drives on the OHSU network, on OHSU 
approved cloud location and on encrypted computers. Electronic data will also be stored in a custom 
database housed on an OHSU secure server. Access to data is restricted to study personnel. Access to 
data requires OHSU ID/password authentication. 
 
Upon enrollment, participants will be assigned a code that will be used instead of their name, medical 
record number or other personally identifying information. Electronic files for data analysis will contain 
only the subject code. Codes will not contain any part of the 18 HIPAA identifiers (initials, DOB, MRN) The 
key associating the codes and the participants personally identifying information will be restricted to the 
PI and study staff. The key will be kept secure on a restricted OHSU network drive in a limited access 
folder.  
 BP will be collected via Caretaker Medical VitalStream™ device, which accurately and wirelessly 
measures vital signs. The VitalStream™ uses an automated readout inflatable finger cuff and is 
connected via Bluetooth to a tablet. The CareTaker™ is completely wireless, and will relay data 
via Bluetooth connectivity to a tablet. It allows for secure wireless monitoring via a real-time 
mobile application, or remote monitoring via a Cloud Portal. For the purposes of the study, we 
will monitor participant data via mobile application on an encrypted Android tablet in a room 
adjacent to the testing room during the laboratory stressor task. There is no storage, processing 
or transmission of any PHI or HIPAA identifiers through VitalStream. It does not connect to OHSU 
network, but is transmitted via Bluetooth to an encrypted tablet.   
 
 
At the completion of the study, if patients consent to sharing data in the repository, their data will be 
released to repository IRB #7436. See repository protocol for details about requesting, releasing, and 
labeling data. 
 

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10) Risks and Benefits  
a) Risks to Subjects 
The risk in participating in the present study is low. Participants may feel distress when 
reporting their PTSD symptoms or identifying their index trauma (i.e., the most salient trauma 
connected to their PTSD symptoms) as part of the administration of the Clinician-Administered 
PTSD Scale (CAPS-5). Participants may also feel discomfort or embarrassment when discussing 
their general experiences during the intervention conditions. They may also feel stress or 
frustration when completing the laboratory stressor paradigm. Participants have the right to 
withdraw, and may attend intervention groups and not actively participate, or may not 
complete MBSR home practice between sessions.  
 
There is no discomfort associated with the collection of physiological data. The CareTaker™ 
device using a Velcro finger cuff attached with similar tightness to an arm cuff blood pressure 
monitor. A thin clear tube connects the finger cuff to a small wrist pack that houses the 
electronic components of the device. The CareTaker™ is completely wireless, and will relay data 
via Bluetooth connectivity to a tablet. 
 
One of the potential risks of participation breach of confidentiality. It is possible that, if someone 
inadvertently obtained data, this could result in harm to research participants, with legal, 
financial, or emotional implications of the affected Veterans. We will take all possible measures 
to protect the security and integrity of personal health information.   
 
b) Potential Benefits to Subjects 
Veterans may find it rewarding to engage in group-based interventions in which they are encouraged to 
share their experiences with other veterans with similar struggles related to PTSD symptoms. They may 
similarly appreciate being able to share their perspectives regarding their ability and strategies for 
coping with symptoms. Participants may also experience reduction in symptoms of PTSD, depression, 
and anxiety as a result of participating in the MBSR condition. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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