Trauma-sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma
Phase: NA
Conditions: Stress Disorders, Post-traumatic
Sponsor: VA Office of Research and Development

IRB Protocol Version 12 
11/23/20 
 
Official Title: Trauma-Sensitive Yoga for Female Veterans with PTSD Who Experienced Military Sexual Trauma 
 
NCT#  
NCT02640690 
 
Document Date: 11/23/2020 
 

IRB Protocol Version 12 
11/23/20 
 
 
Full Title: 
 A Randomized Controlled Trial Comparing Trauma Center-Trauma Sensitive Yoga and 
Cognitive Processing Therapy for PTSD and Associated Symptoms in Women Veterans 
 
Short Title: 
RCT of Yoga versus CPT in Women Veterans (Project Stress-Less II) 
 
Coordinating Center (Atlanta):  
 
Principal Investigator:  Ursula A. Kelly, PhD, ANP-BC, PMHNP-BC 
 
 
 
     Nurse Scientist 
  
 
 
     Atlanta VA Medical Center, Trauma Recovery Program 
 
Local Site (Portland):  
 
Principal Investigator:   Belle Zaccari, PsyD 
                 Staff Psychologist 
                 VA Portland Health Care Center, Rural Telemental Health 
 
 
 
 
Sponsor Information 
This study is funded by VA HSR&D Nursing Research Initiative award, VA HSRD Funding # 5I01HX001087-
02. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

IRB Protocol Version 12 
11/23/20 
 
A. SPECIFIC AIMS 
 
This project builds directly on a one-year pilot study (Project Stress-Less) conducted by the PI which 
demonstrated the feasibility of the current protocol. This study will test the effectiveness of a Trauma Center-
Trauma Sensitive Yoga (TC-TSY) intervention to improve the health, social functioning, and quality of life for 
women Veterans with posttraumatic stress disorder (PTSD) related to military sexual trauma (MST). The 
randomized controlled trial (RCT) will compare results from a TC-TSY group (experimental group) to an 
evidence-based PTSD treatment known as Cognitive Processing Therapy- (CPT; control group).   
 
 
The specific aims of the RCT:  
 
Aim 1:  
To evaluate the effectiveness of Trauma Center-Trauma Sensitive Yoga (TC-TSY) 
compared to Cognitive Processing Therapy (CPT) in reducing PTSD symptoms, chronic 
pain, and insomnia in women Veterans with PTSD related to MST. 
 
Aim 2:   
To evaluate the effectiveness of TC-TSY as compared to CPT in improving quality of life 
and social functioning in women Veterans with PTSD related to MST. 
 
 
Aim 3:   
 
To evaluate the effectiveness of TC-TSY as compared to CPT on biological stress  
 
 
 
 
response and psychophysiological hyper-responsivity. 
 
 
 
B. Theoretical Framework 
 
The proposed study is based on a theoretical framework in which the impact of the yoga intervention is 
conceived to directly counteract immunological and psychophysiological responses to trauma. Our proposed 
model suggests that, through its effects on the central nervous system, yoga reduces the inflammation and 
psychophysiological hyperarousal associated with trauma and improves autonomic regulation. We propose 
that these effects (reduced inflammation and hyperarousal and improved autonomic regulation) are one 
pathway through which the practice of yoga may lead to reduced PTSD symptoms, chronic pain and insomnia. 
Because of the data suggesting a bidirectional relationship between inflammation/autonomic 
dysregulation/hyperarousal and PTSD symptoms/chronic pain/insomnia, it is also expected that the yoga 
intervention will facilitate improved functioning in both domains (inflammation/autonomic 
dysregulation/hyperarousal and PTSD symptoms/chronic pain/insomnia). It is hoped that this synergistic 
improvement across the two domains will counteract the alternate process in which increases in one domain 
lead to increases in the second, thereby increasing the overall negative impact of trauma exposure.  
 
C. STUDY DESIGN AND METHODS 
 
COVID-19 Contingency Plan (Atlanta and Portland) 
As a result of the COVID-19 pandemic, local directive (3/12/2020) suspended study intervention visits for this 
study and national (3/17/2020) directive suspended all non-essential, in-person visits until further notice.  Thus, 
we have modified the study design and methods to conduct group interventions and data collection virtually 
when possible.  All interview-based assessments will be conducted via a suitable/authorized remote 
conferencing service between participant and research coordinator, i.e. Zoom Pro.  All group intervention 
sessions will be conducted via a suitable/authorized remote conferencing service with group facilitators and 
group participants, i.e. Zoom Pro.  Participant self-report will be entered by participant via direct entry of fully 
de-identified data into a secure REDCap web-based application. In the event self-report and/or interview-based 
assessments cannot be conducted via remote/virtual methods, the assessments will be administered via 
telephone.   Informed consent and HIPAA authorization will be emailed and mailed to potential participants and 
reviewed via remote conferencing service or telephone.  Once signed consent has been received by research 

IRB Protocol Version 12 
11/23/20 
staff, data collection visits and interventions will be conducted in the aforementioned manner. We will suspend 
collection of in-person physiological data at the Atlanta site. Portland site will utilize mail and drop off/ pick up 
for data collection kits such as portable KardioScreen ECG machines finger-stick blood collection method, 
portable BodyGuard HRV devices (Atlanta and Portland). Devices will be cleaned/sterilized in concordance 
with manufacturer’s instructions and CDC guidelines. 
 
Setting and Location (Atlanta) 
This is a multi-site study with Atlanta VA Health Care System as the Coordinating Center.  Study procedures in 
Atlanta will be conducted at the VA Clinical Studies Center. The Acoustic Startle Lab and the Atlanta VA 
Trauma Recovery Program located at the Henderson Mill Annex will also be used for intervention and data 
collection visits. 
 
Clinical Studies Center (CSC) 
The CSC is a professional center designated to facilitate human subjects’ research at the Atlanta VA Medical 
Center and includes a laboratory (equipped with centrifuge, freezer, and biosafety hood), phlebotomy services 
for participants, and exam rooms to conduct study visits. The study team will utilize these services throughout 
the study. 
 
Acoustic Startle Lab 
The Acoustic Startle Lab is conveniently located on the fifth floor of the main VA. This space is dedicated to the 
collection of psychophysiological data (acoustic startle, HRV, skin conductance) and includes a Biopac 
System, sound attenuating audiology booth and control room for staff. 
 
Trauma Recovery Program 
The Trauma Recovery Program is located on the fourth floor of a leased VA space in the Henderson Mill 
Annex (2296 Henderson Mill Road) and contains ample parking, office space and group rooms. Study 
procedures including informed consent, self-report measures, interview-based assessments and dark 
psychophysiological data collection will also be conducted in a dedicated research office within the TRP. 
Additionally, the yoga and CPT group sessions will be conducted in the TRP group rooms. 
 
 
 
Setting and Location (Portland) 
 
Study procedures will be conducted at the VA Portland Health Care System at both the Portland and 
Vancouver VA Medical Centers. Specifically, intervention sessions (Yoga and CPT) will be held at the 
VAPHCS Vancouver, WA campus and data collection visits will be conducted at the main VAPHCS 
campus in Portland, OR.  Once IRB approval is received, space will be designated for data collection and 
intervention sessions for the duration of this study.   
 
 
Participant Selection 
Inclusion Criteria  
1) Women Veterans who experienced military sexual trauma; 
2) Meets DSM-V criteria for PTSD due to military sexual trauma  
3) Difficulty falling asleep or difficulty staying asleep (insomnia)  
4) Ability to give informed consent; 
5) Willing to participate in either TC-TSY or CPT; 
6) Available to attend the study intervention at the scheduled times. 
 
Exclusion Criteria 
1) Diagnosis of schizophrenia with significant psychotic symptoms (determined via clinician interview); 
2) Current, active suicidal intent or plan (determined via clinician interview); 
3) Current severe alcohol substance use disorder (determined via clinician interview); 

IRB Protocol Version 12 
11/23/20 
4) Medical conditions that can contribute significantly to psychiatric symptoms, including poorly controlled 
hypo/hyperthyroidism, kidney or liver failure (determined via review of medical record); 
5) Dementia (determined via review of medical record); 
6) Moderate or severe traumatic brain injury (TBI) or other cognitive impairment sufficient to interfere with 
ability to give informed consent (determined via review of medical record); 
7) Pain due to acute injury (<3 months), post-surgical pain (<3 months) or pain due to malignancy 
(determined through Veteran self-report and/or medical record); 
8) Receiving mental health trauma focused therapy (TFT) treatment outside of the VA (determined 
through Veteran self-report); 
9) Current engagement in trauma-focused treatment, yoga practice or other treatment/intervention at odds 
with the study intervention. 
 
 
 
 
Recruitment (Atlanta) 
Veterans will be recruited in the following ways: 
1) Veterans may self-refer from flyers and brochures located in waiting areas and bulletin boards located 
in various clinics within the VA including the TRP, Women’s Wellness and Primary Care. Flyers may 
also be distributed during VA sponsored events (For Example: Vet Fest, Heart Health events, VA 
Research Day). Following initial contact, a phone screen and chart review will be completed to assess 
eligibility. 
2) Clinicians within the TRP, Women’s Wellness and Primary Care, and any other out-patient clinic or 
community-based out-patient clinic (CBOC) may also refer patients to the study. Veterans will be given 
the option to contact the study team directly or they may give consent to be contacted by a member of 
the study team. A brochure with an overview of study information and contact information may be 
provided to the interested Veteran by the clinician. Following initial contact, a phone screen and chart 
review will be completed to assess eligibility. 
3) Study staff will conduct ongoing chart review of patients who have been referred to TRP for services, 
and/or who have recently completed TRP intake. The study team will contact TRP clinicians regarding 
any patient who could be a potential candidate for the study. At that time, the TRP provider will discuss 
the study with the Veteran and if the Veteran expresses interest, TRP staff will provide study contact 
information or facilitate an introduction to the study team. The study team and TRP providers will work 
closely to make sure that anyone who is interested will be screened for the study. 
4) Study staff will attend TRP psychoeducational groups and staff meetings to present the study. Flyers 
with study contact information will be provided so that anyone who is interested may contact the team 
directly. 
5) Study staff will conduct pre-screening of selected out-patient clinics within the Atlanta VAHCS to 
identify potential participants, for example, Women’s Wellness. We have obtained a partial HIPAA 
waiver for this purpose. The clinical providers of potentially eligible participants will be contacted to 
request that they inform the patient of the study.  
6) Recruitment will also be done outside of the VA setting. Study staff will place flyers in clinics, centers, 
college campuses, and other locations in the community which have the potential to reach women 
Veterans. Study staff will get consent from these locations prior to posting the flyers. In addition, study 
staff will attend community events geared towards Veterans in order to explain the research study to 
providers and provide information to those who may be interested. Note: The study team will not be 
recruiting non-Veterans into the study, but will expand recruitment efforts outside the VA setting. 
7) To supplement provider referrals, we may also conduct initial outreach to potentially eligible participants 
via recruitment letters, as required by the IRB. In addition to patients identified via pre-screening, we 
propose to use the VA Informatics and Computing Infrastructure (VINCI) databases to identify patients 
at the Atlanta VA Health Care System who may be eligible for participation in the research study.  We 
will ask the VINCI data managers to pull requested data from the Corporate Data Warehouse (CDW).  
The data pulled from VINCI will include patient names, phone numbers and address, dates, social 
security number, visit and hospital information, and other health information.  This information will be 

IRB Protocol Version 12 
11/23/20 
necessary to recruit participants, and a partial HIPAA authorization waiver has been obtained.  These 
identified data will be directly transferred electronically from the VINCI environment to the secured 
research server VHAATGFPC10 located in the OIT server room at the facility.  This will be done by 
Christine Jasien, Atlanta VAMC statistician.  The servers are managed by the Atlanta and Region 3 OIT 
offices and security is managed by the Information Security Officers at that facility.  The server room 
has appropriate security controls in place (including a locked room, password protection, and 
encryption), and the drive that the data will reside at will be controlled so that only the research team 
has access to the data.  Patients identified for contact will be sent an IRB-approved letter referring to 
the study as “Project Stress-Less” for privacy purposes.  The study team will discuss the study with 
interested patients by telephone, providing further information about the study. 
The PI has been granted a partial HIPAA waiver in order to conduct these pre-screening/recruitment activities 
which facilitate identification of eligible participants. Recruitment rates will be calculated by comparing the total 
number of patients screened for the study to the number of patients who provide informed consent to 
participate. 
 
Recruitment (Portland) 
Veterans will be recruited in the following ways: 
1) Veterans may self-refer from flyers and brochures located in waiting areas and bulletin boards located 
in various clinics within the VAPORHCS including the Mental Health Clinic (MHC), Women Veteran 
Health Clinic (WVHC), PTSD Clinical Team (PCT), and Primary Care Mental Health Integration 
(PCMHI). Following Veteran initiated contact, a phone screen and chart review will be completed to 
assess eligibility. 
2) Clinicians within participating mental health clinics and any other out-patient clinics (CBOC) may also 
refer patients to the study. Veterans that are identified by treatment providers (who have pre-existing 
relationships with the potential participant), meet criteria, and are interested in participation will be 
provided a verbal explanation and printed IRB-approved study flyer from that provider who also will 
collect verbal consent to be contacted by a study member. At that time, Veterans will be given take 
home information about the study purpose and details. Consent of potential participants to be contacted 
by a study team member will prompt the treatment provider to refer the Veteran by first and last name 
along with last 4 digits of the Veteran's SSN to the study team either via encrypted email, phone, or by 
attaching a study team member as a cosigner to a CPRS note.  Providers will document in CPRS the 
conversation with the Veteran and the Veteran having consented to be contacted for study 
participation. Following Veteran consent to be contacted, a study team member will follow up with a 
phone screen and chart review will be completed to assess eligibility. 
3) Study staff will conduct pre-screening of selected out-patient clinics within the VAPORHCS to identify 
potential participants. In cases where a potential participant was not identified as such by other 
recruitment efforts described in this waiver (e.g. via their treating clinicians or flyers), under the principle 
of beneficence, the study should be made available to them.  In those cases, a study team member will 
request permission from the clinician in charge of the clinic to reach out to the potential participant.  If 
granted permission by the clinician in charge to contact the potential participant, a study team member 
will contact the potential participant.  That contact will include a letter to the identified potential 
participant acknowledging PHI that assists the Veteran in understanding why they were identified for 
participation and will be signed by the treating clinician or clinician in charge.  In addition, that contact 
will include a letter signed by a member of the study team introducing the study to the potential 
participant as a means for recruitment.  This letter will not be individualized and will include a 
brief/general description of the study.  The two letters included in this contact will be documented in the 
CPRS chart but included as a research related document that is not viewable to the Veteran.  
4) Study staff will attend staff meetings of participating mental health clinics to present the study. Flyers 
with study contact information will be provided so that anyone who is interested may contact the team 
directly. 
5) Study staff will conduct pre-screening of selected out-patient clinics within the VAPORHCS to identify 
potential participants, for example, Women Veterans Health Clinic. We have requested a partial HIPAA 
waiver for this purpose. The clinical providers of potentially eligible participants will be contacted to 

IRB Protocol Version 12 
11/23/20 
request that they inform the patient of the study. Additionally, study staff will send opt-out letters to 
these identified potential participants as a means of recruitment (see Appendix 2). 
6) Recruitment will also be done outside of the VA setting. Study staff will place flyers in clinics, centers, 
college campuses, and other locations in the community which have the potential to reach women 
Veterans. Study staff will get consent from these locations prior to posting the flyers. In addition, study 
staff will attend community events geared towards Veterans in order to explain the research study to 
providers and provide information to those who may be interested. Note: The study team will not be 
recruiting non-Veterans into the study but will expand recruitment efforts outside the VA setting. 
7) To supplement provider referrals in Portland, we may also conduct initial outreach to potentially eligible 
participants via recruitment letters, as required by the IRB. In addition to patients identified via pre-
screening, we propose to use the VA Informatics and Computing Infrastructure (VINCI) databases to 
identify patients at the VA Portland Health Care System who may be eligible for participation in the 
research study.  We will ask the VINCI data managers to pull requested data from the Corporate Data 
Warehouse (CDW).  The data pulled from VINCI will include patient names, phone numbers and 
address, dates, social security number, visit and hospital information, and other health information.  
This information will be necessary to recruit participants, and a partial HIPAA authorization waiver will 
be requested.  These identified data will be directly transferred electronically from the VINCI 
environment to the secured research server VHAATGFPC10 located in the OIT server room at the 
facility then to the secure research folder at VAPORHCS.  This will be done by Christine Jasien, Atlanta 
VAMC statistician.  The servers are managed by the respective OIT offices and security is managed by 
the Information Security Officers at that facility.  The server room has appropriate security controls in 
place (including a locked room, password protection, and encryption), and the drive that the data will 
reside at will be controlled so that only the research team has access to the data.  Patients identified for 
contact will be sent an IRB-approved letter referring to the study as “Project Stress-Less” for privacy 
purposes.  The study team will discuss the study with interested patients by telephone, providing further 
information about the study. 
The PI will request a partial HIPAA waiver in order to conduct these pre-screening/recruitment 
activities which facilitate identification of eligible participants. Recruitment rates will be calculated 
by comparing the total number of patients screened for the study to the number of patients who 
provide informed consent to participate. 
 
Methods  
 
Data Collection (See Table 1: Study Flowchart and Data Collection Schedule) 
Participants will be assessed at five time-points during the study. Following the phone pre-screening interview, 
the participant will be scheduled for the Screening/Consent Visit (Time 0) for further determination of eligibility. 
If eligible, participants will be scheduled for the Baseline/Randomization Visit (Time 1) followed by the Mid-
Treatment Visit (Time 2), the 2-Week Post Treatment Visit (Time 3) and the 3-Month Follow-Up Visit (Time 4). 
Each study visit will last 2-3 hours and includes collection of self-report measures, interview-based 
assessments, psychophysiological assessment, and immunological measures. Finally, if the participant 
completes intervention and elects to participate in the crossover intervention, they will be asked to complete 
several self-report measures (PCL, BDI, BPI, PSQI, VR-12 & Treatment Evaluation Form) before treatment, 
midway through treatment and again 2-weeks and 3-months post treatment. Participants opting to do the 
crossover intervention will not be compensated and will be given the option to complete the measures via 
phone. 
 
Self-Report and Interview-Based Assessments 
Participant self-report and interview-based assessments will be administered on paper forms or via direct entry 
of fully de-identified data into the VA REDCap web-based application. Various self-report forms and interviews 
will be administered at each study visit.  
 
The following self-report and interview-based measures will be used for patient assessment during the course 
of the study: 
 

IRB Protocol Version 12 
11/23/20 
Medical Outcomes 
• 
Adverse Events will be assessed at each time-point. 
• 
Concomitant Medications will be assessed at the Baseline/Randomization Visit and any changes will be 
documented at follow-up visits. 
• 
VA Group Engagement will be assessed at all timepoints to determine if the Veteran is engaged in 
other groups and if so, which groups and how frequently they attend.  
 
Demographics 
• 
A Basic Demographics form will be administered at the screening visit and updates to demographics 
and contact information will be assessed at each follow-up visit.  
• 
Currently enrolled participants that have consented to additional demographic survey questions, will be 
administered a sexual orientation and gender identify (SOGI) survey.  New participants enrolled will be 
administered the SOGI survey during the demographics portion of the screening visit.  
• 
 
 
Trauma Exposure: 
• 
The Deployment Risk and Resilience Inventory-278 (DRRI-2) was prepared with support from the 
Department of Veterans Affairs and contains questions regarding experiences before, during and after 
deployment. For purposes of this study, Section D (Combat Experiences) will be administered to 
assess level of combat exposure. 
• 
The Childhood Trauma Questionnaire (CTQ) assesses exposure to and severity of childhood trauma 
across five subscales including: physical neglect, physical abuse, emotional neglect, emotional abuse 
and sexual abuse.  
• 
The Life Events Checklist (DSM-5 version) is a self-report measure with established psychometrics 
designed to screen for potentially traumatic events in a respondent's lifetime and has been used with 
Veterans1.  
 
 
PTSD Severity: 
• 
The Clinician Administered PTSD Scale (CAPS-5) is the gold-standard for assessing PTSD. The CAPS 
uses a  clinician-administered diagnostic instrument that assesses lifetime and current PTSD diagnosis 
and symptoms and global PTSD symptom severity2. The CAPS also yields a continuous measure of 
the severity of both overall PTSD and of the four PTSD symptom clusters. It assesses the validity of the 
participant's responses and has excellent psychometric properties. The Past-Month version will be 
administered at Baseline and the Past Week version will be administered at each of the follow-up visits. 
CAPS-5 interviews will be audio-recorded for quality assurance purposes.  
• 
The PTSD Checklist (PCL-5) is a 20-item self-report rating-scale instrument that parallels diagnostic 
criteria for PTSD, as delineated in the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) 3. 
The PCL is the standard measure of PTSD symptoms in the VA and can be used to determine PTSD 
diagnosis and PTSD symptom severity. 
 
Psychiatric Symptoms/Diagnoses: 
• 
The MINI International Neuropsychiatric Interview-Version82 (MINI) 7.0.0 will be administered to assess 
participant’s mental health symptoms/diagnoses according to DSM-V criteria. MINI Interviews will be 
audio recorded for quality assurance purposes.  
• 
The Beck Depression Inventory-II (BDI-II) is a 21-item psychometrically sound self-report rating scale of 
the common symptoms of depression and the severity of these symptoms4.  
• 
The Difficulties in Emotion Regulation Scale (DERS) is a brief, 36-item, self-report questionnaire 
designed to assess multiple aspects of emotion dysregulation. The measure yields a total score as well 
as scores on six scales derived through factor analysis.  
• 
The Dissociative Experiences Scale (DES) is a 28-question self-report form developed as a screening 
tool for Dissociative Identity Disorder. 
 

IRB Protocol Version 12 
11/23/20 
Symptoms: 
• 
The Brief Pain Inventory84 is a widely used measurement tool for assessing pain severity and pain 
interference.  
• 
The Pittsburgh Sleep Quality Index (PSQI) is a self-report scale consisting of 19 items that produce a 
global sleep quality score and the following seven component scores: sleep quality, sleep latency, 
sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime 
dysfunction5. The PSQI has established internal consistency and reliability in various clinical 
populations of women (Cronbach alphas 0.80 across groups).  
• 
The Berlin Questionnaire86 for sleep obstructive apnea is a 10-item questionnaire well-known for its 
accuracy in predicting the presence of sleep apnea in patients. It has established sensitivity and 
specificity (Cronbach alphas 0.86 and 0.77, respectively, when polysomnography was used for 
confirmation).  
• 
The Epworth Sleepiness Scale87 is an 8-item self-report measure which provides a measure of a 
general level of daytime sleepiness, or average sleep propensity in daily life. It is widely used for 
making this assessment. 
• 
The Patient Health Questionnaire-15 (PHQ-15) is a 15 item scale that inquires about somatic 
symptoms or symptom clusters that account for more than 90% of the physical complaints reported in 
the outpatient setting and include 14 of the 15 most prevalent DSM-V somatization disorder somatic 
symptoms88. It has demonstrated internal consistency and convergent validity with the BDI (r = 0.559; p 
< 0.01). 
 
Social Functioning and Quality of Life: 
• 
The Veterans RAND 12 Item Health Survey89 (VR-12) is a 12-item instrument used to measure health 
related quality of life and will be administered at various time-points. 
• 
The PROMIS® instruments use modern measurement theory to reliably and validly assess patient–
reported outcomes (PROs) for clinical research and practice. The PROMIS ® short forms for social 
functioning will be used in the proposed study. 
 
Sexual Orientation and Gender Identity (SOGI): 
• 
In the current study, we will expand data collection of demographic variables to include sexual 
orientation and gender identity based on current recommendations for inclusive research. Currently 
enrolled participants in the study will be asked to verbally consent to participate in a follow-up phone 
visit to complete a demographic survey lasting no more than 15 minutes. This follow-up survey will 
include pertinent demographic items including sexual orientation and gender identity. Research team 
members will review the electronic medical record of the enrolled participants to gather their most 
current phone number and address. Currently enrolled participants will then be contacted by phone. If 
the participants are unable to be reached by phone within 10 days of first contact, a letter will be sent to 
the last known address of the participant. This letter will provide information regarding the follow-up visit 
and how to complete the visit or opt-out of the visit. All future participants will complete the SOGI 
demographic survey as part of their initial visit and will not require an additional follow-up phone visit. 
 
Dark Enhanced Startle Assessment (Atlanta Only) 
Dark enhanced startle response will be assessed using a paradigm in which acoustic startle (blink) response is 
assessed in darkness versus light conditions. Data will be collected by trained research staff using Biopac 
MP150 for Windows. The acquired data will be processed using Mindware software and then exported to Excel 
for analyses. Dark enhanced startle data will be collected at Baseline, 2-Weeks Post and 3-Months Post 
Treatment.  
 
Heart Rate Variability Assessment 
In order to measure heart rate variability, we will utilize the Firstbeat Bodyguard-290 device which is a reliable 
R-R interval recording device for short and long-term measurements. The device is lightweight and user 
friendly. The device is attached directly to the skin with two chest electrodes and begins recording data 
automatically. Participants will wear the device for up to 48-hours. Data will be downloaded directly to Firstbeat 

IRB Protocol Version 12 
11/23/20 
Analysis Server or SPORTS software for analysis. This data will be used to monitor changes in heartbeat due 
to stress. 
 
Cardiovascular Disease Assessment (CVD) 
In order to screen for CVD, a 12-lead ECG will be conducted at the Baseline and Time 3 Visits by trained study 
staff. Results will be interpreted by Dr. Amit Shah, a co-investigator and cardiologist at the Atlanta VAMC and 
will be analyzed to evaluate the relationship between heart health and PTSD diagnosis/severity. Additionally, 
there are some ECG markers that are autonomic in nature (QT interval) and TC-TSY could positively influence 
this measure. 
 
Polysomnogram (Atlanta Only) 
Participants with moderate to high risk scores on the Berlin questionnaire and the Epworth Sleepiness Scale 
will be given the option of participating in a sub-study which involves taking part in an overnight sleep study 
(polysomnogram) at the Atlanta VA Sleep Lab.  This will yield information regarding the prevalence of OSA and 
other sleep disorders in this sample of women Veterans as well as an objective measure of sleep quality. 
Participants who consent will be asked to complete an overnight sleep study at any point during their 
participation in the study. A stand-alone consent and HIPAA form will be provided to eligible, interested 
participants. 
 
Immunological Measures (IL-6, IL-10, C-Reactive Protein) 
Trained study personnel, CSC phlebotomists and VA Lab phlebotomists will perform blood draws. Blood 
samples of 25mL will be obtained using EDTA-containing (purple top) tubes. Tubes will be spun in a centrifuge 
and plasma will be pipetted into cryovials which will be stored in a freezer located in a VA laboratory. Trained 
study personnel will be responsible for processing the samples, ensuring proper storage and sample tracking. 
Samples will be labeled with the subject identification number and visit number. No identifiers will be included 
in the sample label. Plasma levels of IL-6, IL-10, and C-Reactive Protein will be obtained at Baseline, 2-Weeks 
Post and 3-Months Post Treatment. 
 
 
Table 1: Study Flowchart and Data Collection Schedule 
 
Pre-
Screen 
Phase 
Screening 
Visita 
Baseline/ 
Randomization 
Visit 
Mid-Tx 
Visit 
2-Week Post 
Treatment 
Visit 
3-Month 
Follow-Up 
Visit 
 
Crossover 
Interventiond 
or subsequent 
survey 
 
Time-0 
Time-1 
Time-2 
Time-3 
Time-4 
 
Phone Screening 
X 
 
 
 
 
 
 
Chart Review/Med. Clearance 
X 
X 
 
 
 
 
 
Inclusion/Exclusion Review 
X 
X 
 
 
 
 
 
Informed Consent/HIPAA 
 
X 
 
 
 
 
 
AEs/Con Meds/VA Groups Log 
 
X 
X 
X 
X 
X 
 
Basic Demographics/Updates 
 
X 
X 
X 
X 
X 
X 
DRRI-2 Combat Experiences 
 
X 
 
 
 
 
 
Childhood Trauma Ques. 
 
X 
 
 
 
 
 
Life Events Checklist 
 
X 
 
 
 
 
 
MINI (for DSM-5) 
 
X 
 
 
 
 
 
Berlin Questionnaire 
 
X 
 
 
 
X 
 
Epworth Sleepiness Scale 
 
X 
 
 
 
X 
 
RANDOMIZATION 
 
 
Xb 
 
 
 
 

IRB Protocol Version 12 
11/23/20 
Beck Depression Inventory 
 
 
X 
X 
X 
X 
X 
Difficulties in Emotion 
Regulation Scale 
 
 
X 
X 
X 
X 
 
Dissociative Experiences Scale 
 
 
X 
X 
X 
X 
 
Brief Pain Inventory 
 
 
X 
X 
X 
X 
X 
Pittsburgh Sleep Quality Index 
 
X 
X 
X 
X 
X 
X 
Patient Health Questionnaire 
 
 
X 
X 
X 
X 
 
PROMIS Measures 
 
 
X 
X 
X 
X 
 
PROMIS Social Isolation 
 
 
 
 
 
 
X 
CAPS-5 
 
 
X 
X 
X 
X 
 
PTSD (PCL-5) 
 
 
 
 
 
 
X 
Chronic Pain Survey (BPI) 
 
 
 
 
 
 
X 
PTSD-Checklist-5 
 
X 
X 
X 
X 
X 
X 
Intervention Tracking 
 
 
 
X 
X 
X 
X 
VR-12 
 
 
X 
X 
X 
X 
X 
12-Lead ECG 
 
 
X 
 
X 
 
 
Dark-Enhanced Startle 
Sessione 
 
 
X 
 
X 
X 
 
Heart Rate Variability Measure 
 
 
X 
 
X 
X 
 
Blood Draw/Processing 
 
 
X 
 
X 
X 
 
Provide Compensation 
 
X 
X 
X 
X 
X 
 
Offer alternate intervention  
 
 
 
 
 
X 
 
Polysomnogram (optional) 
 
Xc,e 
 
 
 
 
 
aGiven the nature of this study, the T-0 and T1 Visits may be combined into one visit 
bRandomization will occur after all other Baseline/Randomization Visit procedures have been completed 
cThe sub-study will be described at the screening visit and if interested, consent will be obtained for eligible participants. The PSG can be completed at any time during study participation 
dIf the participant elects to do the crossover intervention, measures will be administered by phone or in-person at baseline, mid-treatment and at 2-weeks and 3-months post treatment 
e Given the availability of equipment, this measure will only be conducted for participants in Atlanta  
 
 
 
 
 
 
Informed Consent Process 
Informed consent in Atlanta will be obtained by trained staff during the Screening/Consent Visit in a private 
room at the AVAMC Clinical Studies Center or the Trauma Recovery Program located at the Henderson Mill 
Annex. In Portland, informed consent will be obtained by trained staff during the Screening/Consent Visit in a 
private room at the VA Portland Health Care System at either the Portland or Vancouver VA Medical Center.   
Participants will be informed that they are being asked to participate in a research study. They will be told the 
nature of the procedures and the interventions, informed of the risks associated with their participation, asked 
to read the consent form, and encouraged to ask questions or discuss any pertinent issues. They will be told 
that declining to participate will not influence or compromise their care or employment at the either VAMC (if 
pertinent). Participants will be notified that the research project is voluntary, that participation can be stopped at 
any time and that participation will not impact any services or benefits they receive at the Atlanta or Portland 
VAMC. Participants will also be informed that they will be compensated for time and travel. All research 
volunteers will be asked to sign the consent form after they have read it and discussed the study with research 
personnel. Participants will be given as much time as needed to read the form thoroughly and have all 
questions addressed. Study personnel will ask questions to determine adequate comprehension of the study. 
Only participants who have given their written informed consent will participate. In addition to informed 

IRB Protocol Version 12 
11/23/20 
consent, subjects will read and sign a HIPAA authorization. Participants may withdraw their consent at any 
time and may withdraw from the study at any time.  
 
Randomization 
Once a participant has completed the Screening/Consent Visit and is found to be eligible to participate, they 
will be assigned a sequential study number which will be used to identify data.  They will be scheduled for a 
Baseline/Randomization Visit prior to the start of study intervention. The study statistician, who is responsible 
for making and maintaining the study randomization schedule, will provide the project manager with the 
randomization assignment for each participant. Each participant’s assignment will be revealed to both study 
staff and participant at the completion of the Baseline/Randomization Visit. The participant will be given 
specific information regarding their treatment assignment and confirm availability for the upcoming sessions.  
 
Study Intervention 
Trauma Center-Trauma Sensitive Yoga  
The yoga intervention consists of a standardized trauma-sensitive Hatha yoga protocol developed by Emerson, 
Spinazzola and colleagues for use with civilian women with treatment-resistant PTSD6.  Hatha yoga is a 
general term to describe the practice of physical postures, breath work, and mindfulness—what is commonly 
referred to in the West simply as “yoga.” There are many styles of Hatha yoga (e.g., Iyengar, vinyasa, 
Ashtanga, Bikram), but when the term Hatha yoga is used in the West in contrast to another specified style, it 
most often designates a more gentle, slower-paced approach to the physical postures. Our protocol uses this 
gentler, slower approach. It involves ten weekly 90-minute group sessions of Trauma Center-Trauma Sensitive 
Yoga. Sessions address themes related to establishing safety, individual choice, being in the present moment, 
and taking effective action. The intervention will be conducted by yoga teachers certified in Trauma Center-
Trauma Sensitive Yoga. Study staff will provide participants in the yoga intervention with detailed information 
related to the sessions. In addition, instructional DVDs will be provided to participants in the yoga intervention 
to facilitate practice at home. For participants who do not have access to a DVD player, a link will be provided 
which will direct participants to the private online videos on YouTube. These videos are hidden from the public, 
therefore the only way to gain access is by entering the link provided by the study team. Finally, reminder calls 
will be made each week to ensure optimal group attendance. During follow-up visits, study staff will assess 
whether participant engaged in at-home TC-TSY practice, and the frequency of at-home practice (via use of 
DVD/online videos, breathing techniques etc.) using an intervention tracking form. 
 
Cognitive Processing Therapy-Cognitive 
The control group, Cognitive Processing Therapy (CPT), is one of the gold-standard therapies for PTSD 
treatment in the VA mental health system. CPT is a cognitively-based, trauma focused treatment which will be 
led by two licensed clinical social workers who work in the Women’s Trauma Program. As per the treatment 
protocol, there are twelve 90-minute weekly sessions. The group sessions focus on identifying how thoughts 
change as a result of trauma exposure and ways in which to realistically evaluate these maladaptive thoughts 
and come up with more accurate alternative thoughts. Also per protocol, group members do not share their 
specific trauma details in group. These sessions will be conducted concurrently with the yoga intervention 
throughout the course of the study. Study staff will provide participants in the CPT group with detailed 
information related to the sessions. Reminder calls will be made each week to ensure optimal group 
attendance. During follow-up visits, study staff will assess the degree to which participant engaged in 
homework assignments and used strategies learned in group using an intervention tracking form. 
 
Compensation (Atlanta) 
Participant compensation will be provided following each study visit and following each treatment session. 
Participants will receive $40 for completion of the Screening/Consent, Baseline/Randomization and Midpoint 
Visits. For completion of the 2-Week and 3-Month post-treatment visits, participants will receive $60. For each 
treatment session, participants will receive $15. Compensation will be sent in the form of a VA check or via 
direct deposit. Each method of payment will be discussed and participants will indicate their preference at the 
initial visit. Eligible participants who consent and complete the sub-study will receive $60 once they have 
completed the sleep study.  The total possible compensation for completion of the study is $480. In certain 
cases, if the participant has to return a second time to complete a study visit, they may receive additional 

IRB Protocol Version 12 
11/23/20 
compensation of up to $20. For visits when the participant receives the heart-rate variability monitor, 
compensation will be sent as soon as the device is returned to the study site. Participants taking part in the 
crossover intervention will not receive compensation for completion of the study forms.  
 
Compensation (Portland) 
Participant compensation will be provided following each study visit and following each treatment session. 
Participants will receive $40 for completion of the Screening/Consent, $60 for Mid-treatment and 3-Month 
Follow-up visit, and $85 for the Enrollment/Baseline/Randomization and 2-Week Post-Treatment Visits. For 
each treatment session, participants will receive $10 for which they attend. Compensation will be sent in 
the form of a VA check or via direct deposit. Each method of payment will be discussed, and participants 
will indicate their preference at the initial visit. The total possible compensation for completion of the study 
is $430-450. In certain cases, if the participant has to return a second time to complete a study visit, they 
may receive additional compensation of up to $20. For visits when the participant receives the heart-rate 
variability monitor, compensation will be sent as soon as the device is returned to the study site. 
Participants taking part in the crossover intervention will not receive any compensation. 
 
 
C. POTENTIAL RISKS/DISCOMFORTS TO STUDY PARTICIPANTS AND MEASURES TO PREVENT 
OCCURRENCE 
 
Self-Report and Interview-Based Assessments 
The assessments include questions about exposure to stressors and other topics that might produce transitory 
distress in some individuals. There is the potential for participants to experience embarrassment or other 
negative consequences if some of the experiences were disclosed, particularly if their identity was linked to 
interview data. We think that these risks are minimal given the protections in place to maintain confidentiality 
and the plans to respond to participants who experience distress.  
 
Study Interventions 
Trauma Center-Trauma Sensitive Yoga: There are physical risks in participating in the yoga intervention, as 
well as the potential for emotional distress during yoga sessions. The protocol has been designed specifically 
for women with PTSD. It is expected that some women will experience intense emotion during the yoga. The 
protocol has been designed to mitigate these risks and address physical and emotional distress if necessary.  
 
Cognitive Processing Therapy-Cognitive: There is a risk for transitory psychological distress in participating 
in the control condition, cognitive processing psychotherapy. This intervention is evidence-based and 
manualized and some psychological distress is expected. Clinicians providing this intervention are highly 
trained to respond to any such distress. 
 
Venipuncture 
The blood draw may cause mild discomfort, bruising, redness, or swelling. Study staff will discuss the process 
of having blood drawn with the participant to determine if there are any concerns or past difficulties with having 
blood drawn. Pertinent information will be relayed to the phlebotomist beforehand. These procedures are only 
done by skilled personnel in order to reduce the risk of any negative reactions. The risks associated with the 
blood draw are unlikely and, if they occur, should resolve within a few days. 
 
 
 
Psychophysiological Data Collection 
Participants may experience mild discomfort or distress during the psychophysiological assessment in 
response to being in the booth during the session which involves periods of light and dark. Procedures will be 
explained fully and participants will be instructed to end the session at any time if they feel any discomfort or 
stress.  
 
Heart Rate Variability Data Collection 

IRB Protocol Version 12 
11/23/20 
Participants may experience redness or itching at the site where the electrodes for the Bodyguard are placed 
(clavicle and ribcage).  These risks are unlikely, and if they occur, should resolve within a few days. 
 
Electrocardiogram 
Participants may experience temporary irritation/discomfort from the ECG electrodes on the skin. 
 
Loss of Confidentiality 
In order to protect against the risk of a breach in confidentiality, study data will be stored in locked filing 
cabinets within a locked research office that can only by accessed by research personnel. No names or 
identifying information will be used in publications that result from this study. Identifying information will not be 
released to any outside party (beyond those connected to the study) without written consent from the 
participant. An electronic dataset that includes identifiers linked to the subject identification code will be stored 
in a password-protected database that is located on a secure LAN within our locked research suite. Hard 
copies of forms that include identifiers (e.g., signed informed consent forms) will be kept in a secure, locked file 
cabinet within a locked VA research office. 
 
D. BENEFITS 
There are potential benefits to participants. Trauma Center-Trauma Sensitive Yoga and Cognitive Processing 
Therapy-Cognitive are both treatments that have the potential to improve PTSD symptoms, sleep, and pain. 
They will be exposed to a therapeutic activity that they can continue outside of sessions if they choose. 
Participants will also be offered the intervention to which they were not randomly assigned following their 
completion of the study intervention and data collection, e.g. those assigned to CPT will be offered Trauma 
Center-Trauma Sensitive Yoga after completion of the study. Participants in this study will be involved in a 
process that may provide future benefit to other MST-exposed female Veterans with PTSD. The potential 
benefits to others include knowledge development necessary to implement this intervention throughout the VA 
if it is successful in treating PTSD, chronic pain and insomnia in female Veteran sexual assault survivors.  
 
The knowledge to be gained in this study is scientifically essential to determine the effectiveness of the 
experimental intervention. This study has the potential to impact PTSD treatment at the national level of the 
VA, which is the largest health care system in the United States. This RCT could yield meaningful data to 
support clinical guidelines for a complementary and alternative medicine intervention which could be 
disseminated to and implemented in VA Medical Centers nationwide, and thus improve the quality of care for 
female Veterans with PTSD.  
 
E. DATA MONITORING AND ANALYSIS 
 
Data Management 
As part of this protocol, we will collect data via chart review, self-report form, interview-based assessment, 
blood collection, heart-rate variability device, ECG report, polysomnogram and dark-enhanced startle testing 
(Atlanta only). Data will either be collected at the AVAMC Clinical Studies Center or the Trauma Recovery 
Program or Portland VA or Vancouver, WA VA location of the VAPORHCS and then subsequently transported 
back to respective VAMC for storage. Any sensitive data including consent forms, session sign-in sheets etc. 
will be transported in a blue lock-bag as outlined in the approved VA Research Data Inventory (Privacy and 
Data Security Section). Data will be captured, stored and processed in the following ways: 
 
Chart Review 
Data will be extracted from the VA medical record including diagnoses, active medications, and reportable 
adverse events (if applicable). These data will be added to the VA REDCap database. 
 
Self-Report and Interview Data: Self-report and interview data will be captured through pen and paper 
measures or through direct data entry into the VA REDCap (Research Electronic Data Capture) project 
database using a VA-approved tablet. REDCap89 is a secure, web-based application designed to support data 
capture for research studies. REDCap for VA is installed and accessible only behind the VA firewall and data is 
backed-up nightly and every 6 hours. In addition, VA REDCap provides data de-identification features and 

IRB Protocol Version 12 
11/23/20 
restricts access to PHI at the user-level. Deidentified self-report and interview data will be securely exported 
from VA REDCap to Excel or SPSS and then uploaded to the VA password-protected research drive for 
analysis as needed. Periodically, deidentified self-report and interview data will be submitted to the study 
statistician for data analysis and review.  
 
Additionally, demographic information, including identifiers (study ID), for each participant will be stored in the 
REDCap database that is password-protected and accessible only by approved members of the research 
team. The research suite is locked at all times with access granted only to authorized personnel. Data residing 
on VA desktop computers are routinely backed up on a secure, off-site server. Thus, all data are protected 
from loss and are stored devoid of all patient identifiers.  
 
Cytokine Data: In Atlanta, blood samples will be collected by trained study staff or CSC staff in the Atlanta 
VA Clinical Studies Center and labelled with date, study ID, and visit number only. Initial sample 
processing will take place in the CSC lab by trained staff before being sent to another lab within the VA for 
final analysis. Any sample remaining after initial analysis will be stored until the end of the study at which 
point remaining specimen will be destroyed. Deidentified cytokine data will be sent from the lab to the 
project manager. These data will be stored on the secure VA research server and the VA REDCap 
database until being sent to the Emory statistician for analysis. In Portland, blood samples will be collected 
by trained study staff in the VAPORHCS and labelled with date, study ID and visit number only. Initial 
sample processing will take place in the Loftis Lab at the VAPORHCS prior to shipment to the CSC of the 
AVAHCS for analysis. Any sample remaining after initial processing will be stored until the end of the 
study at which point remaining specimens will be destroyed. 
 
 
Heart Rate Variability (HRV) Data: At both sites, HRV data will be captured using the portable 
Bodyguard device which participants will wear for up to 48 hours. In Atlanta, once the device is returned to 
study staff, deidentified HRV data from the USB device will be downloaded to either an Emory laptop or VA 
computer that belongs to the PI and contains data analysis software. The data will then be analyzed by 
trained study staff and exported to Excel. Periodically, the data will be retrieved from the laptop and 
uploaded to Box.net. Dr. Amit Shah (Cardiologist/Co-Investigator) will assist the study staff with 
troubleshooting any issues and address any questions that arise during the data analysis process. Dr. 
Shah will process the de-identified HRV data on his Emory workstation for generation of heart rate 
variability metrics. Data, although de-identified, will be transferred via HIPAA compliant methods, including 
encrypted VA-issued USB flash drive, and Box.net.  
In Portland, HRV data will be captured using the portable Bodyguard device which participants will wear for 
up to 48 hours. Once the device is returned to study staff, fully de-identified HRV data from the USB device 
will be downloaded to a VA computer and saved on the secured research folder designated for this study 
(\\R01PORHSM03.r01.med.va.gov\Research\Zaccari Research\Project Stress Less II) to which Dr. Amit 
Shah will have access for the purpose of data analysis. 
 
Electrocardiogram Data: In Atlanta, 12-Lead ECGs will be completed by trained study staff using an IRB 
approved ECG machine. Paper ECG reports coded with the SID will be printed, stored in the participant binder 
and scanned to the secure VA research server where they will be reviewed periodically by Dr. Amit Shah 
(Cardiologist/Co-Investigator). These reports will contain the subject identification number and time-point, but 
no protected health information. Periodically, these data will be saved to a VA-issued USB drive and uploaded 
to the secure research drive and VA REDCap database. Dr. Shah will process the de-identified ECG data on 
his Emory workstation for generation of repolarization metrics. Data, although de-identified, will be transferred 
via HIPAA compliant methods, including encrypted VA-issued USB flash drive, and Box.net. 
 
In Portland, 12-Lead ECGs will be completed by trained study staff using an IRB approved ECG machine. 
Paper ECG reports coded with the SID will be printed, stored in the participant binder and scanned to the 
secure VA research server. These reports will contain the subject identification number and time-point, but 

IRB Protocol Version 12 
11/23/20 
no protected health information. The PI will have access to these original data to provide to Dr. Amit Shah 
(cardiologist/CO-Investigator) for analysis. 
 
 
Polysomnogram Data (Atlanta Only) 
Polysomnogram results will be extracted from the VA medical record, recorded onto a form, and entered into 
the VA REDCap database.  
 
Psychophysiological Data (Dark-Enhanced Startle [Atlanta Only]) 
Psychophysiological data will be captured on a laptop containing Biopac software. These deidentified data will 
be analyzed using Mindware software and then exported to Excel. These data will be stored on the VA 
research drive. 
 
 
Data Quality 
All data will be examined for completeness and an assessment of missing data will be performed to check for 
any biases which may occur. Data will be monitored and entered promptly in order to detect issues as they 
arise. Special attention will be paid to note what, if any, demographic and clinical factors may be related to 
subject attrition, retention and adherence.  Study retention refers to those who complete all study-related 
assessments. Dose-effects will be accounted for based on the number of treatment sessions attended by each 
subject relative to their assigned group. Analyses will be performed to determine what if any covariates may be 
predictive of missing data over time and these variables will be adjusted for in subsequent models90. Close 
attention will be paid to underlying normality assumptions. Numerical transformations (such as square root, log, 
and inverse functions) may be applied to correct for deviations due to skewness.  
 
 
 
Power Analysis 
Given the estimated final sample size of 104 (52 per group) after expected levels of attrition (50% attrition from 
210), we will be powered at 80% to detect moderate effect sizes for any differences between the groups (two-
group independent t-tests effect size (Cohen’s d) of 0.555 and chi-square tests for differences in proportions 
between the two-groups effect size (Cohen’s omega, ω) 0.274 and higher) as well as moderate-to-large effect 
sizes detected for differences between the groups over time (repeated measures group-by-time interaction 
effects: effect size of 0.28, Cohen’s f) will be detected. Power analyses will be completed using PASS 
v.13.0.891. 
  
Statistical Analysis 
Comparisons between the groups at baseline will be run using t-tests, Mann Whitney non-parametric tests, and 
chi-square tests as appropriate. However, when numerical transformations are not sufficient, non-parametric 
and generalized non-normal response functions may also be employed. Multilevel mixed models (MLM) will be 
used instead of repeated-measures analysis of variance (RM-ANOVA), to analyze the differences between the 
groups over time. As opposed to RM-ANOVA which assumes independence between time points and 
assumes complete data for all subjects at all time-points, MLM adjusts for attrition (missing data) over time and 
applies appropriate correlation structure between the time points92. Multilevel modeling also provides insight 
into the variance components of the outcomes relative to those related to within-subject variability over time 
and those related to between-subject differences. These variance components are important for understanding 
the utility of each measure relative to reliably assessing each outcome. Generalized functions of these MLM 
models may also be run for non-normal outcomes due to highly skewed or zero-inflated data (common with 
biomarker and some behavioral measures) or binary outcomes (e.g. diagnosis determinations). These 
statistical modeling approaches will be applied appropriately to the outcome measures of interest for each of 
the three research aims. SPSS Version 22.0 will be used for all statistical analyses. 
 
F. TRAINING 

IRB Protocol Version 12 
11/23/20 
All study team members have completed the web-based Collaborative IRB Training Initiative (CITI) Program in 
the Protection of Human Subjects Research. The Project Manager will ensure that all study team members 
stay current with all required Emory and VA research trainings.  
 
In addition, for all study team members working directly with participants, trainings will be conducted on the 
administration of structured interviews (CAPS, MINI), informed consent process, psychophysiological data 
collection, ECG, HRV data collection, phlebotomy (if applicable) and specimen processing. Once the staff 
member has met all training requirements for each item, they can begin working with study participants. 
 
A detailed log of all study-related trainings will be maintained throughout the study. 
 
 
G. DATA AND SAFETY MONITORING PLAN 
 
Data and Safety Monitoring Plan (DSMP) 
Safety Monitoring: The PI or anyone else who has contact with study participants during study activities 
have the responsibility to monitor for any potential adverse events and protocol deviations. Any potential 
participant for an adverse event will be reported immediately via “warm transfers” per VA guidelines at 
respective site and PI, who will contact the participant and determine if additional intervention is needed to 
ensure participant safety. Study personnel will be trained on these procedures, including contacting VA 
Police, on-call Mental Health providers Veterans Crisis Line and/or local crisis lines,   Protocol deviations 
will also be immediately reported to respective site PI who will ensure that adverse events deemed to be 
unanticipated problems and protocol deviations are properly reported to the IRB in a timely manner. 
Detailed written documentation will be kept for all adverse events that occur over the course of the study. 
PI will hold regular meetings with study staff where they will discuss adverse events and protocol 
deviations associated with this project and ways to reduce repeat occurrences. Research staff will 
examine all cumulative adverse events quarterly to determine if there are any systematic problems and to 
implement protocol corrections as needed after receiving IRB approval. 
 
Data Monitoring: All information linking study data to PHI will be kept within VHA electronically in secure 
computer files stored behind firewalls requiring password access, or in hardcopy form in locked file 
cabinets in locked offices. All patient identifiers will be removed prior to analysis. All investigators and team 
members who will have access to the data will have received appropriate background checks as part of 
hiring and/or credentialing and will have completed Data Security Training within the prior 12 months. 
 
Per VHA guidelines, data resulting from this study will be stored locally on VHA password-secure folders. 
Requests for data access will be considered and responded to within one month of the request and 
datasets will be made available electronically. Requests must be made in writing to the study PI and 
provide information on the purpose for accessing the data. 
 
All data used in final, published results will be made available for sharing. Published data will be available 
upon request to any investigator in order to enable independent validation and interpretation of published 
data. 
 
Once the current study is closed, we will store de-identified, anonymized dataset in an approved data 
repository consistent with policies in 1200.12 (Use of Data and Data Repositories in Research). A sharing 
agreement will prohibit the recipient from identifying or re-identifying (or taking steps to identify or re-
identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. 
 
Adverse Event Reporting 

IRB Protocol Version 12 
11/23/20 
The principal investigator will be responsible for following adverse event reporting requirements as outlined 
below in the protocol. These responsibilities include: 1) reviewing the accuracy and completeness of all 
adverse events reported, 2) compliance with local IRB policies for reporting adverse events and/or serious 
adverse events, and 3) overseeing monitoring of research volunteers at each follow-up visit and as indicated 
by notification by the yoga teachers at each yoga intervention session. Relatedness involves an assessment of 
the degree of causality between the study intervention and the event. The PI will perform an assessment of 
relatedness, in conjunction with Dr. Skelton, who has significant experience in data safety monitoring. All AEs 
with a reasonable, causal relationship to the intervention will be considered “related.” A definite relationship 
does not need to be established.  
 
AE and SAE Monitoring 
For the proposed study, participants will be monitored at each data collection point and as indicated by 
notification from the yoga/CPT teachers at each intervention session. Adverse events and serious adverse 
events will be assessed for relatedness to study participation and whether the event was anticipated or 
unanticipated. Those adverse events found to be unanticipated and related to study participation will be 
reported to IRB and VA R&D according to local reporting guidelines.  
 
Safety Assessments  
Safety assessments will be conducted with any study participant who reports new onset of: suicidal or 
homicidal thoughts, psychosis, substance use, or physical pain/symptom or physical injury that is determined 
to require medical evaluation beyond evaluation conducted within the TRP by Dr. Skelton or her designee.  
 
Expedited Reporting of SAEs 
Serious Adverse Events found to be related to participation in the research will be reported to IRB and Atlanta 
VA R&D according to local reporting requirements.   
 
 
Collaborative Research 
 
This protocol describes a multi-site study to be conducted at the AVAHCS and the VAPORHCS. AVAHCS 
is the coordinating center with VAPORHCS recently added as an additional site. 
 
As the primary site/coordinating center, study staff of the AVAHCS will be responsible for equivalent study 
procedures described in this protocol but conducted in Atlanta. Additionally, AVAHCS study staff will be 
responsible for assistance in screening for the purposes of recruitment and the storage and analysis of 
biophysiological data that is collected from participants of VAPORHCS. Where applicable, these tasks have 
been described as to be conducted at AVAHCS. Project Management of the coordinating center is being 
conducted by Terri Haywood (Terri.Haywood@va.gov; 404-321-6111, ext. 207026). 
 
Certificate of Confidentiality 
 
N/A. The study does not include a Certificate of Confidentiality 
 
Disclosure/Sharing 
 
N/A. The study does not include disclosure/sharing outside the IRB-approved VAPORHCS and AVAHC study 
personnel. 
 
 
 

IRB Protocol Version 12 
11/23/20 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
References 
 
1. 
Gray M, Litz B, Hsu J, Lombardo T. Psychometric properties of the Life Events Checklist. Assessment. 2004;11:330-341. 
2. 
Weathers FW, Keane TM, Davidson JR. Clinician-Administered PTSD Scale: A review of the first ten years of research. 
Depression and Anxiety. 2001;13(3):132-156. 
3. 
Weathers FW, Litz BT, Huska JA, Keane TM. PTSD Checklist—Civilian version. Boston: National Center for PTSD, Behavioral 
Science Division;1994. 
4. 
Beck AT, Steer RA, Ball R, Ranieri WF. Comparison of Beck Depression Inventories-IA and -II in Psychiatric Outpatients. 
Journal of Personality Assessment. 1996;67(3):588. 
5. 
Carpenter JS, Andrykowski MA. Psychometric evaluation of the Pittsburgh sleep quality index. Journal of Psychosomatic 
Research. 1998;45(1):5-13. 
6. 
Emerson D, Hopper E, Levine PA, Cope S, Van Der Kolk B. Overcoming Trauma Through Yoga: Reclaiming Your Body. North 
Atlantic Books; 2011. 
 
 
 

IRB Protocol Version 12 
11/23/20 
Statistical Analysis Post hoc: Equivalence Testing  
 
Detailed Methods: 
 
While the original RCT was designed for inequality hypothesis testing, given the lack of differences seen 
between the 2 treatments (both performed well), we additionally conducted equivalence tests of means between 
the two treatment groups using two one-sided unequal-variance t-tests (TOST). These equivalence tests were 
performed using the TOSTER v.0.4.0 package for R [REFS Lakens (2017); Lakens, Scheel and Isager (2018)]. 
The changes from baseline to each follow-up time point were computed for each participant. These change 
scores were then used to perform two one-sided t-tests (TOST) between the two treatment groups to test for 
equivalence and reject the presence of the smallest effect size of interest (SESOI). This approach essentially 
checks to see if the 90% confidence interval bounds for the mean difference between the two groups are within 
the limits defined by the SESOI. Similar to Sloan, et.al. (2022), a margin of 10 was used as the SESOI. Sloan 
was only interested in one-side of the margin and performed non-inferiority tests since they assumed one 
treatment might be inferior to the other. However, we did not have an initial assumption that one treatment 
would be better than the other, so two one-sided tests or TOSTs were performed to test for equivalence within 
+/- 10 points. This SESOI was used for both the CAPS-5 and PCL-5 change score differences between the two 
treatment groups. It has also been suggested that a difference as small as 5 points for the CAPS-5 may be useful 
for comparing treatments for PTSD so the mean and standard deviation of all changes scores are also reported 
by group and time for descriptive comparisons. For clinical diagnostic comparisons, similar to Schnurr, et.al. 
(2022), the percentage of participants at each time point who still have PTSD are reported as well as the 
percentage who achieved a clinical response (reduction of CAPS-5 severity scores by 10 or more points from 
baseline), loss of diagnosis (CAPS-5 change <= -10, no PTSD diagnosis and CAPS-5 severity score <25), as 
well as those who achieved remission (loss of diagnosis plus CAPS-5 score < 12). All statistical analyses 
completed using SPSS version 27.0.0.0 [IBM Corp (2020)] and R version 4.1.2 [R Core Team (2021)].