Outcomes of a Holistic Yoga Program Designed to Relieve PTSD (RELIEVE Trial)
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Sponsor: VA Office of Research and Development

 
Study #1406327436 
 
 
v. 5/26/2017 
 
 
 
 
 
 
 
 
Protocol: 
Outcomes of a Holistic Yoga Program Designed to Relieve PTSD (RELIEVE trial) 
 
 
Louanne W. Davis, PsyD. 
Roudebush VA Medical Center 
1481 West 10th Street 
Indianapolis, IN 46202 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Study #1406327436 
 
 
v. 5/26/2017 
 
 
 
Table of Contents: 
 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Inclusion/Exclusion Criteria 
4.0 
Enrollment/Randomization 
5.0 
Study Procedures 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to Participants or Others 
7.0 
Study Withdrawal/Discontinuation 
8.0 
Statistical Considerations 
9.0 
Privacy/Confidentiality Issues 
10.0 
Follow-up and Record Retention 
 
 

 
Study #1406327436 
 
 
v. 5/26/2017 
1.0 
Background 
 
Overview of the Problem:  PTSD affects 7-12% of the general population15 or approximately 21 million 
Americans16 who will use health care services frequently for many years. The annual cost of anxiety disorders 
such as PTSD is substantial, estimated at about $42.3 billion in the United States.14 Furthermore, individuals 
with PTSD are among the most frequent users of healthcare services, with nonpsychiatric direct medical costs 
(e.g., doctor and hospital visits) estimated at approximately $23 billion a year.14 Societal costs include both 
psychiatric and nonpsychiatric medical treatment, indirect workplace costs, and mortality costs. More than half 
of these costs are attributed to repeat use of healthcare services to relieve anxiety-related symptoms that 
mimic those of other physical conditions. Therefore, PTSD is a source of chronic disability for veterans and 
civilians and costly for the US government in terms of treatment as well as disability payments. Despite some 
success with currently used medications, many PTSD patients report little meaningful improvement in their 
symptoms. Furthermore, veterans whose PTSD symptoms have been present for many years pose the 
particularly complex challenge of being more resistant to the beneficial effects of medications for PTSD 
symptoms.28 Medications currently used to treat PTSD are of limited effectiveness as they were not designed 
to target the unique pathophysiology of PTSD, and remain one of many challenges in PTSD treatment.33 
Although there are effective, available PTSD-specific treatments such as Cognitive Processing Therapy and 
Prolonged Exposure, many PTSD sufferers delay seeking professional help for years to decades.4 Such 
factors as avoidance (one of the three PTSD symptom clusters), fears that directly addressing the trauma will 
only make matters worse, and the stigma related to PTSD and mental health treatment, are thought to 
contribute to this reluctance to engage in treatment.5 In addition, dropout rates are high for current PTSD 
treatments and they may not be effective for all evidenced by the significant number who remain symptomatic 
despite pharmacotherapy and psychotherapy.6 Although there are now psychological treatments that can 
effectively treat individuals with PTSD, the majority of individuals with PTSD, including active duty military 
personnel, veterans, and civilians, receive treatments of unknown efficacy.34 Unresolved or untreated trauma 
has been associated with the development of multiple, severe, and persistent physical and mental health 
problems, substance abuse, future criminal behavior, and social problems.35 Thus there is a need for more 
effective PTSD treatments options, particularly which do not require direct verbal processing of the trauma but 
can calm the hyperactive threat system typical of PTSD. 
 
Other treatments are needed when PTSD symptoms are not relieved: The lack of relief from 
existing treatments can be extremely frustrating to patients who may feel that they have exhausted all options 
for PTSD treatment. This is also frustrating for VA and other mental health providers concerned about the 
limited efficacy of medications and lack of additional treatment options. Therefore, novel treatment approaches 
are needed that have potential for application across multiple VA clinical settings and in the community, to 
supplement existing services for PTSD care. Increasingly, patients are interested in complementary and 
alternative medicine (CAM) treatment options.36 This growing interest in CAM is likely multifactorial, involving 
concerns about limited efficacy of conventional medicine, adverse effects of medications, and avoidance-
beliefs related to medications or mental health treatments. CAM treatment options typically have minimal 
physical and emotional risks, and may allow patients to take a more active role in managing their illness.  
Yoga holds promise for PTSD as it combines physical and mental techniques: Yoga therapy is 
defined by the International Association of Yoga Therapists as “the process of empowering individuals to 
progress toward improved health and well-being through the application of the philosophy and practice of 
yoga”.38 Although there are many types of yoga, all involve a combination of stretching exercises and postures 
with breathing and meditative practices aimed at: (1) lengthening and toning muscles;  (2) maintaining flexibility 
in the joints and spine; (3) increasing oxygenation of the brain; and, (4) training attention and concentration.39 
Accumulating research evidence supports yoga as an acceptable and efficacious intervention for those who 
have experienced trauma, reducing clinician rated9 and self-reported PTSD symptoms symptoms,10-12 
depression12, anxiety.12 Research evidence also supports the benefits of yoga in those with other physical and 
mental health conditions for challenges typical of those with PTSD including increased resiliency to chronic and 
acute stress43,44, anger-hostility,13,45 disturbed sleep.46,47 Studies of Mindfulness-Based Stress Reduction 
(MBSR), an intervention that combines mindfulness meditation with gentle hatha yoga, also provide evidence 
to support the use of yoga for treatment of trauma.  
A trial evaluating holistic yoga for PTSD is timely and needed: Although there has been increased 
military and VA interest in CAM approaches, such as yoga and meditation, which do not require trauma 

 
Study #1406327436 
 
 
v. 5/26/2017 
processing, research has been limited although promising in terms of acceptability and efficacy. 7 Our recent 
search of the ClinicalTrials.com website revealed a total of 10 studies of yoga as an intervention for PTSD (5 
completed and 5 current), with such limitations as small samples, uncontrolled or waitlist/usual care controls, 
and much variation in the style of yoga and components of yoga studied. Thus, randomized controlled trials 
with large samples to evaluate a standardized traditional holistic yoga intervention are urgently needed to 
inform VA policy makers and clinicians of what outcomes to expect from a yoga intervention for PTSD. We 
believe that the proposed trial, “Outcomes of a Holistic Yoga Program Designed to Relieve PTSD” (RELIEVE 
trial), designed as a large randomized controlled efficacy study of a standardized, traditional holistic yoga 
intervention (postures, breathing practices, deep muscle contraction practices, relaxation practices), is a 
significant step beyond previous studies that have evaluated a variety of yoga approaches and/or one yoga 
component such as relaxation, or yoga as only a part of a mind-body intervention such as Mindfulness-Based 
Stress Reduction. The Holistic Yoga Program will be documented in a treatment manual and will be taught by 
teachers registered at least at the 200 hour level with the Yoga Alliance. Additional standardized training and 
supervision will be provided by an experienced yoga therapist. Thus, if found to be effective, the Holistic Yoga 
Program and teacher training will have been documented and tested, allowing for swift dissemination and 
implementation within the VA system. 
 
Significance: PTSD poses enormous public health challenges due to its effects on mental and physical 
health, and functioning, including interpersonal, social and occupational.34 PTSD is also a critical mental health 
problem among veterans and constitutes a substantial proportion of the burden of illness among veterans 
affecting as many as 14 to 16%.17 Apart from the significant psychological cost to individuals with PTSD and 
their families, there is a steep financial cost to society, in terms of entitlements and lost productivity. PTSD is 
the most common psychiatric disorder for which veterans seek and receive compensation and most common 
cause of disability within the VA system and the U.S.2 Although individuals suffering from PTSD desire relief, it 
is difficult for them to present for treatment due to the avoidance, a hallmark symptom of the disorder. Additional 
research is desperately needed to find more effective approaches to assisting individuals with PTSD to 
engage in treatment earlier by providing treatment options that relieve symptoms yet do not require the 
feared trauma processing. Armed with new skills and some symptom relief from less intense treatment 
options, those with PTSD may feel more confident to pursue the more intense evidence-based treatments 
such as Cognitive Processing Therapy, Prolonged Exposure and Cognitive-Behavioral Conjoint Therapy for 
PTSD.   
Yoga, in its traditional, holistic form, is aimed at improving physical, mental and spiritual well-being and 
involves teaching individuals skills they can practice at home. Yoga has been found to reduce trauma-related 
symptoms, and thereby may improve the ability of individuals with PTSD to attend to and become aware of 
their cognitive, emotional and physical states, including dysfunctional thinking and behavioral patterns that 
contribute to emotional suffering and interfere with effective functioning. Until recently, those who have PTSD 
have been largely ignored in yoga research. Our proposal is significant as it will be the first large, rigorously 
designed, randomized, controlled trial comparing a holistic yoga intervention tailored for individuals with 
PTSD to an attention control. Results of the proposed study may scientifically validate the therapeutic value 
of yoga as an intervention for veterans with PTSD, in particular, revealing what kinds of clinical and 
rehabilitation benefits can be expected from augmenting current VA PTSD treatment with a yoga intervention, 
e.g. reduced PTSD and PTSD-related symptoms, improved well-being, and enhanced quality of life. Results 
will yield scientifically sound information for policy makers and clinicians in the VA system and those outside 
the VA system, e.g. health insurers, healthcare delivery systems, clinical researchers, and public education 
systems (media). Results may provide support for investigating these procedures in other treatment settings, 
allowing for replication and further refinement. Enhancing current VA trauma services with a yoga intervention 
holds promise that many veterans may achieve gains who might otherwise fail to benefit from treatment.  
 
2.0 
Rationale and Specific Aims 
 
Post Traumatic Stress Disorder (PTSD) has been recently conceptualized as a disorder of impeded recovery 
that is defined by the primary symptoms of re-experiencing, negative alterations in cognitions and mood, 
avoidance/numbing, and hyperarousal (DSM-5). While these symptoms are natural reactions to trauma, 
avoidance of feelings and reminders that continue to signal danger interferes with making sense of the 

 
Study #1406327436 
 
 
v. 5/26/2017 
traumatic event and symptom remission.1 PTSD constitutes a substantial proportion of the burden of 
illness among veterans.2 The course of PTSD varies in duration of symptoms and level of disability, and many 
experience disabling symptoms for years.3   Although effective PTSD-specific treatments are available (e.g. 
Cognitive Processing Therapy, Prolonged Exposure), many of those who have PTSD wait years to decades 
before seeking professional help, if they seek help at all.4 PTSD symptoms such as avoidance, fueled by fears 
that directly addressing the trauma will worsen symptoms, and the stigma of PTSD and mental health 
treatment, contribute to delayed engagement in treatment.5 In addition, dropout rates are high for current 
PTSD treatments and they may not be effective for all who suffer from PTSD, as evidenced by the significant 
number who remain symptomatic despite pharmacotherapy and psychotherapy.6 As a result, there has been 
increased interest within the military and VA leadership, as well as active duty military and veterans, in 
Complementary and Alternative Medicine (CAM).7 CAM approaches, such as yoga and meditation, do not 
require trauma processing, yet appear to relieve symptoms. Yoga is a holistic system of mind-body practices 
historically developed as a spiritual discipline that supports a mentally and physically healthy lifestyle and 
incorporates such elements as physical postures, breathing practices, and meditation.8 Accumulating research 
evidence indicates that yoga practices are acceptable and efficacious for those who have experienced trauma, 
demonstrating reductions in clinician rated9 and self-reported PTSD symptoms, 10-12 as well as depression, 12 
and anxiety.12 However, few studies exist that have evaluated yoga for PTSD and they have involved small 
sample sizes and are either uncontrolled or waitlist/usual care controlled. In addition, there is much variation 
among studies in the style and components of yoga interventions, i.e. yoga philosophy, postures (asanas), 
breathing practices (pranayama), relaxation practices (body scan, Yoga Nidra or yogic sleep), and/or practices 
that cultivate attention and concentration (meditation). 13 Thus, a fully powered and rigorous randomized 
controlled trial (RCT) of a standardized, traditional, holistic yoga intervention is urgently needed to inform VA 
policy makers and clinicians of the potential benefits of yoga as an adjunct to currently available PTSD 
treatments.  
 
The Outcomes of a Holistic Yoga Program Designed to Relieve PTSD (RELIEVE trial) is a two-arm parallel 
group randomized clinical trial. The RELIEVE trial will include 232 individuals with PTSD randomized to one of 
two groups:  
1) a 16-week Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction 
practices, relaxation) or  
2)   a 16-week Wellness Lifestyle Program (WLP) (attention control comprised of low intensity walking with 
didactics about wellness topics).  
 
The Holistic Yoga Program (HYP) will be taught by experienced yoga teachers registered with the Yoga 
Alliance (200-hour level), who have received additional military and trauma-related training. Thus, if found to be 
effective, the yoga intervention and teacher training utilized in this trial will have been documented and tested, 
allowing for swift dissemination and implementation within the VA system. 
 
Study Aims: 
 
1) To compare the interventions’ effects (HYP vs. WLP) on overall PTSD symptom severity at 8 weeks 
(early response), 4 months (immediately post intervention), and 7 months (sustained effects). 
 
2) To compare the interventions’ effects on specific PTSD symptoms (anger, sleep) and related 
symptoms and outcomes (well-being/quality of life, depression, anxiety, pain). 
 
3) To manualize the Holistic Yoga Program (HYP) and procedure to train experienced yoga teachers to 
deliver the HYP to individuals with PTSD in order to facilitate future study and dissemination efforts. 
 
Our primary hypothesis is that the Holistic Yoga Program (HYP) will be more effective than the Wellness 
Lifestyle Program (WLP) in reducing overall PTSD severity measured by the Clinician Administered PTSD 
Scale (CAPS) and the self-report PTSD Checklist (PCL).  
 

 
Study #1406327436 
 
 
v. 5/26/2017 
Our secondary hypothesis is that the Holistic Yoga Program (HYP) will be more effective than the Wellness 
Lifestyle Program (WLP) in improving secondary outcomes including specific PTSD symptoms (anger, sleep), 
and PTSD-related symptoms and outcomes (well-being/quality of life, depression, anxiety, pain). 
 
 
3.0 
Inclusion/Exclusion Criteria 
 
Inclusion Criteria 
• 
18 or older 
• 
CAPS-confirmed PTSD diagnosis 
• 
Access to a working telephone for ease of contact during the course of the study 
Exclusion Criteria 
• 
Severe medical conditions in which yoga is contraindicated 
• 
Active psychosis 
• 
Active suicidal intent 
• 
Moderate to severe cognitive impairment as determined by the short Mini-Mental Status Examination 
(MMSE) 
• 
Involvement in ongoing yoga classes and/or regular home practice of yoga in the previous 3 months 
• 
Receiving ongoing medical or psychological treatment that includes more than one hour weekly of 
relaxation and mind-body based stress reduction strategies (related directly to meditation and yoga) 
 
4.0 
Enrollment/Randomization 
 
Potential participants will primarily be identified by querying the VA’s electronic medical record system, CPRS 
(Computerized Patient Record System), to create a master list of veterans who have a documented PTSD 
diagnosis or related diagnoses (e.g. adjustment disorder, anxiety, panic disorder), that may suggest 
undiagnosed PTSD. A recruitment letter and approved study brochure will be mailed to qualifying veterans who 
have been identified through the methods explained above to describe the study. These potential participants 
will be contacted by phone within a week after receipt of the letter by a trained study staff member to determine 
their interest in participating and if interested, an appointment will be scheduled to obtain consent. A second 
method will be contact of potential participants by their providers and referral to the study, which will be used at 
the RVAMC, the IU Psychiatry Clinic and affiliates, and with clinicians at other locations in the community as 
mentioned in the table below. A third method is self-referral by patients responding to word of mouth or study 
advertisement displayed in RVAMC elevators and clinics, community-based clinics and provider offices, 
military and veterans organizations, in MyHealtheVet, on tv monitors stationed throughout RVAMC facility, and 
on the RVAMC Facebook page. A fourth method will identify potential participants by querying medical record 
data from Regenstreif and IU Health (IUH), ResNet, to create initial lists of patients from each institution who 
have a documented PTSD diagnosis or related diagnoses that may suggest undiagnosed PTSD. After an initial 
list is identified, the distribution of patient information will adhere to the procedures of each institution before it 
will be distributed to the study staff.  ResNet Research Assistants will be utilized to aid with the recruitment of 
study participants. ResNet will identify potential subjects at the Eskenazi outpatient clinics using Regenstrief 
Medical Record data (INPC).  ResNet will provide the study team with recruitment information after obtaining 
an Authorization of Release of Health Information form. IUH ResNet will provide each individual IUH primary 
care practitioner information about the study and its procedures, the types of patients who would be eligible 
and a list of the individual patients.  The providers have two weeks from the delivery of the lists, to decide if 
they want their patients to participate and then to review each patient’s suitability, excluding those who are not 
a good fit.  Lists are returned to IUH ResNet; patients excluded (if any) from the query.  After the two weeks 
have expired, if IUH ResNet has not received a response from the provider, the patients are deemed eligible 
for recruitment. Once these procedures have been completed, staff members at Indiana CTSI will work in 
consultation with members of the study team to make follow-up phone calls to prospective participants and 
schedule consent appointments for those who are interested. All communication between staff members at 
Indiana CTSI and VA regarding patients and sensitive research information will be completed exclusively over 
the phone. A fifth method will identify subjects from the Indiana CTSI INresearch volunteer registry, IU IRB 
Protocol #1105005444, a website created for interested individuals to contact Indiana CTSI and sign up to 

 
Study #1406327436 
 
 
v. 5/26/2017 
receive information about ongoing studies and is supported by the Indiana CTSI Subject Enrollment and 
Research Volunteer Engagement (SERVE) program. An email will be sent to INresearch volunteers who meet 
the study criteria. Participants are given a few days to respond to INresearch staff if they do not wish to be 
contacted by the study team.  After 3 days, the contact information for the remaining eligible individuals is 
released to the study team through slashtemp secure.  Only relevant information is provided to the study team 
such as name, contact information, and the best time to reach the participant.  Participants will also have the 
opportunity to reach out to the study team directly.  If after a week of sending the email, additional participants 
are needed for the study, a staff member will begin contacting the identified participants directly either by email 
or phone to determine their interest in participating. A sixth method is self-referral by patients responding to TV, 
radio or newspaper advertisement.    
 
Table 1: Recruitment sites for RELIEVE trial  
Veterans 
with PTSD 
Non-Veterans 
with PTSD 
RVAMC Psychiatry Service clinics (PAC, Trauma Recovery, OEF-OIF-OND) and Domiciliary  
X 
 
5 RVAMC Primary Care Clinics  
X 
 
3 RVAMC Community-Based Outreach Clinics (CBOCs) in Terre Haute, Bloomington, Martinsville 
X 
 
Vet Center, National Guard, and Reserves 
X 
 
IU School of Medicine Psychiatry Clinic and affiliated IU Health clinics 
X 
X 
Community Mental Health Centers & University Counseling Centers 
X 
X 
Mental Health Providers in Private Practice 
X 
X 
 
Following informed consent and once a participant has been screened and meets inclusion criteria a baseline 
assessment will be performed. Participants will then be randomly assigned to either the holistic yoga program 
(HYP) or the wellness lifestyle program (WLP). The randomization process will be directed by Joanne Daggy, 
Ph.D. (statistician) using a program within the REDCap database. Randomization will be stratified by gender 
(men vs. women) and veteran/non-veteran status. Within strata, randomization with block sizes of 4 will be 
executed to ensure balance. Once an eligible participant has signed informed consent, been screened, and 
has completed the baseline measures the  project coordinator will obtain the randomization from the REDCap 
database. The participant identifier and date are recorded. To ensure allocation concealment, only the project 
coordinator, Dr. Davis and Dr. Daggy will have access to the randomization function within REDCap (and will 
not conduct outcome assessments). The research assistant who will conduct outcome assessments will be 
blinded to group assignment. No one will be allowed access to randomization assignment until all baseline 
measures have been completed. 
 
5.0 
Study Procedures 
 
• 
Following informed consent and once a participant has been screened and meets inclusion criteria per 
the screening interview, a baseline assessment will be performed. The baseline assessment includes 
collection of sociodemographic data, substance use, psychiatric treatment utilization history, and 
assessments of PTSD (CAPS) and PTSD symptoms (self-reported PTSD symptoms, anger, sleep, 
anxiety, depression), and related outcomes (pain, well-being, quality of life, interoceptive awareness, 
and self-regulation). Substance use will be measured with 2 items. Alcohol use disorders will be 
assessed with the Alcohol Use Disorders Identification Test Consumption (AUDIT-C), which is 
commonly used in primary care settings, including VA primary care66 and corresponds reasonably well 
with the full AUDIT90. It can be scored continuously from 0 to 12, with higher scores representing riskier 
drinking, or categorically, with cutpoints of 3 for women and 4 for men having good sensitivity and 
specificity for hazardous drinking. Other substance use will be measured with the 10-item Drug Abuse 
Screening Test (DAST)91 which has shown to have good test-retest reliability, validity, and sensitivity, 
and specificity in detecting problem substance use69. 
See Table 1 below for the administration schedule for all measures and time estimates for the assessment 
batteries.  
 
 
 

 
Study #1406327436 
 
 
v. 5/26/2017 
 
Table 1. Outcome Assessment Protocol: Measures and Schedule of Administration 
Domain 
Measure 
Items Time 
 (min) 
Schedule 
Screen 
BL 
 
8  
wk 
FU  
4 
Mo 
FU 
7 
Mo 
FU 
 
Demographics 
and Covariates 
Screening Interview –  
Eligibility 
22 
10 
X 
 
 
 
 
Demographic/Covariat
e Form (BL/FU) 
AUDIT-C alcohol use 
DAST – drug use 
21/12) (7/3) 
 
X  
X  
X  
X  
Overall 
PTSD 
Symptoms 
CAPS – Clinician 
Interview 
30 
45 
X 
 
 
X 
X 
PCL – Self Report 
20 
6 
 
X 
X 
X 
X 
PTSD-Specific 
Symptoms 
PROMIS Anger Short 
Form 
5 
2 
 
X 
X 
X 
X 
MOS – Sleep  
12 
3 
 
X 
X 
X 
X 
PTSD-Related 
Outcomes 
BDI – Depression  
21 
7 
 
X 
X 
X 
X 
STAI – Anxiety (state 
only) 
20 
5 
 
X 
X 
X 
X 
BPI – Pain 
11 
3 
 
X 
X 
X 
X 
SF-20 – Well-
being/quality of life 
20 
6 
 
X 
X 
X 
X 
Other Related 
Outcomes 
MAIA - Interoceptive 
Awareness and /Self 
Regulation 
SCS-SF-Self 
compassion 
NGSES – self-efficacy 
Mental Illness Stigma 
FACIT-SP - spirituality 
 
32 
 
12 
8 
6 
12 
10 
 
3 
3 
2 
3 
 
X 
 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
Treatment   
Factors 
PPQ – Treatment 
Credibility 
5 
2 
 
X 
 
 
 
CSQ-8 – Client 
Satisfaction   
9 
3 
 
 
 
X 
 
Program Evaluation 
Questionnaire 
10 
8 
 
 
 
X 
 
Total Time 
55 Min 67 Min 61 Min 
117 
Min 
106 
Min 
 
Primary Outcome Measures. The primary outcome measures include the total score from the Clinician 
Administered PTSD Scale (CAPS) 65 and the total score from the PTSD Checklist (PCL).66 The CAPS is 
considered the “gold standard” diagnostic tool for PTSD assessment by the National Center for PTSD and has 
been extensively used and validated in clinical trials.68,69 The CAPS is a semi-structured clinician interview that 
measures PTSD diagnostic status and symptom severity consistent with the Diagnostic and Statistical Manual 
of Mental Disorders (5th ed.).67 The CAPS yields both continuous and dichotomous scores for current PTSD 
symptoms. PTSD self-reported symptom severity will be assessed with the PTSD Checklist, a 20-item self-
report measure of the DSM-5 symptoms of PTSD used as a measure of change in PTSD symptoms as a 
function of treatment. The PCL has demonstrated sensitivity and specificity >70%.66, 69, 70 The DSM-5 versions 
of these measures are not yet normed but should be available for use in this study. 
 

 
Study #1406327436 
 
 
v. 5/26/2017 
PTSD-Specific Symptoms: The Medical Outcomes Study 12-item Sleep Scale (MOS) will assess sleep 
quality (sleep disturbance, adequacy of sleep, and sleep quantity) and has demonstrated good psychometric 
properties.74    Anger will be assessed by the PROMIS Item Bank v. 1.1 – Emotional Distress - Anger - Short 
Form 5a  PROMIS stands for the NIH Patient Reported Outcome Measurement Information System which 
provides questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as 
their ability or lack of ability to function that have been psychometrically validated..  
 
PTSD-Related Symptoms/Outcomes: Depression will be measured by the Beck Depression Inventory 
(BDI),  a 21-item self-report measure,71 and anxiety will be measured by the Spielberger State-Trait Anxiety 
Inventory (STAI), consisting of a 20-item scale: State Anxiety.72 These measures have well-established 
reliability and validity and have been widely used in PTSD treatment research. Pain will be assessed using the 
Brief Pain Inventory (BPI), an 11-item, multidimensional pain measurement tool with demonstrated reliability in 
patients with arthritis as well as other pain conditions.75, 76 The BPI rates the intensity of pain as well as the 
interference of pain with mood, physical activity, work, social activity, relations with others, sleep, and 
enjoyment of life. Physical and Psychological Well-Being/Quality of Life will be measured by the Medical 
Outcomes Study Short Form Questionnaire (SF-20), which assesses physical and mental functioning/well-
being in 8 domains and gives reliable, valid and responsive summary scores.77 The   SF-20 is a widely used 
self-report instrument that assesses perception of overall health status and the impact of physical limitations, 
emotional problems and pain on work, social activities and everyday tasks during the preceding 4 weeks. The 
SF-20 will be used to evaluate potential changes in perceived physical and psychological well-being and QOL 
that may be associated with the study intervention. 
 
• Potential Mediators/Moderators: Interoceptive Awareness and Emotional Awareness/Self-Regulation 
will be assessed by the Multidimensional Assessment of Interoceptive Awareness (MAIA), a 32-item 
measure designed to assess interoceptive body awareness, includes eight subscales: noticing, not-
distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening and 
trusting. Psychometric properties are acceptable for the intended use in an exploratory analysis.80  We will 
use the total score for interoceptive awareness and the self-regulation subscale total as an indicator of 
emotional regulation. The Self-Compassion Scale-short form (SCS-SF) is a 12-item scale used to measure 
the degree to which individuals display self-kindness against self-judgment, common humanity, isolation, 
mindfulness and over-identification. The short scale has a near perfect correlation with the long scale when 
examining total scores. Questions are rated on a Likert scale from 1 (almost never) to 5 (almost always) with 
subscales scores computed by calculating the mean of subscale item responses.  The New General Self-
Efficacy Scale will be used to measure the general self-efficacy of participants. It is an 8 item, 5-point scale 
consisting of strongly disagree (1) to strongly agree (5)96. The sum of this unidimensional96 measure 
indicates the level of general self-efficacy, defined as “one’s belief in one’s overall competence to effect 
requisite performances across a wide variety of achievement situations,”97 (p.75) with higher scores 
indicating greater levels of general self-efficacy. Internal consistency of the test responses range from .85-
.9098, while the stability coefficients of r = 6296. Mental Illness Stigma asks respondents about personal and 
perceived societal attitudes towards mental illness, including 3 questions used in a CDC random survey of 
202,065 adults in the U.S93  and 3 questions developed in focus groups of depressed patients94 and 
completed by more than 78,000 depressed individuals responding to an Internet survey95. The FACIT-SP 
(Functional Assessment of Chronic Illness Therapy – Spirituality) is a 12-item scale designed to measure 
spiritual well-being independent of religious beliefs. It has been adapted for use with non-medical populations 
and comprises two subscales; meaning and peace and faith99 The FACIT-Sp is a part of the larger FACIT 
battery100 that assesses quality of life associated with chronic illness and has been found to be valid and 
reliable (α = .81-.88)99. 
Treatment Factors will be assessed by three measures. The Pre-Program Questionnaire (PPQ) 81 is an 
adaptation of Borkovec and Nau’s format82 and is a frequently used measure of treatment credibility. The 
questionnaire asks subjects to rate how confident they are in the program, how logical the program seems, 

 
Study #1406327436 
 
 
v. 5/26/2017 
how successful they think it will be, how helpful the program leaders will be, and whether they would 
recommend the program to a friend, on a 10-point Likert-type scale. Treatment Satisfaction will be measured 
by the Client Satisfaction Questionnaire (CSQ-8), an 8-item scale that uses a 4-point likert scale to indicate 
participants’ appraisal of their satisfaction with the intervention.83 The CSQ-8 has excellent internal 
consistency, with a coefficient alpha of .87-.93, and evidence for the construct and concurrent validity of this 
measure has been reported as well.84 A one-hour Program Evaluation Focus Group will be conducted with 15 
randomly selected HYP participants to gather detailed information about participants’ experience of the 
intervention to guide improvement of its structure and content. These participants will receive $15 for 
completing the interview. Dr. Sternke, a sociologist experienced in qualitative methods, will train a member of 
the study staff to conduct the interviews, which will be audio recorded and transcribed. Dr. Sternke will explore 
the data in order to understand participants’ perceptions of the program, particularly in relation to PTSD, using 
Grounded Theory, an emergent constant comparative method.89 The secondary analysis (Situational Analysis), 
will map all major features of participants’ characteristics, perceptions, material elements and settings, in order 
to understand the relations and differences among them. All other participants will complete a brief program 
evaluation questionnaire with open-ended questions to ascertain likes and dislikes as well as suggestions for 
improvement of HYP or WLP. Treatment Engagement will be assessed by examining totals of treatment 
sessions attended and home practice completed. 
 
Study questionnaires, rating scales, and other assessments will be completed by study participants through an 
on-line survey or paper questionnaires (when the participant is unable to use the on-line survey and to capture 
home practice), assisted if needed by trained study staff blinded to condition. When on-line surveys are used to 
capture data, participants will be provided with a survey link and a code which will allow them to access the 
survey. The survey link will be sent to the participant in an email from Outlook on the VA network. The access 
code will be provided to the participant separately by another method, such as a hard-copy presented in-
person, verbally over the phone, or a STREEM text. Data will be entered from paper self-report questionnaires 
or interviews conducted by trained study staff (e.g. CAPS). Within the REDCap database, algorithms will be 
created to check for inappropriate or missed data entry. Computer algorithms will automatically score 
questionnaires within the same database. These data will be backed up daily onto a password protected, 
secured server at the IU School of Medicine. Participant social security numbers, names, addresses and other 
personally identifiable information will be restricted to authorized personnel to protect confidentiality and will be 
stored in a separate password protected Microsoft Access Database on the RVAMC secured server. We have 
experience in setting up data integrity protocols and data back-up to minimize the risk for lost or inaccurate 
data. Participant personally identifiable information will be restricted to authorized personnel to protect 
confidentiality. We have experience using this strategy successfully in previous research, accurately 
completing assessments, protecting patient privacy and minimizing the risk for lost or inaccurate data. For our 
current PTSD study, audits revealed very low rates of data entry error (0.00079 or 0.079%) and missing data 
(average of 0.00083 or 0.083%). We have used similar length or longer batteries of measures in several 
previous or current trials without over-burdening patients. Self-report assessments will be completed via on-line 
surveys (REDCap) and interviews will be conducted in-person as we have found that rapport is more easily 
established face-to-face. If multiple attempts have failed for on-line surveys and/or in-person interviews, we 
have employed two strategies to capture outcome assessments: (1) conduct assessments by phone; and (2) 
mail questionnaires with postage paid, self-addressed envelope to our office. At times in past studies, 
participants have needed assistance to cover the cost of driving to the RVAMC for an assessment, especially if 
they live more than 30 minutes away. In these situations, the Project Coordinator may authorize  a $10 gas 
card to defray the round trip cost of travelling to a scheduled study visit for assessment purposes.  We have 
previously arranged taxi cab rides to and from our VA. To maintain participant confidentiality, our study staff 
will adhere to careful interview and data collection procedures. First, participants will be told that their 
responses will remain confidential and that every effort will be made to fulfill that assurance. Second, the 
interviews will be conducted in an appropriate setting (i.e., private interview room). Third, any completed paper 
surveys will be stored in a secure location in our locked RVAMC office in a locked file cabinet. The screening 
and assessment interviews and study databases (using Microsoft Access) will be designed by trained study 
staff under the direction of Dr Davis or the Project Manager. 
 

 
Study #1406327436 
 
 
v. 5/26/2017 
Once baseline assessments are completed, the participant will be randomly assigned to the Holistic Yoga 
Program (HYP) or Wellness Lifestyle Program (WLP). The Holistic Yoga Program (HYP) arm will involve a 
standardized 16-week, yoga intervention consisting of: 1) a program orientation session conducted by a yoga 
instructor; 2) once weekly in-person group yoga class (postures, breathing practices, deep muscle contraction 
practices, relaxation practices) taught by a yoga instructor registered with Yoga Alliance at a minimum of the 
200 hour level; 3) audio recordings of guided yoga postures, breathing, and relaxation practices for home-use; 
3) a handbook to reinforce concepts taught during in-person session. Patients randomized to the Wellness 
Lifestyle Program (WLP) arm will participate in a standardized 16-week intervention that will consist of: 1) a 
program orientation conducted by a trained member of the study staff; 2) once weekly in-person group 
wellness classes (didactics and discussion of wellness topics and low intensity physical activity consisting of 
walking  taught by a clinical psychologist with experience in trauma with consultation available from an 
experienced athletic trainer; 3) a handbook to reinforce wellness concepts and physical activity instructions 
taught during in-person session and to assist with home practice. After completing the program, participants 
will be asked to complete the same assessments as baseline with the addition of 2 program evaluation 
questionnaires. To minimize the potential for ascertainment bias, follow-up assessments (8 weeks, 4 months, 7 
months) will be conducted by on-line survey and the interviews by a trained research assistant  who will be 
blinded to treatment assignment. Participants will receive $25 for completing the 8-week assessments, $35 for 
completing the 16-week assessments and $45 for completing the 7-month follow-up assessment. Those who 
fail screening will be given $15. 
 
We will conduct both interventions on a continuous schedule so that interested participants may begin the 
intervention immediately without having to wait for an entire cohort to be recruited. The Holistic Yoga Program 
(HYP) and Wellness Lifestyle Program (WLP), will both provide one 90-minute session each week for 16 
weeks. The first session for each participant will consist of an orientation session with a trained member of the 
study staff. Group sessions will average 7-8 participants with the upper limit of 15 participants.. We may offer 
an additional 16-week session in years 2-4 if needed to recruit adequate numbers of participants to 
accommodate participants who are unable to attend the ongoing class day/time. Sessions will be held in a 
large multipurpose room at the RVAMC or the National Guard Armory at Stout Field or a classroom at the 
Regenstrief Institute on W. 10th Street (a block from RVAMC). Attendance will be recorded to assess 
adherence. If a participant is assigned to an intervention class that meets at a location offsite and paid parking 
is required, study staff will provide a parking voucher to the participant at the end of each class attended in 
order to cover the cost of parking. 
 
 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to Participants or Others 
 
Adverse events that are expected and do not pose additional risk to participants will be reported at the time of 
continuing review. Adverse events that pose risk to participants and unanticipated problems will be reported to 
the IRB within 5 business days of becoming aware of the event. The event will be reported using the “Prompt 
Reporting Form for VA Research” and will be submitted both to the IU IRB and the Indy VA Research 
Compliance and logged by the Project Coordinator. 
 
7.0 
Study Withdrawal/Discontinuation 
 
A participant may withdraw from the study at any time by notifying the PI, Dr. Louanne Davis, of their request in 
writing. Additionally, participants may be urged to withdraw for clinical reasons, such as severe suicidal 
thoughts. Their participation may also be terminated at the discretion of the PI if they violate any rules or 
regulations of the Roudebush VA Medical Center. 
 
8.0 
Statistical Considerations 
 
RELIEVE will involve a 2-arm, parallel group, RCT.  Since participants cannot be blinded to treatment 
assignment, observed outcomes (if positive) could be affected by expectation bias. To account for this potential 
bias, we will assess treatment expectations at baseline and account for them in our analyses. We will 

 
Study #1406327436 
 
 
v. 5/26/2017 
randomize at the patient level rather than the provider level for two reasons (1) randomization at patient level 
saves sample size; and (2) patients from the same provider in the two arms will be adjusted for “provider 
effect.” Contamination will also be low because there is relatively minimal involvement required of VA providers 
in RELIEVE. In addition, randomization will be stratified by veteran and non-veteran status and gender (4 
strata) to avoid potential imbalance of these factors between the two arms. Dr. Daggy, PhD (statistician) will 
create a randomization scheme in REDCap for each of the four strata to randomize patients in blocks of 4 
assignments within each of 4 stratum. 
 
Sample size. Our sample size is calculated based on estimated differences of intervention effects between 
two arms on the primary outcome:  CAPS total score at 4 months, or treatment end. The CAPS total score is a 
continuous measure (0-136) and reflects a combined score reflecting symptom frequency and symptom 
severity. A recently published yoga pilot study for patients with PTSD9 found a pre-treatment CAPS score of 
77.33 (standard deviation = 28.6). Post-treatment scores were reduced by 34% (CAPS = 51.1, SD = 27.6, 
effect size = 0.9) from the yoga intervention. We powered on a medium effect size of 0.55 which requires a 
larger sample size than 0.9. We recognize the correlation of outcomes from subjects within the same yoga 
class may reduce the effective sample size compared to the same sample with independent observations. This 
possible “clustering effect” has implications for power. Randomization will occur at the individual not cluster or 
clinic level. Also, we expect that the intra-cluster correlation (ICC) will be near zero because groups will have a 
mixture of participants from the various recruitment sites: therefore, there is no reason to believe that 
participants within groups would be more correlated on the outcomes than participants from different groups. 
We have no preliminary data to estimate the intra-cluster correlation (ICC) for participants within the same 
group. However, based on similarly designed published studies, we expect the ICC to be relatively small and 
balanced across the two treatment arms since the cluster sizes will be similar. We will assume an ICC of 0.05 
for both groups. We will also assume a 20% difference between treatment groups. The absolute score 
difference at 4 months is estimated to be approximately 15.4 points (61.6, 80% of 77). Assuming a common 
standard deviation of 28 and using a two-sample t-test, we will need 60 evaluable subjects in each arm to 
detect such a difference (Cohen’s d = 0.55) with >85% power and 5% Type I error rate. With approximately 8 
subjects per treatment group/class session or cluster, the design effect is 1+ (8-1) ×0.05=1.35. Therefore, we 
will inflate our sample size by 35% to accommodate the potential clustering effects. We then need 81 
evaluable subjects in each arm. With an assumed 30% attrition, we will then need (81*2)/0.70 = 232 subjects 
(116 in each arm). 
 
Data analysis: Baseline characteristics of the RELIEVE sample. To evaluate representativeness, we will 
compare enrollees and those who decline enrollment on baseline characteristics (socio-demographic variables, 
psychiatric comorbidity, and current and prior PTSD treatments). Any differences will be considered when 
interpreting results of subsequent analyses. We will also examine differences in baseline characteristics 
between patients who remain in the study and those who dropout. The linear mixed modeling approach (see 
next section) will ensure that all available data are used for subjects who have missing data. The models will 
also incorporate dropout status to adjust for follow-up missing data pattern. All participants will have baseline 
data. The possible missing data patterns will be (1) missing 4 month, not 7 month, (2) missing 7 month, not 4 
month, (3) missing both 4 and 7 months, and (4) complete data. 
 
Main analysis of the primary outcome. Our main analysis will use the ANCOVA (analysis of covariance) 
approach to linear mixed modeling of repeated measures in which the baseline measure of the relevant 
outcome scores (i.e., CAPS or PCL) is adjusted as a covariate in the model.85 The model for CAPS will be 
adjusted for baseline CAPS score. The model for PCL, a continuous measure with a possible range of 17-85, 
will be adjusted for baseline PCL score. The CAPS and PCL are measured at every time point (baseline, 8 
weeks, 4 months, 7 months) except the CAPS is not administered at 6 weeks in order to reduce participant 
burden, since the CAPS and PCL are highly correlated. We plan an intent-to-treat analysis with the primary 
endpoint at 4 months and evaluation of “early” response at 8 weeks and “sustained” response at 7 months (3 
months post-intervention). The models will simultaneously incorporate three post-baseline measures (8 weeks 
([PCL only], 4 months, and 7 months) of the relevant response variable. The main predictors will be group 
(treatment arm), time (categorical with indicator variables to avoid restrictive assumption of linearity over time), 
and their interaction.  A random intercept will be used to adjust for the potential clustering effect for patients in 

 
Study #1406327436 
 
 
v. 5/26/2017 
a specific yoga group. And a subject-specific random intercept (nested within the group effect) will 
accommodate the correlation among repeated measurements from the same patient. Aim 1 will involve testing 
intervention effects by using the appropriate contrast from the model to test the difference in CAPS score and 
PCL score between the two treatment arms at 8 weeks (early response), 4 months (the primary end point 
which occurs immediately post intervention), and 7 months (sustained effect of intervention).  Descriptive 
statistics including adjusted means, SD, and effect sizes (differences between two arms on adjusted means 
divided by pooled SD) will be reported for outcomes at each time point. Variables that are either known, or 
shown with our data, to be significantly correlated to the outcomes, will be considered as covariates, 
irrespective of their degree of baseline imbalance between randomized groups (e.g., combat vs. con-combat 
PTSD, baseline credibility score, and mTBI). 
 
Secondary analysis of primary outcome. For the CAPS and PCL total scores, we will also report a clinically 
relevant descriptive statistic in which we define the patients with more than 30% reduction from baseline as 
“responders.” We will then compare the probability of responders between treatment arms using a generalized 
linear mixed model with a logit link. The responding status of each patient at 8 weeks (for PCL only), 4 months 
and 7 months will be used as the outcome variables. Main predictors are group (treatment arm), time (8 weeks 
for PCL only, 4 months and 7 months) and their interaction. A significant coefficient of group indicates a 
significant odds ratio of being a responder between the two arms. 
 
Analysis of secondary outcomes. Since RELIEVE is not specifically powered for secondary outcomes, these 
results should be interpreted cautiously unless they are highly significant (p < .001). PTSD-specific symptoms 
(anger, sleep) and PTSD-related symptoms/outcomes (well-being/QOL, depression, anxiety, pain) will be 
analyzed using the linear mixed modeling approach described above for the primary outcome. The secondary 
outcomes will be PTSD-specific symptoms including: anger (STAXI score), sleep (MOS score) and PTSD-
related symptoms/outcomes: depression (BDI score), anxiety (STAI score), well-being/QOL (SF-12), and pain 
(BPI). Since there will be a number of secondary outcomes, we will adjust for multiple-comparisons by using 
the false discovery rate (FDR) 86 method to control the overall false positive rate at 0.05.  Exploratory analyses 
of potential mediators/moderators: interoceptive awareness and self-regulation. Moderation effects will be 
assessed by testing two-way interactions between intervention group membership and demographic and 
baseline scales including treatment credibility, interoceptive awareness, self-regulation and type of trauma 
(combat vs non-combat related), mTBI. Mediation effects will be analyzed using the MPLUS structural equation 
modeling (SEM) software to test the direct, indirect, and total effects of paths in a multilevel SEM model that 
includes potential mediators measured at various study points (see table of measures) including client 
satisfaction, interoceptive awareness and self-regulation. Adherence to the interventions and home practice 
will also be assessed for its dose-response effects on the primary and secondary outcomes. 
 
Missing data.87 Based on our prior studies, we anticipate a possible dropout rate of 30%, which is reflected in 
the sample size calculation. We will first run a logistic model with missing status as the response variable, 
intervention arm, patients’ demographic characteristics as covariates, to check whether the missing status 
depends on the intervention group assignment and patient characteristics. Second, our linear mixed effects 
model can accommodate missing-at-random (or MAR which is assumed in many trials) where no bias will be 
introduced by ignoring the missing-data mechanism. If drop-outs are Missing Not At Random (MNAR), 
meaning the likelihood of drop-out depends on an un-observed outcome, and the missing data mechanism is 
ignored, potential bias can be introduced. We will run sensitivity analyses using linear mixed models with the 
“multiple imputation” method and 100 generated data sets to compare results with the standard linear mixed 
effects modeling without imputation to assess the robustness of the inference. 
 
9.0 
Privacy/Confidentiality Issues 
 
Participants names will not appear on any of the data collected, including video or audio recordings. All of their 
answers will be matched with a code number only. The key to this code number will be stored in a password 
protected computer file, separate from other data. All VA sensitive research information and any copies thereof 
will be used, stored, and remain within the VA. Only de-identified data will be stored in the IU REDCap 

 
Study #1406327436 
 
 
v. 5/26/2017 
database. Only staff working on this project and designees or members of the IU Institutional Review Board will 
be able to see records relating to this study.  
 
10.0 
Follow-up and Record Retention 
 
This study will last for approximately 1 year. Research records, including audio and video, will be maintained 
by the investigator in accordance with the VHA Records Control Schedule.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Reference List 
 

 
Study #1406327436 
 
 
v. 5/26/2017 
1.  Monson, C. M., & Fredman, S. J. (2012). Cognitive-behavioral conjoint therapy for PTSD: Harnessing the 
healing power of relationships. New York, NY: The Guilford Press. 
2. 
U.S. Department of Veterans Affairs. (2011). Veterans Benefits Administration Annual Benefits Report 
Fiscal Year 2010. Washington, DC: Author. 
3. 
Kessler, R. C., Sonnega, A., Bromet, E., & Hughes, M. (1995). Posttraumatic stress disorder in the 
National Comorbidity Survey. Archives of General Psychiatry, 52(12), 1048-1060. 
4.  Sayer, N. A., Friedemann-Sanchez, G., Spoont, M. R., Murdoch, M., Parker, L. E., Chiros, C. E., & 
Rosenheck, R. A. (2009). A qualitative study of determinants of PTSD treatment initiation in veterans. 
Psychiatry, 72(3), 238-255. 
5.  Hoge, C. W., Castro, C. A., Messer, S. C., McGurk, D., Cotting, D. I., & Koffman, R. L. (2004). Combat 
duty in Iraq and Afghanistan, mental health problems, and barriers to care. The New England Journal Of 
Medicine, 351(1), 13-22. 
6.  Erbes, C.R., Curry, K.T., & Leskela, J. (2009). Treatment presentation and adherence of Iraq/Afghanistan 
era veterans in outpatient care for posttraumatic stress disorder. Psychological Services, 6(3), 175-183. 
7.  Cabral, P., Meyer, H. B., & Ames, D. (2011). Effectiveness of yoga therapy as a complementary treatment 
for major psychiatric disorders: a meta-analysis. Primary Care Companion for CNS Disorders, 13(4). 
8. 
Khalsa, S. B. S. (2004b). Yoga as a therapeutic intervention: a bibliometric analysis of published research 
studies. Indian Journal Of Physiology And Pharmacology, 48(3), 269-285. 
9.  Johnston, J, & Khalsa, S.B. (2011, September). Yoga as an intervention for post-traumatic stress disorder 
(PTSD) in Military Personnel. Accepted Scientific Research Works (Abstracts), Symposium on Yoga 
Therapy and Research, Pacific Grove, CA. 
10.  Stoller, C.C, Greulel, J.H., Cimini, L.S., Fowler, M.S., & Koomar, J.A. (2012). Effects of Sensory-Enhanced 
Yoga on Symptoms of Combat Stress in Deployed Military Personnel. The American Journal of 
Occupational Therapy, 66(1), 59-68.  
11. Telles, S., Bhardwaj, A. K., Kumar, S., Kumar, N., & Balkrishna, A. (2012). Performance in a substitution 
task and state anxiety following yoga in army recruits. Psychological Reports, 110(3), 963-976. 
12.  Descilo, T., Vedamurtachar, A., Gerbarg, P. L., Nagaraja, D., Gangadhar, B. N., Damodaran, B., . . .  
Brown, R. P. (2010). Effects of a yoga breath intervention alone and in combination with an exposure 
therapy for post-traumatic stress disorder and depression in survivors of the 2004 South-East Asia 
tsunami. Acta Psychiatrica Scandinavica, 121(4), 289-300. 
13.  Khalsa, S. B. S., Shorter, S. M., Cope, S., Wyshak, G., & Sklar, E. (2009). Yoga ameliorates performance 
anxiety and mood disturbance in young professional musicians. Applied Psychophysiology and 
Biofeedback, 34(4), 279-289. 
14.  The Posttraumatic Stress Disorder (PTSD) Alliance. Post Traumatic Stress Disorder fact sheet. Retrieved 
from The Sidran Institute, Traumatic Stress Education & Advocacy website: 
http://www.sidran.org/sub.cfm?contentID=66&sectionid=4 
15.  Seedat, S., & Stein, M. B. (2001). Post-traumatic stress disorder: A review of recent findings. Current 
Psychiatry Reports, 3(4), 288-294. 
16.  Norris, F. H., & Slone, L. B. (2007). The epidemiology of trauma and PTSD. In M. J.  Friedman, T. M. 
Keane, & P. A. Resick (Eds.), Handbook of PTSD: Science and practice (pp. 78-98). New York, NY US: 
Guilford Press. 
17.  Gates, M. A., Holowka, D. W., Vasterling, J. J., Keane, T. M., Marx, B. P., & Rosen, R. C. (2012). 
Posttraumatic stress disorder in veterans and military personnel: Epidemiology, screening, and case 
recognition. Psychological Services, 9(4), 361-382. 
18.  Zhang, L., Li, H., Benedek, D. M., Li, X. X., & Ursano, R. J. (2009). A strategy for the development of 
biomarker tests for PTSD. Medical Hypotheses, 73(3), 404-409. 
19.  Erbes, C. R., Kaler, M. E., Schult, T., Polusny, M. A., & Arbisi, P. A. (2011). Mental health diagnosis and 
occupational functioning in national Guard/Reserve veterans returning from Iraq. Journal of Rehabilitation 
Research and Development, 48(10), 1159-1170. 
20.  Warshaw, M. G., Fierman, E. J., Pratt, L. A., Hunt, M. F., Yonkers, K. A., Massion, A. O., & Keller, M. B. 
(1993). Quality of life and dissociation in anxiety disorder patients with histories of trauma or PTSD. 
American Journal of Psychiatry, 150(10), 1512-1516. 
21.  Tarrier, N., & Gregg, L. (2004). Suicide risk in civilian PTSD patients: Predictors of suicidal ideation, 
planning and attempts. Social Psychiatry and Psychiatric Epidemiology, 39(8), 655-661. 

 
Study #1406327436 
 
 
v. 5/26/2017 
22.  Dube, S. R., Anda, R. F., Felitti, V. J., Chapman, D. P., Williamson, D. F., & Giles, W. H. (2001). 
Childhood abuse, household dysfunction, and the risk of attempted suicide throughout the life span: 
Findings from the adverse childhood experiences study. Journal of the American Medical Association, 
286(24), 3089-3096. 
23.  Gould, D. A., Stevens, N. G., Ward, N. G., Carlin, A. S., Sowell, H. E., & Gustafson, B. (1994). Self-
reported childhood abuse in an adult population in a primary care setting: Prevalence, correlates, and 
associated suicide attempts. Archives of Family Medicine, 3(3), 252-256. 
24.  Adams, D. P., Barton, C., Mitchell, G. L., Moore, A. L., & Einagel, V. (1998). Hearts and minds: Suicide 
among united states combat troops in Vietnam, 1957-1973. Social Science and Medicine, 47(11), 1687-
1694.  
25.  Davidson, J. R. T., & van der Kolk, B. A. (1996). The psychopharmacological treatment of posttraumatic 
stress disorder. In B. A. v. d. Kolk, A. C. McFarlane & L. Weisaeth (Eds.), Traumatic stress: The effects of 
overwhelming experience on mind, body, and society (pp. 510-524). New York, NY, US: Guilford Press. 
26.  Brady, K., Pearlstein, T., Asnis, G. M., Baker, D., Rothbaum, B., Sikes, C. R., & Farfel, G. M. (2000). 
Efficacy and safety of sertraline treatment of posttraumatic stress disorder: a randomized controlled trial. 
JAMA, 283(14), 1837-1844.  
27.  Marshall , R. D., Beebe, K. L., Oldham, M., & Zaninelli, R. (2001). Efficacy and safety of paroxetine 
treatment for chronic PTSD: a fixed-dose, placebo-controlled study. The American Journal of Psychiatry, 
158(12), 1982-1988.   
28.  Friedman, M. J., Marmar, C. R., Baker, D. G., Sikes, C. R., & Farfel, G. M. (2007). Randomized, double-
blind comparison of sertraline and placebo for posttraumatic stress disorder in a department of veterans 
affairs setting. Journal of Clinical Psychiatry, 68(5), 711-720. 
29.  Chung, M. Y., Min, K. H., Jun, Y. J., Kim, S. S., Kim, W. C., & Jun, E. M. (2004). Efficacy and tolerability of 
mirtazapine and sertraline in Korean veterans with posttraumatic stress disorder: a randomized open label 
trial. Human Psychopharmacology, 19(7), 489-494. 
30.  Raskind , M. A., Peskind, E. R., Hoff, D. J., Hart, K. L., Holmes, H. A., Warren, D., . . . McFall, M. E. 
(2007). A Parallel Group Placebo Controlled Study of Prazosin for Trauma Nightmares and Sleep 
Disturbance in Combat Veterans with Post-Traumatic Stress Disorder. Biological Psychiatry, 61(8), 928-
934.  
31.  Braun , P., Greenberg, D., Dasberg, H., & Lerer, B. (1990). Core symptoms of posttraumatic stress 
disorder unimproved by alprazolam treatment. Journal of Clinical Psychiatry, 51(6), 236-238.  
32.  Gelpin , E., Bonne, O., Peri, T., Brandes, D., & Shalev, A. Y. (1996). Treatment of recent trauma survivors 
with benzodiazepines: a prospective study. The Journal Of Clinical Psychiatry, 57(9), 390-394.  
33.  Friedman , M. J., & Davidson, J. R. T. (2007). Pharmacotherapy for PTSD. In M. J. Friedman, T. M. Keane 
& P. A. Resick (Eds.), Handbook of PTSD: Science and practice. (pp. 376-405). New York, NY US: 
Guilford Press. 
34.  Foa, E. B., Gillihan, S. J., & Bryant, R. A. (2013). Challenges and successes in dissemination of evidence-
based treatments for posttraumatic stress: Lessons learned from prolonged exposure therapy for PTSD. 
Psychological Science in the Public Interest, 14(2), 65-111. 
35.  Frueh , B. C., Cousins, V. C., Hiers, T. G., Cavenaugh, S. D., Cusack, K. J., & Santos, A. B. (2002). The 
need for trauma assessment and related clinical services in a state-funded mental health system. 
Community Mental Health Journal, 38(4), 351-356. 
36.  Libby, D.J., Reddy, F., Pilver, C.E., & Desai, R.A. (2012). Issues in yoga therapy: The use of yoga in 
specialized VA PTSD treatment programs. International Journal of Yoga Therapy, 22, 79-87. 
37.  Kabat-Zinn, J. (1990). Full catastrophe living: Using the wisdom of your body and mind to face stress, 
pain, and illness. New York, NY: Random House, Inc. 
38.  Taylor, M. J. (2007). What is Yoga Therapy? An IAYT definition. Yoga Therapy in Practice, 3(3), 3.  
39.  Field, T. (2011). Yoga clinical research review. Complementary Therapies in Clinical Practice, 17(1), 1-8. 
40.  Streeter, C. C., Gerbarg, P. L., Saper, R. B., Ciraulo, D. A., & Brown, R. P. (2012). Effects of yoga on the 
autonomic nervous system, gamma-aminobutyric-acid, and allostasis in epilepsy, depression, and post-
traumatic stress disorder. Medical Hypotheses, 78(5), 571-579. 
41.  Defrin, R., Ginzburg, K., Solomon, Z., Polad, E., Bloch, M., Govezensky, M., & Schreiber, S. (2008). 
Quantitative testing of pain perception in subjects with PTSD--implications for the mechanism of the 
coexistence between PTSD and chronic pain. Pain, 138(2), 450-459. 

 
Study #1406327436 
 
 
v. 5/26/2017 
42.  Mollo, K., Schaaf, R., & Benevides, T. (2008). The use of Kripalu Yoga to decrease sensory 
overresponsivity: A pilot study. Sensory Integration Special Interest Section Quarterly, 31(3), 1-4. 
43.  Michalsen, A., Jeitler, M., Brunnhuber, S., Lüdtke, R., Büssing, A., Musial, F., . . . Kessler, C. (2012). 
Iyengar Yoga for Distressed Women: A 3-Armed Randomized Controlled Trial. Evidence-based 
Complementary & Alternative Medicine (eCAM), 1-9. 
44.  Malathi, A., Damodaran, A., Shah, N., Krishnamurthy, G., Namjoshi, P., & Ghodke, S. (1998). 
Psychophysiological changes at the time of examination in medical students before and after the practice 
of yoga and relaxation. Indian Journal Of Psychiatry, 40(1), 35-40. 
45.  Lavey, R., Sherman, T., Mueser, K. T., Osborne, D. D., Currier, M., & Wolfe, R. (2005). The effects of 
yoga on mood in psychiatric inpatients. Psychiatric Rehabilitation Journal, 28(4), 399-402. 
46.  Taibi, D. M., & Vitiello, M. V. (2011). A pilot study of gentle yoga for sleep disturbance in women with 
osteoarthritis. Sleep Medicine, 12(5), 512-517. 
47.  Khalsa, S. B. S. (2004). Treatment of Chronic Insomnia with Yoga: A Preliminary Study with Sleep-Wake 
Diaries. Applied Psychophysiology and Biofeedback, 29(4), 269-278. 
48.  Kimbrough, E., Magyari, T., Langenberg, P., Chesney, M., & Berman, B. (2010). Mindfulness intervention 
for child abuse survivors. Journal of Clinical Psychology, 66(1), 17-33. 
49.  Kearney, D.J., McDermott, K., Malte, C.,  Martinez, M. &  Simpson, T.L. (2012). Association of 
participation in a mindfulness program with measures of PTSD, depression and quality of life in a veteran 
sample.  Journal of Clinical Psychology, 68(1), 101-116. 
54.  Brown, L. F., Davis, L. W., LaRocco, V. A., & Strasburger, A. (2010). Participant perspectives on 
mindfulness meditation training for anxiety in schizophrenia. American Journal of Psychiatric 
Rehabilitation, 13(3), 224-242. 
50.  Davis, L. W., & Luedtke, B. L. (2012). Mindfulness-based cognitive-behavioral conjoint therapy for 
posttraumatic stress disorder. Unpublished manual. 
51.  Schmid, A. A., Van Puymbroeck, M., Altenburger, P. A., Schalk, N. L., Dierks, T. A., Miller, K. K., . . . 
Williams, L. S. (2012). Poststroke Balance Improves With Yoga. Stroke, 43(9), 2402-2407. 
52.  Schmid, A. A., Van Puymbroeck, M., & Koceja, D. M. (2010). Effect of a 12-week yoga intervention on fear 
of falling and balance in older adults: a pilot study. Archives Of Physical Medicine And Rehabilitation, 
91(4), 576-583. 
53.  Van Puymbroeck, M., Schmid, A. A., Shinew, K. J., & Hsieh, P. C. (2011). Influence of Hatha yoga on 
physical activity constraints, physical fitness, and body image of breast cancer survivors: A pilot study. 
International Journal of Yoga Therapy, 21(1). 
54.  Brown, L. F., Davis, L. W., LaRocco, V. A., & Strasburger, A. (2010). Participant perspectives on 
mindfulness meditation training for anxiety in schizophrenia. American Journal of Psychiatric 
Rehabilitation, 13(3), 224-242. 
55.  Davis, L. W., Strasburger, A. M., & Brown, L. F. (2007). Mindfulness: An intervention for anxiety in 
schizophrenia. Journal of Psychosocial Nursing and Mental Health Services, 45(11), 23-29. 
56.  Davis, L. W., Lysaker, P. H., Strasburger, A. M., Kristeller, J. L., & Brown, L. F. (2009). Mindfulness 
meditation: A potential intervention for treatment of anxiety in schizophrenia. Unpublished manuscript. 
57.  Tanielian, T., & Jaycox, L. H. (2008). Invisible wounds of war: Psychological and cognitive injuries, their 
consequences, and services to assist recovery. Santa Monica, California: RAND Center for Military Health 
Policy Research. 
58.  Magruder, K. M., Frueh, B. C., Knapp, R. G., Davis, L., Hamner, M. B., Martin, R. H., . . . Arana, G. W. 
(2005). Prevalence of posttraumatic stress disorder in Veterans Affairs primary care clinics. General 
Hospital Psychiatry, 27(3), 167-179. 
59.  National Center for PTSD. (2011, April 26). How Common is PTSD?  Retrieved from: 
http://www.ptsd.va.gov/public/pages/how-common-is-ptsd.asp. 
60.  Milliken , C. S., Auchterlonie, J. L., & Hoge, C. W. (2007). Longitudinal assessment of mental health 
problems among active and reserve component soldiers returning from the Iraq war. JAMA: The Journal 
Of The American Medical Association, 298(18), 2141-2148. 
61. Marx, B. P., & Holowka, D. W. (2011). PTSD disability assessment. PTSD Research Quarterly, 22(4), 1-6. 
62.  Belsher , B. E., Tiet, Q. Q., Garvert, D. W., & Rosen, C. S. (2012). Compensation and treatment: disability 
benefits and outcomes of U.S. veterans receiving residential PTSD treatment. Journal of Traumatic 
Stress, 25(5), 494-502.  

 
Study #1406327436 
 
 
v. 5/26/2017 
63.  Hanson, R. W., Gerber, K. E. (1990). Models of Pain (pp. 15-44). In Coping with Chronic Pain: A Guide to 
Patient Self-Management. New York, NY: Guilford Press. 
64.  Callahan , C. M., Unverzagt, F. W., Hui, S. L., Perkins, A. J., & Hendrie, H. C. (2002). Six-item screener to 
identify cognitive impairment among potential subjects for clinical research. Medical Care, 40(9), 771-781. 
65.  Weathers, F.W., Blake, D.D., Schnurr, P.P., Kaloupek, D.G., Marx, B.P., & Keane, T.M. (2013). The 
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Interview available from the National Center for 
PTSD at www.ptsd.va.gov. 
66.  Weathers, F.W., Litz, B.T., Keane, T.M., Palmieri, P.A., Marx, B.P., & Schnurr, P.P. (2013). The PTSD 
Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov. 
67.  American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). 
Arlington, VA: American Psychiatric Publishing. 
68.  Blake, D. D., Weathers, F. W., Nagy, L. M., Kaloupek, D. G., Gusman, F. D., & Charney, D. S. (1995). The 
development of a Clinican-Administered PTSD Scale. Journal of Traumatic Stress, 8, 75-90.  
69.  Weathers, F. W., Keane, T. M., & Davidson, J. R. (2001). Clinician-administered PTSD scale: a review of 
the first ten years of research. Depression and Anxiety, 13(3), 132-156. 
70.  Weathers, F. W., & Ford J. (1996). Psychometric review of PTSD Checklist (PCL-C, PCL-S, PCL-M, PCL-
PR). In B. H. Stamm (Ed.), Measurement of Stress, Trauma, and Adaptation. Lutherville: Sidran Press. 
71.  Beck, A. T., Ward, C. H., Mendelsohn, M., Mock, J., & Erbaugh, J. (1961). An inventory for measuring 
depression. Archives of General Psychiatry, 4, 561-571.  
72.  Spielberger, C. D. (1983). Manual for the state-trait anxiety inventory (form Y) (self-evaluation 
questionnaire). Palo Alto, CA: Consulting Psychologists Press. 
73.    
74.  Allen, R. P., Kosinski, M., Hill-Zabala, C. E., & Calloway, M. O. (2009). Psychometric evaluation and tests 
of validity of the Medical Outcomes Study 12-item Sleep Scale (MOS sleep). Sleep Med, 10(5), 531-539.  
75.  Cleeland, C. S., & Ryan, K. M. (1994). Pain assessment: global use of the Brief Pain Inventory. Ann Acad 
Med Singapore, 23(2), 129-138.  
76.  Tan, G., Jensen, M. P., Thornby, J. I., & Shanti, B. F. (2004). Validation of the brief pain inventory for 
chronic nonmalignant pain. The Journal of Pain, 5(2), 133-137. 
77.  Stewart, A. L., Hays, R. D., & Ware, J. E. (1988). The MOS short-form general health survey: Reliability 
and validity in a patient population. Medical Care, 26(7), 724-735.  
78.  Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. 
Johnston, Measures in health psychology: A user’s portfolio. Causal and control beliefs (pp. 35-37). 
Windsor, UK: NFER-NELSON. 
79.  Ritsher, J. B., Otilingam, P. G., & Grajales, M. (2003). Internalized stigma of mental illness: psychometric 
properties of a new measure. Psychiatry Research, 121(1), 31-49. 
80.  Mehling, W. E., Price, C., Daubenmier, J. J., Acree, M., Bartmess, E., & Stewart, A. (2012). The 
Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS ONE, 7(11), e48230. 
81.  Monson, CM & Taft, CT. (2005). PTSD and intimate relationships. PTSD Research Quarterly, 16, 1-7. 
82.  Teasdale , J. D., Segal, Z. V., Williams, J. M. G., Ridgeway, V. A., Soulsby, J. M., & Lau, M. A. (2000). 
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Journal of 
Consulting and Clinical Psychology, 68(4), 615-623. 
83.  Larsen, D. L., Attkisson, C. C., Hargreaves, W. A., & Nguyen, T. D. (1979). Assessment of client/patient 
satisfaction: Development of a general scale. Evaluation and Program Planning, 2, 197-207. 
84.  Nguyen, T. D., Attkisson, C. C., & Stegner, B. L. (1983). Assessment of patient satisfaction: Development 
and refinement of a service evaluation questionnaire. Evaluation and Program Planning, 6(3-4), 299-313. 
85.  Samuels, M. L. (1986). Use of analysis of covariance in clinical trials: a clarification. Controlled Clinical 
Trials, 7(4), 325-329. 
86 .  Benjamini, Y., & Hochberg, Y. (1995). Controlling the false discovery rate: A practical and powerful 
approach to multiple testing. Journal of the Royal Statistical Society, Series B (Methodological), 57(1), 
289-300.   
87.  Rubin, D. B. (1976). Inference and Missing Data. Biometrika, 63(3), 583-91.   
88. Resick, P. A., Galovski, T. E., Uhlmansiek, M. O. B., Scher, C. D., Clum, G. A., & Young-Xu, Y. (2008). A 
randomized clinical trial to dismantle components of cognitive processing therapy for posttraumatic stress 

 
Study #1406327436 
 
 
v. 5/26/2017 
disorder in female victims of interpersonal violence. Journal of Consulting and Clinical Psychology, 76(2), 
243-258. 
89.  Charmaz, K. (2006). Constructing grounded theory: a practical guide through qualitative analysis. 
Thousand Oaks, CA: Sage Publications, Inc.  
90. Skinner HA. The drug abuse screening test. Addictive behaviors. 1982;7(4):363-371. 
91. Yudko E, Lozhkina O, Fouts A. A comprehensive review of the psychometric properties of the Drug Abuse 
Screening Test. Journal of substance abuse treatment. Mar 2007;32(2):189-198. 
92. NGSES ref 
93. Centers for Disease Control and Prevention. Attitudes toward mental illness - 35 states, District of 
Columbia, and Puerto Rico, 2007. MMWR. Morbidity and mortality weekly report. May 28 
2010;59(20):619-625. 
94. Cooper-Patrick L, Powe NR, Jenckes MW, Gonzales JJ, Levine DM, Ford DE. Identification of patient 
attitudes and preferences regarding treatment of depression. J Gen Intern Med. 1997;12(7):431-438. 
95. Givens JL, Katz IR, Bellamy S, Holmes WC. Stigma and the acceptability of depression treatments among 
african americans and whites. J Gen Intern Med. Sep 2007;22(9):1292-1297. 
96. 
Chen, G., Gully, S. M., & Eden, D. (2001). Validation of a new general self-efficacy scale. 
Organizational Research Methods, 4(1), 62-83.97.  Eden, D. (2001). Means efficacy: External sources of 
general and specific efficacy. In M. Erez & 
       U. Kleinbeck (Eds.), Work motivation in the context of a globalizing economy (pp. 73-85). Mahwah, 
       NJ: Lawrence Erlbaum. 
98.  Henson, R. K. (2001). Understanding internal consistency reliability estimates: A conceptual primer on 
       coefficient alpha. Measurement and Evaluation in Counseling and Development, 34, 177-189. 
99.  Peterson, A. H., Fitchett, G., Brady, M. J., Hernandez, L., & Cella, D. (2002). Measuring spiritual well- 
       being in people with cancer: The functional assessment of chronic illness therapy – spiritual well-being     
       scale (FACIT-Sp). Annals of Behavioral Medicine, 24(1), p.49-58. 
100. Cella, D. (Ed.). (2004). Manual of the Functional Assessment of Chronic Illness Therapy 
        (FACIT) measurement system, Version 4.1. Evanston, IL: Center on Outcomes, Research and 
        Education (CORE) Evanston Northwestern Healthcare and Northwestern University.