Mindful Self Compassion for Combat Deployed Veterans With Moral Injury and Co-occurring PTSD-SUD
Phase: NA
Conditions: Substance Use Disorder, Post-traumatic Stress Disorder, Moral Injury
Sponsor: VA Office of Research and Development

 
 
Department of Veterans Affairs Internal Review Board 
Research Protocol  
Content Requirements for Full Committee Review 
 
 
 
Principal Investigator:  Erica M. Eaton, Ph.D.     
Department:  Mental Health and Behavioral Sciences Service (MHBSS) 
Study Title: Mindful Self-Compassion for combat deployed Veterans with Moral 
Injury and co-occurring PTSD-SUD.  
Funding Source (Sponsor):   Department of Veterans Affairs, Rehabilitation Research & 
Development 
Full Protocol Version Date:  08.15.18; 09.17.18; 10.19.18; 11.29.18, 4/29/19, 
06/11/19, 07/16/19, 05/18/20, 07/09/20, 08/16/20, 08/27/20, 
09/01/20, 10/14/20, 11/23/20  
Co-Investigators 
Christy Capone, Ph.D. 
Staff Psychologist, Providence VAMC, & 
Assistant Professor, Department of 
Psychiatry and Human Behavior, Brown 
University 
 
Tracie Shea, Ph.D. 
Staff Psychologist, Providence VAMC, & 
Assistant Professor, Department of 
Psychiatry and Human Behavior, Brown 
University 
J. Greg Serpa, Ph.D. 
Clinical Psychologist, Greater Los Angeles 
Healthcare System 
Whole Health Education Champion, Office 
of Patient Centered Care and Cultural 
Transformation 
Clinical Professor, UCLA Dept of Psychology 
 
 

 
 
Location of Study: 
All assessment and intervention sessions will be conducted at the Veterans Affairs Medical 
Center in Providence, Rhode Island.     
Time Required to Complete the Research: 
The project start date is 10/01/2018 and the study will continue until 09/30/2021 (with NCE). 
NCT Number: NCT03681288 
 
 
 
 

 
 
Contents 
 
1. 
Synopsis ......................................................................................................................................... 4 
2. 
Abbreviations and Acronyms ........................................................................................................ 4 
3. 
Introduction / Background * ........................................................................................................ 5 
4. 
Objectives * ................................................................................................................................. 10 
5. 
Study Methodology * .................................................................................................................. 11 
6. 
Study population ......................................................................................................................... 12 
7. 
Study procedure * ....................................................................................................................... 12 
8. 
Data Management * ................................................................................................................... 22 
9. 
Adverse Event Reporting ............................................................................................................ 24 
10. 
Statistical  Analysis .................................................................................................................. 25 
11. 
Quality assurance, monitoring & safety ................................................................................. 26 
12. 
Finance and resource use* ..................................................................................................... 27 
13. 
Dissemination of Results and Publication policy ................................................................... 28 
14. 
References * ............................................................................................................................ 32 
 
 
 
 

 
1. Synopsis 
 
PTSD-SUD is particularly common following combat exposure, and Veterans with PTSD-SUD 
experience more severe symptomatology, increased risk of suicidality, poorer quality of life, and 
poorer response to existing treatments than Veterans with either disorder alone. Combat 
Veterans often report experiencing moral injury defined as perpetrating, failing to prevent, or 
witnessing acts that violate the values they live by in their civilian lives. Veterans who negatively 
appraise their actions or inaction during combat may experience guilt, a common posttraumatic 
reaction. Posttraumatic guilt has been implicated as a risk factor for the development and 
maintenance of several forms of psychopathology including PTSD, SUD, depression, and 
suicidality.  
 
Mindful Self Compassion (MSC) combines the skills of mindfulness and self-compassion, 
providing self-soothing skills to respond to difficult thoughts and feelings. Self-compassion (SC) 
emphasizes kindness towards one’s self, a feeling of connectedness with others, and mindful 
awareness of distressing experiences. Furthermore, because SC is negatively associated with 
self-criticism, rumination, thought suppression, anxiety, and depression, and positively 
associated with healthy psychological functioning, it is well suited to addressing posttraumatic 
psychopathology, shame, and guilt. 
 
This proposal will begin to address a gap in the field’s knowledge about MSC, and its role in the 
treatment of co-occurring disorders in Veterans with moral injury. The study will recruit 48 
Veterans with PTSD-SUD and moral injury to participate in pilot groups of MSC. We will evaluate 
changes in self-compassion, post-traumatic guilt, shame, and PTSD and SUD symptom severity. 
In addition to symptom reduction, we will focus on functional outcomes (e.g., quality of life, 
suicidality).  
 
The specific aims of the proposed study are as follows: 1) to test acceptability and feasibility of 
MSC with Veterans with PTSD-SUD and moral injury, 2) to provide preliminary evidence of the 
effects of MSC, and 3) refine study procedures and make adaptations to MSC as applied to 
Veterans based upon experience gained in the pilot in preparation for a fully powered RCT to 
test the effectiveness of MSC.   
 
 
2. Abbreviations and Acronyms 
PTSD = Posttraumatic Stress Disorder 
SUD = Substance Use Disorder 
OEF/OIF/OND = Veterans of Operation Iraqi Freedom, Operation Enduring Freedom, and  
Operation New Dawn 
PE = Prolonged Exposure 
MSC = Mindful Self-Compassion  
SC = Self-Compassion 
SCFT = Self-Compassion Focused Treatment 
RCT = randomized control trial 

 
SEM = Standard Error of Measurement 
NCCIH = National Center for Complementary and Integrative Health  
DSM = Diagnostic and Statistical Manual 
CPT = Cognitive Processing Therapy 
CBT = Cognitive Behavioral Therapy 
IRB = Institutional Review Board 
 
 
 
3. Introduction 
 
3.1 Background, significance, rationale 
PTSD-SUD is common following combat exposure, affecting a rapidly increasing number of U.S. 
military Veterans (Petrakis, Rosenheck, & Desai, 2011). The co-occurrence of these disorders 
presents added challenges to the VA treatment delivery system, presently in need of effective 
integrated treatments. Veterans with PTSD-SUD experience more severe symptomatology, 
increased risk of suicidality, reduced quality of life, and poorer response to existing treatments 
than Veterans with either disorder alone (Maguen et al., 2010; Nash, 2007; Possemato, Wade, 
Andersen, & Ouimette, 2010). Furthermore, research examining Veterans of Operation Iraqi 
Freedom, Operation Enduring Freedom, and Operation New Dawn (OIF/OEF/OND) suggests that 
a significant number are at risk of poor community reintegration upon return home from 
deployment (Resnik & Allen, 2007). These findings underscore the need to effectively and 
efficiently address comorbidity in Veterans who present to treatment. 
 
One approach is to develop interventions that target mechanisms thought to underlie multiple 
highly prevalent disorders, such as guilt and shame related to traumatic experiences. The 
experience of a moral injury suggests the inability to contextualize or justify actions (or inaction), 
and the unsuccessful accommodation of those morally challenging events into pre-existing moral 
schemas, resulting in guilt and shame (Litz et al., 2009). Posttraumatic guilt has been implicated 
as a risk factor for the development and maintenance of several forms of psychopathology 
including PTSD, SUD, depression, and suicidality (Bryan, Morrow, Etienne, & Ray-Sannerud, 2013; 
Hendin & Haas, 1991; Hyer, McCranie, Woods, & Boudewyns, 1990; Litz et al., 2009; Sher, 
Braquehais, & Casas, 2012). However, to date, treatments for posttraumatic psychological health 
have been primarily disorder specific, with a focus largely on symptom reduction. Therefore, 
greater understanding of modifiable factors that influence PTSD-SUD and functional impairment 
is needed to enhance treatment efforts and aid the readjustment of war Veterans.  
Moral Injury is a Promising Target for Intervention. Combat soldiers face many moral and ethical 
challenges (Drescher et al., 2011; Litz et al., 2009). They may violate their own deeply held moral 
beliefs, witness the unethical behaviors of others, or question the justness of their country’s 
involvement in war. As a result, they may experience internal conflict between morally 
questionable actions and their beliefs. In addition, soldiers often witness intense human 
suffering and cruelty, thereby shaking many core beliefs about humanity (Worthington & 
Langberg, 2012). 

 
Litz and colleagues present a model of moral injury (Litz et al., 2009) highlighting the distress and 
difficulties commonly faced by combat Veterans. Initial empirical work exploring the potential 
causes of and consequences associated with moral injury suggest that the construct is distinct 
from the classic fear-based conception of trauma. In a qualitative study, findings indicated that 
the most commonly identified stressors that might precipitate a moral injury included betrayals 
(e.g., leadership failures, failure to act in accordance with one’s personal values), incidents 
involving injury or harm to civilians (e.g., killing, unnecessary destruction of property), within-
rank violence (e.g., friendly fire incidents), inability to prevent death/suffering, and ethical 
dilemmas/moral conflicts (Drescher et al., 2011). Likewise, just as potential causes of moral 
injury extend beyond threat to life, the potential indicators of moral injury also extend beyond 
anxiety and fear-based emotional responding (Flipse Vargas, Hanson, Kraus, Drescher, & Foy, 
2013). In addition to PTSD and mental health disorders routinely assessed in military 
populations, possible indicators of moral injury include disproportionate guilt and shame, social 
or relational issues (e.g., avoiding intimacy, anger, reduced trust in other people), 
spiritual/existential problems (e.g., loss of spirituality or weakened religious faith, lack of 
forgiveness), substance use, and suicide and other self-harm behaviors (Drescher et al., 2011; 
Flipse Vargas, Hanson, Kraus, Drescher, & Foy, 2013; Litz et al., 2009). 
Trauma-related guilt is highly prevalent and well-documented among military Veterans. In a 
Veteran sample with PTSD, 54% endorsed experiencing posttraumatic guilt in their lifetime, 35% 
reported being moderately to extremely bothered by these symptoms (Miller et al., 2013). Guilt 
has been shown to partially mediate the relationship between combat exposure and symptoms 
of PTSD and depression in Veterans (Browne, Evangeli, & Greenberg, 2012; Marx et al., 2010) 
and has been implicated as a risk factor for the development of multiple forms of posttraumatic 
psychopathology, including SUD (Dearing, Stuewig, & Tangney, 2005; Ianni, Hart, Hibbard, & 
Carroll, 2010; Kim, Thibodeau, & Jorgensen, 2011; Leskela, Dieperink, & Thuras, 2002; Marlatt & 
Donovan, 2005). Guilt related to trauma is also associated with suicidal ideation, particularly 
among combat Veterans (Bryan, Morrow, et al., 2013; Hendin & Haas, 1991; Hyer et al., 1990). 
Furthermore, shame has been robustly associated with substance use, anger, and aggression 
(Farnsworth, Drescher, Nieuwsma, Walser, & Currier, 2014). Several studies have found that 
shame is associated with higher risk for suicide in service members (Bryan, Ray-Sannerud, 
Morrow, & Etienne, 2013), even when controlling for concurrent depression and PTSD 
symptoms (Bryan, Morrow, et al., 2013). Numerous clinical descriptions of combat-related 
symptomatology specify shame and self-condemnation as a central source of dysfunction and an 
obstacle to recovery (Clewell, 1987; Haley, 1974; Singer, 2004). 
Treatment Targeting Guilt and Moral Injury is Needed. The VA-DoD Clinical Practice Guidelines 
for comorbid PTSD-SUD (Defense, 2010), and an Institute of Medicine report on treating PTSD in 
Veterans (Institute of Medicine, 2012) concluded that more research is needed to develop and 
evaluate treatments that address PTSD-SUD comorbidity. Currently, Seeking Safety (Najavits, 
2002) is the most widely implemented and available approach for co-occurring PTSD-SUD. 
Outcome findings, however, have been mixed and it has not outperformed treatment as usual in 
clinical trials (Hien, Cohen, Miele, Litt, & Capstick, 2004), including with Veteran samples (Bowen 
et al., 2014; Hien et al., 2009). If, as suggested by the self-medication hypothesis, avoidance and 

 
distress related to guilt and shame cognitions are contributing to substance use, resolution or 
amelioration of moral injury and associated guilt and shame may be necessary for substance use 
treatment to be fully effective. Current front-line interventions for trauma have shown efficacy 
in reducing PTSD in military samples (Eftekhari et al., 2013; Monson et al., 2006), but concerns 
about client drop-out, nonresponse rates, and the fit between the proposed therapeutic 
mechanisms and moral injury raise questions about the effectiveness of these interventions for 
all forms of trauma (Nash & Litz, 2013; Schottenbauer, Glass, Arnkoff, Tendick, & Gray, 2008). 
Further, posttraumatic guilt appears to be less amenable to change by exposure based 
treatments such as prolonged exposure (PE; Foa, Chrestman, & Gilboa-Schechtman, 2008) than 
other forms of posttraumatic distress and has been found to impede the processing of fear and 
other emotions related to traumatic events (Arntz, Tiesema, & Kindt, 2007; Brewin, Dalgleish, & 
Joseph, 1996; Foa & Meadows, 1997; Henning & Frueh, 1997; Mills et al., 2012; Nishith, Nixon, & 
Resick, 2005; Pitman et al., 1991; Riggs, Dancu, Gershuny, Greenberg, & Foa, 1992). 
Consequently, trauma-related guilt and shame may continue to burden Veterans who struggle 
with PTSD and potentially prevent them from being able to recover (Kubany & Watson, 2003).  
Therefore, there is a need for additional and complementary therapeutic options targeting 
trauma-related moral emotions such as guilt and shame. These emotions are highly distressing, 
challenging to treat, and associated with poorer psychosocial function and maintenance of 
multiple disorders including PTSD-SUD. A recent review (Farnsworth et al., 2014) of the moral 
injury literature suggests that as a complement to evidenced-based treatment approaches, 
interventions that promote mindfulness and target the elicitation of positive moral emotions 
(e.g., self-compassion) may work to improve spiritual, social, and psychological functioning by 
promoting tolerance and adaptive responses to negative emotional states (Gilbert, 2009; Hayes, 
Strosahl, & Wilson, 2011; Neff & Germer, 2013). 
3.2 Mindful Self-Compassion 
Mindful Self-Compassion (MSC; Neff & Germer, 2013) is an 8-session group program that 
combines the skills of mindfulness and self-compassion (SC), utilizing self-soothing skills to 
respond to difficult thoughts and feelings with kindness, sympathy, and understanding through 
meditation. A growing body of research has documented the beneficial effects of directing 
compassion toward oneself, a process that Neff describes as “being touched by and open to 
one’s own suffering, not avoiding or disconnecting from it, generating the desire to alleviate 
one’s suffering and to heal oneself with kindness” (p. 87; Neff, 2003).  MSC is negatively 
associated with aversive emotions, including guilt and shame (Gilbert & Procter, 2006), self-
criticism, rumination, thought suppression, anxiety, and depression in the general population. In 
addition, SC is positively associated with healthy psychological functioning (e.g., overall life 
satisfaction; MacBeth & Gumley, 2012; Neff, 2012; Neff, Rude, & Kirkpatrick, 2007). MSC is 
therefore well suited to address moral injury, negative moral emotional states (e.g., guilt and 
shame) and poor psychosocial functioning among Veterans (Section 7.6 and Appendix D describe 
the components of the intervention). 
Role of MSC in PTSD-SUD Treatment. Mindfulness and SC are overlapping but distinct constructs 
that characterize how people relate to emotional distress. MSC combines the awareness of 
mindfulness and the self-soothing qualities of SC to bring attention to and tolerate difficult 

 
emotions. The overarching philosophy is that individuals need mindfulness to be self-
compassionate; one has to be aware that one is suffering while one is suffering, otherwise there 
cannot be a compassionate response. In other words, mindfulness can be viewed as the first step 
in learning to be more self-compassionate. Self-compassion comes next and is the emotional 
attitude of mindfulness in the face of suffering. Whereas mindfulness training orients the 
practitioner to moment-to-moment experience, compassion training focuses on the experiencer. 
Both mindfulness and SC allow one to live with less resistance to oneself and one’s life (C. 
Germer, personal communication, July 2016). 
Recent literature links both mindfulness and SC with improvement in multiple life domains (Neff, 
2012), reduced emotional stress (Gilbert & Procter, 2006; Neff, 2012), and lower levels of 
psychopathology (MacBeth & Gumley, 2012), including reduced levels of shame and self-
criticism among clinical and general cohorts (Albertson, Neff, & Dill-Shackleford, 2015; Gilbert & 
Procter, 2006; Leaviss & Uttley, 2015; Shahar et al., 2015). SC has also been shown to be a 
modifiable trait for civilians and Veterans that can increase via SC focused programs (Gilbert & 
Procter, 2006; Kearney et al., 2013; Neff & Germer, 2013); as well as mindfulness-based 
programs (Kuyken et al., 2010; Shapiro, Astin, Bishop, & Cordova, 2005; Shapiro, Brown, 
Thoresen, & Plante, 2011). MSC is a promising treatment for guilt, shame, and experiential 
avoidance, mechanisms that can impede PTSD and SUD treatment and successful reintegration 
of Veterans, and thereby has the potential to bolster treatment outcomes. Further, research 
suggests that self-compassion serves as a buffer to negative emotion while simultaneously 
encouraging taking responsibility for personal failures (Leary, Tate, Adams, Batts Allen, & 
Hancock, 2007). Thus, MSC may be ideally suited for work with moral injury in that it does not 
require acquittal from personal culpability in order to provide benefits. Given the complexity of 
Veterans presenting with PTSD-SUD, treatment often involves a multi-pronged approach. MSC is 
promising as an addition to treatment programs or for non-responders to trauma-focused 
treatments. 
Mindfulness and SC have been associated with reduced experiential avoidance among civilian 
(Keng, Smoski, Robins, Ekblad, & Brantley, 2012) and Veteran (Vujanovic, Niles, Pietrefesa, 
Schmertz, & Potter, 2013) samples, a mechanism associated with the maintenance of PTSD-SUD 
symptoms (Foa, Steketee, & Rothbaum, 1989; Held, Owens, Schumm, Chard, & Hansel, 2011; 
Tangney, Stuewig, & Mashek, 2007), and shame (Kubany & Watson, 2003). SC has been 
associated with a greater willingness to engage painful emotions and a lower need to avoid 
painful experiences (Leary et al., 2007; Neff et al., 2007). Individuals high in SC may be less likely 
to feel threatened by and, therefore, avoid painful thoughts, memories, and emotions. Instead, 
they may be more likely to experience a natural process of exposure to trauma-related stimuli 
(Vujanovic et al., 2013). Additionally, SC practice may activate the innate soothing and self-
regulating functions (Gilbert, 2014), which, in turn, helps balance the overactive threat system 
commonly observed with posttraumatic stress (Lee & James, 2013).  
Regarding substance use, there is evidence to suggest lower levels of mindfulness, and SC among 
those with alcohol use disorders than the general population (Brooks, Kay-Lambkin, Bowman, & 
Childs, 2012), indicating that increasing mindfulness and SC may aid in reducing the reliance on 
substances to avoid negative affect and psychiatric symptoms. Indeed, research indicates that 

 
civilian participants with substance use disorder who received mindfulness-based relapse 
prevention exhibited significantly lower risk of relapse to substance use and heavy drinking and, 
among those who continued to use substances, significantly fewer days of substance use and 
heavy drinking at the 6-month follow-up (Bowen et al., 2014).  
Mindfulness & Self-Compassion Treatment with Veterans. Few studies have directly examined SC 
treatment among Veterans; however, preliminary findings suggest that SC is a modifiable and 
teachable trait in this population (Held & Owens, 2015; Kearney et al., 2013). In an uncontrolled 
treatment study, a sample of 42 Veterans with PTSD completed a 12-week loving-kindness 
meditation course designed to facilitate feelings of compassion for self and others. SC was 
negatively associated with total symptom severity, and participants reported increases in SC and 
decreases in PTSD symptoms at posttreatment and 3-month follow-up. Moreover, changes in SC 
mediated the reduction in PTSD symptoms, suggesting that compassion may serve as a 
mechanism for moral repair (Kearney et al., 2013).  
Similarly, significant associations were found among mindfulness and SC with PTSD symptom 
severity and functional disability in 115 trauma-exposed Iraq and Afghanistan Veterans (Dahm et 
al., 2015). Results indicated that mindfulness and SC were each uniquely, negatively associated 
with PTSD symptom severity and functional disability. 
Another study examined the concurrent and prospective relationship between SC and PTSD 
symptom severity after accounting for level of combat exposure and baseline PTSD severity 
(Hiraoka et al., 2015). SC was negatively associated with baseline PTSD symptoms and predicted 
12-month PTSD symptom severity after accounting for combat exposure and baseline PTSD 
severity. Findings suggest that SC is a potentially modifiable factor implicated in the 
development and maintenance of PTSD and that interventions that increase SC may be 
beneficial for treating chronic PTSD symptoms in Veterans. 
Finally, one study examined the effects of a 4-week self-administered SC training on trauma-
related guilt in comparison to a stress-inoculation control group in 47 homeless male Veterans 
(Held & Owens, 2015). Participants in both interventions reported increased levels of SC and 
equal reductions in trauma-related guilt, providing preliminary evidence for the use of SC and 
stress-inoculation as effective interventions for guilt.  
 
In sum, a small but growing body of research indicates that mindfulness and SC have theoretical 
relevance for understanding moral injury and associated guilt and shame, as well as the 
development and maintenance of PTSD and substance use in war Veterans.  
3.3 Summary and Significance  
Use of alternative therapies in the treatment of Veterans is an area of increased interest within 
the VA (US Dept of Veteran Affairs, 2011), and a 2016 objective of the National Center for 
Complementary and Integrative Health (NCCIH) is to conduct studies in “real world” clinical 
settings to test the safety and efficacy of complementary health approaches (NCCIH, 2016). 
Veterans with co-occurring PTSD-SUD are more likely to have increased psychiatric symptoms, 
medical problems, social and family problems, unemployment, suicidality and poorer treatment 

 
compliance (Brown, Recupero, & Stout, 1995; McGovern, June 2005; Najavits et al., 2007; P. 
Ouimette, Moos, & Finney, 2003; P. C. Ouimette, Finney, & Moos, 1999; Read, Brown, & Kahler, 
2004). Services researchers have also tracked higher residential, inpatient, and other treatment 
utilization (Calabrese et al., 2011; Edens, Kasprow, Tsai, & Rosenheck, 2011). Posttraumatic guilt 
and shame have been linked to several forms of psychopathology and distress, including PTSD 
and SUD. MSC has been shown to reduce key symptoms of posttraumatic symptomology, 
including avoidance, rumination, depression, anxiety, and overall distress.  However, MSC has 
not been examined in Veterans thus far. There have been a handful of VAs nationally that have 
initiated the implementation of MSC among Veterans (G. Serpa, personal communication, 
February 2018), however the program has not been systematically evaluated and there has been 
no data published to date. This intervention has the potential to improve outcomes for Veterans 
with moral injury and add to existing options for practitioners to more effectively help their 
patients with this challenging comorbidity. If, as hypothesized, MSC leads to increased SC, and 
reductions in posttraumatic guilt, shame, this would reduce burden and stress on Veterans, 
caregivers, and healthcare systems. Given the chronicity of symptoms for Veterans with PTSD-
SUD and the need for alternative and integrated treatment approaches for co-occurring 
disorders, this study represents an innovative and significant contribution to the field.  
 
 
4. Objectives * 
 
Our objective is to conduct a Stage I study of MSC with Veterans with co-occurring PTSD-SUD. 
The primary goals of this project are to conduct a pilot study of MSC with Veterans with PTSD-
SUD within a group modality and evaluate changes in self-compassion, post-traumatic guilt, 
shame, and PTSD and SUD symptom severity. In addition to symptom reduction, we will focus on 
functional outcomes (e.g., quality of life, suicidality). The specific aims of the proposed study are 
as follows:  
 
1. To test acceptability and feasibility of MSC with Veterans with PTSD-SUD and moral injury as 
indicated by recruitment, retention rates, and participant feedback.  
2. To provide preliminary evidence of the effects of MSC. We hypothesize that: 
2a. Participants will endorse increased self-compassion, and reduced posttraumatic guilt 
and shame following MSC. 
2b. Participants will report improved quality of life, lower PTSD and depressive 
symptoms, and greater percent days abstinent (PDA) post-treatment and at follow-up 
after completing MSC. 
3. EXPLORATORY AIM: Suicidality. We hypothesize that MSC will decrease suicidal ideation. This 
aim will be evaluated descriptively by examining clinically meaningful change pre- to post-
treatment. 
4. To refine study procedures and make adaptations to MSC as applied to Veterans based upon 
the experience gained in the pilot in preparation for a fully powered RCT to test the effectiveness 
of MSC. 

 
5. Study Methodology * 
 
5.1 Overview of Design 
This project will use a non-randomized, longitudinal design to conduct a pilot trial of MSC with 
Veterans who endorse moral injury and are presenting for PTSD-SUD treatment. We will recruit 
48 eligible Veterans who will be consented in person. They will then complete their baseline 
assessment with a trained clinician by their choice of in person, via VA Video Chat, Zoom for 
Healthcare or by telephone and attend 8 sessions of MSC group format with trained clinicians. In 
general, groups will be held in person in the PVAMC. During the time of the COVID-19 pandemic, 
groups will be held virtually via VA Video Chat (VVC) or Zoom for Healthcare. Participants will 
complete follow-up assessments at post-treatment, and 1-month follow-up virtually via VA Video 
Chat (VVC), Zoom for Healthcare, or by telephone (see Table 1). Participants will also have the 
option to complete the self-report measures during baseline, follow-up (post-treatment and 
one-month), and process assessments (during group) through Qualtrics. Qualtrics will be used 
for self-report measures only and will include the following measures:  PCL, SCS, CSQ, ISS, TRGI, 
IES, TRSI, Qual-LIFE, WHODAS, and PHQ. The same procedures will be used for Qualtrics across 
all time points including baseline, process measures during group, post-treatment and one-
month follow up. We will gather feedback from participants in order to guide potential 
refinement of the MSC protocol for further study. 
5.2 Setting and Feasibility of Recruitment 
The PVAMC is the site for the proposed research and includes specialized outpatient programs in 
PTSD and substance use. During fiscal year 2013, approximately 3,600 Veterans with a primary 
or secondary diagnosis of PTSD received outpatient mental health services at PVAMC. It is 
estimated that the prevalence of co-occurring PTSD-SUD among treatment-seeking Veterans 
with PTSD is approximately 40% (Milliken, Auchterlonie, & Hoge, 2007; Thomas et al., 2010). We 
further estimate that between 27%-36% of Veterans with PTSD-SUD will endorse significant 
moral injury based on current research examining posttraumatic guilt in Veterans with PTSD and 
alcohol use disorder (S. Norman, personal communication, May 29, 2015). These numbers are 
more than sufficient to meet our recruitment goals (N=48). We estimate that we will need to 
assess approximately 48 Veterans (20% more than our target sample) in order to allow for those 
who may be ineligible or will discontinue participation after the initial evaluation. At the 
expected rate of 2-3 participants per month, the timeline for recruitment is approximately 12 
months. We are aware of the difficulties in recruitment for this population and acknowledge that 
long waitlists can lead to dropout. As such we have elected to have smaller groups (4 groups of 6 
members) in order to minimize wait time. 
 
5.3 Experimental condition - MSC Program 
MSC (Neff & Germer, 2013) is an 8-session group program designed to teach SC and mindfulness 
skills. For the purposes of this study, we elected to include the original MSC protocol unchanged 
as a first step to investigate its feasibility among Veterans with PTSD-SUD. The MSC program 
includes 2 core meditations, 9 additional meditations, and 18 informal SC practices. The ultimate 
goal is to be in the presence of personal suffering with a sense of safety, so that the pain is felt 
and the process of healing can begin. Participants are encouraged to be experimental in how 

 
they adapt the practices to their own lives. MSC sessions will highlight the three interacting 
components of SC: 1) self-kindness versus self-judgment, 2) a sense of common humanity versus 
isolation, and 3) mindfulness versus over-identification when confronting painful thoughts and 
emotions. Each session of the program focuses on a specific topic as well as formal and informal 
SC exercises (See Appendix D). In order to be considered as receiving a sufficient dose of 
treatment, participants must attend at least 5 of the 8 sessions.  
6. Study population 
 
6.1 Participants 
We will recruit 48 Veterans who endorse moral injury and co-occurring PTSD-SUD (4 groups of 6 
- 12 each) enrolled at the Providence VA Medical Center. Potential subjects will be receiving 
PTSD or substance use treatment services at the PVAMC, and will be referred by clinicians in 
these respective clinics (or self-refer) for participation in the study.  
Eligibility criteria were designed to recruit a representative sample of Veterans with co-occurring 
PTSD-SUD. Eligible participants will be enrolled at the Providence VA Medical Center:  
Inclusion criteria:  
1) moral injury as captured by at least one “strongly agree” response on the Moral Injury 
Events Scale;  
2) diagnosis of PTSD (within the last 30 days) confirmed by the Clinician Administered PTSD 
Scale (CAPS) with a total symptom score of 25 or more;  
3) diagnosis of a substance use disorder confirmed by the Structured Clinical Interview for 
DSM-5 Section E (SCID-E);  
4) willing and able to provide informed consent.  and  
5) not currently receiving trauma-focused treatment.  
 
Exclusion criteria:  
1) individuals with an acute psychotic disorder or acute psychotic symptoms are not eligible 
if their symptoms are unstable and if they are not well connected with appropriate 
mental health services;  
2) patients with a psychiatric hospitalization or suicide attempt within the past month will 
be excluded; and  
3) Currently receiving trauma-focused treatment (e.g., PE, CPT, CBT for PTSD). Patients 
currently enrolled in trauma-focused treatment may be enrolled when they have 
completed the treatment if they remain interested and continue to have PTSD.  
4) individuals with life-threatening or unstable medical illness. Diagnoses of mild cognitive 
impairment (e.g. mTBI) and other anxiety and depressive disorders will not be excluded 
because of their high comorbidity with PTSD and SUD.80  
 
7. Study procedure * 
 
7.1 Recruitment, Screening, and Informed Consent Procedures 

 
Recruitment Procedures. Participants will be recruited from a range of sources. The primary 
recruitment source will be the Providence VA Medical Center, including the OEF/OIF/OND 
specialty primary care clinic, the Returning Veterans Outreach Program, Collaborative Addiction 
and Recovery Service (CARS), and the Trauma Recovery Service (TRS). Drs. Shea, Capone and 
Eaton are members of the TRS clinic staff and will coordinate efforts with the appropriate mental 
health staff to refer patients to the study. The current TRS clinic caseload includes close to 1800 
Veteran with PTSD, average of 7-8 referrals per week. Thus, the PVAMC has a very large pool of 
potential participants for recruitment. Study participants will also be recruited through outreach 
efforts to local Vet Centers and CBOC’s, military family organizations, community-based troop 
support organizations, and Veteran organizations.  
 
A recruitment flyer and brochure will be designed to reach eligible veterans. Included on this 
flyer and brochure is contact information for the project coordinator. Flyers and brochures will 
be distributed in the PVAMC mental health clinics and available to view on clinic television monitors. 
Additionally, flyers will be posted on the Providence VA Medical Center’s Facebook page, sent out 
electronically via MyHealthEVet and to those people who follow the PVAMC’s Twitter account. All 
postings will be sent electronically by the PVAMC’s Public Relations Officer who has approved all newly 
proposed recruitment methods pending the PVAMC’s Institutional Review Board (IRB)’s approval. 
Language to be used on Twitter by the PVAMC’s Public Relations Officer will be approved by the 
PVAMC’s IRB as well. 
Screening Procedures. Potential subjects will be receiving or presenting to care for PTSD, 
substance use or other mental health services and will be referred for participation by clinicians 
providing those services. Additionally, Veterans may self-refer via posted flyers.  
 
If interested, potential participants will have the option of signing a form giving permission to the 
investigators to contact them, or they can contact the investigators directly. In addition, should the 
referral come directly from the potential participant’s provider (without the form providing 
permission to contact), potential participants will be sent a recruitment letter (see Appendix A) notifying 
them that the study coordinator will be contacting them by phone to invite them to participate in a 
phone screening for the study. Approximately one week after the recruitment letter is sent, the project 
coordinator will contact potential participants by telephone (see phone script, Appendix B) to provide 
information that will enable potential participants to decide whether they want to be considered for the 
study (i.e., purpose of the study, description of the intervention condition, audio recording of sessions, 
time commitment required for both treatment and assessment, and schedule of payments).  
 
The project coordinator will review the patient’s electronic medical record to screen for broad 
eligibility criteria (e.g., absence of psychotic disorder diagnosis or suicide attempt in the last 
month) and chart diagnoses (we will obtain a waiver of written informed consent in order to 
screen referred Veterans’ medical charts to determine preliminary eligibility, i.e., PTSD 
symptoms, substance use).  

 
Interested and eligible individuals will obtain an appointment with the project coordinator. During 
this next stage of screening, interviewers will review the Informed Consent forms to explain the 
study in greater detail.  
Informed Consent Procedures. The participant will be fully informed of the nature and extent of 
study participation, the objectives of the study, and the MSC intervention. Participants will also be 
informed about the follow-up assessments they will complete. Participants will be given as much 
time as they need to review the consent form, to ask questions as needed, and to make a 
decision as to whether or not to participate. Participants will be told that they may refuse 
participation without any negative consequences, and that if they decide to participate, they will 
be free to withdraw from the study at any time.  Informed consent is considered an ongoing 
process and members of the research team will regularly answer questions about the study and 
inquire about the subject’s experience as a participant throughout the duration of the study.   
The project coordinator and evaluators will be trained to ensure that participants comprehend the 
study and the consent form and willingness to adhere to study conditions. Potential participants 
will sign the consent and receive a copy to take home. 
Consent visits will be held face-to-face following the COVID-19 precaution guidelines including 
social distancing and proper PPE equipment (e.g., face masks). All consent procedures will take 
place in Building 32 at the Providence VA Medical Center. After reviewing the consent form, the 
interviewer will ask the participant if they are interested in proceeding with the next phase of 
screening to determine if s/he meets all study inclusion/exclusion criteria. If s/he is willing to 
proceed s/he will also be asked to sign a HIPAA authorization form.  
Once the consent procedures are complete, participants may elect to continue with the initial 
assessment in-person or remotely via video (VVC or Zoom) or via telephone. The screening 
assessment takes about 2-3 hours and is done by a trained interviewer. 
Initial Screening Assessment 
• The interviewer will ask you questions about your stressful life experiences and related problems, 
your use of alcohol and drugs, and your mood. 
• The interviewer will also ask you about current and past mental health treatments you may have 
received, including medications. 
• You will receive compensation in either a $50 gift card or electronic funds transfer (EFT) for your 
time after the interview is done. 
• If you are eligible for the study based on these questions, you will go on to the next step in the 
study. If you are not eligible, you will be finished with the study. We will refer you back to your 
treatment providers at the VA for continued treatment. 
In the final stage of screening, assessors will complete interviews to establish inclusion and 
exclusion criteria, as described below (see Measures). Participants that do not meet the inclusion 
criteria will be referred back to their current treatment providers at PVAMC. Participants 

 
providing informed consent and meeting inclusion/exclusion criteria as confirmed by the 
baseline will be scheduled for an initial MI session (see Appendix E) with a study therapist and 
then will be assigned to receive 8 sessions of MSC. If participants are determined to be ineligible, 
they will not complete the MI session, nor be assigned to MSC.  
 
For this study, participants will not be randomly assigned to treatment condition; all eligible 
subjects will receive MSC in a group format facilitated by MSC certified teachers (TBD).   
With the exception of participating in trauma-focused treatments, participants may continue to 
receive their existing mental health services (e.g., medication management, skills-based groups) 
and we will carefully track these throughout their involvement in the study.  
All participants will be assessed immediately post-treatment and at 1-month follow up. 
Participants will be compensated for time spent completing the three assessments and will 
receive $50 for each assessment in the form of gift cards to local stores (e.g., CVS) or Electronic 
Funds Transfer (EFT) per assessment. We anticipate that the baseline assessment will take 
approximately 2.5-3 hours and follow-ups will take approximately 2 hours to complete. We will 
attempt to obtain follow-up data on all participants, regardless of whether or not they complete 
the intervention portion of the study.  
7.2 Measures 
If informed consent is granted, the participant will be interviewed by an on-site member of the 
research team for the baseline assessment. If the subject continues to meet eligibility criteria 
(i.e., PTSD and SUD diagnoses are confirmed), he or she is invited to continue participation in the 
study. In either case, the subject receives a $50 gift card for completing the baseline interview. 
All assessment measures are described below and summarized in Table 1. 
Table 1. Measures by assessment point 
 
Baseline 
During TX 
(wkly) 
Post-TX 
FU 
1M FU 
Feasibility Assessments 
Client Satisfaction Questionnaire 
 
 
X 
 
Home SC Practice 
 
X 
X 
X 
Self-Compassion 
Self-Compassion Scale 
X 
X 
X 
X 
Impact of Event: Avoidance Subscale 
X 
 
X 
X 
Guilt/Shame and Moral Injury 
Trauma-Related Guilt Inventory 
X 
 
X 
X 
Internalized Shame Scale  
X 
 
X 
X 
Trauma Related Shame Inventory 
X 
 
X 
X 
Moral Injury Questionnaire 
X 
 
 
 
Moral Injury Events Scale 
X 
 
 
 
Quality of Life & Functioning  

 
Quality of Life Enjoyment and 
Satisfaction Questionnaire 
X 
 
X 
X 
The WHO Disability Assessment 
Schedule  
X 
 
X 
X 
PTSD & SUD Assessments 
Clinician Administered PTSD Scale  
X 
 
X 
X 
PTSD Checklist 
X 
X 
X 
X 
SCID Substance use disorders section 
X 
 
 
 
Timeline Follow-Back 
X 
 
X 
X 
Full Combat Exposure Scale 
X 
 
 
 
Exploratory Aim 
Beck Scale for Suicidal Ideation  
X 
 
X 
X 
Screening & Control Measures 
Demographics 
X 
 
 
 
Treatment Services Received 
X 
 
X 
X 
Patient Health Questionnaire 
X 
 
X 
X 
COVID-19 Measure  
X 
 
X 
X 
 
Feasibility Assessments: 
Client Satisfaction Questionnaire (Larsen, Attkisson, Hargreaves, & Nguyen, 1979): an 8-item 
questionnaire assessing treatment satisfaction.  
Rates of recruitment, retention, and attendance will also be used as measures of feasibility.  
Home SC Practice: will be assessed by self-report of type, frequency, and duration.  
 
Self-Compassion Outcomes: 
Self-Compassion Scale(Neff, 2003): is a 26-item self-report questionnaire in which respondents 
describe how they relate to themselves during times of distress. Higher scores reflect higher 
levels of SC.  
Impact of the Event (Avoidance)-Revised(Weiss & Marmar, 1997): Used to measure avoidance of 
difficult thoughts and feelings.  
 
Guilt, Shame and Moral Injury Outcomes: 
Trauma-Related Guilt Inventory (Kubany et al., 1996): is a 32-item self-report measure assessing 
traumatic guilt. The TRGI has three scales—Global Guilt, Distress, and Guilt Cognitions.  
Internalized Shame Scale (Cook & Coccimiglio, 2001): is a 30-item self-report measure assessing 
shame proneness scored on a 5-point Likert scale. The ISS yields sum scores for two subscales, 
self-esteem and internalized shame.  
Trauma Related Shame Inventory (Øktedalen, Hagtvet, Hoffart, Langkaas, & Smucker, 2014): is a 
24-item measurement instrument that assesses for shame within the context of trauma.  
Moral Injury Questionnaire-Military Version (Currier, Holland, Drescher, & Foy, 2015): assesses a 
comprehensive range of moral injury events that might occur in warzone deployments. The 
measure covers several different types of betrayals (i.e., by peers, leadership, trusted civilians, or 
self), acts of disproportionate violence in the warzone (e.g., acts of revenge and/or retribution, 

 
unnecessary destruction of civilian property), incidents involving death/harm to civilians, acts of 
violence committed within military ranks (i.e., friendly fire incidents), inability to prevent 
death/suffering, and ethical dilemmas or moral conflicts from deployment-related 
decisions/actions (e.g., violating rules of engagement to save the life of a comrade or civilian.  
Moral Injury Events Scale (Nash et al., 2013): The MIES is a 9-item scale measuring exposure to 
events in a military context with the potential to contradict deeply held moral beliefs and yields 
two subscales: 1) perceived transgressions and 2) perceived betrayals. Participants rate their 
agreement/ disagreement to each situation on a scale of 1 = strongly disagree to 6 = strongly 
agree.  
 
Quality of Life and Psychosocial Functioning Outcomes:  
Quality Of Life Enjoyment & Satisfaction Questionnaire (Endicott, Nee, Harrison, & Blumenthal, 
1993): is a validated self-report measure that includes 8 subscales examining a variety of 
domains. The 16-item General Activities sub-scale will be used to measure perceptions of 
satisfaction with daily life.  
The World Health Organization Disability Assessment Schedule (Üstün, 2010): is a 26-item self-
report measure of functional disability in the past 30 days. It provides a total score based on six 
domains: mobility, self-care, cognition, getting along with others, participation in society, and life 
activities.  
PTSD and SUD Assessments: 
Clinician Administered PTSD Scale for DSM-5(CAPS-5; Weathers et al., 2013) will be 
administered to assess diagnostic criteria for PTSD. Participants must meet criteria on this 
measure, considered the “gold standard” for PTSD diagnosis, to be eligible for the study. 
Participants must also have a total score of 23 or greater, which constitutes at least a moderate 
(or clinically significant) level of symptom severity. The follow-up version will be used at post-
treatment and at 1-month follow-up as a primary measure of outcome.  
Structured Clinical Interview Patient Edition, Section E (SCID; First et al., 1996): For the present 
study, DSM-5 version of the SCID, Section E, will be administered at baseline to assess for the 
presence of current (past three months), severe substance use disorder (SUD) and alcohol use 
disorder (AUD).  Diagnostic information from the SCID-I/P will be used to assess eligibility criteria 
as well as for descriptive purposes. 
PTSD Checklist (PCL-5; Weathers et al., 2013) is a 20-item self-report measure that assesses 
DSM-5 symptoms of PTSD and PTSD symptom severity on a 5-point scale. The self-report rating 
scale is 0-4 for each symptom, from “Not at all” to “Extremely.” We will use this measure to track 
PTSD symptoms throughout treatment.  
Timeline Follow-back (Sobell & Sobell, 1992): gathers self-report information about alcohol and 
other substance use for the past 90 days.  
Full Combat Exposure Scale (Hoge et al., 2004): is an18-item measure designed to assess a range 
of combat elements (e.g., receiving small arms fire, provided aid to wounded). Participants rate 
their frequency of exposure to each situation on a scale of 0 = never to 4 = 10 or more.  
 
Exploratory Aim Assessment: 

 
Beck Scale for Suicidal Ideation (Beck & Steer, 1991): is a 21-item self-report of current (past 
week) intensity of attitudes, behaviors, and plans to commit suicide.  
Screening and Control Measures:  
Demographics: Basic demographics (e.g., age, gender, race/ethnicity) will be collected at the 
baseline assessment as well as military service information (e.g., branch of service, rank, number 
of deployments).  
Treatment Utilization (Keller et al., 1987):  The Longitudinal Interval Follow-Up Assessment (LIFE) 
treatment section provides information about mental health and medical treatments, including 
number of hospitalizations, days spent in hospital, and number of outpatient visits for non-
mental health medical treatments, mental health contacts, including inpatient and outpatient 
treatment, and psychiatric medications, including dosages. A baseline version (LIFE-Base) 
assesses mental health treatment received prior to entering the study. We will adapt the LIFE-
Base to assess whether prior treatment focused specifically on PTSD or substance use. The LIFE 
treatment section will be administered at post-treatment and at the 1-month follow-up 
assessments to track any non-study treatment received.  
Patient Health Questionnaire (PHQ; Spitzer et al., 1999) self-administered 9-item survey 
assessing severity of depressive symptoms. This self-report measure will be used to track 
symptoms that are commonly comorbid with PTSD and expected to change along with PTSD.   
Coronavirus Stressor Survey (COVID-19; McLean & Cloitre, 2020) self-administered 10-item 
survey assessing different levels of stressful experiences related to the ongoing coronavirus 
pandemic. is a survey will be used to determine stressors patients face during the coronavirus 
pandemic? This assessment will be given at all assessment timepoints 
  
Process Assessments. During treatment, MSC teachers will administer the Home SC Practice and 
the PTSD Checklist (PCL), and the Self-Compassion Scale (SCS) to each participant every week in 
order to regularly assess severity of PTSD symptoms, level of self-compassion and home practice. 
Regular assessment of symptoms will help inform treatment directions and track symptoms over 
the course of treatment. During the COVID-19 pandemic, these weekly assessments will be 
completed either over the telephone or via a Qualtrics survey. Qualtrics surveys will be 
preferable as they reduce burden on staff and participants. All participants will be asked if they 
are comfortable receiving a Qualtrics survey to complete self-reported assessments, and if not, 
will continue to complete assessments over the telephone. Qualtrics is accessed through Brown 
University credentials and is a HIPAA compliant platform. The surveys within Qualtrics for 
process assessments will include the PCL and SCS. Participants will be sent their own participant-
specific link to the survey. The links will be sent to the participant’s email by study staff using 
their secure VA email accounts only. Furthermore, participants will be informed that: “This link 
cannot be forwarded to others, it is unique to your study ID number” in the email containing the 
link to the survey. They will be reminded to keep all study communications confidential and to 
complete the survey in privacy. When participants fill out the surveys, the data comes back to 
the website, only linked to their unique study ID. See section 8.1 for details about Qualtrics data 
security. 
 

 
Follow-up Assessments. Upon completion of the treatment sessions, the participants will again 
be interviewed by a member of the research team (i.e., post-treatment follow-up and one-
month follow-up). The post-therapy assessment will consist of the Client Satisfaction Survey, 
Home SC Practice, SCS, Impact of the Event, Avoidance Subscale, TRGI, ISS, QoL, WHO, CAPS, 
PCL, TLFB, BSSI, Treatment Services Received, PHQ-9. The subject is compensated in the form of 
a $50 gift card for completing the assessment. All research activities, including all assessments 
and therapy sessions will be conducted on-site at the Providence VA Medical Center. During the 
COVID-19 pandemic, follow-up assessments will be completed remotely via telephone or Zoom. 
Participants will also have the option to complete the self-report assessments during follow-ups 
through Qualtrics. For follow-ups, assessments within Qualtrics would include PCL, SCS, CSQ, ISS, 
TRGI, IES, TRSI, Qual-LIFE, WHODAS, and PHQ. The same process used for Qualtrics during the 
group assessments would be used for the follow-up assessments. 
 
Intervention Feedback and Post-Intervention Exit Interviews 
During week 4 and at the end of the MSC intervention, participants will complete questionnaires 
assessing the perceived usefulness and comprehension of MSC modules and the appropriateness 
of the daily home practice assignment. At the conclusion of the 8-week MSC intervention, 
participants will also complete a brief satisfaction measure, as well as a semi-structured qualitative 
exit interview conducted by either Drs. Capone or Eaton. The interview will be used to collect 
further information regarding the perceived usefulness and applicability of MSC. Further, to 
determine the safety, feasibility and acceptability of the intervention, we will examine adherence 
to intervention sessions, percent of completed home practice logs, dropout rates, and adverse 
events. Dr. Eaton, along with co-investigators will consult regularly to review and discuss 
participant feedback and exit interview responses and consider potential modifications to the MSC 
intervention. 
 
7.3 Assessor Training and Evaluation 
The project assessor will complete standardized training to criterion for the CAPS, SCID and 
TLFB assessments. Training will be conducted by Dr. Capone. The assessor will observe a 
minimum of two assessments for each measure and then be observed for a minimum of two 
assessments. The assessor will not complete assessments until achieving at least .80 interrater 
reliability on practice assessments. During the study, a random sample (20%) of audio 
recordings will be independently evaluated by Dr. Capone on a monthly basis to provide 
feedback and evaluate interrater reliability. The assessor’s ratings will be compared with Dr. 
Capone’s ratings and any discrepancies in ratings will be discussed. 
 
7.4 Procedures to Enhance Completion of Assessment Protocols 
A number of procedures will be used to minimize the likelihood that participants will fail to 
complete the schedule of assessments. Self-report measures will be completed at the time of 
the assessment and reviewed for completeness before the participant leaves. We will monitor 
carefully for fatigue and encourage breaks if needed. We will obtain the name and phone 
number of a close relative, friend, or other person who is likely to maintain contact with the 
participant, and to contact that person if attempts to contact the participant are unsuccessful. 
Post-treatment and the 1-month follow-up assessment will be conducted in person. The 

 
participant will receive a letter or telephone call one week prior to the interview and a similar 
reminder a few days prior.  
 
Five contact attempts will be made before a participant is considered to be unreachable at that 
time point. Participants who fail to appear for a scheduled assessment will be contacted by 
phone, or mail or email when necessary, for rescheduling. If participants move away during their 
participation in the study or are otherwise unavailable for an in-person interview, we will perform 
follow-up assessments over the telephone to avoid missing data. Participants will be 
compensated $50 for the pre-treatment, post-treatment, and follow-up interviews.  
 
7.5 Compensation 
Participants will be compensated for the time required to complete all assessments. They will be 
paid $50 for the baseline, post-treatment, and 1-month follow-up assessments.  
 
7.6 Description of Mindful Self-Compassion Intervention 
Mindful Self Compassion will be conducted either in person or virtually via video visits using VA 
Video Chat or Zoom for Healthcare in a group setting over 8 sessions, 2-2.5 hours per session 
dependent on level of COVID-19 limitations placed upon research. The program is designed to 
teach SC and mindfulness skills. The MSC program includes 2 core meditations, 9 additional 
meditations, and 18 informal SC practices. The ultimate goal is to be in the presence of personal 
suffering with a sense of safety, so that the pain is felt and the process of healing can begin. 
Participants are encouraged to be experimental in how they adapt the practices to their own lives. 
MSC sessions will highlight the three interacting components of SC: 1) self-kindness versus self-
judgment, 2) a sense of common humanity versus isolation, and 3) mindfulness versus over-
identification when confronting painful thoughts and emotions. Each session of the program 
focuses on a specific topic as well as formal and informal SC exercises (See Appendix D). In order 
to be considered as receiving a sufficient dose of treatment, participants must attend at least 5 of 
the 8 sessions.  
 
The treatment groups will be conducted by trained MSC teachers (TBD). Each session of the 
program focuses on a specific topic, and the content is outlined in Table 2.  
 
Table 2. MSC Sessions  
Session Number 
Topic 
1 
Discovering Mindful Self-Compassion 
2 
Practicing Mindfulness 
3 
Practicing Loving Kindness 
4 
Discovering your Compassionate Voice 
5 
Living Deeply 
6 
Meeting Difficult Emotions 
7 
Exploring Challenging Relationships 
8 
Embracing Your Life 
 

 
7.7 Therapist Selection, Supervision and Adherence Monitoring 
Therapists will be certified MSC Teachers, having completed the MSC Teacher Training Program. 
Since the therapists will have already been trained and certified in MSC, no additional training will 
be conducted with regard to the conduct of MSC. Two MSC teachers will lead the treatment 
groups over the course of 8 weeks. Therapists will be carefully supervised by Dr. Greg Serpa (a 
MSC teacher and National Mindfulness Consultant for the Department of Veteran Affairs) using 
audio recordings of group therapy sessions. These recordings will be reviewed only by study 
research staff including Dr. Serpa (a licensed clinical psychologist at the VA Greater Los Angeles 
Healthcare System) to see how well those conducting the sessions and the interviews are doing. 
Recordings will be kept confidential and will be stored in a restricted file on a secure VA server, 
and only our research team including Dr. Serpa will be able to hear them.  
 
Dr. Serpa will have access to our secure research server 
(\\vhaproappres01.v01.med.va.gov\RESEARCH_PROTOCOLS\Eaton\MSC) and recorded sessions 
to provide supervision to our study staff. Bi-weekly clinical supervision sessions will examine 
clinical issues and adherence to the study protocol. Every caution will be taken to protect 
disclosure of information protected under HIPAA during supervision with Dr. Serpa. Audio 
recordings will be identified via study ID number and not include any personal identification of 
participants. Supervision will focus on broad clinical issues, flow of group material, and 
adherence to study protocol.  
 
Study investigators will listen to audio-recordings of each therapist and complete fidelity 
rating sheets for each session. Further, Dr. Serpa will provide bi-weekly supervision of 
therapists to evaluate their implementation of and adherence to the therapy manuals. In 
addition, therapists will keep a session by session “MSC Session Tracking Form,” which 
includes self-ratings about the “% of time” spent “using the manual” and covering the relevant 
module content.  
 
All sessions will be conducted locally and audio recorded using Cyber Acoustics cvl-1084 USB 
Desktop Microphones and the VA computers’ Windows audio recording program.  The USB 
microphones will plug directly into the computer using the sound recorder program. These 
audio recordings will be saved and stored on the VA secure server behind the VA firewall 
(\\vhaproappres01.v01.med.gov\research_protocols\Eaton\MSC-R). For supervision purposes, 
Dr. Serpa will have access to a VA approved encrypted thumb drive (FIPS 140-2 Validated 
Removable Storage Device: Aegis Secure Key - USB 3.0) to download audio and listen off-site.  
These data will be used only for the purpose of training, supervision, and adherence ratings. 
 
 
 
7.8 Timetable 
Table 3. Timeline of the proposed project 

 
 
        Year 1 
       Year 2 
Activities 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Research team recruitment and training 
X 
X 
 
 
 
 
 
 
Obtain IRB approvals  
X 
X 
 
 
 
 
 
 
Recruitment of participants 
 
X 
X 
X 
X 
 
 
 
Treatment phase 
 
 
X 
X 
X 
X 
 
 
Follow-up phase 
 
 
 
X 
X 
X 
X 
 
Data collection, entry, and management 
 
 
X 
X 
X 
X 
X 
 
Statistical analyses 
 
 
 
 
 
X 
X 
X 
Report writing, preparation & submission 
 
 
 
 
 
 
X 
X 
8 Data Management * 
 
8.1 Data Management 
All data collected for this study will be used for research purposes only. Study data (all de-
identified), including digital recordings of assessments and therapy sessions, will be managed using 
the secure VA server. Only research staff will have access to the original data. The project 
coordinator will oversee data management procedures. He/she will be responsible for initial 
editing and correction of forms before data is entered. As forms are entered into the database, 
they will be checked against the participant-tracking file to ensure that all data that are gathered 
have been entered. Furthermore, (1) data sheets will be stored in locked offices of research study 
staff, building 32 of the PVAMC,  (2) data will be entered in coded form, (3) data will be stored on a 
secure server behind the VA firewall 
(\\vhaproappres01.v01.med.va.gov\research_protocols\Eaton\MSC-R, (4) data will be protected 
from unauthorized access by passwords, (5) information that might potentially allow an individual 
participant to be identified will not be allowed in any publications or reports sent to individuals 
outside the  study, (6) all employees who are to handle data will be trained in confidentiality 
policies and procedures, and (7) all data-related incidents will be reported to the local ISO and PO 
per VA  policy.  
 
Study files will be maintained in accordance with the Department of Veterans Affairs Record 
Control Schedule 10-1. Only personnel involved in the study will have access to the data base.  
 
The Brown University-licensed Qualtrics provides a web-based, secure, Health Insurance 
Portability and Accountability Act (HIPAA) compliant platform which meets all VA 
security/encryption/storage requirements; their data handling procedures meet strict privacy 
standards (https://www.qualtrics.com/privacy-statement/). The Brown University Qualtrics 
surveys will not contain any PHI; patient study ID will be imbedded in the link to the survey itself. 
Anyone with access to the survey links will be able to access the surveys; however, they will not 
be able to view participant responses that were submitted as part of the survey. The Brown 
University Qualtrics data centers utilize many security measures. Brown University Qualtrics’ 
database access is restricted and requires authorization. The PI and co-investigators will be able 
to access the study Brown University Qualtrics account. Only those staff who need access to 

 
Brown University Qualtrics to perform their job duties will be given user access. Web traffic does 
not directly access the database and database requests are reversed proxy via an application 
server to the database. All information is secured via industry standard firewalls and stringent IT 
security policies and procedures. Brown University Qualtrics utilizes industry standard web 
application firewalls and DDOS protection. Brown University Qualtrics also leverages panel 
partners who are meticulous in their multiple levels of security, which include redundant data 
centers, secure servers, encryption which includes one-way encryption, numeric IDs, secure .NET 
platforms, security clearance, industry standard firewalls, 24/7 monitoring of data centers, 
confidentiality agreements, and physical, electronic, and managerial procedures. Brown 
University Qualtrics uses Transport Layer Security (TLS) encryption (also known as HTTPS) for all 
transmitted data and protect surveys with passwords and HTTP referrer checking. Data are 
processed by application servers and sent to database servers for storage. Web data are 
delivered to the respondent in the form of survey questions, graphics, and other content created 
in the survey design. While Brown University Qualtrics typically tracks IP addresses as part of its 
protocol, our research project will opt out of IP address tracking to ensure that survey responses 
remain confidential. Once a participant completes a survey on Brown University Qualtrics, the 
data will be downloaded from the Brown University Qualtrics secure server and securely stored 
on the VA's network server and combined with the study’s REDCap dataset at the PVAMC. It will 
then be permanently deleted/destroyed on the Brown University Qualtrics server by the study 
team. The Brown University Qualtrics study account can be accessed from the VA network 
system/VA workstation; thus, the downloaded data can be directly saved on the VA server and 
entered into the REDCap database, eliminating any need for data transfer. No personally 
identifiable data outlined in the list of 18 HIPAA identifiers are collected as part of the Brown 
University Qualtrics survey. 
 
8.2 Privacy and Confidentiality 
Every effort will be taken to protect the confidentiality of the participants in this study. First, all 
study personnel who are to handle data will be trained in conducting responsible research and 
confidentiality policies and procedures.  In addition, all research data will be kept in locked files 
under a study ID number.  The name-number code will be kept in a separate locked file. 
Computerized data will be de-identified and stored on a secure server at PVAMC.   
Participants will be informed that some information regarding participation in this study will be 
included in their VA electronic medical record. Specifically, a brief note indicating that the 
patient has consented to participate in the study and a note documenting the completion of 
their participation will be included. Weekly research appointments will also be documented but 
no detailed information regarding participants’ progress will be provided unless there are acute 
safety concerns. Records will be maintained per Veterans Affairs Record Control Schedule 10-1.  
The study therapists may have access to information the participant shares in sessions, not 
immediately available to their other clinical mental health team members.  Therefore, a clear 
understanding of precisely what information will be freely shared among site personnel is very 
important.  Only necessary information will be shared with the participant’s treatment team and 
these are explained in detail in the consent form. The study therapists will share information 

 
about attendance and status in the therapy, and may share information about the participant’s 
use of substances, PTSD symptom severity, or deterioration in psychiatric symptom or 
functioning.  Specific details about the participant’s traumatic experiences and the specifics of 
the actual study therapy will not be shared unless there is a safety issue (e.g., acute suicidality, 
marked deterioration in clinical status).  In case of a safety issue, only that information critical to 
maintaining patient safety will be revealed. 
Participants will also be informed that due to the nature of groups being held virtually via VVC or 
Zoom for Healthcare during the COVID-19 pandemic that there are additional precautions that 
need to be adhered to including finding a private space for phone/video sessions to help keep 
their sessions private. Participants will be informed that it might be possible that others may 
overhear or walk into the cameras view allowing identification of other group members during 
the session.  
Participants will also be informed that issues with confidentiality may include study 
therapists/staff having to work with participants during group sessions on well-being or safety 
checks if the participant’s behavior warrants clinical intervention. Procedures to   be used will 
mirror interventions used in clinical practice. First, in an effort to maintain confidentiality during 
such an episode, study staff will immediately remove the participant from view to other 
participants and mute the audio while other study staff work   directly with the participant in 
need.  Study staff will then attempt to contact participant directly via telephone. If unable to 
contact participant, study staff will contact participant’s emergency contact for a wellness check. 
If study staff are unable to contact     the participant’s emergency contact, study staff will contact 
the police in order to have them conduct a wellness check. At all times study staff will inform the 
PI of the status of the participant and the status of the wellness check until the issue is resolved.  
As part of standard clinical safety protocol practice, each participant is informed of these limits 
of confidentiality and the procedures utilized should we become concerned about their safety or 
the safety of others at the time of the baseline session.   
Adverse Event Reporting 
 
8.2 Adverse Events 
Under the direction of the PI, all members of the research team (co-investigators, coordinator, 
therapists) will participate in monitoring adverse events. At each contact, participants will be 
queried about any physical, emotional, mental, or behavioral problems since the last contact and 
a determination will be made whether the participant’s report of a condition, symptom or event 
is “serious” and/or “unexpected.” A serious AE would include death or disability, life-threatening 
events, hospitalization or prolonging of existing hospitalization, and atypical and rapid 
deterioration in functioning. An “unexpected” AE is an event that was not anticipated by or the 
specificity or severity is inconsistent with the study protocol.  
 
In the case of an Adverse Effect (AE) or unanticipated problem, these incidences will be reported to 
the IRB per IRB requirements.  

 
 
9.2 Procedure for the Withdrawal/Termination of Subjects 
It will be made clear that participation in this research study is completely voluntary, and the 
participant may decide to stop his/her participation at any point in the study. A participant will 
be withdrawn from the entire study if, at any time during the study: 
1. The PI feels that continuation in the study would be detrimental, as evidenced by the 
participant reporting discomfort during study procedures or not meeting study inclusion 
requirements, including safety aspects, or based on psychiatric health assessment.  
2. The participant so desires. 
If the participant is terminated from the study by the PI, he/she will be thanked for his/her 
participation, and the appropriate referrals will be made to ensure follow-up treatment/services 
are received, if and as needed. 
 
 
9 Statistical Analysis  
 
9.1 Overall Approach 
Our analytical approach is commensurate with Phase I research and will focus primarily on 
evaluating feasibility of the MSC protocol and examining clinically meaningful change. Statistical 
analyses will be conducted using intent-to-treat analytic strategies.  
9.2 Basic Statistical Analysis 
Initial statistical analyses will provide descriptive statistics on the demographic and clinical 
characteristics of the study participants using means, standard deviations, median, and range for 
continuous variables and frequencies and percentages for categorical variables.  
10.3 Determining Acceptability and Feasibility of Study Procedures and MSC 
We will examine whether recruitment met proposed targets within the time frame (N=48 
participants). To determine the feasibility and acceptability of MSC, we will examine rates of 
session attendance, drop outs, completion of assessments, number of adverse events, degree of 
adherence to the intervention protocol, qualitative exit interviews, and satisfaction ratings. We 
anticipate that retention in MSC will be comparable to other contemplative and alternative 
treatments for PTSD with an expected retention rate of at least 75%, and mean satisfaction with 
MSC in the highest ranked category (>28 of possible 32 points, extremely satisfied). We would 
consider completion of a minimum of 75% of post-treatment and follow-up assessments to 
indicate feasibility. We also expect fewer than 5% experiencing adverse events. Home practice 
will also be examined and the number of minutes spent engaged in MSC formal and informal 
exercises will be assessed. Finally, therapist input will be collected regarding ease of delivery of 
the protocol, content, flow, and experience with engaging Veterans in the treatment.  
10.4 Clinically Meaningful Change 
We hypothesize that participants will endorse increased self-compassion, and reduced 
posttraumatic guilt and shame following MSC therapy. As a stage 1 study with a small sample, 

 
statistical analyses will focus on direction of effects from pre- to post-treatment and whether 
there is suggestive evidence of clinically meaningful change. We will examine effect sizes, 
recognizing the inherent difficulties in relying on effect sizes generated from pilot studies to 
power larger trials (Kraemer, Mintz, Noda, Tinklenberg, & Yesavage, 2006), and that confidence 
intervals could potentially be large. Preliminary analyses will include examining patterns of 
missing data, non-normality of outcome variables, and univariate statistics on all key variables. 
Consistent with previous behavioral therapy research, we will examine clinically meaningful 
change using the standard error of measurement (SEM),  operationally defined as a reduction in 
scores by at least one SEM (Eisen, Ranganathan, Seal, & Spiro, 2007). 
10.5 Bivariate Correlations 
We hypothesize that participants will report improved quality of life, lower PTSD and depressive 
symptoms, and greater percent days abstinent (PDA) post-treatment and at follow-up after 
receiving MSC therapy. In this pilot study, we will not have adequate power to investigate 
whether these mechanisms mediate treatment effects. However, we will be able to examine 
bivariate correlations among baseline posttraumatic guilt, shame, and SC scores and measures of 
baseline PTSD, depression, and substance use. We will also examine whether changes in quality 
of life, posttraumatic guilt, shame, and SC over the course of treatment are correlated with 
changes in PTSD-SUD symptoms. 
10.6 Exploratory Aim: Suicidality 
We hypothesize that MSC will decrease suicidal ideation. This aim will be evaluated by examining 
clinically meaningful change pre-to post-treatment. 
 
10.7 Intention-to-treat vs. Treatment-exposed Analyses 
Initial analyses of the primary hypotheses will be conducted on the full sample of assigned 
participants, regardless of actual exposure to treatment (intention-to-treat sample). It is possible 
that we will then analyze the subset of participants who were sufficiently exposed to treatment 
(the treatment-exposed sample). The need to conduct both types of analyses depends on the 
rate and nature of participation in the treatment. The intention-to-treat sample will include all 
participants for whom we have follow-up data, even if partial. To accommodate missing values 
on both outcome and covariates, we will conduct multiple imputation as needed. These analyses 
are an important gauge on the effectiveness of the interventions under real-world conditions.     
10 Quality assurance, monitoring & safety 
 
Data Safety and Monitoring  
This study involves low risks to study participants. The PI is responsible for study monitoring and 
ensuring the safety of participants and the validity and integrity of the data. Research team 
meetings will be held weekly.  The PI will supervise the project coordinator in structured 
diagnostic interviews, assessments, and data entry.  
The PI will ensure that all research team members are familiar with the data and safety 
monitoring plans, systems for adverse event reporting, data integrity, confidentiality, and the 

 
protection of participants’ safety. All study personnel will complete the required training and 
education on the protection of human subjects and the study will receive initial review and 
ongoing monitoring by the PVAMC IRB.  
Data monitoring will be performed on an ongoing and regular basis. The project coordinator will 
collect data via interviewer- and self- administered formats, generating both paper and 
electronic data. All paper data collection forms will be reviewed for accuracy and completeness 
prior to data entry.  Onsite at the PVAMC, paper data will then be entered into a purpose-
designed client-server database, and each item will be subject to range testing and validity 
checks as provided by the data system. We will use a double-entry method whereby data are 
entered twice and entries are matched against each other to flag inconsistencies, which are then 
corrected prior to data analyses. Data collected via the computer will also be reviewed by the 
PVAMC project coordinator for accuracy and completeness before data are compiled for 
analyses, and will have built-in range testing and validity checks.   
11 Finance and resource use* 
 
12.1 Funding 
This research is funded by Rehabilitation Research and Development (RR&D) at the Providence 
VA Medical Center.  
 
Table 4. Project Budget 
Project Year 
Direct and Indirect Costs 
1 
74,974 
2 
75,731 
Total 
150, 705 
 
 
12.2 Resources 
The research team has sufficient resources available to conduct the proposed study. Dr. Eaton’s 
primary clinical and research office space is on site at the PVAMC where the study will be 
conducted, and includes telephone/email and internet service, access to photocopier, shredder, 
fax machine, printers, and adequate storage space to securely store study related data. Co-
Investigators Capone and Shea also have office space on site at the PVAMC.  
 
The Providence VA Medical Center (PVAMC) provides health care for Veterans in Rhode Island, 
southeastern Massachusetts and eastern Connecticut.  The PVAMC is a major teaching and 
research affiliate of the Brown Medical School, with 238 acute care beds and more than 250,000 
outpatient visits per year. The PVAMC provides a full range of patient care services with state-of-
the-art technology and active affiliations with Brown University and Boston University Medical 
Schools. It has established patient-oriented research programs in mental health and substance 
use disorders, dermatology, oncology, gastroenterology, hypertension, and cardiac and 

 
pulmonary diseases. Over 300 University residents, interns, students and fellows are trained at 
the PVAMC each year.   
 
The proposed research will be conducted in designated research space in Building 32. Available 
resources include exam rooms, a gait and motion lab, a virtual reality lab, a large conference 
room, several meeting rooms, a large physical therapy area, and offices used by investigators 
and research staff. Building 32 is a secure space for research-related equipment and files. Project 
personal computers are password protected, behind the VA firewall, and are located in locked 
temperature-controlled offices.  The building can only be accessed with limited electronic 
passkey access. In addition, the IRM of the Medical Center houses a secured research server with 
ample storage to house the data used by investigators. The database management facilities are 
built with multiple levels of security.  Access to the data is limited to persons with IRB approval 
and appropriate VA privacy, human subjects, and security training.  Access privileges to research 
project directories on the server are monitored on a quarterly basis by research personnel. 
 
Dr. Eaton also has access to resources in the Department of Psychiatry and Human Behavior 
(DPHB) at Brown University. Dr. Eaton has full access to Brown’s library facilities and on-line access 
to research materials. Brown University and PVAMC have forged a strong alliance in regard to 
research and training. The faculty at PVAMC and Brown University include many outstanding 
psychologists and psychiatrists who are widely recognized for their scientific contributions. There 
are numerous opportunities for intellectual connections with other investigators including Grand 
Rounds, Visiting Guest Lecture Series, and monthly faculty meetings.  This scientific environment 
and strong institutional support will undoubtedly contribute to the success of this project. The 
research team, already well qualified to carry out the proposed work, will have access to other 
leaders in clinical research to consult with as indicated. 
12 Dissemination of Results and Publication policy 
 
The principal investigator will share de-identified datasets, statistics, and results collected from 
this proposal by depositing these data at the National Library of Medicine (NLM) PubMed Central 
website repository as this is a VA supported data repository. Additional documentation including 
metadata that will include information about the methodology and study procedures used to 
collect the data, details about code, and `definition of variables will also be included. 
We will also register with clinicaltrials.gov, which contains over 100,000 trials sponsored by a 
variety of federal and private industry sources, and receives over 50 million page views per 
month and over 65,000 visitors daily. Study findings will be submitted to a peer-reviewed journal 
and presented at professional conferences, such as the International Society for Traumatic Stress 
Studies, the APA, and appropriate VA and DoD conferences. Dr. Eaton will work with the 
research team to analyze and disseminate publications.  

 
If we find evidence for the feasibility and acceptability of MSC among the Veteran population, 
these data will be used to submit a larger RCT.  
13 Human Subjects 
 
14.1 Risks/ Benefits Assessment 
In previous and current studies of the assessment and SC treatment procedures, no serious 
adverse events have been observed or reported. Regardless, several protections will be in place 
regarding the risk of emotional discomfort and every effort will be made to minimize risk of the 
potential for participant emotional distress. In addition to the training of assessment and therapy 
personnel to observe and monitor, participants themselves are clearly informed about the risk of 
emotional upset, are encouraged to let us know if they become upset, and several options for 
handling this are discussed and detailed in the consent form.  Crisis and relapse plans are 
formulated as standard procedure by the PVAMC programs for all patients, and participants will 
be encouraged to utilize emergency services, including presenting at the PVAMC Urgent Care 
clinic or calling the Veterans Crisis Hotline, should the need arise.  Any issues that arise are 
discussed in research team meetings so that all members of the team are aware of potential 
participant reactions and appropriate responses to them.  This also allows us to monitor adverse 
events, evaluate them according to federal regulations and IRB policies, and decide on an action 
plan for reporting them when appropriate. 
Depressive symptoms will be assessed via the Patient Health Questionnaire (PHQ-9) and Beck 
Scale for Suicide Ideation (BSSI) at baseline and follow-ups. The project coordinator will 
administer the PHQ-9 and BSSI and review the participant's responses. If a participant endorses 
current self-harm thoughts, the project coordinator will notify the PI (Dr. Eaton).  The PI will 
meet with the participant to further assess risk of self-harm, and consult with the research team 
if necessary. If the participant is deemed at imminent risk, standard procedures for addressing SI 
will be followed – the participant will be escorted to the Urgent Care Clinic at the Providence VA 
(equivalent of a walk-in urgent care clinic for crisis management) and, if appropriate, will be 
offered hospitalization. If Dr. Eaton is not available, the project coordinator will escort the 
participant to Urgent Care for further evaluation by licensed clinicians. 
The proposed research could potentially involve pregnant women and persons with limited 
literacy.  The involvement of pregnant women in the study is clearly within the bounds of the 
federal regulations (45 CFR 46.204) and poses no additional risk to the woman (or her fetus) 
beyond what would normally be encountered in a clinical therapy or addiction treatment setting.  
The additional monitoring, evaluation, and contact provided through the research context will 
likely offer more protection or support than would a typical treatment setting.   
 
The Risk of Worsening Symptoms or Lack of Improvement during/after MSC: Risks associated 
with participation in this trial include possible lack of positive response to MSC. There is no 
guarantee that the MSC program will lead to improvement of symptoms.  During the program or 
after finishing the final session, symptoms may worsen.  Although MSC is considered a very safe 
intervention, it is possible that difficult emotional material will surface during practice. Adverse 

 
events that are identified by spontaneous report and direct query during or after MSC sessions 
will be referred for appropriate follow-up care according to good clinical practice.   
Furthermore, there are potential risks and challenges that may arise during the MSC group 
sessions and during home practice. These challenges include attuning to and an increased 
awareness of difficult emotions and body sensations. There is a possibility that participants may 
experience things more intensely, have an increase in traumatic memory reexperiencing, or 
relaxation-induced panic or anxiety. It is estimated that these effects occur at rates 
approximately equal to what happens generally in psychotherapy. Should any of these concerns 
arise, we encourage participants to discuss with their trained MSC clinician and/or contact the 
principal investigator. The research team is staffed with licensed clinical psychologists trained to 
treat such conditions, and the staff will attempt to minimize any discomfort participant’s may 
feel throughout the course of the study.  
The Risk of Inconvenience and Burden of Required Time/Travel: Participants may engage in 
screening procedures and learn they are not eligible for participation in the research treatment 
trial. Frequent visits to the research clinic, for the MSC training (1 day per week) for 8 weeks, 
may represent an inconvenience, especially if a participant travels a great distance or has other 
constraints on their time or transportation.   
Psychiatric Interview and Questionnaires: Emotional discomfort may be associated with 
completing the assessments and questionnaires. Subjects will be informed that if they 
experience discomfort during symptom assessment, study personnel will take appropriate 
measures, including debriefing and referral to the principal investigator or co-investigators for 
further evaluation. If the presence of a mental health concern arises, participants will be referred 
for appropriate care according to VA guidelines.  
The Risks Associated with Using Virtual Platforms to Conduct Video Groups:  
Veterans will be informed prior to their first group session, that attending group sessions via 
remote video platforms can present some privacy issues as other group members will be able to 
see into the Veteran’s home environment during group sessions. Study staff will advise Veterans 
to choose the location in which they connect to the group wisely, stressing the importance of 
finding a private quiet space to participate in the group virtually as doing so will reduce the risk 
of people in the Veteran’s home seeing or hearing fellow group members group participation 
and possibly disclosing any personal information. Suggestions to reduce these risks will be made 
to the Veteran by asking him/her to remove all pictures of loved ones, discussing the importance 
of privacy and confidentiality with the people who they live with and stress the importance of 
these people not interrupting the group sessions, walking into the camera’s field of vision or 
talking to the Veteran during the group session as overhearing what is being discussed breaks 
confidentiality. Additionally, if the Veteran is unable to find a private room, study staff will help 
find locations where the Veteran could be present for the group sessions while not disclosing 
any personal information (e.g., their car, office, finished basement). In an effort to prevent 
disclosure, the use of headphones and hanging a sign on the door to “please not disturb” during 

 
group sessions will be recommended to those who are having a difficult time finding private 
space for the group sessions.  
 
Confidentiality: To minimize the risks of confidentiality violation, all data will be obtained by 
trained staff. Because of the sensitive nature of some of the data gathered, several precautions 
will be taken to prevent disclosure of information to unauthorized parties.  Specifically: (1) Data 
sheets will be stored in the investigator’s locked office (Building 32, Providence VA Medical 
Center as assigned); (2) data will be entered in coded form; (3) data will be stored in computer 
files protected from unauthorized access by passwords; (4) information that might potentially 
allow an individual participant to be identified will not be allowed in any publications or reports 
sent to individuals outside the study; and (5) all employees who are to handle data will be 
trained in confidentiality policies and procedures. Access to data will be limited to study 
investigators and staff.  
Confidentiality issues related to Using Virtual Platforms to Conduct Video Groups:  
Additional risks of confidentiality are associated with conducting group therapy via Video VA 
Chat or Zoom for Healthcare. We will ask participants in the group to respect everyone’s privacy 
and confidentiality, and not to identify anyone in the group or repeat what is said during the 
group discussion. However, while group leaders will not disclose any participant communications 
or information, group participant communications are not protected. As such, confidentiality 
within the group setting is often based on mutual trust and respect. Confidentiality issues related 
to persons outside the group (e.g. family members and roommates present during the group 
sessions) will be addressed with participants as well. Plans to mitigate these risks include 
informing participants that others should not be able to overhear the group visit. Participants will 
be informed that study staff will help them find solutions (e.g. private space, use of headphones) 
in order to protect the privacy of other group participants. Suggestions will be made to the 
Veterans that they put a sign on the door of the room they are in to “please not disturb”, alerting 
others in the house to provide privacy to the Veteran and other group members during group 
sessions. Participants will be informed that if they cannot find a private space to meet with the 
group virtually, they will not be able to participate in the group sessions. 
 
As always, the participants’ well-being will always be placed above research considerations. 
Participants will understand that they can refuse to answer any question and to stop an 
interview at any time. The participants will be clearly informed that they are free to terminate 
participation in the study at any point. 
  
14.2 Potential Benefits of the Proposed Research 
As described earlier, Veterans with co-occurring posttraumatic stress and substance use disorders 
are at greater risk for negative outcomes for both disorders, and for treatment attrition. This 
intervention has potential to improve outcomes for both substance use and posttraumatic stress 
disorders, and to improve the effectiveness of treatment by increasing retention. Both addiction 
treatment and PTSD therapy practitioners have expressed the need for assessment and treatment 
strategies for co-occurring substance use and other psychiatric disorders. This study has the clear 

 
potential to add to the existing options for practitioners to more effectively help their patients 
with this challenging co-morbidity. 
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