A Trial of Loving-Kindness Meditation and Cognitive Processing Therapy for PTSD
Phase: NA
Conditions: Posttraumatic Stress Disorder, Depression
Sponsor: VA Office of Research and Development

A trial of Loving-Kindness Meditation and Cognitive Processing Therapy for PTSD 
Study Protocol and Statistical Analysis Plan 
NCT01962714 
3/31/2014

SPECIFIC AIMS   
Posttraumatic stress disorder (PTSD) is a common consequence of trauma that can persist for decades 
and result in a major reduction in quality of life.2 Symptoms of PTSD occur in 21 - 31% of soldiers previously 
deployed to Iraq, 10-31% of Veterans who served in Vietnam, and in similar percentages of victims of 
assaultive violence and civilian populations exposed to war or acts of violence.2 It is estimated that the typical 
person with PTSD experiences symptoms for at least two decades over the lifespan and has a significant 
lifetime risk of suicide.3 PTSD often disrupts interpersonal relationships, reduces the ability to work, decreases 
quality of life, and increases the risk of physical illnesses, substance abuse, and affective disorders.4  
The VA National Center for PTSD recommends evidence-based pharmacologic and behavioral 
interventions for PTSD, including medications (selective serotonin-reuptake inhibitors and prazosin), and 
psychotherapeutic approaches (cognitive therapy, exposure therapy, stress management skills training, and 
eye movement desensitization reprocessing-EMDR).5 Cognitive processing therapy (CPT), has been found to 
be effective in the treatment of PTSD in randomized clinical trials.6 Despite the availability of these and other 
interventions, many persons with PTSD continue to experience persistent PTSD symptoms, as well as anger, 
difficulties with interpersonal relationships, shame, and grief.7  
Increasing evidence suggests that as many as half of Veterans seen in VA primary care settings report 
using Complementary and Alternative Medicine (CAM) interventions to address a variety of difficulties8 and 
that many do so to limit their use of medications and to ensure that their social and spiritual needs are 
addressed.9 A CAM intervention that holds promise for addressing PTSD and depression among Veterans is 
Loving-Kindness Meditation (LKM). Consistent with Fredrickson’s broaden-and-build model of positive 
emotions, LKM has been shown to broaden individuals’ emotional repertoires through increased positive 
emotions, which mediates the building of a range of personal resources  (e.g., improved social support or a 
sense of environmental mastery), which in turn leads to improved clinical outcomes (e.g., reduced 
depression).10 Pilot data from an open trial conducted in our laboratory indicate that LKM is well tolerated by 
Veterans and is associated with increases in positive emotions, enhanced personal resources, and reductions 
in PTSD and depressive symptoms. 
The proposed study is a randomized, controlled non-inferiority trial that will assess whether LKM results 
in improvement in PTSD symptoms and depression that are not meaningfully different than Cognitive 
Processing Therapy—Cognitive only (CPT-C), among Veterans with current PTSD. PTSD symptoms will be 
measured by the Clinician Administered PTSD Scale - CAPS and depression will be measured by the NIH 
PROMIS measure.11  Additional analyses will assess whether mediators of response are consistent with the 
mechanisms conceptualized for each intervention. One hundred seventy Veterans with PTSD will be 
randomized to LKM (n = 85) or CPT-C (n = 85). Comprehensive assessments will take place post-treatment 
and 3- and 6- months later. The following specific aims will be accomplished through the proposed clinical trial: 
Aim 1: Evaluate if LKM is non-inferior to CPT-C in producing reductions in PTSD symptoms among Veterans 
with current PTSD.   
Hypothesis 1: Veterans randomized to LKM will report mean reductions in PTSD symptom severity 
that are not meaningfully worse than CPT-C, as indicated by a lower limit of the 95% confidence 
interval for difference in 6-month mean CAPS scores that is greater than -10 (corresponding to a 
standardized effect size of 0.5 between randomization arms). Results will also be assessed at the 
immediate post-test and 3-month time intervals. 
Aim 2: Evaluate the non-inferiority of LKM and CPT-C in producing reductions in depressive symptoms among 
Veterans with current PTSD.   
Hypothesis 2: Veterans randomized to LKM will report mean reductions in depressive symptoms that 
are not meaningfully worse than CPT-C, as indicated by a lower limit of the 95% confidence interval for 
difference in 6-month mean PROMIS depression measure that is greater than -4, corresponding to a 
standardized effect size of approximately 0.5 between randomization arms.12 Results will also be 
assessed at the immediate post-test and 3-month time intervals. 
Exploratory Aim:  Evaluate potential mediators of response to LKM and to CPT to provide preliminary 
information regarding whether they are consistent with the mechanisms of change conceptualized by each 
intervention to be associated with improvement in PTSD and depression. 
Exploratory Hypothesis 1: Enhanced self-compassion will more strongly mediate PTSD and 
depressive symptom improvement for those assigned to LKM than those assigned to CPT-C. 
Exploratory Hypothesis 2: Reductions in posttraumatic maladaptive beliefs will more strongly mediate 
PTSD and depressive symptom improvement for those assigned to CPT-C than those assigned to 
LKM. 

BACKGROUND AND SIGNIFICANCE 
Posttraumatic stress disorder (PTSD) is a common consequence of trauma that can persist for decades 
and result in a major reduction in quality of life.2 PTSD affects approximately 8% of the general population of 
the US. The clinical hallmarks of PTSD include recurrent, intrusive recollections or reexperiencing of a 
traumatic event, avoidance of external or internal cues that can trigger reexperiencing, emotional numbing, and 
hyperarousal.13 PTSD has been shown to have a greater impact on quality of life than major depression and 
obsessive-compulsive disorder.14 Symptoms of PTSD occur in 21 to 31% of soldiers previously deployed to 
Iraq,15 10-31%16 of Veterans who served in Vietnam, and in similar percentages of victims of assaultive 
violence and civilian populations exposed to war or acts of violence.2 It is estimated that the typical person with 
PTSD experiences active symptoms for at least two decades over the lifespan2 and has a significant lifetime 
risk of suicide; PTSD has a stronger association with suicidality than any other anxiety disorder.3 PTSD often 
disrupts interpersonal relationships, reduces the ability to work, impairs quality of life, and increases the risk of 
physical illnesses, substance abuse, and affective disorders.4 Among individuals seeking treatment for PTSD, 
the rate of PTSD/depression comorbidity was found to be nearly 50% in the original national comorbidity study 
sample.17 Individuals suffering from both PTSD and depression have higher rates of suicidal ideation than 
those with either disorder alone, though rates of actual suicide attempts are consistent across those with PTSD 
only and comorbid PTSD/depression, and both groups report significantly higher rates than those with 
depression only.18 Comorbid PTSD and depression is also associated with greater risk of various physical 
conditions than is PTSD alone.4 Thus, PTSD complicated by co-occurring depression is associated with even 
greater suffering and compromised functioning than is PTSD alone. 
The VA National Center for PTSD recommends evidence-based pharmacologic and psychotherapeutic 
interventions for PTSD, including medications (selective serotonin-reuptake inhibitors and prazosin), and 
psychotherapeutic approaches (cognitive therapy, exposure therapy, stress management skills training, and 
eye movement desensitization reprocessing-EMDR).5 Selective serotonin reuptake inhibitors (SSRIs) produce 
improvement in the major symptom clusters of PTSD, although the magnitude of the treatment effect is 
modest.19 Prazosin, an alpha-antagonist, reduces trauma-related nightmares and has also been found to have 
a significant effect on all of the PTSD symptom clusters.19 Despite these and other pharmacologic agents, 
many persons with PTSD continue to experience persistent PTSD symptoms, as well as anger, difficulties with 
interpersonal relationships, shame, and grief.7 Psychotherapeutic techniques are often combined with 
pharmacotherapy in the treatment of PTSD.  Prolonged exposure (PE) therapy facilitates emotional processing 
of the traumatic event, helping individuals to develop less phobic responses to internal and external trauma 
cues.20 However, PE is difficult for many Veterans to complete, as evidenced by a high dropout rate (38%).21 
PE may also fail to address the entire realm of posttraumatic psychopathology including anger control, 
interpersonal difficulties or grief.7 In addition, PE and EMDR are usually administered by an individual therapist 
rather than as a group treatment, which limits the ability to efficiently deliver these interventions to large 
numbers of persons.  Cognitive Processing Therapy (CPT) can be delivered either individually or in group 
settings and has some initial support for efficacy in addressing PTSD among Veterans. In addition to concerns 
about dropout for some Veterans, another potential shortcoming of current treatment for PTSD is the lack of 
empirical data to guide treatment for persons with multiple psychiatric diagnoses. Psychiatric conditions other 
than PTSD commonly co-occur with PTSD,17 yet persons with multiple psychiatric diagnoses have often been 
excluded from clinical trials. A further limitation is that many studies employed interventions delivered by expert 
PTSD therapists with extensive experience, raising the question of whether the favorable results from these 
clinical studies can be generalized.21  
The VA has invested considerable resources to disseminate both PE and CPT through national roll-
outs to increase the likelihood that Veterans will have access to these empirically supported treatments. 
Although research published in 2004 indicated that neither of these empirically supported treatments were 
widely utilized by therapists within the VA,22 more recent findings suggest that the roll-outs have met with initial 
success and plans are in place to monitor future penetration of PE and CPT within the VA.23 These efforts will 
no doubt relieve a great deal of suffering among Veterans with PTSD. However, given the large number of 
Veterans with PTSD, many with significant comorbidities and not all of whom will benefit from or elect to 
participate in PE or CPT, additional cost-effective treatments suitable for broad implementation are needed. 
Evidence indicates that about 15% of the US adult population utilizes mind-body therapies, with a 
significantly higher rate found among persons with two or more chronic diseases.24 Emerging evidence 
indicates that Veterans also use various complementary and alternative medicine (CAM) interventions at high 
rates.  A large multisite study of VA outpatients found that 27% of Veterans had utilized some form of CAM in 
the past year.25  Another study of Veterans found that nearly 50% reported using a CAM intervention, and high 

daily stress, chronic medical illness and a perceived negative impact of military service on mental or physical 
health were significant predictors of CAM use.8  Qualitative research among Veterans also suggests that 
dissatisfaction with the reliance of conventional care on prescription medications and neglect of social and 
spiritual aspects of health serve as motivating factors for CAM use.9  In addition to chronic symptoms of PTSD 
and depression, the presence of chronic illnesses associated with PTSD along with dissatisfaction with 
reliance on prescription medications are likely to positively impact recruitment for the current study.  Our past 
experience offering meditation-based interventions as a clinical service to Veterans provides additional 
evidence that LKM is likely to be an acceptable treatment modality among Veterans.  
Loving-Kindness Meditation (LKM) is a CAM approach that facilitates increased positive emotions 
through meditation exercises designed to develop feelings of warmth, kindness, and compassion for self and 
others. A growing body of literature indicates that self-compassion is associated with healthy psychological 
functioning (including life satisfaction and social connectedness), and negatively associated with self-criticism, 
rumination, thought suppression, anxiety and depression.26 Self-criticism, rumination and thought suppression 
are phenomena frequently associated with PTSD, as is depression.27 Therefore an intervention that increases 
self-compassion may impact clinical manifestations of PTSD.  In a study of PTSD symptoms in university 
students, greater self-compassion significantly correlated with lower rates of avoidance symptoms, but not re-
experiencing or hyperarousal,28 suggesting that individuals with higher self-compassion may engage in fewer 
avoidance strategies. ‘Compassionate mind training,’ which is an intervention designed to teach self-
compassion, was offered to six individuals in a small pilot study by Gilbert et al. 29 The authors found significant 
reductions in depression, self-criticism, anxiety and shame over time, and postulated that teaching techniques 
that generate feelings of self-soothing and inner warmth may be particularly helpful for persons with a history of 
trauma, due to pervasive feelings of shame and self-criticism coupled with the relative inability for self-soothing 
in this population.29 Many persons with PTSD have a long history of traumatic experiences, and have rarely felt 
safe or reassured. Pervasive feelings of shame and guilt are common in the setting of PTSD. 
Increasing evidence supports LKM as a technique for enhancing positive emotions and health 
generally.  Support for the efficacy of LKM to increase positive emotions was found in a study by Fredrickson 
and colleagues.10 This study was conducted with 139 community dwelling individuals employed by a single 
company. The subjects were randomized to either LKM (n=67) or waitlist control (n=72). Those in the LKM 
group reported significantly greater positive emotions and were significantly less depressed at the end-point 
assessment than the no-LKM group, even though both groups reported a similar frequency of negative 
emotions day-to-day. They also found that positive emotions persisted after meditation sessions ended, and 
that over time, repeated LKM practice produced a cumulative increase in positive emotions on subsequent 
days, regardless of whether the individual had practiced meditation on that day.10 A pilot study of LKM for 
chronic low back pain by Carson et al compared a group that underwent LKM (n=18) with a group receiving 
standard care (n = 22) and found that those in the LKM group reported lower pain ratings, less anger, and less 
psychological distress (note: positive emotions do not appear to have been assessed).30 Another study of LKM, 
performed in a  group of community participants, indicated that a single brief session of LKM training led to 
increased self-esteem and sense of social connectedness relative to a control condition.31 In a report of case 
studies in which LKM was taught to persons with schizophrenia, LKM appeared to be of potential benefit for 
persistent negative symptoms.32 
In LKM practice, a person sits quietly and calls to mind a particular person (e.g., a good friend) and 
focuses on bringing a sense of positive regard to that individual through a series of standard phrases invoking 
the desire for safety, happiness, health, and ease or peace for them. Classically, four phrases are used, such 
as: “may you be safe,” “may you be happy,” “may you be healthy,” and “may your life unfold with ease.” Next, 
the person brings positive regard to other individuals or categories of people, including themselves, neutral 
persons, and those who have caused difficulty or harm (see Approach section), changing the phrases as 
needed (i.e., “may you be safe” becomes “may I be safe”).33 This systematic development of kindness toward 
self and others is intended to change the orientation to one’s self, others, one’s life experiences, and to result 
in a broadening of the range of emotional responses and choices available. Loving-kindness practice has its 
roots in the Buddhist tradition, but as described above an increasing number of studies have successfully 
applied it as a non-religious practice. The phrase loving-kindness derives from the Pali word metta, which can 
be translated as “love” or “unconditional friendliness,” or “loving-kindness,” akin to the Greek word “agape,” 
which is typically translated as wide open unconditional love. The words loving-kindness are intended to 
describe an emotional state that is not a sentimental love or a feeling of passion. Rather, it can be described as 
an unconditional friendliness, benevolence, and openness toward experience – even difficult experience.  

It can be postulated that the intentional cultivation of kindness and acceptance promoted in LKM 
practice will positively influence multiple aspects of recovery from trauma.  Although the factors described 
below might also be developed through mindfulness practice (e.g., in MBSR through breathing meditation), 
LKM is a distinct form of practice that is often considered more accessible and therefore more helpful to 
persons who are in significant ongoing distress.  Simply said, many persons find it easier, and more helpful, to 
adopt and stay with a practice of LKM, which relies on the repetition of simple phrases meant to foster 
kindness and compassion towards self and others, as compared to practicing breathing or body scan 
meditation. This may be particularly true when an individual is in severe emotional pain.  This is in agreement 
with the recommendations of Buddhist teachers, who have been reported to recommend LKM practice instead 
of other forms of practice when people are in significant distress.33  The lives of persons with PTSD are marked 
by ongoing severe emotional (and often accompanying physical) pain, including the hallmark emotion of fear. 
In the historical Buddhist record, LKM was originally taught as a way of working with and ‘staying with’ the 
strong emotion of fear, which, as noted, is the predominant emotional experience in PTSD. Indeed, one of the 
core features of PTSD is thought to be a phobic response to reminders of a traumatic event and to the 
memories associated with that event, which in conjunction with information processing problems, lead to 
pervasive fear and poor functioning.34 One aspect of LKM practice that can be hypothesized to apply to a key 
post-trauma sequela is re-establishment of a sense of safety, or basic trust.  Trauma can shatter the sense of 
basic trust in others, oneself, and the world at large.  Disruptions in basic trust, as well the tendency to avoid 
reminders of the trauma in social situations, often result in withdrawal from close relationships.35 The repetition 
of LKM phrases can be hypothesized to represent a mechanism to recreate a safe ‘holding environment,’ 
which in LKM is created by self-directed phrases of positive intention.  This may prove particularly helpful when 
kindness and support are lacking in the environment.  Social support has been shown to be an important factor 
in recovery from PTSD.36 The incremental restoration of a sense of basic trust, as well as an increased ability 
to self-modulate pervasive feelings of shame, guilt and inferiority may lead to an enhanced sense of self-
efficacy. Over time, enhancement of these factors might be expected to play a role in restoration of a 
connection to the sense of self that has been lost through traumatic experiences, and may lead to a sense of 
reconnection with the community as well.  The cultivation of positive emotions through LKM might be also 
particularly helpful for the numbing and constrictive symptoms characteristic of chronic PTSD, which can 
present as feelings of chronic alienation and deadness.  Providing a technique through which positive emotions 
can repeatedly be enhanced, as in LKM practice, may provide an innovative pathway to address these 
numbing and constrictive symptoms.        
While practicing LKM, a person is asked to notice and feel the positive emotion elicited by each of the 
phrases of positive intention, or to notice if there is a sense of reluctance, hesitation, or even aversion for the 
self or another. The practitioner is encouraged to have compassion for these responses and to notice them 
without judgment. More generally, during LKM, when a person becomes distracted by thoughts that arise 
during the practice, they are instructed to notice what has distracted them with an attitude of non-judgmental, 
mindful attention, then return to the LKM phrases and the breath without self-criticism. Walking meditation is 
also used as a method to teach LKM.  Informal LKM practices are also encouraged - participants are asked to 
practice LKM toward themselves or others during everyday activities such as walking, eating, washing the 
dishes, or standing in line at the grocery store.  
LKM and the Broaden-and-Build Theory of Positive Emotions 
The broaden-and-build theory of positive emotions provides a framework for understanding the 
potential influence of LKM practice on affect, behaviors, and quality of life.10, 37  The broaden-and-build theory 
proposes that positive emotions momentarily broaden a person’s attention and thinking, and with this 
broadened outlook they are able to build personal resources. A key postulate in the broaden-and-build theory 
is that positive emotions broaden a person’s thought-action repertoire.37  As described by Fredrickson: “Joy 
sparks the urge to play, interest sparks the urge to explore, contentment sparks the urge to savour and 
integrate, and love sparks a recurring cycle of each of these urges within safe, close relationships.”37 The 
broadened mindset associated with positive emotions is contrasted to a narrow focus often associated with 
negative emotions, and characterized by specific, repetitious thought-action tendencies (e.g., fight or flight).  A 
second key postulate of the broaden-and-build theory is that the broadened mindset associated with positive 
emotions leads to the building of enduring personal resources.  These personal resources are thought to arise 
through new thought-action sequences such as play, curiosity, and openness to new situations and ideas, as 
well as new social interactions. Personal resources built may include cognitive resources (e.g., the ability to 
mindfully attend to the present moment), psychological (e.g., a sense of purpose in life, self-acceptance or self-
compassion, or a sense of environmental mastery) social (e.g., improved ability to give and receive social 

support) or physical (e.g., reduced susceptibility to stress-associated illnesses).10   According to the broaden-
and-build theory, people who have developed these personal resources are more likely to successfully 
navigate life’s challenges and live happier, healthier lives.  
There is growing evidence in support of the broaden-and-build theory.  The ‘broaden’ hypothesis 
predicts that positive emotions broaden a person’s attention and thinking.  Support for this hypothesis comes 
from studies of experimentally-induced positive emotional states (through LKM in some cases as well as 
through other means), which show that positive emotions broaden the scope of a person’s visual attention, 
increases one’s openness to new experiences, improves ability to accept critical feedback, improves ability to 
recognize persons of another race,38 broadens one’s repertoire of desired actions, and enhances a sense of 
connection with others.10 In a randomized controlled trial of LKM vs. a waitlist control (described in detail 
above), the findings supported both the ‘broaden’ aspect (enhanced positive emotions) as well as the ‘build’ 
part of the theory (enhanced personal resources).10  When life satisfaction was assessed as an outcome, 
positive emotions predicted life satisfaction only to the extent that they built personal resources.10  In addition, 
when depression was assessed as an outcome, LKM was found to have direct effects on depressive 
symptoms as well as additional effects mediated by built personal resources.10 The built cognitive, 
psychological and social resources appear to have enhanced the ability of persons randomized to LKM to ward 
off symptoms of depression.  Similarly, in the proposed trial, we hypothesize that personal resources will be 
built as a result of LKM practice, which will positively influence both depressive and PTSD symptoms.  
Mediators 
Identification of active components  of treatments is a priority for treatment research.39  The proposed study will 
evaluate potential mediators of change thought to be specific to each intervention.   
LKM:  We will evaluate whether enhanced self-compassion mediates change in PTSD and depression for 
LKM. Self-compassion can be considered a healthy form of self-acceptance. Neff defines self-compassion as 
comprised of three facets:  (1) treating oneself kindly and without harsh judgment in the setting of pain and 
failure, (2) perceiving that mistakes and hardships are part of the common human experience rather than 
isolating, and (3) maintaining mindful, non-judgmental awareness of thoughts and feelings rather than or 
overidentifying with them.40 Self-compassion is distinct from self-esteem, which is typically defined as an 
evaluative process in which one’s abilities and characteristics are compared to standards.40 Self-compassion is 
also distinct from self-centeredness, because self-compassion acknowledges the ubiquity of pain and hardship 
among humans. LKM is considered a method to enhance self-compassion.  As suggested by our pilot work 
with LKM, we hypothesize that for those in the LKM arm of the study self-compassion will mediate improved 
outcomes for persons with PTSD such that changes in self-compassion will both temporally precede changes 
in PTSD and when they are statistically controlled, the changes in PTSD will be attenuated.  There is initial 
support for this hypothesis from the literature.41, 42 In an analysis of people with a history of major depression 
randomized to a mindfulness intervention or maintenance antidepressants, enhanced self-compassion 
mediated the relationship between participation in mindfulness training and reduced depressive symptoms at 
follow-up.42  The possibility of a key role for self-compassion is consistent with emerging theory and evidence 
that self-compassion is adaptive in the setting of painful or difficult thoughts and feelings. 29, 41 It is also possible 
that changes self-compassion will mediate changes in PTSD for those in the CPT-C arm of the study, but we 
anticipate that these effects will be less robust than for those in the LKM arm of the study. 
CPT-C:  We will evaluate whether reductions in posttraumatic maladaptive cognitions mediates improvement in 
PTSD and in depression for CPT-C. CPT is hypothesized to facilitate improved emotional processing through 
repeated practice restructuring dysfunctional beliefs and appraisals of situations that are related to the 
individual’s trauma history, which lead to painful affect and reactive behavioral choices.43, 44 Reduction of 
posttraumatic maladaptive beliefs is postulated to be a key ingredient in CPT that will mediate improvement. 
Indeed, recent work evaluating whether cognitive change predicts symptom reduction in the context of 
cognitive therapy found support for this idea. Analysis of weekly measures collected during a course of 
cognitive therapy found that changes in posttraumatic cognitions preceded and predicted changes in PTSD 
symptom severity and that changes in PTSD symptom severity did not precede or predict changes in 
posttraumatic cognitions.45 Although this work was done in the context of an alternate cognitive therapy 
intervention, Cognitive Therapy for PTSD, and not CPT, the finding suggests that CPT is also likely to result in 
such changes in beliefs and appraisals that in turn mediate PTSD symptom reduction. The proposed project 
would afford the opportunity to evaluate whether this is the case for Veterans who participate in group-based 
CPT-C. 46 We will also be able to assess whether reductions in maladaptive cognitions also mediates 
reductions in PTSD for those who receive training in LKM. 

The Approach:  What LKM Is and Isn’t 
Having provided an overview of what LKM is, we also believe it is important to delineate it from other 
approaches with which it may be confused. First, although both LKM and mindfulness meditation practices 
involve sitting meditation, typically with closed eyes and an initial focus on the breath, they differ in several 
respects. Mindfulness meditation cultivates the ability to pay attention, without judgment in the present 
moment, whereas LKM specifically develops the ability to experience kindness, warmth, and openheartedness 
toward self and others. The intentionality of LKM is toward developing the ability to experience positive 
emotions, rather than developing non-judgmental awareness. Second, LKM differs from intercessory prayer. 
Although in LKM practice the phrases repeated express the intention of wellbeing for self and others (see 
below), it is made clear that there is no expectation that the LKM phrases will actually benefit others. Instead, it 
is made explicit that the goal of LKM practice is to benefit oneself, such that in developing the capacity to 
experience kindness toward self and others, the person who holds this intention actually benefits. 
Unfortunately the intercessory prayer literature has not evaluated whether praying for others has a salutary 
effect on the people doing the praying, though research on spiritual involvement, including prayer activity, has 
found that Veterans with greater spiritual involvement have better physical and mental health than those with 
less spiritual involvement.47 Third, although LKM involves the repetition of phrases, it is distinct from mantram 
repetition practices, which involve bringing attention to a repeated phrase or word that facilitates 
disengagement from difficult thoughts and feelings, and encourages relaxation.  In LKM, phrases of positive 
intention are utilized as a means to bring forth compassion for self and others, and to foster a broadened 
emotional repertoire. Through the process of practicing LKM with different people in mind, LKM is thought to 
reshape relationships with others, as well as to foster self-compassion. Of note, an additional effect of LKM is 
that in the process of choosing phrases of positive intention (which carry personal meaning for a participant), 
clarification of values and one’s intentions occurs.  LKM is also distinct from practices explicitly intended to 
promote forgiveness, although forgiveness may occur through LKM practice. For the purposes of scientific 
study, we have chosen to not include explicit forgiveness practice as part of our study. In LKM, the practice is 
intended to develop the ability to look at others and see oneself, and in so doing, develop self-compassion and 
compassion for others. An expanded understanding of the commonality of human experience, such that all 
humans suffer and all desire happiness, which is fostered by LKM, is likely to lead to forgiveness. In addition, 
LKM is also distinct from the practice of verbalizing positive affirmations. While there may be some overlap with 
regard to the shared emphasis on positivity, affirmations tend to be stated as though they are definite personal 
qualities and are intended to strengthen self-confidence (e.g., “I am a good, kind person”), whereas LKM is 
usually stated as an invitation or request that is intended to tap into the intention for kindness and compassion 
for oneself and for others (e.g., “may I be safe from harm;” “may you be happy and healthy”). Importantly, 
another way that LKM is distinct from positive affirmations is that LKM is a meditation practice intended to 
broaden attention and allow positive emotions to remain in awareness for sustained periods of time. Finally, 
LKM is not intended to be used to remove painful thoughts or feelings. Rather than attempting to rid oneself of 
these experiences, it is anticipated that individuals with PTSD can learn through LKM that pain can co-exist 
with positive feelings because, after all, it is part of being human to experience both. This may help address the 
phenomenon that we have frequently observed clinically wherein individuals with PTSD are afraid to 
experience positive emotions because it is painful when they end. By re-learning (or learning for the first time) 
that it is safe to feel good and that it is normal to have good feelings (and painful ones) that wax and wane, the 
often profound emotional numbing typically associated with PTSD may be mitigated.48  
Overview of Proposed Interventions 
Intervention #1:  Loving-Kindness Meditation (LKM) 
The LKM course follows the instructions for LKM as described by Salzberg.33 During the12 meetings 
the ten to twelve group participants will receive instruction from two expert meditation teachers (who will co-
teach the sessions) in the practice of LKM, including both in-session practice of LKM and group discussions. 
The intervention is designed to allow patients to adopt skills and techniques they can continue to practice 
without the need for an ongoing relationship with a therapist. LKM is taught in a non-religious format.  A class-
by-class outline is provided in the participant workbook (Appendix 3). 
In order to help develop concentration, a necessary component of LKM practice, the first two sessions 
focus on cultivating mindful attention of one’s breath. The primary LKM practice begins in week 3, and involves 
sitting in a comfortable, relaxed position with closed eyes or a neutral visual focus and then bringing to mind 
various categories of beings – self and others. The meditator is then asked to gently repeat phrases to the 
person who he or she has brought to mind; these phrases are intended to have meaning in terms of what is 
wished for that person. In order to facilitate stepped learning, the class begins their LKM practice focusing on a 

positive benefactor and over the remaining nine weeks other individuals and categories of individuals are 
introduced, including the self and people who have caused the participant difficulty or harm. 
Intervention #2:  Cognitive Processing Therapy (CPT). The CPT intervention is based on Patricia Resick and 
colleagues’ manual for treating PTSD among military veterans.49 This version of CPT highlights both combat traumas 
and interpersonal violence and is therefore more appropriate for our population than the original version, which 
focuses on adult rape survivors. (See CPT manual:  Appendix 4) CPT evolved directly out of Social-cognitive 
Information Processing Theory (SCIPT), which posits that deficits in emotional and cognitive processing of traumatic 
events lead to the development of PTSD.49 The fundamental assumption of the theory is that post-trauma 
psychopathology occurs when there is a failure to integrate perceptions of the traumatic event with preexisting 
beliefs.50 SCIPT posits recovery from a traumatic event occurs when beliefs affected by the traumatic event are 
integrated with prior beliefs.50 Recovery happens when beliefs affected by the event are accurate and realistic and 
negative affect about the trauma is processed. Avoidance symptoms, according to this theory, maintain the other 
symptoms, in that they both prevent the memory of the traumatic event from being integrated with prior beliefs, and 
prevent the examination of inaccurate beliefs affected by the traumatic event.  
CPT combines cognitive restructuring with emotional processing of trauma related content. The therapy 
sessions initially focus on rigid or inaccurate beliefs about the traumatic event itself, which often reflect self-
blame or hindsight bias. Later sessions address over-generalized beliefs about the self and others that result 
from a traumatic event. CPT focuses on over-generalized trauma-related beliefs relevant to five key areas: 
safety, trust, power, esteem, and intimacy. Over the course of treatment, clients learn to identify and modify 
these beliefs in order to develop more balanced, flexible, and ultimately, more adaptive beliefs.  
Cognitive processing therapy (CPT), has been found to be effective in the treatment of PTSD in 
randomized clinical trials conducted by different research teams and with different trauma exposed 
populations, including survivors of sexual and physical assault51 and combat Veterans.52 In these trials, CPT 
was effective in reducing symptoms of PTSD and depression for up to 5 to ten years.51  CPT has also been 
found to be effective in reducing negative emotions such as grief, shame, guilt and anger.51, 52 Based on these 
randomized clinical trials, CPT is being widely disseminated, including to the US Veterans’ Administration (VA) 
mental health system.  
A version of CPT that does not include writing a trauma narrative has also been evaluated, CPT-C, and 
has been found to be associated with more rapid improvement than standard CPT-C as well as comparable 
outcomes to standard CPT.44 The elimination of the trauma narrative makes CPT-C more conducive to a 
group-based delivery platform as it reduces the risk that group participants will be traumatized by one another’s 
stories. CPT-C has recently been shown to be effective in a group format for Veterans, active duty military 
personnel, and reservists with PTSD.6 In a randomized controlled trial (N=107), group CPT-C was compared to 
present-centered therapy (PCT) and the former found to be more effective than the latter in reducing PTSD 
and depressive symptoms in active duty military personal with PTSD.  Between group comparisons showed 
that the CPT-C group had significantly greater improvement in PTSD symptoms than PCT with a medium 
effect size (d=0.42; p = 0.03).6  
Importance of Study Findings to VHA:  The demand for mental health services provided by VHA has grown 
dramatically in recent years - more than a half millions Operations Iraqi Freedom and Enduring Freedom 
(OIF/OEF) Veterans have sought VHA care while the number of Vietnam Veterans receiving VHA mental 
health services has doubled over the past decade.53 PTSD is highly prevalent among Veterans, with 
prevalence rates 14of approximately 20 - 30% of combat Veterans.15 16 A study of approximately 104,000 
OIF/OEF Veterans found that 25% received a mental health diagnosis when they accessed VA health care, 
and of these, 13% were diagnosed with PTSD.54  To respond to the growing demand for mental health 
services, consensus recommendations have identified the need for further research on nontraditional delivery 
systems and group-based interventions to significantly expand the availability of cost-effective therapies.55 
Given the large number of persons with PTSD, not all of whom will opt for or benefit sufficiently from PE or 
CPT, additional cost-effective treatments suitable for broad implementation are needed that address persistent 
symptoms and reduced QOL. Thus, if LKM is shown to be non-inferior to CPT, it would represent a novel, and 
likely cost effective, approach to mental health care delivery.   
A key tenet of patient-centered care is that health care practitioners listen to and honor patient and 
family perspectives and choices. Patient and family knowledge, values, beliefs, and cultural backgrounds are 
incorporated into the planning and delivery of care. This study would provide information to help patients 
decide whether a contemplative practice, such as LKM meditation, presents a viable alternative to a trauma-
focused behavioral intervention such as CPT-C.  

PRELIMINARY STUDIES 
Drs. Kearney, Simpson, Rodgers, and Zhou are an experienced team of investigators that has conducted 
and/or collaborated on numerous interventions for PTSD,56-59 including other studies of a meditation-based 
intervention (MBSR), as well as a pilot study of LKM.60 Additionally, we have utilized innovative assessment 
methodologies to collect measures on a frequent basis. In addition, the research team has experience in 
managing longitudinal data and enhancing participant recruitment and retention in populations that typically 
evidence high attrition. 
LKM for PTSD 
In an open pilot study, 42 Veterans with PTSD (mean age 54 years, 58% male) took part in a once 
weekly, 90 minutes per class, 12-week duration LKM course.60  Measures were obtained at baseline, post-LKM 
and 3 months post-LKM. Analyses calculated standardized mean differences (SMD; with 95% confidence 
intervals) between baseline and post-LKM, and between baseline and 3-month follow-up. Measures included 
assessment of clinical phenomena hypothesized to be broadened by LKM as well as of personal resources 
predicted to be enhanced (built) by repeated LKM practice. Clinical outcomes assessed were PTSD symptoms 
and depression, assessed using the PTSD symptom scale interview (PSS-I)61 and NIH PROMIS measure for 
depression.11  Potentially broadened phenomena assessed included positive emotions, identification with one’s 
symptoms (decentering), and executive cognitive function (attention allocation). Personal resources with the 
potential to be ‘built’ through LKM were assessed, and are summarized in the table below. Using procedures 
recommended to assess mediation in within-subject designs, the influence of self-compassion (assessed by 
the self-compassion scale; SCS40) as a potential mediator of change in PTSD symptoms and depression, 
between baseline and follow-up was analyzed. Results: Compliance with the intervention was high; 86% 
attended 5 or more classes, and 74% attended 9-12 classes.  Additionally, compliance with the research 
protocol was high, with 38 of 42 participants (90%) providing data at the post-test and at the 3-month follow-up. 
Effect sizes (SMD) are presented in Table 1 below: 
Table 1. Results of LKM intervention for Veterans with PTSD 
  
Baseline to Post-LKM 
Baseline to 3-month f/u 
  
SMD 
95% CI 
SMD 
95% CI 
Measures of Broadened Experience 
 
 
 
 
 
 
 
 
Attention Network Test62 
 
 
 
 
 
 
 
 
Alerting 
0.41 
-0.04 − 0.87 
0.56 
0.09 − 1.04 
Executive control 
-0.61 
-1.07 − -0.14 
-0.88 
-1.37 − -0.39 
Emotions (Circumplex Measure)63 
 
 
 
 
 
 
 
 
Activated Pleasant 
0.31 
-0.14 − 0.77 
0.37 
-0.08 − 0.83 
Unactivated Pleasant 
0.77 
0.30 − 1.24 
0.76 
0.29 − 1.23 
Activated Unpleasant 
-0.68 
-1.14 − -0.21 
-0.73 
-1.20 − -0.26 
Unactivated Unpleasant 
-0.46 
-0.92 − 0.00 
-0.55 
-1.01 − -0.09 
Decentering (Experiences Questionnaire)64 
0.88 
0.41 − 1.34 
0.99 
0.52 − 1.45 
Potential ‘Built’ Resources 
 
 
 
 
 
 
 
 
Mindfulness (FFMQ)65 
0.79 
0.33 − 1.25 
0.60 
0.15 − 1.05 
Self-Compassion Scale (Total)40 
0.82 
0.36 − 1.28 
0.94 
0.48 − 1.41 
Psychological Wellbeing Scales66 
  
  
  
  
  
  
  
  
Purpose in Life 
0.62 
0.16 − 1.09 
0.71 
0.25 − 1.18 
Environmental mastery 
0.39 
-0.06 − 0.85 
0.63 
0.17 − 1.09 
Sense of Support Scale (Total)67 
0.55 
0.10 − 1.00 
0.38 
-0.07 − 0.83 
Clinical Outcomes 
 
  
 
 
 
 
 
PTSD symptoms (PSS-I)61 
-0.74 
-1.20 − -0.28 
-0.89 
-1.35 − -0.43 
Depression (NIH PROMIS)11 
-0.34 
-0.78 − 0.10 
-0.49 
-0.94 − -0.04 
Note: Bolded values indicate significant changes from baseline to post-test or 3-month follow-up. 
 
These results indicate that following involvement in the LKM intervention, the participants showed both 
broadening via improvements in attention allocation, increases in less activated positive emotions (i.e., calm, 

serene, content, relaxed), a decrease in unpleasant emotions (activated and deactivated) and increased ability 
to decenter or detach from identification with their symptoms.  The results also demonstrate an increase in built 
personal resources, including improved self-compassion, mindfulness, sense of purpose in life, environmental 
mastery, and sense of social support. In addition, a large effect size was found for PTSD symptoms from 
baseline to 3-month post-LKM (d = -0.89), and a medium effect size was found for depression from baseline to 
3-month follow-up (d = -0.49). Mediation analyses showed that self-compassion mediated changes in PTSD 
symptoms and depression. Conclusions:  LKM appears safe and acceptable for Veterans with PTSD, and is 
associated with reduced symptoms of PTDS and depression.  We also found evidence that participation in 
LKM is associated with an increase in key personal resources suggested by Fredrickson’s broaden-and-build 
theory.   
Other Studies of Meditation Interventions for PTSD:  Mindfulness-Based Stress Reduction (MBSR) 
Drs. Kearney and Simpson have performed two pilot studies of MBSR for PTSD.   
Pilot Study #1:  Relationship between MBSR participation, PTSD symptoms and QOL (PI: Kearney, 
Co-I: Simpson).57  Measures of mental health and QOL were examined before and after participation in 
MBSR, delivered in groups of 20-30 Veterans representing a mix of clinical and research patients.  Of 
92 subjects (22 female), nearly three-quarters screened positive for PTSD.  Results:  The mean 
number of class sessions attended was 5.7 ± 2.83, out of 9 possible classes.  Sixty-nine participants 
(74%) attended at least 4 class sessions. Main results are presented below in Table 2.  
Table 2. Mean summary scores and Cohen's d effect sizes with 95% CI for main outcome measures 
Summary scores 
Baseline 
mean ±SD 
(n=92) 
Post-
Treatment 
mean ±SD 
(n=74) 
4-month 
Follow-Up 
mean ±SD 
(n=66) 
Standardized Mean 
Difference:  
Baseline to Post-Tx 
(95% CI) 
Standardized Mean 
Difference:  
Baseline to 4 mo f/u  
(95% CI) 
PCL 
52.4 ± 16.3 
43.4 ± 16.3* 
41.9 ± 16.8* 
-0.55 (-0.87 to -0.24) 
-0.64 (-0.96 to -0.31) 
SF-8 MCS 
33.2 ± 10.6 
40.3± 12.3* 
41.3 ± 12.2* 
0.62 (0.31 to 0.93) 
0.72 (0.39 to 1.04) 
FFMQ 
108.0 ± 25.3 
126.2 ± 27.7* 
127.9 ± 26.1* 
0.69 (0.38 to 1.01) 
0.78 (0.45 to 1.11) 
P values assessed using repeated measures ANOVA with planned contrasts 
*P < .001      PCL = PTSD checklist     SF-8 MCS:  Mental Component Summary score of SF-8  FFMQ:  Five Facet Mindfulness Questionnaire 
We also found evidence of mediation of change in PCL and MCS at 4-month follow-up by mindfulness 
skills from baseline to post-test, as assessed by the Five Facet Mindfulness Questionnaire (FFMQ). Overall, 
pilot study #1 found that Veterans who took part in MBSR had improvement in measures of PTSD and mental 
health-related QOL over 4 months follow-up, that mindfulness skills increased significantly, and that increased 
mindfulness skills mediated changes in key outcomes. 
Pilot Study #2:  A Randomized Controlled Pilot Study of MBSR for Veterans with PTSD.  A randomized 
controlled pilot trial of MBSR compared to Treatment as Usual (TAU) for Veterans with PTSD.56 (PI: Kearney, 
Co-I: Simpson) 47 Veterans with PTSD 
were randomized to MBSR (n = 25) or TAU 
(n = 22). Each was assessed at baseline, 2 
months (post-treatment), and 4 months after 
completion of MBSR.  The modal number of 
classes attended by Veterans randomized 
to MBSR was 9 (all 8 weekly sessions plus 
the Saturday session).  The figure below 
shows mean summary scores for PTSD 
symptoms (PCL) and Mental Health QOL 
(MCS) with 95% CI for Veterans 
Randomized to MBSR (n=25) or TAU (n=22).  
In intent-to-treat analyses, between group effect sizes, Cohen’s d; (95% CI) were, for PCL: at 2 months, 
-0.51; (-1.12 to 0.11), at 4 months, d = -0.42, (-1.03 to 0.20).  For MCS: at 2 months 0.69, (0.07 to 1.32), at 6 
months, 0.57 (-0.06 to 1.2).  For FFMQ: d = 0.65; (0.03 to 1.27), at 6 months, 0.67 (0.04 to 1.31).  Overall, pilot 
study #2 showed: 1. Veterans with PTSD are willing to undergo randomization in a trial involving a meditation 
intervention; 2. A high rate of compliance with MBSR, and 3. Relative to TAU, in intention-to-treat analyses, 
significant improvement in health-related QOL at immediate post-test, and significant improvement in 
mindfulness skills.   
40
45
50
55
60
65
70
0
2
4
6
PCL Score
MBSR
TAU
Baseline
2-month
6-month
Assessment
20
25
30
35
40
45
50
0
2
4
6
MCS-8  Score
MBSR
TAU
Baseline
2-month
6-month
Assessment
MBSR               TAU

Additional Ongoing Randomized Controlled Trial of MBSR  
          We are conducting a study titled “A randomized controlled pilot study of a mindfulness-based 
intervention for Gulf War Syndrome,” funded as a VA merit review.  (Co-P.I.’s Dr. Kearney and Dr. S. Hunt, 
with Dr. Simpson is a co-investigator). The goals are to establish feasibility and collect efficacy data regarding 
MBSR for Veterans with medically unexplained illnesses (Gulf War Syndrome). Outcomes include fatigue, 
pain, cognitive failures, and neuropsychological testing.  PTSD, depression, and QOL are also assessed.  
Recruitment and follow-up has been completed and data analysis is underway. This project allowed us to 
refine recruitment methods that consistently resulted in recruitment of 6-8 Veterans per month with Gulf War 
Syndrome - a relatively uncommon condition.  The rate of recruitment in this study is approximately the same 
as will be required for the current grant application.    
Additional Experience with Treatment Outcome Studies 
• 
Randomized Clinical Trial Evaluating Prazosin for Alcohol Dependence (AD). Dr. Simpson conducted a 6-
week, double-blind, placebo-controlled pilot study to evaluate prazosin for alcohol dependence.68 
Participants entering treatment for alcohol dependence (AD) were randomized (N=24) and completed IVR 
telephone monitoring once per day to provide reports of alcohol use and cravings. Twenty of the 24 (83%) 
completed the trial. The compliance rate on the IVR daily monitoring for the 20 completers was 94.5%. Dr. 
Simpson is currently extending this research in an NIAAA-funded R01 evaluating prazosin for AD and as 
part of an NIAAA funded center P20 evaluating prazosin for individuals with comorbid PTSD and AD 
(R01AA017184, PI: Simpson; P20 AA017839-01, Center PI: Saxon; Study PI: Simpson). Both studies use 
daily Interactive Voice Response (IVR) monitoring to collect close to real-time information regarding 
drinking, mood, PTSD (P20 only), and medication compliance. 
• 
IVR Daily Monitoring of Reducing Alcohol Use & PTSD w/ Cognitive Restructuring and Experiential 
Acceptance. Dr. Simpson (PI) and colleagues have completed recruitment for a study examining use of 
IVR to evaluate mechanisms of change associated with two coping strategies, experiential acceptance and 
cognitive restructuring, as compared to an attention control, for decreasing alcohol use and PTSD in 
PTSD/AUD individuals (n = 78). Preliminary results indicate that the overall follow-up rate and IVR 
compliance rate are both 91%. These findings support the feasibility of using frequent monitoring strategies 
and demonstrate our ability to recruit and retain individuals with pronounced psychiatric impairment (1 R21 
AA 17130-01, PI: Simpson). 
Summary of Preliminary Studies  
 
Our previous research demonstrates: (1) empirical support for a relationship between participation in LKM 
and reduced PTSD symptomatology and reduced depressive symptoms; (2) that Veterans with PTSD can 
safely participate in LKM, and find the intervention acceptable; (3) our ability to successfully screen, recruit and 
retain Veterans with PTSD in clinical trials; (4) support for our ability to collect and effectively analyze  frequent 
monitoring data in PTSD populations; Together, these examples of our past accomplishments indicate that we 
have a strong team with relevant experience and expertise that is capable of carrying out the proposed work 
and thus adding important information to the knowledge base regarding treatment options for Veteran with 
PTSD. 
APPROACH 
Design Overview and Rationale 
The proposed study is a randomized controlled non-inferiority trial comparing Loving-Kindness Meditation 
(LKM) with Cognitive Processing Therapy – Cognitive only (CPT-C) for treatment of PTSD and depression 
among Veterans recruited from the VA Puget Sound Health Care System. Veterans (N = 170) with PTSD will 
be randomized to receive 12 weeks of either LKM (n = 85) or CPT-C (n = 85).  The two interventions are 
structurally similar - Each intervention meets for 90 minutes per week for twelve weeks; the overall amount of 
treatment time is the same across the two interventions. Both interventions will be delivered to groups of 
Veterans by experienced leaders, and fidelity coding from audiotapes will evaluate protocol adherence. 
Participants will complete brief online assessments weekly for the 12-week duration of the active treatment 
phase to assess key outcomes, potential mediators of change, and completion of homework assignments. All 
participants in each study condition will complete an in-person baseline assessment, which will be repeated 
immediately after the treatment phase as well as 3- and 6- months post-intervention.  In-person assessments 
will be performed by a blinded assessor.  
Use of an Active Control Arm:  The active control will account for the non-specific elements of LKM (e.g., 
group support, positive expectancy). The proposed control arm is CPT-C, which will provide the same amount 
of clinician-exposure time (it is also a group-based, 12-week duration, 90-minute per session program).  Similar 

to LKM, CPT-C is taught by experienced instructors who believe in the benefit of the program; allegiance of the 
researcher/therapist has been shown to be strong predictor of treatment outcomes.69  CPT-C therefore 
contains key elements of an active control – it is structurally similar to LKM (thus controlling for non-specific 
elements of the intervention) and given that it is an accepted PTSD treatment, CPT-C will foster positive 
expectation for intervention success by both therapists and patients.  Each of these elements has been 
described as necessary for an appropriate active control.70  
Settings, Recruitment, and Participants 
Settings. The study’s clinical activities will take place at VAPSHCS; Seattle Division. In FY10 over 17,700 
Veterans with chart diagnoses of PTSD received care at VAPSHCS and over 10,000 of them had a mental 
health stop code, indicating that the majority were likely invested in addressing their PTSD symptoms. VA 
Puget Sound has the nation’s largest clinical program for PTSD.   
Recruitment. The primary mechanism of recruitment will be letters sent to Veterans with a diagnosis of 
PTSD (as identified using a VA database called the Corporate Data Warehouse; CDW).  To illustrate the 
effectiveness of this method, we are currently conducting a trial of MBSR for Gulf War Syndrome (see 
preliminary studies) for which we are already successfully recruiting at the same rate as for the proposed RCT.  
Thus, the goal of recruiting 8 Veterans per month with PTSD is feasible given the large pool of Veterans with 
PTSD.   
Participants. Based on our experiences recruiting individuals with PTSD for LKM and MBSR research, we 
anticipate that we will need to conduct phone screens with approximately 350 individuals and in-person 
screening. We anticipate that we will enroll at least 250 male and female Veterans over age 18 with a current 
DSM-IV diagnosis of PTSD enrolled at VAPSHCS who will provide informed consent and undergo in-person 
screening.  Of these, we anticipate that 170 individuals with PTSD who meet study criteria will be randomized. 
Gender and ethnic/racial distribution of the participants is expected to mirror that of our prior PTSD MBSR 
studies in which similar recruitment strategies were used; that is 40% female, 79% Caucasian, 8% African 
American, 6.5% Hispanic, and 6.5% other.  
Inclusion and Exclusion Criteria. Inclusion criteria: current DSM-IV diagnosis of PTSD, age  18 years, and 
English fluency. Participants must be willing to not participate in Mindfulness-Based Stress Reduction (MBSR) 
or other meditation/yoga programs, as well as Prolonged Exposure (PE) therapy during the study period. 
Exclusion criteria: current substance use dependence disorder other than alcohol; alcohol involvement that 
poses a safety concern (i.e., currently drinking and has a past year history of alcohol-related seizures or 
delirium tremens) or is associated with an inability to follow through on assessments and class attendance as 
evidenced by past month appointment attendance recorded in CPRS, suicide attempt or suicidal ideation with 
intent or plan, self-harm in the past month, a psychotic disorder, uncontrolled bipolar disorder, chart diagnoses 
of borderline personality disorder or antisocial personality disorder, in-patient admission for psychiatric reasons 
within the past month, prior participation in MBSR, LKM, or CPT. Medication, supportive individual or group 
counseling, case management, and self-help programs will be allowed concurrently and assessed as potential 
covariates. Note: we will use DSM-V criteria for all inclusion/exclusion criteria and relevant outcomes when 
they become available. 
Sequence of Study Visits 
Telephone Screen. Veterans who contact the Project Manager will be provided an overview of the study. 
Veterans who remain interested will undergo a 15-20 minute telephone screen to ascertain basic 
inclusion/exclusion criteria.  
In-person Screen and Baseline Assessment. Following informed consent, participants will undergo a 2-
hour assessment. The Study Assessor will conduct standardized interviews for the presence of exclusionary 
disorders (relevant subsections of the MINI International Neuropsychiatric Interview) and for diagnosing PTSD 
(Clinician Administered PTSD Survey; CAPS).71 Self-report measures will be administered on a VA-approved 
computer.  Those who are eligible to continue the study will receive their randomization assignment within 
approximately one week and will begin either LKM or CPT-C within one month.  
Weekly Online Assessments. Participants will complete brief online measures of PTSD and depressive 
symptomatology, the hypothesized mediators of change (self-compassion and maladaptive posttraumatic 
cognitions), and homework activity for 12 weeks during the active treatment phase. 
Follow-up Assessments. Participants will complete a post-treatment assessment within a week of 
completing LKM or CPT-C, and will repeat the assessment battery 3- and 6-months thereafter.  
Randomization 
We will utilize a blocked randomization approach stratified by symptom severity on PTSD because our pilot 

studies indicate that those who score in the severe range (60 or higher)71 on the PCL decrease their PTSD 
symptoms more than those with less severe PTSD but are still more symptomatic at immediate post-test. 
Baseline severity of PTSD will be dichotomized based on CAPS scores > 59. Because our pilot data did not 
suggest that severity of depression moderated outcome, we will not include that in the randomization 
stratification. Similarly, we chose not to stratify on gender because our pilot data indicate that this factor is not 
predictive of PTSD symptoms at follow-up. A series of randomization tables will be constructed and will be 
maintained by the research coordinator. Subjects will be randomized in small blocks of varying size using 
concealed allocation, after the baseline assessment and within two weeks before the next study cohort is set to 
begin treatment.   
Study Interventions:  
#1 LKM Course Overview 
Prior to starting the LKM course, each participant randomized to LKM will attend an orientation session 
during which they will view a 30-minute video72 that describes the LKM intervention for PTSD and have the 
chance to ask questions about the course. The video follows five Veterans through their experiences in the 
LKM class, showing how each incorporated the practices into their own lives and were variously affected by 
them. This orientation session will also provide the Veterans with an opportunity to ask questions and air any 
concerns they may have about the LKM class or the research. 
Each class meeting will begin with either a brief mindfulness meditation (weeks 1 and 2) or an LKM 
meditation followed by an opportunity for participants to discuss their experiences integrating LKM class 
material into their daily lives. New material will then be presented, typically introducing a new category of 
beings (i.e., benefactor, oneself, strangers, etc.) and particular challenges associated with working with that 
category of beings will be discussed. The class will then practice LKM incorporating the new category and then 
discuss the experience. At the end of each class the homework for the next week will be presented and class 
will end with another brief LKM practice. Participants will be provided with an LKM meditation CD and a 
workbook to accompany the class. (See appendix 3, LKM manual, for additional details). An overview of the 
class schedule is provided below: 
Classes 1 and 2 provide an introduction to in mindfulness meditation.  
Class 3 introduces LKM, including the LKM phrases and a description of the meaning of each phrase.  Begin 
LKM practice toward a benefactor, which is defined as a person who has been kind or helpful and for whom 
there is gratitude, and respect. Participants will be asked to recall the ways this benefactor has helped them, 
and the goodness within this person.  
Class 4 introduces the theme of commitment to our own happiness as a basis for intimacy and connection with 
self and others. Exercise: “Remembering the good within you” (Instructions: “For 10-15 minutes call to mind 
something you have said or done that was a kind or good action”). Acknowledgement and discussion of the 
finding that LKM toward our self is often difficult. If participant is unable to practice LKM toward self, suggestion 
of the concept that underlying all action is a desire to be happy – this may provide a method of noticing 
kindness toward oneself that already exists; this may act as a starting point for feeling positive emotion for 
oneself. LKM toward benefactor and self with the 4 phrases.  
Class 5 begins with a discussion of homework - LKM in the previous week toward a benefactor and self. 
Introduction of walking meditation and the concept of a beloved friend (may be a person or an animal).  
Class 6 begins with a discussion of how it is often more difficult to practice LKM toward self as compared to a 
benefactor or beloved friend. Examination of how our life experiences up to this point may affect our 
experience practicing LKM.  
Class 7 introduces the concept of a neutral person – someone we do not strongly like or dislike. Perhaps this is 
a person we do not know well. This may bring up the awareness that this may be difficult because of the 
judgments we hold for people around us as well as pervasive fears and mistrust.  
Class 8 begins with a discussion of homework - LKM to a neutral person. Have your feelings for that person 
changed? Introduction of a difficult person: a person with whom we have experienced conflict and toward 
whom we feel anger or lack of forgiveness. This could be someone who has been unsupportive or who 
responded to us in ways that were not helpful when we needed them. At this stage, participants will be 
instructed at this stage to not choose the person who has caused them the most pain or suffering in their lives 
– while acknowledging that this is a suggested goal of LKM practice. Discussion of how practicing LKM does 
not mean a sentimental love toward that person, as well as a discussion of anger – how it can serve the 

purpose of setting boundaries and can challenge injustice, but can also cause suffering for the person who 
holds anger as well as for the person who receives it.  
Class 9 introduces the difficulties involved in LKM to a difficult person. Discussion: When you are feeling anger, 
who is the person suffering from anger? Include discussion that LKM toward difficult person is actually 
compassionate toward oneself, because it promotes letting go of this anger. Introduction of concept of difficult 
aspects of oneself, including painful feelings, thoughts, memories, and symptoms. What aspects of ourselves 
do we reject and feel anger or hatred toward?  
Class 10 provides opportunity for further discussion of LKM toward difficult person. Introduction of LKM toward 
groups. Discussion of how we often accumulate biases or prejudices toward groups or categories, and these 
biases are often not in our conscious awareness. Practice LKM toward complementary sets of groups, with 
discussion of whether participants feel an affinity or sense of unease practicing LKM toward one part of a 
group. Examples of groups include: males/females, young/elderly, Veteran/civilian, all those known to me/all 
those unknown to me, those near/those far.  
Class 11 begins with discussion of LKM toward groups, with an emphasis on whether unconscious affinity or 
bias was detected in the ability to practice LKM.  
Class 12 begins with discussion of walking meditation. Introduction of LKM for all beings. Discussion of 
different categories of beings as appropriate for each person – alive or dead, human or animal. Practice LKM 
toward self, friend, benefactor, neutral person, difficult person, groups, toward all beings. 
Homework for those randomized to LKM homework will consist of 30 minutes of sitting or walking 
mindfulness (first two weeks) or LKM meditation facilitated by CD recordings with new categories of beings 
added as described above. Participants will also be instructed to identify opportunities for informal LKM 
practice each week.   
#2 CPT-C Course Overview.  
CPT-C will be led by clinicians who will be contracted by the grant to deliver this service. The group co-
leaders will all have completed the VA’s CPT-C training and certification program or the equivalent in the 
community. In addition, these clinicians will go through the necessary background checks and credentialing 
procedures prior to having contact with any Veterans.  
Those randomized to CPT-C will attend a 45-minute session to watch the VA’s 15 minute video73 
describing CPT-C and to have the opportunity to ask questions. The video describes individually delivered CPT 
that includes the standard trauma narrative. During the CPT-C orientation it will be explained to study 
participants that this element of the treatment will not be included and that studies have shown that people 
have equally good outcomes without it.  Although not a standard element of CPT-C, this orientation session will 
parallel that provided for LKM. Those assigned to CPT-C will then attend weekly 90 minute group therapy 
sessions for 12 weeks. Treatment will be provided in groups of 10 to 12 male and female Veterans with PTSD. 
Session 1 provides an introduction to CPT-C and education about both PTSD as a response to trauma and 
how trauma exposure can lead to distorted thinking and beliefs. Patients are oriented to the Impact Statement 
homework.  
Session 2 draws from the Impact Statement homework and reviews how patients are currently framing the 
meaning of their index trauma with regard to its impact on their lives in the following areas: safety, trust, 
power/control, esteem, and intimacy. The concept of trauma-related cognitive “stuck points” is introduced.  
Session 3 introduces a basic cognitive therapy overview of the relationship between thoughts and feelings 
prompted by triggering events through the ABC sheet (A = activating event; B = beliefs; C = consequences). 
Session 4 elaborates on the idea of “stuck points” (e.g., “I am damaged goods;” “I’m a failure because I 
couldn’t save my best buddy,” etc.) that may have arisen as a result of the trauma exposure and each group 
member is assisted in identifying their own specific “stuck points.”  
Session 5 provides a standard list of challenging questions that patients use to help themselves identify stuck 
points.  
Session 6 provides an overview of common patterns of problematic thinking (e.g., all/none thinking, confusing 
feelings with facts, etc.). The Challenging Beliefs Worksheet is introduced in this session.  
Session 7 provides further instruction on the use of the Challenging Beliefs Worksheet.  
Session 8 reviews the safety module and patients are instructed to focus on at least one safety-related issue 
when completing worksheets for homework.  

Session 9 reviews the trust module and patients are instructed to focus on at least one trust-related issue when 
completing worksheets for homework.  
Session 10 reviews issues related to power/control and patients are instructed to focus on at least one 
power/control-related issue when completing worksheets for homework.  
Session 11 reviews self- and other-esteem issues and patients are instructed to focus on at least one esteem-
related issue when completing worksheets for homework and to write their final impact statement.  
Session 12 reviews intimacy issues and the patients’ current sense of the event’s meaning. 
Homework for those randomized to CPT-C will consist of 30 minutes of CPT-C-related homework 6 days a 
week including writing an impact statement at the beginning and the end of treatment, completing CPT-C 
worksheets, and completing exercises regarding safety, trust, power/control, esteem, and intimacy.   
Procedures for Maximizing Research Integrity and Patient Safety  
LKM Fidelity. The LKM teachers are highly experienced meditation teachers with experience teaching 
meditation to Veterans with PTSD at VAPSHCS.  These teachers currently teach LKM groups and 
Mindfulness-Based Stress Reduction (MBSR) groups at VAPSHCS, which are offered as hospital-wide clinical 
programs.  These teachers have extensive personal experience involving LKM. LKM is also included as a 
small component of the MBSR program, although the primary focus of MBSR is on mindfulness meditation. 
Each of these teachers is employed as a WOC-status contract employee, and meets stringent foundational 
teacher training requirements for MBSR, which we also apply to LKM teaching requirements: longstanding 
practice of mindfulness and loving-kindness meditation, experience with a body-centered awareness practice, 
attendance at silent mindfulness meditation retreats of at least 7 days duration, completion of the University of 
MA Center for Mindfulness Residential Training/Retreat as well as a teacher practicum in MBSR.  We believe 
that these teacher training requirements and prior experience teaching MBSR will be directly applicable to 
high-quality teaching of LKM. 
To assure quality control, Dr. David Kearney will review at least 2 early session tapes from each LKM 
cohort to provide supervisory feedback. Teaching responsibilities will be shared by Carolyn McManus, PT, MA 
and Jonas Batt, MA, MHC, both of whom currently teach LKM at VAPSHCS.  They will co-teach the LKM 
courses to provide different perspectives and gender balance across the facilitators. If either of these teachers 
becomes unavailable, there are 3 additional experienced mindfulness and loving-kindness meditation teachers 
who are currently teaching other meditation classes at VAPSHCS who will be available to teach LKM. A subset 
of 20% of LKM classes will be coded for protocol adherence by two independent raters (see Appendix 5). 
Adherence and competence will be measured using treatment fidelity ratings based on the LKM curriculum. 
Our pool of undergraduate raters will be trained by Dr. Kearney, who will provide ongoing supervision 
regarding fidelity ratings.  
CPT-C Fidelity. CPT-C group leaders selected to provide CPT-C will have completed either the VA’s 
national rollout dissemination training and certification process or the community equivalent, and thus will have 
had at least 6 months of supervised experience delivering CPT-C. They will also be employed as WOC 
contractors. The CPT-C supervisor will be Dr. Carie Rodgers is a national trainer in CPT for the VA National 
Center for PTSD who was trained by CPT originator, Dr. Patricia Resick and has extensive experience both 
delivering group-based CPT-C herself within VHA and supervising others.. She will provide weekly supervision 
based on both review of session tapes and oral reports from the group co-leaders to assure real-time quality 
control of CPT-C delivery. 
A random subset of 20% of each group’s 12 sessions will be coded for protocol adherence and 
competence by two independent raters from our pool of undergraduate raters (see Appendix 6 for coding 
forms). Adherence and competence will be measured using established published measures of CPT-C 
treatment fidelity. Raters will be trained by Dr. Galovski (CPT-C) with ongoing supervision provided by Dr. 
Rodgers.  
CAPS Interview Fidelity. The Study Assessor will a be master’s level clinician who will undergo training on 
the CAPS interview by Dr. Simpson. Dr. Simpson will listen to at least 5% of the CAPS interviews to provide 
ongoing supervision. Also, a random subset of 5% of the CAPS assessments will be coded for adherence and 
competence by two independent raters. Raters will be trained by Dr. Simpson. 
Maintaining the Assessment Blind. The Study Assessor will be kept blind to participant condition: 
participants will be reminded not to disclose treatment assignment, and other study personnel will avoid 
communications that could provide such information.  
Procedures for Maximizing Retention. Participants will update contact information at each visit and will be 
paid $20 for baseline, post-test,  $30 for the 3- and 6-month assessments, and $5 per week for the 12 online 

assessments. The maximum remuneration is $160 per enrollee. Frequent contact maximizes participant 
retention.74  
Project Management. We will utilize web-based software, including a dedicated Sharepoint portal, to 
ensure coordination among study team members and reliable participant tracking.  
Electronic Data Capture. We will utilize the version of Survey Monkey that conforms to VHA privacy and 
security requirements to create user friendly electronic versions of our measures that participants will complete 
either using VA desktop computers during the in-person major assessment appointments. Similarly, the Study 
Assessors will administer the interview portions of these assessments using Survey Monkey templates. Study 
participants will be able to login to complete the Survey Monkey weekly assessments from home or other 
Internet access points (paper-and-pencil options will be available for the various self-report measures, 
including the weekly measures). This method of collecting data will ensure that items that are skipped are 
intentionally skipped, thus cutting down on missing data. It will also reduce the need for manual data entry, 
thereby decreasing the risk of introducing human error into the dataset and increasing the efficiency of moving 
from data collection to data cleaning and analysis.  
Maintaining Participant Safety.  Participants will be provided a phone number to call if they require 
psychiatric assistance, as well as the local county crisis clinic phone number.  See also Appendix 7 for a full 
description of safety procedures. 
Study Instruments and Materials (Table 3; see Appendix 8 for study measures) 
 
Study Construct/Variables 
Study  
Phase 
 
   Measurement Scale 
 
Purpose 
Inclusion/Exclusion Criteria 
Demographic information 
B 
 
sample description, blocking 
(gender); moderators 
MINI International Neuropsychiatric 
Interview V-5 (DSM-IV)76 
B 
dichotomous 
sample description, exclusion 
Medical history interview (seizures, DT’s) 
B 
dichotomous 
exclusion 
Tracking 
Contact form 
B,P,3,6 
 
retention 
Primary Outcomes 
Life Events Checklist77 
B 
dichotomous 
inclusion (establish Criterion A) 
Clinician-Administered PTSD Scale    
   (CAPS)71  
 
NIH PROMIS depression measure11 
B, P,3,6 
 
 
 
B,P,3,6 
continuous 
 
 
continuous 
 
inclusion, blocking, primary 
outcome 
 
 
primary outcome 
Mediation Analyses 
Self-Compassion Scale-Short Form78  
B, W,P,3,6 
continuous 
mediation analyses 
Posttraumatic cognitions inventory79 
B,W,P,3,6 
continuous 
mediation analyses 
PTSD Checklist; Civilian Version (PCL-
C)80 
B,W,P,3,6 
continuous 
mediation analyses, secondary 
outcome measure 
NIH PROMIS depression measure (static 
version-SF8a)11 
B,W,P,3,6 
continuous 
mediation analyses, secondary 
outcome measure 
VA mental health care 
Corporate data warehouse mental health 
psychotherapy and medication 
management stopcodes 
9-month post-
baseline interval 
dichotomous  
& continuous 
check on VA mental health 
services received by both 
conditions 
CPRS review for engagement in mental 
health treatment 
9-months post-
baseline  
dichotomous 
check on whether either PE or 
CPT was obtained during study 
Baseline (B), Post-test (P), Weekly, 3- and 6-month Assessments 
Overview of Outcome Measures Chosen, and Further Description of Measures   
We have chosen the following measures in order to assess outcomes for the aims of this study, 
including PTSD symptomatology, depression, and potential mediators.  The weekly monitoring phase will 
record the amount of homework practice completed (for both LKM and CPT-C), in order to provide the ability to 
assess whether homework practice is predictive of improved outcomes.   

PTSD Symptoms. Participants’ PTSD symptomatology will be assessed using the Clinician-Administered 
PTSD Scale (CAPS) and the PTSD checklist (PCL).   
The CAPS is the primary outcome measure.  The CAPS requires a clinician to rate 17 diagnostic 
symptoms of PTSD, as defined by DSM-IV criteria. (Note: because a new version of the DSM is due out in May 
2013, we will update our inclusion/exclusion criteria and the main outcome assessment materials once DSM-V 
is made available). The CAPS gives both a continuous measure of PTSD severity and a dichotomous 
diagnosis of PTSD. The psychometric properties of the CAPS have been evaluated in several studies and 
have been found to be excellent.71 The CAPS takes approximately 45 minutes to complete and will be 
administered at baseline, week 8, and at each major assessment (post-LKM/CPT-C, 3- and 6-months). 
The PCL-C is a 17-item self-report measure that correlates highly with scores derived from the Clinician 
Administered PTSD Scale (CAPS).80 The PCL has good internal consistency, item-total correlations, 
concurrent and convergent validity, and test-retest reliability.  Each item is rated by the patient on a scale of 1 
to 5, and the total score of the PCL is calculated as the sum of the all the items.  Higher scores reflect more 
severe PTSD.59 The PCL will be administered during the weekly monitoring phase in order to allow 
assessment of clinical outcomes as part of mediation analyses, and will be included at weekly time points 
(post-LKM/CPT-C, 3- and 6-months) as a secondary outcome measure. 
Traumatic events. The number and type of traumatic events sustained over the course of each the Veteran’s 
life will be assessed using the Life Events Checklist (LEC).  The LEC assesses lifetime history of exposure to 
a wide range of potentially traumatic events.77  The LEC will be used to describe the study population, and to 
establish PTSD diagnostic status as part of the inclusion criteria. 
Depression. The depression measure at each time point will be from the NIH-sponsored Patient-Reported 
Outcomes Measurement Information System (PROMIS) assessment suite. PROMIS was developed in 
order to measure patient-reported outcomes using item response theory (IRT) and computerized adaptive 
testing (CAT) which allows for efficient, psychometrically robust assessment of patient-reported outcomes in 
clinical trials involving a wide range of chronic conditions, and they have been validated in over 21,000 
persons.11, 81 CAT is a method by which the items administered are adaptive to the health status of the subject, 
i.e., the instrument used is not “static” for each subject. Using CAT and IRT, the PROMIS measures are 
designed to gain the maximal information content from each question by gauging the point of disease severity 
a question is most efficient.  The greater precision gained by use of these techniques has been estimated to 
allow reduction in sample size requirements by up to half compared with “static” pen and paper instruments.81  
Most PROMIS item banks utilize a 7-day recall period.  These measures utilize item-response theory82 and 
computerized adaptive testing (CAT), in order to provide a high degree of precision. Using CAT, each domain 
measures average 5-8 questions in length and takes only 1-2 minutes to complete. We will utilize the CAT 
version of the PROMIS depression measure for the major assessment points, and the static version of the 
PROMIS depression measure (SF8a) at the weekly assessments (using Survey Monkey for electronic data 
capture).   
Self-compassion. The Self-Compassion Scale – Short Form (SCS-SF)78 is a 12-item measure of self-
compassion (see also broaden-and-build section of background/significance).  It has been shown to be reliable 
(Cronbach’s alpha = 0.86) and to have a very high degree of correlation (r ≥ 0.97) with the longer and 
previously validated self-compassion scale.40 
Posttraumatic Cognitions Inventory (PTCI).79 The PTCI is a 36-item measure that assesses trauma-related 
thoughts and beliefs including negative cognitions about self, about the world, and self-blame. Items are rated 
on a 7-point scale ranging from “totally disagree” to “totally agree.” The PTCI has been found to discriminate 
well between people who do and do not have PTSD and has been found to have good internal consistency, 
test-retest reliability, and construct validity. The PTCI will be administered at baseline and follow-up time points 
as a secondary outcome measure. The abbreviated 22-item version45 will be collected weekly to assess 
whether changes in posttraumatic cognitions mediate changes in the primary outcome measures. 
Weekly monitoring assessment protocol. Weekly assessment of type and duration of LKM and CPT-C 
homework practices completed along with measures of PTSD and depression and the proposed intervention 
mediators will be assessed weekly during the twelve weeks of LKM or CPT-C treatment.  The weekly 
assessments will be administered via novel web-based technology (Survey Monkey; paper-and-pencil options 
will be available for those without internet access). (See Appendix 9 for weekly items.) 
Assessment of Usual VA Mental Health Care. In order to quantify the amount of VA mental health care that 
study participants obtain during their involvement in the proposed study, data extraction from both the VA  
Corporate Data Warehouse (CDW) and from the computerized patient record system (CPRS).  The number of 

individual and group psychotherapy stopcodes and mental health medication management stopcodes will be 
recorded for all participants for the period of time they are directly involved in LKM (and equivalent time period 
for CPT-C) from the CDW. These numbers will be cross-checked via CPRS and CPRS therapy notes will be 
assessed to determine whether study participants were involved in treatments for PTSD during their 
involvement in LKM or the follow-up period (and equivalent time period for CPT-C).  We will also use CPRS to 
code for psychiatric and pain medication adjustments during study involvement. 
Data Analysis 
Overview. Before performing the primary analyses, outliers, shape of distributions, and associations 
between outcomes will be determined. Covariates or propensity scores will be utilized to adjust for differences 
if imbalances between treatment groups on key variables are identified. Gender and type of trauma will also be 
considered as covariates. All analyses will be performed using an intention-to-treat sample as well as per 
protocol analyses.  Per protocol analyses are the preferred method for non-inferiority analyses, in order to 
avoid biasing the results toward no difference between groups, which could occur in intention-to-treat samples. 
In addition, pattern-mixture models will be used to identify potential missing data patterns,83 and multiple 
imputation techniques will be used to accommodate missing data.84 
AIMS 1 and 2. To determine if LKM is therapeutically similar to CPT-C, we will estimate the effect of 
LKM vs. CPT-C using a multilevel mixed effects model with random effects for repeated measures.  If 
significant correlation exists between outcomes among participants in the same therapy group (i.e., ICC>0), 
therapy group also will be included as a random effect in the model. The primary outcomes for AIM 1 are 
participant scores on the CAPS.77  As the models for AIM 1 and AIM 2 (PTSD and depressive symptoms, 
respectively) will be identical, we focus on the CAPS. The analysis will include all of the primary assessment 
time points (Baseline, post-LKM/CPT-C, 3- and 6- months). Mixed models are an appropriate choice for three 
reasons. First, they accommodate the clustered nature of the data at multiple levels (i.e., repeated measures 
within persons). Second, should significant correlation exist among participants in the same therapy group, 
inclusion of group as a random factor allows for generalization of results to LKM and CPT-C groups in general 
(not just the groups in the study). Third, they are flexible with respect to missing data.85 Mixed effects models 
will include treatment condition (LKM vs. CPT-C), time, and time by treatment interaction to determine if 
differences in exist between conditions by time. Time will be modeled as a dummy variable to allow for 
variation in effects over time. Both unadjusted and adjusted (covariates include baseline PROMIS depression 
score for Aim 1 and baseline CAPS for Aim2, age, gender) models will be run. Subgroup effects of PTSD 
severity on outcomes will be explored using tests of interaction. 
 
A non-inferiority analysis determines if the effects of a new intervention are similar to an established 
treatment within a pre-stated margin of or range of non-inferiority that is considered clinically acceptable (δ).86 
We chose a non-inferiority margin of 10 points on the CAPS.  A difference of 10 points on the CAPS 
represents Cohen’s d = 0.50 in treatment-seeking Vietnam Veterans with PTSD, for whom the SD is roughly 
20.87 A reduction of 10 points on the CAPS is considered the minimal effect that would be clinically 
meaningful.87 [Addendum:  The above description of the non-inferiority margin was based on the CAPS-IV 
measure of PTSD. The CAPS-5 measure became available before the study was initiated and was used 
instead of the CAPS-IV. Calculation of the non-inferiority margin was repeated for CAPS-5 using the same 
criteria as above, i.e. as an effect size of Cohen’s d = 0.5. We therefore defined the non-inferiority margin as 5 
points on the CAPS-5 (based on data indicating the SD of baseline CAPS-5 scores is approximately 10 in a 
large sample (N=198) of treatment-seeking veterans; personal communication, Marx)]. A reduction of 4 points 
on the PROMIS depression measure is the minimal effect considered clinically meaningful, which corresponds 
to an effect size of approximately 0.5.12  Hypothesis testing in a non-inferiority analysis is reversed from the 
standard formulation. The null hypothesis (H0) states that LKM is at least an amount δ worse than CPT-C. The 
alternative (HA) states that the post-treatment mean in LKM is no worse than amount δ as compared to CPT-
C.88 We will assess non-inferiority at 6 month follow-up, as well as other time points (post-LKM/CPT-C, 3-
month follow-up) using methods outlined by Mascha and Sessler.1 Non-inferiority of LKM to CPT-C for 
reduction in PTSD symptoms will be claimed if the lower limit of the 95% confidence interval for difference in 6-
month mean CAPS scores is greater than -10.  Non-inferiority of LKM to CPT-C for reduction in depressive 
symptoms will be claimed if the lower limit of the 95% confidence interval for difference in 6-month mean t-
score in the PROMIS depression measure is greater than -4.12  The test of non-inferiority is similar to the usual 
test for differences between treatments obtained in a mixed effects model except that the non-inferiority margin 
δ is added to the treatment effect coefficient
3b  and divided by the standard error.1  

T NI = b 3 + d
S E
 
If n o n-i nf eri orit y i s n ot s h o w n i n t h e a b o v e a n al y s e s f or AI M 1, tr a diti o n al ‘ s u p eri orit y’ a n al y s e s will b e 
c o n d u ct e d f or c o m p ari s o n s b et w e e n t h e i nt er v e nti o n s. T hi s will i n v ol v e a si m pl e c o m p ari s o n of m e a n s at t h e  
6 -m o nt h ti m e p oi nt o n t h e pri m ar y o ut c o m e s. W e c h o s e a n eff e ct si z e of d =. 5 05 2 , 8 7  f or t h e c o m p ari s o n of t h e 
a cti v e tr e at m e nt s.  Alt h o u g h t h e st u d y i s p o w er e d f or t h e n o n -i nf eri orit y a n al y s e s, w e al s o r e p ort a p o w er 
a n al y si s f or t h e s e pr eli mi n ar y a n al y s e s. A s s u mi n g a n eff e ct of d =. 5 0 b et w e e n tr e at m e nt ar m s a n d a t w o -si d e d 
α of 0. 0 5 r e s ult e d i n a p o w er e sti m at e of a p pr o xi m at el y 9 0 %.  
P o w er a n d S a m pl e Si z e:  
S a m pl e si z e f or t h e n o n -i nf eri orit y h y p ot h e s e s s p e cifi e d i n AI M 1 w a s d et er mi n e d u si n g St at a st ati sti c al 
s oft w ar e. 8 9   A s s u mi n g a n o n -i nf eri orit y m ar gi n of 1 0 p oi nt s o n t h e C A P S ( s e e r ati o n al e n ot e d a b o v e) a n d t h e 
t y pi c al al p h a f or a o n e-si d e d n o n -i nf eri orit y t e st (. 0 2 5),8 8  a t ot al s a m pl e of 1 2 6  p arti ci p a nt s, ( 6 3  P T S D p ati e nt s 
p er r a n d o mi z ati o n ar m ) r e s ult e d i n a p o w er e sti m at e of 8 0 %. T o pr ot e ct a g ai n st t h e eff e ct s of attriti o n, w e 
a d d e d 2 6 % t o t hi s fi n al s a m pl e si z e f or a r e cr uit m e nt g o al of 1 7 0  p ati e nt s. T hi s attriti o n e sti m at e w a s b a s e d o n 
o ur pil ot st u d y a s s e s si n g l o n git u di n al o ut c o m e s of L K M.   
I n a pr eli mi n ar y a n al y si s of o ur L K M pil ot d at a ( s e e pr eli mi n ar y st u di e s s e cti o n), t h e i ntr a cl a s s c orr el ati o n 
(I C C) f or P T S D s y m pt o m s ( u si n g t h e P S S-I; n = 4 2) w a s ρ = 0. 0 0 a n d f or d e pr e s si o n ( u si n g t h e P R O MI S 
m e a s ur e) w a s 0. 0 2 6 ( p = N S f or b ot h).   A d diti o n all y,  pil ot d at a b a s e d o n t h e V A P S H C S M B S R pr o gr a m 
s h o wi n g a n I C C f or P T S D s y m pt o m s ( u si n g t h e P C L; n = 1 1 8) of ρ = 0. 0 0 at p o st -tr e at m e nt a n d ρ = 0. 0 5 at 
f oll o w-u p ( p = N S).  B e c a u s e o ur pil ot d at a o bt ai n e d at o ur sit e d o n ot i n di c at e si g nifi c a nt c or r el ati o n of 
m e a s ur e s wit hi n gr o u p s, w e pr o p o s e a n al y s e s t h at d o n ot i n c or p or at e I C C r e s ult s a n d ar e n ot p o w er e d t o 
a c c o u nt f or t h e m.  
E x pl or at or y AI M:   M e di at or s of r e s p o n s e t o L K M a n d C P T -C  
 
T o a s s e s s m e di ati o n, w e will fir st a s s e s s t e m p or alit y of c h a n g e of t h e pr o p o s e d m e di at or s a n d o ut c o m e s 
( a s d e s cri b e d b el o w).  If it i s e st a bli s h e d t h at c h a n g e s i n t h e pr o p o s e d m e di at or s pr e c e d e c h a n g e s i n 
d e pr e s si v e  a n d P T S D s y m pt o m s, w e will a s s e s s m e di at i o n u si n g a n a n al yti c fr a m e w or k d e v el o p e d f or u s e i n 
r a n d o mi z e d c o ntr oll e d tri al s of t w o i nt er v e nti o n s wit h e q ui v al e nt o ut c o m e s.2 0  T h e  fr a m e w or k d e v el o p e d b y 
G all a g h er a n d R e si c k
2 0  ( d e s cri b e d i n m or e d et ail b el o w) all o w s a s s e s s m e nt of w h et h er t w o i nt er v e nti o n s 
pr o d u c e si mil ar o ut c o m e s t hr o u g h diff er e nt m e di ati o n al pr o c e s s e s.  I n t h e pr o p o s e d tri al c o m p ari n g L K M t o 
C P T -C, t h e t w o i nt er v e nti o n s s h ar e m a n y c o m m o n f a ct or s, b ut diff er i n t h e f o c u s of t h e i nt er v e nti o n (i. e. , L K M 
e m p h a si z e s s elf -c o m p a s si o n wit h o ut a f o c u s o n c o g niti v e r e str u ct uri n g, w h er e a s C P T -C  pl a c e s a pri m ar y 
e m p h a si s o n c orr e cti n g m al a d a pti v e c o g niti o n s  wit h o ut a pri m ar y f o c u s of d e v el o pi n g s elf -c o m p a s si o n ).  W e 
pr o p o s e t o e x a mi n e m e c h a ni s m s of c h a n g e f or e a c h i nt er v e nti o n b y a s s e s si n g i ntr ai n di vi d u al c h a n g e i n s elf -
c o m p a s si o n a n d m al a d a pti v e  c o g niti o n s, a n d t h e n t o e x a mi n e w h et h er i ntr ai n di vi d u al c h a n g e  i n t h e pr o p o s e d 
m e di at or s m e di at e s o ut c o m e s ( P T S D s y m pt o m s, d e pr e s si v e s y m pt o m s).   
 
E st a bli s h m e nt of T e m p or al  S e q u e n c e of C h a n g e i n M e di at or s a n d O ut c o m e M e a s ur e s :  T o a s s e s s 
m e di ati o n, it i s  i m p ort a nt t o a s s e s s w h et h er c h a n g e s i n t h e pr o p o s e d m e di at or s ( s elf-c o m p a s si o n, 
p o sttr a u m ati c m al a d a pti v e c o g niti o n s) pr e c e d e c h a n g e i n cli ni c al o ut c o m e s  ( P T S D a n d d e pr e s si v e 
s y m pt o m s) .9 0   W e e kl y m e a s ur e s will b e o bt ai n e d d uri n g t h e tr e at m e nt p h a s e, i n or d er t o pr o vi d e a n 
a s s e s s m e nt s c h e d ul e t h at all o w s  m e a s ur e m e nt  of t h e m e di at or s b ef or e i m pr o v e m e nt o c c ur s i n cli ni c al 
o ut c o m e s  (P T S D a n d d e pr e s si v e s y m pt o m s ).   T h e t e m p or al r el ati o n s hi p b et w e e n t h e pr o p o s e d m e di at or s a n d 
cli ni c al o ut c o m e s will b e a n al y z e d a c c or di n g t o m et h o d s  d efi n e d b y Kl ei m a n d c oll e a g u e s ( 2 0 1 2) 4 5  u si n g 
bi v ari at e l at e nt gr o wt h m o d eli n g.  Bri efl y, t hi s  fir st i n v ol v es  m o d eli n g w e e kl y l at e nt c h a n g e pr o c e s s e s i n 
m e di at or s a n d o ut c o m e s s e p ar at el y,  t o fi n d t h e b e st r e pr e s e nt ati o n of l at e nt tr aj e ct ori e s. A d u al li n e ar gr o wt h 
c ur v e i s t h e n c al c ul at e d, i n w hi c h l at e nt gr o wt h c ur v e s ar e si m ult a n e o u sl y e sti m at e d f or t h e pr o p o s e d 
m e di at or s a n d t h e cli ni c al o ut c o m e s.   N e xt,  t h e d e gr e e t o w hi c h c h a n g e i n t h e pr o p o s e d m e di at or at w e e k X i s 
a s s o ci at e d wit h c h a n g e i n P T S D at w e e k X + 1 ( a s w ell a s t h e i n v er s e t o t e st w h et h er c h a n g e s i n 
d e pr e s si v e/ P T S D s y m pt o m s pr e di ct c h a n g e s i n t h e pr o p o s e d m e di at ors ) i s e v al u at e d t o e x a mi n e w h et h er t h e 
r e q uir e m e nt of c h a n g e in t h e m e di at or pr e c e di n g c h a n g e i n t h e o ut c o m e i s m et.   T hi s pr o c e s s a s s e s s e s 
w h et h er a l ar g er t h a n a v er a g e c h a n g e o n o n e v ari a bl e i s a s s o ci at e d wit h a l ar g er t h a n a v er a g e c h a n g e o n t h e 
ot h er v ari a bl e at a l at er ti m e p oi nt.  Wit hi n t hi s fr a m e w or k, w h e n, f or  e x a m pl e a gr e at er r e d u cti o n i n 
p o sttr a u m ati c m al a d a pti v e c o g niti o n s i s a s s o ci at e d wit h a gr e at er r e d u cti o n i n P T S D s y m pt o m s i n t h e n e xt 
s e s si o n, it i s a s s u m e d t h at c h a n g e s i n t h e fir st v ari a bl e c a u s e c h a n g e s i n t h e s e c o n d v ari a bl e.  T h e s e m o d el s 

will be utilized to determine the optimal time points (from baseline) to assess change scores in mediators and 
outcomes for the mediation models described below.    
 
Mediation:  Within-treatment intraindividual changes will first be analyzed for self-compassion, 
maladaptive cognitions, PTSD and depression using difference scores (each week’s score minus baseline 
score for each measure) using procedures defined by Gallagher and Resick (2012).20  The degree to which 
change in self-compassion mediates change in outcome in LKM relative to CPT-C will be evaluated by 
examining the indirect effect of treatment condition (LKM vs. CPT-C) on intraindividual change in PTSD 
symptoms via intraindividual change in self-compassion.   
     These procedures will be repeated to evaluate the degree to which change in maladaptive cognitions 
mediates change in CPT-C relative to LKM by examining the indirect effect of treatment condition (CPT-C vs. 
LKM) on intraindividual change in PTSD symptoms via intraindividual change in maladaptive cognitions.  The 
above analysis will be repeated for depressive symptoms. 
 
Indirect effects will be calculated to yield bias-corrected and accelerated bootstrapped confidence 
intervals of indirect effects. If the confidence interval of the indirect effect does not include zero, mediation will 
be shown.  
 
  
Project Timeline  
The overarching project timeline is reflected in Table 4. Approximately 20-22 Veterans will be recruited for 
each of the 8 study cohorts. The first cohort will undergo baselines assessments in month 5 (following a 4-
month recruitment phase) and the final follow-up for cohort 8 will happen by month forty (Table 5). Cohorts will 
be approximately evenly distributed over the course of the study.  We have previously been successful in 
obtaining timely regulatory approvals for LKM and MBSR studies at VAPSHCS, including the two randomized 
pilot trials described in the preliminary studies section. 
 
Table 4. Project Timeline 
PROJECT YEAR 
1 
   2 
    3 
    4 
OBTAIN HUMAN SUBJECTS AND R&D APPROVAL 
 
 
 
 
PROGRAM ON-LINE & IN-PERSON ASSESSMENTS 
 
 
 
 
HIRE AND TRAIN CAPS ASSESSORS 
 
 
 
 
RECRUIT PARTICIPANTS 
 
 
 
 
POST-TREATMENT FOLLOW-UP ASSESSMENT 
 
 
 
 
3-MONTH FOLLOW-UP ASSESSMENT 
 
 
 
 
6-MONTH FOLLOW-UP ASSESSMENT 
 
 
 
 
TRACKING AND RETENTION 
 
 
 
 
ANALYZE DATA 
 
 
 
 
PREPARE PAPERS/REPORTS 
 
 
 
 
Table 5. 
 
MONTH 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
 
11 
 
12 
 
13 
 
14 
 
15 
 
16 
 
17 
 
18 
 
19 
 
20 
 
21 
 
22 
 
23 
 
24 
Cohort  
1 
 
 
 
 
B 
 
 
 
P 
 
 
3 
 
 
6 
 
 
 
 
 
 
 
 
 
2 
 
 
 
 
 
 
 
B 
 
 
 
P 
 
 
3 
 
 
6 
 
 
 
 
 
 
3 
 
 
 
 
 
 
 
 
 
B 
 
 
 
P 
 
 
3 
 
 
6 
 
 
 
 
4 
 
 
 
 
 
 
 
 
 
 
 
 
B 
 
 
 
P 
 
 
3 
 
 
6 
 
5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
B 
 
 
 
P 
 
 
6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
B 
 
 
 
7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Month 
 
25 
 
26 
 
27 
 
28 
 
29 
 
30 
 
31 
 
32 
 
33 
 
34 
 
35 
 
36 
 
37 
 
38 
 
39 
 
40 
 
41 
 
42 
 
43 
 
44 
 
45 
 
46 
 
47 
 
48 
Cohort 
(5) 
3 
 
 
6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(6) 
P 
 
 
3 
 
 
6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

(7) 
 
B 
 
 
 
P 
 
 
3 
 
 
6 
 
 
 
 
 
 
 
 
 
 
 
 
(8) 
 
 
 
 
 
B 
 
 
 
P 
 
 
3 
 
 
6 
 
 
 
 
 
 
 
 
Shaded = LKM / CPT-C group; Evaluations: B (baseline), P (post-LKM/CPT-C), 3,6 (3 or 6 month assessment) 
 
 
 
 
Limitations 
The study design is a fairly ambitious one with a weekly monitoring feature that could pose challenges for 
retention and compliance with the research protocol. A modest remuneration schedule is likely to help maintain 
compliance with the study protocol, and our previous research with PTSD and alcohol dependent individuals 
examining frequent monitoring has shown excellent compliance. Other design considerations include the 
inclusion of male and female participants with mixed trauma histories and inclusion of individuals with 
Substance Abuse and/or Alcohol Dependence (AD). Briefly, most PTSD treatment trials have involved fairly 
homogeneous samples, which while likely reducing experimental noise, also limit the generalizability of the 
findings. We felt that the ability to obtain data that has a chance of being highly generalizable to Veterans who 
are seeking care for PTSD, which is more often than not associated with comorbid conditions,17 was preferable 
to maintaining strict experimental control. In addition, we have successfully delivered LKM in mixed-gender 
groups and our clinical impression is that both the male and the female Veterans benefited from the exposure 
to the opposite gender in this therapeutic context.  
Another design consideration is that each of the two interventions will be delivered in closed-group 
format and there is some risk that people within each of the groups will influence one another to the extent that 
there are group effects on outcomes.91  If ICC’s are significant in the proposed study, this would result in 
decreased statistical power to detect the primary outcomes.  
   
Despite limitations the proposed research has considerable conceptual and clinical merit and represents a 
necessary step in examining whether LKM is associated with clinical benefit for Veterans with PTSD. Results 
of this research can be readily applied in both VA and community settings to treat PTSD.  
Application Summary 
The proposed research is an extension of our previous and ongoing work. This application will address 
a relative void in the intervention literature for PTSD by assessing the non-inferiority of a standardized 
meditation intervention, LKM. In light of the growing interest in complementary and alternative medicine among 
Veterans and the lack of empirical data on such approaches for common disorders, such as PTSD, this 
research will make an important contribution to the field. We believe the proposed research is timely, 
important, and innovative, and the track records of Drs. Kearney and Simpson and the research team indicate 
we are capable of successfully carrying out and completing the proposed work.  

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