A Proof of Concept and Feasibility Trial of Compassion Meditation for PTSD
Phase: NA
Conditions: Posttraumatic Stress Disorder
Sponsor: Veterans Medical Research Foundation

Manual of Procedures 
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Sept  2014 
A Proof of Concept and Feasibility Trial 
of Compassion Meditation for PTSD 
 
NCT 02372396 
September 2014 
 
Clinical Intervention Study 
Protocol  
 

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A Proof of Concept and Feasibility Trial of Compassion Meditation for PTSD 
 
Principal Investigator:   
 
Ariel J Lang, PhD, MPH 
Principal Investigator 
UCSD Department of Psychiatry 
9500 Gilman Dr. (MC 0855) 
La Jolla, CA 92093 
Phone #: (858) 246-0631 
FAX #: (858) 534-6460 
E-mail: ajlang@ucsd.edu 
 
Supported by:  
The National Center of Complementary and Alternative Medicine  
Grant # 1R34AT007936-01A1 
 
Study Intervention Provided by:  
N/A 
 
Sponsor of IND (IDE):  
N/A 

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Page 
Clinical Intervention Study Protocol .......................................................................................... 1 
Tool Revision History ................................................................................................................... 3 
TABLE OF CONTENTS ................................................................ Error! Bookmark not defined. 
STUDY TEAM ROSTER............................................................................................................... 6 
PARTICIPATING STUDY SITES ................................................................................................ 7 
PRÉCIS ........................................................................................................................................... 8 
1. STUDY OBJECTIVES ............................................................................................................. 9 
1.1 
Primary Objective ........................................................................................................... 9 
1.2 
Secondary Objectives...................................................................................................... 9 
2. BACKGROUND AND RATIONALE .................................................................................... 9 
2.1 
Background on Condition, Disease, or Other Primary Study Focus .............................. 9 
2.2 
Study Rationale ............................................................................................................. 10 
3. STUDY DESIGN ..................................................................................................................... 10 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS .............................................. 12 
4.1 
Inclusion Criteria .......................................................................................................... 12 
4.2 
Exclusion Criteria ......................................................................................................... 13 
4.3 
Study Enrollment Procedures ....................................................................................... 13 
5. STUDY INTERVENTIONS .................................................................................................. 14 
5.1 
Interventions, Administration, and Duration ................................................................ 14 
5.2 
Handling of Study Interventions ................................................................................... 17 
5.3 
Concomitant Interventions ............................................................................................ 17 
5.3.1 
Allowed Interventions ............................................................................................... 17 
5.3.2 
Required Interventions .............................................................................................. 17 
5.3.3 
Prohibited Interventions ............................................................................................ 17 
5.4 
Adherence Assessment ................................................................................................. 18 
6. STUDY PROCEDURES ........................................................................................................ 19 
6.1 
Schedule of Evaluations ................................................................................................ 19 
6.2 
Description of Evaluations ............................................................................................ 21 
6.2.1 
Screening Evaluation ................................................................................................ 21 
6.2.2 
Enrollment, Baseline, and/or Randomization ........................................................... 22 
6.2.3 
Blinding..................................................................................................................... 22 
6.2.4 
Followup Visits ......................................................................................................... 22 
6.2.5 
Completion/Final Evaluation .................................................................................... 23 
7. SAFETY ASSESSMENTS ..................................................................................................... 23 
7.1 
Specification of Safety Parameters ............................................................................... 23 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters .... 24 
7.3 
Adverse Events and Serious Adverse Events ............................................................... 25 
7.4 
Reporting Procedures .................................................................................................... 25 
7.5 
Followup for Adverse Events ....................................................................................... 26 
7.6 
Safety Monitoring ......................................................................................................... 26 
8. INTERVENTION DISCONTINUATION ........................................................................... 26 
9. STATISTICAL CONSIDERATIONS .................................................................................. 27 
9.1 
General Design Issues ................................................................................................... 27 
9.2 
Sample Size and Randomization .................................................................................. 27 
9.3  
Definition of Populations .............................................................................................. 27 

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9.4 
Interim Analyses and Stopping Rules ........................................................................... 28 
9.5 
Outcomes ...................................................................................................................... 28 
9.5.1 
Primary Outcome ...................................................................................................... 28 
9.5.2 
Secondary Outcomes ................................................................................................ 28 
9.6 
Data Analyses ............................................................................................................... 28 
10. DATA COLLECTION AND QUALITY ASSURANCE .................................................. 29 
10.1 
Data Collection Forms .................................................................................................. 29 
10.2 
Data Management ......................................................................................................... 30 
10.3 
Quality Assurance ......................................................................................................... 30 
10.3.1 
Training ................................................................................................................. 30 
10.3.2 
Quality Control Committee................................................................................... 31 
10.3.3 
Metrics .................................................................................................................. 31 
10.3.4 
Protocol Deviations ............................................................................................... 31 
10.3.5 
Monitoring ............................................................................................................ 32 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................... 32 
11.1 
Institutional Review Board (IRB) Review .................................................................... 32 
11.2 
Informed Consent Forms .............................................................................................. 32 
11.3 
Participant Confidentiality ............................................................................................ 32 
11.4 
Study Discontinuation ................................................................................................... 33 
12. COMMITTEES..................................................................................................................... 33 
13. PUBLICATION OF RESEARCH FINDINGS .................................................................. 33 
14. REFERENCES ...................................................................................................................... 33 
15. SUPPLEMENTS/APPENDICES ........................................................................................ 33 
I. Procedures Schedule 
II. Informed Consent Form Template 
III. Other (add as many appendices as necessary) 

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STUDY TEAM ROSTER  
 
Ariel J Lang, PhD, MPH 
Principal Investigator 
UCSD Department of Psychiatry 
9500 Gilman Dr. (MC 0855) 
La Jolla, CA 92093 
Phone #: (858) 246-0631 
FAX #: (858) 534-6460 
E-mail: ajlang@ucsd.edu 
 
Toni Robinson  
Research Coordinator 
UCSD Department of Psychiatry 
8939 Villa La Jolla Drive. Suite 200 MC 0855 
La Jolla, CA 92037 
858 534-6426 
Fax: 858 534-6460 
E-mail: trobinson@ucsd.edu  
Shahrokh Golshan, PhD 
Co-Investigator, Biostatistician 
Veterans Medical Research Foundation 
3350 Via La Jolla Dr. MC 151A 
San Diego, CA 92161 
858 642-1264 
Fax: 858 642-3425 
Email: sgolshan@ucsd.edu 
Pollyanna Casmar, PhD 
Co-Investigator, Therapist 
Oceanside Mental Health Clinic 
1300 Rancho Del Oro Rd. MC 116B 
San Diego, CA 92056 
760 643-2031 
Fax: 760 643-2096 
Email: pollyanna.casmar@va.gov 
Michael Essex, MD 
Co-Investigator, Content expert 
Oceanside Mental Health Clinic 
1300 Rancho Del Oro Rd. MC 116A 
San Diego, CA 92056 
760 643-2031 
Fax: 760 643-2096 
Email: Michael.essex@va.gov 

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Janina Scarlet, PhD 
Clinical Research Associate 
3350 La Jolla Village Dr. (151A)  
Building 13  
San Diego, CA 92161 
United Stated of America 
Phone: 1(858) 230-0935 
Fax: (858) 534-6460 
Email: Janina.Scarlet@gmail.com  
Raquel Celeste Good 
Clinical Research Associate 
3350 La Jolla Village Dr. (151A)  
Building 13  
San Diego, CA 92161 
United Stated of America 
Phone: 1(619) 569-5469 
Fax: (858) 534-6460 
Email: rgood@ucsd.edu  
Samantha Hurst, PhD 
University of California San Diego   
Department of Family & Preventive Medicine  
9500 Gilman Drive - MC 0725 
La Jolla, CA 92093-0725 
Office: 858.822.0766  
Fax: 858.534.4642 
Email: shurst@ucsd.edu  
PARTICIPATING STUDY SITES 
 
VA San Diego Healthcare System (VASDHS) 
Ariel J Lang, PhD, MPH 
Principal Investigator 
UCSD Department of Psychiatry 
9500 Gilman Dr. (MC 0855) 
La Jolla, CA 92093 
Phone #: (858) 246-0631 
FAX #: (858) 534-6460 
E-mail: ajlang@ucsd.edu 
 
VASDHS Oceanside Clinic 
1300 Rancho Del Oro Dr. 
Oceanside, CA 92056 
 

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University of Wyoming 
Matt Gray, PhD 
Co-Investigator 
1000 E. University Ave. 
Bio Sciences Bldg 122 
Laramie, WY 82071 
Phone #: (307) 766-2927 
Email: gray@uwyo.edu  
 
PRÉCIS  
Study Title  
A Proof of Concept and Feasibility Trial of Compassion Meditation for PTSD  
  
Objectives  
1. To refine an existing compassion meditation protocol for PTSD by evaluating participants’ 
reactions to the intervention components and refining the practices to maximize engagement and 
induction of cognitive/emotional states that are most likely to counteract PTSD. 
2. To evaluate the acceptability of and refine a likely future control condition (i.e., relaxation). 
3. To identify the best strategies by which to recruit and retain subjects (including women) in the 
protocol. 
4. To evaluate the feasibility of conducting compassion meditation as an intervention for PTSD. 
5. To establish preliminary estimates of effect size and other parameters to inform future efficacy 
studies of compassion meditation. 
6. To identify potential mechanisms of action and predictors of response. 
Design and Outcomes  
This project is a feasibility and proof of concept study of compassion meditation (CM) for 
Veterans with posttraumatic stress disorder (PTSD; N ≈ 100). Phase 1 (N ≈ 60, nonrandomized), 
Protocol Refinement, will consist of up to 4 CM and 2 Relaxation groups with 6-12 participants in 
each group. Iterative refinement of the treatment protocols will be done based on quantitative and 
qualitative data from participants. Phase 2 (N ≈ 40), Pilot Evaluation is a randomized controlled 
study with 4 groups (2 CM and 2 relaxation groups, 6-12 in each group) to examine the feasibility 
of a randomized trial and to estimate response to CM. 
Interventions and Duration  
The interventions to be compared are CM and Relaxation Training. 
 CM is a meditative practice focused on the wish that others and the self may be free of 
suffering. The Compassion Meditation Protocol was developed by consultant Geshe 
Lobsang Negi, PhD. It consists of 8 2-hour sessions and accompanying at home practice. 
The intervention begins with basic breathing-focused meditation and awareness of internal 
experience. Participants go on to cultivate compassion toward the self and others. 
 The Relaxation Training Protocol utilized herein was used in Taylor et al.’s (2003) PTSD 
trial. It will be delivered in 8 2-hour sessions with accompanying at home practice. 
Participants will be taught a variety of relaxation techniques and how to apply these to 
enhance coping with daily stressors and symptoms. 

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Participant participation will be approximately 3 months. Baseline evaluation will be completed 
within 1 month of the beginning of the treatment groups. Groups will last 8 weeks, and post-
treatment assessment will be completed at the end of the groups. 
Sample Size and Population  
Participants in both phases will be Veterans with PTSD who are able to consent and willing to 
participate (refer to Human Subjects for detailed inclusion/exclusion criteria). In Phase 1, we will 
run up to 4 CM groups and 2 relaxation groups; we will aim for a group size of 6-12 in each 
group. In Phase 2, we will conduct a pilot study with random assignment to 4 groups (2 CM and 2 
relaxation groups, 6-12 in each group. We estimate that 60 people will take part in Phase 1 of the 
research, and approximately 40 participants in Phase 2, for a total sample size of approximately 
100 people. 
 
1. STUDY OBJECTIVES 
 
1.1 
Primary Objective 
1. To refine an existing compassion meditation protocol for PTSD by evaluating participants’ 
reactions to the intervention components and refining the practices to maximize engagement and 
induction of cognitive/emotional states that are most likely to counteract PTSD. 
2. To evaluate the acceptability of and refine a likely future control condition (i.e., relaxation). 
3. To evaluate the feasibility of conducting compassion meditation as an intervention for PTSD. 
4. To establish preliminary estimates of effect size and other parameters to inform future efficacy 
studies of compassion meditation. 
 
1.2 
Secondary Objectives 
1. To identify the best strategies by which to recruit and retain subjects (including women) in the 
protocol. 
2. To identify potential mechanisms of action and predictors of response. 
 
2. BACKGROUND AND RATIONALE 
 
2.1 
Background on Condition, Disease, or Other Primary Study Focus 
 
PTSD is a psychopathological response to exposure to a traumatic stressor and is 
characterized by recurrent re-experiencing of the event, avoidance of reminders of the trauma, 
negative alterations in mood and cognitions, and increased arousal (American Psychiatric 
Association, 2014). The disorder typically follows a chronic course and leads to significant work 
and social impairment and increased healthcare utilization (e.g., Hidalgo & Davidson, 2000; 
Jaycox & Foa, 1999; Stein, McQuaid, Pedrelli, Lenox & McCahill, 2000). Although there are 
psychotherapies that effectively reduce PTSD symptoms, additional approaches are needed 
because no single intervention is universally effective, acceptable and/or feasible (Bradley, Greene, 
Russ, Dutra, & Westen, 2005; Schottenbauer, Glass, Arnkoff, Tendick & Gray, 2008). 
 
There is a strong demand by patients and clinicians for complementary and alternative 
treatments such as meditation for the amelioration of symptoms of posttraumatic stress disorder 
(PTSD). Mental health problems are among the most frequently cited reasons for seeking help 
from a complementary and alternative medicine provider (Strauss, Coeytaux, McDuffie, Nagi, & 
Williams, 2011) and a recent national survey shows that 40% of patients with PTSD used a 

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complementary and alternative medicine approach in the past year, with meditation being one of 
the most commonly used approaches (Libby, Pilver, & Desai,, 2012). In spite of this, there is little 
empirical evidence to support their use. Compassion meditation, which is a meditative practice 
that focuses on the wish that the self and others be free of suffering, has been associated with 
positive changes in nonclinical samples. In particular, compassion meditation has been shown to 
increase positive emotion and social connectedness, both of which are areas of deficit for 
individuals with PTSD. However, CM has never been evaluated in relation to PTSD.  
 
2.2 
Study Rationale 
A variety of meditation techniques are currently being used to address mental and physical 
health issues, and several studies show that meditation is acceptable to Veterans with PTSD 
(Bormann et al., 2011; Kearney et al., 2012; Niles et al., 2012). It may be unwise, however, to 
view all meditative practices as interchangeable. For example, baseline brain activation appears to 
predict the type of meditation (mindfulness or compassion meditation) in which an individual will 
engage (Mascaro, Rilling, Negi, & Raison, 2013b).  
We hypothesize that CM will relieve PTSD symptoms and improve quality of life by 
fostering positive emotion and social connectedness, processes that are negatively impacted by 
PTSD. Evidence for this hypothesis comes from observed responses to CM and loving kindness 
meditation (LKM), a closely related approach. Hutcherson, Seppala and Gross (2008) compared a 
7-minute LKM exercise to an imagery exercise and found that even this very brief intervention, as 
compared to imagery, led to increased positive mood and decreased negative mood. Beneficial 
effects are also observed when LKM is delivered over multiple sessions as an intervention. LKM 
delivered in six 60-minute sessions over 7 weeks to workers (n = 102), led to increased positive 
emotion as compared to WL control (n = 100) (Fredrickson, Cohn, Coffey, Pek, & Finkel, 2008). 
Results from a small pilot study (n = 18) of LKM for negative symptoms of schizophrenia 
showed that the practice increased positive emotion and decreased negative emotion (Garland et 
al. 2010) and indicates that this technique can induce positive emotion in clinical samples. 
Evidence from functional MRI shows activation in areas typically associated with positive affect 
(left medial prefrontal cortex and anterior cingulate gyrus) in an expert meditator engaged in CM 
(Engstrom & Söderfeldt, 2010). Positive emotions are thought to enhance coping (Fredrickson, 
2001) and have been associated with resilience, i.e., the ability to recover from negative 
experiences and to change based on situational demands (Tugade & Fredrickson, 2004). In 
particular, positive emotions have been tied to the process of coping with highly stressful events. 
For example, Fredrickson and colleagues (2003) found that positive emotions were a critical 
component in resilience among college students after the September 11 terrorist attacks. 
Similarly, bereaved caregivers who experienced positive emotion during their grief found more 
positive meaning in their loss and demonstrated more long-term goal-setting and planning, which 
corresponded to greater well being 12 months later (Moskowitz, 2001). CM is also thought to 
enhance social connectedness. LKM has been associated with more positive explicit and implicit 
reactions to others (Hutcherson et al., 2008), and CM is linked to increased empathic accuracy 
and activation or associated brain circuitry (Mascaro, Rilling, Negi, & Raison, 2013a). A sense of 
connection, or belongingness, is associated with better psychological and social functioning 
(Hagerty, Williams, Coyne, & Early, 1996), including reduced anxiety and greater self-esteem 
(Lee & Robbins, 1998), and may have a protective effect against stress, depression and PTSD 
(see, for example Cacioppo, Hughes, Waite, Hawkley, & Thisted, 2006; Cacioppo & Patrick, 
2008). Conversely, social isolation may be the strongest and most reliable predictor of suicidal 

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thoughts and behavior (Van Orden et al., 2010) and deficits in empathy have been associated with 
verbal aggression in v eterans with PTSD (Teten, Miller, Bailey, Dunn, & Kent, 2008).  
CM has not been specifically evaluated for PTSD but has been applied for stress reduction 
and in one clinical sample. Pace et al. (2009) recruited 61 college students into a study comparing 
CM and health education discussion. Participants were assessed using a standardized stress test 
(public speaking followed by mental arithmetic) and physiological measures. The more students 
practiced meditation at home, the less distress they reported after the stress test. In the single 
study with a psychiatric population, Johnson et al. (2011) conducted a pilot study of LKM with 
individuals diagnosed with schizophrenia-spectrum disorders (n = 18). Eighty-eight percent 
completed the treatment, and the practice was perceived to be easy, enjoyable and useful. 
Participants actively engaged in the meditation, practicing an average of 3.7 days per week. LKM 
was associated with a large effect size increase in positive emotion and life satisfaction, a large 
effect size reduction in negative symptoms and anhedonia, and a medium effect size reduction in 
asociality. These gains generally were maintained over a 3 month follow-up period (Johnson et 
al., 2011). Finally, Carson et al. (2005) applied LKM for low back pain. They found that, as 
compared to standard care, LKM led to reduced general psychological distress, anxiety and 
hostility after the intervention and 3 months later.  
 
Interventions. The initial CM group for Phase I of this study will follow the existing Emory 
Compassion Meditation Protocol. The protocol will be iteratively refined until we have a version 
(and accompanying manual) that has been optimized for veterans. This final version will be used 
in Phase 2. 
 
Relaxation Training was selected as the control condition. It was selected because it is a 
good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact 
with a mental health provider) and it is structurally similar to meditation (e.g., restful, in session 
and at home exercises). 
 
Both groups will be delivered in 8 two-hour sessions by a trained therapist. 
 
3. STUDY DESIGN 
 
Design. The proposed project is a feasibility and proof of concept study of compassion 
meditation (CM) for posttraumatic stress disorder (PTSD). Phase 1 (N ≈ 60, nonrandomized), 
Protocol Refinement, will consist of up to 4 CM and 2 Relaxation groups with 6-12 participants in 
each group. Iterative refinement of the treatment protocols will be done based on quantitative and 
qualitative data from participants.  Phase 2 (N ≈ 40), Pilot Evaluation is a randomized controlled 
study with 4 groups (2 CM and 2 relaxation groups, 6-12 in each group) to examine the feasibility 
of a randomized trial and to estimate response to CM. 
 
Outcomes. In Phase 1, outcomes will include treatment credibility, qualitative reactions to 
groups, time spent practicing, satisfaction, emotional responding, social connectedness, self-
compassion and heart rate variability (HRV). 
 
Study population and groups. Participants in both phases will be Veterans with PTSD 
who are able to consent and willing to participate. Co-occurring disorders such as depression, 
anxiety, or treated substance abuse or dependence problems are permitted provided that PTSD is 
the primary presenting complaint. We estimate that 60 people will take part in Phase 1 of the 
research and approximately 40 participants in the second phase, for a total sample size of 
approximately 100 people. 

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Study location. The study will take place at the VA San Diego Healthcare System, with 
groups conducted at the Oceanside Mental Health Clinic. 
 
Duration. Phase 1 will last approximately 18 months, with 6 months of therapist training 
and 12 months of recruitment and delivery of the interventions. Phase 2 will last approximately 
12 months. For a given participant, involvement in the study will last approximately 3 months, 
including assessments before and after the group and the 8-week intervention. 
 
Interventions. The first CM group in Phase 1 will follow the existing Emory Compassion 
Meditation Protocol. This well-developed protocol has been used extensively with non-clinical 
populations but some initial refinement will be done to assure that the material is accessible to 
veterans. The subsequent groups will be delivered using the protocol version developed with the 
prior group until a well-received protocol has been established. The initial relaxation group will 
follow Dr. Taylor’s protocol with minor modification to match the timeline of the CM protocol 
(i.e., extending sessions from 90 minutes to 2 hours and providing similar amounts of homework) 
and modality of administration (group rather than individual). If necessary, this protocol will be  
refined based on participant feedback as well. The final versions of the protocols will be 
employed in Phase 2. Both types of groups will be conducted in person by a trained licensed 
clinical psychologist in eight 2-hour sessions. 
 
Randomization. There is no randomization in Phase 1. In Phase 2, groups will be 
randomized in a 1:1 allocation ratio to CM or Relaxation Training; no stratification will be used. 
The assessor will be kept blind to treatment condition. Random assignment of groups to study 
conditions will be conducted by study statistician, Dr. Golshan, after the groups have been 
formed. Prior to enrollment, the study statistician will write a program in SPSS (IBM Software 
Group. SPSS User’ Guide, Version 21. Chicago, Il, 2013) to create a list of subject identification 
numbers with randomized treatment assignments (2 CM and 2 relaxation groups), which will be 
held by the unblended project coordinator during the trial. Variable blocked randomization will 
be used with random block size (4 or 6).  Separate lists (up to 4) of replacement subject 
identification numbers will also be created so that replacement subjects are assigned the same 
treatment as subjects they are replacing. Subjects will be randomized to study treatment group in 
a 1:1 ratio. 
 
 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 
Inclusion Criteria 
To be included in this study, an individual must be a (1) veteran of (2) at least 18 years of 
age with (3) PTSD as defined by DSM-5 and the (4) capacity to consent and (5) 
capacity/willingness to comply with study procedures. We expect the demographic make-up to 
approximate that of the VASDHS, which has a majority men and Caucasians. Co-occurring 
disorders such as depression, anxiety, or treated substance abuse or dependence problems are 
permitted provided that PTSD is the primary presenting complaint. There will not be a restriction 
on concomitant medication use, but the individual’s provider must not anticipate changes during 
the study period. There is no restriction on prior therapy experience but an individual may not be 
simultaneously receiving another psychosocial treatment to address PTSD. Pregnant women will 
not be excluded and contraception is not necessary as there is no known risk to the woman or 
fetus associated with meditation or relaxation. No additional protections are needed.  
 

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4.2 
Exclusion Criteria 
 
The following are criteria for exclusion: (1) serious suicidality or homicidality that has 
required urgent or emergent evaluation or treatment within the past three months, (2) a known, 
untreated substance use disorder (inclusion is possible if there is evidence that the individual has 
been afforded and is complying with treatment for the substance problem), (3) serious Axis I 
mental disorders, such as psychotic disorders or bipolar type I, or serious dissociative symptoms 
(4) cognitive impairment that would interfere with consent or treatment, (5) circumstances that 
lead to recurrent traumatization (e.g., engaged in a violent relationship) and (6) concurrent 
enrollment in any other treatment specifically targeting PTSD symptoms or social functioning 
(e.g., couples therapy). Participants can continue current pharmacological treatment (provided 
they have stabilized on medication, i.e., no additional treatment response is expected, and that no 
changes are anticipated during the study period) or any supportive or nonspecific therapy. If a 
participant is institutionalized or imprisoned during the course of the study, he/she will be 
withdrawn. Pregnant women will not be excluded from the study. 
 
4.3 
Study Enrollment Procedures  
Potential participants will be recruited from VA mental health clinics and the community. 
We will interface with staff at the VA Medical Center, VA Oceanside Community Based 
Outpatient Clinic, and Vet Center clinics to encourage referral of interested patients to the study. 
Clinicians will introduce the study to their patient and if the veteran is interested will give his/her 
permission to pass their name and phone number to the study coordinator. We will use a tool 
adapted from other approved VA studies that provides a summary of the study objectives, lists 
patient's name and phone number and that the patient initials. This tool will be given to the study 
coordinator. We will also recruit from the community through posting flyers in local mental 
health clinics, by use of advertisements in periodicals (especially those that focus on 
complementary and alternative healing practices) and via Web-based resources. The coordinator 
will maintain a study log to document the source of all potential participants; we will match this 
information with data about whether or not they participated and, if not, reasons for ineligibility 
to subsequently analyze the effectiveness of various recruitment practices. 
This study will be conducted at the VA Medical Center in compliance with Title 45 Part 
46 of the CFR pertaining to protection of human subjects. Signed consent documents for VA 
subjects use VA form 10-1086. Consenting will take place at the Oceanside VA clinic with a 
trained assessor/study coordinator in a private room and the participant will be given ample time 
to read the consent form and ask questions. At the first visit, prior to initiation of any study-
related procedures, subjects will give their written consent to participate in the study after having 
been informed about the nature and purpose of the study, participation/termination conditions, 
risks, and potential benefits. Informed consent is a process that is initiated prior to the 
individual’s agreeing to participate in the study and continuing throughout the individual’s study 
participation. Upon reviewing the document, the assessor will explain the research study to the 
participant and answer any questions that may arise. Extensive discussion of risks and possible 
benefits of this therapy will be provided to the participants as needed. The investigator will 
explain study procedures. The participants will sign the informed consent document prior to any 
procedures being done specifically for the study. The participants may withdraw consent at any 
time throughout the course of the trial. A copy of the informed consent document will be given 
to the participants for their records. The rights and welfare of the participants will be protected 
by emphasizing to them that the quality of their medical care will not be adversely affected if 

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they decline to participate in this study. VA subjects will consent to the audio-video recording 
using VA form 10-3203. 
Decisional capacity will be assessed based on the interviewer’s judgment during the dialog that 
takes place during recruitment and screening. In addition, the participant participates in a 
comprehensive psychological assessment as part of the screening including questions about 
traumatic brain injury. We also anticipate that the clinician referral will screen out anyone with 
severe cognitive problems. Participants with questionable decisional capacity will be excluded 
from the study.  
 
5. STUDY INTERVENTIONS  
 
5.1 
Interventions, Administration, and Duration  
 
The interventions used for this study will include CM and Relaxation Training. The 
interventions will be of equal length – 8 two-hour sessions – with approximately equal at home 
practice of the skills. Both types of groups will be conducted in person by a trained licensed 
clinical psychologist in an outpatient mental health clinic. 
 
The first CM group in Phase 1 will follow the existing Emory Compassion Meditation 
Protocol. This well-developed protocol has been used extensively with non-clinical populations 
but some initial refinement will be done to assure that the material is accessible to veterans. The 
subsequent groups will be delivered using the protocol version developed with the prior group 
until a well-received protocol has been established. The initial relaxation group will follow Dr. 
Taylor’s protocol with minor modification to match the timeline of the CM protocol (i.e., 
extending sessions from 90 minutes to 2 hours and providing similar amounts of homework) and 
modality of administration (group rather than individual). If necessary, this protocol will be  
refined based on participant feedback as well. The final versions of the protocols will be 
employed in Phase 2. 
 
Week  
 
Emory Compassion Meditation  
Protocol  
Taylor Relaxation Training  
Protocol  
1 
Developing Attention and Stability  
of Mind: Provide rationale for the practice 
and introduce breath meditation for 
cultivation of a basic degree of refined 
attention and mental stability as the 
foundation for the practice.  
Homework: 5 minute daily meditation with 
journal, log of mindfulness exercises 
Treatment Rationale and Initial  
Relaxation Exercise: Provide initial 
rationale for treatment protocol and 
establish goals as they relate to the 
relaxation training. Initial 
in-session relaxation exercise.  
Homework: 5 minute daily relaxation with 
self-monitoring 
2 
Cultivating Insight into the Nature of  
Mental Experience: The stabilized mind is 
employed to gain insight into the nature of 
the inner world of thoughts, feelings, 
emotions and reactions.  
Homework: 10 minute daily meditation 
with journal, log of mindfulness exercises 
Checking Patient’s Understanding of  
Rationale, Correction and Further 
Relaxation Training: Similar format to 
Week #1, with review of week’s activities 
and clarification of rationale.  
Homework: 10 minute daily relaxation 
with self-monitoring 
3 
Cultivating Self-Compassion: The 
participant observes the innate aspirations 
Reviewing At Home Practice, Problem-
Solving Difficulties, Progressive 

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for happiness and well being as well as 
those for freedom from unhappiness and 
dissatisfactions, i.e., which mental states 
contribute to fulfillment and which ones 
prevent it. The participant then makes a 
determination to emerge from the toxic 
mental and emotional states that promote 
unhappiness.  
Homework: 20 minute daily meditation 
with journal 
Relaxation: Similar format to Week #2, 
with review of week’s activities and 
problem-solving.  
Homework: 20 minute daily relaxation with
self-monitoring 
4 
Developing Equanimity: Normally one 
tends to hold fast to categories of friends, 
enemies, and strangers and to react 
unevenly to people, based on those 
categories. By examining these categories 
closely, the participant comes to 
understand their superficiality and learns to 
relate to people from a deeper perspective: 
everyone is alike in wanting to be happy 
and to avoid unhappiness.  
Homework: 20 minute daily meditation 
with journal 
Reviewing Homework and introduce 
Relaxation with script: Review of at home 
practice, engage in progressive relaxation 
with script and record this week. Introduce 
directed relaxation for “red flag” situations 
in which participants know they will face 
difficulty with anxiety and other 
symptoms.  
Homework: 20 minute daily relaxation with
self-monitoring 
5 
Developing Appreciation and Gratitude for 
Others: When the participant realizes 
interdependence with others and the many 
benefits that others offer every day, the 
participant develops appreciation and 
gratitude for them.  
Homework: 30 minute daily meditation 
with journal 
Reviewing Homework and next Relaxation 
with script: Review of at home practice, 
engage in progressive relaxation with script 
and record this week. Discussion of “red 
flag” situations this week.  
Homework: 30 minute daily relaxation 
with self-monitoring 
6 
Developing Affection and Empathy: 
Deeper contemplation and insight into the 
ways in which myriad benefits are derived 
from countless others, along with 
awareness that this kindness should be 
repaid, enables the participant to relate to 
others with a deeper sense of 
connectedness and affection. 
Homework: 30 minute daily meditation 
with journal  
Reviewing at-home practice and next 
Relaxation with script: Review of at home 
practice, engage in progressive relaxation 
with script and record this week.  
Homework: 30 minute daily relaxation with
self-monitoring 
7 
Realizing Wishing and Aspirational 
Compassion: Enhanced empathy for others, 
coupled with intimate awareness of their 
suffering and its causes, naturally gives rise 
to compassion: the wish for others to be 
free from suffering and its conditions. 
Reviewing Homework and next Relaxation 
with script: Review of at home practice, 
engage in progressive relaxation with script 
and record this week.  
Homework: 30 minute daily relaxation with
self-monitoring 

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Homework: 30 minute daily meditation 
with journal  
8 
Realizing Active Compassion for  
Others: In the final step, the participant  
is guided through a meditation designed  
to move from simply wishing others to be  
free of unhappiness to actively  
committing to assistance in their pursuit  
of happiness and freedom from suffering.  
Reviewing at-home practice, next 
Relaxation and Relapse Prevention: 
Review of at home practice, engage in 
progressive relaxation and record at home 
this week. Introduce relapse prevention 
concept. 
 
 
Refinement strategies. The interventions will be refined based on participant feedback, 
which will be solicited on a weekly basis through a variety of measures (refer to the Measures 
section for more detail) as well as through direct inquiry about reactions to the group. 
Participants will understand the goal of refining the intervention, so will be encouraged to 
provide honest feedback about their experience.  
Dr. Negi or a designated supervisor from Emory will review the recording of every group 
meeting and meet with the VASDHS team on a weekly basis. In that meeting, they will discuss 
their observations of the group as well as feedback from participants. In particular, they will be 
looking for any difficulty in understanding the concepts being presented (different approach? 
more or less time for discussion?), the perceived appropriateness of examples/metaphors (did 
Veterans relate personally? do they fit with military/veteran culture?), challenges in engaging in 
the practice (to what extent did Veterans engage in practice outside the session? any observable 
discomfort or lack of engagement in the class setting?). Based on that material, they modify that 
session in the protocol and plan for the next class session (e.g., choosing to explain again 
material that was not well understood, to give an alternative metaphor to assist in understanding 
a concept, or to modify a practice). Adjustments made to the original protocol will be 
incorporated into the manual by Drs. Lang, Casmar and the team and reviewed by the Emory 
group for use in the next iteration of the intervention. In addition, the therapist and Emory team 
will meet at the end of the set of classes to discuss the class as a whole and to incorporate 
additional information that was gathered after treatment (refer to Measures). The month before 
the next group begins will be used to make additional refinements for the next set of classes and 
to review the entire revised protocol. Decisions about protocol changes will be made by 
consensus. Some examples of observations about the procedures or intervention and potential 
refinements are presented below. Published trials will be used as benchmarks to determine low 
or poor performance. 
 
Observation 
Potential Refinements 
Low proportions of patients enrolling in the 
study or beginning group sessions 
Better informational material for patients and 
providers, alternate mechanisms for reaching 
potentially interested individuals 
Low treatment credibility 
Modification of manner in which the rationale 
is discussed 
Poorly received material or overall satisfaction; 
high drop-out 
Modification of explanations, metaphors or 
exercises based on the nature of the feedback 
(logic, understandability, applicability and 
efficacy in applying it) 

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Poor homework compliance 
Modify explanations of rationale for 
homework, incorporate strategies to increase 
motivation or reduce barriers to practice, 
modify exercises, institute between-session 
reminders 
Increase in negative emotion, little change in 
positive emotion, social connectedness or self-
compassion 
Modify nature, length or order of topics 
 
In addition, Dr. Hurst will conduct qualitative interviews with study participants during 
and after treatment to gather information about the perceived acceptability and utility of the 
approach. With female participants she will also emphasize the role their gender has played in 
their reactions to the intervention. 
Potential adverse effects. At the eligibility assessment and other assessments for enrolled 
subjects, the interview questions and/or questionnaires may produce discomfort or anxiety from 
the discussion of personal, emotional, or anxiety-provoking topics. Meditation and relaxation 
have been evaluated in prior studies with patients with PTSD, and have been shown to be safe and 
well-tolerated. 
 
5.2 
Handling of Study Interventions  
 
The interventions will be delivered following treatment manuals, which will be 
developed in Phase 1. It will not be possible for the patient or therapist to be blind to treatment 
condition. 
 
The prerequisite for training in the CM protocol is at least one year of contemplative 
practice and having attended at least one 7-day, teacher-led retreat. The training itself involves a 
9 day training/retreat followed by an 8-week practicum. The practicum includes attendance at an 
8-week (1.5 hours/week) CM course delivered by staff from Dr. Negi’s group, a 2.5 hour 
seminar and discussion week’s material, daily practice and journaling about the practice, 
readings and development of class plans. The practicum concludes with a 17-hour weekend 
workshop. 
 
Training in the relaxation protocol will involve careful review of the treatment manual 
and hour:hour audio/video-based supervision of its execution.  
 
5.3 
Concomitant Interventions  
 
5.3.1 
Allowed Interventions 
Participants can continue current pharmacological treatment (provided that they have 
stabilized on medication, i.e., no additional treatment response is expected, and that no changes 
are anticipated during the study period) or any supportive or nonspecific therapy. Detailed 
information on these treatments will be collected to be used to explore differential effect of the 
compassion meditation. 
 
5.3.2 
Required Interventions 
None 
 
5.3.3 
Prohibited Interventions 
Participants based on concurrent enrollment in any other treatment specifically targeting 

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PTSD symptoms or social functioning (e.g., couples therapy). If a participant is institutionalized 
or imprisoned during the course of the study, he/she will be withdrawn. 
 
5.4 
Adherence Assessment  
We will follow accepted standards (Perepletchikova & Kazdin, 2005) in establishing and 
assessing the CM integrity and fidelity. This includes: a) treatment manuals with weekly 
objectives, outcomes, and agendas, b) clinician training, and c) ongoing evaluation of treatment 
integrity through audio-rating of therapy sessions and supervision. A fidelity measure will be 
developed for each intervention at the end of the refinement phase and will be utilized in the pilot 
phase. In addition, ongoing supervision based on review of sessions will be used, with corrective 
feedback as needed in weekly supervision. The participant evaluation method of quality 
assurance, which involves asking each participant to complete a brief checklist that queries the 
content of their session, will be employed as well. 
Participant adherence will be gauged by records of between-session practice.    
 

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6. STUDY PROCEDURES  
6.1 Schedule of Evaluations 
Phase 1. 
Baseline 
Session 1 
Session 2 
Session 3 
Session 4 
Session 5 
Session 6 
Session 7 
Session 8 
Post-
treatment 
Demographics 
X 
MoCA 
X 
 
MINI 
X 
 
 
 
 
 
 
DES 
X 
 
Emory 
Treatment 
Resistance 
Interview for 
PTSD (ETRIP) 
X 
 
 
 
 
 
X 
Credibility 
X 
SCS-R 
X 
 
X 
SCS-SF 
X 
 
X 
Reactions to 
group 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
CSQ-8 
 
 
 
 
 
 
 
 
X 
Practice Diary 
X 
X 
X 
X 
X 
X 
X 
X 
mDES 
X 
X 
X 
X 
X 
X 
X 
X 
LEC-5/PCL-5 
 
X 
X 
X 
X 
X 
X 
X 
X 
PHQ-9 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
AUDIT-C 
 
X 
X 
X 
X 
X 
X 
X 
X 
HRV 
X 
72 hr 
X 
X 
X 
X 
X 
X 
X 
X 
X 
72 hr 
 
 
 

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Phase 2 
Screening
/Baseline 
Session 1 
Session 2 
Session 3 
Session 4 
Session 5 
Session 6 
Session 7 
Session 8 
Post-
treatment 
Demographics 
X 
MoCA 
X 
 
MINI 
X 
 
 
 
 
 
 
DES 
X 
 
Emory 
Treatment 
Resistance 
Interview for 
PTSD (ETRIP) 
X 
 
 
 
 
 
X 
CAPS-5 
X 
 
 
 
 
 
 
 
 
X 
BSI 
X 
 
 
 
 
 
 
 
 
X 
SDS 
X 
 
 
 
 
 
 
 
 
X 
SWLS 
X 
 
 
 
 
 
 
 
 
X 
PHLMS 
X 
 
 
 
 
 
 
 
 
X 
SCS-R 
X 
 
X 
SCS-SF 
X 
 
X 
PROMIS pain 
X 
 
 
 
 
 
 
 
 
X 
PROMIS sleep 
X 
 
 
 
 
 
 
 
 
X 
Credibility 
X 
Reactions to 
group 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Practice Diary 
X 
X 
X 
X 
X 
X 
X 
X 
CSQ-8 
 
 
 
 
 
 
 
 
X 
mDES 
X 
X 
X 
X 
X 
X 
X 
X 
PCL-5 
 
X 
X 
X 
X 
X 
X 
X 
X 
PHQ-9 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
AUDIT-C 
 
X 
X 
X 
X 
X 
X 
X 
X 
HRV 
X 
72 hr 
X 
X 
X 
X 
X 
X 
X 
X 
X 
72 hr 
 

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6.2 Description of Evaluations 
 
 
6.2.1 
Screening Evaluation 
 
Following consent, participants will complete the following set of measures to establish 
their fit with inclusion/exclusion criteria. For participants meeting study entry criteria, baseline 
evaluation will immediately follow. 
•Demographics: age, gender, race/ethnicity, relationship status, years of education,  
SES/income/living situation, occupation/work status, branch of service/highest rank  
Eligibility:  
•Dissociative Experiences Scale (DES; Bernstein & Putnam, 1986): score of 30 or  
greater will trigger clinical evaluation of dissociative symptoms.  
•Mini International Neuropsychiatric Interview (MINI 6.0; Sheehan et al 1998): 15- 
30 minute interview used to establish PTSD and absence of serious mental illness,  
untreated substance dependence, serious suicidality, supplemented with questions to  
assess homicidality and current trauma exposure  
•Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005): brief (~10  
minutes) clinician-administered cognitive screening test. If the score is < 26,  
patients will be referred for additional evaluation and excluded, unless a qualified  
clinician provides clearance to participate.  
• Emory Treatment Resistance Interview for PTSD (ETRIP; phenxtoolkit.org) is a tool that 
combines self-report and interview-based review of treatments received for PTSD. 
 
Consenting Procedure 
This study will be conducted at the VA Medical Center in compliance with Title 45 Part 
46 of the CFR pertaining to protection of human subjects. Signed consent documents for VA 
subjects use VA form 10-1086. Consenting will take place at the Oceanside VA clinic with a 
trained (per VA standards) assessor/study coordinator in a private room and the participant will 
be given ample time to read the consent form and ask questions. At the screening/baseline visit, 
prior to initiation of any study-related procedures, subjects will give their written consent to 
participate in the study after having been informed about the nature and purpose of the study, 
participation/termination conditions, risks, and potential benefits. Informed consent is a process 
that is initiated prior to the individual’s agreeing to participate in the study and continuing 
throughout the individual’s study participation. Upon reviewing the document, the assessor will 
explain the research study to the participant and answer any questions that may arise. Extensive 
discussion of risks and possible benefits of this therapy will be provided to the participants as 
needed. The investigator will explain study procedures. The participants will sign the informed 
consent document prior to any procedures being done specifically for the study. The participants 
may withdraw consent at any time throughout the course of the trial. A copy of the informed 
consent document will be given to the participants for their records. The rights and welfare of the 
participants will be protected by emphasizing to them that the quality of their medical care will 
not be adversely affected if they decline to participate in this study. VA subjects will consent to 
the audio-video recording using VA form 10-3203. Decisional capacity will be assessed based on 
the interviewer’s judgment during the dialog that takes place during recruitment and screening. 
In addition, the participant participates in a comprehensive psychological assessment as part of 
the screening including questions about traumatic brain injury. We also anticipate that the 
clinician referral will screen out anyone with severe cognitive problems. Participants with 
questionable decisional capacity will be excluded from the study. 

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Consent documents will be stored securely (locked cabinet in a locked room and separate 
from subject data). The PI and coordinator will be responsible for assuring that the current 
consent documents are use at all times. In addition, the VA performs an annual consent audit to 
review compliance and to correct sources of any identified errors. 
 
6.2.2 
Enrollment, Baseline, and/or Randomization 
Enrollment is defined as the date all of the screening criteria are met and the individual 
agrees to participate (typically the screening/baseline visit. 
 
Baseline Assessments 
Phase 1: 
•Short form of the Self Compassion Scale (SCS-SF; Raes, Pommier, Neff, & Gucht,  
2011), 12 items  
•Social Connectedness Scale – Revised (SCS-R; Lee, Draper & Lee, 2001), 20 items 
•Heart rate monitoring 
 
Phase 2: 
•Brief Symptom Inventory (BSI; Derogatis, 1983), 53 items  
•Clinician Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013), 45- 
60 minute clinician-rated measure referencing the Life Events Checklist (LEC) for lifetime trauma  
•Philadelphia Mindfulness Scale (PHLMS; Cardaciotto, Herbert, Forman, Moitra, &  
Farrow, 2008), 20 items  
•PROMIS measures of pain intensity, pain interference, sleep disturbance and  
sleep-related impairment  
•Short form of the Self Compassion Scale (SCS-SF; Raes, Pommier, Neff, & Gucht,  
2011), 12 items  
•Social Connectedness Scale – Revised (SCS-R; Lee, Draper & Lee, 2001), 20 items  
•Sheehan Disability Scale (SDS; Sheehan, Harnett-Sheehan, & Raj, 1996), 3 items  
•Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen, & Griffin, 1985), 5  
items  
•Heart rate monitoring 
 
Randomization 
Phase 2 randomization will occur within 1 month of baseline assessment and within 1 week of the 
beginning of treatment groups.  
 
6.2.3 
Blinding 
In Phase 2, all study personnel will remain blind to treatment condition until data is locked 
with the exception of (a) Ms. Robinson, who will execute randomizations and (b) the study 
therapists, who will execute the interventions. The supervisors will be aware of some identifying 
features of individuals (e.g., first name, appearance) in the groups under their review. There is no 
need for unblinding procedures as the treating clinician will not be blind to condition. 
 
6.2.4 
Followup Visits (sessions 1-8) 
 
In both Phases, the following measures will be completed between or before sessions and 
collected by therapists at group meetings. 
•Credibility, 3-item measure adapted from Borkovec & Nau, 1972 (end of session 1 only).  

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•Modified Differential Emotions Scale (mDES; Fredrickson et al., 2003), daily ratings of the 
strongest experience of 19 specific emotions in the preceding 24 hours 
•Practice diary of time spent in and reactions to daily practice  
•Reactions to group, survey and interview-based methods to gather reactions to group 
sessions and practices. 
•Within-session heart rate monitoring (pending IRB approval)  
 
6.2.5 
Completion/Final Evaluation (after session 8) 
 
The final evaluation will be completed within 1 week after completion of session 8. 
Phase 1: 
•Short form of the Self Compassion Scale (SCS-SF; Raes, Pommier, Neff, & Gucht,  
2011), 12 items  
•Social Connectedness Scale – Revised (SCS-R; Lee, Draper & Lee, 2001), 20 items  
•Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 1994), 8-items 
•Emory Treatment Resistance Interview for PTSD (ETRIP; phenxtoolkit.org)  
•Heart rate monitoring 
 
Phase 2: 
•Brief Symptom Inventory (BSI; Derogatis, 1983), 53 items  
•Clinician Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013), 45- 
60 minute clinician-rated measure referencing the baseline LEC and post-treatment LEC for trauma 
during participation  
•Philadelphia Mindfulness Scale (PMS; Cardaciotto, Herbert, Forman, Moitra, &  
Farrow, 2008), 20 items  
•PROMIS measures of pain intensity, pain interference, sleep disturbance and  
sleep-related impairment  
•Short form of the Self Compassion Scale (SCS-SF; Raes, Pommier, Neff, & Gucht,  
2011), 12 items  
•Social Connectedness Scale – Revised (SCS-R; Lee, Draper & Lee, 2001), 20 items  
•Sheehan Disability Scale (SDS; Sheehan, Harnett-Sheehan, & Raj, 1996), 3 items  
•Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen, & Griffin, 1985), 5  
items  
•Emory Treatment Resistance Interview for PTSD (ETRIP; phenxtoolkit.org)  
•Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 1994), 8-items  
•Heart rate monitoring 
 
For participants who terminate treatment early, we will make every effort to get them to 
complete the post-treatment measures. Early termination would most commonly occur because a 
participant stops attending groups but could also based on clinical judgment that termination 
would be in the participant’s best interest.  This information is important part of the feasibility of 
this study. 
 
7. SAFETY ASSESSMENTS  
At the eligibility assessment and other assessments for enrolled subjects, the interview 
questions and/or questionnaires may produce distress or discomfort from the discussion of 
personal, emotional, or anxiety-provoking topics. Assessors will be trained to identify signs of 
such distress and to engage a licensed clinician if it should occur. 

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Meditation and relaxation have been evaluated in prior studies with patients with PTSD, 
and have been shown to be safe and well-tolerated. It is unlikely but possible that some distress 
will arise during the intervention. In particular, it is possible that sitting quietly with one’s 
internal experience during meditation practice, having compassion for oneself (in cases where 
guilt and shame predominate), or trying to wish a perpetrator to be free of suffering will be 
emotionally challenging for people with PTSD. The likelihood of such distress is equal to or less 
than that associated with current empirically supported treatments for PTSD, which typically 
involve disclosure of the traumatic event or challenge difficult beliefs about the event(s).  
 
The course of PTSD is often characterized by fluctuations in symptoms, particularly 
based on reminders of traumatic experiences. Thus, it is possible that significant exacerbations of 
PTSD symptoms will occur during the course of treatment. Exacerbations of co-occurring 
conditions, including depression or suicidality, alcohol or substance use or dissociation, are also 
possible. As has been demonstrated previously, significant exacerbation of symptoms during 
psychotherapeutic treatment of PTSD is relatively rare and has no impact on rates of attrition or 
improvement (Foa et al., 2002). In order to monitor such changes, the following measures will be 
administered on a weekly basis. 
•Alcohol Use Disorders Identification Test (Saunders, Aasland, Babor, de la Fuente, &  
Grant, 1988) consumption questions (AUDIT-C), 3 items  
•Patient Health Questionnaire, depression items (PHQ-9; Spitzer, Kroenke, & Williams, 1999), 9-
item self-report depression scale, anchored to the past week 
•PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013), 20 items, anchored to the past week  
 
 
Rates of suicidality and homicidality are elevated in individuals with depression and 
PTSD. Suicidality will be evaluated weekly through the PHQ-9. Both suicidality and 
homicidality will be monitored by therapists, who will receive additional training in management 
of these issues, including introduction to site-specific procedures and resources. Dr. Lang will be 
notified immediately about high risk patients (e.g., cannot establish a plan with their therapist to 
assure their safety, hospitalization required). 
 
Thus the possible adverse events (AEs) during both of these interventions include: 
 Alcohol use 
 Anxiety 
 Depression 
 Discomfort 
 Dissociation 
 Homicidality 
 Substance use 
 Suicidality 
If an AE occurs, the therapist, in consultation with Dr. Lang, will decide what measures are 
needed to manage the problem. Referrals for additional services will be provided as necessary.  
 
7.1 
Specification of Safety Parameters 
 
Distress will be identified by a clinically significant increase in total score on the AUDIT, 
PHQ-9 or PCL or by increases on specific items, such as PHQ item 9 which queries suicidality.  
 
At each contact with the participant, the assessor or therapist will seek information on 
AEs by specific questioning. Information on all AEs will be recorded immediately in the study 
records and VA CPRS. All AEs occurring during the study period will be recorded on AE forms. 

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The clinical course of each event will be followed until resolution, stabilization, or until it has 
been determined that the study treatment or participation is not the cause.  
 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
 
Weekly symptom monitoring is standard practice for monitoring safety during treatment 
of PTSD. Dr. Lang will review AEs on an ongoing basis as they occur and in aggregate, along 
with Dr. Golshan, at the end of each group. 
 
7.3 
Adverse Events and Serious Adverse Events  
An adverse event (AE) will be defined as any unfavorable and unintended diagnosis, symptom, 
sign (including an abnormal laboratory finding), syndrome or disease which either occurs during 
the study, having been absent at baseline, or if present at baseline, appears to worsen. Adverse 
events are to be recordedRepor regardless of their relationship to the study intervention.   
A serious adverse event (SAE) will be defined as any untoward medical occurrence that results 
in death, is life threatening, requires inpatient hospitalization or prolongation of existing 
hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly. 
 
Expected psychiatric AEs will be solicited through weekly assessments and therapist 
inquiries. Other types of medical AEs, which are very unlikely to be related to the study 
interventions, will be unsolicited but could be noted by therapists during weekly inquiries about 
how each participant is doing. 
Information on all adverse events will be recorded immediately in AE forms. All adverse 
events occurring during the study period will be recorded. The clinical course of each event will 
be followed until resolution, stabilization, or until it has been determined that the study treatment 
or participation is not the cause. Serious adverse events (SAEs) that are still ongoing at the end 
of the study period will be followed up to determine the final outcome. Any SAE that occurs 
after the study period and is considered to be possibly related to the study treatment or study 
participation will be recorded and reported immediately. Minimum information required for each 
AE includes type of event, duration (start and end dates), severity, seriousness, causality to study 
intervention, action taken, and outcome. 
 
Evaluating Adverse Events. Assessment will include the intensity (severity) of the event and 
the relationship to study intervention. Severity of AEs will be graded using the following criteria 
as guidelines: 1. Mild: Nuisance, barely noticeable. 2. Moderate: Uncomfortable, troublesome 
symptoms not significantly interfering with daily activities or sleep. 3. Severe: Symptoms 
significantly interfere with daily activities or sleep. The relationship of the AE to the study will 
be specified using the following definitions: 1. Not Related: Concomitant illness, accident or 
event with no reasonable association with treatment. 2. Unlikely: The reaction has little or no 
temporal sequence from participation and/or a more likely alternative etiology exists. 3. Possibly 
Related: The reaction follows a reasonable temporal sequence from participation and follows a 
known response pattern to the intervention; the reaction could have been produced by the study 
intervention or could have been produced by the subject’s clinical state or by other modes of 
treatment administered to the subject. 4. Probably Related: The reaction follows a reasonable 
temporal sequence from participation and cannot be reasonably explained by the known 
characteristics of the subject’s clinical state. 5. Definitely Related: The reaction follows a 
reasonable temporal sequence from participation and cannot be explained by the known 
characteristics of the subject’s clinical state. 

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7.4 
Reporting Procedures 
Reporting of AEs.  Negative events that occur during study involvement do not constitute 
adverse events unless they lead to physical harm (in which case the injury is the AE) or 
deterioration of mental health functioning (in which case the symptoms are the AE). Negative 
events that may potentially affect response to the intervention or study involvement should be 
reported as AEs. Examples might include legal problems or traumatic events.  
 
An AE form will be placed in the participant folder. This form is cumulative and captures 
adverse events of a single participant throughout the study. The study therapist will document 
each AE reported on the form. The study coordinator will periodically review and compile the 
information into summary or table form for reporting to both the Independent Monitoring 
Committee (IMC) and the VASDHS IRB at the time of continuing review. 
 
Reporting of Serious Adverse Events and Unanticipated Problems. An AE occurring in a 
participant  enrolled in a research study is serious if it results in any of the following outcomes: 
death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of 
existing hospitalization, a persistent or significant disability/incapacity, or is a congenital 
anomaly/birth defect. Examples of possible UPRs for psychotherapeutic interventions:  
1. Psychosis or mania 
2. New onset or clinically significant exacerbation of an Axis I disorder  
3. Suicide and suicide attempts. 
Any study-related unanticipated problem posing risk of harm to subjects or others and any 
serious adverse event regardless of relatedness  will be reported immediately to the PI, the 
VASDHS IRB within 10 days using the VASDHS Human Research Protections Program form 
REPORT OF UNANTICIPATED PROBLEM INVOLVING RISK TO SUBJECT OR OTHERS 
(dated 7/9/12), and NCCAM according to requirements.   
 
7.5 
Follow-up for Adverse Events 
The clinical course of each event will be followed until resolution, stabilization, or until it 
has been determined that the study treatment or participation is not the cause. Serious adverse 
events that are still ongoing at the end of the study period will be followed up to determine the 
final outcome. Any serious adverse event that occurs after the study period and is considered to 
be possibly related to the study treatment or study participation will be recorded and reported 
immediately. 
 
7.6 
Safety Monitoring  
This project will be monitored by an Independent Monitoring Committee. Refer to Data 
and Safety Monitoring Plan.  
 
8. INTERVENTION DISCONTINUATION  
An intervention can be discontinued if the participant chooses to do so or if the therapist 
or Dr. Lang believes it is in the participant’s best interest. If the therapist or Dr. Lang judges that a 
subject requires a different approach or higher intensity care, the subject will be provided with 
referrals for outpatient or inpatient care, as appropriate. Participants will be asked to complete the 
all remaining assessments if they discontinue early. 
 
 

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9. STATISTICAL CONSIDERATIONS  
 
9.1 
General Design Issues  
This project is a feasibility and proof of concept study of compassion meditation (CM) for 
Veterans with posttraumatic stress disorder (PTSD; N ≈ 100). Phase 1 (N ≈ 60, nonrandomized), 
Protocol Refinement, will consist of up to 4 CM and 2 Relaxation groups with 6-12 participants in 
each group. Iterative refinement of the treatment protocols will be done based on quantitative and 
qualitative data from participants. Phase 2 (N ≈ 40), Pilot Evaluation is a randomized controlled 
study with 4 groups (2 CM and 2 relaxation groups, 6-12 in each group) to examine the feasibility 
of a randomized trial and to estimate response to CM. The study is not hypothesis driven, but 
rather developmental in nature. 
 
The primary outcome measures in Phase 1 (see section 6.2) are related to refinement of the 
intervention, i.e., participants’ behavior and reactions to the material and change in processes that 
are believed to be modified by CM (i.e., positive emotion, social connectedness, self-
compassion). The primary outcome measures in Phase 2 (refer to section 6.2) are related to 
estimating the amount of change in symptomatology, functioning and psychological processes 
thought to be associated with CM. 
 
9.2 
Sample Size and Randomization 
For Phase 1, we estimated sample size based on past experience in intervention 
development; we believe that we will need to run 4 CM groups to achieve Phase 1 refinements 
(e.g., Lang, Norman, & Casmar, 2006). For the relaxation protocol, which was used in a prior 
PTSD study, we will begin with our modified version and expect 2 groups will be sufficient given 
the very minor modification. We will aim for a group size of 6-12, which can be recruited within 
the 1-month period we have allocated to recruitment before each group. Thus, we estimate that 60 
people will take part in Phase 1 of the research. 
In Phase 2, we will conduct a pilot study with 4 groups (2 CM and 2 relaxation groups, 6-
12 in each group) to examine the feasibility of a randomized trial and response to CM. Thus, we 
anticipate approximately 40 participants in the second phase 
 
Treatment Assignment Procedures 
In phase 2, groups will be randomly assigned a treatment condition in a 1:1 ratio. The 
assessor will remain blind to these assignments; the study team will be careful not to disclose 
which group or therapist is seeing a given participant and participants will be asked to refrain 
from discussing the nature of their intervention during assessments. There is no need for breaking 
blind as treating clinicians will be aware of the treatment assignment. 
 
9.3  
Definition of Populations 
 
Participants in both phases will be Veterans with PTSD who are able to consent and 
willing to participate. Co-occurring disorders such as depression, anxiety, or treated substance 
abuse or dependence problems are permitted provided that PTSD is the primary presenting 
complaint.  Sixty people will take part in Phase 1 of the research and approximately 40 
participants in the second phase, for a total sample size of approximately 100 people.  This is 
intent to treat protocol and all subjects will be included in the study data analysis. 

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9.4 
Interim Analyses and Stopping Rules 
Not applicable  
 
9.5 
Outcomes  
 
9.5.1 
Primary Outcome   
 
The primary outcomes of Phase 1 are participant reactions to the group (credibility, 
satisfaction, attendance, practice compliance, and weekly qualitative and quantitative feedback) as 
well as variables that reflect changes that are expected with practice of CM (positive emotion, 
social connectedness, self compassion). These includes: Client Satisfaction Questionnaire,  
credibility score, modified Differential Emotions Scale, time spent in and reactions to daily 
practice,  reactions to group, short form of the Self Compassion Scale  and Social Connectedness 
Scale. Refer to section 6.2 for the schedule of administration and descriptions of measures. 
 
The primary outcome of Phase 2 is the CAPS-5, which quantifies PTSD symptomatology.  
 
9.5.2 
Secondary Outcomes   
 
The secondary outcomes of Phase 1 are the rate of study enrollment based on various 
types of recruitment strategies as well as gender. 
 
The secondary outcomes of Phase 2 include symptoms that frequently co-occur with 
PTSD (Brief Symptom Inventory, PROMIS measures of pain intensity, pain interference, sleep 
disturbance and sleep-related impairment), functioning/quality of life (Sheehan Disability Scale 
and Satisfaction with Life) as well as variables that capture the mechanisms by which CM may 
create change, including positive emotion (modified Differential Emotions Scale), social 
connectedness (Social Connectedness Scale), self-compassion (Short form of the Self 
Compassion Scale) and mindfulness (Philadelphia Mindfulness Scale). 
 
9.6 
Data Analyses  
Although majority of data will be quantitative, some qualitative data also will be 
collected. Dr. Golshan has experience with qualitative coding and analyses. Dr. Hurst also has 
been added to the study team for her experience with qualitative interviewing, coding and 
analyses. We will analyze qualitative data using atlas.ti, a qualitative data analysis software 
package. Qualitative data analysis starts with coding, a process in which quotes are marked and 
labeled. The labeled quotes are then sorted and grouped, so that categories, then concepts, then 
themes can be developed. As is often standard practice for qualitative data analysis, analysis will 
be concurrent with data acquisition. 
Quantitative data will be analyzed using SPSS version 18. These data will be examined 
initially for missing values. The primary aims of our data analytic strategy in phase 1 will be 
directed toward the development of CM and collection of data that will inform modification of 
the interventions. In phase 2 it will be directed toward examining the feasibility of CM. We 
would like to emphasize that, although we aim to estimate an effect sizes to assist in future 
power calculations, this is not our major focus. Recent work by Kraemer (2006) has highlighted 
important limitations of this aim due to the large standard error surrounding the pilot study effect 
size. As a result, we will focus our analyses on a feasibility of conducting a larger CM study and 
report our findings with this limitation in mind. Our goal is to collect important data regarding 
the development of CM protocols, our ability to implement recruitment strategies, and the 
feasibility of the treatment and measurements. Information derived from our research will leads 

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to better-designed full-scale studies and informs decisions regarding whether it is worthwhile to 
commit additional resources to future CM treatment development. Due to our small sample size 
our statistical analytical findings should be interpreted with caution.  
For quantitative data, descriptive statistics will be used to summarize the variables as well 
as to detect outliers and data entry errors. When applicable, normality of the distribution will be 
examined for outcome variables with a normal probability plot. HRV measures will be generated 
from heart rate data per the recommendations of the Task Force of the European Society of 
Cardiology and the North American Society of Pacing and Electrophysiology (Task Force, 
1996). Chi- squares and Analysis of Variance will be used to assess the effectiveness of the 
randomization procedures by comparing participants in each treatment condition on baseline 
variables. Although there are important limitations associated with the analysis of our phase 2 
data, we do propose to conduct limited statistical analyses. First, keeping in mind the theoretical 
and practical issues reviewed above, all analyses will be considered preliminary. We will 
calculate an estimated effect size for our primary outcome, though it will be interpreted with 
caution, and in the context of the 95% confidence interval that surrounds it. It will also be 
interpreted within the context of other important information such as the clinical significance of 
study findings, and existing data from prior relevant research studies.  
Primary analyses will assess whether CM is superior to Relaxation. The two groups will 
be compared on CAPS, BSI, SDS and Philadelphia Mindfulness Scale using analysis of variance. 
We are also particularly interested in evaluation of patterns of missing data, dropout rates, 
distributional properties of variables, and correlations among measures. Missing data will be 
examined to assess randomness. The pattern of missing data will be examined according to the 
procedure recommended by Little and Rubin (1987), which includes comparing group 
differences in the primary outcomes of subjects with versus without missing data. We will test 
whether the drop-outs are random or systematic by comparing the drop-outs with the study 
completers on the baseline data. An absence of significant differences would support the random 
nature of drop- outs. Dropout rate will be compared between the groups using chi-square 
analysis. Given the limited sample size, multiple linear regression may be used carefully to 
examine whether group assignment predicts PTSD symptom severity at the follow-up 
assessment while controlling for initial values. Other potential covariates will include baseline 
demographic or clinical variables (e.g., concomitant medication use) that are not equivalent 
between the two treatment groups. Effect size for the difference between groups will be 
calculated according to procedures described by Cohen (1988). We will also explore the effect of 
patterns of missing data using Mixed Effects models (random regression models). We will 
perform sensitivity analyses for the impact that potentially informative missing data and dropout 
may have on the analyses. The mixed effects framework is robust with respect to drop-out and 
missing data, unless the drop-out mechanism or cause of missing is informative. We will use 
pattern-mixture models to assess if there is bias due to drop out or missing data. 
 
 
10. DATA COLLECTION AND QUALITY ASSURANCE 
 
10.1 
Data Collection Forms  
Indicate how information will be collected for each participant and by whom. For example if a 
blinded observer will perform outcome assessments, state who this person will be. Describe 
methods for maintaining confidentiality of participant records. Identify any data that will be 

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recorded directly on the CRFs (i.e. no prior written or electronic record of data) as this will be 
considered source data. (ICH Guidelines, E6.4.9)  
 
 
Trained assessors will administer the measures for this study. Data collected in this project 
includes a structured interview and self-report measures about mental health symptoms, including 
alcohol use, quality of life, functioning and response to meditation practice. Designated staff 
members will have access to individually identifiable private information about human subjects. 
All such staff will receive training in proper handling of research data, and systems will be put in 
place to maintain subject confidentiality to the greatest extent possible. For example, paper data 
will be stored in locked file cabinets in locked rooms. Subject names (including consent forms 
and the key associating names with subject numbers) and contact information will be stored 
separately from other study data, which will be identified using a subject ID number. Electronic 
data will be stored on a password-protected secure server. 
 
10.2 
Data Management  
Data management will be supervised by the study statistician, Dr. Golshan.  He has more 
than 28 years experience in data management and analysis. The computer systems to be used (VA 
and Veterans Medical Research Foundation) are HIPAA compliant and housed in locked rooms, 
accessible only to authorized personnel and employees.  All subjects are assigned a unique ID 
number.  The patient names are never used in conjunction with the unique clinic ID number.  The 
single name-to-ID relational file is kept in an encrypted form electronically and in a locked filing 
cabinet physically.  Data will be collected on paper forms and entered into an already existing 
data management system. Prior to inferential analyses, data will be examined for missing values 
and statistical outliers. All statistical transfer routines are inherently secure via their operating 
platform and they contain no patient names or personal data.   
 
10.3 
Quality Assurance  
 
10.3.1 Training 
Assessment. The assessor in Phase 2 will be a doctoral-level psychologist with familiarity 
with diagnostic interviewing. Dr. Gray will provide study-specific training prior to conducting 
interviews. Training for the MINI will include a didactics on the interview, including the 
suicidality/homicidality assessment, and administration of practice interviews with a mock patient. 
Training in the CAPS will include review of training materials, observation of CAPS administration, 
and diagnostic matching on three CAPS interviews. To establish matching, Dr. Gray will co-rate 
the training interviews conducted by the assessor. A match occurs when the assessor and Dr. 
Gray agree on the diagnosis and are within 2 points of severity (frequency + intensity) on all of 
the symptom clusters (PTSD criteria B, C, and D). Each assessor will be considered trained on 
CAPS when he or she matches Dr. Gray on three interviews (this requirement may be reduced with 
documentation of prior rigorous CAPS training). If the assessor does not match on three interviews 
after five attempts, Dr. Gray will provide additional training or the assessor will be replaced. 
Dr. Gray will supervise the assessor’s interviews throughout the study, and all interviews will be 
audio-recorded in case detailed review of an interview is needed. We will follow standard 
procedure for ensuring inter-rater reliability over time. Each assessor’s score will be compared to 
the Dr. Gray “gold standard” rating. Intra-class correlation coefficients (ICCs) of each assessor 
must be .90 or higher. If the ICC falls below .90, retraining will be done. Reliability will be re-
established annually or more frequently if requested by the project PI or the study statistician. 

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Interventions. 
We will follow accepted standards (Perepletchikova & Kazdin, 2005) in establishing and 
assessing the integrity and fidelity of the interventions. This includes: a) treatment manuals with 
weekly objectives, outcomes, and agendas, b) clinician training, and c) ongoing evaluation of 
treatment integrity through audio-rating of therapy sessions and supervision. 
The CM protocol will be taught using the Emory Intensive Teacher Training Program. 
The program is designed to help potential teachers explore effective contemplative pedagogy, 
understand and adapt to the needs of various populations, and deepen their personal meditation 
practice. The prerequisites for this training are having a regular meditation practice of at least 
one year and having attended at least one teacher-led residential retreat. The first portion of the 
training (taught as a week-long or two-weekend intensive) involves an introduction to the key 
concepts, skills, and practices, including understanding the theory and practice of CM, learning 
how CM differs from other meditation-based programs and recognizing the rationale and 
significance of teaching secularized meditation programs. The second portion of the training, 
which is a retreat, affords participants an opportunity to deepen their practice and experience 
with CM. Participants are expected to continue deepening their personal meditation practice on 
their own after the intensive training. The third training component involved supervised 
administration of the protocol. A supervisor from Emory will watch a video- recording of every 
class and provide feedback to the therapist prior to the next class. 
The relaxation protocol will be conducted following the Taylor manual. Dr. Lang will 
review recordings of every session to assure adherence to the protocol. A fidelity measure will be 
developed for each intervention at the end of the refinement phase and will be evaluated in the 
pilot phase. To identify problems early, the Emory group will listen to audiotapes of each 
session. Corrective feedback will be provided as needed in weekly supervision. The participant 
evaluation method of quality assurance, which involves asking each participant to complete a 
brief checklist that queries the content of their session, will be employed as well.  
 
10.3.2 Quality Control Committee  
Data monitoring will be the responsibility of Drs. Lang and Golshan. 
 
10.3.3 Metrics 
Outcome measures will be checked for missing and impossible values as well as for 
internal inconsistencies. 
 
10.3.4 Protocol Deviations 
A protocol deviation or violation is any change, divergence, or departure from the study design 
or procedures of a research protocol. Investigators are required to conduct their research 
according to the plans reviewed and approved by the IRB. Staff will be trained to avoid protocol 
deviations to the extent possible. Instances where this does not occur, either inadvertently due to 
circumstances beyond the investigator’s control or due to errors of omission or commission by 
research project staff, will be reported.  
 
Protocol deviations will be recorded and maintained by the study coordinator on the Protocol 
Deviation Log and reviewed by Drs. Lang and Golshan.  
 

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Protocol deviations that do not affect participant safety or data integrity will be reported to the 
VASHS IRB at continuing review.  Any protocol deviation resulting in harm or risk to the 
participant must be reported within ten business days to the VASDHS IRB using the VASDHS 
Human Research Protections Program form REPORT OF UNANTICIPATED PROBLEM 
INVOLVING RISK TO SUBJECT OR OTHERS (dated 7/9/12).   
 
10.3.5 Monitoring 
The VA San Diego conducts annual reviews of consent forms to assure compliance. 
Research assistants and therapists will be trained to review all instruments for completeness 
before the participant leaves the appointment. Drs. Lang and Golshan will review the data set for 
completeness at the end of each group cycle.  
 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
 
11.1 
Institutional Review Board (IRB) Review  
This protocol and the informed consent document and any subsequent modifications will 
be reviewed and approved by the VA San Diego IRB and R&D Committee.  
 
11.2 
Informed Consent Forms 
Consenting will take place at the Oceanside VA clinic with a trained assessor/study 
coordinator in a private room and the participant will be given ample time to read the consent 
form and ask questions. At the first visit, prior to initiation of any study- related procedures, 
subjects will give their written consent to participate in the study after having been informed 
about the nature and purpose of the study, participation/termination conditions, risks, and 
potential benefits. Informed consent is a process that is initiated prior to the individual’s agreeing 
to participate in the study and continuing throughout the individual’s study participation. Upon 
reviewing the document, the assessor will explain the research study to the participant and 
answer any questions that may arise. Extensive discussion of risks and possible benefits of this 
therapy will be provided to the participants as needed. The investigator will explain study 
procedures, including the variable length of follow-up in this study, and let the participant know 
how many follow-up assessments he/she will be asked to complete. The participants will sign the 
informed consent document prior to any procedures being done specifically for the study. The 
participants may withdraw consent at any time throughout the course of the trial. A copy of the 
informed consent document will be given to the participants for their records. The rights and 
welfare of the participants will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study. VA 
subjects will consent to the audio-video recording using VA form 10-3203. Decisional capacity 
will be assessed based on the interviewer’s judgment during the dialog that takes place during 
recruitment and screening. In addition, the participant participates in a comprehensive 
psychological assessment as part of the screening including questions about traumatic brain 
injury. We also anticipate that the clinician referral will screen out anyone with severe cognitive 
problems. Participants with questionable decisional capacity will be excluded from the study.  
 
11.3 
Participant Confidentiality  
Patient confidentiality will be protected to the extent permitted by law. Participant names 
will be held separate from data. Subjects will be assigned a unique ID number, and the single 

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name-to-ID relational file will be kept in an encrypted form electronically and in a locked filing 
cabinet physically.  
Designated staff members will have access to individually identifiable private 
information about human subjects. All such staff will receive training in proper handling of 
research data, and systems will be put in place to maintain subject confidentiality to the greatest 
extent possible. For example, all data will be stored in locked file cabinets in locked rooms. 
Subject names (including consent forms and the key associating names with subject numbers) 
and contact information will be stored separately from other study data, which will be identified 
using a subject ID number. Electronic data will be stored on a password-protected secure server. 
All statistical transfer routines are inherently secure via their operating platform and they contain 
no patient names or personal data.  
All computer entry and networking programs will be done using PIDs only. Information 
will not be released without written permission of the participant, except as necessary for 
monitoring by IRB, the FDA, the NCCAM, and the OHRP. 
 
11.4 
Study Discontinuation  
The study may be discontinued at any time by the IRB, the NCCAM, the OHRP, the FDA, 
or other government agencies as part of their duties to ensure that research participants are 
protected.  
 
12. COMMITTEES 
Not applicable. 
 
13. PUBLICATION OF RESEARCH FINDINGS  
Any presentation, abstract, or manuscript will be made available for review by the VA San 
Diego and the NCCAM prior to submission. All analyses and reports will be done or supervised 
by Drs. Lang and Golshan. All abstracts and manuscripts will be reviewed by the research team 
and must be approved prior to be reviewed by any other individual.  
 
 
14. REFERENCES  
Bormann, J. E., Thorp, S. R., Wetherell, J. L., Golshan, S., &Lang, A. J. (2011). Meditation-
based mantram intervention for veterans with military-related posttraumatic stress 
disorder: A randomized trial. Manuscript submitted for publication.  
Desbordes, G., Negi, L. T., Pace, T. W., Wallace, B. A., Raison, C. L., &Schwartz, E. L. (2012). 
Effects of mindful-attention and compassion meditation training on amygdala response to 
emotional stimuli in an ordinary, non-meditative state. Frontiers of Human Neuroscience, 
6, article 292.  
Fredrickson, B. L., Cohn, M. A., Coffey, K. A., Pek, J., &Finkel, S. M. (2008). Open hearts build 
lives: Positive emotions, induced through loving-kindness meditation, build consequential 
personal resources. Journal of Personality and Social Psychology, 95, 1045-1062.  
Kearney, D. J., McDermott, K., Malte, C., Martinez, M., &Simpson, T. L. (2012) Association of 
participation in a mindfulness program with measures of PTSD, depression and quality of 
life in a veteran sample. Journal of Clinical Psychology, 68, 101-116. DOI: 
10.1002/jclp.20853  

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Lang, A. J., Strauss, J. L., Bomyea, J., Bormann, J. E., Hickman, S. D., Good, R. C., &Essex, M. 
(2012). The theoretical and empirical basis for meditation as an intervention for PTSD. 
Behavior Modification. DOI: 10.1177/0145445512441200  
Niles, B. L., Klunk-Gillis, J., Ryngala, D. J., Silberbogen, A. K., Paysnick, A., &Wolf, E. J. 
(2012). Comparing mindfulness and psychoeducation treatments for combat- related 
PTSD using a telehealth approach. Psychological Trauma: Theory, Research, Practice, and 
Policy, 4, 538-547.  
Taylor, S., Thordarson, D. D., Maxfield, L., Fedoroff, I. C., Lovell, K., & Ogrodniczuk, J. 
(2003). Comparative efficacy, speed, and adverse effects of three PTSD treatments: 
Exposure therapy, EMDR, and relaxation training. Journal of Consulting and Clinical 
Psychology, 71, 330-338.  
Task Force of the European Society of Cardiology and the North American Society of Pacing 
and Electrophysiology (1996).  Heart rate variability: standards of measurement, 
physiological interpretation, and clinical use.  European Heart Journal, 17, 354-81. 
 
15. SUPPLEMENTS/APPENDICES