Primary-Care Based Mindfulness Intervention for Chronically Traumatized Individuals
Phase: NA
Conditions: Post Traumatic Stress Disorder, Major Depressive Disorder
Sponsor: Emory University

Study Protocol 
 
Title: Primary Care Based Mindfulness Intervention for Chronically 
Traumatized Individuals 
 
NCT Number: NCT03922581 
 
Protocol date: January 21, 2022 

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Scientific Protocol
Research Study:  Primary Care Based Mindfulness 
Intervention for Chronically Traumatized Individuals
Principal Investigator:
Abigail Powers Lott, PhD,
Assistant Professor
Department of Psychiatry and Behavioral Sciences
Version: 12
Version Date: January 21, 2022
External Collaborators:
Nicole Nugent, PhD, Associate Professor, Department of Psychiatry and Human Behavior

De-identified Data Analysis/Statistics

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Abstract
There is significant public health burden of chronic trauma exposure in low income, 
predominantly ethnic minority, urban communities, which is reflected in the extraordinarily high 
levels of trauma-related psychiatric disorders, particularly posttraumatic stress disorder (PTSD) 
and major depressive disorder (MDD). Despite this, limited access to behavioral health 
treatment and significant barriers to treatment engagement and success remain[1] and 
integrating mind-body approaches in medical settings could be a critical next step in treating 
chronically traumatized individuals in these urban settings. This study will utilize a randomized 
controlled trial design along with a multi-method assessment approach to ascertain the 
feasibility, acceptability, and preliminary mechanisms of action and outcomes of mindfulness-
based cognitive therapy versus wait-list control in 80 African Americans with chronic trauma 
exposure and comorbid PTSD and MDD symptoms. Subjects will be recruited from primary care 
waiting rooms at Grady Memorial Hospital. Individuals must screen positive for depression and 
PTSD in order to be eligible for the study through the Patient Health Questionnaire-9 and 
Primary Care PTSD Screen. Once enrolled, subjects will be randomized to an 8 session (90 
minutes each) group intervention or wait-list control. We will examine retention and follow-up 
rates, subjects’ report of acceptability and interest in the intervention, and examine barriers to 
treatment engagement through self-report measures and exit interviews. We will also 
investigate preliminary mechanisms of action and outcomes of the mindfulness intervention in 
targeting emotion regulation and autonomic processes by measuring self-report of emotion 
dysregulation using the Difficulties in Emotion Regulation Scale and autonomic arousal to 
trauma cues using Esense technology to assess skin conductance during administration of 
Standardized Trauma Interview. Latent growth modeling will assess relative changes in emotion 
dysregulation and autonomic function over time through intervention and 1 month follow-up.
Introduction and Background
More than half of individuals in the United States experience at least one traumatic event in their 
lifetime.[2, 3] Exposure to multiple traumatic events increases risk for psychiatric disorders in a 
dose-response manner; as the number of traumas experienced increases, comorbid PTSD and 
MDD symptoms also increase.[4, 5] In the general population, the lifetime prevalence of PTSD 
and MDD have been estimated to be 5-10%[6] and 8-16%[7-9] respectively, but rates as high as 
30-50% for these disorders are observed among civilians living in areas with high violence, with 
up to half of those individuals meeting criteria for both disorders.[10-12] Low socioeconomic status 
is strongly associated with increased exposure to multiple traumatic events, and as a result 
exhibit elevated rates of PTSD and MDD.[1, 13-16] Furthermore, economically disadvantaged 
African Americans living within urban environments experience particularly high levels of 
trauma, often beginning early in life.[13-18] Because chronic trauma exposure substantially 
increases the risk of PTSD and MDD,[6, 19] it is critical to intervene with at-risk, underserved 
populations where chronic trauma is highly likely to occur. 
While individuals exposed to chronic trauma often have high levels of psychiatric symptom 
severity, they may be less likely than individuals with a discrete trauma exposure to engage in 
or improve from standard PTSD treatment.[20] Historically, trauma-based cognitive behavior 
therapies, such as Prolonged Exposure and Cognitive Processing Therapy, have been 
considered first-line treatments for PTSD.[21, 22] However, there are a number of limitations with 
these treatments related to low tolerability for patients with chronic trauma exposure, high rates 
of drop out, and continued presence of PTSD diagnosis.[22, 23] In addition, both treatments 
involve significant writing and worksheet-based homework. The target population in this study 

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includes individuals with limited literacy[24, 25] and requiring written homework may not be 
appropriate. Even those who are literate often have low levels of education, making the idea of 
written homework a barrier to treatment.[26] Furthermore, limited access to behavioral health 
care and stigma against such treatment reduces the chances that individuals from low-income 
environments seek care or are willing to engage in direct exposure-based trauma treatment.[26-
28] Finally, despite the high co-occurrence of PTSD and MDD and the fact that PTSD 
interventions can also reduce some depressive symptoms, PTSD interventions directly target 
symptoms that do not overlap as clearly with MDD (e.g. re-experiencing, avoidance) and 
although PTSD interventions can also reduce some depressive symptoms, it is important to 
consider alternative treatment approaches among those with comorbid PTSD and MDD 
following chronic trauma exposure. Thus, turning toward complementary and integrative mind-
body approaches may be critical for improving treatment success for a low-income traumatized 
population with comorbid PTSD and MDD. 
One potential contender is mindfulness-based approaches, such as mindfulness-based stress 
reduction (MBSR) and mindfulness-based cognitive therapy (MBCT, a variant of MBSR), as 
these are associated with improvements in  physical and behavioral health conditions 
broadly,[29-35] medical resource utilization,[36-38] and  ability to cope with physical health problems 
in most,[29, 32] but not all[39, 40] studies. Recently, both MBSR and MBCT approaches have been 
used with combat PTSD and childhood sexual abuse and studies show initial efficacy in 
reducing PTSD symptoms, particularly avoidance and numbing.[41-46] In addition, mindfulness 
approaches - particularly MBCT - are also effective in treating MDD[47, 48] and reducing risk of 
relapse.[49] Further, mindfulness approaches have shown promise in low-income African 
American populations. For example, recent studies reveal that another variant of a mindfulness-
based intervention, compassion-based cognitive therapy, is associated with reductions in self-
criticism and compassion, which in turn predict improvements in MDD symptoms among 
suicidal low-income African Americans.[50, 51] In addition, two studies have shown initial feasibility 
and acceptability in implementing an 8-week MBSR training with African American women with 
chronic trauma exposure.[52, 53] While examination of mind-body approaches in urban 
traumatized populations remains limited, the above studies indicating feasibility, acceptability, 
and symptom reduction suggest further research into these approaches is warranted.
Given significant barriers to behavioral healthcare among chronically traumatized, low-income 
African Americans[24, 25], bringing complementary and integrative behavioral health treatment to 
primary care locations where this population is already using resources may increase access 
and reduce stigma.[54] Evidence supports the use of mindfulness interventions in primary care 
settings.[37] For example, a recent study examining a brief MBSR protocol for use with combat 
veterans in primary care found preliminary evidence that the intervention was feasible, 
acceptable to the veterans, and effective in reducing both PTSD and MDD symptoms[46] and in 
enhancing physiological functioning.[55] The use of a mindfulness intervention in primary care 
may reduce the risk of drop outs and lower the burden on patients. Additionally, the mindfulness 
intervention will be fully experiential and therefore may reduce difficulty with engagement in 
treatment due to components like written homework. Such a complementary and integrative 
mind-body intervention may prove particularly efficacious if it targets ED and autonomic 
processes that characterize chronically traumatized individuals with PTSD and MDD. 
Identifying and targeting underlying mechanisms that contribute to PTSD and MDD in low-
income, chronically traumatized, African Americans is imperative. Emotion dysregulation (ED), 
or deficits in the ability to adaptively respond to emotional distress, is particularly prominent in 
individuals with chronic trauma exposure and may be a critical mechanism to consider.[56, 57] 

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There are many components of adaptive emotion regulation, including awareness and 
acceptance of emotional experience, adequate strategies to manage emotional responses, and 
the ability to control behavioral responses in the presence of strong emotions;[58] individuals with 
chronic trauma exposure show deficits across all areas of emotion regulation. Dysregulation of 
the autonomic nervous system is seen as one key objective marker of ED. Dysfunction of 
autonomic processes is associated with child abuse exposure,[59-61] often an indicator of more 
chronic trauma exposure,[62] although direct associations with chronic trauma exposure remain 
unclear. 
  
ED is a transdiagnostic process that contributes to many types of psychiatric conditions related 
to trauma, including PTSD and MDD.[63-65] Poor emotion regulation predicts greater PTSD 
symptom severity and therefore may be a mechanism that accentuates or perpetuates PTSD 
symptoms.[66] Impaired autonomic function also correlates with PTSD and MDD and is another 
proposed mechanism of risk for the development of these disorders.[67] PTSD is associated with 
heightened physiological reactivity[68, 69]  while MDD is associated with heightened baseline 
sympathetic arousal and blunted sympathetic response to stress.[70] In fact, research in our 
lab[68] has shown that enhanced reactivity to fearful stimuli is a biomarker of PTSD, but not 
depression among trauma-exposed individuals. Importantly, not all individuals with PTSD exhibit 
this autonomic pattern; some individuals also show a blunted physiological response. Research 
suggests there may in fact be two distinct subtypes of PTSD reflecting emotional 
undermodulation (hyperarousal and enhanced sympathetic activation) and emotional 
overmodulation (dissociation and emotional numbing with blunted sympathetic activation).[71] 
Enhanced reactivity relates most strongly to hyperarousal symptoms[68] and treatment studies 
using Prolonged Exposure have shown that greater physiological reactivity prior to treatment 
predicts better treatment success.[72] However, since not all individuals with PTSD exhibit strong 
physiological reactivity, and chronic trauma exposure increases the likelihood of the presence of 
emotional overmodulation (i.e., dissociation, numbing), choosing a mind-body treatment that 
can target ED, regardless of the type, may be very beneficial in populations with high rates of 
chronic trauma exposure across the lifespan. Furthermore, emotional numbing is a core 
component of PTSD that strongly overlaps with depression and may help maintain PTSD 
symptoms[48, 73], and so using a treatment that may target such symptoms is warranted. 
In considering mechanisms of action for our mind-body intervention, multiple studies have 
shown the benefits of mindfulness-based approaches in enhancing emotion regulation and 
autonomic function.[44, 74-76] Mindfulness acts to increase attentional control, enhance awareness 
of emotional experience, and provide a space for experiential exposure to internal emotional 
responses through nonjudgment and acceptance.[77, 78] A common element in evidence-based 
treatments for PTSD is exposure.[79] While mindfulness does not directly target exposure to 
trauma memories, the treatment does provide interoceptive exposure to emotions, which is a 
critical part of healthy emotion regulation and enhancing emotion regulation may result in 
reductions in PTSD and MDD symptoms in turn. Furthermore, focus on enhancing autonomic 
function through mindfulness may be associated with marked improvement in symptoms related 
to hypoarousal (such as emotional numbing)[80-82], which are often the PTSD symptoms hardest 
to treat.[73] Additionally, MBCT’s focus on decoupling from negative cognitions may help to 
reduce the frequency of negative cognitions and resulting negative emotional reactions[83] which 
could aid in reducing cognitive symptoms present across both PTSD and MDD.
While there is substantially less empirical evidence to demonstrate the effectiveness of mind-
body approaches like mindfulness in treating trauma patients at present, for the reasons 
described above, our mindfulness intervention may in fact be more acceptable than currently 

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employed cognitive-behavioral approaches for this underserved population of chronically 
traumatized adults. This study will utilize MBCT, an 8-week complementary and integrative 
behavioral health protocol in a primary care setting, determine its feasibility and acceptability, 
and gather preliminary evidence for its ability to effectively target ED and autonomic function 
among chronically traumatized African Americans. It is hoped that results will advance our 
understanding of the psychological and physiological mechanisms of action that drive PTSD 
and MDD symptom change through mindfulness interventions in chronically traumatized low-
income African Americans.  
Objectives
Specific Aim 1: Evaluate feasibility and acceptability of mindfulness intervention in a high-risk, 
underserved population. Aim 1a: Examine retention and follow-up rates in the intervention and 
control groups. Completion of assessments and intervention session attendance will be tracked. 
Aim 1b: Examine subjects’ report of acceptability of and interest in the intervention. Satisfaction 
with intervention will be assessed with a self-report measure and through an exit interview post-
intervention. Descriptive statistics and frequency distributions will be evaluated. Aim 1c: 
Examine barriers to treatment engagement in the intervention. Barriers to treatment will be 
assessed with a self-report measure and through descriptions provided by subjects post-
intervention. Descriptive statistics and frequency distributions will be evaluated.
Specific Aim 2: Investigate preliminary mechanisms of action and outcomes of mindfulness 
intervention in targeting emotion regulation and autonomic processes. Aim2a: Evaluate if 
intervention results in greater reductions in ED than wait-list control. Self-report ED (emotional 
awareness, acceptance, strategy use, behavioral control) data will be collected at four time-
points (pre-intervention, half-way through intervention, post-intervention, 1m follow-up). Aim 2b: 
Evaluate if intervention results in greater normalization of autonomic function than wait-list 
control. Autonomic arousal to trauma cues (using skin conductance; pre- and post-intervention, 
3 month follow-up) will be measured. Latent growth modeling (LGM) will assess relative 
changes in ED and autonomic function through intervention and follow-up.
Study design and methods
Procedure: Initial screening for eligibility will occur in the medical clinics of Grady Memorial 
Hospital or through phone-based screening through a parent project, the Grady Trauma Project 
(IRB00078593). After initial screening through the Grady Trauma Project to determine eligibility 
for the study associated with this study and appropriate informed consent procedures, subjects 
will participate in a pre-intervention assessment. These may be in person or virtually depending 
on safety-related challenges due to the COVID-19 pandemic. Virtual assessments will either 
occur via phone or Zoom (HIPAA-compliant platform). Following the pre-intervention 
assessment, they will be randomly assigned using a random number generator to either the 
MBCT intervention or wait-list control group condition. We will use block stratified randomization 
(in blocks of 20) to ensure variability in PTSD and MDD diagnosis in the two groups. We will 
also use allocation concealment by placing the treatment allocation information in opaque 
envelopes so the study staff that are enrolling subjects do not know in advance which treatment 
condition will be assigned next. I will generate the allocation sequence and will not be in charge 
of recruiting subjects. I will also not be blind to assignment and will not collect dependent 
variables. In the case of virtual assignment to condition, 2 independent staff members not 
engaged in active recruitment or assessment will have the allocation sequence and will provide 
it to the staff member doing the pre-assessment following the completion of the interview. The 

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staff members who will conduct the CAPS and MINI (to assess other Axis I disorders) will be 
blind to group assignment.  The time requirement for the MBCT intervention group will be eight 
90-minute sessions. Groups will be offered virtually. Subjects will be compensated $10 for their 
time at each intervention session. Upon the completion of the 8 sessions (MBCT group) or 8 
weeks after the pre-intervention assessment (assessment-only wait-list group), a post-
intervention assessment will be conducted. Again, this may occur in person or virtually 
depending on COVID-19 conditions. One month later, a follow-up assessment will be conducted 
by phone or Zoom. The time requirement for the pre and post assessment will be ~3 hours and 
subjects will be compensated $60 for these assessments. The follow up assessment will take 
approximately one hour and subjects will be compensated $20 for that assessment.
Measures
Intervention (8 weeks)
Screen
Pre
1
2
3
4
5*
6
7
8
Post
FU
Traumatic Events Inventory
X
Alcohol Use Disorders Identification 
Test
X
Drug Abuse Screening Test
X
Primary Care PTSD Screen
X
X
X
Patient Health Questionnaire-9
X
X
X
PTSD Checklist for DSM-5
X
X
X
Beck Depression Inventory, II
X
X
X
Standardized Trauma Interview (+ 
SC)
X
X
X
Difficulties in Emotion Regulation 
Scale
X
X
X
X
X
X
Clinician Administered PTSD Scale
X
X
MINI International Neuropsychiatric 
Interview
X
X
Five Facet Mindfulness 
Questionnaire
X
X
X
Self Compassion Scale, Short Form
X
X
X
PANAS
X
X
X
Client Satisfaction Questionnaire
X
Perceived Barriers to Psychological 
Treatments
X
Post-group Follow-up 
Questionnaire**
X
*Assessment-only subjects will also fill out measures for intervention week 5.
**For group intervention participants only
Psychological Measures: As part of the parent study, subjects will be administered five baseline 
measures to determine eligibility for proposed study: 1) The Traumatic Events Inventory[11] will 
detail frequency and type of Criterion A trauma exposure during childhood and adulthood; 2)  
The Alcohol Use Disorders Identification Test[84, 85] is a screening measure for alcohol misuse 
(≥8 will serve as our cutoff for potential alcohol use disorder); 3) The Drug Abuse Screening 
Test, 10 item version[86, 87] is a screening measure for drug abuse (≥6 will serve as our cutoff for 
potential substance use disorder); 4) The Primary Care PTSD Screen (PC-PTSD)[88] is a 4-item 
screen designed for use in primary care will assess for presence of PTSD symptoms and serve 
as PTSD screener; and 5) The Patient Health Questionnaire-9 (PHQ-9)[89] will assess for 
presence of depressive symptoms and serve as MDD screener; Classification of PTSD+ will 
include scores ≥3 on PC-PTSD and MDD+ will include scores ≥5 on PHQ-9. Other measures 

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that will be used in the proposed study include: 1) Standardized Trauma Interview[90] , a 41-item 
clinician-administered interview that gathers information on relevant aspects of the trauma and 
demographic information at baseline; 2) Difficulties in Emotion Regulation Scale[58] , which 
measures ED and includes six subscales (non-acceptance of emotions, difficulty with goal-
directed behavior in the presence of negative emotions, difficulty controlling impulses in the 
presence of negative emotions, lack of awareness of emotions, limited use of effective emotion 
regulation strategies, and lack of understanding of emotions); 3) Five Facet Mindfulness 
Questionnaire[91] will assess mindfulness; it  includes five facets (observing, describing, acting 
with awareness, non-judging of inner experience, and non-reactivity to inner experience); 4) Self 
Compassion Scale, Short Form[92] will assess self compassion. 5) The PTSD Checklist for DSM-
5[93] will be used as another self-report measure of PTSD. 6) The Beck Depression Inventory, 
II[94] will be used as another self-report measure of depression symptoms. Diagnoses at pre- 
and post-assessments also will be assessed by the MINI International Neuropsychiatric 
Interview[95] (for MDD) and the Clinician Administered PTSD Scale[96] (for PTSD), both of which 
are semi-structured interviews. 7) The Positive and Negative Affect Scale[97] will be used to 
assess trait level positive and negative affect.
Physiological Response to Trauma: Skin conductance (SC) response will be measured using a 
mobile SC device, eSense (Mindfield Biosystems). Continuous recording of SC is measured 
with electrodes on hands and data is transmitted through the eSense app. Using the PhenX 
Toolkit protocol (#630901), a two minute baseline measure of SC will be obtained and then SC 
levels will be measured during administration of the Standardized Trauma Interview immediately 
following to determine physiological reactivity to trauma stimuli. SC response is calculated by 
subtracting SC level at the end of baseline recording (average of last 30 seconds) from the 
maximum SC level value during the trauma interview. This has been previously tested and 
found feasible for use in this population.[98] eSense will only be collected if it is deemed safe for 
participants to come to the laboratory for this portion of the assessment. If not, all other 
psychological measures will be gathered virtually and this portion of the assessment will be 
skipped.
Study Design: Following random assignment to assessment-only or intervention group, subjects 
will participate in either assessment only or 8-visit group intervention. Groups will vary in size 
depending on participant recruitment but will not exceed 8. Intervention: The group intervention 
will be an adapted version for our population from the MBCT for the prevention of depression 
relapse intervention. The main adaptations include 1) substitution of psychoeducation about 
MDD alone with psychoeducation geared toward trauma and stress physiology and discussion 
of MDD and PTSD symptoms and 2) no written homework or monitoring, although formal and 
informal practice during the week and in times of distress will be encouraged. The adapted 
MBCT will consist of eight, weekly 90-minute group sessions that will involve skills training and 
in-class practice in: 1) mindfulness techniques including 20-minute meditation exercises; 2) 
psychoeducation; and 3) feedback and supportive group discussion of exercises. Specific in-
class mindfulness exercises will include: a) ‘mindful eating’, b) brief ‘body-scan’, c) ‘mindful 
stretching’, d) ‘mindful walking’, e) sitting mindfulness meditation exercises with various objects 
(breath, sounds, emotional states, thoughts). We are using this adapted version to reduce 
length of sessions and burden on subjects and enhance feasibility for use in primary care 
settings. The manualized intervention will be delivered by trained and closely supervised 
therapists who are overseen by the PI. Group sessions will occur via Zoom. Group guidelines 
and safety considerations for telehealth group sessions will be reviewed at the start of every 
group. Participants will be asked to find a private space to participate to protect the 
confidentiality of other group members. If all group members agree, all group sessions will be 

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video recorded to evaluate fidelity and aid in supervision of therapists. At weeks 3, 5, and 7 ED 
will be assessed given its role as a mechanism of change. Wait-list Control: Subjects in the 
assessment-only group will engage in the pre, post, and follow-up assessments, and an 
additional brief assessment mid-way between the pre-and post- assessment that will include the 
same measure of ED that is administered to the intervention group at Week 5. No active 
treatment will be given to subjects randomized to this condition since the question of clinical 
interest and practical import at this stage is whether MBCT is more effective than treatment as 
usual; however subjects will be given the option to participate in the group following participation 
in the assessments.
 
Training: All research study therapists will be experienced practicum students in doctoral clinical 
psychology graduate programs with training in empirically-supported treatment for psychiatric 
conditions or postdoctoral fellows that have already received a PhD in clinical psychology. 
These research personnel will be under the supervision of licensed clinical psychologists on the 
study team who will oversee all treatment and provide weekly supervision on every participant. 
The study therapists will be trained in all measures being used in the study and will fully 
understand the goals and purpose of the research proposed.
Risks to Participation: One potential risk is that the participant may be asked to talk about prior 
experiences and events that may be emotionally difficult to discuss and may bring up 
distressing feelings. The intervention is not focused on purposefully discussing past traumas; 
however, mindfulness therapy can increase individuals’ awareness of negative thoughts and 
emotions. Additionally, if at any point during any session, the participant feels uncomfortable, 
they will always be given the option to stop engagement in group session. Therapists will 
monitor participants’ subjective symptom and distress level at every therapy session and will 
conduct a risk assessment if symptoms appear to have increased. 
In addition to monitoring participants within the sessions, therapists will provide 
information at the first session of treatment for what the participant should do if they experience 
a significant increase in symptoms or have any emotional problems outside of their study visit. 
This information will include the therapist’s work phone number where they can be reached 
during business hours (8:00am - 5:00pm), as well as the phone number for the Georgia Crisis 
and Access Line, which is a 24-hour hotline with licensed psychologists and social workers who 
can take crisis calls and provide immediate assistance should the participant need it. 
Throughout the study, participants will be reminded of these resources.
Benefits to Subject: One potential benefit is that the participants will see a decrease in 
depression and/or PTSD symptoms and will be better able to function day-to-day. Additionally, 
this study may provide insight into how treatment can affect emotion regulation, depression, and 
PTSD and may inform treatment options particularly in low-income populations in the future.
Participant selection
Population: Participants will be men and women between the ages of 18 and 65, recruited from 
Grady Memorial Hospital medical clinics. Grady Memorial Hospital is an inner-city hospital in 
downtown Atlanta, GA (Target N=80). 
Subject Inclusion/Exclusion Criteria and Rationale: Inclusion criteria. 1) Ability to provide 
informed consent, 2) Willingness to participate in study, 3) Self-identity as African American, 4) 
18-65 years old, 5) History of childhood and/or adult trauma exposure (3 total criterion A 
traumas) 6) positive PTSD screen (PC-PTSD ≥ 3), and 7) positive MDD screen (PHQ-9 ≥ 5). 
Exclusion criteria. 1) Presence of intellectual disability, bipolar, or psychotic disorder; and 2) 

Page 9 of 18
Presence of current substance use disorder (past 1 month; see cut off scores in psychological 
measures below), and 3) active suicidality (for scores ≥1 on suicide item from the Patient Health 
Questionnaire (PHQ-9), a suicide risk assessment will be conducted by a study clinician to 
determine if active suicidality is present and safety procedures as outlined in Protection of 
Human Subjects will be initiated). Rationale for inclusion criteria in subjects: To ensure 
consistent presence of chronic trauma exposure across subjects, we will require individuals to 
report exposure to at least 3 traumatic events in their lifetime. We will also require the presence 
of PTSD and at least mild levels of depression based on screening measures, as comorbidity 
among these disorders is more common in chronically traumatized populations and will allow for 
examination of whether the intervention is helpful in targeting the underlying mechanisms that 
are predicted to cut across these two disorders. Preliminary data from a subsample of subjects 
(n=988) that were recruited from the Grady Trauma Project in the primary care setting show 
feasibility of this approach. Using only the items that are found on the screener measures from 
PTSD and depression proposed for this study, and the proposed inclusion criteria (i.e., scores 
≥3 on PC-PTSD and scores ≥10 on PHQ-9), indicated that 76.5% (n=756) of subjects met 
inclusion criteria for both PTSD and depression symptoms. However, due to challenges in 
recruitment since the study began, we have lowered the requirements for depressive symptoms 
to include mild levels of depression (PHQ-9 ≥ 5).
Setting: Data collection for pre-, post-, and follow up assessments will take place at the Glenn 
Building on Grady Hospital Campus. The Glenn Building is an Emory building where all of our 
research offices are located on the basement level. We have five interview rooms that will be 
used for both clinical interviews. These rooms are private. Group therapy sessions will take 
place in large group rooms located in the primary care clinics at Grady Memorial Hospital. 
Recruitment: Participant identification and recruitment will follow several steps.  First, 
participants will be screened from active recruiting efforts through the Grady Trauma Project 
(IRB00078593) which focuses on screening active patients in medical clinics at Grady Memorial 
Hospital. If the participant is consented and participates in the Grady Trauma Project and during 
the course of his or her participation is found to meet inclusion criteria for this study, our study 
will be briefly described, and participants will be given the option of whether or not to allow a 
study coordinator to contact them. We will also recruit through direct provider referral from 
medical providers in Grady Memorial Hospital clinics if the patient agrees to have the provider 
give us their information. Agreeing to be contacted does not require agreeing to participate in 
the study. If a participant expresses interest in this study, agrees to be contacted, and provides 
contact information, a study co-investigator will contact him or her by phone to assess whether 
the participant is still interested and to set up an initial clinical interview to determine 
appropriateness for the study.
If a subject wishes to withdraw from the study and sends the revocation of authorization letter or 
reaches out the study team and expresses their desire to withdraw they will be considered 
discontinued from the study at that point.  The subject will be given the opportunity to also 
remove all of their previous data from the analysis at this point as well.  Since subjects are 
compensated on time and travel per visit completed, there will be no change in the payment 
schedule
Informed Consent
Participants will complete informed consent electronically using the redcap e-consent format. 

Page 10 of 18
A study co-investigator or research fellow will verbally describe the contents of the document 
and answer any questions. If the participant agrees to be in the study, he or she will indicate 
consent by e-signing the consent form. Only participants who can give full authorized self-
consent will be included in the study. We will not enroll any individual for whom consent needs 
to be obtained by a legally authorized individual. Consent will be obtained in a private office 
room with both the participant and a study co-investigator or research fellow present. Consent 
will be obtained during the initial interview for the study, at least 24 hours prior to the first 
session of treatment. Consent for videotaping will be separately reviewed with the study 
participant following consent to participate in the study and explanation that consent to 
videotape is voluntary and not necessary to participate in the study will be provided. Consent 
will be obtained by co-investigators or research fellows that have been fully trained in obtaining 
informed consent.
If during the course of the study, it is deemed helpful for continuity of care for the study clinician 
to discuss psychiatric symptoms or progress in group intervention with a current provider 
(physician, psychiatrist, or therapist), a consent for release of subject information will be 
reviewed with the participant and if the participant agrees to the release of subject information, 
he or she will indicate consent by signing the consent form. 
Statistical analysis
Overall analytic approach: Analyses will be conducted using a combination of R[99], SAS and 
MPlus 6.1.[100] Proposed models capitalize on the benefits (power, minimization of measurement 
error, minimization of multiple testing) of latent modeling. Interpretation of results will adjust for 
number of tests performed using the step-down procedure.[101, 102] MPlus, used to test composite 
models, permits the use of both frequentist and Bayesian analysis estimation for handling 
missing data. Bayesian estimation procedures allow multiple imputation of multiple datasets, 
subsequently used for maximum likelihood estimation with parameter estimates averaged 
across imputed datasets. Consistent with Kraemer’s recommendations for design of intervention 
development research[103], the proposed research is focused on evaluating feasibility and 
acceptability (Aim 1) and preliminary examination of mechanisms of action of the intervention 
(Aim 2). We expect to meet all Feasibility and Acceptability criteria as demonstrated by 
acceptable recruitment, retention, and adherence to the intervention and subjects will report that 
the intervention protocol is acceptable and easy. Preparing/defining variables: Data will be 
examined for assumptions, with estimation procedures applied as a function of data 
characteristics (Poisson distribution, zero-inflation, etc). Analyses will not impose artificial cutoffs 
but examine naturally-existing continua, which enhance power and permit the potential 
identification of nonlinear relationships in which small, cumulative, changes in predictor 
variables result in large, discontinuous changes in outcomes as predicted by “cusp 
catastrophe”; we have previously reported such nonlinear influences of early life stress.[104] 
Measurement models will be formally tested to assess constructs. If analyses do not support the 
presence of the expected unitary constructs, subsequent analyses will examine aims as defined 
by observed variables. Model invariance tests will also be used to assess appropriate statistical 
treatment of sex;[105-107] if measurement invariance is not observed, analyses will stratify by sex. 
Pending model invariance testing, time invariant and time varying covariates will be included in 
composite models. Analyses will adjust for relevant time varying and time invariant covariates. 
Aim 1a: Examine retention and follow-up rates in the intervention and control groups. 
Retention rates will be assessed using session attendance. Previous MBSR interventions 
among low-income minority populations have yielded completion rates of 53-80%.[52, 53, 108] 
Based on 80% completion rates of MBSR in primary care[46] and 75% completion rates of 

Page 11 of 18
MBCT[45] both in combat vet samples and our anticipated improved accessibility through primary 
care, I expect that subjects in the intervention group will evidence at least 75% retention and 
follow-up rates.
Aim 1b: Examine subjects’ report of acceptability of and interest in the intervention. 
Feasibility and acceptability will be assessed using the Client Satisfaction Questionnaire. We 
will compare the descriptive statistics and frequency distributions to an established threshold of 
an average of at least a 3 (mostly satisfied) on subjects’ responses. We expect to find that the 
intervention will meet or exceed expectations. 
Aim 1c: Examine barriers to treatment engagement. Barriers to treatment will be assessed 
using the Perceived Barriers to Psychological Treatment. We will compare our descriptive 
statistics and frequency distributions to our established threshold of at least one “substantial” 
barrier (items endorsed as making it extremely difficult or impossible to attend intervention 
session) on the measure. We expect similar rates of “substantial” barriers in assessment-only 
and intervention groups, but higher rates of barriers to be related to higher symptom severity of 
PTSD and MDD.
Aim 2a: Evaluate if MBCT results in greater reductions in ED than wait-list control. In 
order to examine the impact of intervention on ED, we will conduct LGM with intervention 
predicting a reduction in ED over the course of the intervention. Specifically, intervention will be 
regressed on slope and time will be parameterized such that baseline is the intercept and 
follow-ups are modeled as weeks post baseline. 
Aim 2b: Evaluate if MBCT results in greater normalization of autonomic function than 
wait-list control. The benefits of LGM will also be applied to our assessment of the effects of 
intervention on autonomic function, with intervention subjects expected to evidence reduced 
autonomic arousal to trauma cues at post-intervention and follow-up relative to controls. 
Specifically, we will conduct an LGM of autonomic arousal to trauma cues, with intervention 
group regressed on slope such that MBCT subjects are expected to show reduced autonomic 
arousal to cues (negative slope) relative to control subjects who are expected to show little to no 
change over time in arousal. 
C.4) Power Analysis. Statistical power was calculated using G-Power 3.1.2.  As described 
above, proposed analyses are tailored to each aim and are designed, in part, to maximize 
power and minimize multiple-testing errors through the use of LGM. However, it is difficult to 
provide a priori estimates of power for full models given that power depends on multiple 
parameters that are difficult to specify prior to the analyses. Accordingly, both for space 
constraints and conservative minimization of assumptions regarding power gains, we estimate 
power using a multiple regression framework. Please note that building on published latent 
factor and latent growth 
simulations,[109] we did conduct a 
few Monte Carlo simulations and 
were able to confirm that our power 
is enhanced (with most simulations 
showing power of .99, assuming 
expected medium sized effects) 
using the proposed analyses. We 
also summarize across aims, to 
conserve space as well as minimize 
assumptions. Defined by Cohen,[110] 
conventions for describing effect 
sizes for multiple regression (f2) are 
.02 for a small effect, .15 for a 
moderate effect, and .35 for a large 
Figure 1. Effect size justification for proposed sample.

Page 12 of 18
effect. Shown in Figure 1, the proposed sample should be adequate (power=.80) to detect a 
moderate small effect of f2=.25. Also shown in Figure 1, although larger samples would of 
course improve power to detect very small effects, the proposed sample of 80 evidences 
notable gains in power over a sample of 60. Given criticisms about the clinical value of very 
small effects, we are most interested in effects sizes that fall in the moderate range. 
Accordingly, the current sample should be well powered to detect effects that are clinically 
meaningful. Similar treatment studies of MBSR and MBCT with veterans and civilians support 
medium to large effect sizes for reduction in PTSD and depression symptoms (d=0.59-0.99).[35, 
42, 45, 46] Extrapolating from the effects indicated in these investigations, we should be well 
powered to detect significant effects across aims. 
Data and Safety Monitoring Plan
The PI and study personnel have completed and passed the Human Subjects Protection 
Education Program provided by Emory University. Certification letters will be provided upon 
request. The present study is an intervention study and therefore we will complete a data safety 
monitoring plan to ensure oversight and monitoring of the study to ensure the safety of 
participants and the validity and integrity of the data. The PI will monitor safety issues 
throughout the study. Specifically, study progress and safety will be reviewed weekly (and more 
frequently if needed). The PI will work closely with Dr. Nadine Kaslow to monitor for potential 
adverse reactions of subjects to mindfulness exercises and if significant exacerbation of 
symptoms or safety concerns emerge, the subject will be offered immediate psychological 
services through the Grady Health System and NIA project. Progress reports, including subject 
recruitment, retention/attrition, and adverse events (AE) will be provided to an Independent 
Monitor (IM) semi-annually. The IM for this study will be the Data Safety Monitoring Board in the 
Department of Psychiatry and Behavioral Sciences. An Annual Report will be compiled and will 
include a list and summary of AEs.  In addition, the Annual Report will address (1) whether AE 
rates are consistent with pre-study assumptions; (2) reason for dropouts from the study; (3) 
whether all participants met entry criteria; (4) whether continuation of the study is justified on the 
basis that additional data are needed to accomplish the stated aims of the study; and (5) 
conditions whereby the study might be terminated prematurely. The Annual Report will be sent 
to the IM and will be forwarded to the IRB. 
Confidentiality
Confidentiality will be protected throughout the study and following completion of the study. This 
will be done in a number of ways. First, all participants will be assigned a subject ID and all data 
gathered and session notes will only contain de-identified information and their subject ID. Also, 
participants will be informed of the confidential nature of the study and informed of the 
limitations of confidentiality. Also, all participant information will be kept in a locked desk drawer 
in a locked office or stored on a password protected and secured electronic network.
The only linkage between identifiable information about participants and their subject IDs will 
be kept on the informed consent forms, which will be separated from all other data and study 
materials and kept in a locked drawer in a locked office. 
Finally, at the beginning of the group intervention, the importance of confidentiality among 
group members outside of session will be emphasized.
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