Mindfulness-based Intervention to Address PTSD in Trauma-exposed, Homeless Women
Phase: NA
Conditions: Stress Disorders, Post-Traumatic, Depressive Symptoms, Hydrocortisone, Substance Use
Sponsor: University of California, Los Angeles

1 
Mindfulness-based Intervention to Address PTSD in Trauma-exposed, Homeless Women
STUDY PROTOCOL 
K01 MD013910-01 
National Institute of Health (Institute of Minority Health and Health Disparities) 
Principal Investigator: Dana Rose Garfin, PhD 
Updated: July 2022
NCT04605198

 
2 
Table of Contents 
SECTION 1A. RESEARCH STUDY OVERVIEW 
4 
Subsection 1A.1 - Overview & Introduction 
4 
Subsection 1A.2 - Overall Structure of Study Team 
5 
Subsection 1A.3 - Research Team and Responsibilities 
6 
Subsection 1A.4 - Research Study Contact List (2/21) 
6 
Subsection 1A.5 - Phase II Timeline 
1 
6 - Basic Definitions 
1 
SECTION 1B. INTRODUCTION TO PTSD AND MBSR 
2 
Subsection 1B.1 - PTSD Basics 
2 
Subsection 1B.2 - MBSR Basics 
4 
SECTION 2. INTERVENTION DELIVERY 
6 
Subsection 2.1 - Phase II Overview 
6 
Subsection 2.2 - Phase II Scope of Work & Participant Flow Diagram 
7 
Subsection 2.3 - Phase II Recruitment & Treatment Overview 
9 
Subsection 2.4 - Phase II Recruitment & Screening 
9 
Subsection 2.5 - Phase II Eligibility Criteria 
10 
Subsection 2.6 - Phase II Laboratory Tests/Sample Collection 
11 
Subsection 2.7 - Phase II Intervention Program Description 
11 
Subsection 2.8 - Phase II Pre-intervention Assessments 
12 
Subsection 2.9 - Phase II Brief Stress Task (Trauma Imagery Task) 
12 
Subsection 2.10 - Phase II Biospecimen Collection 
13 
Subsection 2.11 - Phase II Biospecimen Analysis 
14 
Subsection 2.12 - Phase II MBSR-based Intervention 
14 
Subsection 2.13 - Phase II Health Promotion Intervention 
16 
Subsection 2.14 - Phase II Post-Assessment 
17 
Subsection 2.15 - Phase II Team Management of Biospecimen Collection Refusal 
17 
Subsection 2.16 - Phase II Dealing with Intervention Program Attrition 
17 
Subsection 2.17 - Phase II Follow-Up Focus Groups 
18 
Subsection 2.18 - Phase II Compensation 
18 
Subsection 2.19 - Program Fidelity 
18 
Subsection 2.20 - Research Staff Competencies and Mock Sessions 
18 
Subsection 2.21 - Data Entry, Management & Confidentiality 
19 

 
3 
Subsection 2.22 – Using REDCap 
20 
Subsection 2.23 - Data Security 
20 
Subsection 2.24 - Post Data Collection 
21 
Subsection 2.25 - End of Study 
21 
SECTION 4. RECRUITMENT 
22 
Subsection 4.1 - Phase II Flyer 
22 
Subsection 4.2 - Phase II MBSR – Script for Introduction at Recruitment Site: For Non-
Research Staff Member 
23 
SECTION 5. SCREENING, INFORMED CONSENT, AND ENROLLMENT 
24 
Subsection 5.1 Screening Protocol 
24 
Instructions: 
24 
Subsection 5.2 Informed Consent 
24 
Subsection 5.3 Baseline Protocol 
24 
APPENDIX I: What to bring to site 
25 
APPENDIX II: Trauma Imagery Script (Brief Stress Task) 
26 
APPENDIX III: Data Safety and Monitoring Plan 
28 
Possible Serious Adverse Events or Adverse Events 
30 
Serious adverse events 
30 
Other adverse events 
30 
Risk Management Protocols in Place to Deal with Adverse Events 
30 
Data and Safety Monitoring Procedures 
31 
Data Safety and Monitoring Board (DSMB) 
31 
Training in Red Flag Procedures 
31 
RED FLAG – SUICIDE 
31 
Harm to others 
33 
APPENDIX IV: Citations for Study Measures 
35 
APPENDIX VII: RECap for Screener (Section 1) and Baseline, Immediate-follow-up, and 6-
months (Section 2) 
40 
 

 
4 
SECTION 1A. RESEARCH STUDY OVERVIEW 
Subsection 1A.1 - Overview & Introduction 
This study aims to determine the effectiveness of a mindfulness-based intervention (MBI) on the 
reduction of posttraumatic stress disorder (PTSD) symptoms (primary outcome) and depression 
substance use disorder (SUD), inflammation, and cortisol reactivity (secondary outcomes) in 
homeless women with PTSD. Biological markers (i.e., cortisol reactivity, C-reactive protein [CRP]) 
of the stress response will be evaluated as correlates of MBI treatment-response will help clarify 
mixed findings regarding dysregulation of the HPA-axis as a function of amount, type, and timing 
of trauma exposure. It will advance theory regarding the use of MBIs for PTSD while exploring 
biological markers that might maintain PTSD symptoms over time. The project has the potential 
to bolster the capacity of service providers to offer feasible and acceptable MBI interventions to 
homeless women and other vulnerable populations. If the proposed aims are achieved, they may 
provide several valuable insights. They will examine the efficacy of MBI to address PTSD in 
homeless women (inform & improve services, interventions, treatments); improve on 
methodological limitations of prior research on MBIs for PTSD (including small sample sizes, lack 
of attention control group, incomplete trauma history); and explore biological markers that 
correlate with PTSD-symptom maintenance or reduction post-MBI (expand concepts). 
Importantly, the MBI that will be used in the intervention was the product of a rigorous preliminary 
mixed-methods inquiry that including a Community Advisory Board (consisting of site staff, 
clinicians, and homeless women) and focus groups with women from the community (i.e., 
homeless women currently residing at a residential drug treatment facility). The results of these 
formative activities resulted in the modification of an evidenced-based MBI – Mindfulness-based 
Stress Reduction (MBSR) for cultural sensitive and appropriateness, increasing acceptability and 
feasibility. Importantly, findings from this proposal may provide a low-cost method to improve 
services for homeless women as they begin to answer key theoretical questions regarding the 
relationship between biological markers of stress regulation and reactivity, the inflammatory 
response, PTSD and related comorbidities (SUD, depression), and MBIs.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
5 
Subsection 1A.2 - Overall Structure of Study Team  
 
 
 

 
6 
Subsection 1A.3 - Research Team and Responsibilities 
Principal Investigator (PI): Dana Rose Garfin, PhD.  
Makes executive decisions regarding the implementation of the study, data entry and data 
analysis approaches, and interpretation of study findings. She will train the research staff and 
assistants to perform content. Dr. Garfin will develop all questionnaires and oversee the design 
and implementation of the MBI and the health promotion attention control.  
 
K01 Mentor: Adeline M. Nyamathi, ANP, PhD, FAAN 
Dr. Nyamathi will advise Dr. Garfin on conducting mix-methods research including qualitative 
focus groups and clinical trials with vulnerable populations.  
 
K01 Mentor: Douglas Granger, PhD, Chancellors Professor of Psychology and Social Behavior 
and Director of the Institute for Interdisciplinary Salivary Bioscience Research (IISBR 
Dr. Granger will advise on all aspects of the project related to saliva collection and analysis and 
the theoretical and statistical integration of salivary measures into psychosocial research.  
 
Secondary K01 co-mentors: Drs. Cameron Neece, E. Alison Holman, & Sanghyuk Shin 
provide guidance on K01, but do not interact with any human subjects participants, will not 
engage with the data, and thus are not included on the IRB forms.  
 
Lab Manager and Lab Coordinator: First line contact for RAs, responsible for RA scheduling, 
delegates lab responsibilities to other RAs, drafts lab meeting agenda, keeps track of 
conference submission deadlines, ensures study supplies are available, oversees budget 
expense tracking and reimbursements.  
 
Biosalivary coordinator: Ensures that cortisol collection is done according to all protocols, 
ensures that collection tubes are labeled ISBBR.  
 
REDCap coordinator:  Ensures all updated to REDCap are entered accurately. Tracks 
participant payments for cash advances and payment reconciliation.  
Subsection 1A.4 - Research Study Contact List (2/21) 
Name 
Role 
Organization 
Phone Number  
Email 
Dana Rose 
Garfin, PhD 
PI 
UCLA 
(415)407-9498  dgarfin@ucla.edu 
 
Adey Nyamathi  
K01 Mentor  
UCI  
 
anyamath@uci.edu 
Doug Granger 
K01 Mentor 
UCI  
 
dagrange@uci.edu 
Michelle Zernick 
Lab Manager 
UCI 
 
zernickm@uci.edu 

 
1 
Subsection 1A.5 - Phase II Timeline 
YEAR 1 (2020) 
19-May 
19-Jun 
19-Jul 
19-Aug 
19-Sep 
19-Oct 
19-Nov 
19-Dec 
20-Jan 
20-Oct 
20-Nov 
21-Dec 
PRIMARY 
ACTIVITIES  
SITE START UP & VISIT 
  
Community Advisory 
Board 
  
Focus Groups 
Finalize Intervention & 
Qualitative Analysis  
Recruit 
Cohort1 
HP Cohort1 
Space/time 
needed 
 
 
 
1 meeting per week 
(1-2 hours) 
Four meetings total, 
each 2 hours 
1 weekly meeting (1-2 
hours) for 4 weeks 
Screening 
space 1-2 
days/week 
per site 
Room for intervention 
1 X per week at each 
site for 1-2 hours 
(same time each 
week) 
YEAR 2 (2021) 
21-Jan 
21-Feb 
21-Mar 
21-Apr 
21-May 
21-June 
21-July 
21-Aug 
21-Sept 
21-Oct 
21-Nov 
21-Ded 
PRIMARY 
ACTIVITIES  
Recruit 
Cohort 2 
MBI & HP C2 
Recruit 
Cohort 3 
MBI & HP Cohort 3 
Recruit 
Cohort 4 
MBI & BP Cohort 4 
Space/time 
needed 
Screening 
space 1-2 
days/week 
per site 
Room for intervention 1 
X per week at each site 
for 1-2 hours (same 
time each week) 
Screening 
space 1-2 
days/week 
per site 
Room for intervention 1 
X per week at each site 
for 1-2 hours (same time 
each week) 
Screening 
space 1-2 
days/week 
per site 
Room for intervention 1 
X per week at each site 
for 1-2 hours (same 
time each week) 
Follow-up 
 
 
 
Cohort 
1 follow-
up 
 
 
 
Cohort 2 
follow-up 
 
 
 
Cohort 3 
follow-up 
YEAR 3 (2022) 
22-Jan 
22-Feb 
22-Mar 
22-Apr 
22-May 
22-June 
22-July 
22-Aug 
22-Sept 
22-Oct 
22-Nov 
22-Dec 
23 Jan-
Feb 
PRIMARY 
ACTIVITIES 
Recruit 
Cohort 5 
MBI & HP Cohort 5 
 
 
Recruit 
Cohort 6-7 
MBI Cohorts 6-7 
 
 
 
 
Space/time 
needed 
Screening 
space 1-2 
days/week 
per site 
Room for intervention 1 
X per week at each site 
for 1-2 hours (same 
time each week) 
 
 
Screening 
space 1-2 
days/week 
per site 
Room for intervention 1 
X per week at each site 
for 1-2 hours (same 
time each week) 
 
 
 
 
Follow-up 
 
 
 
Cohort 
4 follow 
up 
 
 
Cohort 5 
follow up 
 
 
 
Cohorts 6-7 follow 
ups 

 
1 
6 - Basic Definitions 
Mindfulness: The process of focusing one’s attention on the present moment (including thoughts, 
feelings, and sensations) without judgement (Kabat-Zinn, 1990; Lang, 2017).  
 
Mindfulness-Based Stress Reduction (MBSR): MBSR is an 8-week, 9 session manualized 
mindfulness-based intervention that is appropriate for participants from different religious, 
spiritual, or ethnic background and is not grounded in religious ideology. During MBSR, 
participants will be trained in mindfulness meditation and the applicability of mindfulness to daily 
life.  
 
Post-traumatic Stress Disorder (PTSD): PTSD is a psychological pathology characterized by 
re-experiencing, avoidance, negative thoughts or cognitions, hyperarousal after experiencing a 
traumatic event. 
 
Trauma: According to the DSM-5, must involve actual or threatened death, serious injury, or 
sexual violence.   
 
Arm: The different groups of the intervention. In this study, Arm 1 is the health promotion 
attention control and Arm 2 is the MBSR. Participants at a given site are assigned to one Arm or 
the other, by cohort).  
 
Cohort: The group of people that are doing the interventions at the same time.  
 
Cortisol: The body’s main stress hormone, triggered by the adrenal glands. Cortisol is a 
glucocorticoid and is released in the body about 20 minutes after a stressor. The immediate 
stress response hormones (adrenaline and epinephrine) are released within seconds or 
minutes; if the brain continues to perceive something as stressful, then cortisol is released.  
 
C-Reactive Protein (CRP): This is a protein made in the liver. CRP tends to increase when 
there is inflammation occurring in the body, (Lindqvist et al., 2014, 2017) induced by proinflammatory 
cytokines in the liver (Eklund, 2009). These heightened inflammatory responses can lead to health 
impairments including atherosclerosis (Wong et al., 2012) and cardiovascular disease (Coughlin, 2011) 
compounding health disparities in disadvantaged populations; CRP, in particular, has been linked with 
obesity (Visser et al., 2011) metabolic syndrome (Ridker et al., 2003) and CVD.(Ridker et al., 1998)  
Thus CRP can be used as marker for general inflammation and risk for inflammatory-related 
problems.  
 
Other acronyms used in this protocol:  
 
IISBR – Institute for Interdisciplinary Salivary Bioscience Research - https://iisbr.uci.edu/ 
- 
IISBR is a shared resource and scientific hub; researchers can gain practical 
experience/knowledge in salivary bioscience through the training programs (e.g., Spit 

 
2 
Camp). IISBR also provides the storage and analyses of the salivary samples collected in 
this study.  
SECTION 1B. INTRODUCTION TO PTSD AND MBSR 
Subsection 1B.1 - PTSD Basics 
PTSD Diagnosis  
PTSD occurs as the result of direct exposure to experiencing, witnessing, or learning of an 
event that involves actual or threatened death or serious injury or harm to self of others 
(American Psychiatric Association, 2013). For a diagnosis of PTSD, symptoms must be present 
for at least one month prior to diagnosis and must include at least one re-experiencing 
symptom, one avoidance symptom, two arousal and reactivity symptoms and two cognition and 
mood symptoms. Re-experiencing symptoms can include flashbacks, nightmares, and invasive 
thoughts. Avoidance symptoms are related to an individual actively avoiding locations, thoughts, 
events, or objects that are reminiscent of the trauma. Arousal and reactivity symptoms include 
feeling easily frightened, tense, increased anger, and having issues sleeping. Cognitive and 
mood symptoms include but are not limited to having trouble remembering key features of the 
trauma, distorted feelings, and loss of interest in previously enjoyable activities. PTSD must be 
diagnosed by a mental health professional, but a variety of measures have been validated for 
use as screens or by non-clinical for research purposes. In our study, we use the Posttraumatic 
Stress Disorder Checklist, Civilian (PCL- C) (Bovin et al., 2016; Wortmann et al., 2016).   
 
DSM-5 Criteria for PTSD 
The following text summarizes the diagnostic criteria for PTSD and was obtained from the 
ptsd.va.gov website.  
 
Criterion A (one required): The person was exposed to: death, threatened death, actual or 
threatened serious injury, or actual or threatened sexual violence, in the following way(s): 
• 
Direct exposure 
• 
Witnessing the trauma 
• 
Learning that a relative or close friend was exposed to a trauma 
• 
Indirect exposure to aversive details of the trauma, usually in the course of professional 
duties (e.g., first responders, medics) 
 
Criterion B (one required): The traumatic event is persistently re-experienced, in the following 
way(s): 
• 
Unwanted upsetting memories 
• 
Nightmares 
• 
Flashbacks 
• 
Emotional distress after exposure to traumatic reminders 
• 
Physical reactivity after exposure to traumatic reminders 
 

 
3 
Criterion C (one required): Avoidance of trauma-related stimuli after the trauma, in the 
following way(s): 
• 
Trauma-related thoughts or feelings 
• 
Trauma-related reminders 
 
Criterion D (two required): Negative thoughts or feelings that began or worsened after the 
trauma, in the following way(s): 
• 
Inability to recall key features of the trauma 
• 
Overly negative thoughts and assumptions about oneself or the world 
• 
Exaggerated blame of self or others for causing the trauma 
• 
Negative affect 
• 
Decreased interest in activities 
• 
Feeling isolated 
• 
Difficulty experiencing positive affect 
 
Criterion E (two required): Trauma-related arousal and reactivity that began or worsened after 
the trauma, in the following way(s): 
• 
Irritability or aggression 
• 
Risky or destructive behavior 
• 
Hypervigilance 
• 
Heightened startle reaction 
• 
Difficulty concentrating 
• 
Difficulty sleeping 
 
Criterion F (required): Symptoms last for more than 1 month. 
 
Criterion G (required): Symptoms create distress or functional impairment (e.g., social, 
occupational). 
 
Criterion H (required): Symptoms are not due to medication, substance use, or other illness. 
 
Two specifications: 
1. Dissociative Specification. In addition to meeting criteria for diagnosis, an individual 
experiences high levels of either of the following in reaction to trauma-related stimuli: 
• 
Depersonalization. Experience of being an outside observer of or detached from 
oneself (e.g., feeling as if "this is not happening to me" or one were in a dream). 
• 
Derealization. Experience of unreality, distance, or distortion (e.g., "things are not 
real"). 
2. Delayed Specification. Full diagnostic criteria are not met until at least six months after 
the trauma(s), although onset of symptoms may occur immediately. 
 
 
 
 

 
4 
How is PTSD Typically Treated?  
CBT, cognitive processing therapy, prolonged exposure therapy (PE), eye movement 
desensitization and reprocessing (EMDR), stress inoculation training, psychopharmalogical 
treatments are all common treatments for PTSD. Cognitive behavioral therapy (CBT) often 
occurs once a week and works with the client to reframe thoughts surrounding the event (i.e. 
feelings of guilt). Similarly, in cognitive processing therapy the client recounts the event and 
related thoughts to a therapist and subsequently processes and learns new ways to live with the 
thoughts and trauma. PE takes place in eight to fifteen ninety minute sessions in which the 
client is taught breathing techniques to combat anxiety before making a list of avoidances and 
learning to face them. EMDR asks the client to watch or listen to something, such as a light 
flashing or sound, while concentrating on the traumatic event so that over time, the client can 
think about something positive while remember the trauma. Stress inoculation training focuses 
on how the client responds to the stress of the trauma and works to teach them methods to 
cope such as breathing techniques and thought stopping. Medications frequently prescribed to 
individuals with PTSD are SSRIs and SNRIs such as Prozac and Zoloft. We are testing whether 
MBSR is an effective complementary treatment for PTSD. Complementary means that it will be 
used in addition to any other interventions used in standard treatment of PTSD.  
 
Subsection 1B.2 - MBSR Basics 
MBSR is a way to teach mindfulness, or the process of focusing one’s attention on the present 
moment without judgement (Kabat-Zinn, 1990). It has have shown promise for reducing 
symptoms of PTSD (Khusid & Vythilingam, 2016; Polusny et al., 2015) and associated 
biological markers of the stress response (Black & Slavich, 2017; Bower et al., 2017) by 
lowering physiological arousal and improving attention and acceptance of the past and present 
(Lang et al., 2012). MBSR is relatively low cost and has demonstrated acceptability and 
feasibility in trauma-exposed, low-SES, high-minority samples (Dutton et al., 2014). An RCT of 
MBSR for PTSD in a sample of veterans demonstrated improved PTSD symptoms at immediate 
follow-up with clinically significant improvement sustained 2-months later (Polusny et al., 2015). 
Congruent findings were indicated in veterans using a one-armed-repeated-measures design 
(Kearney et al., 2012). MBIs have also been linked with statistically significant reductions in 
markers of inflammation (Bower et al., 2017; Rosenkranz et al., 2013). that are associated with 
PTSD, including CRP (Creswell & Irwin, 2012; Malarkey et al., 2013). In relation to stress 
reactivity, in repeated measures analyses, an MBI significantly reduced cortisol reactivity to a 
stress task (Rosenkranz et al., 2013). Participation in an MBI compared to a treatment-as-usual 
condition in veterans with PTSD was associated with reduced cortisol, suggesting a brief MBI 
might have beneficial responses on stress physiology (Bergen-Cico et al., 2014). Data suggests 
that biological dysregulation may precede the development of – and at a minimum mutually 
maintain – PTSD symptoms (van Zuiden et al., 2013). This means that the physiological 
response may actually occur prior to the psychological symptoms, but more research is needed. 
Moreover, participation in MBIs have been associated with effective relapse prevention in those 
with SUD (Bowen et al., 2006) and lower depression in a sample of economically disadvantaged 
women (Burnett-Zeigler et al., 2016). As such, MBIs, which concurrently target regulation of the 
physiological stress responses, emotional cognitive symptoms of PTSD, and related 

 
5 
psychological comorbidities may provide a low-cost, feasible method to address the complexity 
of PTSD symptom maintenance over time. 
 
MBSR was first developed in the 1970s by Dr. Jon Kabat-Zinn at the University of 
Massachusetts Medical Center (Kabat-Zinn, 1990). MBSR uses many practices that have been 
around for thousands of years, but manualized these practices into an 8 week, 9 session 
program.  MBSR has been used in hospital, school, work, athletic, and prison settings with 
beneficial results. MBSR is a group-based class and is not therapy. It generally should be used 
as an adjunct to other psychiatric and physical healthcare, not as a supplement.  
 
The general flow of the eight-week program is as follows:  
 
Week 1: Introductory Material. This includes an overview of the course, building trust within the 
group, introduction to mindful eating, some standing yoga stretches, mindful breathing and body 
scan meditation (Homework: Body Scan recording using MP3 player; eating one meal mindfully; 
optional informal meditation practice.)  
 
Week 2: Understanding Perceptions. This session focuses on self-responsibility and short and 
long-term changes for health enhancing behaviors; how you see things determines how you 
react or respond. (Homework: Body Scan recording using MP3; fill out Pleasant Events 
Calendar; select one activity to bring full awareness to).  
 
Week 3: Hatha Yoga, Sitting Meditation, Walking Meditation. The theme is the pleasure and 
power of being present; this week teaches how to investigate the mind and body through yoga 
and meditation. (Homework: Alternate Body Scan recording with Lying-down Yoga using MP3 
player; fill out Unpleasant Events Calendar; sitting meditation). 
 
Week 4: Concentration and Awareness. This theme relates to how conditioning and perception 
influence one’s experience and new ways to relate to stress. (Homework: Alternate Body Scan 
recording with Lying-down Yoga using MP3 player; be aware of being stuck, sitting meditation). 
 
Week 5: Unhealthy Patterns and Getting Unstuck. This week examines conditioned patterns 
and the passive ways that people cope (e.g., numbing, denial, passive-aggressiveness, 
suppression of feelings, substance dependency). (Homework: Fill out Difficult Communications 
Calendar; Sitting Meditation and Standing Yoga Sequence).  
 
Week 6: Transformational Coping Strategies. This for this week include how to deal with 
stressful communication and knowing and expressing your feelings. (Homework: Alternate 
Sitting Meditation recording with Body Scan and/or Standing or Lying down Yoga recording).  
 
Week 7: Retreat. This will be a silent class, with sitting and walking practice. Guided meditations 
will include loving-kindness meditation. 
 

 
6 
Week 8: Maintaining Discipline and Flexibility. This class focus on how to more fully integrate 
mindfulness into daily life. Instructors and participants discuss lifestyle choices and limiting 
patterns. (Homework: no recordings; try to practice formal sitting meditation; recordings can be 
used if necessary.) 
 
Week 9: Course Review. In this session, students will reflect on the course, the instructor 
provides additional resources, participants discuss their experiences with the group.  
    
Common Uses:  
MBSR is used as a complementary treatment for anxiety, panic, depression, eating disorders, 
pain, sleep issues, and a growing number of additional maladies. MBSR is also used increase 
productivity, performance, emotion regulation, and general wellbeing.  
 
 
 
SECTION 2. INTERVENTION DELIVERY 
Subsection 2.1 - Phase II Overview 
In Phase II, we will assess the potential benefit of MBSR to reduce PTSD (primary outcomes) 
and secondary outcomes (e.g., depression, SUD, CRP, cortisol reactivity), among 130 eligible 
homeless women who exhibit likely subthreshold or threshold PTSD living at one of two 
residential drug treatment facilities. MBSR will be compared to an attention-control group 
(Health Promotion Wellness Classes; HP). There originally intended to be five cohorts of 
women, each with 12-15 women (total of 24-30 women per cohort). However, due to COVID-19 
adjustments have been made in terms of the class size and randomization procedure. At each 
cohort, sites will be randomized to receive either the MBSR or the HP. Although sites will 
alternate between MBSR and HP by cohort, each participant will receive either the MBSR or the 
HP. Randomization will occur using RedCAP. The women participate in either MBSR or HP for 
9 weeks. Psychosocial data will be collected at baseline, immediately following final intervention 
session, and at 6-month follow-up via tablet questionnaires. After psychosocial data collection, a 
stress task (Trauma Imagery Task) will be conducted at each time point, with saliva collected 
both before and after the task to assay cortisol and CRP. This proposal will improve on the 
methodological rigor of prior research on MBIs for PTSD in disadvantaged populations by using: 
randomization procedures that account for cross-contamination; blind evaluators; longitudinal 
follow-up; an attention control group equal to the MBI intervention in both contact visits and 
hours; increased demographic diversity; comprehensive lifetime trauma assessment; and 
inclusion of objective indices of stress responses to accurately evaluate the effectiveness of 
MBIs in treating trauma-related symptoms. 
 
 
Confidentiality and Ethical Issues  
 
All program staff must follow confidentiality and ethical procedures throughout this program to 
ensure that everybody is treated with respect and dignity.  
 
1. Communication with study participants must remain confidential. To maintain confidentiality 
for participants, any personal information provided, such as participants' name, age, etc., will 

 
7 
be protected by use of subject code on all data and questionnaires. Data including subject 
identifiable information will be linked to a code on RedCap for this study for access and only 
research staff will have access. An exception to this rule is the clinic provider and site staff 
who work directly with the women onsite.  
 
Program Team 
 
The Lab Manager and Lab Coordinator will help the PI (Dr. Garfin) in organizing all aspects of 
the study. These individuals will be current or former students from the Department of 
Psychological Science’s Postbaccalaureate Program. They will be responsible for tracking 
recruitment, scheduling research assistants, and ensuring that the site is well-stocked with 
necessary supplies. Weekly, the Lab Manager and Lab Coordinator will meet with Dr. Garfin to 
review all aspects of the study, troubleshoot any problems, and create schedule for the other 
Research Assistants (RAs). The RAs will be highly trained Postbaccalaureate, graduate, or 
undergraduate students from the University of California, Irvine.  
 
 
Safety of Program Staff 
 
While we believe that conducting this study is highly important for public health, it is critical that 
the program staff prioritize their own safety first.  If you feel that you are in danger (physically, 
emotionally, psychologically) in any way, end the study activities and inform the research 
coordinator or the PI as soon as you can safely do so. This is particularly important during 
COVID-19. Please report any lapses in COVID-19 protocol to Dr. Garfin and the Leadership 
team immediately. If there is any chance you have been exposed, it is imperative that you do 
not come to site. The study leadership (Dr. Garfin and the Lab Manager / Lab Coordinator)  
 
Subsection 2.2 - Phase II Scope of Work & Participant Flow Diagram 
1. General Recruitment 
a. We will recruit 5 cohorts of women from the two sites by research staff via flyers and 
announcements during site programming. Due to COVID-19, this strategy may 
change as the situation evolves.  
b. Participants will then be given an eligibility screener via tablet with either Dr. Garfin or 
the Lab Manager/Lab Coordinator available to answer any questions. 
i. A key inclusion criteria is subthreshold current PTSD. Thus, the women will 
be given a PTSD screener for the trauma that is bothering them most right 
now. There may be multiple traumas the women have experienced – they 
should be prompted to pick the one that is most troubling to them at the time 
of screener completion.  
c. Tablets will be programmed by the Research Director from the School of Nursing and 
responses will be automatically, electronically scored. All participants who complete 
the screener will receive $3. 
i. Note: those who complete the screener must complete the consent to screen, 
but are not assigned a participant ID at this time as they have not completed 
the Informed Consent. As such it is imperative that accurate information be 
obtained with respect to the individual’s name as that will be used to link it to 
their subsequent data.  
 

 
8 
2. Group Assignment and Intervention Procedure (may chance due to evolving 
circumstances due to COVID-19) 
a. Prior to recruitment, the Residential Treatment Sites (RTS; Pomona and Escondido) 
will be randomized to receive the MBI or serve as the attention-control (HP); 
recruitment and research procedures (MBI or attention-control) will occur at both sites 
simultaneously. Women will live at sites prior to recruitment. 
b. Informed consent – there are TWO versions of the Informed Consent documents. 
One is for the MBSR course; the other is for the HP course. Women will complete 
ONE of the Informed Consent forms, depending on which group they are in. It is 
imperative that the correct form is filled out and uploaded onto REDCap.  
c. Baseline questionnaire administered:  
i. After informed consent, participants will complete a baseline questionnaire. In 
addition to the traumas indicated in the PCL-5, participants will report lifetime 
history of trauma (including whether events occurred in adulthood, childhood, 
or both). 
ii. Questionnaire data will be collected via tablet and transferred to RedCap. 
iii. Participants will provide a urine sample for a drug test to validate self-report. 
Then participants will complete the brief stress (Trauma task providing saliva 
samples both before and after the task. 
d. Locator guide: this is a critical part of maintaining contact with our participants. 
However, they may not be inclined to provide all the information on the first or second 
meeting. PLEASE TAKE THE PICTURE AT THE TIME OF ADMINISTERING 
INFORMED CONSENT. The rest of the locator guide can be filled out over the course 
of the study. Given issues with COVID-19, we will start completing the Locator Guide 
after session 2 or 3. Please see PI or Lab Management Team for further guidance.  
e. Intervention 
i. Participants will begin MBSR/HP activities within one month of baseline 
assessment, dependent on the time of their baseline assessment within 
recruitment schedule 
ii. Both groups (MBSR and HP) will consist of nine sessions, each 
approximately 2 hours in length. 
b. Immediate follow-up  
i. After the 9th session, participants will complete a questionnaire via tablet that 
will assess PTSD (primary outcome), secondary outcomes (e.g., depression, 
substance use), and traumatic events that occurred since first assessment, 
as well as key covariates (e.g., fidelity to intervention) and additional 
outcomes (e.g., mindfulness, emotion regulation).  
ii.  Women will provide urine for drug test and repeat the Trauma Imagery 
Stress Task, providing saliva samples before and after the task.  
c. 6-month follow-up 
i. Primary and secondary outcomes and covariates (e.g., fidelity to intervention) 
will be reassessed via tablet 
ii. Women will provide urine for a drug test and repeat the Trauma Imagery 
Stress Task, providing saliva samples before and after the stress task. 
 
3.  Phase II Reimbursement 
d. Women will receive $15 for the baseline assessment, $10 per MBSR/HP session, $15 
for completing the post-intervention assessment, and $30 for the 6-month follow-up 
assessment. 

 
9 
i. Women are paid in cash and must sign on the iPad (via REDCap) that they 
have received the payment. This must also be initialed, signed, and dated by 
the RA in charge of payment.  
 
 
Subsection 2.3 - Phase II Recruitment & Treatment Overview 
 
 
Subsection 2.4 - Phase II Recruitment & Screening 
The study was designed so that recruitment at Pomona would be paced to match that at the 
Escondido site so that all procedures across sites happen in tandem, thus avoiding history 
effects; recruitment data will be evaluated weekly to inform pacing. Site staff at Prototypes will 
assist with participant recruitment, informing Prototypes residents of the opportunity during 
formal announcements during programing. Recruitment flyers will also be posted around the 
RTS. RAs will help recruit women and conduct the initial screening in a private room after 
obtaining informed consent; progress will be monitored closely by Dr. Garfin the Lab 
Management team. Modifications will be made to allow for the study to continue during the 
COVID-19 pandemic to ensure safety of Ras, site staff, and participants.  
 
Ideally, recruitment will be staggered according to cohorts and paced equally across sites. In 
total, five cohorts of women will be recruited. Each will have approximately 26- 28 women in 
each group/site (n=13-14 MBSR; n=13-14 attention control); recruitment proceeds for one 
month, the intervention runs for approximately 2 months (9 weeks), then there is one month 
break. However, this schedule may vary due to COVID-19 restrictions, limitations, and 
other feasibility issues.  
 
Dr. Garfin will explain the study during an initial meeting with potential participants and answer 
any questions. Then women will be screened for eligibility. Prior to obtaining any data, the 
women will provide a “consent to screen”. This is because we need to obtain data from the 
women to determine if they are eligible, but they are not officially enrolled as human subjects. 
By providing their “consent to screen”, we are obtaining verbal consent/permission to ask them 
questions. Their data will not be used by the research team if they are not eligible.  
 
The RA will read the consent to screen script on REDCap. Potential participants are free to stop 
at any time – remind them that all procedures are completely voluntary. Dr. Garfin and/or 
someone from the Lab Management team will always be onsite to help answer questions.  

 
10 
 
Participants will then be given an eligibility screener via tablet with either Dr. Garfin or a trained 
research assistant available to answer any questions. The screener will first assess for age, 
prior homelessness, and cognitive competence. The screener then screens for PTSD using the 
PTSD Checklist for DSM-5 (PCL-5) for the worst event in their life. We will assess PTSD to 
their most recent event (in the past year) during the baseline and follow-up assessments. The 
standard PCL-5 initially starts with the identification of the presence of exposure to a DSM-5 
traumatic event and then assesses whether it involved actual or threatened death, serious injury 
or sexual violence. The RA may need to prompt the potential participant with examples to keep 
them on track and to ensure that the participant is responding to an actual DSM-5 traumatic 
event. The next 20 items on the PCL-5 assess all four B-E PTSD criterion (re-experiencing, 
avoidance, negative thoughts or cognitions, hyperarousal), assessed on a Likert-type scale 0 
“not at all”, 1 “a little bit”, 2 “moderately”, 3 “quite a bit”, 4 “extremely”. Subthreshold PTSD will 
be defined as endorsing “moderately” or more to at least 2 B-E criteria; probable-PTSD will be 
measured by meeting criteria A-G for PTSD.  
 
 
Data collection method: All data will be collected via encrypted tablets will be programmed by 
the Research Director from the School of Nursing and responses will be automatically, 
electronically scored. Data is not stored on the tablets. It is automatically transferred to the All 
participants who complete the screener will receive $3. 
 
Subsection 2.5 - Phase II Eligibility Criteria 
 
Inclusion Criteria: 
1) Homeless women (N=134; 67 in each group) 
a. Women over 18 years of age 
b. Able to speak English  
c. Homeless in the last 6 months: a homeless person is defined as anyone who 
spent the previous night in a public or private shelter, or on the street.  
d. Lifetime exposure to trauma as defined by the Diagnostic and Statistical 
Manual for Mental Disorders, 5th Edition (DSM-5). 
e. Likely subthreshold or threshold PTSD, as measured by the PCL-5. 
 
Exclusion Criteria: 
 
The following will not be eligible for participating:  
1) Persons who are: 
a. Not able to speak English 
b. Judged to be cognitively impaired, as indicated by score > 10 on the Short-
Blessed Screener 
 

 
11 
Subsection 2.6 - Phase II Laboratory Tests/Sample Collection 
Saliva Sampling and Results 
 
Saliva Collection 
- 
Pre-task, saliva will be collected. All saliva collection will occur between 10am-2pm to 
minimize diurnal fluctuation effects. (Study procedures may start before 10, but first 
saliva sample must be collected after 10:00am; the second sample must be collected 
before 2pm – participants must be scheduled according to these specifications).  
- 
Two whole saliva samples will be collected using an unstimulated passive drool 
technique.  
- 
Women will be instructed to avoid eating, brushing teeth, or smoking for one hour prior 
to the assessment and will be asked to wait to begin the task if they have. 
- 
Participants will rinse their mouths thoroughly with water for 10 minutes before samples 
are collected. Participants will then passively drool into a collection vial for three minutes 
or until 0.80 milliliters of fluid is collected.  
- 
Saliva samples will be immediately placed in the on-site freezer (or ice cooler) and be 
taken to IISBR within 36 hours to be frozen at -80°C until assayed.  
- 
All samples will be assayed for salivary cortisol and CRP using a highly sensitive 
enzyme immunoassay (Salimetrics, IISBR). 
- 
Twenty minutes after task completion, saliva samples will be collected again in an 
identical manner to that described above.  
- 
Participants will then be offered snacks and a drink and be debriefed to ensure they are 
not experiencing severe task-related psychological distress. In the unlikely event of 
participant distress, an immediate referral will be made to on-site professional staff. 
 
Subsection 2.7 - Phase II Intervention Program Description 
General Description: Among 134 eligible trauma-exposed homeless women, assess the 
impact of the MBSR intervention program PTSD symptoms (primary outcomes), and substance 
abuse, depression, cortisol reactivity, and inflammation (secondary outcomes). 
Data Collection Time points: Baseline, 2 months, and 6 months 
Total Duration: 6 months 
The following sections will outline the intervention process: 
● Pre-intervention Assessments 
● Brief Stress Task (Trauma Imagery Stress Task) 
● Biospecimen Collection 
● Biospecimen Analysis 
● MBSR Intervention 
● Health Promotion Intervention 
● Post-Assessment 
● Team Management of Biospecimen Collection Refusal 
● Dealing with Program Attrition 

 
12 
Subsection 2.8 - Phase II Pre-intervention Assessments 
After Informed Consent, participants will complete a series of self-report measures. These 
measures will be administered by Research Staff at a private location at the site. Responses 
options to each question will be provided to the participant, organized in a clearly labeled binder. 
The Research Staff will display the response options for each measure, read the options out 
loud, and then record the response on the tablet. At the end of each measure, the RA will “lock” 
the measure. There will be a prompt if any items have been missed. Please check that there is 
no missing data. The participant may take a break at any time. However, the participant should 
refrain from eating, drinking (except for water ~ 10 minutes prior to stress task), or smoking until 
after the second saliva collection to ensure the accuracy of the saliva sample.  
Order of assessments  
1. Drug test (urine) 
2. TCU Drug Screen (self-report) 
3. Self-compassion scale – short form  
4. General self-efficacy scale  
5. Mindful Attention Awareness Scale  
6. Difficulties I Emotion Regulation Scale  
7. Satisfaction with Life Scale  
8. Quality of Life Enjoyment and Satisfaction Questionnaire 
 9. MOS Social Support 
10. Perceived Stress Scale  
11. Dimensions of Anger Reactions  
12. PROMIS – Anxiety  
13. PROMIS – Depression  
 
*NOTE: For time constraints, the urine test can be administered during the waiting period prior 
to the second cortisol sample.  
 
AT THIS POINT, THE FIRST SALIVARY SAMPLE IS COLLECTED  
 
14. Negative Life Events Inventory  
15. PCL 5- Worst life event (this is the event that bothers them the most, from their entire life) 
16. PCL 5 – Recent (past year) this is a traumatic event that has happened to them recently (in 
the past year) – it may or may not be the same as #16 
17. Trauma Imagery Stress Task (the Negative Life Events Inventory and the PCL build up to 
this) 
Subsection 2.9 - Phase II Brief Stress Task (Trauma Imagery Task) 
After completing the PROMIS Depression, the participant will provide a saliva sample. They will 
then complete the negative life events inventory and the PCL 5 (for worst event in their life and 
a recent event). The reason that the saliva sample is taken before these measures and not 
directly before the Trauma Imagery Task is because in pilot studies the women began to 

 
13 
become distressed when recounting their traumas during the Negative Life Events Inventory 
and the PCL; thus, the “baseline” for cortisol is now taken PRIOR to these items.  
After completing the PCL for worst event and recent event, the participant will complete a a 
modified script-driven imagery task (Seo et al., 2013), derived from prior research with women 
with PTSD. Participants will be asked to recount a traumatic event via written response. The RA 
will provide a paper and pen and instruct the participant to recall the event exactly as it 
happened. The RA can offer prompts to recall sight, smell, and sound. The participant will then 
recount the event to the RA. Script driven imagery tasks have been effectively and safely used 
to assess traumatic-stress responses in individuals with PTSD. However, RAs will be highly 
trained to assess any severe distress that may arise and will immediately notify the PI and site 
clinical staff immediately. Responses will be subsequently destroyed.  AFTER THE 
COMPLETION OF THE TRAUMA IMAGERY TASK THE 20 MINUTE POST-SALIVA SAMPLE 
TIMER STARTS! When the timer starts, the RA will not interact with the participant. They 
should sit quietly or may read.  
Subsection 2.10 - Phase II Biospecimen Collection 
Urine Collection: Participants will provide a urine sample to validate self-report drug use. A 5-
panel FDA-approved urine test cup will be used in this study. The participant will be instructed to 
urinate in the cup, close the cup, and then bring it back to the RA to read. Gloves will be used at 
all times and the RA should read the cup without touching it if possible. The participant will then 
be instructed to dispose of their urine in the restroom.  
 
Saliva Collection: Before and twenty minutes after the brief stress task (Trauma Imagery 
Stress Task), women will be asked to provide a salivary sample. Women will be instructed to 
avoid eating, brushing teeth or smoking for one hour prior to the collection of saliva and will be 
asked to wait to begin the task if they have. Participants will passively drool into a collection vial 
for three minutes or until 0.80 milliliters of fluid is collected. 
 
Saliva samples will be immediately placed in the on-site freezer or cooler and be taken to IISBR 
or to Dr. Garfin’s research lab for storage. Saliva samples will be transferred to IISBR within 36 
hours to be frozen at -80°C until assayed. After the second and final collection, participants will 
be offered snacks and a drink and be debriefed using an IRB-approved script (see below).  
 
Debriefing script:  
Thanks so much for your participation. I know that might have been difficult for you to 
recall this event. I want to thank you and let you know that we think your participation in 
this task will help other women who have experienced adversity. While feeling a little 
distressed might be expected, we want to make sure you are not experiencing a lot of 
distress. Right now are you are experiencing a lot of distress? 
 

 
14 
If yes, ask if they want you to get a site staff from Prototypes/Serenity House AND 
contact the Principal Investigator, Dr. Dana Rose Garfin immediately AND provide Dr. 
Garfin's contact information to them). 
 
If no, thank them for their time and remind them if anything comes up they can call the 
Principal Investigator, Dr. Dana Rose Garfin and/or talk to any of the Prototypes/Serenity 
House site staff. (Provide Dr. Garfin's contact information to them).  
 
Provide water and snacks at this time and pay close attention to any noticeable changes 
in mood until they are released to the care of the Prototypes/Serenity House site staff. 
Immediately inform Dr. Garfin AND Prototypes/Serenity House site staff of any potential 
issues.  
 
Subsection 2.11 - Phase II Biospecimen Analysis 
 
Urine Sample: The 5-panel FDA-approved urine test cup screens for metabolites of the 
following drugs of abuse at the established cut-off levels and is used for qualitative purposes: 
Amphetamines (1000 ng/mL), Cocaine (300 ng/mL), Methamphetamines/ MDMA (500 
ng/mL), Opiates (2000 ng/mL), and THC (50 ng/mL). Urine sample validity checks will be 
provided by temperature and adulterant monitoring strips built into the test cup. Participants 
whose urine does not pass validity checks will be counted as positive for drugs.  Results will 
be coded qualitatively (above or below threshold). All positive results will be interpreted as 
positive, regardless of self-report. 
 
Saliva Sample: The saliva sample is collected to determine resting cortisol, cortisol reactivity, 
and C-RP (a marker of inflammation). All saliva will be assayed in duplicate using standard 
manufacturer's protocol (Salimetrics). The concentration of CRP in saliva will be determined 
using a Salivary C-Reactive Protein ELISA kit, an enzyme-linked immunoassay. The standard 
curve is run on every assay plate and must have an R2 value of > 0.99. The replicates must 
have a %CV < 15 or an absolute difference <0.030 between the replicates. The mean values 
across saliva duplicates will be computed for each sample and used in the statistical 
analyses. 
Subsection 2.12 - Phase II MBSR-based Intervention 
Standard MBSR is an eight-week long mindfulness-based intervention (MBI) with one 1.5-2.5 
hour session per week (the seventh week has two sessions as one is a mini-retreat). The 
intervention will be run by a highly experienced instructor with prior experience conducting 
MBSR with individuals exposed to trauma with PTSD. 
 

 
15 
During MBSR, participants are trained in mindfulness meditation and the applicability of 
mindfulness to daily life. During MBSR programing, teachers will lecture about key topics in 
mindfulness and lead class discussions. Participants are given opportunities to ask the 
instructor questions and to share their experiences with each other. Snacks and drinks will be 
provided. Important to note, the intervention in this study is not true MBSR. It has been 
modified to fit the specific needs of the target population. This includes shorter sessions and 
shorter meditations, and additional flexibility on the part of the trainer. Although many of the 
same tools and procedures in traditional MBSR will be utilized, given these critical differences 
the intervention administered in this study is not true MBSR.  
  
Each week in the MBSR program focuses on a different theme and has specific short 
homework assignments that students are asked to complete. The sessions are as follows: 
● Week 1: Introductory Material. This includes an overview of the course, building trust 
within the group, introduction to mindful eating, some standing yoga stretches, mindful 
breathing and body scan meditation 
○ Homework: Body Scan recording using MP3 player; eating one meal 
mindfully; optional informal meditation practice. Participants will also complete 
a trauma-informed safety plan to ensure that, although MBSR is given in a 
group format, the MBSR trainer is responsive to the unique needs of the 
individual.  
● Week 2: Understanding Perceptions. This session focuses on self-responsibility and 
short and long-term changes for health enhancing behaviors; how you see things 
determines how you react or respond. 
○ Homework: Body Scan recording using MP3; fill out Pleasant Events 
Calendar; select one activity to bring full awareness to.  
● Week 3: Hatha Yoga, Sitting Meditation, Walking Meditation. The theme is the 
pleasure and power of being present; this week teaches how to investigate the mind 
and body through yoga and meditation.  
○ Homework: Alternate Body Scan recording with Lying-down Yoga using MP3 
player; fill out Unpleasant Events Calendar; sitting meditation. 
● Week 4: Concentration and Awareness. This theme relates to how conditioning and 
perception influence one’s experience and new ways to relate to stress. 
○ Homework: Alternate Body Scan recording with Lying-down Yoga using MP3 
player; be aware of being stuck, sitting meditation. 
● Week 5: Unhealthy Patterns and Getting Unstuck. This week examines conditioned 
patterns and the passive ways that people cope (e.g., numbing, denial, passive-
aggressiveness, suppression of feelings, substance dependency). 
○ Homework: Fill out Difficult Communications Calendar; Sitting Meditation and 
Standing Yoga Sequence.  
● Week 6: Transformational Coping Strategies. This week includes how to deal with 
stressful communication and knowing and expressing your feelings. 

 
16 
○ Homework: Alternate Sitting Meditation recording with Body Scan and/or 
Standing or Lying down Yoga recording.  
● Week 7a: Retreat. This will be a silent class, with sitting and walking practice. Guided 
meditations will include loving-kindness meditation. 
● Week 7b: Maintaining Discipline and Flexibility. This class focuses on how to more 
fully integrate mindfulness into daily life. Instructors and participants discuss lifestyle 
choices and limiting patterns. 
○ Homework: no recordings; try to practice formal sitting meditation; recordings 
can be used if necessary. 
● Week 8: Course Review. In this session, students will reflect on the course, the 
instructor will provide additional resources, and participants will discuss their 
experiences with the group.  
Subsection 2.13 - Phase II Health Promotion Intervention 
The Health Promotion program is eight weeks long with one 1.5-2 hour session per week (the 
seventh week has two sessions to ensure the same number of contact hours as the “mini-
retreat” in the MBSR course). The Health Promotion Classes were designed to be analogous to 
the MBSR classes in terms of length and contact hours. This is because the effect of being in a 
group and participating in a study could help participants, without the benefit having much – if 
anything – to do with the actual intervention.  
 
The program will be run by a UCI graduate or postbac student with a BA or higher. The SMART 
(Specific Measurable Achievable Relevant Time-based) framework will be used for goal setting. 
In this framework, specific, achievable goals are outlined by the participant as relevant to each 
class. This helps with information retention and helps reinforce concepts and positive behaviors. 
Snacks and drinks will be provided. 
 
Each week in the Health Promotion program focuses on a different theme. The sessions are as 
follows: 
1. Introduction & overview  
2. Envisioning Health through Art 
3. Chronic Disease I – Heart Health  
4. Chronic Disease II – Diabetes 
5. Nutrition and Hydration  
6. Infectious Disease Prevention 
7. Skin Care 
8. Oral Health  
9. Promoting Social Integration & Course Graduation  
 

 
17 
Subsection 2.14 - Phase II Post-Assessment 
After the ninth session (of either MBSR or Health Promotion), a post-assessment will be 
administered via tablet. Urine will again be collected to validate self-report drug use. 
Participants will repeat the brief stress task (Trauma Imagery Task) using an identical strategy 
and provide saliva samples before and after. The Lead Researcher or a postbac student 
researcher will be on site to answer any questions or clarify any items. Urine and saliva 
samples will both be stored in a freezer on-site or at Dr. Garin’s research office and then 
transferred to UCI for analysis within 36 hours. Follow-ups will occur on site unless participant 
has moved to sober living or other location. Zoom or phone will be implemented for those who 
moved out of state 
 
Subsection 2.15 - Phase II Team Management of Biospecimen 
Collection Refusal 
Participants have the right to refuse the collection of urine or saliva and it is important to 
understand that an individual may want to refuse due to the following: 
 
Step 1: Assess reasons why participant does not want to have their sample collected. 
● May experience concern that their friends, acquaintances, or shelter staff will be 
informed of the results of their surveys or urine. 
● Other possible reasons? 
 
In the event a participant refuses the sample collection, inquire about the following: 
  
Step 2: Respond to their reasons why they do not want to give urine or saliva samples. 
 
We encourage our participants to complete as many of the procedures as they are comfortable 
with. Please offer to have Dr. Garfin or Lab Management answer any questions the participant 
may have regarding the measures. However, participation is completely voluntary, and the 
participant may skip any aspect of the procedure that they chose without penalty and still be in 
the study.   
Subsection 2.16 - Phase II Dealing with Intervention Program Attrition 
Attrition is conservatively estimated at 10% for first follow-up and 20% for 6 month follow-up. 
To account for an estimated 30% of women to be screened with subthreshold or threshold 
PTSD, 448 women will be screened, approximately 134 enrolled, with approximately 120 for 
immediate post-intervention assessment and 96 at 6-month follow-up. This may change due 
to COVID-19, but we will work hard to ensure retention of participants during the study. The 
Locator Guide is key to maintaining effective follow-up.  
● Completion of the intervention program is defined by completing at least 6 out of the 9 
classes. We will keep track of the number of classes using the adherence tracker on 
REDCap. Make-up classes will be offered to women who can not make the class, 

 
18 
particularly as it pertains to COVID-19 or other obligations the women have such as 
court appearances.  
○ The minimum amount of time required for the regimen is 8 weeks and the 
maximum is 10 weeks. 
Subsection 2.17 - Phase II Follow-Up Focus Groups 
At six-month follow-up, we will contact the women with assistance from the site supervisor or 
by using our Locator Guide (see Appendix). Research Staff will travel to the participant’s 
location, as they may not be available to return to site due to COVID-19 restrictions or other 
factors. If participant moved out of state, the follow-ups may be conducted over Zoom or 
phone.  
Subsection 2.18 - Phase II Compensation 
The Phase II compensation is listed below. Each participant will receive a total of up to $153 
over the course of the study. 
 
$3 – screener (after completing screener) 
$15 – baseline measures (after completing) 
$10 – per class (at the end of each class; for a total of 9 classes) 
$15 – immediate post-intervention follow-up measures (after the 9th class) 
$30 – 6-month follow-up (after completion)  
 
Participants who complete 6 or more of the sessions will also be given a Certificate of 
Completion. Participants who complete all 9 sessions will be given a Certificate of Perfect 
Attendance (see Appendix).  
Subsection 2.19 - Program Fidelity  
To ensure program fidelity, all procedures will be closely supervised by the PI, Dr. Garfin. 
Detailed training materials will be provided to all staff, and staff will be required to complete a 
quiz prior to working on site. For those involved in administering the interventions, a detailed 
teachers manual will be provided, and all staff will be expected to adhere to the manual, with 
some flexibility allowed depending on the needs of the group.  
Subsection 2.20 - Research Staff Competencies and Mock Sessions  
UC Irvine has implemented an educational program on the protection of human research 
subjects. All study personnel who are responsible for the design and conduct of this project 
must complete the Collaborative Institutional Training Initiative Human Research Curriculum 
(CITI program), with the confirmation of completion of the trainings on file. The following courses 
should be completed by all staff prior to engaging in study activities. 
● Human Research - Social & Behavioral Researchers & Staff  

 
19 
● Good Clinical Practices (GCP) courses 
● Refresher courses are also available on CITI website 
https://about.citiprogram.org/en/homepage/) as needed.  
 
Further, all research staff will be highly trained by the PI in the following:  
• 
Trained in specific protocols for dealing with emotional and mental distress (e.g., 
remaining calm, immediately finding appropriate onsite clinical staff).  
● Trained in observational and communication skills, and in providing psychosocial 
support, particularly as it relates to emotional and information support 
● Trained in the California Mandatory Reporting Laws governing reporting of child abuse, 
domestic violence, and elder/dependent abuse. Protocols governing reports to the 
California Department of Family and Child Protective Services, or (in the case of 
domestic violence) local police, will be carefully followed. Study participants will receive 
full disclosure regarding mandatory reporting laws during the informed consent process 
and discussion of confidentiality.  In terms of current or recent abuse experience, 
research staff will refer the participants to the onsite Prototypes clinical staff.  
 
During research study training, Research Staff will be evaluated using the competency grid and 
mock session review. Research Staff will also complete a quiz to be reviewed with the PI prior 
to interacting with the participants.  
Subsection 2.21 - Data Entry, Management & Confidentiality 
In Phase 2, secure and encrypted platforms will be used:  
● REDCap: Interview data will be captured electronically using REDCap (Research 
Electronic Data Capture; http://project-redcap.org/), a secure, web-based application 
designed to support data entry and storage for research studies. Participants will answer 
surveys via an electronic tablet and the data will be uploaded in real-time. Possible 
errors, including incomplete responses, logic checks, and data range checks will be 
flagged by the RedCap software during input so that they can be corrected immediately. 
Laboratory data will be entered in REDCap electronic forms. 
● Dr. Garfin will routinely check to ensure data is accurately entered. The Data Safety and 
Monitoring Board (DSMB) will also meet after the enrollment of every 30 participants to 
review/  
 
Procedures to safeguard confidentiality 
Confidentiality of data will be protected by use of subject code on all data and questionnaires. 
Any forms that link participant with their codes will be stored electronically on UCI’s secure 
server and only senior research staff and the PI will have access. All self-report data will be 
immediately uploaded onto UCI’s secure server via RedCAP. Saliva samples will use the 
subject code number and will not be labeled with the participant’s name.  

 
20 
● Participants will be reminded that their interview questions will be provided over a tablet 
that will immediately transfer the data to the UCI secure server and site staff will not see 
their data.  
● We will minimize the risk by strictly adhering to confidentiality procedures. All study staff 
will be rigorously trained in methods to promote confidentiality. The staff will also be 
taught to treat participants in a non-judgmental, professional and confidential manner.   
● A Data Safety and Monitoring Board will be put in place for monitoring of the data 
collected. 
● Confidentiality of data will be protected by use of subject code on all data and 
questionnaires. Data including subject identifiable information (eg: locator form etc) will 
be linked to a code on REDCap for access in real time to track participants and only 
research staff will have access. REDCap also allows for participant’s names and IDs to 
be viewed without access to their responses to the other items in the survey. Tracking of 
participants for their follow-ups will be based upon the information the participant reveals 
on their Locator Guide. When contacting people over the phone, we will use their 
preferred method and the research staff will identify themselves per participants’ wishes. 
● To protect confidentiality and reassure subjects, the research staff will be providing 
explicit explanations in the beginning of the program that they will share no confidential 
information. The trained research staff will administer the questionnaires individually to 
the participants.  
● Subject identifiable data will be destroyed upon completion of the study. All the data will 
be stripped off any identifiable information and only de-identified database will be kept 
for analysis and dissemination. 
Subsection 2.22 – Using REDCap 
● For electronic data entry, log onto RedCap (https://redcap.med.upenn.edu/) with your 
user ID and password. 
● RedCap also incorporates suitable validity checks at the point of data entry to prevent 
“out of range,” “missing” or other checkable data entry errors.  
 Subsection 2.23 - Data Security 
● All CRFs and questionnaires must be identified by a code number (Study ID) only and 
patient identifier information will also be linked on REDCap through this code.  
● The informed consent with the participants’ names and signature will be on REDCap and 
a digital copy should be printed out of REDCap and stored in a local hard drive not 
connected to server.  
● All databases are accessible only to key investigators and senior leadership of the 
project.  
● The electronic data files are stored on the secure, password-protected UCI Health 
Science server.  

 
21 
● This data is available for analyses on the UCI server to authorized users through a web 
VPN application. 
● 
 Authorized users can export the data into Excel or other statistical software sheets for 
further analyses. 
● The de-identified database will be archived for future analyses and all other identifying 
data will be destroyed at the end of the study as per NIH policy.  
Subsection 2.24 - Post Data Collection 
● Validity checks on REDCap should be done right after any interview or other data 
collection is completed. 
● Routine statistical validity checks should identify missing or suspect entries at agreed 
defined intervals (twice per month or as needed) by approved study staff, so that correct 
data can be obtained from the research staff, participants or their records if needed. 
● Thorough data cleaning should be performed before any data analysis. 
  
Subsection 2.25 - End of Study 
● De-identified electronic data will be maintained for the period agreed in the study 
protocol (indefinitely). 
● Final cleaned electronic data will be used for all statistical analyses. 
 
 
 
 
 
 
 
 
 
 

 
22 
SECTION 4. RECRUITMENT  
Subsection 4.1 - Phase II Flyer 
 

 
23 
Subsection 4.2 - Phase II MBSR – Script for Introduction at 
Recruitment Site: For Non-Research Staff Member 
 
Introduction:   Hello, my name is__________________________. I’m a staff member from 
Prototypes/Serenity House Residential Treatment Center. I would like to inform you about a 
research study by sharing a flyer with you.  This study is conducted by Dr. Dana Rose Garfin of 
the UCI, Sue & Bill Gross School of Nursing.  
  
Question:         Would you like to receive a flyer? 
❏ Yes, I would like to receive more information. 
❏ No, not at this time. [If not interested, thank person for their time] 
  
Directions:      If interested, hand flyer and say: The research study being conducted at 
Prototypes/Serenity House and is a separate activity from the services offered by this site. If you 
decide to participate, your decision to participate in the research will not affect your relationship 
with Prototypes/Serenity House. 
  
Directions:      If you are interested, an information session will be held at ________ [DATE] at 
__________ [TIME] for you to learn more. 
  
Question:        Would you like to attend an information session and be screened to see if you 
are eligible to participate in this study? 
❏ Yes [If yes, refer participant to Project Director]  
❏ No  [If no, thank person for their time] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
24 
SECTION 5. SCREENING, INFORMED CONSENT, AND 
ENROLLMENT 
 
Subsection 5.1 Screening Protocol  
Instructions:  
1. Read participant consent to screen document (listed in Appendix)  
2. If they agree to consent to screen, you will open the Screening Module in REDCap.  
1. Age? (Must be 18 or older) 
2. Able to speak English (infer, don’t ask) 
3. Homeless in the last 6 months.  
i. 
Homeless is defined as anyone who spent the previous night in a public 
or private shelter, or on the street. Some women will have been 
incarcerated. If this is the case and they did not have another residence 
to return to, they are eligible to be in the study.  
4. Administer Short Blessed Test.  
i. 
Must meet (Normal Cognition 0-4) 
5. Meet likely subthreshold or threshold PTSD as measured by PCL-5 (see 
Appendix).  
6. Subthreshold PTSD 
i. 
Must meet Criteria A (exposure to a traumatic event).  
ii. 
Must endorse “moderately” or more to at least 2 B-E criteria. This will be 
automatically scored in REDCap.  
Subsection 5.2 Informed Consent   
1. If eligible, read to them the informed consent, going over key highlighted areas.  
i. 
Provide them a paper copy of the consent, and highlight the contact 
information for Dr. Garfin and the IRB.   
ii. 
Download a copy of informed consent (save in downloads). Have them 
sign. Then re-upload and delete from downloads.  
2. START locator guide.  
i. 
Make sure you get their FULL LEGAL NAME!  
ii. 
TAKE PICTURE USING THE “ADD DOCUMENT” ITEM, DO NOT SAVE 
TO CAMERA AND THEN UPLOAD. 
Subsection 5.3 Baseline Protocol 
1. Tell them there will be a urine test. They can take it before or after interview (their 
choice). You will hand them a cup. They will return the cup and you will record 
their urine results in REDCap. Use gloves. It is not considered a biohazard so 
can be thrown in trash (or urine poured in toilet).  
 

 
25 
APPENDIX I: What to bring to site 
 
Screening  
o Charged iPads 
o Charged iPencils   
o Compensation in 1 dollar bills, as participants will be paid $3 per screening  
o Light snacks 
o PPE for COVID-19, including face masks, face shields, tissues, Clorox wipes, hand 
sanitizer, and gloves.  
Baseline, immediate follow-up, and 6-month follow-up 
o Charged iPads 
o Charged iPencils   
o Compensation in $10- and $5-dollar bills, as participants will be paid $15 each (Note: for 
6-month follow-up please bring $10 dollar bills as participants will be paid $30.) 
o Light snacks 
o Bottles of water 
o PPE for COVID-19, including face masks, face shields, tissues, Clorox wipes, hand 
sanitizer, and gloves. 
o Color coded and labeled vials for saliva collection  
o White boxes to store saliva samples 
o Cooler with ice  
o Drug test kits   
o Paper and pens for stress task (trauma imagery task) 
Weekly – Health Promotion class 
o Charged iPads 
o Charged iPencils   
o Compensation in $5 or $10 dollar bills, as participants will be paid $10 each   
o Light snacks 
o PPE for COVID-19, including face masks, face shields, tissues, Clorox wipes, hand 
sanitizer, and gloves. 
o Teacher manual  
o Extra participant book  
o Materials for each week – please see teacher manual for weekly supply list 
Weekly – MBSR class 
o Charged iPads 
o Charged iPencils   
o Compensation in $5 or 10 bills, as participants will be paid $10 each   
o Light snacks 
o PPE for COVID-19, including face masks, face shields, tissues, Clorox wipes, hand 
sanitizer, and gloves. 
o Extra participant book  
o Extra MP3 players 
o Extra yoga mat or two 
 

 
26 
APPENDIX II: Trauma Imagery Script (Brief Stress Task) 
 
 
TRAUMA IMAGERY SCRIPT 
 
NOTE TO RA: Make sure the participant has not had anything to eat or drink for one hour and 
that they had some water to drink at least 10 minutes before starting the task.  
RA: Thank you for your participation in this part of the project. We are going to be asking you to 
recall and describe a stressful or traumatic event. We want to remind you that you can stop at any 
time if you are uncomfortable, although your participation will help us understand more about 
the stress process in women who have experienced adversity. The general overview of this 
procedure is that we are going to take a saliva sample to assess your stress hormones; have you 
participate in a short stress task; and then take another saliva sample to assess your stress 
hormones after the task. If this gets to be too intense for you, you can stop at any time. If you 
experience any severe distress, let me know and we will stop the task and immediately contact 
your onsite clinician/therapist. I want to remind you that this is completely voluntary and you can 
stop at any time and can still be in the study. Are you ready to begin? Do you have any 
questions?  
NOTE TO RA: Participants will then passively drool into a collection vial for three minutes or 
until 0.80 milliliters of fluid is collected. Instruct to lean forward, and allow saliva to pool at the 
bottom of your mouth. Instruct to use tongue to slowly push the saliva into a straw-like collection 
tool that leads into a tube until you have collected roughly 1 teaspoon of saliva. Immediately put 
saliva in cooler! 
RA: First, I am going to ask you to recall a stressful or traumatic event for a few minutes. Some 
examples are a serious accident, fire, disaster, physical assault, abuse, war, homicide or suicide. 
Then, you will write about it and then read or describe it aloud. I can also take notes for you if 
you prefer to do it that way. You can face whatever direction you want and you can have your 
eyes open or closed. However, I ask that you try to recall each part of the event in as much detail 
as you can in your mind’s eye. Think of the actions, events, thoughts, feelings, smells, and 
sensations. Try to remember how you felt and what was happening in your body. Do you have 
any questions?  
I am going to give you a few minutes to imagine the event and write some notes. Here is a pen 
and some paper. Anything you write will be destroyed after the task. 
NOTE TO RA: Give the participant some time to write. Re-iterate any of the instructions if they 
ask or seem stuck. Stop the procedure if the participant is extremely distressed and contact a 
Prototypes site staff and Dr. Garfin. Remind them they can still be in the study if they don’t want 
to complete this part of the procedures.  
RA: Now please read what you wrote aloud and vividly imagine it in your mind’s eye. (Time ~ 5 
minutes).  

 
27 
NOTE TO RA: 20 minutes after completion, collect saliva samples in an identical manner to the 
first sample. Participants will then passively drool into a collection vial for three minutes or until 
0.80 milliliters of fluid is collected. Instruct to lean forward, and allow saliva to pool at the 
bottom of your mouth. Instruct to use tongue to slowly push the saliva into a straw-like collection 
tool that leads into a tube until you have collected roughly 1 teaspoon of saliva. Immediately put 
saliva in cooler! 
 
POST-TASK DEBRIEFING 
Thanks so much for your participation. I know that might have been difficult for you to recall 
this event. I want to thank you and let you know that we think your participation in this task will 
help other women who have experienced adversity. While feeling a little distressed might be 
expected, we want to make sure you are not experiencing a lot of distress. Right now are you are 
experiencing a lot of distress?  
If yes, ask if they want you to get a site staff from Prototypes/Serenity House AND contact the 
Principal Investigator, Dr. Dana Rose Garfin immediately AND provide Dr. Garfin’s contact 
information to them).  
If no, thank them for their time and remind them if anything comes up they can call the Principal 
Investigator, Dr. Dana Rose Garfin and/or talk to any of the Prototypes/Serenity House site staff. 
(Provide Dr. Garfin’s contact information to them).  
Provide water and snacks at this time and pay close attention to any noticeable changes in mood 
until they are released to the care of the Prototypes/Serenity House site staff. Immediately 
inform Dr. Garfin AND Prototypes/Serenity House site staff of any potential issues.  
 
 
 
NOTE TO RA: Please provide the following to the participant (note: can also remind the 
participant this is also included in the informed consent). 
 
CONTACT INFORMATION 
If you have any concerns please contact the Principal Investigator, Dr. Dana Rose Garfin at 
dgarfin@uci.edu or (657) 251-9219. You can also call the University of California, Irvine 
Institutional Review Board at Human Research Protections unit in the Office of Research by 
calling (949) 824-6068 or (949) 824-2125 Monday – Friday, 8 am – 5 pm; or by e-mail at 
IRB@research.uci.edu; or by writing us at 141 Innovation Drive, Suite 250, Irvine, CA 92697. 
 
 
 
 
 
 
 

 
28 
APPENDIX III: Data Safety and Monitoring Plan 
 
Institutional Review Board 
Human Research Protections 
Appendix S – DESCRIPTION OF DATA 
SAFETY MONITORING PLAN (DSMP) 
FOR CLINICAL/ BIOMEDICAL 
RESEARCH 
 
Version 09-19-2018 
Researchers:  
 
• 
All studies involving greater than minimal risk to participants are, 
at a minimum, required to develop a detailed plan to ensure that 
there is appropriate safety oversight.  
• 
For clinical studies involving a test article, it is common to have an 
independent Data Safety Monitoring Board (DSMB).  
• 
Please read the applicable HRP webpage for further guidance. 
 
HS#:   
(to be completed by the IRB) 
 
 
 
 
Lead Researcher/Investigator Name:  Dana Rose Garfin 
 
Researchers may cut and paste into Appendix S from the following sources, as applicable.   
Please remember to submit the following documents with your IRB APP: 
 
• 
For NIH-sponsored clinical trials, the DSMP should be part of the grant application.  
• 
For industry sponsor-initiated clinical trials, a FDA-approved DSMP should be part of the Master 
Protocol or the Data Safety Monitoring Committee/Board Charter. 
• 
For studies conducted at the Institute for Clinical and Translational Science (ICTS) or Cancer 
Center (PRMC), the DSMP information approved by one of these committees should be inserted 
into this appendix. 
 
Please answer all of the following: 
 
1. Provide details of those individuals who will be responsible for the safety oversight of your study, 
including the relevant experience/expertise of each individual (for UCI investigator initiated 
studies conducted only at UCI, provide the names and titles as well). 
 
The study will have a Data Safety and Monitoring Board (DSMB) 
1. Dana Rose Garfin, PhD (Assistant Adjunct Professor and Lead Investigator, Sue & Bill Gross 
School of Nursing). Dr. Garfin has over 12 years of experience researching stress and trauma 
in both epidemiological and community-based samples. She has conducted prior studies with 
vulnerable populations (e.g., homeless women, trauma-exposed children; post-disaster 
survivors, demographically diverse samples). Dr. Garfin’s recent work has explored the 
efficacy of community-based interventions on high risk samples (i.e., HIV-positive women in 
India). Dr. Garfin has recently completed a qualitative study exploring the acceptability and 
feasibility of a mindfulness-based intervention for trauma-exposed, homeless women. Dr. 
Garfin has an MA in Social Ecology and a PhD in Psychology.  
2. Adeline M. Nyamathi, PhD, ANP, FAAN (Founding Dean and Distinguished Professor, Sue 
& Bill Gross School of Nursing). Dr. Nyamathi has been Principal Investigator of more than 

 
29 
one dozen NIH-funded intervention studies with high risk groups that have resulted in 
significant reductions in drug and/or alcohol use and risky sexual behaviors, high rates of HBV 
vaccine completion, latent TB treatment completion, and improvement in emotional health and 
substance use outcomes. She has worked with homeless adults for over 32 years as well as 
other vulnerable populations both domestically and internationally.  
3. E. Alison Holman, PhD, FNP (Associate Professor, Sue & Bill Gross School of Nursing).) 
Dr. Holman is a health psychologist and family nurse practitioner with over 20 years of 
clinical experience working with sick children and their families as well as survivors of 
a variety of traumatic life events. Over the past 20 years, she has served as Principal 
Investigator and/or co-PI on several studies of individuals coping with trauma (e.g., 
9/11, incest, war, and natural disaster). She has also served as the data manager and 
analyst for several studies including her prospective longitudinal study of coping with 
the September 11th terrorist attacks. She is PI of an ongoing epidemiological study of 
American’s responses to traumatic events and an NIH-funded R01 studying the acute 
stress response in stroke survivors.  
4. Sanghuk S. Shin, PhD (Assistant Professor, Sue & Bill Gross School of Nursing) Dr. Shin is 
an epidemiologist and biostatistician with expertise in data management, biostatistics, and 
protocol development and adherence. He has been PI or co-I and lead statistician for 
numerous NIH-funded intervention studies with high risk samples including homeless 
individuals and those with infectious diseases including TB and HIV.  
5. Jung-Ah Lee, PhD, BSM, MN (Associate Professor, Sue & Bill Gross School of Nursing) Dr. 
Lee’s expertise is in healthcare systems and how the structure and processes of a healthcare 
system affects patient safety and clinical and organizational outcomes. She has investigated 
quality improvement techniques, patient safety issues, effective healthcare delivery models, 
and cost-effectiveness of care. She has expertise working with vulnerable populations 
including older adults and those with chronic diseases. Dr. Lee is is not a member of the 
research team and will provide independent oversight.  
6. Yuqing Guo, PhD, MN (Associate Professor, Sue & Bill Gross School of Nursing). Dr. Guo 
has expertise in women’s health and health disparities. She has run numerous family-
centered interventions in community settings. She is PI of a study examining maternal care 
for underserved communities and is well equipped to provide consult and oversight on 
potential problems with the population of interest. Dr. Guo is not a member of the research 
team and will provide independent oversight.  
 
 
2. Indicate how frequently accumulated study data will be reviewed and evaluated for participant 
safety, study conduct and progress, and, when appropriate, efficacy.  
 
They will meet face-to-face at least once a year and maintain and approve minutes of meetings.  
Every 30 participants.  
 
 
 
3. Describe the events that would trigger an unscheduled review. Also include stopping guidelines 
and un-blinding rules if applicable.  
 
Events where the participant became extremely distressed as part of the research procedure or 
expressed suicidality or if they were a harm/threat to self or others.  The Data Safety and 
Monitoring Plan (attached, submitted in the NIH grant that funded this application), we provide 
specific guidelines to assess suicidality or harm to others. The research staff would follow all 

 
30 
procedures to ensure the safety of the participant. And the DSMB would be  
 
4. List who will be locally monitoring and collecting information on adverse events and/or 
unanticipated problems (e.g., UCI Lead Researcher, Research Coordinator, etc.). Include the 
name, title and experience of the individual(s) and further describe each individual’s role in the 
oversight of subject participating in the study. 
 
The Principal Investigator (Dr. Dana Rose Garfin) will be responsible for locally monitoring and 
collecting information on adverse events and unanticipated problems. Dr. Garfin will be onsite 
during participant recruitment and during the administration of intervention procedures. In the 
event that Dr. Garfin is not able to be onsite, a senior staff will be in contact directly with Dr. 
Garfin should any problems arise. Moreover, when Dr. Garfin is not onsite, staff will report daily 
on study progress and any potential issues. Dr. Garfin will monitor all data weekly.  
 
5. Describe the plan for annual reporting of the participants’ safety, and the study’s conduct, 
progress, and efficacy, when appropriate. Note: At the Continuing Review, please provide all 
relevant documentation related to the review of the accumulated data for safety. For the case 
your submission includes a DSMB charged with the oversight of data safety, include all available 
DSMB reports as part of your submission.  
 
Annual reporting will occur at the DSMB meeting. The Principal Investigator will keep detailed 
notes from the meeting and evaluate the study’s conduct (e.g., any unanticipated problems), 
progress (e.g., recruitment, retention), and efficacy (e.g., results of any preliminary data 
analyses).  
 
 
DATA SAFETY AND MONITORING PLAN 
 
Possible Serious Adverse Events or Adverse Events 
 
Serious adverse events 
 
• 
Suicide attempt, severe violence to another person 
   
Other adverse events 
 
• 
Inadvertent disclosure of illegal immigrant status  
• 
Adverse reaction to stress task 
 
Risk Management Protocols in Place to Deal with Adverse Events 
 
• 
Date Safety and Monitoring (DSM) issues are raised at quarterly meetings with all research staff 
• 
Events will be reported as they occur 
• 
A certificate of confidentiality will be secured. 
• 
Research staff will administer the questionnaires individually. 
• 
Participants will be cautioned not to disclose any confidential information within the group sessions. 
• 
Unique identifiers are used on all data.  Access to identifiers is restricted to the study PI, lead mentors 
and data manager by a combination lock. 

 
31 
 
Data and Safety Monitoring Procedures 
 
• 
Serious adverse events (SAE) must be reported to the NIH Project Officer (PO) by email or telephone 
within 24 hours of the SAE.  A more complete written report documenting the event must occur within 
72 hours of the event.   
• 
All adverse events will be reported by email to the NIH PO twice a year: six months after the Notice of 
Grant Award (NGA) and at the end of the budget year.  
 
Data Safety and Monitoring Board (DSMB) 
 
The board will be composed of six members, including the PI, mentors (Nyamathi, Shin, Holman) and two 
mid-level to senior investigators from our institution with psychological expertise (Dr. Yuqing Guo and Dr. 
Jung-Ah Lee). They will meet face-to-face at least once a year and maintain and approve minutes of 
meetings. The NIH PO will be kept informed regarding changes to the membership of the DSM board. 
Data will be reviewed as every 30 participants enter the study. 
 
Training for all staff 
 
During the orientation prior to start of the grant, all research staff and research assistants will be trained on 
recognizing all types of potential crises, how to make a thorough assessment, and role play protocols that 
are featured below and in the DSMB section. During these meetings, in services that address mental 
health crises and associated symptomatology will be provided to enhance the staffs’ ability to confidently 
engage in the protocols for participants who may be experience psychiatric or psychological distress. All 
research assistants will also meet weekly with the PI to review challenging interactions, circumstances, or 
situations that may have arisen with the participants.  Discussions will focus on how the incident could 
have been handled differently and what the ideal outcome for that situation might have been. 
 
Training in Red Flag Procedures 
 
 
Research staff will be trained to assess and react as follows: 
 
 
RED FLAG – SUICIDE 
 
During your work as a research staff, you may encounter a respondent who expresses suicidal intentions, 
or you may suspect that a respondent may be suicidal. Be sure to document all the information in sections 
I and II as you will need to provide that information to the treatment program counselor or on-call clinician. 
 
I. 
Is this person a suicide risk? 
 
 
 ____ The individual is currently thinking about suicide. 
 
 ____ The individual has a plan and the means to commit suicide. 
 
 ____ The individual has attempted suicide in the past. 
 

 
32 
 
If any of the above are true or if you suspect the client is suicidal, also note if: 
 
 ____ The individual is currently exhibiting serious depression/anxiety. 
 
 ____ The individual is experiencing stressful life events. 
 
II. 
Assessment of support system: 
 
a) Is the individual under professional care (i.e., psychologist, psychiatrist, counselor)? 
 
b) Does the individual have a social support network (i.e., friends, family, sponsor)? 
 
c) Has the individual talked with any of the members of his or her social support network in 
the last 30 days? 
 
d) Is the individual able to talk about this issue with his or her support system? 
 
e) Is the individual aware of available social service programs? 
 
III. 
If the person appears to be suicidal or has attempted suicide since the last interview: 
 
a) Let the respondent know that you are concerned, and that you need to inform a clinician 
and your supervisor.   
 
b) If you are not at a treatment program, have the client wait with you or hold on the line while 
you take the following steps:   
1) If the client has indicated that he/she is under professional care, ask the client for 
permission to contact his/her clinician and, if permission is granted, obtain the clinician’s 
contact information. Be sure to document the client’s permission and clinician contact 
information, you will need to provide it to the on-call clinician who will confirm client 
permission and make the contact. 
2) Contact the on-call clinician at the Los Angeles County Mobile Crisis Response Team 
(MCRT); _____________. A clinician is on call 24 hours a day. Provide the clinician 
with all the suicidality information you have gathered. Facilitate phone contact between 
your client and the MCRT clinicians. The clinician will make the decision about what 
steps to take with this client. Document the details of the clinician call. 
 
d) Report back to the PI immediately.  
 
• 
Your Principal Investigator Dana Rose Garfin Ph.D., 415-407-9498 
 
The situation will be evaluated by the group and a decision will be made if it should be 
reported to the LAC MCRT; they will advise us on how we need to proceed. 
 
e) If the person attempts to harm himself or herself in your presence, contact the police (911).  
The police may place the person in a psychiatric facility for a 72-hour observational hold.  
Get the police report number. 
 
f) 
Complete an Incident Report detailing the problem and action taken.  Be sure that the 
Incident Report is placed in the respondent’s file. 

 
33 
 
g) Make arrangements to follow-up on your client’s status with the treatment program 
counselor, supervising counselor, or on-call clinician within the next seven days. 
 
If the MCRT is called, an assessment will be done by the MCRT staff at the location of the 
participant. Based on the assessment of the MCRT, the participant may be transported to a hospital for 
inpatient treatment. If it is determined that the person does not need to be hospitalized, the participant will 
be referred to the outpatient services at the neighborhood clinic. If the participant is at the same location 
as the staff, the staff will find out if the participant has taken any active steps such as already having taken 
pills, etc. If the participant is not in immediate danger, the staff will find out the following: history of drug and 
alcohol abuse; history of familial suicide; history of familial mental illness. The staff will find out if the 
participant has a plan for how he would commit suicide. If she does have a plan, the staff will find out if 
she/he has any weapons, pills, etc, and remove all weapons from her possession, and explore the nature 
of her various plans. The PI, once they have arrived, will continue to focus on the reasons the participant 
wants to live and build on his support system. The staff will get phone numbers from the participant of 
those of his outside support system with whom he wishes to be in contact, for future use in case of another 
emergency. The research staff will collaborate with the treating psychiatrist to facilitate referral and follow 
through with a counseling psychiatrist/psychotherapist after discharge from the hospital. The staff/PC will 
document each step of this process. 
 
If it is determined that the person does not need to be hospitalized, any additional treatment will 
be facilitated with Prototypes staff. To facilitate communication the participant will be asked to sign a 
Release of Information. If the participant provides a Release of Information, the PC will follow-up to ensure 
that the participant is receiving the necessary treatment. Depending on the outcome of the event, the PI 
may recommend that the participant withdraw from study participation. The staff/PC will document each 
step of this process in an adverse event log. 
 
 
In addition, the DSMB will be informed of reports of suicidal ideation and current or recent abuse, 
reported by the staff to the proper authorities. Further, the DSMB will monitor that these reports are made 
expeditiously and with the full knowledge of the respondent. Monitoring information is also provided in the 
HSPC segment of this application.   
 
Harm to others  
 
I. Is this respondent dangerous to others? 
The individual expressed intent to harm or kill a specified person. 
The individual has the means (gun, knife, etc.) to harm that person. 
The individual has a thought-out plan. 
 
II. If you feel that the person is dangerous to others, and is likely to follow through with his/her 
plans: 
 
Assess the situation.  If it is safe, complete the study protocol is the participant desires.  Report 
the information to your supervisor, the PI and the licensed clinician on staff at Prototypes.  If you 

 
34 
feel unsafe or are not sure about it, complete the research procedures; only if possible.  But if 
the situation is volatile, terminate immediately.  Try to be as graceful and subtle as possible.  
For example, complete the specific task you are on or make up some reason for leaving, and 
say you will have to reschedule the rest of the procedures.  Pay the subject in full, or leave 
immediately if you don’t feel safe to do so.  Trust your sense of the situation, and act 
accordingly.  
 
Report back to your supervisor or call in immediately.  If something takes place outside of the 
work hours, call your supervisor at home.  The supervisor should then immediately contact the 
project’s PI. Supervisors are: 
 
Your Principal Investigator Dana Rose Garfin, Ph.D., 415-407-9498 
 
The situation will be evaluated quickly by the group and a decision will be made if the LAC 
MCRT needs to be called; they will advise us on how we need to proceed. If the situation is 
reported to the police, get the report number from the police. 
 
III. Complete an Incident Report.  Be sure to put a copy of the Incident Report in the 
respondent’s file so that those working with the file in the future know an incident occurred.  
Aside from the DSMB, the PI will carefully monitor the data weekly. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
35 
APPENDIX IV: Citations for Study Measures  
Primary Outcome:  
 
PTSD Checklist for DSM-5 (PCL-5; Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 
2013). Responses will be scored continuously and according to diagnostic criteria as 
implemented in previous research.(143) The PCL-5 initially starts with the identification of the 
presence of exposure to a DSM-V traumatic event (i.e., “Briefly identify the worst event (if you 
feel comfortable doing so)”) and then assesses whether it involved actual or threatened 
death, serious injury or sexual violence; whether the person directly experienced it (through 
direct exposure, witness to the event, occurred to a close friend or family member, or exposed 
as part of job). There are then twenty-items that assess all four B-E criterion (re-experiencing, 
avoidance, negative thoughts or cognitions, hyperarousal), assessed on a Likert-type scale 0 
“not at all”, 1 “a little bit”, 2 “moderately”, 3 “quite a bit”, 4 “extremely”. 
 
Secondary outcomes:  
 
Substance use:  
Self-report drug use: Texas Christian University (TCU) Screen at Baseline and 6-month follow 
up. Yes/No to each drug will be assessed for use vs dependency.  The total score ranges 
from 0 - 9; higher scores (> 3) correspond to the DSM drug dependence diagnosis.  This will 
be assessed at baseline, immediately following 9th/final intervention session, and 6-month 
follow-u (Institute of Behavioral Research, 2017).  
 
Objective drug use assessment: A 5-panel FDA-approved urine test cup will be used in this 
study.  The test cup screens for metabolites of the following drugs of abuse at the established 
cut-off levels and is used for qualitative purposes: Amphetamines (1000 ng/mL), Cocaine 
(300 ng/mL), Methamphetamines/ MDMA (500 ng/mL), Opiates (2000 ng/mL), and THC (50 
ng/mL). Urine sample validity checks will be provided by temperature and adulterant 
monitoring strips built into the test cup. Participants whose urine does not pass validity checks 
will be counted as positive for drugs.  Results will be coded qualitatively (above or below 
threshold). All positive results will be interpreted as positive, regardless of self-report. 
 
Depression: will be assessed using the PROMIS measure for depression (Emotional 
Distress). The 8-tem form will be used. It assesses negative mood, views of self (e.g., 
worthlessness), decreased positive affect and anhedonia. In self-report when all participants 
are given the same questions, it is desirable to use the 8-item short form, which has reliability 
and validity comparable to the 28-item computer adaptive form (PROMIS Health 
Organization, 2019).  
 
Cortisol reactivity: Saliva samples will be collected via passive drool before and after a 
modified script driven imagery task. Saliva All saliva will be assayed in duplicate using 
standard manufacturers protocol (Salimetrics). The concentration of CRP in saliva will be 
determined using a Salivary C-Reactive Protein ELISA kit, an enzyme-linked immunoassay. 
The standard curve is run on every assay plate and must have an R2 value of > 0.99. The 

 
36 
replicates must have a %CV < 15 or an absolute difference <0.030 between the replicates. 
The mean values across saliva duplicates will be computed for each sample and used in the 
statistical analyses. 
 
C-reactive protein (CRP) All saliva will be assayed in duplicate using standard 
manufacturers protocol (Salimetrics). The concentration of CRP in saliva will be determined 
using a Salivary C-Reactive Protein ELISA kit, an enzyme-linked immunoassay. The standard 
curve is run on every assay plate and must have an R2 value of > 0.99. The replicates must 
have a %CV < 15 or an absolute difference <0.030 between the replicates. The mean values 
across saliva duplicates will be computed for each sample and used in the statistical 
analyses. 
 
Perceived stress scale: 10-item Perceived Stress Scale (PSS) will be used to measure 
participant's perception of stress (Cohen, 1993). 
 
Quality of life: will be measured using the 10-item short form of the Quality of Life Enjoyment 
and Satisfaction Questionnaire. Participants indicate their satisfaction with health, finances, 
and other life domains during the past week on a scale of 0 (very unsatisfied) to 3 (very 
satisfied) (Endicottt, Nee, Harrison, & Blumenthal, 1993).  
 
Satisfaction with life scale: A 5-item scale designed to measure global cognitive judgments 
of one’s life satisfaction (not a measure of either positive or negative affect) (Diener, Emmons, 
Larsen, & Griffin, 1985).  
 
Mindful awareness attention scale (MAAS): is a 15-item scale designed to assess a core 
characteristic of mindfulness, namely, a receptive state of mind in which attention, informed 
by a sensitive awareness of what is occurring in the present, simply observes what is taking 
place (Brown & Ryan, 2003; Carlson & Brown, 2005).  
 
Five facet Mindfulness Questionnaire (FFMQ) is a 39 item questionnaire that assesses five 
independent sub-scales: observing, describing, acting with awareness, non-judging of inner 
experience, and non-reactivity to inner experience (Baer et al., 2008).  
 
Life event history: Life events history will be assessed by asking respondents whether they 
ever experienced each of 40 specific negative life events (NLEs; will include both trauma and 
stressors), and, if so, at what age(s) this occurred. This will also be updated with respect to 
recent events upon immediate completion of the 9 week courses as well as at the 6-month 
follow up. The measure was modified from the Diagnostic Interview Schedule trauma section 
(Robins, Helzer, 
Croughan, & Ratcliff, 1981) by including several stressful or traumatic events reported by 
primary care patients (Holman, Silver, & Waitzkin, 2000) and has provided rates of events 
comparable to other community-based studies (e.g., Seery et al., 2010). 
 

 
37 
Emotion regulation: will be assessed with the Difficulties in Emotion-Regulation Scale 
(DERS; Gratz & Roemer, 2004; Kaufman et al., 2016), short form.  DERS is a 18- item 
questionnaire that aims to measure how much one is able to regulate/deregulate their 
emotions. The 41 questions are based off of six factors including acceptance of emotions, 
impulsiveness, ability to work towards goals, awareness of own emotions, clarity of emotions, 
and accessibility to emotion-regulation strategies 
 
Social support will be assessed using the MOS Social Support scale (Sherbourne & 
Stewart, 1993) This 19 item measure assesses social support.  
 
Anxiety: will be assessed using the PROMIS measure for anxiety (Emotional Distress). The 
8-tem form will be used. It assesses symptoms of Generalized Anxiety Disorder. it is desirable 
to use the 8-item short form, which has reliability and validity comparable to the 28-item 
computer adaptive form (PROMIS Health Organization, 2019).  
 
General Self-efficacy scale: This 10-item scale was created to assess a general sense of 
perceived self-efficacy (Schwarzer & Jerusalem, 1995). 
 
Demographics: Age, ethnicity, sexual orientation, incarceration history, religion, income, 
education, number of children, pregnancy status, mental health history (previous diagnosis) 
employment history. 
 
Prior Doctor-diagnosed Health Conditions. This survey, modified from the CDC’s National 
Center for Health Statistics Annual National Health Interview Survey, asks respondents to 
report doctor diagnosed health ailments. This will be assessed at baseline, immediately 
following 9th/final intervention session, and 6-month follow-up. 
 
Adherence. Measured by class attendance and self-reported time in mindfulness meditation 
and doing at-home assignment. 
 
Short self-compassion scale. This 12-item scale assesses self-compassion (Raes, 
Pommier, Neff, & Van Gucht, 2011).  
 
Free Response: Participants will be given the opportunity to provide written feedback 
regarding their experiences that may not have been captured with these quantitative 
measures. Prompt will include: We will ask: “Do you have any other thoughts and/or feelings 
about your participation in this program? Is there anything that you wish to share with us 
regarding your experience?” 
 
 
 
 
 
 

 
38 
APPENDIX V: Salivary Data Collection During COVID-19 
 
 
Collection Procedure* 
*Please keep a roster of all samples collected from October 2019 onwards. Samples may 
contain SARS- CoV-2, and this will ensure safe handling in the future as labs may take extra 
precautions when handling samples collected during this time. 
 
1. Participants wash hands for 20 seconds prior to collecting the saliva sample(s). 
2. Collect saliva sample as normal (follow typical passive drool or swab collection 
protocols). Tubes should be labeled prior to providing them to participants. 
3. Sample tubes should be immediately capped and sealed. Outsides of tubes should be 
disinfected following collection. Disinfectants are listed on the CDC website 
(https://www.epa.gov/pesticide- 
registration/list-n-disinfectants-use-against-sars-cov-
2). Ensure no disinfectants leak into the tube via an unsealed or partially sealed tube. 
4. Samples should be placed in a secondary container (sealed plastic bag with absorbent 
material, freezer box, etc.) that is labeled, then placed in a freezer (-20°C) as soon as 
possible. See below for more guidelines. 
5. Participants should wash hands for at least 20 seconds after collecting the saliva 
sample(s). 
 
Sample Storage and Shipping 
 
Always check with your EHS and IRB groups at your institution before collecting and/or shipping 
saliva samples to ensure you have received proper training and are following appropriate 
rules/regulations. Additionally, please refer to the following link for CDC guidelines prior to 
shipping samples: https://www.cdc.gov/coronavirus/2019-ncov/lab/biosafety-faqs.html 
 
Sample storage: 
 
1. Once collected, samples should be stored in a freezer between -20°C (home freezer) 
or -80°C (ultra-cold lab grade freezer) when possible 
2. Samples should be placed inside sample storage boxes (or biohazard Ziploc bags + 
absorbent material for home collections) 
3. The sample storage box should be placed inside a large biohazard Ziploc bag (or 
Ziploc bag with a biohazard sticker on it) 
4. A piece of absorbent material (paper towel, etc.) should be placed inside the Ziploc bag to 
absorb any potential spillageSample Pickup/Shipping: 
 

 
39 
1. Samples in bags or boxes should be placed inside cooler or in a bioshipper on dry ice. 
2. Bioshipper should be labeled with the following: 
a. Hazard labeled with UN Identification Number already on label – UN 3373 
b. Biological Substance, Category B 
c. Hazard Labeled with UN Identification Number- UN 1845 
d. Dry Ice along with the net weight (kg) of the dry ice 
e. Shipper’s name and address 
f. 
Receiver’s name and address 
g. Name and phone number of a responsible person. 
 
Receiving samples: 
 
1. Lab personnel receiving samples should wear appropriate PPE before handling 
samples. 
2. Ensure samples are labelled, are frozen, and tubes are in good condition (no cracks or 
leaks). 
3. Sample collection tubes should be disinfected once received by the lab. Disinfectants 
are listed on the CDC website (https://www.epa.gov/pesticide-registration/list-n-
disinfectants-use-against- sars-cov-2). 
4. Boxes with samples can be marked with date received, and a label noting if the samples 
were collected during the COVID-19 pandemic. This can act as an indicator to use extra 
safety precautions while handling those samples in the future. Samples should be stored 
in -80°C as soon as possible. 
5. Sample processing should be performed in a biological safety cabinet. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
40 
APPENDIX VII: RECap for Screener (Section 1) and Baseline, 
Immediate-follow-up, and 6-months (Section 2) 

 
1 
MINDFULNESS-BASED INTERVENTION FOR 
TRAUMA-EXPOSED, HOMELESS WOMEN 
 
STUDY PROTOCOL 
 
K01 MD013910-01 
National Institute of Health (Institute of Minority Health and Health Disparities) 
 
 
Principal Investigator: Dana Rose Garfin, PhD 
Updated: July 2022 
 
 

 
2 
Table of Contents 
SECTION 1A. RESEARCH STUDY OVERVIEW 
4 
Subsection 1A.1 - Overview & Introduction 
4 
Subsection 1A.2 - Overall Structure of Study Team 
5 
Subsection 1A.3 - Research Team and Responsibilities 
6 
Subsection 1A.4 - Research Study Contact List (2/21) 
6 
Subsection 1A.5 - Phase II Timeline 
1 
6 - Basic Definitions 
1 
SECTION 1B. INTRODUCTION TO PTSD AND MBSR 
2 
Subsection 1B.1 - PTSD Basics 
2 
Subsection 1B.2 - MBSR Basics 
4 
SECTION 2. INTERVENTION DELIVERY 
6 
Subsection 2.1 - Phase II Overview 
6 
Subsection 2.2 - Phase II Scope of Work & Participant Flow Diagram 
7 
Subsection 2.3 - Phase II Recruitment & Treatment Overview 
9 
Subsection 2.4 - Phase II Recruitment & Screening 
9 
Subsection 2.5 - Phase II Eligibility Criteria 
10 
Subsection 2.6 - Phase II Laboratory Tests/Sample Collection 
11 
Subsection 2.7 - Phase II Intervention Program Description 
11 
Subsection 2.8 - Phase II Pre-intervention Assessments 
12 
Subsection 2.9 - Phase II Brief Stress Task (Trauma Imagery Task) 
12 
Subsection 2.10 - Phase II Biospecimen Collection 
13 
Subsection 2.11 - Phase II Biospecimen Analysis 
14 
Subsection 2.12 - Phase II MBSR-based Intervention 
14 
Subsection 2.13 - Phase II Health Promotion Intervention 
16 
Subsection 2.14 - Phase II Post-Assessment 
17 
Subsection 2.15 - Phase II Team Management of Biospecimen Collection Refusal 
17 
Subsection 2.16 - Phase II Dealing with Intervention Program Attrition 
17 
Subsection 2.17 - Phase II Follow-Up Focus Groups 
18 
Subsection 2.18 - Phase II Compensation 
18 
Subsection 2.19 - Program Fidelity 
18 
Subsection 2.20 - Research Staff Competencies and Mock Sessions 
18 
Subsection 2.21 - Data Entry, Management & Confidentiality 
19 

 
3 
Subsection 2.22 – Using REDCap 
20 
Subsection 2.23 - Data Security 
20 
Subsection 2.24 - Post Data Collection 
21 
Subsection 2.25 - End of Study 
21 
SECTION 4. RECRUITMENT 
22 
Subsection 4.1 - Phase II Flyer 
22 
Subsection 4.2 - Phase II MBSR – Script for Introduction at Recruitment Site: For Non-
Research Staff Member 
23 
SECTION 5. SCREENING, INFORMED CONSENT, AND ENROLLMENT 
24 
Subsection 5.1 Screening Protocol 
24 
Instructions: 
24 
Subsection 5.2 Informed Consent 
24 
Subsection 5.3 Baseline Protocol 
24 
APPENDIX I: What to bring to site 
25 
APPENDIX II: Trauma Imagery Script (Brief Stress Task) 
26 
APPENDIX III: Data Safety and Monitoring Plan 
28 
Possible Serious Adverse Events or Adverse Events 
30 
Serious adverse events 
30 
Other adverse events 
30 
Risk Management Protocols in Place to Deal with Adverse Events 
30 
Data and Safety Monitoring Procedures 
31 
Data Safety and Monitoring Board (DSMB) 
31 
Training in Red Flag Procedures 
31 
RED FLAG – SUICIDE 
31 
Harm to others 
33 
APPENDIX IV: Citations for Study Measures 
35 
APPENDIX VII: RECap for Screener (Section 1) and Baseline, Immediate-follow-up, and 6-
months (Section 2) 
40 
 

 
4 
SECTION 1A. RESEARCH STUDY OVERVIEW 
Subsection 1A.1 - Overview & Introduction 
This study aims to determine the effectiveness of a mindfulness-based intervention (MBI) on the 
reduction of posttraumatic stress disorder (PTSD) symptoms (primary outcome) and depression 
substance use disorder (SUD), inflammation, and cortisol reactivity (secondary outcomes) in 
homeless women with PTSD. Biological markers (i.e., cortisol reactivity, C-reactive protein [CRP]) 
of the stress response will be evaluated as correlates of MBI treatment-response will help clarify 
mixed findings regarding dysregulation of the HPA-axis as a function of amount, type, and timing 
of trauma exposure. It will advance theory regarding the use of MBIs for PTSD while exploring 
biological markers that might maintain PTSD symptoms over time. The project has the potential 
to bolster the capacity of service providers to offer feasible and acceptable MBI interventions to 
homeless women and other vulnerable populations. If the proposed aims are achieved, they may 
provide several valuable insights. They will examine the efficacy of MBI to address PTSD in 
homeless women (inform & improve services, interventions, treatments); improve on 
methodological limitations of prior research on MBIs for PTSD (including small sample sizes, lack 
of attention control group, incomplete trauma history); and explore biological markers that 
correlate with PTSD-symptom maintenance or reduction post-MBI (expand concepts). 
Importantly, the MBI that will be used in the intervention was the product of a rigorous preliminary 
mixed-methods inquiry that including a Community Advisory Board (consisting of site staff, 
clinicians, and homeless women) and focus groups with women from the community (i.e., 
homeless women currently residing at a residential drug treatment facility). The results of these 
formative activities resulted in the modification of an evidenced-based MBI – Mindfulness-based 
Stress Reduction (MBSR) for cultural sensitive and appropriateness, increasing acceptability and 
feasibility. Importantly, findings from this proposal may provide a low-cost method to improve 
services for homeless women as they begin to answer key theoretical questions regarding the 
relationship between biological markers of stress regulation and reactivity, the inflammatory 
response, PTSD and related comorbidities (SUD, depression), and MBIs.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
5 
Subsection 1A.2 - Overall Structure of Study Team  
 
 
 

 
6 
Subsection 1A.3 - Research Team and Responsibilities 
Principal Investigator (PI): Dana Rose Garfin, PhD.  
Makes executive decisions regarding the implementation of the study, data entry and data 
analysis approaches, and interpretation of study findings. She will train the research staff and 
assistants to perform content. Dr. Garfin will develop all questionnaires and oversee the design 
and implementation of the MBI and the health promotion attention control.  
 
K01 Mentor: Adeline M. Nyamathi, ANP, PhD, FAAN 
Dr. Nyamathi will advise Dr. Garfin on conducting mix-methods research including qualitative 
focus groups and clinical trials with vulnerable populations.  
 
K01 Mentor: Douglas Granger, PhD, Chancellors Professor of Psychology and Social Behavior 
and Director of the Institute for Interdisciplinary Salivary Bioscience Research (IISBR 
Dr. Granger will advise on all aspects of the project related to saliva collection and analysis and 
the theoretical and statistical integration of salivary measures into psychosocial research.  
 
Secondary K01 co-mentors: Drs. Cameron Neece, E. Alison Holman, & Sanghyuk Shin 
provide guidance on K01, but do not interact with any human subjects participants, will not 
engage with the data, and thus are not included on the IRB forms.  
 
Lab Manager and Lab Coordinator: First line contact for RAs, responsible for RA scheduling, 
delegates lab responsibilities to other RAs, drafts lab meeting agenda, keeps track of 
conference submission deadlines, ensures study supplies are available, oversees budget 
expense tracking and reimbursements.  
 
Biosalivary coordinator: Ensures that cortisol collection is done according to all protocols, 
ensures that collection tubes are labeled ISBBR.  
 
REDCap coordinator:  Ensures all updated to REDCap are entered accurately. Tracks 
participant payments for cash advances and payment reconciliation.  
Subsection 1A.4 - Research Study Contact List (2/21) 
Name 
Role 
Organization 
Phone Number  
Email 
Dana Rose 
Garfin, PhD 
PI 
UCLA 
(415)407-9498  dgarfin@ucla.edu 
 
Adey Nyamathi  
K01 Mentor  
UCI  
 
anyamath@uci.edu 
Doug Granger 
K01 Mentor 
UCI  
 
dagrange@uci.edu 
Michelle Zernick 
Lab Manager 
UCI 
 
zernickm@uci.edu 

 
1 
Subsection 1A.5 - Phase II Timeline 
YEAR 1 (2020) 
19-May 
19-Jun 
19-Jul 
19-Aug 
19-Sep 
19-Oct 
19-Nov 
19-Dec 
20-Jan 
20-Oct 
20-Nov 
21-Dec 
PRIMARY 
ACTIVITIES  
SITE START UP & VISIT 
  
Community Advisory 
Board 
  
Focus Groups 
Finalize Intervention & 
Qualitative Analysis  
Recruit 
Cohort1 
HP Cohort1 
Space/time 
needed 
 
 
 
1 meeting per week 
(1-2 hours) 
Four meetings total, 
each 2 hours 
1 weekly meeting (1-2 
hours) for 4 weeks 
Screening 
space 1-2 
days/week 
per site 
Room for intervention 
1 X per week at each 
site for 1-2 hours 
(same time each 
week) 
YEAR 2 (2021) 
21-Jan 
21-Feb 
21-Mar 
21-Apr 
21-May 
21-June 
21-July 
21-Aug 
21-Sept 
21-Oct 
21-Nov 
21-Ded 
PRIMARY 
ACTIVITIES  
Recruit 
Cohort 2 
MBI & HP C2 
Recruit 
Cohort 3 
MBI & HP Cohort 3 
Recruit 
Cohort 4 
MBI & BP Cohort 4 
Space/time 
needed 
Screening 
space 1-2 
days/week 
per site 
Room for intervention 1 
X per week at each site 
for 1-2 hours (same 
time each week) 
Screening 
space 1-2 
days/week 
per site 
Room for intervention 1 
X per week at each site 
for 1-2 hours (same time 
each week) 
Screening 
space 1-2 
days/week 
per site 
Room for intervention 1 
X per week at each site 
for 1-2 hours (same 
time each week) 
Follow-up 
 
 
 
Cohort 
1 follow-
up 
 
 
 
Cohort 2 
follow-up 
 
 
 
Cohort 3 
follow-up 
YEAR 3 (2022) 
22-Jan 
22-Feb 
22-Mar 
22-Apr 
22-May 
22-June 
22-July 
22-Aug 
22-Sept 
22-Oct 
22-Nov 
22-Dec 
23 Jan-
Feb 
PRIMARY 
ACTIVITIES 
Recruit 
Cohort 5 
MBI & HP Cohort 5 
 
 
Recruit 
Cohort 6-7 
MBI Cohorts 6-7 
 
 
 
 
Space/time 
needed 
Screening 
space 1-2 
days/week 
per site 
Room for intervention 1 
X per week at each site 
for 1-2 hours (same 
time each week) 
 
 
Screening 
space 1-2 
days/week 
per site 
Room for intervention 1 
X per week at each site 
for 1-2 hours (same 
time each week) 
 
 
 
 
Follow-up 
 
 
 
Cohort 
4 follow 
up 
 
 
Cohort 5 
follow up 
 
 
 
Cohorts 6-7 follow 
ups 

 
1 
6 - Basic Definitions 
Mindfulness: The process of focusing one’s attention on the present moment (including thoughts, 
feelings, and sensations) without judgement (Kabat-Zinn, 1990; Lang, 2017).  
 
Mindfulness-Based Stress Reduction (MBSR): MBSR is an 8-week, 9 session manualized 
mindfulness-based intervention that is appropriate for participants from different religious, 
spiritual, or ethnic background and is not grounded in religious ideology. During MBSR, 
participants will be trained in mindfulness meditation and the applicability of mindfulness to daily 
life.  
 
Post-traumatic Stress Disorder (PTSD): PTSD is a psychological pathology characterized by 
re-experiencing, avoidance, negative thoughts or cognitions, hyperarousal after experiencing a 
traumatic event. 
 
Trauma: According to the DSM-5, must involve actual or threatened death, serious injury, or 
sexual violence.   
 
Arm: The different groups of the intervention. In this study, Arm 1 is the health promotion 
attention control and Arm 2 is the MBSR. Participants at a given site are assigned to one Arm or 
the other, by cohort).  
 
Cohort: The group of people that are doing the interventions at the same time.  
 
Cortisol: The body’s main stress hormone, triggered by the adrenal glands. Cortisol is a 
glucocorticoid and is released in the body about 20 minutes after a stressor. The immediate 
stress response hormones (adrenaline and epinephrine) are released within seconds or 
minutes; if the brain continues to perceive something as stressful, then cortisol is released.  
 
C-Reactive Protein (CRP): This is a protein made in the liver. CRP tends to increase when 
there is inflammation occurring in the body, (Lindqvist et al., 2014, 2017) induced by proinflammatory 
cytokines in the liver (Eklund, 2009). These heightened inflammatory responses can lead to health 
impairments including atherosclerosis (Wong et al., 2012) and cardiovascular disease (Coughlin, 2011) 
compounding health disparities in disadvantaged populations; CRP, in particular, has been linked with 
obesity (Visser et al., 2011) metabolic syndrome (Ridker et al., 2003) and CVD.(Ridker et al., 1998)  
Thus CRP can be used as marker for general inflammation and risk for inflammatory-related 
problems.  
 
Other acronyms used in this protocol:  
 
IISBR – Institute for Interdisciplinary Salivary Bioscience Research - https://iisbr.uci.edu/ 
- 
IISBR is a shared resource and scientific hub; researchers can gain practical 
experience/knowledge in salivary bioscience through the training programs (e.g., Spit 

 
2 
Camp). IISBR also provides the storage and analyses of the salivary samples collected in 
this study.  
SECTION 1B. INTRODUCTION TO PTSD AND MBSR 
Subsection 1B.1 - PTSD Basics 
PTSD Diagnosis  
PTSD occurs as the result of direct exposure to experiencing, witnessing, or learning of an 
event that involves actual or threatened death or serious injury or harm to self of others 
(American Psychiatric Association, 2013). For a diagnosis of PTSD, symptoms must be present 
for at least one month prior to diagnosis and must include at least one re-experiencing 
symptom, one avoidance symptom, two arousal and reactivity symptoms and two cognition and 
mood symptoms. Re-experiencing symptoms can include flashbacks, nightmares, and invasive 
thoughts. Avoidance symptoms are related to an individual actively avoiding locations, thoughts, 
events, or objects that are reminiscent of the trauma. Arousal and reactivity symptoms include 
feeling easily frightened, tense, increased anger, and having issues sleeping. Cognitive and 
mood symptoms include but are not limited to having trouble remembering key features of the 
trauma, distorted feelings, and loss of interest in previously enjoyable activities. PTSD must be 
diagnosed by a mental health professional, but a variety of measures have been validated for 
use as screens or by non-clinical for research purposes. In our study, we use the Posttraumatic 
Stress Disorder Checklist, Civilian (PCL- C) (Bovin et al., 2016; Wortmann et al., 2016).   
 
DSM-5 Criteria for PTSD 
The following text summarizes the diagnostic criteria for PTSD and was obtained from the 
ptsd.va.gov website.  
 
Criterion A (one required): The person was exposed to: death, threatened death, actual or 
threatened serious injury, or actual or threatened sexual violence, in the following way(s): 
• 
Direct exposure 
• 
Witnessing the trauma 
• 
Learning that a relative or close friend was exposed to a trauma 
• 
Indirect exposure to aversive details of the trauma, usually in the course of professional 
duties (e.g., first responders, medics) 
 
Criterion B (one required): The traumatic event is persistently re-experienced, in the following 
way(s): 
• 
Unwanted upsetting memories 
• 
Nightmares 
• 
Flashbacks 
• 
Emotional distress after exposure to traumatic reminders 
• 
Physical reactivity after exposure to traumatic reminders 
 

 
3 
Criterion C (one required): Avoidance of trauma-related stimuli after the trauma, in the 
following way(s): 
• 
Trauma-related thoughts or feelings 
• 
Trauma-related reminders 
 
Criterion D (two required): Negative thoughts or feelings that began or worsened after the 
trauma, in the following way(s): 
• 
Inability to recall key features of the trauma 
• 
Overly negative thoughts and assumptions about oneself or the world 
• 
Exaggerated blame of self or others for causing the trauma 
• 
Negative affect 
• 
Decreased interest in activities 
• 
Feeling isolated 
• 
Difficulty experiencing positive affect 
 
Criterion E (two required): Trauma-related arousal and reactivity that began or worsened after 
the trauma, in the following way(s): 
• 
Irritability or aggression 
• 
Risky or destructive behavior 
• 
Hypervigilance 
• 
Heightened startle reaction 
• 
Difficulty concentrating 
• 
Difficulty sleeping 
 
Criterion F (required): Symptoms last for more than 1 month. 
 
Criterion G (required): Symptoms create distress or functional impairment (e.g., social, 
occupational). 
 
Criterion H (required): Symptoms are not due to medication, substance use, or other illness. 
 
Two specifications: 
1. Dissociative Specification. In addition to meeting criteria for diagnosis, an individual 
experiences high levels of either of the following in reaction to trauma-related stimuli: 
• 
Depersonalization. Experience of being an outside observer of or detached from 
oneself (e.g., feeling as if "this is not happening to me" or one were in a dream). 
• 
Derealization. Experience of unreality, distance, or distortion (e.g., "things are not 
real"). 
2. Delayed Specification. Full diagnostic criteria are not met until at least six months after 
the trauma(s), although onset of symptoms may occur immediately. 
 
 
 
 

 
4 
How is PTSD Typically Treated?  
CBT, cognitive processing therapy, prolonged exposure therapy (PE), eye movement 
desensitization and reprocessing (EMDR), stress inoculation training, psychopharmalogical 
treatments are all common treatments for PTSD. Cognitive behavioral therapy (CBT) often 
occurs once a week and works with the client to reframe thoughts surrounding the event (i.e. 
feelings of guilt). Similarly, in cognitive processing therapy the client recounts the event and 
related thoughts to a therapist and subsequently processes and learns new ways to live with the 
thoughts and trauma. PE takes place in eight to fifteen ninety minute sessions in which the 
client is taught breathing techniques to combat anxiety before making a list of avoidances and 
learning to face them. EMDR asks the client to watch or listen to something, such as a light 
flashing or sound, while concentrating on the traumatic event so that over time, the client can 
think about something positive while remember the trauma. Stress inoculation training focuses 
on how the client responds to the stress of the trauma and works to teach them methods to 
cope such as breathing techniques and thought stopping. Medications frequently prescribed to 
individuals with PTSD are SSRIs and SNRIs such as Prozac and Zoloft. We are testing whether 
MBSR is an effective complementary treatment for PTSD. Complementary means that it will be 
used in addition to any other interventions used in standard treatment of PTSD.  
 
Subsection 1B.2 - MBSR Basics 
MBSR is a way to teach mindfulness, or the process of focusing one’s attention on the present 
moment without judgement (Kabat-Zinn, 1990). It has have shown promise for reducing 
symptoms of PTSD (Khusid & Vythilingam, 2016; Polusny et al., 2015) and associated 
biological markers of the stress response (Black & Slavich, 2017; Bower et al., 2017) by 
lowering physiological arousal and improving attention and acceptance of the past and present 
(Lang et al., 2012). MBSR is relatively low cost and has demonstrated acceptability and 
feasibility in trauma-exposed, low-SES, high-minority samples (Dutton et al., 2014). An RCT of 
MBSR for PTSD in a sample of veterans demonstrated improved PTSD symptoms at immediate 
follow-up with clinically significant improvement sustained 2-months later (Polusny et al., 2015). 
Congruent findings were indicated in veterans using a one-armed-repeated-measures design 
(Kearney et al., 2012). MBIs have also been linked with statistically significant reductions in 
markers of inflammation (Bower et al., 2017; Rosenkranz et al., 2013). that are associated with 
PTSD, including CRP (Creswell & Irwin, 2012; Malarkey et al., 2013). In relation to stress 
reactivity, in repeated measures analyses, an MBI significantly reduced cortisol reactivity to a 
stress task (Rosenkranz et al., 2013). Participation in an MBI compared to a treatment-as-usual 
condition in veterans with PTSD was associated with reduced cortisol, suggesting a brief MBI 
might have beneficial responses on stress physiology (Bergen-Cico et al., 2014). Data suggests 
that biological dysregulation may precede the development of – and at a minimum mutually 
maintain – PTSD symptoms (van Zuiden et al., 2013). This means that the physiological 
response may actually occur prior to the psychological symptoms, but more research is needed. 
Moreover, participation in MBIs have been associated with effective relapse prevention in those 
with SUD (Bowen et al., 2006) and lower depression in a sample of economically disadvantaged 
women (Burnett-Zeigler et al., 2016). As such, MBIs, which concurrently target regulation of the 
physiological stress responses, emotional cognitive symptoms of PTSD, and related 

 
5 
psychological comorbidities may provide a low-cost, feasible method to address the complexity 
of PTSD symptom maintenance over time. 
 
MBSR was first developed in the 1970s by Dr. Jon Kabat-Zinn at the University of 
Massachusetts Medical Center (Kabat-Zinn, 1990). MBSR uses many practices that have been 
around for thousands of years, but manualized these practices into an 8 week, 9 session 
program.  MBSR has been used in hospital, school, work, athletic, and prison settings with 
beneficial results. MBSR is a group-based class and is not therapy. It generally should be used 
as an adjunct to other psychiatric and physical healthcare, not as a supplement.  
 
The general flow of the eight-week program is as follows:  
 
Week 1: Introductory Material. This includes an overview of the course, building trust within the 
group, introduction to mindful eating, some standing yoga stretches, mindful breathing and body 
scan meditation (Homework: Body Scan recording using MP3 player; eating one meal mindfully; 
optional informal meditation practice.)  
 
Week 2: Understanding Perceptions. This session focuses on self-responsibility and short and 
long-term changes for health enhancing behaviors; how you see things determines how you 
react or respond. (Homework: Body Scan recording using MP3; fill out Pleasant Events 
Calendar; select one activity to bring full awareness to).  
 
Week 3: Hatha Yoga, Sitting Meditation, Walking Meditation. The theme is the pleasure and 
power of being present; this week teaches how to investigate the mind and body through yoga 
and meditation. (Homework: Alternate Body Scan recording with Lying-down Yoga using MP3 
player; fill out Unpleasant Events Calendar; sitting meditation). 
 
Week 4: Concentration and Awareness. This theme relates to how conditioning and perception 
influence one’s experience and new ways to relate to stress. (Homework: Alternate Body Scan 
recording with Lying-down Yoga using MP3 player; be aware of being stuck, sitting meditation). 
 
Week 5: Unhealthy Patterns and Getting Unstuck. This week examines conditioned patterns 
and the passive ways that people cope (e.g., numbing, denial, passive-aggressiveness, 
suppression of feelings, substance dependency). (Homework: Fill out Difficult Communications 
Calendar; Sitting Meditation and Standing Yoga Sequence).  
 
Week 6: Transformational Coping Strategies. This for this week include how to deal with 
stressful communication and knowing and expressing your feelings. (Homework: Alternate 
Sitting Meditation recording with Body Scan and/or Standing or Lying down Yoga recording).  
 
Week 7: Retreat. This will be a silent class, with sitting and walking practice. Guided meditations 
will include loving-kindness meditation. 
 

 
6 
Week 8: Maintaining Discipline and Flexibility. This class focus on how to more fully integrate 
mindfulness into daily life. Instructors and participants discuss lifestyle choices and limiting 
patterns. (Homework: no recordings; try to practice formal sitting meditation; recordings can be 
used if necessary.) 
 
Week 9: Course Review. In this session, students will reflect on the course, the instructor 
provides additional resources, participants discuss their experiences with the group.  
    
Common Uses:  
MBSR is used as a complementary treatment for anxiety, panic, depression, eating disorders, 
pain, sleep issues, and a growing number of additional maladies. MBSR is also used increase 
productivity, performance, emotion regulation, and general wellbeing.  
 
 
 
SECTION 2. INTERVENTION DELIVERY 
Subsection 2.1 - Phase II Overview 
In Phase II, we will assess the potential benefit of MBSR to reduce PTSD (primary outcomes) 
and secondary outcomes (e.g., depression, SUD, CRP, cortisol reactivity), among 130 eligible 
homeless women who exhibit likely subthreshold or threshold PTSD living at one of two 
residential drug treatment facilities. MBSR will be compared to an attention-control group 
(Health Promotion Wellness Classes; HP). There originally intended to be five cohorts of 
women, each with 12-15 women (total of 24-30 women per cohort). However, due to COVID-19 
adjustments have been made in terms of the class size and randomization procedure. At each 
cohort, sites will be randomized to receive either the MBSR or the HP. Although sites will 
alternate between MBSR and HP by cohort, each participant will receive either the MBSR or the 
HP. Randomization will occur using RedCAP. The women participate in either MBSR or HP for 
9 weeks. Psychosocial data will be collected at baseline, immediately following final intervention 
session, and at 6-month follow-up via tablet questionnaires. After psychosocial data collection, a 
stress task (Trauma Imagery Task) will be conducted at each time point, with saliva collected 
both before and after the task to assay cortisol and CRP. This proposal will improve on the 
methodological rigor of prior research on MBIs for PTSD in disadvantaged populations by using: 
randomization procedures that account for cross-contamination; blind evaluators; longitudinal 
follow-up; an attention control group equal to the MBI intervention in both contact visits and 
hours; increased demographic diversity; comprehensive lifetime trauma assessment; and 
inclusion of objective indices of stress responses to accurately evaluate the effectiveness of 
MBIs in treating trauma-related symptoms. 
 
 
Confidentiality and Ethical Issues  
 
All program staff must follow confidentiality and ethical procedures throughout this program to 
ensure that everybody is treated with respect and dignity.  
 
1. Communication with study participants must remain confidential. To maintain confidentiality 
for participants, any personal information provided, such as participants' name, age, etc., will 

 
7 
be protected by use of subject code on all data and questionnaires. Data including subject 
identifiable information will be linked to a code on RedCap for this study for access and only 
research staff will have access. An exception to this rule is the clinic provider and site staff 
who work directly with the women onsite.  
 
Program Team 
 
The Lab Manager and Lab Coordinator will help the PI (Dr. Garfin) in organizing all aspects of 
the study. These individuals will be current or former students from the Department of 
Psychological Science’s Postbaccalaureate Program. They will be responsible for tracking 
recruitment, scheduling research assistants, and ensuring that the site is well-stocked with 
necessary supplies. Weekly, the Lab Manager and Lab Coordinator will meet with Dr. Garfin to 
review all aspects of the study, troubleshoot any problems, and create schedule for the other 
Research Assistants (RAs). The RAs will be highly trained Postbaccalaureate, graduate, or 
undergraduate students from the University of California, Irvine.  
 
 
Safety of Program Staff 
 
While we believe that conducting this study is highly important for public health, it is critical that 
the program staff prioritize their own safety first.  If you feel that you are in danger (physically, 
emotionally, psychologically) in any way, end the study activities and inform the research 
coordinator or the PI as soon as you can safely do so. This is particularly important during 
COVID-19. Please report any lapses in COVID-19 protocol to Dr. Garfin and the Leadership 
team immediately. If there is any chance you have been exposed, it is imperative that you do 
not come to site. The study leadership (Dr. Garfin and the Lab Manager / Lab Coordinator)  
 
Subsection 2.2 - Phase II Scope of Work & Participant Flow Diagram 
1. General Recruitment 
a. We will recruit 5 cohorts of women from the two sites by research staff via flyers and 
announcements during site programming. Due to COVID-19, this strategy may 
change as the situation evolves.  
b. Participants will then be given an eligibility screener via tablet with either Dr. Garfin or 
the Lab Manager/Lab Coordinator available to answer any questions. 
i. A key inclusion criteria is subthreshold current PTSD. Thus, the women will 
be given a PTSD screener for the trauma that is bothering them most right 
now. There may be multiple traumas the women have experienced – they 
should be prompted to pick the one that is most troubling to them at the time 
of screener completion.  
c. Tablets will be programmed by the Research Director from the School of Nursing and 
responses will be automatically, electronically scored. All participants who complete 
the screener will receive $3. 
i. Note: those who complete the screener must complete the consent to screen, 
but are not assigned a participant ID at this time as they have not completed 
the Informed Consent. As such it is imperative that accurate information be 
obtained with respect to the individual’s name as that will be used to link it to 
their subsequent data.  
 

 
8 
2. Group Assignment and Intervention Procedure (may chance due to evolving 
circumstances due to COVID-19) 
a. Prior to recruitment, the Residential Treatment Sites (RTS; Pomona and Escondido) 
will be randomized to receive the MBI or serve as the attention-control (HP); 
recruitment and research procedures (MBI or attention-control) will occur at both sites 
simultaneously. Women will live at sites prior to recruitment. 
b. Informed consent – there are TWO versions of the Informed Consent documents. 
One is for the MBSR course; the other is for the HP course. Women will complete 
ONE of the Informed Consent forms, depending on which group they are in. It is 
imperative that the correct form is filled out and uploaded onto REDCap.  
c. Baseline questionnaire administered:  
i. After informed consent, participants will complete a baseline questionnaire. In 
addition to the traumas indicated in the PCL-5, participants will report lifetime 
history of trauma (including whether events occurred in adulthood, childhood, 
or both). 
ii. Questionnaire data will be collected via tablet and transferred to RedCap. 
iii. Participants will provide a urine sample for a drug test to validate self-report. 
Then participants will complete the brief stress (Trauma task providing saliva 
samples both before and after the task. 
d. Locator guide: this is a critical part of maintaining contact with our participants. 
However, they may not be inclined to provide all the information on the first or second 
meeting. PLEASE TAKE THE PICTURE AT THE TIME OF ADMINISTERING 
INFORMED CONSENT. The rest of the locator guide can be filled out over the course 
of the study. Given issues with COVID-19, we will start completing the Locator Guide 
after session 2 or 3. Please see PI or Lab Management Team for further guidance.  
e. Intervention 
i. Participants will begin MBSR/HP activities within one month of baseline 
assessment, dependent on the time of their baseline assessment within 
recruitment schedule 
ii. Both groups (MBSR and HP) will consist of nine sessions, each 
approximately 2 hours in length. 
b. Immediate follow-up  
i. After the 9th session, participants will complete a questionnaire via tablet that 
will assess PTSD (primary outcome), secondary outcomes (e.g., depression, 
substance use), and traumatic events that occurred since first assessment, 
as well as key covariates (e.g., fidelity to intervention) and additional 
outcomes (e.g., mindfulness, emotion regulation).  
ii.  Women will provide urine for drug test and repeat the Trauma Imagery 
Stress Task, providing saliva samples before and after the task.  
c. 6-month follow-up 
i. Primary and secondary outcomes and covariates (e.g., fidelity to intervention) 
will be reassessed via tablet 
ii. Women will provide urine for a drug test and repeat the Trauma Imagery 
Stress Task, providing saliva samples before and after the stress task. 
 
3.  Phase II Reimbursement 
d. Women will receive $15 for the baseline assessment, $10 per MBSR/HP session, $15 
for completing the post-intervention assessment, and $30 for the 6-month follow-up 
assessment. 

 
9 
i. Women are paid in cash and must sign on the iPad (via REDCap) that they 
have received the payment. This must also be initialed, signed, and dated by 
the RA in charge of payment.  
 
 
Subsection 2.3 - Phase II Recruitment & Treatment Overview 
 
 
Subsection 2.4 - Phase II Recruitment & Screening 
The study was designed so that recruitment at Pomona would be paced to match that at the 
Escondido site so that all procedures across sites happen in tandem, thus avoiding history 
effects; recruitment data will be evaluated weekly to inform pacing. Site staff at Prototypes will 
assist with participant recruitment, informing Prototypes residents of the opportunity during 
formal announcements during programing. Recruitment flyers will also be posted around the 
RTS. RAs will help recruit women and conduct the initial screening in a private room after 
obtaining informed consent; progress will be monitored closely by Dr. Garfin the Lab 
Management team. Modifications will be made to allow for the study to continue during the 
COVID-19 pandemic to ensure safety of Ras, site staff, and participants.  
 
Ideally, recruitment will be staggered according to cohorts and paced equally across sites. In 
total, five cohorts of women will be recruited. Each will have approximately 26- 28 women in 
each group/site (n=13-14 MBSR; n=13-14 attention control); recruitment proceeds for one 
month, the intervention runs for approximately 2 months (9 weeks), then there is one month 
break. However, this schedule may vary due to COVID-19 restrictions, limitations, and 
other feasibility issues.  
 
Dr. Garfin will explain the study during an initial meeting with potential participants and answer 
any questions. Then women will be screened for eligibility. Prior to obtaining any data, the 
women will provide a “consent to screen”. This is because we need to obtain data from the 
women to determine if they are eligible, but they are not officially enrolled as human subjects. 
By providing their “consent to screen”, we are obtaining verbal consent/permission to ask them 
questions. Their data will not be used by the research team if they are not eligible.  
 
The RA will read the consent to screen script on REDCap. Potential participants are free to stop 
at any time – remind them that all procedures are completely voluntary. Dr. Garfin and/or 
someone from the Lab Management team will always be onsite to help answer questions.  

 
10 
 
Participants will then be given an eligibility screener via tablet with either Dr. Garfin or a trained 
research assistant available to answer any questions. The screener will first assess for age, 
prior homelessness, and cognitive competence. The screener then screens for PTSD using the 
PTSD Checklist for DSM-5 (PCL-5) for the worst event in their life. We will assess PTSD to 
their most recent event (in the past year) during the baseline and follow-up assessments. The 
standard PCL-5 initially starts with the identification of the presence of exposure to a DSM-5 
traumatic event and then assesses whether it involved actual or threatened death, serious injury 
or sexual violence. The RA may need to prompt the potential participant with examples to keep 
them on track and to ensure that the participant is responding to an actual DSM-5 traumatic 
event. The next 20 items on the PCL-5 assess all four B-E PTSD criterion (re-experiencing, 
avoidance, negative thoughts or cognitions, hyperarousal), assessed on a Likert-type scale 0 
“not at all”, 1 “a little bit”, 2 “moderately”, 3 “quite a bit”, 4 “extremely”. Subthreshold PTSD will 
be defined as endorsing “moderately” or more to at least 2 B-E criteria; probable-PTSD will be 
measured by meeting criteria A-G for PTSD.  
 
 
Data collection method: All data will be collected via encrypted tablets will be programmed by 
the Research Director from the School of Nursing and responses will be automatically, 
electronically scored. Data is not stored on the tablets. It is automatically transferred to the All 
participants who complete the screener will receive $3. 
 
Subsection 2.5 - Phase II Eligibility Criteria 
 
Inclusion Criteria: 
1) Homeless women (N=134; 67 in each group) 
a. Women over 18 years of age 
b. Able to speak English  
c. Homeless in the last 6 months: a homeless person is defined as anyone who 
spent the previous night in a public or private shelter, or on the street.  
d. Lifetime exposure to trauma as defined by the Diagnostic and Statistical 
Manual for Mental Disorders, 5th Edition (DSM-5). 
e. Likely subthreshold or threshold PTSD, as measured by the PCL-5. 
 
Exclusion Criteria: 
 
The following will not be eligible for participating:  
1) Persons who are: 
a. Not able to speak English 
b. Judged to be cognitively impaired, as indicated by score > 10 on the Short-
Blessed Screener 
 

 
11 
Subsection 2.6 - Phase II Laboratory Tests/Sample Collection 
Saliva Sampling and Results 
 
Saliva Collection 
- 
Pre-task, saliva will be collected. All saliva collection will occur between 10am-2pm to 
minimize diurnal fluctuation effects. (Study procedures may start before 10, but first 
saliva sample must be collected after 10:00am; the second sample must be collected 
before 2pm – participants must be scheduled according to these specifications).  
- 
Two whole saliva samples will be collected using an unstimulated passive drool 
technique.  
- 
Women will be instructed to avoid eating, brushing teeth, or smoking for one hour prior 
to the assessment and will be asked to wait to begin the task if they have. 
- 
Participants will rinse their mouths thoroughly with water for 10 minutes before samples 
are collected. Participants will then passively drool into a collection vial for three minutes 
or until 0.80 milliliters of fluid is collected.  
- 
Saliva samples will be immediately placed in the on-site freezer (or ice cooler) and be 
taken to IISBR within 36 hours to be frozen at -80°C until assayed.  
- 
All samples will be assayed for salivary cortisol and CRP using a highly sensitive 
enzyme immunoassay (Salimetrics, IISBR). 
- 
Twenty minutes after task completion, saliva samples will be collected again in an 
identical manner to that described above.  
- 
Participants will then be offered snacks and a drink and be debriefed to ensure they are 
not experiencing severe task-related psychological distress. In the unlikely event of 
participant distress, an immediate referral will be made to on-site professional staff. 
 
Subsection 2.7 - Phase II Intervention Program Description 
General Description: Among 134 eligible trauma-exposed homeless women, assess the 
impact of the MBSR intervention program PTSD symptoms (primary outcomes), and substance 
abuse, depression, cortisol reactivity, and inflammation (secondary outcomes). 
Data Collection Time points: Baseline, 2 months, and 6 months 
Total Duration: 6 months 
The following sections will outline the intervention process: 
● Pre-intervention Assessments 
● Brief Stress Task (Trauma Imagery Stress Task) 
● Biospecimen Collection 
● Biospecimen Analysis 
● MBSR Intervention 
● Health Promotion Intervention 
● Post-Assessment 
● Team Management of Biospecimen Collection Refusal 
● Dealing with Program Attrition 

 
12 
Subsection 2.8 - Phase II Pre-intervention Assessments 
After Informed Consent, participants will complete a series of self-report measures. These 
measures will be administered by Research Staff at a private location at the site. Responses 
options to each question will be provided to the participant, organized in a clearly labeled binder. 
The Research Staff will display the response options for each measure, read the options out 
loud, and then record the response on the tablet. At the end of each measure, the RA will “lock” 
the measure. There will be a prompt if any items have been missed. Please check that there is 
no missing data. The participant may take a break at any time. However, the participant should 
refrain from eating, drinking (except for water ~ 10 minutes prior to stress task), or smoking until 
after the second saliva collection to ensure the accuracy of the saliva sample.  
Order of assessments  
1. Drug test (urine) 
2. TCU Drug Screen (self-report) 
3. Self-compassion scale – short form  
4. General self-efficacy scale  
5. Mindful Attention Awareness Scale  
6. Difficulties I Emotion Regulation Scale  
7. Satisfaction with Life Scale  
8. Quality of Life Enjoyment and Satisfaction Questionnaire 
 9. MOS Social Support 
10. Perceived Stress Scale  
11. Dimensions of Anger Reactions  
12. PROMIS – Anxiety  
13. PROMIS – Depression  
 
*NOTE: For time constraints, the urine test can be administered during the waiting period prior 
to the second cortisol sample.  
 
AT THIS POINT, THE FIRST SALIVARY SAMPLE IS COLLECTED  
 
14. Negative Life Events Inventory  
15. PCL 5- Worst life event (this is the event that bothers them the most, from their entire life) 
16. PCL 5 – Recent (past year) this is a traumatic event that has happened to them recently (in 
the past year) – it may or may not be the same as #16 
17. Trauma Imagery Stress Task (the Negative Life Events Inventory and the PCL build up to 
this) 
Subsection 2.9 - Phase II Brief Stress Task (Trauma Imagery Task) 
After completing the PROMIS Depression, the participant will provide a saliva sample. They will 
then complete the negative life events inventory and the PCL 5 (for worst event in their life and 
a recent event). The reason that the saliva sample is taken before these measures and not 
directly before the Trauma Imagery Task is because in pilot studies the women began to 

 
13 
become distressed when recounting their traumas during the Negative Life Events Inventory 
and the PCL; thus, the “baseline” for cortisol is now taken PRIOR to these items.  
After completing the PCL for worst event and recent event, the participant will complete a a 
modified script-driven imagery task (Seo et al., 2013), derived from prior research with women 
with PTSD. Participants will be asked to recount a traumatic event via written response. The RA 
will provide a paper and pen and instruct the participant to recall the event exactly as it 
happened. The RA can offer prompts to recall sight, smell, and sound. The participant will then 
recount the event to the RA. Script driven imagery tasks have been effectively and safely used 
to assess traumatic-stress responses in individuals with PTSD. However, RAs will be highly 
trained to assess any severe distress that may arise and will immediately notify the PI and site 
clinical staff immediately. Responses will be subsequently destroyed.  AFTER THE 
COMPLETION OF THE TRAUMA IMAGERY TASK THE 20 MINUTE POST-SALIVA SAMPLE 
TIMER STARTS! When the timer starts, the RA will not interact with the participant. They 
should sit quietly or may read.  
Subsection 2.10 - Phase II Biospecimen Collection 
Urine Collection: Participants will provide a urine sample to validate self-report drug use. A 5-
panel FDA-approved urine test cup will be used in this study. The participant will be instructed to 
urinate in the cup, close the cup, and then bring it back to the RA to read. Gloves will be used at 
all times and the RA should read the cup without touching it if possible. The participant will then 
be instructed to dispose of their urine in the restroom.  
 
Saliva Collection: Before and twenty minutes after the brief stress task (Trauma Imagery 
Stress Task), women will be asked to provide a salivary sample. Women will be instructed to 
avoid eating, brushing teeth or smoking for one hour prior to the collection of saliva and will be 
asked to wait to begin the task if they have. Participants will passively drool into a collection vial 
for three minutes or until 0.80 milliliters of fluid is collected. 
 
Saliva samples will be immediately placed in the on-site freezer or cooler and be taken to IISBR 
or to Dr. Garfin’s research lab for storage. Saliva samples will be transferred to IISBR within 36 
hours to be frozen at -80°C until assayed. After the second and final collection, participants will 
be offered snacks and a drink and be debriefed using an IRB-approved script (see below).  
 
Debriefing script:  
Thanks so much for your participation. I know that might have been difficult for you to 
recall this event. I want to thank you and let you know that we think your participation in 
this task will help other women who have experienced adversity. While feeling a little 
distressed might be expected, we want to make sure you are not experiencing a lot of 
distress. Right now are you are experiencing a lot of distress? 
 

 
14 
If yes, ask if they want you to get a site staff from Prototypes/Serenity House AND 
contact the Principal Investigator, Dr. Dana Rose Garfin immediately AND provide Dr. 
Garfin's contact information to them). 
 
If no, thank them for their time and remind them if anything comes up they can call the 
Principal Investigator, Dr. Dana Rose Garfin and/or talk to any of the Prototypes/Serenity 
House site staff. (Provide Dr. Garfin's contact information to them).  
 
Provide water and snacks at this time and pay close attention to any noticeable changes 
in mood until they are released to the care of the Prototypes/Serenity House site staff. 
Immediately inform Dr. Garfin AND Prototypes/Serenity House site staff of any potential 
issues.  
 
Subsection 2.11 - Phase II Biospecimen Analysis 
 
Urine Sample: The 5-panel FDA-approved urine test cup screens for metabolites of the 
following drugs of abuse at the established cut-off levels and is used for qualitative purposes: 
Amphetamines (1000 ng/mL), Cocaine (300 ng/mL), Methamphetamines/ MDMA (500 
ng/mL), Opiates (2000 ng/mL), and THC (50 ng/mL). Urine sample validity checks will be 
provided by temperature and adulterant monitoring strips built into the test cup. Participants 
whose urine does not pass validity checks will be counted as positive for drugs.  Results will 
be coded qualitatively (above or below threshold). All positive results will be interpreted as 
positive, regardless of self-report. 
 
Saliva Sample: The saliva sample is collected to determine resting cortisol, cortisol reactivity, 
and C-RP (a marker of inflammation). All saliva will be assayed in duplicate using standard 
manufacturer's protocol (Salimetrics). The concentration of CRP in saliva will be determined 
using a Salivary C-Reactive Protein ELISA kit, an enzyme-linked immunoassay. The standard 
curve is run on every assay plate and must have an R2 value of > 0.99. The replicates must 
have a %CV < 15 or an absolute difference <0.030 between the replicates. The mean values 
across saliva duplicates will be computed for each sample and used in the statistical 
analyses. 
Subsection 2.12 - Phase II MBSR-based Intervention 
Standard MBSR is an eight-week long mindfulness-based intervention (MBI) with one 1.5-2.5 
hour session per week (the seventh week has two sessions as one is a mini-retreat). The 
intervention will be run by a highly experienced instructor with prior experience conducting 
MBSR with individuals exposed to trauma with PTSD. 
 

 
15 
During MBSR, participants are trained in mindfulness meditation and the applicability of 
mindfulness to daily life. During MBSR programing, teachers will lecture about key topics in 
mindfulness and lead class discussions. Participants are given opportunities to ask the 
instructor questions and to share their experiences with each other. Snacks and drinks will be 
provided. Important to note, the intervention in this study is not true MBSR. It has been 
modified to fit the specific needs of the target population. This includes shorter sessions and 
shorter meditations, and additional flexibility on the part of the trainer. Although many of the 
same tools and procedures in traditional MBSR will be utilized, given these critical differences 
the intervention administered in this study is not true MBSR.  
  
Each week in the MBSR program focuses on a different theme and has specific short 
homework assignments that students are asked to complete. The sessions are as follows: 
● Week 1: Introductory Material. This includes an overview of the course, building trust 
within the group, introduction to mindful eating, some standing yoga stretches, mindful 
breathing and body scan meditation 
○ Homework: Body Scan recording using MP3 player; eating one meal 
mindfully; optional informal meditation practice. Participants will also complete 
a trauma-informed safety plan to ensure that, although MBSR is given in a 
group format, the MBSR trainer is responsive to the unique needs of the 
individual.  
● Week 2: Understanding Perceptions. This session focuses on self-responsibility and 
short and long-term changes for health enhancing behaviors; how you see things 
determines how you react or respond. 
○ Homework: Body Scan recording using MP3; fill out Pleasant Events 
Calendar; select one activity to bring full awareness to.  
● Week 3: Hatha Yoga, Sitting Meditation, Walking Meditation. The theme is the 
pleasure and power of being present; this week teaches how to investigate the mind 
and body through yoga and meditation.  
○ Homework: Alternate Body Scan recording with Lying-down Yoga using MP3 
player; fill out Unpleasant Events Calendar; sitting meditation. 
● Week 4: Concentration and Awareness. This theme relates to how conditioning and 
perception influence one’s experience and new ways to relate to stress. 
○ Homework: Alternate Body Scan recording with Lying-down Yoga using MP3 
player; be aware of being stuck, sitting meditation. 
● Week 5: Unhealthy Patterns and Getting Unstuck. This week examines conditioned 
patterns and the passive ways that people cope (e.g., numbing, denial, passive-
aggressiveness, suppression of feelings, substance dependency). 
○ Homework: Fill out Difficult Communications Calendar; Sitting Meditation and 
Standing Yoga Sequence.  
● Week 6: Transformational Coping Strategies. This week includes how to deal with 
stressful communication and knowing and expressing your feelings. 

 
16 
○ Homework: Alternate Sitting Meditation recording with Body Scan and/or 
Standing or Lying down Yoga recording.  
● Week 7a: Retreat. This will be a silent class, with sitting and walking practice. Guided 
meditations will include loving-kindness meditation. 
● Week 7b: Maintaining Discipline and Flexibility. This class focuses on how to more 
fully integrate mindfulness into daily life. Instructors and participants discuss lifestyle 
choices and limiting patterns. 
○ Homework: no recordings; try to practice formal sitting meditation; recordings 
can be used if necessary. 
● Week 8: Course Review. In this session, students will reflect on the course, the 
instructor will provide additional resources, and participants will discuss their 
experiences with the group.  
Subsection 2.13 - Phase II Health Promotion Intervention 
The Health Promotion program is eight weeks long with one 1.5-2 hour session per week (the 
seventh week has two sessions to ensure the same number of contact hours as the “mini-
retreat” in the MBSR course). The Health Promotion Classes were designed to be analogous to 
the MBSR classes in terms of length and contact hours. This is because the effect of being in a 
group and participating in a study could help participants, without the benefit having much – if 
anything – to do with the actual intervention.  
 
The program will be run by a UCI graduate or postbac student with a BA or higher. The SMART 
(Specific Measurable Achievable Relevant Time-based) framework will be used for goal setting. 
In this framework, specific, achievable goals are outlined by the participant as relevant to each 
class. This helps with information retention and helps reinforce concepts and positive behaviors. 
Snacks and drinks will be provided. 
 
Each week in the Health Promotion program focuses on a different theme. The sessions are as 
follows: 
1. Introduction & overview  
2. Envisioning Health through Art 
3. Chronic Disease I – Heart Health  
4. Chronic Disease II – Diabetes 
5. Nutrition and Hydration  
6. Infectious Disease Prevention 
7. Skin Care 
8. Oral Health  
9. Promoting Social Integration & Course Graduation  
 

 
17 
Subsection 2.14 - Phase II Post-Assessment 
After the ninth session (of either MBSR or Health Promotion), a post-assessment will be 
administered via tablet. Urine will again be collected to validate self-report drug use. 
Participants will repeat the brief stress task (Trauma Imagery Task) using an identical strategy 
and provide saliva samples before and after. The Lead Researcher or a postbac student 
researcher will be on site to answer any questions or clarify any items. Urine and saliva 
samples will both be stored in a freezer on-site or at Dr. Garin’s research office and then 
transferred to UCI for analysis within 36 hours. Follow-ups will occur on site unless participant 
has moved to sober living or other location. Zoom or phone will be implemented for those who 
moved out of state 
 
Subsection 2.15 - Phase II Team Management of Biospecimen 
Collection Refusal 
Participants have the right to refuse the collection of urine or saliva and it is important to 
understand that an individual may want to refuse due to the following: 
 
Step 1: Assess reasons why participant does not want to have their sample collected. 
● May experience concern that their friends, acquaintances, or shelter staff will be 
informed of the results of their surveys or urine. 
● Other possible reasons? 
 
In the event a participant refuses the sample collection, inquire about the following: 
  
Step 2: Respond to their reasons why they do not want to give urine or saliva samples. 
 
We encourage our participants to complete as many of the procedures as they are comfortable 
with. Please offer to have Dr. Garfin or Lab Management answer any questions the participant 
may have regarding the measures. However, participation is completely voluntary, and the 
participant may skip any aspect of the procedure that they chose without penalty and still be in 
the study.   
Subsection 2.16 - Phase II Dealing with Intervention Program Attrition 
Attrition is conservatively estimated at 10% for first follow-up and 20% for 6 month follow-up. 
To account for an estimated 30% of women to be screened with subthreshold or threshold 
PTSD, 448 women will be screened, approximately 134 enrolled, with approximately 120 for 
immediate post-intervention assessment and 96 at 6-month follow-up. This may change due 
to COVID-19, but we will work hard to ensure retention of participants during the study. The 
Locator Guide is key to maintaining effective follow-up.  
● Completion of the intervention program is defined by completing at least 6 out of the 9 
classes. We will keep track of the number of classes using the adherence tracker on 
REDCap. Make-up classes will be offered to women who can not make the class, 

 
18 
particularly as it pertains to COVID-19 or other obligations the women have such as 
court appearances.  
○ The minimum amount of time required for the regimen is 8 weeks and the 
maximum is 10 weeks. 
Subsection 2.17 - Phase II Follow-Up Focus Groups 
At six-month follow-up, we will contact the women with assistance from the site supervisor or 
by using our Locator Guide (see Appendix). Research Staff will travel to the participant’s 
location, as they may not be available to return to site due to COVID-19 restrictions or other 
factors. If participant moved out of state, the follow-ups may be conducted over Zoom or 
phone.  
Subsection 2.18 - Phase II Compensation 
The Phase II compensation is listed below. Each participant will receive a total of up to $153 
over the course of the study. 
 
$3 – screener (after completing screener) 
$15 – baseline measures (after completing) 
$10 – per class (at the end of each class; for a total of 9 classes) 
$15 – immediate post-intervention follow-up measures (after the 9th class) 
$30 – 6-month follow-up (after completion)  
 
Participants who complete 6 or more of the sessions will also be given a Certificate of 
Completion. Participants who complete all 9 sessions will be given a Certificate of Perfect 
Attendance (see Appendix).  
Subsection 2.19 - Program Fidelity  
To ensure program fidelity, all procedures will be closely supervised by the PI, Dr. Garfin. 
Detailed training materials will be provided to all staff, and staff will be required to complete a 
quiz prior to working on site. For those involved in administering the interventions, a detailed 
teachers manual will be provided, and all staff will be expected to adhere to the manual, with 
some flexibility allowed depending on the needs of the group.  
Subsection 2.20 - Research Staff Competencies and Mock Sessions  
UC Irvine has implemented an educational program on the protection of human research 
subjects. All study personnel who are responsible for the design and conduct of this project 
must complete the Collaborative Institutional Training Initiative Human Research Curriculum 
(CITI program), with the confirmation of completion of the trainings on file. The following courses 
should be completed by all staff prior to engaging in study activities. 
● Human Research - Social & Behavioral Researchers & Staff  

 
19 
● Good Clinical Practices (GCP) courses 
● Refresher courses are also available on CITI website 
https://about.citiprogram.org/en/homepage/) as needed.  
 
Further, all research staff will be highly trained by the PI in the following:  
• 
Trained in specific protocols for dealing with emotional and mental distress (e.g., 
remaining calm, immediately finding appropriate onsite clinical staff).  
● Trained in observational and communication skills, and in providing psychosocial 
support, particularly as it relates to emotional and information support 
● Trained in the California Mandatory Reporting Laws governing reporting of child abuse, 
domestic violence, and elder/dependent abuse. Protocols governing reports to the 
California Department of Family and Child Protective Services, or (in the case of 
domestic violence) local police, will be carefully followed. Study participants will receive 
full disclosure regarding mandatory reporting laws during the informed consent process 
and discussion of confidentiality.  In terms of current or recent abuse experience, 
research staff will refer the participants to the onsite Prototypes clinical staff.  
 
During research study training, Research Staff will be evaluated using the competency grid and 
mock session review. Research Staff will also complete a quiz to be reviewed with the PI prior 
to interacting with the participants.  
Subsection 2.21 - Data Entry, Management & Confidentiality 
In Phase 2, secure and encrypted platforms will be used:  
● REDCap: Interview data will be captured electronically using REDCap (Research 
Electronic Data Capture; http://project-redcap.org/), a secure, web-based application 
designed to support data entry and storage for research studies. Participants will answer 
surveys via an electronic tablet and the data will be uploaded in real-time. Possible 
errors, including incomplete responses, logic checks, and data range checks will be 
flagged by the RedCap software during input so that they can be corrected immediately. 
Laboratory data will be entered in REDCap electronic forms. 
● Dr. Garfin will routinely check to ensure data is accurately entered. The Data Safety and 
Monitoring Board (DSMB) will also meet after the enrollment of every 30 participants to 
review/  
 
Procedures to safeguard confidentiality 
Confidentiality of data will be protected by use of subject code on all data and questionnaires. 
Any forms that link participant with their codes will be stored electronically on UCI’s secure 
server and only senior research staff and the PI will have access. All self-report data will be 
immediately uploaded onto UCI’s secure server via RedCAP. Saliva samples will use the 
subject code number and will not be labeled with the participant’s name.  

 
20 
● Participants will be reminded that their interview questions will be provided over a tablet 
that will immediately transfer the data to the UCI secure server and site staff will not see 
their data.  
● We will minimize the risk by strictly adhering to confidentiality procedures. All study staff 
will be rigorously trained in methods to promote confidentiality. The staff will also be 
taught to treat participants in a non-judgmental, professional and confidential manner.   
● A Data Safety and Monitoring Board will be put in place for monitoring of the data 
collected. 
● Confidentiality of data will be protected by use of subject code on all data and 
questionnaires. Data including subject identifiable information (eg: locator form etc) will 
be linked to a code on REDCap for access in real time to track participants and only 
research staff will have access. REDCap also allows for participant’s names and IDs to 
be viewed without access to their responses to the other items in the survey. Tracking of 
participants for their follow-ups will be based upon the information the participant reveals 
on their Locator Guide. When contacting people over the phone, we will use their 
preferred method and the research staff will identify themselves per participants’ wishes. 
● To protect confidentiality and reassure subjects, the research staff will be providing 
explicit explanations in the beginning of the program that they will share no confidential 
information. The trained research staff will administer the questionnaires individually to 
the participants.  
● Subject identifiable data will be destroyed upon completion of the study. All the data will 
be stripped off any identifiable information and only de-identified database will be kept 
for analysis and dissemination. 
Subsection 2.22 – Using REDCap 
● For electronic data entry, log onto RedCap (https://redcap.med.upenn.edu/) with your 
user ID and password. 
● RedCap also incorporates suitable validity checks at the point of data entry to prevent 
“out of range,” “missing” or other checkable data entry errors.  
 Subsection 2.23 - Data Security 
● All CRFs and questionnaires must be identified by a code number (Study ID) only and 
patient identifier information will also be linked on REDCap through this code.  
● The informed consent with the participants’ names and signature will be on REDCap and 
a digital copy should be printed out of REDCap and stored in a local hard drive not 
connected to server.  
● All databases are accessible only to key investigators and senior leadership of the 
project.  
● The electronic data files are stored on the secure, password-protected UCI Health 
Science server.  

 
21 
● This data is available for analyses on the UCI server to authorized users through a web 
VPN application. 
● 
 Authorized users can export the data into Excel or other statistical software sheets for 
further analyses. 
● The de-identified database will be archived for future analyses and all other identifying 
data will be destroyed at the end of the study as per NIH policy.  
Subsection 2.24 - Post Data Collection 
● Validity checks on REDCap should be done right after any interview or other data 
collection is completed. 
● Routine statistical validity checks should identify missing or suspect entries at agreed 
defined intervals (twice per month or as needed) by approved study staff, so that correct 
data can be obtained from the research staff, participants or their records if needed. 
● Thorough data cleaning should be performed before any data analysis. 
  
Subsection 2.25 - End of Study 
● De-identified electronic data will be maintained for the period agreed in the study 
protocol (indefinitely). 
● Final cleaned electronic data will be used for all statistical analyses. 
 
 
 
 
 
 
 
 
 
 

 
22 
SECTION 4. RECRUITMENT  
Subsection 4.1 - Phase II Flyer 
 

 
23 
Subsection 4.2 - Phase II MBSR – Script for Introduction at 
Recruitment Site: For Non-Research Staff Member 
 
Introduction:   Hello, my name is__________________________. I’m a staff member from 
Prototypes/Serenity House Residential Treatment Center. I would like to inform you about a 
research study by sharing a flyer with you.  This study is conducted by Dr. Dana Rose Garfin of 
the UCI, Sue & Bill Gross School of Nursing.  
  
Question:         Would you like to receive a flyer? 
❏ Yes, I would like to receive more information. 
❏ No, not at this time. [If not interested, thank person for their time] 
  
Directions:      If interested, hand flyer and say: The research study being conducted at 
Prototypes/Serenity House and is a separate activity from the services offered by this site. If you 
decide to participate, your decision to participate in the research will not affect your relationship 
with Prototypes/Serenity House. 
  
Directions:      If you are interested, an information session will be held at ________ [DATE] at 
__________ [TIME] for you to learn more. 
  
Question:        Would you like to attend an information session and be screened to see if you 
are eligible to participate in this study? 
❏ Yes [If yes, refer participant to Project Director]  
❏ No  [If no, thank person for their time] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
24 
SECTION 5. SCREENING, INFORMED CONSENT, AND 
ENROLLMENT 
 
Subsection 5.1 Screening Protocol  
Instructions:  
1. Read participant consent to screen document (listed in Appendix)  
2. If they agree to consent to screen, you will open the Screening Module in REDCap.  
1. Age? (Must be 18 or older) 
2. Able to speak English (infer, don’t ask) 
3. Homeless in the last 6 months.  
i. 
Homeless is defined as anyone who spent the previous night in a public 
or private shelter, or on the street. Some women will have been 
incarcerated. If this is the case and they did not have another residence 
to return to, they are eligible to be in the study.  
4. Administer Short Blessed Test.  
i. 
Must meet (Normal Cognition 0-4) 
5. Meet likely subthreshold or threshold PTSD as measured by PCL-5 (see 
Appendix).  
6. Subthreshold PTSD 
i. 
Must meet Criteria A (exposure to a traumatic event).  
ii. 
Must endorse “moderately” or more to at least 2 B-E criteria. This will be 
automatically scored in REDCap.  
Subsection 5.2 Informed Consent   
1. If eligible, read to them the informed consent, going over key highlighted areas.  
i. 
Provide them a paper copy of the consent, and highlight the contact 
information for Dr. Garfin and the IRB.   
ii. 
Download a copy of informed consent (save in downloads). Have them 
sign. Then re-upload and delete from downloads.  
2. START locator guide.  
i. 
Make sure you get their FULL LEGAL NAME!  
ii. 
TAKE PICTURE USING THE “ADD DOCUMENT” ITEM, DO NOT SAVE 
TO CAMERA AND THEN UPLOAD. 
Subsection 5.3 Baseline Protocol 
1. Tell them there will be a urine test. They can take it before or after interview (their 
choice). You will hand them a cup. They will return the cup and you will record 
their urine results in REDCap. Use gloves. It is not considered a biohazard so 
can be thrown in trash (or urine poured in toilet).  
 

 
25 
APPENDIX I: What to bring to site 
 
Screening  
o Charged iPads 
o Charged iPencils   
o Compensation in 1 dollar bills, as participants will be paid $3 per screening  
o Light snacks 
o PPE for COVID-19, including face masks, face shields, tissues, Clorox wipes, hand 
sanitizer, and gloves.  
Baseline, immediate follow-up, and 6-month follow-up 
o Charged iPads 
o Charged iPencils   
o Compensation in $10- and $5-dollar bills, as participants will be paid $15 each (Note: for 
6-month follow-up please bring $10 dollar bills as participants will be paid $30.) 
o Light snacks 
o Bottles of water 
o PPE for COVID-19, including face masks, face shields, tissues, Clorox wipes, hand 
sanitizer, and gloves. 
o Color coded and labeled vials for saliva collection  
o White boxes to store saliva samples 
o Cooler with ice  
o Drug test kits   
o Paper and pens for stress task (trauma imagery task) 
Weekly – Health Promotion class 
o Charged iPads 
o Charged iPencils   
o Compensation in $5 or $10 dollar bills, as participants will be paid $10 each   
o Light snacks 
o PPE for COVID-19, including face masks, face shields, tissues, Clorox wipes, hand 
sanitizer, and gloves. 
o Teacher manual  
o Extra participant book  
o Materials for each week – please see teacher manual for weekly supply list 
Weekly – MBSR class 
o Charged iPads 
o Charged iPencils   
o Compensation in $5 or 10 bills, as participants will be paid $10 each   
o Light snacks 
o PPE for COVID-19, including face masks, face shields, tissues, Clorox wipes, hand 
sanitizer, and gloves. 
o Extra participant book  
o Extra MP3 players 
o Extra yoga mat or two 
 

 
26 
APPENDIX II: Trauma Imagery Script (Brief Stress Task) 
 
 
TRAUMA IMAGERY SCRIPT 
 
NOTE TO RA: Make sure the participant has not had anything to eat or drink for one hour and 
that they had some water to drink at least 10 minutes before starting the task.  
RA: Thank you for your participation in this part of the project. We are going to be asking you to 
recall and describe a stressful or traumatic event. We want to remind you that you can stop at any 
time if you are uncomfortable, although your participation will help us understand more about 
the stress process in women who have experienced adversity. The general overview of this 
procedure is that we are going to take a saliva sample to assess your stress hormones; have you 
participate in a short stress task; and then take another saliva sample to assess your stress 
hormones after the task. If this gets to be too intense for you, you can stop at any time. If you 
experience any severe distress, let me know and we will stop the task and immediately contact 
your onsite clinician/therapist. I want to remind you that this is completely voluntary and you can 
stop at any time and can still be in the study. Are you ready to begin? Do you have any 
questions?  
NOTE TO RA: Participants will then passively drool into a collection vial for three minutes or 
until 0.80 milliliters of fluid is collected. Instruct to lean forward, and allow saliva to pool at the 
bottom of your mouth. Instruct to use tongue to slowly push the saliva into a straw-like collection 
tool that leads into a tube until you have collected roughly 1 teaspoon of saliva. Immediately put 
saliva in cooler! 
RA: First, I am going to ask you to recall a stressful or traumatic event for a few minutes. Some 
examples are a serious accident, fire, disaster, physical assault, abuse, war, homicide or suicide. 
Then, you will write about it and then read or describe it aloud. I can also take notes for you if 
you prefer to do it that way. You can face whatever direction you want and you can have your 
eyes open or closed. However, I ask that you try to recall each part of the event in as much detail 
as you can in your mind’s eye. Think of the actions, events, thoughts, feelings, smells, and 
sensations. Try to remember how you felt and what was happening in your body. Do you have 
any questions?  
I am going to give you a few minutes to imagine the event and write some notes. Here is a pen 
and some paper. Anything you write will be destroyed after the task. 
NOTE TO RA: Give the participant some time to write. Re-iterate any of the instructions if they 
ask or seem stuck. Stop the procedure if the participant is extremely distressed and contact a 
Prototypes site staff and Dr. Garfin. Remind them they can still be in the study if they don’t want 
to complete this part of the procedures.  
RA: Now please read what you wrote aloud and vividly imagine it in your mind’s eye. (Time ~ 5 
minutes).  

 
27 
NOTE TO RA: 20 minutes after completion, collect saliva samples in an identical manner to the 
first sample. Participants will then passively drool into a collection vial for three minutes or until 
0.80 milliliters of fluid is collected. Instruct to lean forward, and allow saliva to pool at the 
bottom of your mouth. Instruct to use tongue to slowly push the saliva into a straw-like collection 
tool that leads into a tube until you have collected roughly 1 teaspoon of saliva. Immediately put 
saliva in cooler! 
 
POST-TASK DEBRIEFING 
Thanks so much for your participation. I know that might have been difficult for you to recall 
this event. I want to thank you and let you know that we think your participation in this task will 
help other women who have experienced adversity. While feeling a little distressed might be 
expected, we want to make sure you are not experiencing a lot of distress. Right now are you are 
experiencing a lot of distress?  
If yes, ask if they want you to get a site staff from Prototypes/Serenity House AND contact the 
Principal Investigator, Dr. Dana Rose Garfin immediately AND provide Dr. Garfin’s contact 
information to them).  
If no, thank them for their time and remind them if anything comes up they can call the Principal 
Investigator, Dr. Dana Rose Garfin and/or talk to any of the Prototypes/Serenity House site staff. 
(Provide Dr. Garfin’s contact information to them).  
Provide water and snacks at this time and pay close attention to any noticeable changes in mood 
until they are released to the care of the Prototypes/Serenity House site staff. Immediately 
inform Dr. Garfin AND Prototypes/Serenity House site staff of any potential issues.  
 
 
 
NOTE TO RA: Please provide the following to the participant (note: can also remind the 
participant this is also included in the informed consent). 
 
CONTACT INFORMATION 
If you have any concerns please contact the Principal Investigator, Dr. Dana Rose Garfin at 
dgarfin@uci.edu or (657) 251-9219. You can also call the University of California, Irvine 
Institutional Review Board at Human Research Protections unit in the Office of Research by 
calling (949) 824-6068 or (949) 824-2125 Monday – Friday, 8 am – 5 pm; or by e-mail at 
IRB@research.uci.edu; or by writing us at 141 Innovation Drive, Suite 250, Irvine, CA 92697. 
 
 
 
 
 
 
 

 
28 
APPENDIX III: Data Safety and Monitoring Plan 
 
Institutional Review Board 
Human Research Protections 
Appendix S – DESCRIPTION OF DATA 
SAFETY MONITORING PLAN (DSMP) 
FOR CLINICAL/ BIOMEDICAL 
RESEARCH 
 
Version 09-19-2018 
Researchers:  
 
• 
All studies involving greater than minimal risk to participants are, 
at a minimum, required to develop a detailed plan to ensure that 
there is appropriate safety oversight.  
• 
For clinical studies involving a test article, it is common to have an 
independent Data Safety Monitoring Board (DSMB).  
• 
Please read the applicable HRP webpage for further guidance. 
 
HS#:   
(to be completed by the IRB) 
 
 
 
 
Lead Researcher/Investigator Name:  Dana Rose Garfin 
 
Researchers may cut and paste into Appendix S from the following sources, as applicable.   
Please remember to submit the following documents with your IRB APP: 
 
• 
For NIH-sponsored clinical trials, the DSMP should be part of the grant application.  
• 
For industry sponsor-initiated clinical trials, a FDA-approved DSMP should be part of the Master 
Protocol or the Data Safety Monitoring Committee/Board Charter. 
• 
For studies conducted at the Institute for Clinical and Translational Science (ICTS) or Cancer 
Center (PRMC), the DSMP information approved by one of these committees should be inserted 
into this appendix. 
 
Please answer all of the following: 
 
1. Provide details of those individuals who will be responsible for the safety oversight of your study, 
including the relevant experience/expertise of each individual (for UCI investigator initiated 
studies conducted only at UCI, provide the names and titles as well). 
 
The study will have a Data Safety and Monitoring Board (DSMB) 
1. Dana Rose Garfin, PhD (Assistant Adjunct Professor and Lead Investigator, Sue & Bill Gross 
School of Nursing). Dr. Garfin has over 12 years of experience researching stress and trauma 
in both epidemiological and community-based samples. She has conducted prior studies with 
vulnerable populations (e.g., homeless women, trauma-exposed children; post-disaster 
survivors, demographically diverse samples). Dr. Garfin’s recent work has explored the 
efficacy of community-based interventions on high risk samples (i.e., HIV-positive women in 
India). Dr. Garfin has recently completed a qualitative study exploring the acceptability and 
feasibility of a mindfulness-based intervention for trauma-exposed, homeless women. Dr. 
Garfin has an MA in Social Ecology and a PhD in Psychology.  
2. Adeline M. Nyamathi, PhD, ANP, FAAN (Founding Dean and Distinguished Professor, Sue 
& Bill Gross School of Nursing). Dr. Nyamathi has been Principal Investigator of more than 

 
29 
one dozen NIH-funded intervention studies with high risk groups that have resulted in 
significant reductions in drug and/or alcohol use and risky sexual behaviors, high rates of HBV 
vaccine completion, latent TB treatment completion, and improvement in emotional health and 
substance use outcomes. She has worked with homeless adults for over 32 years as well as 
other vulnerable populations both domestically and internationally.  
3. E. Alison Holman, PhD, FNP (Associate Professor, Sue & Bill Gross School of Nursing).) 
Dr. Holman is a health psychologist and family nurse practitioner with over 20 years of 
clinical experience working with sick children and their families as well as survivors of 
a variety of traumatic life events. Over the past 20 years, she has served as Principal 
Investigator and/or co-PI on several studies of individuals coping with trauma (e.g., 
9/11, incest, war, and natural disaster). She has also served as the data manager and 
analyst for several studies including her prospective longitudinal study of coping with 
the September 11th terrorist attacks. She is PI of an ongoing epidemiological study of 
American’s responses to traumatic events and an NIH-funded R01 studying the acute 
stress response in stroke survivors.  
4. Sanghuk S. Shin, PhD (Assistant Professor, Sue & Bill Gross School of Nursing) Dr. Shin is 
an epidemiologist and biostatistician with expertise in data management, biostatistics, and 
protocol development and adherence. He has been PI or co-I and lead statistician for 
numerous NIH-funded intervention studies with high risk samples including homeless 
individuals and those with infectious diseases including TB and HIV.  
5. Jung-Ah Lee, PhD, BSM, MN (Associate Professor, Sue & Bill Gross School of Nursing) Dr. 
Lee’s expertise is in healthcare systems and how the structure and processes of a healthcare 
system affects patient safety and clinical and organizational outcomes. She has investigated 
quality improvement techniques, patient safety issues, effective healthcare delivery models, 
and cost-effectiveness of care. She has expertise working with vulnerable populations 
including older adults and those with chronic diseases. Dr. Lee is is not a member of the 
research team and will provide independent oversight.  
6. Yuqing Guo, PhD, MN (Associate Professor, Sue & Bill Gross School of Nursing). Dr. Guo 
has expertise in women’s health and health disparities. She has run numerous family-
centered interventions in community settings. She is PI of a study examining maternal care 
for underserved communities and is well equipped to provide consult and oversight on 
potential problems with the population of interest. Dr. Guo is not a member of the research 
team and will provide independent oversight.  
 
 
2. Indicate how frequently accumulated study data will be reviewed and evaluated for participant 
safety, study conduct and progress, and, when appropriate, efficacy.  
 
They will meet face-to-face at least once a year and maintain and approve minutes of meetings.  
Every 30 participants.  
 
 
 
3. Describe the events that would trigger an unscheduled review. Also include stopping guidelines 
and un-blinding rules if applicable.  
 
Events where the participant became extremely distressed as part of the research procedure or 
expressed suicidality or if they were a harm/threat to self or others.  The Data Safety and 
Monitoring Plan (attached, submitted in the NIH grant that funded this application), we provide 
specific guidelines to assess suicidality or harm to others. The research staff would follow all 

 
30 
procedures to ensure the safety of the participant. And the DSMB would be  
 
4. List who will be locally monitoring and collecting information on adverse events and/or 
unanticipated problems (e.g., UCI Lead Researcher, Research Coordinator, etc.). Include the 
name, title and experience of the individual(s) and further describe each individual’s role in the 
oversight of subject participating in the study. 
 
The Principal Investigator (Dr. Dana Rose Garfin) will be responsible for locally monitoring and 
collecting information on adverse events and unanticipated problems. Dr. Garfin will be onsite 
during participant recruitment and during the administration of intervention procedures. In the 
event that Dr. Garfin is not able to be onsite, a senior staff will be in contact directly with Dr. 
Garfin should any problems arise. Moreover, when Dr. Garfin is not onsite, staff will report daily 
on study progress and any potential issues. Dr. Garfin will monitor all data weekly.  
 
5. Describe the plan for annual reporting of the participants’ safety, and the study’s conduct, 
progress, and efficacy, when appropriate. Note: At the Continuing Review, please provide all 
relevant documentation related to the review of the accumulated data for safety. For the case 
your submission includes a DSMB charged with the oversight of data safety, include all available 
DSMB reports as part of your submission.  
 
Annual reporting will occur at the DSMB meeting. The Principal Investigator will keep detailed 
notes from the meeting and evaluate the study’s conduct (e.g., any unanticipated problems), 
progress (e.g., recruitment, retention), and efficacy (e.g., results of any preliminary data 
analyses).  
 
 
DATA SAFETY AND MONITORING PLAN 
 
Possible Serious Adverse Events or Adverse Events 
 
Serious adverse events 
 
• 
Suicide attempt, severe violence to another person 
   
Other adverse events 
 
• 
Inadvertent disclosure of illegal immigrant status  
• 
Adverse reaction to stress task 
 
Risk Management Protocols in Place to Deal with Adverse Events 
 
• 
Date Safety and Monitoring (DSM) issues are raised at quarterly meetings with all research staff 
• 
Events will be reported as they occur 
• 
A certificate of confidentiality will be secured. 
• 
Research staff will administer the questionnaires individually. 
• 
Participants will be cautioned not to disclose any confidential information within the group sessions. 
• 
Unique identifiers are used on all data.  Access to identifiers is restricted to the study PI, lead mentors 
and data manager by a combination lock. 

 
31 
 
Data and Safety Monitoring Procedures 
 
• 
Serious adverse events (SAE) must be reported to the NIH Project Officer (PO) by email or telephone 
within 24 hours of the SAE.  A more complete written report documenting the event must occur within 
72 hours of the event.   
• 
All adverse events will be reported by email to the NIH PO twice a year: six months after the Notice of 
Grant Award (NGA) and at the end of the budget year.  
 
Data Safety and Monitoring Board (DSMB) 
 
The board will be composed of six members, including the PI, mentors (Nyamathi, Shin, Holman) and two 
mid-level to senior investigators from our institution with psychological expertise (Dr. Yuqing Guo and Dr. 
Jung-Ah Lee). They will meet face-to-face at least once a year and maintain and approve minutes of 
meetings. The NIH PO will be kept informed regarding changes to the membership of the DSM board. 
Data will be reviewed as every 30 participants enter the study. 
 
Training for all staff 
 
During the orientation prior to start of the grant, all research staff and research assistants will be trained on 
recognizing all types of potential crises, how to make a thorough assessment, and role play protocols that 
are featured below and in the DSMB section. During these meetings, in services that address mental 
health crises and associated symptomatology will be provided to enhance the staffs’ ability to confidently 
engage in the protocols for participants who may be experience psychiatric or psychological distress. All 
research assistants will also meet weekly with the PI to review challenging interactions, circumstances, or 
situations that may have arisen with the participants.  Discussions will focus on how the incident could 
have been handled differently and what the ideal outcome for that situation might have been. 
 
Training in Red Flag Procedures 
 
 
Research staff will be trained to assess and react as follows: 
 
 
RED FLAG – SUICIDE 
 
During your work as a research staff, you may encounter a respondent who expresses suicidal intentions, 
or you may suspect that a respondent may be suicidal. Be sure to document all the information in sections 
I and II as you will need to provide that information to the treatment program counselor or on-call clinician. 
 
I. 
Is this person a suicide risk? 
 
 
 ____ The individual is currently thinking about suicide. 
 
 ____ The individual has a plan and the means to commit suicide. 
 
 ____ The individual has attempted suicide in the past. 
 

 
32 
 
If any of the above are true or if you suspect the client is suicidal, also note if: 
 
 ____ The individual is currently exhibiting serious depression/anxiety. 
 
 ____ The individual is experiencing stressful life events. 
 
II. 
Assessment of support system: 
 
a) Is the individual under professional care (i.e., psychologist, psychiatrist, counselor)? 
 
b) Does the individual have a social support network (i.e., friends, family, sponsor)? 
 
c) Has the individual talked with any of the members of his or her social support network in 
the last 30 days? 
 
d) Is the individual able to talk about this issue with his or her support system? 
 
e) Is the individual aware of available social service programs? 
 
III. 
If the person appears to be suicidal or has attempted suicide since the last interview: 
 
a) Let the respondent know that you are concerned, and that you need to inform a clinician 
and your supervisor.   
 
b) If you are not at a treatment program, have the client wait with you or hold on the line while 
you take the following steps:   
1) If the client has indicated that he/she is under professional care, ask the client for 
permission to contact his/her clinician and, if permission is granted, obtain the clinician’s 
contact information. Be sure to document the client’s permission and clinician contact 
information, you will need to provide it to the on-call clinician who will confirm client 
permission and make the contact. 
2) Contact the on-call clinician at the Los Angeles County Mobile Crisis Response Team 
(MCRT); _____________. A clinician is on call 24 hours a day. Provide the clinician 
with all the suicidality information you have gathered. Facilitate phone contact between 
your client and the MCRT clinicians. The clinician will make the decision about what 
steps to take with this client. Document the details of the clinician call. 
 
d) Report back to the PI immediately.  
 
• 
Your Principal Investigator Dana Rose Garfin Ph.D., 415-407-9498 
 
The situation will be evaluated by the group and a decision will be made if it should be 
reported to the LAC MCRT; they will advise us on how we need to proceed. 
 
e) If the person attempts to harm himself or herself in your presence, contact the police (911).  
The police may place the person in a psychiatric facility for a 72-hour observational hold.  
Get the police report number. 
 
f) 
Complete an Incident Report detailing the problem and action taken.  Be sure that the 
Incident Report is placed in the respondent’s file. 

 
33 
 
g) Make arrangements to follow-up on your client’s status with the treatment program 
counselor, supervising counselor, or on-call clinician within the next seven days. 
 
If the MCRT is called, an assessment will be done by the MCRT staff at the location of the 
participant. Based on the assessment of the MCRT, the participant may be transported to a hospital for 
inpatient treatment. If it is determined that the person does not need to be hospitalized, the participant will 
be referred to the outpatient services at the neighborhood clinic. If the participant is at the same location 
as the staff, the staff will find out if the participant has taken any active steps such as already having taken 
pills, etc. If the participant is not in immediate danger, the staff will find out the following: history of drug and 
alcohol abuse; history of familial suicide; history of familial mental illness. The staff will find out if the 
participant has a plan for how he would commit suicide. If she does have a plan, the staff will find out if 
she/he has any weapons, pills, etc, and remove all weapons from her possession, and explore the nature 
of her various plans. The PI, once they have arrived, will continue to focus on the reasons the participant 
wants to live and build on his support system. The staff will get phone numbers from the participant of 
those of his outside support system with whom he wishes to be in contact, for future use in case of another 
emergency. The research staff will collaborate with the treating psychiatrist to facilitate referral and follow 
through with a counseling psychiatrist/psychotherapist after discharge from the hospital. The staff/PC will 
document each step of this process. 
 
If it is determined that the person does not need to be hospitalized, any additional treatment will 
be facilitated with Prototypes staff. To facilitate communication the participant will be asked to sign a 
Release of Information. If the participant provides a Release of Information, the PC will follow-up to ensure 
that the participant is receiving the necessary treatment. Depending on the outcome of the event, the PI 
may recommend that the participant withdraw from study participation. The staff/PC will document each 
step of this process in an adverse event log. 
 
 
In addition, the DSMB will be informed of reports of suicidal ideation and current or recent abuse, 
reported by the staff to the proper authorities. Further, the DSMB will monitor that these reports are made 
expeditiously and with the full knowledge of the respondent. Monitoring information is also provided in the 
HSPC segment of this application.   
 
Harm to others  
 
I. Is this respondent dangerous to others? 
The individual expressed intent to harm or kill a specified person. 
The individual has the means (gun, knife, etc.) to harm that person. 
The individual has a thought-out plan. 
 
II. If you feel that the person is dangerous to others, and is likely to follow through with his/her 
plans: 
 
Assess the situation.  If it is safe, complete the study protocol is the participant desires.  Report 
the information to your supervisor, the PI and the licensed clinician on staff at Prototypes.  If you 

 
34 
feel unsafe or are not sure about it, complete the research procedures; only if possible.  But if 
the situation is volatile, terminate immediately.  Try to be as graceful and subtle as possible.  
For example, complete the specific task you are on or make up some reason for leaving, and 
say you will have to reschedule the rest of the procedures.  Pay the subject in full, or leave 
immediately if you don’t feel safe to do so.  Trust your sense of the situation, and act 
accordingly.  
 
Report back to your supervisor or call in immediately.  If something takes place outside of the 
work hours, call your supervisor at home.  The supervisor should then immediately contact the 
project’s PI. Supervisors are: 
 
Your Principal Investigator Dana Rose Garfin, Ph.D., 415-407-9498 
 
The situation will be evaluated quickly by the group and a decision will be made if the LAC 
MCRT needs to be called; they will advise us on how we need to proceed. If the situation is 
reported to the police, get the report number from the police. 
 
III. Complete an Incident Report.  Be sure to put a copy of the Incident Report in the 
respondent’s file so that those working with the file in the future know an incident occurred.  
Aside from the DSMB, the PI will carefully monitor the data weekly. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
35 
APPENDIX IV: Citations for Study Measures  
Primary Outcome:  
 
PTSD Checklist for DSM-5 (PCL-5; Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 
2013). Responses will be scored continuously and according to diagnostic criteria as 
implemented in previous research.(143) The PCL-5 initially starts with the identification of the 
presence of exposure to a DSM-V traumatic event (i.e., “Briefly identify the worst event (if you 
feel comfortable doing so)”) and then assesses whether it involved actual or threatened 
death, serious injury or sexual violence; whether the person directly experienced it (through 
direct exposure, witness to the event, occurred to a close friend or family member, or exposed 
as part of job). There are then twenty-items that assess all four B-E criterion (re-experiencing, 
avoidance, negative thoughts or cognitions, hyperarousal), assessed on a Likert-type scale 0 
“not at all”, 1 “a little bit”, 2 “moderately”, 3 “quite a bit”, 4 “extremely”. 
 
Secondary outcomes:  
 
Substance use:  
Self-report drug use: Texas Christian University (TCU) Screen at Baseline and 6-month follow 
up. Yes/No to each drug will be assessed for use vs dependency.  The total score ranges 
from 0 - 9; higher scores (> 3) correspond to the DSM drug dependence diagnosis.  This will 
be assessed at baseline, immediately following 9th/final intervention session, and 6-month 
follow-u (Institute of Behavioral Research, 2017).  
 
Objective drug use assessment: A 5-panel FDA-approved urine test cup will be used in this 
study.  The test cup screens for metabolites of the following drugs of abuse at the established 
cut-off levels and is used for qualitative purposes: Amphetamines (1000 ng/mL), Cocaine 
(300 ng/mL), Methamphetamines/ MDMA (500 ng/mL), Opiates (2000 ng/mL), and THC (50 
ng/mL). Urine sample validity checks will be provided by temperature and adulterant 
monitoring strips built into the test cup. Participants whose urine does not pass validity checks 
will be counted as positive for drugs.  Results will be coded qualitatively (above or below 
threshold). All positive results will be interpreted as positive, regardless of self-report. 
 
Depression: will be assessed using the PROMIS measure for depression (Emotional 
Distress). The 8-tem form will be used. It assesses negative mood, views of self (e.g., 
worthlessness), decreased positive affect and anhedonia. In self-report when all participants 
are given the same questions, it is desirable to use the 8-item short form, which has reliability 
and validity comparable to the 28-item computer adaptive form (PROMIS Health 
Organization, 2019).  
 
Cortisol reactivity: Saliva samples will be collected via passive drool before and after a 
modified script driven imagery task. Saliva All saliva will be assayed in duplicate using 
standard manufacturers protocol (Salimetrics). The concentration of CRP in saliva will be 
determined using a Salivary C-Reactive Protein ELISA kit, an enzyme-linked immunoassay. 
The standard curve is run on every assay plate and must have an R2 value of > 0.99. The 

 
36 
replicates must have a %CV < 15 or an absolute difference <0.030 between the replicates. 
The mean values across saliva duplicates will be computed for each sample and used in the 
statistical analyses. 
 
C-reactive protein (CRP) All saliva will be assayed in duplicate using standard 
manufacturers protocol (Salimetrics). The concentration of CRP in saliva will be determined 
using a Salivary C-Reactive Protein ELISA kit, an enzyme-linked immunoassay. The standard 
curve is run on every assay plate and must have an R2 value of > 0.99. The replicates must 
have a %CV < 15 or an absolute difference <0.030 between the replicates. The mean values 
across saliva duplicates will be computed for each sample and used in the statistical 
analyses. 
 
Perceived stress scale: 10-item Perceived Stress Scale (PSS) will be used to measure 
participant's perception of stress (Cohen, 1993). 
 
Quality of life: will be measured using the 10-item short form of the Quality of Life Enjoyment 
and Satisfaction Questionnaire. Participants indicate their satisfaction with health, finances, 
and other life domains during the past week on a scale of 0 (very unsatisfied) to 3 (very 
satisfied) (Endicottt, Nee, Harrison, & Blumenthal, 1993).  
 
Satisfaction with life scale: A 5-item scale designed to measure global cognitive judgments 
of one’s life satisfaction (not a measure of either positive or negative affect) (Diener, Emmons, 
Larsen, & Griffin, 1985).  
 
Mindful awareness attention scale (MAAS): is a 15-item scale designed to assess a core 
characteristic of mindfulness, namely, a receptive state of mind in which attention, informed 
by a sensitive awareness of what is occurring in the present, simply observes what is taking 
place (Brown & Ryan, 2003; Carlson & Brown, 2005).  
 
Five facet Mindfulness Questionnaire (FFMQ) is a 39 item questionnaire that assesses five 
independent sub-scales: observing, describing, acting with awareness, non-judging of inner 
experience, and non-reactivity to inner experience (Baer et al., 2008).  
 
Life event history: Life events history will be assessed by asking respondents whether they 
ever experienced each of 40 specific negative life events (NLEs; will include both trauma and 
stressors), and, if so, at what age(s) this occurred. This will also be updated with respect to 
recent events upon immediate completion of the 9 week courses as well as at the 6-month 
follow up. The measure was modified from the Diagnostic Interview Schedule trauma section 
(Robins, Helzer, 
Croughan, & Ratcliff, 1981) by including several stressful or traumatic events reported by 
primary care patients (Holman, Silver, & Waitzkin, 2000) and has provided rates of events 
comparable to other community-based studies (e.g., Seery et al., 2010). 
 

 
37 
Emotion regulation: will be assessed with the Difficulties in Emotion-Regulation Scale 
(DERS; Gratz & Roemer, 2004; Kaufman et al., 2016), short form.  DERS is a 18- item 
questionnaire that aims to measure how much one is able to regulate/deregulate their 
emotions. The 41 questions are based off of six factors including acceptance of emotions, 
impulsiveness, ability to work towards goals, awareness of own emotions, clarity of emotions, 
and accessibility to emotion-regulation strategies 
 
Social support will be assessed using the MOS Social Support scale (Sherbourne & 
Stewart, 1993) This 19 item measure assesses social support.  
 
Anxiety: will be assessed using the PROMIS measure for anxiety (Emotional Distress). The 
8-tem form will be used. It assesses symptoms of Generalized Anxiety Disorder. it is desirable 
to use the 8-item short form, which has reliability and validity comparable to the 28-item 
computer adaptive form (PROMIS Health Organization, 2019).  
 
General Self-efficacy scale: This 10-item scale was created to assess a general sense of 
perceived self-efficacy (Schwarzer & Jerusalem, 1995). 
 
Demographics: Age, ethnicity, sexual orientation, incarceration history, religion, income, 
education, number of children, pregnancy status, mental health history (previous diagnosis) 
employment history. 
 
Prior Doctor-diagnosed Health Conditions. This survey, modified from the CDC’s National 
Center for Health Statistics Annual National Health Interview Survey, asks respondents to 
report doctor diagnosed health ailments. This will be assessed at baseline, immediately 
following 9th/final intervention session, and 6-month follow-up. 
 
Adherence. Measured by class attendance and self-reported time in mindfulness meditation 
and doing at-home assignment. 
 
Short self-compassion scale. This 12-item scale assesses self-compassion (Raes, 
Pommier, Neff, & Van Gucht, 2011).  
 
Free Response: Participants will be given the opportunity to provide written feedback 
regarding their experiences that may not have been captured with these quantitative 
measures. Prompt will include: We will ask: “Do you have any other thoughts and/or feelings 
about your participation in this program? Is there anything that you wish to share with us 
regarding your experience?” 
 
 
 
 
 
 

 
38 
APPENDIX V: Salivary Data Collection During COVID-19 
 
 
Collection Procedure* 
*Please keep a roster of all samples collected from October 2019 onwards. Samples may 
contain SARS- CoV-2, and this will ensure safe handling in the future as labs may take extra 
precautions when handling samples collected during this time. 
 
1. Participants wash hands for 20 seconds prior to collecting the saliva sample(s). 
2. Collect saliva sample as normal (follow typical passive drool or swab collection 
protocols). Tubes should be labeled prior to providing them to participants. 
3. Sample tubes should be immediately capped and sealed. Outsides of tubes should be 
disinfected following collection. Disinfectants are listed on the CDC website 
(https://www.epa.gov/pesticide- 
registration/list-n-disinfectants-use-against-sars-cov-
2). Ensure no disinfectants leak into the tube via an unsealed or partially sealed tube. 
4. Samples should be placed in a secondary container (sealed plastic bag with absorbent 
material, freezer box, etc.) that is labeled, then placed in a freezer (-20°C) as soon as 
possible. See below for more guidelines. 
5. Participants should wash hands for at least 20 seconds after collecting the saliva 
sample(s). 
 
Sample Storage and Shipping 
 
Always check with your EHS and IRB groups at your institution before collecting and/or shipping 
saliva samples to ensure you have received proper training and are following appropriate 
rules/regulations. Additionally, please refer to the following link for CDC guidelines prior to 
shipping samples: https://www.cdc.gov/coronavirus/2019-ncov/lab/biosafety-faqs.html 
 
Sample storage: 
 
1. Once collected, samples should be stored in a freezer between -20°C (home freezer) 
or -80°C (ultra-cold lab grade freezer) when possible 
2. Samples should be placed inside sample storage boxes (or biohazard Ziploc bags + 
absorbent material for home collections) 
3. The sample storage box should be placed inside a large biohazard Ziploc bag (or 
Ziploc bag with a biohazard sticker on it) 
4. A piece of absorbent material (paper towel, etc.) should be placed inside the Ziploc bag to 
absorb any potential spillageSample Pickup/Shipping: 
 

 
39 
1. Samples in bags or boxes should be placed inside cooler or in a bioshipper on dry ice. 
2. Bioshipper should be labeled with the following: 
a. Hazard labeled with UN Identification Number already on label – UN 3373 
b. Biological Substance, Category B 
c. Hazard Labeled with UN Identification Number- UN 1845 
d. Dry Ice along with the net weight (kg) of the dry ice 
e. Shipper’s name and address 
f. 
Receiver’s name and address 
g. Name and phone number of a responsible person. 
 
Receiving samples: 
 
1. Lab personnel receiving samples should wear appropriate PPE before handling 
samples. 
2. Ensure samples are labelled, are frozen, and tubes are in good condition (no cracks or 
leaks). 
3. Sample collection tubes should be disinfected once received by the lab. Disinfectants 
are listed on the CDC website (https://www.epa.gov/pesticide-registration/list-n-
disinfectants-use-against- sars-cov-2). 
4. Boxes with samples can be marked with date received, and a label noting if the samples 
were collected during the COVID-19 pandemic. This can act as an indicator to use extra 
safety precautions while handling those samples in the future. Samples should be stored 
in -80°C as soon as possible. 
5. Sample processing should be performed in a biological safety cabinet. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
40 
APPENDIX VII: RECap for Screener (Section 1) and Baseline, 
Immediate-follow-up, and 6-months (Section 2) 

Statistical Analysis Plan  
All analyses were conducted using STATA 18. First, descriptive statistics were calculated for the 
total sample. Next, a series of multilevel models were conducted for each primary and 
secondary outcomes using a multilevel, random-intercept mixed. Participants were entered as 
random effects to nest observations within participants, allowing for correlations within each 
individual over time. Group assignment (i.e., MBSR vs. HP Control), time (i.e., T1, T2, and T3), 
and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-
effect, given the low number (i.e., two) of sites1. Covariates were screened for inclusion in 
bivariate analyses and included if statistically significant and theoretically meaningful. An 
independent covariance pattern was specified as our final models were random-intercept 
(nested within participant) only2. Results are presented using restricted maximum likelihood for 
optimal control of Type 1 error3. An intention-to-treat analysis was conducted, where every 
participant was included in the final analyses, regardless of whether they completed all of the 
sessions. 
Bibliography  
1.  
Feaster DJ, Mikulich-Gilbertson S, Brincks AM. Modeling site effects in the design and 
analysis of multi-site trials. Am J Drug Alcohol Abuse. 2011;37(5):383-391. 
doi:10.3109/00952990.2011.600386 
2.  
Weise RE. Modeling Longitudinal Data. 1st ed. Springer; 2005. 
3.  
Luke SG. Evaluating significance in linear mixed-effects models in R. Behav Res 
Methods. 2017;49(4):1494-1502. doi:10.3758/s13428-016-0809-y