Mindful Self-Compassion to Address PTSD and Substance Use in Unhoused Women
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD), Anxiety, Depression - Major Depressive Disorder
Sponsor: University of California, Los Angeles

1 
 
 
 
 
 
 
 
Mindful Self-Compassion for Co-occurring PTSD/SUD in Trauma-Exposed 
Women Experiencing Homelessness, Phase II 
 
Study Protocol  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

2 
Table of Contents 
 
SECTION 1A. RESEARCH STUDY OVERVIEW 
Subsection 1A.1 Overview & Introduction 
Subsection 1A.2 Research Team and Responsibilities 
Subsection 1A.3 Research Study Contact List 
Subsection 1A.4 Phase II Timeline 
6. BASIC DEFINITIONS 
SECTION 1B. INTRODUCTION TO PTSD AND MSC 
Subsection 1B.1 PTSD Basics 
Subsection 1B.2 MSC Basics 
SECTION 2. INTERVENTION DELIVERY 
Subsection 2.1 - Phase II Overview 
Subsection 2.2 - Phase II Scope of Work & Participant Flow Diagram 
Subsection 2.3 - Phase II Recruitment & Treatment Overview 
Subsection 2.4 - Phase II Recruitment & Screening 
Subsection 2.5 - Phase II Eligibility Criteria 
Subsection 2.6 - Phase II Intervention Program Description 
Subsection 2.7 - Phase II Pre-Intervention Assessments 
Subsection 2.8 - Phase II MSC Intervention 
Subsection 2.9 - Phase II Treatment as Usual 
Subsection 2.10 - Phase II Post Assessment 
Refusal Subsection 2.11 - Phase II Dealing with Program Attrition 
Subsection 2.12 - Phase II Follow-up 
Subsection 2.13 - Phase II Compensation 
Subsection 2.14 - Program Fidelity 
Subsection 2.15 - Research Staff Competencies & Training 
Subsection 2.16 - Data Entry, Management, & Confidentiality 
Subsection 2.17 - Using REDCap 
Subsection 2.18 - Data Security 
Subsection 2.19 - Post Data Collection 
Subsection 2.20 - End of Study 

3 
SECTION 1A. RESEARCH STUDY OVERVIEW 
Subsection 1A.1 Overview & Introduction 
This three-year study will be a mixed-method, open-label cluster randomized clinical 
trial to test the benefit of the adapted mindful self-compassion intervention (MSC) at 
improving primary (PTSD, substance use) and secondary outcomes (depression, 
anxiety, helplessness, loneliness) among a sample of women experiencing 
homelessness (WEH) with PTSD/SUD residing in a residential drug treatment site 
(RDTS). An exploratory aim will be to elucidate mechanisms of treatment-response 
and maintenance or remission of symptoms.   
 
Phase 1 of this three-year study was completed in December 2023. In Phase 1, a 
Community Advisory Board (CAB) was created, with women from the RDTS as well as 
site staff (including clinicians and substance use counselors). The CAB and the UCLA 
research team jointly created a semi-structured interview guide that was used with four 
focus groups (total N=27) of trauma-exposed WEH living at the RDTS. The participants 
completed acceptability and feasibility questionnaires and provided feedback on program 
design and administration. These suggestions were brought to the CAB and together the 
study design was finalized accordingly.  
 
Phase II of this study will begin in Winter/Spring 2024. This will be a clinical trial 
comparing the MSC intervention to treatment as usual (TAU).  
Subsection 1A.2 Research Team and Responsibilities  
Principal Investigator (PI): Dana Rose Garfin, PhD 
 
Oversees scientific and administrative direction of the project. 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 select all questionnaires and oversee the design, implementation, 
and evaluation of the MSC and treatment as usual (TAU) control. Dr. Garfin takes final 
responsibility for the integrity of the data and the accuracy of the data analysis. She will 
also be responsible for tracking and reporting any adverse events that occur.  
 
Mindful Self Compassion Instructor: Amy Noelle, MPT 
Amy Noelle, MPT will help lead the administration of the MSC course. Ms.  Noelle 
has developed and taught mindfulness and SC courses for over 10 years. Ms. Noelle 
has previously taught MBSR to WEH with PTSD/SUD and has worked with our 
community partners at HealthRIGHT 360 since 2020. Ms. Noelle worked closely 
with Dr. Garfin and the CAB to develop and adapt the MSC intervention. Ms. Noelle 
will be responsible for training and supervising any additional MSC trainers on the 
project.   
 
 
 

4 
Graduate Student Researchers (GSRs):  
First line contact for RAs, responsible for RA scheduling, delegates lab responsibilities to 
other RAs, oversees RAs on site at the RDTS, keeps track of supplies, reimbursements, 
and participant compensation, assists with research tasks including qualitative data group 
coding, setting up REDCap, and writing papers.  
 
Undergraduate Research Assistants (RAs):  
Assist with delegated lab tasks, including ordering supplies, screening and interviewing 
study participants at the RDTS, and inputting data into REDCap.  
Subsection 1A.3 Research Study Contact List 
Name 
Role 
Organization Email 
Dana Rose Garfin, PhD PI 
UCLA 
dgarfin@ucla.edu 
Amy Noelle, MPT 
MSC 
Instructor 
Contractor 
amynoellept@gmail.com 
Krysta Pelowich, MPH 
GSR 
UCLA 
kpelowich@g.ucla.edu 
Frances Kiles, BS 
GSR 
UCLA 
frannykiles26@g.ucla.edu 
Lauren Anderson, BA 
GSR 
UCLA 
laurenrenee37@g.ucla.edu 
Subsection 1A.4 Phase II Timeline  
 
 

5 
 
6. BASIC DEFINITIONS 
 
Mindful Self Compassion (MSC): is a mind-body integrative health intervention that  
utilizes meditations, other contemplative practices, home practices, and experiential 
exercises  (including group discussions) to increase SC. To increase feasibility of MSC  for 
use in the RDTS, we will adapt MSC  to 7 sessions (6 weekly sessions in  alignment with 
the MSC short course plus  the half day retreat included in the full  course to facilitate skill 
consolidation).  
 
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 treatment as 
usual (TAU) control and Arm 2 is the MSC. Participants are assigned to one Arm or 
the other, by cohort). 
 
Cohort: The group of people that are doing the interventions at the same time. 
 
Other Acronyms used in the protocol:  
 
WEH: women experiencing homelessness 
SUD: substance use disorder 
TAU: treatment as usual control group  
RDTS: residential drug treatment site 
SECTION 1B. INTRODUCTION TO PTSD AND MSC 
Subsection 1B.1 PTSD Basics 
 
PTSD 
 
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, 

6 
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 this study, PTSD symptoms will be 
measured using the PTSD Checklist for DSM-5 (PCL-5).  
 
DSM-5 Criteria for PTSD 
The following text summarizes the diagnostic criteria for PTSD 
 
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 
 
 
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 

7 
• 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. 
 
How is PTSD Typically Treated? 
 
CBT, cognitive processing therapy, prolonged exposure therapy (PE), eye movement 
desensitization and reprocessing (EMDR), stress inoculation training, psychopharmacological 
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 
MSC 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 MSC Basics 
MSC is a mind-body integrative health intervention that utilizes meditations, other 
contemplative practices, home practices, and experiential exercises  (including group 
discussions) to increase SC. MSC can be done in groups of 10-25. The full  program 
typically consists of eight sessions, approximately 2.5 hours long, and a 4-hour (half-

8 
day)  silent retreat. There are a total of 25 practices in MSC (including three core 
meditations, four other meditations, and 18 informal practices for daily life); all 
incorporate loving-kindness (e.g.,  self-compassion). An official MSC adaptation, the 
MSC short course consists of six sessions and has been increasingly used in 
healthcare  settings.116 Our prior work with WEH found  that the majority of WEH 
completed 7/9  available sessions (6 sessions or more were  considered treatment 
completion), with  most WEH citing early discharge from  RDTS as the reason for 
lower dose of  sessions. To increase feasibility of MSC  for use in RDTSs, we will 
aim to adapt MSC  to 7 sessions (6 weekly sessions in  alignment with the MSC short 
course plus  the half day retreat included in the full  course to facilitate skill 
consolidation).  Sessions will be conducted in a group-based format: prior research 
found group-based formats equivalent to individual-level  interventions for 
PTSD/SUD. 
 
Table 1. Progression of the adapted 6-week MSC intervention 
 
 
 

9 
SECTION 2. INTERVENTION DELIVERY 
Subsection 2.1 - Phase II Overview 
In Phase II, we will assess the benefit of MSC to produce improvements in primary (PTSD, 
SUD) and secondary outcomes (depression, anxiety, hopelessness, loneliness) compared to 
Treatment as Usual (TAU) and to explore mechanisms of symptom change over time. We will 
implement an open-label cluster randomized clinical trial of an adapted MSC course for 
PTSD/SUD with WEH (N=202), randomized to MSC (n=101) or TAU (n=101). Women will be 
recruited from Prototypes, a HealthRIGHT 360 RDTS. Inclusion criteria will be: 1) woman age 
18 and over; 2) probable PTSD as judged by the PCL-5 (score of 31 or higher, indicated as having 
optimal signal detection); 3) no cognitive impairment according to a score of < 10 on the Short-
Blessed Test; 4) experienced homelessness in the past 6 months or prior to incarceration (“spent 
night in public or private shelter or on the street”); and 5) able to speak and understand English. 
We will recruit 8 cohorts of 24-26 WEH and each cohort will be divided into 2 groups. Cohorts of 
participants will be randomized to an adapted MSC course or TAU prior to enrollment of the first 
participant and randomization will occur at the level of the cohort rather than the participant. This 
is to minimized contamination in cohorts as women live together at the RDTS but cycle out after 
~3 months. Women receiving MSC or TAU will complete psychosocial questionnaires, 
demographics, and a Locator Guide at baseline. Women receiving MSC will participate in weekly 
MSC classes for 6 weeks, followed by a post-intervention follow-up and 4-month follow-up. 
Women receiving TAU will complete short psychological surveys each week for 6-weeks, 
followed by a 6-week post-baseline and 4-month follow-up.  
 
Confidentiality and Ethical Issues 
 
All program staff, RAs, GSRs, and MSC trainers must follow confidentiality and ethical 
procedures throughout this program to ensure that everybody is treated with respect and dignity. 
 
● Communication with study participants must remain confidential. To maintain 
confidentiality for participants, any personal information provided, such as participants' 
name, age, etc., will be protected by use of subject code on all data and questionnaires and 
stored on REDCap on the UCLA server and never anywhere else. Data including subject 
identifiable information will be linked to a code on RedCap for this study for access and 
only UCLA-approved staff, RAs, or GSRs will have access though a password-protected 
login.  
 
Program Team 
 
The Graduate Student Researchers (GSRs) will help the PI (Dr. Garfin) in organizing all 
aspects of the study. These individuals will be current graduate students in the UCLA 
Jonathan and Karin Fielding School of Public Health. They will be responsible for tracking 
recruitment, scheduling research assistants, and ensuring that the site is well-stocked with 
necessary supplies. Weekly, the GSRs will meet with Dr. Garfin to review all aspects of 
the study, troubleshoot any obstacles, participate in ongoing training, and create schedules 
for the other RAs. The RAs will be highly trained undergraduate students from the 
University of California, Los Angeles. 

10 
 
Safety of Program Staff 
 
While we believe that conducting this study is highly important for public health, it is 
critical that the research team prioritizes their own safety first. If any member of the 
research team feels that they are in danger (physically, emotionally, psychologically) in 
any way, they will be instructed to end the study activities and inform the research 
coordinator or the PI as soon as it is safe to do so. This is particularly important during 
COVID-19 and ongoing viral outbreaks. Exposures will be promptly reported to the PI and 
any applicable UCLA protocols will be strictly followed.  
Subsection 2.2 - Phase II Scope of Work & Participant Flow Diagram 
 
1. General Recruitment  
 
a. We will recruit ~8 cohorts of 24-26 WEH from Prototypes, a HealthRIGHT 360 RDTS. 
The RDTS staff will assist the PI and GSRs in providing a minimum of two informational 
meetings (advertised through flyers and verbally by staff) for interested women where they 
will be informed about the opportunity. 
 
b. Dr. Garfin, GSRs, or RAs will administer an eligibility screener to participants using an 
iPad and will collect the data using REDCap. 
i. Key inclusion criteria are subthreshold or threshold PTSD as measured by the 
PCL-5 PTSD screener and no cognitive impairment as measured by the Short-
Blessed Test.  
 
c. All participants who complete the screener will receive $5. 
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. This will be stored on REDCap on the UCLA secured server and 
never anywhere else.  
d. Eligible WEH who wish to  participate will be invited back within the next week for 
enrollment and baseline assessments. The research team will review the informed 
consent with the potential participant and  provide a copy for them to take for review. 
Potential participants will be given 24 hours to review the document before enrolling 
in the study and completing baseline measures; participants are free to waive this 
waiting period at their own discretion.  
 
2. Group Assignment and Intervention Procedure 
a. Cohorts of participants will be randomized to an adapted MSC course or TAU prior 
to enrollment of the first participant. Consistent with the cluster design,  
randomization will occur at the level of the cohort rather than the participant. This 
design was  chosen to avoid contamination within the cohorts, since participants 

11 
reside at the same RDTS. There will be eight cohorts in total, each with two 
intervention groups of 12-14 WEH. Each cohort  will receive the same intervention 
(e.g., in Cohort 1 there will be two groups of MSC, in Cohort 2  there will be two 
groups of TAU). See Table 2 below: 
 
Table 2: Group Assignment Flowchart 
 
 
Intervention 
 
MSC 
TAU 
Cohort 1 
Group 1 (12-14 WEH) 
Group 2 (12-14 WEH) 
 
Cohort 2 
 
Group 3 (12-14 WEH) 
Group 4 (12-14 WEH) 
Cohort 3 
Group 5 (12-14 WEH) 
Group 6 (12-14 WEH) 
 
Cohort 4 
 
Group 7 
Group 8 
Cohort 5 
Group 9 
Group 10 
 
Cohort 6 
 
Group 11 
Group 12 
Cohort 7 
Group 13  
Group 14 
 
Cohort 8 
 
Group 15 
Group 16 
 
b. Informed Consent: Interested and eligible women will  complete informed consent at 
a private location at the RDTS with the PI, a GSR, or a RA. Only the PI and GSR can 
sign the informed consent so undergraduate RAs may answer questions about the 
informed consent but final signatures must be obtained from the PI or GSR.  
 
c. Baseline questionnaire administered: 
i. After informed consent, participants will complete an assisted  psychosocial 
interview to measure primary outcomes (PTSD and substance use), secondary 
outcomes (anxiety, depression, hopelessness, ), mediators (emotion-
regulation, self-compassion, moral injury, trauma-related guilt, trauma-
related shame, craving, mindfulness), and covariates (e.g., negative life 

12 
events).  
ii. GSRs and RAs will verbally read  questions with response options provided 
both verbally and on a response card and record  responses on iPads using 
REDCap, accessed through a password. Data will be immediately transferred 
to UCLA’s secure server. 
iii. Women will receive $15 for completing the baseline assessment.  
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. NOTE TO RESEARCH ASSISTANTS: PLEASE TAKE THE 
PICTURE AT THE TIME OF (IMMEDIATELY AFTER) ADMINISTERING 
INFORMED CONSENT. Note that the picture (like any measure) is optional and 
participants can refuse the picture and still participate in the study.   
i. 
The Locator Guide is stored on REDCap and updated at each contact with 
participant, beginning with enrollment and baseline. Participants provide their 
name, date of birth, email, phone number, and social media accounts. We also 
maintain information on the residence of the participant after they are 
discharged from treatment: participants nearly all transfer to a sober living 
home near the Prototypes facility after discharge. In our experience, most 
participants have a phone and can be reached on their phone or via social 
media if their phone is disconnected after discharge. On occasion, after 
discharge, participants live with a friend or family member, but in our prior 
experience working with this population, this is relatively uncommon. 
1. Participants will provide name, email(s), phone number(s), and social 
media account(s) for their close friends and relatives. We will prompt 
the participant for each potential friend or relative, starting with 
parents (mom, dad, stepmother, stepfather), aunts and uncles, adult 
children, partners (husband, wife, father of children, etc.), friends, 
cousins, and other. We update this at each intervention session, as 
participants will often disclose more information to us over time as 
they build trust with our team. In our experience, our participants tend 
to keep in touch with at least one friend or family member, even if 
they return to using substances and become unhoused after discharge.  
2. During follow-ups, GSRs will be responsible for contacting 
participants to schedule their follow-up appointments. We first try to 
contact the participant several times via phone, email, and social 
media accounts. If we are unable to reach the participant, we use the 
Locator Guide and begin to contact their friends and family members. 
We take detailed notes in the Locator Guide on REDCap, including 
dates of contact, who we talked to, and what information we obtained. 
If we can not reach a participant, we continue to re-contact the 
participant and their family until we reach the individual or unless the 
participant, friend, or family member requests us not to contact them 
again.  
a. Another strategy we use is to track unreachable participants is 
to ask other participants in the program if they have spoken to 
the unreachable participant. Frequently, someone else in the 

13 
study will have updated contact information, know where the 
individual is residing, or is able to pass along our contact 
information so the unreachable participant can reach out to us.  
 
e. Intervention  
i. 
Participants will participate in a seven session (six sessions + retreat) adapted 
MSC short course administered over a 6-week timeframe or TAU. WEH will 
be compensated $10 per session.   
 
f. Post-Intervention Follow-up  
i. 
Following the MSC or TAU sessions, participants will complete the 
psychosocial metrics that were assessed at baseline again and be compensated 
$20. Psychosocial assessments for women who leave the RDTS will be 
administered at a location convenient for the participant (e.g., sober living 
home) or by Zoom. 
ii. 
Women in the MSC group will also be invited to participate in-depth 
interviews (approximately 20 minutes in length) to share their experiences 
with the intervention and be compensated $10 for the interview. 
 
g. 4-Month Follow-Up 
i. 
Four months after baseline (approximately 2 months after post-assessment), 
primary and secondary outcomes will be re-assessed, in addition to key 
covariates and recent negative life events. Participants will be contacted using 
the Locator Guide and compensated $30. These sessions will occur in person 
(at a private location convenient for the participant) or over Zoom as 
requested by participant. 
 
3. Phase II Reimbursement 
 
a. Women will receive $5 for the eligibility screener; $15 for completing baseline measures; 
$10 per session in the intervention; $20 for the post-intervention follow-up and $10 if they 
complete an additional interview; and $30 for the 4-month follow-up. 
i. 
Women are paid in cash or a Visa gift card and must sign on the iPad (via REDCap) 
that they have received the payment. If a virtual follow-up, the individual who 
provides compensation will sign.  This must also be initiated, signed, and dated by 
the RA or GSR in charge of payment. 
 
Subsection 2.3 - Phase II Recruitment & Treatment Overview 
 
Table 3. Overview of Phase II Assessments 
Intervention  Recruitment  
Eligibility 
Screen  
Baseline  
Weekly  
Post-
Intervention  
Follow-up 
4-Month  
Follow-up 

14 
MSC  
Info  
meetings 
with PI at 
RDTS 
PTSD  
SBTa  
Psychosocial   
questionnaires
b,c,d  
Demographics  
Locator 
Guidee 
Home 
practice  
adherence  
Accept & 
feasibility  
activitiesf  
Psychosocial   
questionnaires
b,c,d   
~20-minute  
interview 
Psychosocial   
questionnaire
sb,c,d  
TAU  
Info 
meetings 
with PI at 
RDTS 
PTSD  
SBTa 
Psychosocial   
questionnaires
b,c,d  
Demographics  
Locator 
Guidee 
Short   
psych 
surveysg 
Psycho-social   
questionnaires
b,c,d  
Psycho-social   
questionnaire
sb,c,d  
aPTSD, SBT=Short Blessed Test (cognitive impairment screen; >9=likely cognitive impairment); bPrimary 
(PTSD, substance use) & Secondary (anxiety, depression, hopelessness, loneliness)  Outcomes, cMediators: 
emotion-regulation, self-compassion, moral injury, trauma-related guilt, trauma-related shame, craving, 
mindfulness; dCovariates: negative life events; eLocator Guide will be updated regularly; fUsed to provide 
detailed feedback on acceptability & feasibility of  MSC intervention; gSurveys on attitudes, personality, other 
non-clinical factors. MSC=Mindful Self Compassion; TAU=Treatment as Usual 
Subsection 2.4 - Phase II Recruitment & Screening 
 
Women will be recruited from Prototypes, a HealthRIGHT 360 RDTS. The RDTS staff will 
assist the PI and GSR in providing approximately two informational meetings (advertised 
through UCLA IRB-approved flyers and verbally by staff) for interested women where they 
will be informed about the opportunity. Recruitment flyers will also be posted around the 
RDTS. GSRs and RAs will help recruit women and conduct the initial screening in a private 
room or in an area onsite where the interview can not be overheard by others after completing 
the Consent to Screen Script. Progress will be monitored closely by Dr. Garfin the Lab 
Management team. 
There will be eight cohorts in total, each with two intervention groups of 12-14 WEH (see 
Table 2). Each cohort will receive the same intervention (e.g., in Cohort 1 there will be two 
groups of MSC, in Cohort 2 there will be two groups of TAU). The cohorts will be divided 
into two smaller groups of 12-14 WEH (24-26 per cohort) rather than one large group of 24-
26 WEH. Recruitment and the intervention for each cohort will take approximately 6-8 
weeks to complete.  
Dr. Garfin and/or lead GSR(s) 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. 
A member of the research team will read the consent to screen script exactly as written 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 (e.g., 
GSR) will always be onsite to help answer questions. 

15 
The RA or GSR will then administer the eligibility screener to participants via iPad. The 
screener will first assess age, prior homelessness, and cognitive impairment. Cognitive 
impairment will be determined by a score greater than 9 on the Short Blessed Test. 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 iPads using REDCap and will be 
immediately transferred to UCLA’s secure server.  
All participants who complete the screener will receive $5. It is very important to 
compensate all individuals who participate in the screening, even if they are not eligible!!!  
Subsection 2.5 - Phase II Eligibility Criteria 
Inclusion Criteria: 
 
1) Unhoused women or individual who identifies as a woman  (N=202; 101 in each group) 
a. Women over 18 years of age 
b. Able to speak English 
c. Experienced homelessness 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. 
e. Likely subthreshold or threshold PTSD, as measured by the PCL-5. 
f. No cognitive impairment according to a score of < 10 on the Short-Blessed Test 
 
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 
c. Do not meet other inclusion criteria  
Subsection 2.6 - Phase II Intervention Program Description 
 
General Description: Among 202 eligible trauma-exposed WEH, assess the 

16 
impact of the MSC intervention at improving primary (PTSD, substance use) and 
secondary outcomes (depression, anxiety, suicidality) in WEH at a RDTS.  
 
Data Collection Time points: Baseline, Post-Intervention follow-up, 4-month follow-up  
 
Total Duration: 4 months 
 
The following sections will outline the intervention process: 
 
● Pre-intervention Assessments 
● MSC Intervention 
● Treatment as Usual 
● Post-Assessment 
● Dealing with Program Attrition 
● Follow-up 
Subsection 2.7 - 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. 
 
Assessments  
 
Primary outcomes: 
● PTSD PCL-5 (lifetime, past year) 
PTSD symptoms will be measured using the PTSD Checklist for  
DSM-5 (PCL-5),1,2 which will be scored continuously and 
according to diagnostic criteria.2 The PCL-5 initially starts with the 
identification of the presence of exposure to a DSM-V traumatic 
event; assesses actual or threatened death, serious injury or sexual 
violence; and whether the person directly experienced it. Twenty 
additional items assess all four B-E criteria (re-experiencing, 
avoidance, negative thoughts or cognitions, hyperarousal), assessed 
on a Likert-type scale from 0 (not at all) to 4 (extremely). Treatment 
response will be defined as a ≥ 5-point reduction in symptoms and 
clinically meaningful improvement as ≥ 10-point reduction in 
symptoms. PTSD will be assessed for worse lifetime event and (if 
applicable) worst event in the past year.  
 
● Alcohol Use Disorders Identification Test (AUDIT)3 
The AUDIT is part of the National Institute on Drug Abuse (NIDA) 
Clinical Trials Network (CTN) Common Data Elements for use in 

17 
clinical trials. The Audit is a 10-item alcohol screen that helps 
identify persons who are hazardous drinkers or who have active 
alcohol use disorders. It can be calculated as a sum score and will 
be analyzed as a continuous and categorical (yes/no used alcohol) 
outcome.  
● Drug Abuse Screening Test-10 item (DAST)3 
The AUDIT is part of the NIDA CTN Common Data Elements for 
use in clinical trials. The DAST is a 10-item brief, self-report 
instrument for population screening, clinical case finding and 
treatment evaluation research. It can be used with adults and older 
youth. The DAST-10 yields a quantitative index of the degree of 
consequences related to drug abuse. The instrument takes 
approximately 5 minutes to administer and may be given in either a 
self-report or interview format. The DAST may be used in a variety 
of settings to provide a quick index of drug abuse problems. It will 
be evaluated continuously and as a categorical outcome (yes/no).  
 
Secondary outcomes: 
 
● Beck hopelessness inventory4 
This twenty-item measure has been widely used5,6 to assess 
hopelessness through a series of true/false statements (1, 0) that 
create a sum score.  
 
● PROMIS – anxiety7 
This clinically valid, 7 item measure has been developed as part of 
the National Institute of Health (NIH) toolkit to assess anxiety in 
individuals 18 and older. Endpoints range from 1=never to 
5=always. It can be used as a sum score and categorizes responses 
as “none to slight”, “mild”, “moderate,” and “severe”.  
● PROMIS - depression7 
This clinically valid, 8 item measure has been developed as part of 
the NIH toolkit to assess depression in the past two weeks. It 
assesses symptoms ranging from 1=never to 5=always and can be 
used in individuals 18 and older. It can be used as a sum score and 
categorizes responses as “none to slight”, “mild”, “moderate,” and 
“severe”. 
 
● PROMIS – loneliness 
This clinically valid, five item measure was developed as part of the 
NIH toolkit to assesses feelings of social isolation on a five-point 
scale from 1=never to 5=not at all.  
 
Mediators & additional outcomes 
● Self Compassion Scale (SCS)8 

18 
This twelve-item scale assesses self compassion on a scale of 
1=almost never to 5=almost always. Items will be summed and used 
as a continuous measure.  
● Difficulties in Emotion Regulation Scale9 
This 18-item scale assesses emotion dysregulation on a scale from 
1=almost never (0-10%) to 5=almost always (91-100%). It can be 
summed up (several items reverse coded) and also has six subscales: 
Nonacceptance of emotional responses, difficulty engaging in goal-
directed behavior, impulse control difficulties, lack of emotional 
awareness, limited access to emotion regulation strategies, and lack 
of emotional clarity. 
● Mindful Attention Awareness Scale10 
This is a 15-item scale that assesses mindfulness on a scale of 
1=almost always to 6=almost never. It is summed and used as a 
continuous measure.  
● Moral Injury and Distress Scale11 
This six item scale measures moral injury on a scale from 0=not at 
all to 4=extremely. It is coded categorically (yes moral injury=1, no 
moral injury=0) and as a continuous outcome.  
● Craving12 
Craving will be measured for alcohol, opioids, methamphetamine, 
marijuana, psychedelics or other substances (provide name) from 
0=no craving at all to 100=maximum possible.  
● Trauma-related Shame Inventory13 
This 24-item measure assesses trauma-related shame from 0=not 
true of me to 4=completely true for me. It is summed and analyzed 
as a continuous outcome.  
 
 
Covariates:  
● Negative life events14–16 
This measure assesses exposure to 31 possible negative life events 
and assesses if they occurred before age 18, after age 18 or in the 
past year. Seven additional adverse childhood experiences17 will 
also be specifically assessed.  
● Interpersonal Violence Short Form/Revised Conflicts Tactics -Short form  
This twenty-item measure is designed to capture intimate partner 
violence. Specifically, it assesses three tactics used when there is 
conflict in the relationships of dating, cohabiting, or marital couples: 
Negotiation, Physical Assault, and Psychological Aggression. 
Questions are answered in terms of frequency of occurrence. 
Scoring can occur in a variety of ways as outlined here  
● Demographics 
Subsection 2.8 - Phase II MSC Intervention  
(MSC) is a mind-body integrative health intervention that utilizes meditations, other 
contemplative practices, home practices, and experiential exercises (including group 

19 
discussions) to increase SC. MSC can be done in groups of 10-25. To increase 
feasibility of MSC for use in RDTSs, we will aim to adapt MSC to 7 sessions (6 
weekly sessions in alignment with the MSC short course plus the half day retreat 
included in the full course to facilitate skill consolidation). Sessions will be conducted 
in a group-based format: prior research found group-based formats equivalent to 
individual-level interventions for PTSD/SUD. 
 
The MSC sessions are as follows:  
 
Session 1: What is MSC?  
 
o Topics: Why am I here? How to approach MSC. Guiding Principles. 3 components 
of SC. Misgivings.  
o Key Practices for PTSD/SUD: How do I treat a friend? Physiology of SC and 
Criticism SC Break. Informal Practice: SC Bracelets 
 
Session 2: Practicing SC 
 
o Topics: “Resistance & backdraft”. How we cause ourselves unnecessary suffering. 
Development of Safety & Trust. Inner Ally 
o Key Practices: Affectionate Breathing. Practicing Loving Kindness. Soles of the 
Feet. Mindfulness & SC in Daily Life. Here and Now Stone. 
  
Session 3: Discovering Your Compassionate Voice 
 
o Topics: Self Criticism & Safety. Core Values. Compassionate Conversations with 
Self.  
o Key Practices: Meeting the Inner Critic. Finding Phrases. Compassionate Letter to 
Ourselves.  
 
Session 4: SC & Resilience  
 
o Topics: Applying SC to Difficult Emotions. Hidden Values in Suffering. Emotion of 
Shame Described & Demystified.  
o Key Practices: Core Values Exercise. Living with a Vow. Silver Linings.  
 
Session 5: Meeting Difficult Emotions 
o Topics: Self-forgiveness. Challenging Relationships.  
o Key Practices: Compassionate Friend. Meeting Unmet Needs. SC Break in 
Relationships. SC with Equanimity.  
 
Living Deeply Half-Day Retreat:  
o Key Practices: Soft Soothe Allow. Affectionate Breathing. Compassionate 
Movement.  
 
Session 6: Making it Count 
o Topics: Integrate Positive Psychology. Concepts of Savoring, Gratitude, Self-
Appreciation. Tips for Maintaining Practice.  
o Key Practices: Savoring. Gratitude. Self-Appreciation. 

20 
Subsection 2.9 - Phase II Treatment as Usual  
Selecting appropriate attention control groups for behavioral intervention research, particularly for 
mindfulness-based interventions, can be problematic. Comparator groups often also improve as 
they tend to target related mechanisms (e.g., social support, health behaviors, improved attention). 
After weighing the pros and cons, a “treatment as usual” (TAU) approach was selected, whereby 
the MSC will be compared to TAU at the RDTS. However, to control for the confound of weekly 
compensation, TAU participants will meet with study staff seven times over the 6-week period 
and fill out short psychosocial surveys on non-distressing topics (e.g., personality tests, attitudes 
surveys) in exchange for compensation commensurate with the MSC group. We believe this will 
also help with retention of the TAU group over time and strike an appropriate balance between 
controlling for the effects of study participation while minimizing confounds that often occur with 
active control groups in behavioral interventions. 
Subsection 2.10 - Phase II Post Assessment  
After the seventh session (of either MSC or TAU), a post-assessment will be 
administered via tablet. 
 
Assessments (see detailed description above) 
 
Primary outcomes: 
● PTSD PCL-5 (lifetime, past year):  
 
● Substance use  
AUDIT  
DAST 
 
Secondary outcomes: 
● Beck hopelessness inventory  
● PROMIS - anxiety 
● PROMIS - depression 
● PROMIS - loneliness  
 
Mediators & additional outcomes 
● Self Compassion Scale (SCS) 
● Difficulties in Emotion Regulation Scale 
● Mindful Attention Awareness Scale 
● Moral Injury and Distress Scale 
● Craving  
● Trauma-related Shame  
 
Covariates:  
● Negative life events (updated) 
● Interpersonal Violence Short Form  
● Demographics 
 

21 
Women in the MSC group will also be invited to participate in-depth, semi-structured 
interviews (approximately 20 minutes in length) to share their experiences with the 
intervention. They will be compensated $10 for the interview. 
Refusal Subsection 2.11 - Phase II Dealing with Program Attrition  
Based on the team’s prior research, we conservatively estimate 80% retention over time for 
a target enrollment of 202, for a total of 8 cohorts of 24-26 participants (divided equally 
into two groups per cohort). In the team’s prior work, 82% of those screened were eligible 
for participation: thus, we will aim to screen 246 WEH. 
 
We will work hard to ensure retention of participants during the study. The Locator Guide 
is key to maintaining effective follow-up. RAs, GSRs, and the PI will work to ensure 
maximum retention.  
Subsection 2.12 - Phase II Follow-up  
At four-month follow-up, we will contact the women with assistance from the site supervisor or 
by using our Locator Guide. These sessions will occur in person (at a private location convenient 
for the participant) or over Zoom on an encrypted UCLA device as requested by the participant.   
Subsection 2.13 - Phase II Compensation  
The Phase II compensation is listed below. Each participant will receive a total of up to $150 
over the course of the study. 
 
$5 – screener (after completing screener) 
$15 – baseline measures (after completing) 
$10 – per session in the intervention (at the end of each session; for a total of 7 sessions) 
$20 – immediate post-intervention follow-up measures (after the final session) 
*$10 - if they complete an additional qualitative interview  
$30 – 4-month follow-up (after completion) 
 
Both the MSC and TAU groups will receive a certificate of completion at the end of the 6-week 
(7 session) program.   
Subsection 2.14 - 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, as is typical with MSC programs. 
All trainers will be certified in MSC and have an interest in working with unhoused persons.  
Subsection 2.15 - Research Staff Competencies & Training 
UCLA has implemented an educational program on the protection of human research 

22 
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 training on file. The following courses 
should be completed by all staff prior to engaging in study activities. 
 
• Human Research - Social & Behavioral Researchers & Staff 
• Good Clinical Practices (GCP) courses (mandatory for RAs & GSRs)  
• 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. 
• Trained in our “RED FLAG” protocol and in reporting adverse events. Any adverse event 
will be documented in REDCap and reported to the IRB if appropriate.  
• During research study training, the research team will be supervised by the PI as they 
practice the scripts for the screener, psychosocial questionnaires, and collecting data using 
REDCap. 
 
Subsection 2.16 - 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. 
• The GSRs, as supervised by Dr. Garfin, will routinely check to ensure data is accurately 
entered. 
 
Procedures to safeguard confidentiality 
Confidentiality of data will be protected by use of subject code on all data and questionnaires. 

23 
Any forms that link participant with their codes will be stored electronically on UCLA’s secure 
server and only senior research staff and the PI will have access. All self-report data will be 
immediately uploaded onto UCLA’s secure server via REDCap.  
 
• Participants will be reminded that their interview questions will be provided over a tablet 
that will immediately transfer the data to the UCLA 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. 
 
• 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 2.17 - Using REDCap 
 
• For electronic data electronic data entry, log onto REDCap with you user ID and password:  
(https://gpsslvpn.mednet.ucla.edu/https/ctrcapps.medsch.ucla.edu/redcap/)  
 
• 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 2.18 - Data Security  
 
• All 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.  

24 
• All databases are accessible only to key investigators and research assistants on the project 
though password-protected login. Each member of the research team has their own 
personal password and login (administered through UCLA Mednet).  
• The electronic data files are stored on the secure, password-protected UCLA server. 
•  This data is available for access on the UCLA server to authorized users through a 
password-protected web application. 
• Authorized users can export deidentified 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.  
Subsection 2.19 - Post Data Collection  
 
• Validity checks on REDCap will 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 2.20 - 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. 
Section 3 – Data analytic plan  
• Power analysis. Sample size was estimated using G*Power18,19 and standard guidelines for 
testing mediation,20 with α=.05, β=.80, and the standard deviation bound at ±1.91. Effect 
size estimates were derived from prior research on SC interventions for PTSD, which found 
a small-medium effect size (Cohen’s d=0.2-0.5).21 Particularly since the effect of MSC to 
reduce PTSD symptoms is emerging research, findings have been mixed regarding effect 
sizes for direct and indirect effects of SC interventions on PTSD, with some studies finding 
large effects of reduced PTSD due to SC interventions,22,23 and others finding medium 
effect sizes.24 (Of note, few randomized trials have been conducted).21  To account for 
additional covariates, the clustering design,25 and Type 1 error due to multiple tests, a 
small-medium effect size of .3 was conservatively estimated. Sample size appropriate for 
mediation was derived from a percentile bootstrap method, which simulations consistently 
show to be the most powerful test compared to similar methods (e.g., Sobel, bias-corrected 
bootstrap).20 This yielded a final sample size of 162. Based on the team’s prior research, 
we conservatively estimate 80% retention over time for a target enrollment of 202, for a 
total of 8 cohorts of 24-26 participants (divided equally into two groups per cohort). In the 

25 
team’s prior work, 82% of those screened were eligible for participation: thus, we will aim 
to screen 246 WEH. 
 
• 
Statistical analysis. Initial analysis will include descriptive statistics. Data will be screened 
for outliers and deviations from normality; results will be considered in subsequent 
analyses. Patterns of missing data will be examined using logistic regression (0=missing; 
1=complete) and will be reported in results. Based on prior research, very little missing 
data on key independent or dependent variables is expected.26,27 Any missing data on 
independent variables or continuous dependent variables will be imputed using multiple 
imputation and related methods.28 Although cohorts should be comparable in terms of 
demographics (e.g., age, ethnicity) and other risk factors (e.g., type of drug use, history of 
recidivism), propensity score methods and/or multilevel analyses (with cohort/cluster as a 
random effect25) will be utilized to account for these or any other covariates statistically 
different between cohorts at baseline. Reliability for computed scores will be assessed 
using Cronbach’s alpha. Next, a series of t-tests and chi-squares will examine differences 
between groups (MSC vs. TAU). Then, for each dependent variable of interest, key 
predictors and covariates will be examined using a series of t-tests, chi-squares, and 
ordinary least squares (for continuous outcomes) and logistic (for dichotomous outcomes) 
bivariate regression models. Type, timing and amount of trauma exposure will be examined 
as covariates, given their link with PTSD incidence, severity,29,30 substance use,31–33 and 
distress. 
 
• To evaluate reductions in PTSD symptoms, first, treatment response (≥ 5-point reduction 
in symptoms) and clinically meaningful improvement (≥ 10-point reduction in symptoms) 
will be calculated for both immediate and 4-month follow-up. Potential covariates (e.g., 
demographic indicators; type, timing and amount of trauma exposure, including history of 
incarceration) will be screened for inclusion (included if p<.05). Change over time will be 
analyzed, using data from the three time points, using a mixed-effects repeated measures 
approach. This will also allow for a test of fixed (e.g., treatment group) and random (e.g., 
cohort) effects over time and conserves power by capitalizing on the longitudinal design. 
Reductions in PTSD will be examined using a modified Poisson distribution with robust 
variance, which tends to be less biased than a logit-based approach. Reductions in 
symptoms (measured continuously) will also be evaluated using a Gaussian distribution. 
Substance use will be evaluated using the TLFB, quantified as time to first use, days of use 
and relapse status (abstinent [did not use], lapse [used after study intervention but did not 
revert to regular use], or relapse [used substances for more than one third of days]).34,35  
Group x time contrasts will be tested. Identical analytic approaches will be used to examine 
secondary outcomes (suicidality, depression, and anxiety).   
 
• To test for mediation effects, AGReMA (A Guideline for Reporting Mediation Analyses 
of Randomized Trials and Observational Studies)36 will be followed. A series of 
longitudinal structural equation models (SEM)37 will examine both direct and indirect 
effects by which change in mediators (emotion regulation, trauma-related guilt, trauma-
related shame, moral injury and craving) are associated with change in PTSD, substance 
use, and secondary outcomes over time. Confidence intervals for indirect effects will be 
obtained through percentile bootstrap.37 SEM has the capacity to test for bidirectional 

26 
effects between PTSD symptoms and substance use.  Model fit (e.g., Root Mean Square 
Error of Approximation) will be compared to find hypothesized paths that best fit the 
data.37  
 
 
Section 4. References 
 
1.  
Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr PP. The PTSD 
Checklist for DSM-5 (PCL-5). Natl Cent PTSD. 2013;5(August):2002. 
doi:10.1037/t02622-000 
2.  
Wortmann JH, Jordan AH, Weathers FW, et al. Psychometric analysis of the PTSD 
checklist-5 (PCL-5) among treatment-seeking military service members. Psychol Assess. 
2016;28(11):1392-1403. doi:10.1037/pas0000260 
3.  
Babor, T., Higgins-Biddle, J. C., Saunders, J. B., Monteiro MG. The Alcohol Use 
Disorders Identification Test: Guidelines for use in primary care. Geneva World Heal 
Organ. Published online 2001. 
4.  
Beck AT. Beck Hopelessness Scale. The Psychological Corporation; 1988. 
5.  
Viswanathan M, Wallace IF, Cook Middleton J, et al. Screening for depression and 
suicide risk in children and adolescents: Updated evidence report and systematic review 
for the US Preventive Services Task Force. JAMA. 2022;328(15):1543-1566. 
doi:10.1001/jama.2022.16310 
6.  
Hacimusalar Y, Kahve AC, Yasar AB, Aydin MS. Anxiety and hopelessness levels in 
COVID-19 pandemic: A comparative study of healthcare professionals and other 
community sample in Turkey. J Psychiatr Res. 2020;129(May):181-188. 
doi:10.1016/j.jpsychires.2020.07.024 
7.  
Schalet BD, Pilkonis PA, Yu L, et al. Clinical validity of PROMIS Depression, Anxiety, 
and Anger across diverse clinical samples. J Clin Epidemiol. 2016;73:119-127. 
doi:10.1016/j.jclinepi.2015.08.036 
8.  
Neff KD. The development and validation of a scale to measure self-compassion. Self 
Identity. 2010;2(3):223-250. doi:10.1080/15298860309027 
9.  
Gratz KL, Roemer L. Multidimensional assessment of emotion regulation and 
dysregulation: Development, factor structure, and initial validation of the Difficulties in 
Emotion Regulation Scale. J Psychopathol Behav Assess. 2004;26(1):41-54. 
doi:10.1023/B:JOBA.0000007455.08539.94 
10.  
Brown KW, Ryan RM. The Benefits of Being Present: Mindfulness and Its Role in 
Psychological Well-Being. J Pers Soc Psychol. Published online 2003. doi:10.1037/0022-
3514.84.4.822 
11.  
Koenig HG, Youssef NA, Pearce M. Assessment of moral injury in veterans and active 
duty military personnel with PTSD: A review. Front Psychiatry. 2019;10(JUN):1-15. 
doi:10.3389/fpsyt.2019.00443 
12.  
McMillan DE, Gilmore-Thomas K. Stability of opioid craving over time as measured by 
visual analog scales. Drug Alcohol Depend. 1996;40:235-239. 
13.  
Øktedalen T, Hagtvet KA, Hoffart A, Langkaas TF, Smucker M. The Trauma Related 
Shame Inventory: Measuring trauma-related shame among patients with PTSD. J 

27 
Psychopathol Behav Assess. 2014;36(4):600-615. doi:10.1007/s10862-014-9422-5 
14.  
Sweeting JA, Garfin DR, Holman EA, Cohen R. Associations between exposure to 
childhood bullying and abuse and adulthood outcomes in a representative national U.S. 
sample. Child Abuse Negl. 2020;101:104048. doi:10.1016/j.chiabu.2019.104048 
15.  
Seery MD, Holman EA, Silver RC. Whatever does not kill us: cumulative lifetime 
adversity, vulnerability, and resilience. J Pers Soc Psychol. 2010;99(6):1025-1041. 
doi:10.1037/a0021344 
16.  
Garfin DR, Holman EA, Silver RC. Exposure to prior negative life events and responses 
to the Boston marathon bombings. Psychol Trauma. 2020;12(3):320-329. 
doi:10.1037/tra0000486 
17.  
Felitti VJ, Anda RF, Nordenberg D, et al. Relationship of childhood abuse and household 
dysfunction to many of the leading causes of death in adults. The Adverse Childhood 
Experiences (ACE) Study. Am J Prev Med. 1998;14(4):245-258. doi:S0749379798000178 
[pii] 
18.  
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: A flexible statistical power 
analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 
2007;39(2):175-191. doi:10.3758/BF03193146 
19.  
Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: 
tests for correlation and regression analyses. Behav Res Methods. 2009;41(4):1149-1160. 
doi:10.3758/BRM.41.4.1149 
20.  
Fritz MS, MacKinnon DP. Required sample size to detect the mediated effect. Psychol 
Sci. 2007;18(3):233-239. doi:10.1111/j.1467-9280.2007.01882.x 
21.  
Winders SJ, Murphy O, Looney K, O’Reilly G. Self-compassion, trauma, and 
posttraumatic stress disorder: A systematic review. Clin Psychol Psychother. 
2020;27(3):300-329. doi:10.1002/cpp.2429 
22.  
Lang AJ, Casmar P, Hurst S, et al. Compassion meditation for veterans with posttraumatic 
stress disorder (PTSD): A nonrandomized study. Mindfulness (N Y). 2020;11(1):63-74. 
doi:10.1007/s12671-017-0866-z 
23.  
Müller-Engelmann M, Schreiber C, Kümmerle S, Heidenreich T, Stangier U, Steil R. A 
trauma-adapted mindfulness and loving-kindness intervention for patients with PTSD 
after interpersonal violence: A multiple-baseline study. Mindfulness (N Y). 
2019;10(6):1105-1123. doi:10.1007/s12671-018-1068-z 
24.  
Kearney DJ, Malte CA, McManus C, Martinez ME, Felleman B, Simpson TL. Loving-
kindness meditation for posttraumatic stress disorder: A pilot study. J Trauma Stress. 
2013;26:426-434. doi:10.1002/jts 
25.  
Wears RL. Advanced statistics: Statistical methods for analyzing cluster and cluster-
randomized data. Acad Emerg Med. 2002;9(4):330-341. 
26.  
Nyamathi AM, Shin SS, Smeltzer J, et al. Achieving Drug and Alcohol Abstinence among 
Recently Incarcerated Homeless Women: A Randomized Controlled Trial Comparing 
Dialectical Behavioral Therapy-Case Management with a Health Promotion Program. 
Nurs Res. 2017;66(6):432-441. doi:10.1097/NNR.0000000000000249 
27.  
Garfin DR, Nyamathi AM. Mindfulness-based intervention for trauma-exposed homeless 
women: A pilot study. In: American Public Health Association Annual Meeting. ; 2022. 
28.  
Li P, Stuart EA, Allison DB. Multiple imputation: A flexible tool for handling missing 
data. JAMA - J Am Med Assoc. 2015;314(18):1966-1967. doi:10.1001/jama.2015.15281 
29.  
Luthra R, Abramovitz R, Greenberg R, et al. Relationship between type of trauma 

28 
exposure and posttraumatic stress disorder among urban children and adolescents. J 
Interpers Violence. 2009;24(11):1919-1927. doi:10.1177/0886260508325494 
30.  
Scott ST. Multiple traumatic experiences and the development of posttraumatic stress 
disorder. J Interpers Violence. 2007;22(7):932-938. doi:10.1177/0886260507301226 
31.  
Steudte-Schmiedgen S, Kirschbaum C, Alexander N, Stalder T. An integrative model 
linking traumatization, cortisol dysregulation and posttraumatic stress disorder: Insight 
from recent hair cortisol findings. Neurosci Biobehav Rev. 2016;69:124-135. 
doi:10.1016/j.neubiorev.2016.07.015 
32.  
Inslicht SS, Marmar CR, Neylan TC, et al. Increased cortisol in women with intimate 
partner violence-related posttraumatic stress disorder{star, open}{star, open}Research 
was conduited at the University of Pittsburgh. First author is now at the Department of 
Veterans Affairs, San Francisco and at. Psychoneuroendocrinology. 2006;31(7):825-838. 
doi:10.1016/j.psyneuen.2006.03.007 
33.  
Friedman MJ, Jalowiec J, McHugo G, Wang S, McDonagh A. Adult sexual abuse is 
associated with elevated neurohormone levels among women with PTSD due to childhood 
sexual abuse. J Trauma Stress. 2007;20(4):611-617. doi:10.1002/jts. 
34.  
Amaro H, Black DS. Mindfulness-based intervention effects on substance use and relapse 
among women in residential treatment: A randomized controlled trial with 8.5-month 
follow-up period from the moment-by-moment in women’s recovery project. Psychosom 
Med. 2021;83(6):528-538. doi:10.1097/PSY.0000000000000907 
35.  
Gossop M, Stewart D, Browne N, Marsden J. Factors associated with abstinence, lapse or 
relapse to heroin use after residential treatment: Protective effect of coping responses. 
Addiction. 2002;97(10):1259-1267. doi:10.1046/j.1360-0443.2002.00227.x 
36.  
Lee H, Cashin AG, Lamb SE, et al. A Guideline for Reporting Mediation Analyses of 
Randomized Trials and Observational Studies: The AGReMA Statement. JAMA. 
2021;326(11):1045-1056. doi:10.1001/jama.2021.14075 
37.  
Goldsmith KA, MacKinnon DP, Chalder T, White PD, Sharpe M, Pickles A. Tutorial: The 
practical application of longitudinal structural equation mediation models in clinical trials. 
Psychol Methods. 2018;23(2):191-207. doi:10.1037/met0000154