Expressing Personal Recollections in English or Spanish to Alleviate Traumatic Emotions (Exprésate)
Phase: NA
Conditions: Post Traumatic Stress Disorder
Sponsor: University of Miami

IRB Study Number: 20190760
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Title: Expressing Personal Recollections in English or Spanish to 
Alleviate Traumatic Emotions (Exprésate)
Protocol Number: 20190760
Protocol Version: 10
Protocol Date: 06/06/2022
PI Name: Roger McIntosh, Ph.D.
NCT number:  NCT05090839
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1)
Protocol Title
Expressing Personal Recollections in English or Spanish to Alleviate 
Traumatic Emotions (Exprésate)
2)
IRB Review History
This study protocol has not been previously submitted for review by an 
external IRB. 
3)
Study Objectives
Participants will be recruited from the greater Miami-Dade area via flyer and chain 
referral. This study aims to recruit 36  Latinas with a history of trauma into one of 3 
separate arms of an augmented 4-week written emotional disclosure (WED) 
intervention: (1) Spanish-only, (2) English-only, and (3) non-trauma daily event 
writing in Spanish). This study seeks to test the hypothesis that WED regarding 
traumatic experience in one’s primary, i.e., Spanish, language will be associated with 
more positive health outcomes than English WED or non-trauma related writing in 
Spanish. Collected prior to and after this intervention will be biomarkers, 
neurocognitive, psychiatric, sociocultural, and neuroimaging data to address the 
following study objectives: 
To determine whether in Latinas with or without HIV exposure to an expressive 
writing intervention in Spanish will have an effect on primary study outcomes, i.e., 
changes in verbal learning & memory as well as symptoms of post-traumatic stress. 
To determine whether exposure to an expressive writing intervention, delivered in 
either English vs. Spanish will have an effect on secondary study outcome biomarkers 
that are linked to cognitive and emotional functioning, i.e., changes in task and resting 
state functional brain activity and connectivity and stress hormone reactivity. 
To explore whether intervention-related changes in primary and secondary outcomes 
is associated with changes in gene expression of transcription factors associated with 
brain glucocorticoid as well as peripheral inflammation-immune activation. 
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4)
Outcome Measures
a) Primary Outcome(s)
Title: Change in PTSD symptoms as assessed by the Impact of Event Scale 
Description: 22-item self-report instrument that corresponds to DSM-IV 
symptoms of PTSD over last 7 days on a scale from 0 (not at all) to 4 (extremely).
Time Frame: Pre-intervention (Session 1) and at post-intervention (Session 6) 
Title: Change in verbal learning as assessed by Hopkins Verbal Learning Task 
Description: Measures verbal learning and memory function. (Three immediate 
recall trials) (0 no words recalled - 12 all words recalled).
Time Frame: at post-intervention (Session 6) 
b) Secondary Outcome(s)
Title: Change in functional connectivity of the Default Mode Network (DMN). 
Description: DMN is a large scale network of interacting brain regions implicated 
in emotion and memory. Activity/connectivity indexed by Fisher’s Z or Beta wt.
Time Frame: Pre-intervention (Session 1) and at post-intervention (Session 6) 
Title: Change in salivary measures of stress reactivity.                                
Description: 200 μL of saliva will be used for immunosorbent assay of alpha 
amylase (sAA) and adrenal corticotrophin releasing hormone (ACTH).
Time Frame: Pre-intervention (Session 1) and at post-intervention (Session 6) 
c) Exploratory Outcome(s)
Title: Change in gene expression of inflammatory immune function.                               
Description: A peripheral blood sample will be used for immunosorbent assay of 
NF-κB p65 which is a transcription factor for a gene that controls inflammatory 
cytokine expression in peripheral white blood cells. 
Time Frame: Pre-intervention (Session 1) and at post-intervention (Session 6)
Title: Change in gene expression of glucocorticoid activity.
Description: A peripheral blood sample will be used for immunosorbent assay of 
FKBP5 which is a transcription factor for a gene that controls co-chaperone that 
modulates glucocorticoid receptor activity in response to stress in brain & body. 
Time Frame: Pre-intervention (Session 1) and at post-intervention (Session 6)
5)
Background 
Trauma and neurocognitive function. Post-traumatic stress disorder (PTSD) and its 
symptoms of emotional numbing, intrusion, avoidance, and hyperarousal is three to 
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five times more likely to be experienced in women living with HIV (WLHIV) 
compared to their HIV-negative counterparts (1-4). Intrusive thoughts of traumatic 
events are vigilantly avoided in PTSD and attention divided or shared between task-
relevant and task-irrelevant thoughts. This places excessive demands of attentional 
and inhibitory cognitive resources, thus depleting cognitive task performance (5, 6). 
Amongst HIV+ women PTSD accelerates the rate of neurocognitive decline (7, 8). 
Hispanics/Latinos not only show higher rates of learning and memory impairment 
than non-Hispanic Whites (9-13), but these impairments are more pronounced in 
older adult Latinas (11).  This accelerated cognitive decline may be attributed to the 
gambit of issues facing Hispanic/Latina or low SES WLHIV such as substance 
abuse, violence, and HIV/AIDS (SAVA) (14-17). Although HIV+ women show 
deficits in multiple cognitive domains, decrements in verbal learning and memory 
are particularly sensitive to traumatic stress associated with violence or sexual abuse 
(7, 18-20). Functional magnetic resonance imaging (fMRI) has recently begun 
elucidating the syndemic effects of SAVA on encoding and recognition phases of a 
verbal learning and memory. In a high-stressed cohort of HIV+ women greater levels 
of PTSD not only predicted poorer verbal memory performance but greater 
deactivation of the medial prefrontal cortex (MPFC) and posterior cingulate cortex 
during episodic memory retrieval suggesting less efficient strategic retrieval (21).
Trauma and neuroendocrine function. Response of the hypothalamic-pituitary-
adrenal (HPA)-axis varies considerably in traumatized women due to sex-endocrine 
changes and glucocorticoid sensitivity (22-25). Nevertheless, it is clear that HPA 
activity enhances the consolidation of fear learning extinction similar to its effect on 
episodic memory retrieval (26). In a most recent study a single dose of hydrocortisone 
was found to enhance learning and memory performance in a high-stressed group of 
HIV+ women (27). Moreover, when exposed to stress, cortisol responders show 
greater memory retrieval of everyday information (28). In tandem with HPA activity 
plasma and salivary cortisol levels have been linked to amygdala (29) and medial 
prefrontal cortex brain metabolism (30, 31). In a study of veterans with and without 
PTSD our group and collaborators observed that individuals with attenuated adrenal 
corticotophic hormone (ACTH) responses to trauma recall showed greater activity in 
the MPFC compared to high ACTH responders to stress (32). Recently, greater 
expression of FKBP5, a gene that regulates glucocorticoid receptor sensitivity 
reducing the affinity of cortisol and the nuclear translocation of the receptor, was 
found to predict higher activity, larger volume and increased coupling of the left 
hippocampus with the medial prefrontal cortex in individuals with a history of 
childhood adversity (33). In the absence of FKBP5 gene expression there is an 
increase in sensitivity of the hypothalamic-pituitary axis to negative glucocorticoid 
feedback thus leading to lower cortisol level after acute stress observed in PTSD (34-
36). 
Inflammation. Although the CD4+ T-helper cell is established as a subclinical 
marker of HIV disease progression, studies have failed to establish a stable 
relationship between either CD4 or peripheral viral load RNA and rate of mood 
disturbance and neurodegeneration. Our group has reviewed literature surrounding 
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the effect of pro-inflammatory monocyte expansion on cognitive, emotional, 
cardiovascular and immune outcomes in persons living with HIV//AIDS (37). A 
particular class of non-typical monocyte, i.e., CD16++, are implicated in the cellular 
signaling, trafficking, proliferation, and apoptosis associated with neurocognitive 
dysfunction (38). Once trafficked to the brain by the monocytes, pro-inflammatory 
cytokines IL-6 and TNF-alpha are released from the HIV gp120 envelope and 
consequentially disrupt subcortical and cortical networks (39-42). Conceivably, these 
neurotrophic processes may alter connectivity of limbic networks. Inversely, HPA 
axis dysregulation attributed to functional brain changes has implications for 
inflammatory-immune regulation in PLWH. For example, medial prefrontal cortex 
(MPFC) MPFC-mediated regulation of the HPA-axis normally increases cortisol 
output and binding to glucocorticoid receptors on monocytes to halt expression of 
pro-inflammatory cytokines (43, 44). Although hypocortisolemia may contribute to 
the pro-inflammatory state in PTSD and HIV, glucocorticoid resistance on peripheral 
monocytes is widely noted (45-47). Under normal circumstances the binding of 
peripheral glucocorticoid receptors suppresses Th1 activity hence down-regulating 
gene expression of pro-inflammatory cytokines in monocytes (48-50). Traumatized 
women show reduced levels of serum and plasma cortisol and higher levels of pro-
inflammatory cytokines (51-56). Moreover, recovery from trauma is associated with 
a decrease in inflammatory cytokine levels (57). A recent study amongst virally-
suppressed HIV+ women found that markers of monocyte activation predicted worse 
verbal learning and memory performance and global cognitive function (58, 59).
Trauma and therapeutic response. Our group has previously reported large gender-
based effects for reductions in PTS symptomology following 1-month following an 
expressive writing intervention for a sample of 96 predominately African-
American HIV+ women living in Miami (60).  Hispanic/Latina women were 
largely underrepresented in this sample.  There is a scarcity of MRI studies 
examining the effects of expressive writing interventions, however a 12-week 
cognitive behavioural therapy intervention in adults with PTSD was not only 
shown to increase hippocampal volume but also expression of FKBP5 suggesting 
greater efficacy of cortisol on brain following a trauma intervention (61, 62). 
Moreover, increased DNA methylation at promotor regions for FKBP5 expression 
have been linked to reduction in symptom severity following exposure therapy in 
persons with anxiety disorders (63). 
6)
Recruitment of Sample  
Study-Wide Recruitment Methods. Thirty-six Hispanic/Latina women with a history 
of trauma, (i.e., childhood abuse, intimate partner, domestic violence), over the age 
of 21 will be recruited from the greater Miami-Dade area. Potential subjects will be 
identified through the use of advertisements placed at local HIV outpatient clinics 
throughout the greater South Florida area. 
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The Miami Center for AIDS Research (CFAR) Behavioral/ Social Science & 
Community Outreach Core (Core E) provides CFAR investigators with consultation 
and resources to expand behavioral clinical studies. The underlying goals are to 
enhance recruitment and retention of community and clinic-based study participants 
with attention to “hard to reach populations.”  Core E offers CFAR investigators the 
services of an Outreach Coordinator who can oversee the study recruitment and 
assessment activities of research projects. The Outreach Coordinator can also 
determine the best recruitment strategy, conduct participant outreach, recruitment, 
assessment and site coordination. Participants may be recruited through the outpatient 
referral service of the CFAR, advertisement at outpatient treatment centers and chain-
referral. The initial (pre-screening) will take place via phone, in-person at the CFAR 
outreach center or electronic via survey link. The collection of this information is 
intended to elucidate whether the individual meets the inclusion criteria for 
participating in the study (see Screening section of procedures below).
Provided inclusion criteria are met, referrals will be scheduled for a telephone follow-
up and scheduling for the first study. Individuals meeting eligibility criteria will be 
then be invited to the Coral Gables campus for an in-person COVID-19 and urine 
toxicology screening, prior to enrollment. 
This study will actively recruit participants through the Community Outreach Core 
and Clinic Registry Project for the Center for HIV and research in Mental Health 
(CHARM) (IRB#20160911) of the University of Miami Center for AIDS Research. 
This mechanism allows IRB-approved study investigators the ability to search and 
identify potential willing research participants who meet study criteria. Upon 
contact, patients will verify their identity before being informed about the study and 
moving forward with the screening process. Patients will also be informed they 
have the right to change their consent in order to decline to be contacted for future 
studies. 
Participants will also be recruited from the Miami MWCCS E-Prost Protocol No. 
20210476, a study of men and women living with HIV in the US. The MWCCS has 
approved a concept sheet to refer MWCCS participants to this study. MWCCS participants 
who meet inclusion criteria will be asked by the MWCCS team, for willingness to 
participate in this study. Those interested participants will be given the contact information 
to contact the study directly, or if they prefer, their contact will be shared with study staff 
to contact them and provide information about the study.
Exclusion criteria. Following initial referral, participants will be assessed for PTSD 
over the phone through the primary care PTSD screen for DSM-5 (PC-PTSD-5) 
(64). After the participant has consented an in-house screener will also be used to 
assess substance dependency, suicidal ideation, history or treatment for 
schizophrenia or bipolar disorder, as well as severe dementia indexed by the Mini-
Mental State Examination (MMSE) (65). Additional exclusion criteria include the 
following: 1) Left-handedness or ambidextrous; 2) Inability to tolerate the scanning 
procedures (e.g., claustrophobia); 3) Metal in body or prior history working with 
metal fragments (e.g., as a machinist); 4) Any other contraindications for MRI 
examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or 
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known metal fragments embedded in the body); 5) currently pregnant or could be 
pregnant ; 6) Heavy alcohol intake (> 3 drinks) within 12 hours prior to participation 
in fMRI ; 7) Evidence from health history of neurological or systemic disorder which 
can cause cognitive impairment; 8) Self-reported current diagnosis of psychiatric 
disorder or psychoactive substance abuse or dependence; 9) Recent history (within 
two years) of myocardial infarction; 10) Severe cardiovascular disease, or currently 
active cardiovascular disease (e.g., angina, cardiomyopathy); 11) Uncontrolled 
hypertension or hypotension; 12) History of closed trauma with loss of 
consciousness; 13) Space occupying lesions (e.g., mass lesions, tumors); 14) CNS 
infection; 15) CNS vasculitis; 16) CNS demyelinating disease (e.g., multiple 
sclerosis); 17) Congenital CNS abnormality (e.g., cerebral palsy); 18) Seizure 
disorders; 19) History of cerebrovascular disease (e.g., stroke, TIA’s)
Inclusion criteria. 1) Age ≥ 21 years; 2) Elevated PTSD symptoms as assessed by 
the PCL-5 using a cut-off of 34 or above. This measure has been validated using the 
gold standard against the goal standard for PTSD, i.e., Clinician-administered PTSD 
scale for DSM-5 (CAPS-5) (66, 67). Although the current gold-standard, i.e., DSM-
5 has not been translated to Spanish, if this is not available at the time of study we 
will revert back to the Spanish version of the PCL-C adapted for DSM-IV (68). The 
Davidson Trauma Scale (DTS) will be used as a back-up to identify DSM-IV 
symptoms for post-traumatic stress disorder (PTSD); 3) on a stable anti-retroviral 
therapy regimen for > 6 months as assessed with the Adult AIDS Clinical Trial Group 
structured interview (69); 4) Spanish-English bilingual as measured by the Brief 
Acculturation Scale for Hispanics (cut-off of 3), Spanish speaker or English speaker 
5) Participant is willing and able to sign ICF; 6) self-report as Latina (i.e. self-
reported); 7) HIV positive serostatus as determined by medical record within the last 
12 months; 8) born female. 
7)
Study Design
a) Primary purpose
To determine whether in (LLWH) exposure to an expressive writing intervention in 
Spanish will have an effect on primary and secondary study outcomes. 
b) Interventional study model
Randomized control trial with participants randomized to either the augmented 
trauma-writing intervention in English, the augmented trauma-writing intervention 
in Spanish or the daily-event-writing control in English/Spanish. Both experimental 
and control participants will visit the study on four occasions during a 4-week 
period so that they could write for 30 min in a private office.
8)
Procedures
General overview. Upon meeting all eligibility criteria individuals will be consented 
into the study. Full participation in the study will involve 6 separate session. The first 
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and sixth sessions will last approximately 4-5 hours. On the evening prior to these 
sessions participants will perform an overnight fast and told to avoid drugs, alcohol 
and exercise. On the mornings of session 1 and 6 participants will report to the Cox 
Neuroscience Annex (CNA). Participants will be compensated $80 each for the pre- 
and post-intervention sessions.  Participants will also receive $20 for attending each 
online writing session. Each participant will be compensated using the Zelle ™ 
mobile banking application.
Screening. Prior to informed consent individuals will undergo screening using the 5-
item PTSD checklist (PC-PTSD-5) in order to determine their eligibility to participate 
in the study.   This is required given trauma interventions can potentially have adverse 
effects on asymptomatic individuals. . After the initial screening, referrals will be 
instructed to bring a copy of their most recent HIV labs (drawn within the last 6 
months) for their in-person screening session, if they are HIV+. Labs will not be 
requested for the HIV- participants. After obtaining informed consent, we will make 
a copy of those labs, remove any identifiable information, and return the original copy 
to the research participant.
Pre- and post-intervention Sessions 1a and 6a (intake). After adhering to overnight 
fasting protocols on both days participants will report to the Neuroimaging Suite 
(NIS) located on the second floor of the University of Miami Neuroscience Building 
(Cox Neuroscience Annex (CNA)) at 5151 San Amaro Drive, Coral Gables, FL 
33146. Participants will be asked to wear comfortable clothing. Participants will 
undergo a series of screenings prior to being admitted entry into the NIS, including 
an fMRI metal screening and (see CNA standard operating procedures). After 
completion of the ICF the initial procedures will involve a clinical intake wherein 
participants will have their height, weight, waist and hip girth measured along with a 
standard information regarding medical history and pre-scan mood state, They will 
then have their time point 1 bloods drawn through an intravenous (IV) Teflon-based 
catheter inserted antecubital by an experienced phlebotomist. Three 10-15ml vials 
will be drawn in (2) heparin and (1) EDTA containers of blood will be drawn from 
all participants at time point 1. 
Pre- and post-intervention Sessions 1b and 6b (MRI). Following the blood draw, the 
participant will have a 10-minute mock scan to allow the them to become acclimated 
to the MR environment and the cognitive task. Following the mock scan participants 
will need to complete an fMRI metal screening and be interviewed by the MR tech 
to ensure there are no potential hazards during scanning. Prior to the scan, and after 
the scan participants will be asked to provide a saliva sample. We will collect a small 
amount of saliva, using a disposable salivette to measure stress hormones and 
inflammation. During the scan, simultaneous recording of pulse, respiratory rate, and 
blood pressure will take place to monitor physiological arousal levels. Immediately, 
following the scan, the IV line will be flushed. At the conclusion of the real MRI 
session (time point 2) an additional (2) 20ml vials of blood will be drawn in 
heparinized tubes. 
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Pre- and post-intervention Sessions 1b and 6b (post-scan assessments). Following the 
blood draw (T2), participants will be escorted to a separate room. Within this room, 
they will be fitted with electrodes for measurement of heart rate, respiratory rate and 
blood pressure during the completion of a behavioral self-compassion task. This task 
will take approximately 30 minutes to complete. Following completion of this task a 
third blood draw (T3) will be performed and (2) 20ml tubes will collected for 
immediate processing.  Following the compassion task a battery of psychosocial and 
neurocognitive measures will be administered lasting approximately 90 – 120 
minutes.  The estimated time of completion for all Session 1a & 6a activities is 4 
hours per session. Participants will compete a psychosocial battery of self-report 
questionnaires using a laptop or personal computer (See Table 1). Following the 
surveys participants will engage in an exit interview. 
Sessions 2-5: Arms and Interventions.
Arms 1 & 2 (Intervention). Twenty-four women will be randomized to the 2 arms of 
the intervention involving written emotional disclosure in English or Spanish. 
During the 4 writing days, participants will be asked to write about the most 
traumatic or upsetting experiences of their entire life. In their writing, they will be 
asked to “really let go” and explore their “very deepest emotions and thoughts.” 
Subjects will be told that it is best to write about a major trauma and encouraged to 
write about the same experience on all 4 days. However, they will also be told it is 
okay if they write about current conflicts. Subjects will be encouraged to write about 
traumas or conflicts they have not discussed in great detail with others. They will be 
told to write continuously for 20 min. These instructions were developed by Dr. Gail 
Ironson and based upon those used in previous studies (70, 71), that were adopted 
along with a writing probe to assess the effect of WED on post-traumatic, depressive 
and disease related outcomes amongst HIV+ women (60). Scripts and instructions 
will be delivered exclusively in Spanish for the S-WED group and exclusively in 
English for the E-WED groups. When the 20-min writing session is complete, 
subjects will be asked to write for an additional 10 min and given the following 
instructions (processing probes) for each session, respectively. Session 1: How you 
have tried to understand and make sense of the traumatic experience(s)?; Session 2: 
How does the traumatic experience affect your feelings about yourself, your self-
worth, and your self-esteem?; Session 3: How does the traumatic experience affect 
your ability to solve problems, to meet future challenges, or to deal with day-to-day 
stress?; and Session 4: How have you tried to understand the trauma and make sense 
of it?
Arm 3 (Daily event writing). Twelve women will be randomly assigned to the daily 
event writing condition will be asked to write a description about what they did 
“yesterday from the time [they] got up until the time [they] went to bed” for 20 min 
continuously. We will counterbalance the language used by these women to journal 
about their daily events. They will be told to “avoid writing about [their] emotions 
or opinions” but to try to be as “accurate and objective as possible.” The 20-min 
writing period will be followed by 10 more min of describing in writing what they 
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have done “today from the time [they] woke in the morning.” These instructions will 
be modified slightly for three subsequent writing sessions to reflect descriptions of 
what they did on different days or what they planned to do on future days.
9)
Study Timeline 
The timeline will begin once the participant has signed the informed consent. Upon 
acquiring informed consent data will be collected during 6 separate time points. After 
the baseline session (1a & 1b) participants returned for the second study visit where 
they will be randomized to either the English trauma-writing intervention, the 
Spanish trauma-writing intervention or the daily-event-writing control. Experimental 
and control participants will be asked to visit their study based on their randomized 
assignment for a total of four occasions over a 4-week period so that they can engage 
in an online expressive writing exercise for 30 min. After each writing session, the 
writings will be submitted online to the researcher staff. All writings will be de-
identified before being stored on secured UM servers and analyzed by study staff. 
Questionnaires, interviews, blood draws, neurocognitive assessments and 
neuroimaging data collected during session 1 were again administered 1 months after 
the end of each participant’s writing intervention. Upon completion of the session 6 
participants involvement with the current study be complete and there will be no other 
study requirements.
10) Data Collection
Blood Assays. Approximately 50 ml of blood will be drawn from all participants, 
once at the first time point and up to 2 times (before and after neuroimaging session) 
at all subsequent time points. HIV-1 viral load and CD4 count will be recorded from 
each participant based upon the last labs drawn. Because menstrual cycle phase 
influence PTSD symptom presentation profile and psychophysiology (72, 73) data 
collection for all pre-menopause women will take place in the luteal phase and blood 
banked for ovarian steroid hormones, (e.g., estradiol). A salivary ACTH kit will be 
used to measure HPA-axis activity pre-scan and again following trauma recall. 
Peripheral GC sensitivity was tested by measuring in-vitro stimulated production of 
interleukin-6 (IL-6) in whole blood before and after cortisol vs. placebo application. 
Salivary cortisol will be analyzed using an Elisa plate reader at the Diabetes Research 
Institute under the supervision of Armando Mendez, Ph.D. 
Flow Cytometry. Absolute counts of individual monocyte subsets and EPCs (cells/µl) 
will be calculated using total monocyte count obtained with hematoanalyser and 
proportions of individual monocyte subsets determined by flow cytometry. Due to 
their pro-inflammatory phenotype, ease of transmigration, and vulnerability to viral 
infection, anti-CD16 Alexa Fluor 488 and anti-CD14-PE antibodies will also be used 
to define monocyte subsets. Monocyte subsets will also be defined as CD14++CD16– 
cells, CD14++CD16+ cells, and CD14+CD16+ cells. The percent of the CD14+ 
HLA-DR+ cell subpopulation that was positive for TNF (‘‘% TNF+ monocytes) will 
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be analyzed based upon their expression upon incubation with lipopolysaccharide 
(LPS) solution and LPS+DEX in 3 final concentrations of 10−8, 10−9, and 10−10 M. 
ELISA. The micro ELISA plate provided in this kit has been pre-coated with an 
antibody specific to Human NF-κB p65. Standards or samples are added to the 
micro ELISA plate wells and combined with the specific antibody. Then a 
biotinylated detection antibody specific for Human NF-κB p65 and Avidin-
Horseradish Peroxidase (HRP) conjugate are added successively to each micro plate 
well and incubated. Free components are washed away. The substrate solution is 
added to each well. Only those wells that contain Human NF-κB p65, biotinylated 
detection antibody and Avidin-HRP conjugate will appear blue in color. The ELISA 
kit from Aviva Systems Biology FKBP5 ELISA Kit (Human) (OKCD08676) is 
based on standard sandwich enzyme-linked immuno-sorbent assay technology. An 
antibody specific for FKBP5 has been pre-coated onto a 96-well plate (12 x 8 Well 
Strips) and blocked. Standards or test samples are added to the wells, incubated and 
removed. A biotinylated detector antibody specific for FKBP5 is added, incubated 
and followed by washing. Avidin-Peroxidase Conjugate is then added, incubated 
and unbound conjugate is washed away. An enzymatic reaction is produced through 
the addition of TMB substrate which is catalyzed by HRP generating a blue color 
product that changes to yellow after adding acidic stop solution. The density of 
yellow coloration read by absorbance at 450 nm is quantitatively proportional to the 
amount of sample FKBP5 captured in the well. For Cortisol/ACTH a competitive 
immunoassay kit will be used. Cortisol/ACTH in standards and samples compete 
with cortisol conjugated to horseradish peroxidase for the antibody binding sites on 
a microtitre plate. After incubation, unbound components are washed away. Bound 
cortisol enzyme conjugate is measured by the reaction of the horseradish peroxidase 
enzyme to the substrate tetramethylbenzidine (TMB). This reaction produces a blue 
color. A yellow color is formed after stopping the reaction with an acidic solution. 
The optical density is read on a standard plate reader at 450 nm. The amount of 
cortisol enzyme conjugate detected is inversely proportional to the amount of 
cortisol present, in the sample.
Anthropometrics. Height, weight, waist girth (umbilicus), and hip girth (greater 
trochanters) measures will be obtained.  The seated subject will undergo casual 
blood pressure assessment (mean of last 2 of 3 readings, taken 3 min apart). 
Saliva. A small amount of saliva will be collected using a disposable salivette just 
before and immediately after the MRI. This saliva will be analyzed within our lab 
for the stress hormones ACTH and alpha-amylase as well and may also include 
inflammatory cytokines including IL-6, IL-1a, and TNF-alpha. 
Neuropsychological assessment Participants will be assessed with an 
acculturation scale (bidimensional acculturation scale (BAS) and Brief Acculturation 
Scale for Hispanic (BASH). There will be a language portion assessment with the 
scale Civilian Spanish-English version PCL-C as well as an assessment for PTSD 
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with the scale Treatment Outcome PTSD Scale (TOP-8) and PTSD checklist for 
DSM-5 (PCL-5). 
An abbreviated 15-item profile of mood states (POMS) questionnaire will be adapted 
to Spanish based on norms and factor structure reported in Hispanic/Latino 
populations (74) at the conclusion of each trauma session to assess levels of distress. 
Subjects will also complete a battery of self-report measures of PTSD symptom 
severity, subject Unit of Distress ,(impact of events scale—revised, IES-R (75), 
anxiety (the Spielberger State and Trait Anxiety Scales and Anxiety Sensitivity 
Index (ASI) (76), depression (Beck Depression Inventory, (BDI-II) (77), 
alexithymia (Toronto Alexithymia Scale-20, TAS-20 (78), multidimensional 
interoceptive awareness Scale, and dissociation using the Dissociative Experiences 
Scale -2 (DES-II) (79), early trauma (Early Trauma Inventory, (ETI) (80), Perceived 
Support Network Inventory, and Brief COPE. Surveys that have been translated and 
are archived by CLaRO will also be included, such as measures of psychological 
symptomology (Brief Symptoms Inventory (BSI) (81) depression (The Center for 
Epidemiological Studies Depression Scale (CESD) (82) anxiety (General Anxiety 
Disorder Scale (GAD-7) (83)) and intimate partner violence (HITS Tool for Intimate 
Partner Violence Screening (HITS) (84). The Physical Symptoms Questionnaire 
(PHQ-15), Pittsburgh Sleep Quality Index (PSQI) and Patient Health Questionnaire 
(PHQ) will also be administered. To assess HIV-associated neurocognitive 
dysfunction a neurocognitive battery will be administered and performance 
compared with published age- and education-adjusted normative data to calculate z 
scores (NPZ), within several cognitive domains. These domains include global 
functioning (Trail Making Test (TMT), Hopkins Verbal Learning Task, Brief Visual 
Memory Test, WAIS-R Digit symbol substitution, WAIS-R Digit Span, WAIS-R 
letter number sequencing, WAIS-R Design  Block Test, COWAT (Spanish), Paced 
Auditory Serial Addition Test, Rey Complex Figure Test, Verbal Fluency Task, 
Stroop Color-Word Interference Test, Grooved Pegboard, and Iowa Gambling Task. 
Anti-retroviral regimen will be assessed with the Adult (ACTG) structured interview 
(69). Health Markers for Review of Systems, Basic Demographic Questionnaire, 
Pittsburgh Sleep Quality Index, and Physical Health Questionnaire. Individuals 
randomized to the S-WED group will be prompted to self-report in Spanish i.e., 
(anger or “enojo”, anxiety or “ansiedad” and depression or “tristeza”. Note: 
“arrepentido por cosas hechas”= regret about things done, desanimado= unmotivated, 
inútil= helpless, aterrorizado= terrorized, and culpable= guilty”. Pronoun use will 
also be quantified from their responses, as research suggests that trauma victims that 
use more first person singular pronouns (e.g. I/mine, “yo/mio”) in trauma narratives 
have worse, long-term symptom severity(86)), which extend to broader use of 
singular pronoun use (87). A similar pattern was observed in depressed and negative 
mood individuals (84).
Cardio-autonomic Function. In addition to understanding vascular mechanisms this 
research is also based upon autonomic mechanisms. Parasympathetic and 
sympathetic function will indexed by heart rate variability (HRV). Because of the 
variation in measure and interpretation of HRV we will use methodology 
recommended by the Task Force of the European Society of Cardiology for both 
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time and frequency domain (88). These values will be derived by in-house software 
made available by Bipoac™ that record and transform HRV from the R-R intervals 
gathered from spontaneously measured heart rate within 2 to 5 minute intervals. 
Overall 5 domains of HRV will be measured in the study (see Table 1) indexing 
relative levels of sympathetic and parasympathetic cardiac input.
Neuroimaging Protocol. Functional and structural brain scans will be performed on 
a GE MR750 3.0-Tesla scanner during a 30-minute session. The protocol will consist 
of 1. Resting-state functional scan (5 minutes), 2. Functional scan during a verbal 
learning and memory task (12 minutes), 3. Structural/anatomical MRI scan (5 
minutes) 4. Trauma recall (5-minutes). 
Trauma Recall in fMRI. The 5 minutes allocated to trauma recall within the scanner 
will be facilitated by an “autobiographical script-driven imagery” protocol adapted 
for the fMRI environment (89, 90). During the protocol participants will listen to 
recordings of personal trauma episodes (recorded during session 1a) and will be asked 
to focus on the evoked mental images and feelings. Recordings and prompts to recall 
the trauma in primary (Spanish) or secondary (English) language will be matched to 
the intervention group to which the participant was randomized. During the protocol 
four 40-second scripts will be constructed for each subject from personal interviews, 
describing either aversive (e.g., sexual or childhood trauma) or neutral events. Two 
traumatic and two neutral conditions will be selected and played during scanning 
counter-balancing for valence. Participants will be instructed to focus on scripts and 
maintain the evoked images and states. Participants will also rate their evoked 
emotional states after each scan using a modified version of the Positive and Negative 
Affect Schedule (PANAS) (91). "Participants will be scanned at baseline and after 
the 4 WED sessions writing about trauma in English or Spanish or the 4 sessions of 
writing about daily activities (for the control group). Three salivary cortisol samples 
will be collected. The first sample will be collected just prior to beginning the 30-
minute scan. The second and third collections being 5 minutes and 10 minutes after 
conclusion of the scan. Salivary ACTH will be assayed using a radioimmunoassay 
kit and analyzed at the DRI. 
Verbal Learning & Memory in fMRI. The test for verbal learning and memory was 
adapted from a previous study (92). Briefly, there are three parts to this task (i.e. 
encoding, distractor, and recall) that repeat in the same order a total of 10 times 
(Fig. 1). During the encoding epochs, participants view pairs of words (e.g., UP and 
FOOT) and are instructed to remember that the two words went together. This 
occurred a total of 10 times, each epoch lasting 19.5 s. There are a total of 10 word-
pairs in the paradigm. Each encoding epoch contains five of the word-pairs. All 
words are presented in white on a black screen. Initially, the first word of the word-
pair was presented alone (1 s) and then accompanied by the second word of the 
word-pair (2 s). Participants pressed a button on the response pad with their right 
index finger when they saw the second word of the word-pair appear on screen to 
validate that they were attending to the stimuli. This also served to control for motor 
activity in other conditions. A black screen (0.9 s) followed each word-pair. The 
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five word-pairs in each encoding epoch are pseudo-randomly selected in a pre-
determined manner such that all of the words are presented one time during epochs 
1 + 2, one time during epochs 3 + 4, etc. Therefore, each of the 10 word-pairs are 
presented a total of five times. The word-pairs were presented in a fixed order 
across participants. The list will contain 6 two-syllable words and 14 one-syllable 
words, randomly combined into 10 pairs. Thirteen of the 20 words in the list will be 
nouns and 7 will be adjectives. No word in the list will have a common associate of 
any other word in the list, based on word association norms (Nelson, McEvoy, & 
Schreiber, 2004).
Each encoding block is followed by a distracter epoch (19.5 s), where participants 
attend to a series of letters (i.e., “XXXXX—YYYYY”) to mimic the active 
stimulus. This is included to discourage rehearsal. Participants pressed with their 
right index finger when they saw the letters to control for motor activity in the other 
conditions. Immediately after each distracter epoch was a 19.5 s recall epoch, 
during which participants saw the first word of each pair from the encoding epoch 
that preceded it (e.g., UP - ___), attempted to recall the second word silently (3 s), 
and viewed a black screen (0.9 s). Subjects indicate perceived success at recalling 
the second word with a right index finger response and perceived failure with a left 
index finger response. After each recall epoch, participants focused on a crosshair 
(6 s) to allow for brain activity to return to its baseline. The sequence of encoding 
epoch, distractor epoch, and recall epoch repeated ten times. Before each new epoch 
began, there was a 3 s prompt to inform the participant which task they would need 
to perform. The full presentation of the task will last 12 m and 24 s. 
The following neuropsychological tests and surveys will be administered during 
session 1 and 2. All forms are submitted and approved by IRB. Each assessment 
takes between 5 and 15 minutes to complete.
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Table 1. Schedule of Assessments
Domain
Measure
T0
screen
T1
pre
T2
write
T3
write
T4
write
T5
write
T6
post
Cognitive
Mini-mental State 
Exam screener 
X
Psychiatric
Mini-International 
Neuropsychiatric 
Interview 
X
Treatment Outcome 
PTSD Scale (TOP-8)
X
X
PTSD Checklist for 
DSM-5 (PCL-5) 
X
Civilian Spanish-
English version PCL-
C 
X
Acculturation 
Brief Acculturation 
Scale For Hispanics 
(BASH)
X
Bidimensional 
Acculturation Scale 
(BAS) 
X
Psychosocial
Subjective Unit of 
Distress
X
X
X
X
X
X
Impact of events 
scale—revised 
X
X
Spielberger State-Trait 
Anxiety Scales 
X
X
Anxiety Sensitivity 
Index
X
X
Beck Depression 
Inventory 
X
X
Toronto Alexithymia 
Scale 
X
X
Multidimensional 
Interoceptive 
Awareness Scale 
X
X
Dissociative 
Experiences Scale 
X
X
Early Trauma 
Inventory 
X
X
Perceived Support 
Network Inventory
X
X
Brief COPE
X
X
*Brief Symptoms 
Inventory 
X
X
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*Center Epi- Studies 
Depression Scale 
X
X
*Self/other-
compassion scales 
X
X
External and Internal 
Shame Scale (EISS)
X
X
*HITS Intimate 
Partner Violence 
Screening Tool
X
X
Religion & Spirituality 
Questionnaire
X
X
Profile of Mood States 
X
X
X
X
X
X
Neurocognitive
Trail Making Test 
X
X
Hopkins Verbal 
Learning Task 
X
X
Brief Visual Memory 
Test
X
X
WAIS-R Digit 
Symbol Substitution 
X
X
WAIS-R Digit Span
X
X
WAIS-R Letter 
Number Sequencing
X
X
WAIS-R Block 
Design Test
X
X
COWAT 
X
X
 
X
X
Paced Auditory Serial 
Addition Test
X
X
Rey Complex Figure 
Test 
X
X
Verbal Fluency Task
X
X
Color-Word 
Interference test 
X
X
Grooved Pegboard 
X
X
Iowa Gambling Task
X
X
Behavioral
Adult (ACTG) 
structured interview  
X
X
Self-compassion task
X
X
Biomarker
Saliva for CORT or  
ACTH & sAA via 
ELISA
X
X
Serum and plasma for 
NFkB & FBPK5
X
X
Serum and plasma 
aliquots for storage
X
X
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Health Markers
Review of systems
X
X
Basic Demographic 
Questionnaire 
X
X
Pittsburgh Sleep 
Quality Index
X
X
Physical Health 
Questionnaire
X
X
 
11) Specimen Banking*
Participants will be asked to abstain from illicit recreational substances, caffeinated 
and decaffeinated substances, aspirin and other medications, alcohol and strenuous 
exercise, and to fast from 10 pm on the night before arrival to the Behavioral Medical 
Research Center (BMRC) between 8 and 10 am before each visit. Participants will 
be advised to consult their physician before beginning the fast if the schedule varies 
from normal eating patterns. On the first visit, a urine toxicology screen (i.e., 
alcohol, barbiturates, benzodiazepines, LSD, PCP, THC, morphine, and 
amphetamines) will be performed. Urine samples will not be stored after analysis.
A blood draw sample in the amount of ~20 ml will be coded with a laboratory number 
and processed and plated within 2 hours of collection for endothelial cell assay. Once 
all the testing has been completed for that visit, the blood samples will be stored 
frozen for cytokine and neuroendocrine assays in a -80 degree freezer located on the 
7th floor of the BMRC. Based on enrollment, those samples will be assayed within 45 
days and the remainder saved for future research. Participants are informed that if 
they do not want their blood samples stored for future research samples to contact the 
study PI and coordinator and their samples will be destroyed at the end of end of this 
study. The remainder specimens will be stored up to 5 years and then destroyed. 
During that time, access to those specimens will only be provided by Roger 
McIntosh, Ph.D.
12) Data Management*
For participants participating in the MWCCS study (E-Prost Protocol No. 
20210476, see recruitment section), deidentified data will be shared with the 
MWCCS investigators following the MWCCS data sharing agreement as per the 
MWCCS approved concept sheet. There is an existing data sharing agreement with 
the University of Miami and other MWCCS sites.
Data Analytical Approach: Standard behavioral and neuroimaging analysis will be 
completed on all psychometric and survey data. Linear mixed models will be used to 
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analyze the effect of intervention exposure on psycho-neurocognitive-immune 
outcomes. The changes with functional brain activations attributed to intervention 
exposure will be evaluated by testing interaction effects (e.g., Group x time) using 
appropriate statistical thresholds, e.g., FWE-correction.
Several different types of MRI scans will be performed using standard sequence 
parameters. Functional scans will be performed to test our main study hypotheses. 
For example, functional scans may be acquired using a 64 x 64 matrix with 
echoplanar single shot gradient echo T2* weighting (TR=2000 msec; TE=40 msec; 
FOV=200mm; 64 x 64 matrix, 3.125 mm voxels) to facilitate an event-related 
analysis, based on stochastic methods. Resting state connectivity scans may be 
collected using similar parameters. Anatomical scans, a high-resolution T1-weighted 
volumetric scan of the whole brain, will be acquired for co-registration and 
morphometry. In addition, we may acquire magnetic resonance spectroscopy (MRS) 
to measure ratios of brain metabolite concentrations.
13) Data Storage
MRI scans obtained at the UM Cox Annex MRI facility will be de-identified and 
housed at the University of Miami in a secure data server for large imaging files. The 
Department of Psychology at the University of Miami also maintains a secure server 
where de-identified data can be stored under a subject ID. Access to this server is 
password protected and data is encrypted. Data will be uploaded to the secure server, 
whereby only the PI will have direct access. After uploading data to the secure server 
hard-copies of forms with all subject data is kept under lock and key in a secured 
cabinet, inside a limited access door (NIS Room 101-C) and will only be available to 
study personnel. All data will de-identified and stored, used and transmitted entirely 
separate from other participant data. Informed consent forms will be kept under lock 
and key in room 1520 of the CRB with card access available into the room by PI 
only.
Study Research Coordinator will be responsible for ensuring quality control of all 
data. Specimen data collected from the second blood draw at time point 2 will be 
processed and plated on the third floor of the NIS building. After preparing the 
sample for endothelial cell assay using flow cytometry, the sample will be frozen and 
stored on the third floor of the NIS building and then later transferred in a secured 
medical courier container, to the 7th floor of the BMRC. Flow cytometry will be 
conducted in conjunction with the Flow Cytometry Core of the Diabetes Research 
Institute, under the direction of Armando Mendez, Ph.D. The Research Coordinator 
will have received and provided proof of updated training in the responsible conduct 
of research.  
14) Provisions to Monitor the Data to Ensure the Safety of Subjects*
Based upon the querying of traumatic events, participants will be closely monitored 
for suicidal ideation (SI). Upon endorsement of survey items indicative of SI or 
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reporting SI during interview or trauma recall the following steps will take place in 
conjunction with the suicide risk packet.
(1) Participant discloses suicidal ideation verbally or through administration of 
a study instrument.  
(2) Assess the risk and severity of suicidal ideation using the HPAC Suicide 
Assessment (see measures). 
(3) Based on the suicide assessment outcome and consultation with the 
postdoctoral fellow and/or supervisor, determine whether the participant is 
at low, moderate, severe, or extreme risk of suicide.
(4) Decide on next steps depending on risk level (in consultation with 
postdoctoral clinical fellow, who will then consult with primary or backup 
supervisor as indicated in the Suicide Risk Assessment Packet.
Participants will also be monitored for elevated levels of psychological distress 
throughout the course of the study. Specifically, participants will be queried 
regarding their distress levels before and after each session using the SUDS as well 
as the POMS. These measures will be scored immediately following each session. If 
levels of distress are elevated, we will go over ways of reducing distress via coping 
and stress management strategies in conjunction with the distress packet:
(1) Things I can do to help cope (e.g., exercise, playing music, relaxation 
exercises, hot shower, journaling, etc.).  
(2) People I can contact to distract and/or support me (e.g., friend, therapist, 
mentor, relative, religious leader, etc.) 
(3) Three positive things I can focus on right now (e.g., something good in my 
life, something positive that happened, ab beautiful sunset, people who care 
about me, an inspirational thought, a nice memory, etc. 
Access to participant records will be limited to the study staff.  All records are kept 
using a study ID number.  Participant number and name will appear together only on 
one form.  That form will be kept in a separate locked cabinet to which only the lead 
Study Coordinator will have access.  All other forms will contain only study ID 
number.  Participant name or other identifiable information will not appear when we 
present this study or publish its results.  Any staff with access to identifying 
information will be required to sign a confidentiality pledge, which prevents them 
from sharing any personal information with anyone else.   The signed 
informed/consent form will stay with PI.  Only coded information will be shared with 
researchers and other doctors that are part of this study.  
Participants will be informed that they have the right to have their data (specimen, 
neuroimaging, psychometric) destroyed at any time following completion of the 
study.
All MRIs will be reviewed by a  neuroradiologist in the Division of Radiology at the 
Miller School of Medicine. The research team would provide de-identified images of 
the MRI scan and limited information (age and gender) to help the radiologist 
examine the images. The radiologist would generate an MRI Summary Report for 
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each MRI that is performed. The principal investigator would communicate any 
results of clinical significance to the research participant. A copy of the written report 
will be provided to allow the participant to communicate with his/her medical doctor. 
The participant may also request a copy of the scans. After obtaining written 
permission, a copy of scans will be given to the participant.  
A plan for ensuring safety of the participant will be establishing a data monitoring 
committee and a plan for reporting findings to the IRB.  The data monitoring 
committee will consist of two components. Progress and issues associated with the 
collection of specimens will reported to Michael Kolber M.D. Ph.D., Director of the 
Comprehensive AIDS Program, Clinical Director of the Adult HIV Section for 
Infectious Diseases and Professor of Medicine at the University of Miami Miller 
School of Medicine. Periodically, the PI will evaluate data collected in order to make 
sure participant data remains safely acquired and stored. This will include review of 
a daily log of all interactions with participant that will be provided by the Study 
Coordinator. Once per week an existing subject ID will be selected at random by the 
PI. The research coordinator will then need to provide a report on the location and 
secured state of the data collected, including but not limited to assessment forms, 
specimen sample & assay banks, encrypted data on server, along with any logs 
collected via direct or indirect communication with the participant
Adverse Event
In the event of any untoward events or conditions that endanger the participant’s 
health, safety, and rights, suspension of the research will occur barring a full report 
of the event to the University of Miami IRB. In the case of an adverse event, i.e., 
unanticipated problem associated with the study, a report will be made indicating: 1) 
type related to psychological/mental or physical events; 2) severity related to the 
degree to which psychiatric or medical intervention is required; 3) scope of the event 
related to the impact it had on the participant’s ability to complete all study 
requirements; 4) consequence of the overall event; and 5) if applicable, frequency of 
the problem. This report will be forward to the HRSO office within 10 days of the 
study team becoming aware of the adverse event. A section of our psychosocial 
surveys do address suicidal ideation. In order to minimize risk to the participant we 
have added language to the confidentiality section regarding our intention to 
intervene if suicidal ideation is derived from survey items. Screening data from the 
MINI psychiatric interview will be reviewed to determine if it meets criteria for 
moderate to high potential suicide risk, based upon recommended guidelines. In 
addition, high suicide risk may be assessed by an individual item on the Beck’s 
Depression Inventory-2. The study PI is qualified to complete the evaluation. If the 
screens are positive and the participant is believed to be at risk, study team members 
will work with the participant contact their doctor, a trusted family member, or a 
therapist to discuss their thought. In more critical situations the study staff may work 
with the individual on a plan that might include getting them safely to a hospital 
environment. This data will not be reported as a part of the analysis.
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15) Provisions to Protect Subjects
Dr. Gail lronson, M.D., Ph.D., will supervise and oversee of all mental health aspects 
of the study pertaining to treatment. Dr. Ironson has over 20 years of experience in 
trauma assessment and counseling. To ensure protection of the participant procedures 
will be adopted from the mentor’s initial study on WED in trauma survivors. 
Participants will answer a few survey items that let us know how they are doing both 
before and after the writing (or trauma recall sessions). These include the POMS 
(Profile of Mood States, short form), a SUDS (subjective unit of distress) question, 
and a question about “How upset are you about the topic you wrote/spoke about 
today? A fluent Spanish-English bilingual trauma therapist will be designated for 
monitoring these responses and will do a brief check-in (about 2 minutes) with each 
participant, paying particular attention to those whose scores indicate distress for the 
safety check. Dr. Ironson has followed this protocol in trials using trauma writing and 
very few people (less than 5%) need extra counseling time. It should be noted that 
compared to 12-week cognitive behavioral therapy interventions, short expressive 
writing interventions such as the one proposed are shown to be non-inferior in terms 
of reducing post-traumatic stress (Sloan, Marx, Lee and Resick, 2018). As we have 
previously mentioned we will screen for such psychiatric comorbidity that would be 
deemed of risk to the participant’s safety following traumatic recall, i.e., (a) exclusion 
for substance dependency as recall may exacerbate symptoms, (b) exclusion for 
recent or current suicidal ideation, and (c) current treatment of major depression and 
other neuropsychiatric conditions involving mood disturbance. To protect the 
participant’s privacy all written samples will be de-identified. Furthermore, during 
the fMRI task there will be no oral or written record of the experience so as to 
preserve the participants right to confidentiality. The participant will be reminded 
that participation is voluntary, and they have the choice to participate or to withdraw 
from the study at any point. 
Additionally, there will be a distress management plan. In the event a participant 
becomes distressed due to study procedures, the coordinator will ask the participant 
if he or she would like to withdraw from the study, and the research personnel will 
consult and refer the participant to the appropriate services if necessary. If necessary, 
participants will be referred to local service providers where they can receive 
treatment. Participants may feel uncomfortable about some of the questions that they 
are being asked about their traumatic experience, but will do so under the supervision 
of a trained trauma therapist. Finally, participants will be debriefed after each trauma 
recall exposure as it is important that those affected by traumatic events or their recall 
be provided practical, pragmatic psychological support and information about 
possible reactions and about how to help themselves access support from around 
them. Furthermore, participants will be contacted by the study coordinator within 24-
72 hours of their writing session to ensure they are not experiencing elevated levels 
of distress in response to the writing probe. 
We will take every precaution to ensure the participant does not experience a 
burdensome amount of distress associated with fMRI paradigm. Prior to the actual 
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scan the participants will go through a simulation in a “mock scanner” where they 
will be introduced to the task and the ambient sounds (MRI noise) they will be 
hearing during the actual scan. During the actual scan participants will have 
constant interaction with the researcher and MRI technician. Participants will be 
provided with an emergency squeeze ball that they may engage at any time to stop 
the procedure. Furthermore, we will continuously monitor heart rate, respiratory 
rate, and blood pressure so that we can ascertain whether the participant is 
experiencing excessive psychophysiological distress. We will take all available 
precautions to make the participant comfortable, e.g., allow time for acclimation, 
practice using a mock scanner, provision of blankets and ear protection, etc.). 
We will make sure that every participant feels comfortable to let us know if they 
feel any discomfort, and most importantly, to let us know if they want to stop the 
study. Participants will be informed that the best way to minimize these events is to 
not clasp one’s hands together and not cross one’s legs during scanning. Should 
discomfort arise, participants may stop the scan at any time and for any reason. We 
will stop the study as soon as a participant communicates to us that he/she wants to 
stop the study. Subjects will be monitored throughout the entire experiment. They 
are reminded that the experimenters can see and hear them at all times to address 
any problems that they are having.  We also interview each subject who completes 
our MRI studies following the study.   Subjects will be reminded before the 
experiment that their participation is completely voluntary and they may stop the 
experiment at any time and for any reason without penalty. If, in the opinion of the 
study staff, PI, subject, or participant’s family, the procedures or study participation 
will be discontinued if they are adversely affecting the subject's emotional well-
being. This may happen even if the participant does not request stopping.  At this 
point, subjects will be interviewed and staff will determine what additional steps 
should be taken.   
With regards to incidental findings resulting from the fMRI scan, the imaging 
facility is a research facility, not a medical facility. The MRI scans obtained at the 
imaging facility are research scans, to be used for scientific purposes. The scientists 
who review the scans are not physicians and they have no competence in evaluating 
the scans for medical or therapeutic purposes. These scans are not meant to provide 
clinical information although all research scans will be read by a radiologist. If any 
results of clinical significance are found, we will communicate this information to 
the participant. This consultation will not result in an additional charge to the 
subject in question. Based on the radiologist's assessment, we may recommend that 
participants seek advice from your primary physician or a specialist. The University 
of Miami will not be responsible for any costs relating to standard medical care. 
Participants will be responsible for such costs, in such an event.
With regards to the sensitive nature of the surveys participants may choose not to 
answer any question that they do not want to answer. Subjects may become frustrated 
when performing tasks. During the consent
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 process, subjects will be told that they should do their best. It should be noted that 
compared to 12-week cognitive behavioral therapy interventions, short expressive 
writing interventions such as the one proposed are shown to be non-inferior in terms 
of reducing post-traumatic stress (Sloan, Marx, Lee and Resick, 2018). As we have 
previously mentioned we will screen for such psychiatric comorbidity that would be 
deemed of risk to the participant’s safety following traumatic recall, i.e., (a) exclusion 
for substance dependency as recall may exacerbate symptoms, (b) exclusion for 
recent or current suicidal ideation, and (c) current treatment of major depression and 
other neuropsychiatric conditions involving mood disturbance.  
Participants name and other personal identifiable information will not be released to 
other parties not mentioned in the Informed Consent, i.e. study personnel, unless 
written specific permission is given by the study participant themselves. Response to 
survey items will be stored in REDCap, i.e., secure web application for building and 
managing online surveys and databases. 
16) Withdrawal of Subjects*
An anticipated circumstance under which subjects will be withdrawn from the 
research without their consent, is in the event that non-removable metal objects were 
not initially reported but detected upon arrival at the MRI facility.  At that time, 
participants will be reminded of the dangers of conducting MRI with metal and their 
participation in the study will be immediately terminated. The participant may 
withdraw from the study at any time. Upon withdrawal the participant will be 
compensated for their participation up to that time point.  
Subject initiated withdrawal from the study may occur at any time during 
participation in the study. Participants may also refuse to answer survey questions or 
take part in particular assessments and still be compensated for their time. 
Participants will be in weekly contact with project staff so that if any issues associated 
with the intervention warranting withdrawal were to arise, they could be dealt with 
immediately. Also, upon early withdrawal from the study, participants will have the 
option of having their data immediately destroyed without affecting compensation 
for their time.  
17) Risks to Subjects*
The research does pose greater than minimal risk to subjects due to recall of severe 
trauma. Participants may feel uncomfortable about some of the questions that they 
are being asked. They may choose not to answer any question that they do not want 
to answer. Subjects may become frustrated when performing tasks. During the 
consent process, subjects will be told that they should do their best. The procedures 
may be long and boring. These procedures will be completed with interspersed breaks 
to reduce any fatigue or discomfort.
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As a part of the phlebotomy protocol participant’s heart rate and blood pressure will 
be taken prior to blood draw. If elevated blood pressure indicative of Stage 2 
hypertension (160/100), any heart rhythm problems or evidence of underlying heart 
disease are found, we will inform the subject promptly, stop the test and refer the 
participant to see a cardiologist.
Bruising, bleeding, and rarely infection could occur at the site where the needle enters 
the vein. To reduce these risks, blood samples are taken in a sterile manner and lines 
will be routinely checked during the experiment by an experienced phlebotomist and 
registered nurse. Uncommonly, fainting might occur. 
It is not uncommon that participants with a chronic illness such as HIV infection may 
tire easily during the neurocognitive battery or imaging scans. We have scheduled 
intermittent breaks throughout both days of the study where the participant will be 
provided access to food and refreshments.  There is a minimum amount of walking 
(approximately 10 minutes) from the university shuttle service to the NIS building. 
Upon arrival on the Coral Gables campus each participant will be accompanied by a 
research assistant. There will not be any special provisions made for individuals with 
physical limitations a shuttle can be arranged from the CRB to Civic Center metro-
rail station and from the University metro-rail station directly to the NIS (Cox Annex) 
building.
The subject’s skin may become irritated during cleaning of the skin prior to 
attachment of electrodes for heart rate and skin conductance. The cleaning procedures 
involve using an exfoliant and alcohol wipes used routinely. Subjects will be 
monitored throughout the experiment for any signs of irritation. Electrodes and gels 
will be removed if any irritation occurs. 
Subjects will be reminded before the experiment that their participation is completely 
voluntary and they may stop the experiment at any time and for any reason without 
penalty.
MRI Risks: Functional brain uses MRI to observe activity-related, hemodynamic 
changes with high spatial and temporal resolution. The most promising method, as is 
used in the current protocol, examines changes in blood oxygenation. Because of the 
different magnetic properties of oxy- and deoxyhemoglobin, increased levels of 
blood oxygenation are associated with increased signal for some MR imaging 
methods, including T2*-weighted gradient echo imaging and echo-planar imaging. 
Increased neural activity is associated with this increased signal, presumably because 
local, activity-related increases in blood flow are greater than increases in oxygen 
extraction, resulting in higher ratios of oxy- to deoxyhemoglobin. Because the change 
in signal is due to properties inherent in normal blood constituents, injection of 
contrast agents or tracers and sampling of plasma are unnecessary. MRIs will not use 
contrast. MRI is widely regarded as a safe, noninvasive procedure for visualization 
of brain tissue in both adults and children. The risks involved with MRI or DTI are 
the same as those involved in standard anatomic MRI, since these procedures rely on 
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the same physical properties of brain tissue. There are no known long-term risks of 
MRI scans.   
As noted above, this study will be performed on an FDA approved 3T scanner. FDA 
standards for minimal risk MRI require that four criteria be met: 1) a static magnetic 
field no greater than 4T; 2) specific absorption rates a) no greater than 4W/kg for the 
entire body for 15 minutes, b) no greater than 3W/kg over the head for 10 minutes, 
and c) no greater than 8W/kg in any gram of tissue in the head or torso or 12W/kg in 
any gram of tissue in the extremities for five minutes; 3) a time rate of change in the 
field that does not produce physical discomfort or painful nerve stimulation; and 4) a 
peak sound pressure level that does not exceed 140 dB or A-weighted R.M.S. 
pressure level that does not exceed 99dBA with hearing protection. Each of these 
guidelines will be monitored throughout the study to insure that none are exceeded.
MRI at 3 Tesla is used on occasion for clinical scanning but is widely used for 
research. This includes studies with children. The gradients for the GE 3 T scanner 
are higher performance, in terms of gradient strength and slew rate, with a maximum 
gradient strength of 4 G/cm. No studies have documented any detrimental effects of 
gradient magnitude. The maximum slew rate, the maximum rate at which the 
gradients change in magnitude, of the gradients on the 3T scanner is 150 mT/m/sec. 
A higher maximum slew rate allows for faster imaging which is generally better 
because the shorter time to collect an image causes images to be less contaminated 
by susceptibility or motion artifacts. It is well known that if the gradients are switched 
too rapidly, peripheral nerve stimulation can take place. The 3T scanner has standard 
safeguards such as a maximal allowable slew rate that is 66% of the FDA limit. 
Lastly, because of the higher radio frequencies associated with the 3T scanner, larger 
amounts of energy are deposited into the tissue during scanning at 3T than at lower 
field strengths. Tissue heating becomes a concern for certain pulse sequences at 
higher field strength. Again, the operating system for the scanner has built-in 
safeguards that only allow scanning with specific absorption rates (SAR) of radio 
frequency that are well below guidelines established by the Bureau of Radiological 
Health, FDA. The operating system limits radio frequency deposition in the head to 
an average rate of 10 watts, < 4 w/kg, which has been shown to raise the average core 
temperature approximately 0.3 deg. C.92 These temperature changes are within the 
normal diurnal rhythms (±1oC) found in human core temperatures or a change 
associated with a brisk 20-minute walk (+1oC).  
During a scan the subject hears a loud rhythmic tapping or banging sound. This noise 
is caused by the switching of the gradient coils that is necessary to produce the image. 
Subjects are warned of this prior to scanning, and most do not find it to be 
objectionable.  Protective earphones or earplugs are provided.  
Some people may experience physical discomfort during scanning, including brief 
periods of muscle twitching, eye discomfort, dizziness, mild nausea, headache, or a 
sensation of flashing lights. We will make sure that every participant feels 
comfortable to let us know if they feel any discomfort, and most importantly, to let 
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us know if they want to stop the study. Participants will be informed that the best way 
to minimize these events is to not clasp one’s hands together and not cross one’s legs 
during scanning. Should discomfort arise, participants may stop the scan at any time 
and for any reason. We will stop the study as soon as a participant communicates to 
us that he/she wants to stop the study.  
Subjects will be monitored throughout the entire experiment. They are reminded that 
the experimenters can see and hear them at all times to address any problems that 
they are having.  
We also interview each subject who completes our MRI studies following the study.   
Subjects will be reminded before the experiment that their participation is completely 
voluntary and they may stop the experiment at any time and for any reason without 
penalty.   
If, in the opinion of the study staff, PI, subject, or his/her family, the procedures or 
study participation will be discontinued if they are adversely affecting the subject's 
emotional well-being. This may happen even if the participant does not request 
stopping.  At this point, subjects will be interviewed, and staff will determine what 
additional steps should be taken.  
The imaging facility is a research facility, not a medical facility. The MRI scans 
obtained at the imaging facility are research scans, to be used for scientific purposes. 
The scientists who review the scans are not physicians and they have no competence 
in evaluating the scans for medical or therapeutic purposes. These scans are not meant 
to provide clinical information. All research scans may be read by a radiologist. If 
any results of clinical significance are found, we will communicate this information 
to the participant. This consultation will not result in an additional charge to the 
subject in question. Based on the radiologist's assessment, we may recommend that 
participants seek advice from your primary physician or a specialist. The University 
of Miami will not be responsible for any costs relating to standard medical care. 
Participants will be responsible for such costs, in such an event.
 Receiving medical information may cause some individuals distress.
18) Potential Benefits to Subjects*
One potential benefit of this study is the development of tailored interventions for 
Latino subgroups who represent pockets of vulnerability, e.g., HIV/AIDS and 
trauma, and require precise and specialized interventions that optimize access to and 
impact of interventions. Another potential benefits of the project to the participant is 
that the participant may acquire and practice expressive writing techniques and that 
this will facilitate management of post-traumatic stress symptomology. It is unknown 
whether this intervention will also facilitate improvements in cognitive function, 
reductions in inflammation and stress hormone reactivity. The minimal risks of the 
proposed research to participants, and the potential benefit, both directly to 
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participants and indirectly to the field, the benefits of the research appear to outweigh 
the risks.
19) Vulnerable Populations*
The research does not include vulnerable populations.
20) Sharing of Results with Subjects*
The imaging facility is a research facility, not a medical facility. The MRI scans 
obtained at the imaging facility are research scans, to be used for scientific purposes. 
The scientists w ho review the scans are not physicians and they have no competence 
in evaluating the scans for medical or therapeutic purposes. These scans are not meant 
to provide clinical or diagnostic information. Moreover, the facility has no medical 
staff to provide clinical information or advice. 
Upon request, a disc copy of the anatomical scan may be provided to the participant. 
The psychometric and cardio-autonomic data is recorded for research purposes. 
There will not be any trained medical professionals available or able to diagnose this 
data as it was not recorded for clinical purposes, however copies of assessments may 
he provided upon request.    
21) Setting
The study will either take place at the BMRC on the 7th floor of the Don Soffer 
Clinical Research Building located at 1120 N.W. 14th Street, Miami, FL 33136 or at 
the University of Miami (main campus) Neuroscience Building (Cox Annex) located 
at 5151 San Amaro Drive, Coral Gables, FL 33146. HIV positive participants will be 
recruited, by flyer, from UM outpatient clinics in conjunction with the Community 
& Outreach ore of the Center for AIDS research. 
22) Resources Available
Personnel.
Roger McIntosh, Ph.D., an Assistant Professor in the Department of Psychology, is 
Principal Investigator of the study and has over 10 years of experience conducting 
neuropsychological and psychophysiological research in persons living with HIV.
Gail Ironson, M.D., Ph.D. is a Co-investigator. Dr. Ironson has over 25 years of 
research on uncovering psychological and biological factors that protect the health of 
people with HIV. She has conducted several randomized clinical trials for both 
trauma treatment and stress management interventions, as well as a longitudinal study 
examining psychological factors in coping with HIV. Dr. Ironson is primary founder 
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of the trauma treatment program at UM and has 20 years of expertise in assessment 
of and treatments for trauma. 
Dr. Jennifer Britton, an Associate Professor in the Department of Psychology, has a 
Ph.D. in Neuroscience. She has been conducting clinical research for 12+ years with 
a particular emphasis on anxiety disorders in both adults and children. Dr. Britton 
will oversee research of this protocol.
Available Resources
The Miami Center for AIDS Research (CFAR) Behavioral/ Social Science & 
Community Outreach Core (Core E) provides CFAR investigators with consultation 
and resources to expand behavioral clinical studies. The underlying goals are to 
enhance recruitment and retention of community and clinic-based study participants 
with attention to “hard to reach populations.”  Core E offers CFAR investigators the 
services of an Outreach Coordinator who can oversee the study recruitment and 
assessment activities of research projects. The Outreach Coordinator can also 
determine the best recruitment strategy, conduct participant outreach, recruitment, 
assessment and site coordination. 
Facilities.
The Behavioral Medicine Research Center (BMRC), directed by Neil Schneiderman, 
Ph.D., is located in the Clinical Research Building (CRB) on the University of Miami 
Miller School of Medicine campus.  The BMRC is a multidisciplinary unit of faculty 
and staff who have worked together for 10-15 years, collaborating on NIH- and 
privately-funded research.  The CRB building has 24-hour security with 
service/reception area that is staffed to greet and direct participants within the strict 
guidelines of privacy prescribed for clinical research protocols.  Adequate parking is 
available on site and the building is within close proximity of public transportation 
(Metrorail, buses and taxis).  The BMRC is contained on two floors and divided by 
function, with the Administrative unit on the 15th floor and the Clinical unit on the 
7th floor.  Located in the Clinical unit are the: 1) Behavioral Medicine and 
Echocardiography Laboratory; 2) Biochemical Assessment Laboratory; and 
3) Hispanic Community Health Study/Study of Latinos field center.  Of note, 
adjacent to the BMRC on the 7th floor in the CRB, is the university’s Clinical 
Research Center (CRC) of the Clinical and Translational Science Institute.  
The Bioassay Clinical Laboratory has 2 locations that have been efficiently integrated 
to provide bioassay services for BMRC, Diabetes Research Institute (DRI) and other 
investigators.  Some processing of biological samples occurs at the BMRC 
Biochemical Assessment Laboratory that occupies 600 sq ft on the 7th floor of the 
CRB.  This lab is on the same floor as the Behavioral Medicine and Clinical 
Physiology Laboratory, where patient samples are collected during the screening 
session.  Some manual ELISA and radioimmunoassay tests are performed in this 
location.  Other sample analysis is performed at the DRI Clinical Research 
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Laboratory, a CLIA and Florida State licensed facility, located on the 3rd floor of the 
DRI building and one block from the BMRC.  Chemistry assays in this lab are 
performed in a room (280 sq ft), containing the automated chemistry equipment.  
ELISA and radioimmunoassays are performed in the adjacent laboratory (600 sq ft).  
A custom Laboratory Information System (LIMS) is used for sample log-in, work-
flow tracking and generation of reports in both hard and electronic formats.  The 
software is connected directly to the automated analyzers for data collection.  The 
data may be electronically exported to the Data Management and Biostatistics 
laboratory using previously established protocols. 
The DRI laboratory has a Roche-Cobas 6000 analyzer that incorporates automated 
chemistry and immunoassay capabilities.  In addition, hemoglobin A1c testing is 
performed on the BioRad Variant analyzer.  These instruments are directly connected 
to the laboratory LIMS system for bidirectional communication of sample test 
requests and data reporting.  Both bioassay laboratories have all the pertinent 
equipment needed for performing ELISA based assays including 2 microplate 
spectrophotometers, a microplate fluorometer and microplate luminometer, and 3 
automated microplate washers.  For radioimmunoassays, the DRI has a shared 
gamma and beta scintillation counter, adjacent to the main DRI labs.  In addition, 
there are 5 dedicated, refrigerated centrifuges used for sample processing, 
4 ultrafreezers (-80°C) at the DRI lab and 4 ultrafreezers at the BMRC lab, housed 
directly adjacent to the labs and available for sample storage.    The imaging lab is 
equipped with a Zeiss LSM510 inverted microscope, immunofluorescence and live 
cell imaging; a station for fluorescence microscopy (Widefield/Apotome); a Leica 
SP5 motorized stage confocal inverted microscope, a Leica MP/SP5/FLIM/FCS 
fixed stage multiphoton/confocal upright microscope enabling live imaging deep into 
tissue and organs; a BD Pathway High Throughput Imaging system; a CompuCyte 
iCys Laser Scanning Cytometry; a Leica Laser Capture Microdissection station; a 
conventional Leica inverted microscope with digital camera; dedicated analysis 
software such as the MetaMorph Imaging System is available to core users. Confocal 
imaging needs of the current project will rely mostly on the LSM-510  instrument 
that has 8 laser lines and four fluorescence photomultiplier tubes (PMTs) for 
detecting UV, visible and near-infrared emission, one transmitted light PMT, and can 
detect up to eight channels. Up to four fluorescent channels can be acquired 
simultaneously.
Cox neuroscience Annex is a The 1200 square foot MRI facility is housed on the first 
floor of the three-floor, 37,700 square foot Neuroscience building adjacent to the Cox 
Science Building on the University of Miami Coral Gables Campus. The facility 
encompasses a MR scanner suite with associated reception and waiting areas, 
dressing rooms and a MR simulator/mock scanner suite. The Neuroimaging Suite has 
a state-of-the-art GE®MR750 3.0T MR scanner and 32-channel head coil capable of 
performing structural and functional scans in human subjects. The MR suite is 
equipped to deliver visual, auditory, and tactile stimuli. In addition, behavioral and 
physiological responses and eye movements can be recorded. The remaining 11,000 
square feet on the first floor of the building includes shared space including a large 
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conference/multipurpose room, kitchen, restrooms, behavioral testing rooms, a 
central server room, a phlebotomy room, and an assay lab. Equipment includes: 
Psychology Software Tools, Inc. Hyperion MRI Digital Projection System, PST-
100984; Current Designs 932 fORP Response Devices (4-button diamond, 4-button 
inline, 5-button Pyka, Trackball2); Biopac Physiological Recording (Heart rate, 
respiration, skin conductance response, electrocardiography, electromyography, 
blood pressure); Avotec, Inc. Silent Scan SS-3300 Hearing Protection, 
Communication and Music System; Resonance Technology Eye-tracking (used with 
8-ch head coil); Midwest Composite Technologies MRI System Simulator; 
Psychology Software Tools, Inc. Motrak Head Motion Tracking System, PST-
100722; and Video camera monitoring.
All research staff will have to participate in a regularly scheduled MRI safety training 
session. This session will ensure that all research staff are aware of the potential 
dangers of MRI testing and assure the safety of the participant at all times. 
23) Prior Approvals
Upon approval by UM IRB, the project will be submitted for review by an 
independent committee at the Cox Neuroimaging Facility. This committee will 
determine whether the protocol may need to be further modified in order to ensure 
patient safety. 
.
24) Local Number of Subjects
The total number of subjects to be accrued locally will be 36.
25) Confidentiality
After samples are collected all biological specimens are coded and stored frozen.
Samples will be assayed on the 3rd floor of the Cox Neuroscience Annex or at the 
Diabetes Research Institute. Once all the testing has been completed and the study is 
over, remaining blood and salivary samples will be stored frozen on the 7th floor 
BMRC located at the Clinical Research Building for future research to better 
understand HIV infection. 
Subjects are asked by written consent to indicate in writing if they give permission
to store any remaining samples for later use in approved studies.
Access to participant records will be limited to the study staff. All records are kept 
using a study ID number. Participant number and name will appear together only on 
one form. That form will be kept in a separate locked cabinet to which only the lead 
Study Coordinator will have access. All other forms will contain only study ID 
number.
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Participant name or other identifiable information will not appear when we present 
this study or publish its results. Any staff with access to identifying information will 
be required to sign a confidentiality pledge, which prevents them from sharing any 
personal information with anyone else. The signed informed/consent form will stay 
with the local physician contractor/investigators. Only coded information will be 
shared with researchers and other doctors that are part of this study. Specimen 
samples will be stored on ice at -80 degrees for up to 5 years. 
Choose the statements below that are applicable to this research: 
 25(a).   ☐  Data will be collected from the EMR or subjects at UHealth or JHS.  If 
checked, answer the following: 
   ☐ Research Subjects will sign a HIPAA Authorization before the research 
will collect this data. 
   ☐ Research Subjects will not sign a HIPAA Authorization for this data 
collection and the research is requesting a waiver of HIPAA authorization 
from the IRB.  (Complete Section 17 below)
   25(b).  Data collected:
 Will not include Protected Health information or Personally 
Identifiable Information
 Will include Protected Health information or Personally Identifiable 
Information
    25(c).  How will the research store the data?                
☒  On a University of Miami electronic device (e.g. encrypted, password-
protected computer)
☐  On a cloud-based storage system that is approved by the University of 
Miami 
☐  Other, specify:  Click here to enter text.
Biospecimens
☐  Not applicable.  No biospecimens will be collected 
  Bio-Specimens obtained for this research will be stored without any 
direct or indirect identifiers.  
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 Bio-Specimens obtained for this research will be stored in a de-
identified coded manner.  
  When required to transport data or bio-specimens for this research, 
the research team will transport the data and bio-specimens in a de-
identified (or anonymous) manner with a link to the individual subject’s 
identity maintain separately from the data and/or bio-specimen.
26) Waiver of Authorization for Use and Disclosure of Protected 
Health Information (HIPAA) 
 This section is not applicable, we are not requesting a waiver of authorization.  
If the research team will access patient medical records or other identifiable health 
information for this research without or prior to obtaining a signed HIPAA 
authorization from the subject or the subject’s legally authorized representative 
(LAR), you must obtain a waiver of the requirement for written authorization from 
the patients to access their medical records. 
Confirm that you will destroy the Protected Health Information (PHI) you and/or 
your Study Team acquire receive from JHS and/or UHealth at the earliest 
opportunity. 
☐    I confirm 
Confirm that the Protected Health Inform (PHI) you acquire from JHS and/or 
UHealth will not be re-used or disclosed to any other person or entity, except as 
required by law or for authorized oversight of the research study or for other research 
for which the use or disclosure of PHI is permissible.           
☐     I confirm  
27) Compensation for Research-Related Injury
There will not be any formal compensation provided for research-related injury. The 
language pertaining to this within the informed consent is provided here: “Although 
injury is unlikely, if injury should occur, treatment will in most cases be available.  If 
you have insurance, your insurance company may or may not pay for these costs.  If 
you do not have insurance, or if your insurance company refuses to pay, you will be 
expected to pay.  Funds to compensate for pain, expenses, lost wages and other 
damages caused by injury are not routinely available.”
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28) Economic Burden to Subjects
Upon arrival at the University of Miami Downton and Coral Gables locations there 
will be no additional costs for which the participants will be responsible. In addition, 
participants will be offered water and light snacks throughout the two sessions. 
29) Consent Process
This study will follow the UM standard operating procedure for the Informed Consent 
Process for Research (HRP-090). The consent process will take place on the 7th floor 
of the BMRC located at the Clinical Research Building in downtown Miami. The 
research coordinator will describe the study to the participants and will go over the 
consent forms to make sure there are no additional questions that were not answered.  
Participants will be asked to sign one copy of the consent form and be provided with 
a signed copy. This consent form will cover participation at during both sessions 1 
and 2. Approximately 20 – 30 minutes will be devoted towards going over the consent 
and an unlimited time will be provided for questions and answers prior to signing the 
consent. Participants will also be informed that they are able to refer to primary care 
physicians and/or loved ones before providing consent to participate in the study. In 
addition, study referrals will be verbally consented in order to complete the pre-
screening process using 
Cognitively Impaired Adults 
Prior to participation in session 1 of the study, at the pre-screening, our group 
will administer the Montreal Cognitive Assessment or Mini-Mental State 
Exam. Individuals scoring at levels indicative of gross cognitive dysfunction 
or dementia will be excluded from the study. Each assessment takes 
approximately 5 minutes to administer. 
30) Process to Document Consent in Writing
Standard operating procedures will be followed in order to attain written 
documentation of consent in conjunction with (HRP-091). 
31) Drugs or Devices
None
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