Telehealth-delivered Massed Imaginal Exposure for PTSD: Toward Increasing Access to Alternative, Evidence-based Treatment Schedules for Virtual Care
Phase: NA
Conditions: Posttraumatic Stress Disorder
Sponsor: Medical University of South Carolina

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NCT05450224 
06/28/2022 
 
PROTOCOL TITLE: 
Telehealth-delivered Massed Imaginal Exposure for PTSD: Toward Increasing 
Access to Alternative, Evidence-based Treatment Schedules for Virtual Care 
PRINCIPAL INVESTIGATOR:   
Lisa M. McTeague, Ph.D. 
 
 
 

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1.0 
Objectives / Specific Aims 
The goal of this project is to establish the safety, feasibility, and acceptability 
of abbreviating and accelerating telehealth-delivered imaginal exposure therapy 
for post-traumatic stress disorder (PTSD). Importantly, conventional telehealth-
delivered Prolonged Exposure (PE) therapy is non-inferior to the conventional, 
gold standard in-person PE for PTSD (Acierno et al., 2017). Intensive or massed 
schedules of in-person exposure- based trauma-focused treatments have 
likewise recently been shown, in a nascent but promising literature, to produce 
comparable treatment outcomes to conventional once or twice weekly schedules, 
but importantly, with lower levels of premature dropout (Sciarrino et al., 2020; 
Zoellner et al., 2017).  
AIM 1: Establish the safety of VVC-delivered massed imaginal exposure 
for PTSD. We hypothesize that VVC-delivered, massed imaginal exposure will 
be safe as indexed by no significant adverse events.  
AIM 2: Establish the feasibility, tolerability, and acceptability of VVC-
delivered massed imaginal exposure for PTSD. We hypothesize that 1) 
veterans will consider the treatment acceptable and tolerable and that 2) 
recruitment and retention will be feasible (> 80% retention).  
EXPLORATORY AIM 1: Establish acceptability among stakeholder 
providers of VVC-delivered massed imaginal exposure for PTSD. We 
hypothesize that 1) telemental healthcare providers will consider the treatment 
acceptable and tolerable and that 2) will be willing to receive training and/or refer 
patients to such services.  
EXPLORATORY AIM 2: Establish the preliminary efficacy of VVC-
delivered massed imaginal exposure for PTSD. We hypothesize that 1) 
veterans will demonstrate moderate reductions in posttraumatic stress and 
associated symptoms and impairment from intake to the end of treatment that will 
in turn, 2) be maintained or extended at the 1-month post-treatment follow-up.  
2.0 
Background 
The need for enhancing PTSD treatment.  PTSD is a chronic, impairing 
condition with variable rates of recovery. PE, which consists primarily of imaginal 
and in vivo forms of exposure to trauma reminders, is an effective first-line 
intervention (Power et al., 2010), with wide acceptance among evidence-based 
practitioners. However, many PTSD patients show non- remittance (~25-50%; 
Rosellini e al., 2018), poor treatment responses (~60%); Loerinc et al., 2015) and 
dropout (~18-68%; Imel et al. 2013). Thus, there are well-defined needs to 
improve the efficacy, effectiveness, efficiency, and tolerability of this challenging, 
but potent form of intervention, and an equally pressing need to develop and 
deploy technologies that enhance access to treatment.  
Accelerated protocols for enhancing treatment efficacy and efficiency. 
In response to calls to enhance the efficiency of exposure-based treatments, 
accelerated protocols have been demonstrated to be non-inferior to the standard 
PE protocol. This includes a previous trial by CoI Dr. Cobbs and colleagues that 
implemented a daily 6-session protocol (Zoellner et al., 2017), resulting in 
comparable efficacy and much lower dropout (6.3%) compared to standard bi-

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weekly 10-session PE. This is consistent with a small, but growing number of 
studies of massed evidence-based treatments for PTSD, which have revealed 
large effects (d = 1.15–2.93) and low attrition across studies (5.1%; Sciarrino et 
al., 2020). Thus, by reducing burden by enhancing efficiency, accelerated 
protocols may especially be indicated for those at high risk of dropout, such as 
Veterans (28.1%; Eftekhari et al., 2013).  
Telehealth delivery of exposure-based interventions. Enhancing access is 
another critical aspect of improving interventions. The VA system has served as 
a guidepost for deployment of empirically-supported telehealth interventions for 
PTSD, and our PTSD Clinical Team (PCT) completed 1,800+ telehealth therapy 
visits using VA video connect (VVC) in the last year. Further, recent seminal work 
from Ralph H. Johnson VAMC (RHJVAMC) investigators has demonstrated 
equivalence of telehealth-delivered versus standard in- person PE for reducing 
trauma-related symptoms (Acierno et al., 2017). Additionally, CoI Dr. Sciarrino 
and colleagues (2020) have recently summarized the emerging literature 
showing the equivalence of intensive trauma-focused treatment (e.g., daily 
sessions) in comparison to standard weekly, or bi-weekly protocols (Sciarrino et 
al., 2020). The present pilot study reflects an extension of these efforts, by 
evaluating a telehealth- delivered accelerated treatment consisting of the core 
imaginal exposure component of PE.  
Remote affective and physiological measures.  Theoretical and empirical 
support suggests emotional and physiological engagement with feared, dreaded, 
and avoided targets is requisite for therapeutic change to occur in exposure-
based interventions (Foa & Kozak, 1986; Lang, 1979).  While it is customary in 
PE to assess engagement based on self-reported distress, there is a need to 
integrate more objective measures of emotional and physiological activation. For 
instance, there is relatively low correspondence between subjectively-reported 
and objectively-measured engagement, and whereas heightened physiological 
activation predicts better outcomes, blunted physiological activation predicts 
poorer outcomes in exposure-based treatments (Wangelin & Tuerk, 2015).  Of 
course, telehealth delivery presents challenges to physiological monitoring.  
However, recent technological advancements, including in areas of machine 
learning, afford the ability to monitor physiological activation and other affective 
markers entirely remotely.  This is achieved by extracting affective and 
physiological signals, such as heart rate, respiratory rate, and facial and vocal 
affective markers based solely on visual and acoustic features of ordinary 
webcam footage (e.g., van der Kooij & Naber, 2019). 
Impact and innovation.  The goal of this proposal is in line with the priorities 
of the VHA and HSR&D priorities as well as the priorities of the Charleston 
HEROIC RIVR Pilot Project Program. Specifically, this proposal aligns with the 
mission stipulated in the HEROIC RFA to focus on “novel applications of 
telemental healthcare delivery including feasibility and/or preliminary 
efficacy/effectiveness trials”. 
We propose that there is strong potential for broader implementation of 
intensive or massed exposure-based, trauma-focused treatments, and that such 
implementation could be even greater if virtual deployment is feasible and 
acceptable to patient and provider alike. Furthermore, an alternative VVC-
delivered trauma- focused treatment with shorter demands on total duration 

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could broaden VA providers’ arsenal of evidence- based interventions. This 
would enable greater tailoring of treatment plans to individual veteran 
preferences for frequency and duration of sessions as well as more flexible 
accommodation to daily life demands and related scheduling barriers. Taken 
together, we propose that establishing the safety, feasibility, and acceptability of 
massed exposure-based therapy delivered via VA Video Connect is a productive 
first step toward advancing telemental health treatment options and furthering 
personalized care for our veterans. 
Importantly, in regards to the likelihood of impact from an implementation 
standpoint, all proposed VVC and therapeutic methods (imaginal exposure) in 
this proposal are already widely adopted across the VA system. This includes an 
extensive IT infrastructure for supporting VVC and the nation’s largest cadre of 
evidence- based, trauma-focused therapists. As such, if findings from this pilot 
and follow up RCTs indicate safety, acceptability and efficacy, VVC-delivered 
massed trauma-focused therapy could be readily implemented in the VA system. 
Our proposal includes unique and important contributions to veteran mental 
healthcare through the following innovations: 
• 
For the first time, we will establish the safety, feasibility, tolerability, and acceptability 
of VVC-delivered, massed imaginal exposure for PTSD. While these aspects have 
been established for in-person imaginal exposure, the remote nature of VVC presents 
unique challenges.  
• 
For the first time, we will establish the preliminary efficacy of VVC-delivered, massed 
imaginal exposure for PTSD. While these findings will be preliminary as the study is 
not powered for efficacy, it will provide preliminary estimates of pre- to post- effect 
sizes and variance in outcomes that will aid in planning well-crafted and properly 
statistically powered follow up RCTs.  
• 
COVID-19 has fundamentally altered the delivery landscape for clinical and research 
practice. The methods proposed here further advance the VA’s capacity to promote 
evidence-based care and research amidst unforeseen disruptions to in-person 
procedures.  
• 
For the first time, we will establish acceptability among stakeholder providers, of VVC-
delivered, massed imaginal exposure for PTSD. While in-person, massed imaginal 
exposure has been effective in RCTs, the perceptions of evidence-based clinical 
providers at the forefront of treating veterans have not been assessed. In order to 
assess implementation likelihood, as well as to assess the need to disseminate 
findings and techniques, input from provider stakeholders is essential.  
3.0 
Intervention to be studied. 
Study Overview. In this open-label pilot, we will recruit 25 veterans with 
PTSD from the Ralph H. Johnson VAMC PTSD Clinical Team (PCT), as 
overseen by CoI, licensed clinical psychologist, and Section Chief, Dr. Wangelin. 
Massed imaginal exposure will be delivered via VVC or any other VA approved 
telehealth platform, modeled after the in-person protocol of Zoellner et al., 
(2017).  Following the initial assessment of PTSD and related symptoms and 
impairment, all veterans will receive six daily 60-minute telehealth sessions 
focusing on imaginal exposure therapy (details below). The initial assessment will 

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be repeated at 1-week post-treatment and 1-month post-treatment completion. 
As an open-label, feasibility pilot study, there is no control arm.  
Intervention: VVC-delivered Massed Imaginal Exposure. Consistent with 
Zoellner et al., (2017), six, 60- minute daily sessions of imaginal exposure will be 
conducted based on the PE manual (Foa et al., 2007).  Session 1 will include 
rationale for imaginal exposure and common reactions to trauma. Sessions 2-6 
will focus on imaginal exposure (45 minutes) and processing (15 minutes), with 
later sessions focused on the most distressing aspect of the trauma memory. 
The final session will include relapse prevention.  Between-session assignments 
will include listening to audio recordings of sessions at least once. All sessions 
will be delivered within a 10-day window.  If participants do not respond, they will 
be offered additional services at no additional cost or loss of benefits for which 
they would otherwise be entitled. 
4.0 
Inclusion and Exclusion Criteria/ Study Population 
Veterans who are aged 18-65 (inclusive), who meet full DSM-5 criteria for 
current PTSD will be recruited from all racial, ethnic and gender categories. The 
rationale regarding a cutoff of 65 years was for correspondence to prior massed 
in-person protocols (e.g., Zoellner et al, 2017). Planned follow up studies will 
include a broader age range and will be powered to analyze age effects on 
outcomes. To contend with dropout, we propose to enroll 25 veterans, with the 
aim of completing assessments and treatment for 20 participants. In-person 
investigations have shown a dropout rate of 5% (Sciarrino et al. 2020), thus a 
20% allowance will ensure adequate recruitment to meet study aims.  
Exclusion Criteria. Participants will be excluded for the following: 1. clinically 
unstable physical illness; 2. bipolar Type I disorder; 3. dementia; 4. repeated 
abuse or dependence upon drugs within 3 months; 5. unstable psychotropic 
regimen within 6-weeks; and finally, 6. active suicidal ideation or a suicide 
attempt within the past year.  
Table 1. Eligibility Criteria 
Inclusion Criteria: 
1. Age 18-65. 
2. Ability to speak, read, and write English. 
3. Diagnosis of PTSD based on CAPS-5 (> 3 mo. post-trauma). 
4. Seeking treatment for PTSD at the Charleston VA. 
5. Willingness and ability to engage in assessment and treatment visits 
through VVC, or another VA-approved telehealth videoconferencing 
platform. 
Exclusion Criteria: 
1. 
Currently receiving psychotherapy for another anxiety- or stress-
related condition. 
2. 
Current substance use disorder diagnosis with repeated abuse or 
dependence within 3 months of study entry and unwillingness to 
abstain for 24 hours prior to study visits. 

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3. 
Unstable dose of psychotropic medications within 6 weeks prior to 
baseline assessment (based on the DMSC; see measures). 
4. 
Medical condition that would contraindicate participation in 
treatment or assessment activities (e.g., severe cardiovascular 
problems; based on MINI, DMSC, and chart review; see 
measures). 
5. 
Current, or history of bipolar I disorder (based on MINI; see 
measures). 
6. 
Current, or history of psychotic symptoms (based on MINI; see 
measures). 
7. 
Serious suicidal risk or a suicide attempt in the past year, as 
determined by self-report (PHQ-9) and clinical interview (C-SSRS; 
see measures). 
8. 
Active neurological conditions, e.g., seizures, stroke, loss of 
consciousness or concussion (based on MINI, DMSC, and chart 
review; see measures) 
 
5.0 
Number of Subjects 
Targeted / planned enrollment.  We will enroll a total of N = 25 participants, 
18-65 years of age (inclusive), who meet full DSM-5 criteria for PTSD.  
Participants will be recruited from all racial, ethnic, and gender categories. 
Women and minorities will be included in the study.  In FY 2014, the PCT 
averaged 25.3 new referrals per week (11% female, 36% Black, 4% Hispanic / 
Latino).  The consistency of PTSD referrals will greatly facilitate recruitment for 
the proposed research. 
 
Table 2. Targeted/Planned Enrollment  
 
Total Planned Enrollment: N = 25 
 
 
TARGETED/PLANNED ENROLLMENT: Number of Subjects 
Ethnic Category 
Sex/Gender 
Females 
Males 
Total 
Hispanic or Latino 
0 
1 
1 
Not Hispanic or 
Latino 
3 
21 
24 
Ethnic Category: 
Total of All 
Subjects* 
25 
Racial 
Categories 
Sex/Gender 
Females 
Males 
Total 
American 
Indian/Alaska 
Native 
0 
0 
0 
Asian 
0 
0 
0 
Native Hawaiian 
or Other Pacific 
Islander 
0 
0 
0 

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Black or African 
American 
1 
8 
9 
White 
2 
14 
16 
Racial 
Categories: Total 
of All Subjects* 
3 
22 
25 
 
6.0 
Setting 
Outcome assessment visits.  All participants will be assessed using a 
standard battery of clinician-administered and self-report outcome assessments 
at pre-treatment, post-treatment (1-week after completing treatment), and at a 1-
month follow-up visit.  These outcome assessments will be conducted entirely 
remotely via VVC or a comparable VA-approved videoconferencing platform 
(e.g., VVC Now, WebEx, Microsoft Teams, etc.).   
Remote telehealth treatment visits.  All treatment visits, which consist of 60 
min. sessions including imaginal exposure (45 min.) followed by emotional 
processing (~15 min.) will take place entirely through telehealth using VVC, or if 
needed, a comparable VA-approved videoconferencing platform (e.g., WebEx).  
Note that telehealth delivery of trauma-focused therapy is already standard 
practice in the Charleston PCT, and our group has consistently demonstrated 
high-fidelity delivery in standard care, with robust clinical gains on par with 
carefully designed and executed RCTs, as documented in several peer-reviewed 
reports (e.g., Tuerk et al, 2018). 
7.0 
Recruitment Methods 
As part of standard clinic procedures, all referrals receive a diagnostic 
assessment and are asked if they would like to hear about opportunities to 
participate in research.  If Veterans respond that they are interested in being 
contacted about research opportunities and if they choose to begin evidence-
based therapy (the modal treatment choice in the PCT), then study staff will 
make contact regarding potential enrollment prior to the Veteran’s first therapy 
session.  Communication between clinic and study staff will be facilitated by the 
PI.  Research recruitment is well-integrated with the standard clinic operating 
procedures and similar recruitment strategies in this environment have supported 
successful recruitment goals of multiple studies in recent years. In support of a 
high likelihood of expeditious attainment of recruitment goals, in FY20, the PCT 
completed nearly 600 assessments for trauma-focused therapy, and triaged over 
1500 consults for PTSD and related conditions via VVC. Further, the PCT has a 
longstanding history of supporting successful recruitment for numerous studies 
targeting treatment innovations.   
8.0 
Consent Process 
All participants will be referred on the basis of a routine intake assessment in 
the PCT or another VA behavioral health clinic prior to study entry.  As indicated 
above in the eligibility criteria, those who report clinical symptoms that suggest 
trauma-focused therapy for PTSD is not in their best interests will be excluded 
from the study and directed to alternate care as recommended by the PCT and 
their clinical care team.  Participants who appear to meet criteria for entry into the 
study will be informed of the study and if they express interest, they will review 

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study consent, and HIPAA Authorization with study personnel (PI, study 
coordinator, or study evaluator).   
The consent process and HIPPA authorization procedures will be completed 
electronically through VVC or another VA-approved videoconferencing platform, 
following all VA institutional guidelines pertaining to the consent and 
authorization procedures.  Consent documents will be provided by mail, or 
through secure messaging, then subsequently reviewed with study personnel at 
the first study visit (i.e., the pre-treatment or baseline assessment).  During 
review of consent, study staff will detail study procedures and ensure that 
patients understand what components are part of the study procedures and what 
is part of standard treatment for PTSD.  Study staff will ensure that potential 
participants understand the study and are interested and able to complete study 
procedures prior to providing signed informed consent.  Participants will receive 
in the consent document emergency contact information for use in case of acute 
exacerbation of symptoms.  Participants will be informed that they can withdraw 
from the study at any time and receive alternate care outside of the study.  
Participants will also be informed that if they report imminent suicidality or 
intolerance for study procedures at any point during the protocol, they may be 
withdrawn from the study and receive alternate care as appropriate (i.e., inpatient 
hospitalization, treatment in outpatient psychiatry, etc.).   
Following review of the consent documents and verbal expression of 
understanding and agreement by the participant, participants will be instructed to 
indicate their consent and authorization on the forms with their signatures.  The 
attending study personnel will then take screen shots of the signature pages, 
save them on a secure, access-controlled, and encrypted VA server, and note 
the consent and authorization in CPRS to document study involvement.  
Participants have the option to indicate they would like to be contacted for 
future research studies that they may qualify for on the consent documents.  For 
participants who provide this consent, their contact information only will be stored 
in a separate secure data repository that will not expire upon study completion.  
The PI, Dr. Lisa McTeague will serve as the repository administrator.  The 
standard operating procedures for administering this repository have been 
outlined in the SOP associated with this protocol.  Note that there will be no 
attempt to identify directly or indirectly any participant in their research data. 
9.0 
Study Design / Methods 
Overview.   
This pilot project will implement an open-label single-arm design to address 
our specific aims to establish the safety, feasibility, tolerability and acceptability of 
massed imaginal exposure therapy for PTSD delivered via telehealth to Veterans 
with PTSD, and to obtain a preliminary estimate of efficacy (i.e., to support 
adequately powered follow-up studies employing group-randomized designs).  All 
participants (N = 25) will receive a total of six-60 min. therapy sessions, delivered 
via VVC or a comparable VA-approved platform.  Outcome assessments 
consisting of clinician-administered interview measures, self-report measures, 
and collection of remote affective and physiological indices derived from webcam 
footage will occur at pre-treatment, and at 1-week and 1-month following 

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treatment completion.  Assessment instruments and procedures are detailed in 
the following sections. 
Assessment Procedures 
Baseline Demographic, Clinical Characteristics, and Diagnostic Measures 
This study will implement a standard battery of clinician-administered and self-
report measures to capture important baseline differences and changes over the 
course of treatment.  These measures are detailed in the following sections, and 
the assessment schedule is provided in Table 1 below. 
 
Table 1.  Schedule of Assessments 
Measure 
Pre-tx 
Tx 
Post-tx 
1-mo. 
follow-up 
Trauma Interview 
x 
  
x 
x 
CAPS-5 
x 
  
x  
x 
MINI 
x 
  
  
  
C-SSRS 
x 
  
x 
x 
CGI 
x 
  
x 
x 
DMSC 
x 
  
  
  
LEC-5 
x 
  
  
  
PCL-5 
x 
x 
x 
x 
PTCI-9 
x 
x 
x 
x 
PHQ-9 
x 
x 
x 
x 
PSBQ 
x 
  
x 
x 
MASQ 
x 
  
x 
x 
SDS 
x 
  
x 
x 
ERNS 
x 
  
  
  
STTS-R 
  
  
x 
x 
TTSQ 
  
  
x 
  
SUDS 
  
x 
  
  
PETQ 
  
x 
  
  

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Note.  Trauma interview = remote affective and physiological measures 
based on video of a standardized trauma interview; CAPS-5 = Clinician 
Administered PTSD Scale for DSM-5; MINI = MINI Neuropsychiatric 
Interview Schedule;  C-SSRS = Columbia-Suicide Severity Rating Scale; 
CGI = Clinical Global Impressions; DMSC = Demographics and Military 
Service characteristics Form; LEC-5 = Life Events Checklist for DSM-5;  
PCL-5 = PTSD Symptom Checklist for DSM-5; PTCI-9 = Posttraumatic 
Cognitions Inventory, 9-Item Version; PHQ-9 = Patient Health 
Questionnaire; PSBQ = PTSD Safety Behaviors Questionnaire; MASQ = 
Mood and Anxiety Symptom Questionnaire; SDS = Sheehan Disability 
Scale; ERNS = Emotional Reactivity and Numbing Scale; STTS-R = 
Satisfaction with Therapy and Therapist Scale; TTSQ = Technology and 
Treatment Satisfaction Questionnaire; SUDS = Subject Units of Distress 
Scale. PETQ = Prolonged Exposure Therapist Questionnaire. 
Demographics and Military Service Characteristics Form (DMSC).  The 
DMSC collects information regarding standard demographics (race, gender, age) 
and military service information (e.g., rank), and will be administered at the pre-
treatment assessment visit. 
Life Events Checklist for DSM-5 (LEC-5).  The LEC-5 is a 17-item self-report 
measure that assesses prior extent of exposure to traumatic events, as defined 
by DSM-5 criteria (Blake et al., 1995; F. W. Weathers et al., 2018).  This 
measure will be administered at the pre-treatment assessment to capture 
baseline differences in lifetime history of trauma exposure. 
MINI Neuropsychiatric Interview Schedule (MINI, version 7.0.2). The MINI is 
a widely-used brief structured interview that assesses common mental health 
diagnoses based on DSM-5 criteria (Pinninti, Madison, Musser, & Rissmiller, 
2003).  This instrument will be administered at the pre-treatment assessment visit 
to capture common diagnostic comorbidities. 
Primary Outcome Measures 
Treatment Dropout/Completion.  We will collect data on treatment completion, 
to include the number of treatment sessions and assessment visits attended, via 
chart review from CPRS.   
Treatment Non-Compliance.  We will collect data on treatment compliance, 
including completion of in-session and between-session assignments, as 
determined by chart review and self-report. 
Satisfaction with Therapy and Therapist Scale - Revised (STTS-R). The 
STTS-R is a 13-item Likert-type self-report scale designed to assess patient 
satisfaction with therapeutic services and providers (Oei & Green, 2008).  This 
instrument will be administered at the post-treatment and 1-month follow-up time-
points. 
Technology and Treatment Satisfaction Questionnaire (TTSQ).  The TTSQ is 
a 14-item self-report measure developed by the investigators.  Items assess 
satisfaction, acceptance, tolerability, perceived utility and treatment outcome-
related expectancies related to incorporating the remote affective physiology 
procedures into the assessment procedures (see below), as well as opinions 
about incorporating such measures into routine care.  Both patients and 

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providers will complete slightly different versions of this measure, addressing the 
same items, but adapted appropriately for wording.  This instrument will be 
administered at the post-treatment time-point. 
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).  The CAPS-5 is a 
structured interview for diagnosis of PTSD and is widely considered the gold-
standard assessment (Blake et al., 1995; F. W. Weathers et al., 2018). The 
CAPS-5 will be administered at pre-treatment, post-treatment, and the 1-month 
follow-up visits, and will be used to evaluate inclusion criteria and as a 
comparative criterion to assess relations between our objective measurements 
and severity of trauma-related symptoms and functional impairments. 
PTSD Symptom Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item self-
report measure of PTSD symptom severity based on the DSM–5 (Wortmann et 
al., 2016).  This measure will be administered at pre-treatment, post-treatment, 
and the 1-month follow-up, serving as a primary self-report outcome measure.  It 
will also be administered at the beginning of each treatment session, to index 
trajectories of change over the course of treatment. 
Patient Health Questionnaire (PHQ-9).  The PHQ-9 is a 9-item widely used 
self-report instrument that assesses core symptoms of major depression 
(Kroenke, Spitzer, & Williams, 2001)  As with the PCL-5, the PHQ-9 will serve as 
a primary outcome measure administered at pre-treatment, post-treatment, and 
the 1-month follow-up, and just prior to each treatment session. 
Secondary Outcome Measures 
Posttraumatic Cognitions Inventory, 9-Item Version (PTCI-9).  The PTCI-9 is 
a 9-item well-validated self-report measure of maladaptive beliefs that commonly 
manifest in PTSD (Wells et al., 2019)  This measure will be administered at pre-
treatment, post-treatment, and the 1-month follow-up, and at the beginning of 
each session to index change in problematic trauma-related beliefs. 
Mood and Anxiety Symptom Questionnaire (MASQ).  The MASQ is a brief 26-
item questionnaire with three separate subscales including general distress, 
anxious arousal, and anhedonic depression (Casillas & Clark, 2000). This 
measure will be administered at pre-treatment, post-treatment, and the 1-month 
follow-up. 
PTSD Safety Behaviors Questionnaire (PSBQ).  The PSBQ is a 10-item 
validated measure of unnecessary protective actions, including avoidant 
behaviors, that are common in cases of PTSD, and are widely believed to serve 
to maintain and exacerbate trauma-related symptoms (Foulser & Telch, 2019) 
This measure will be administered at pre-treatment, post-treatment, and the 1-
month follow-up. 
Emotional Reactivity and Numbing Scale (ERNS).  The ERNS is a 62-item 
self-report measure that assesses tendencies to experience a restricted range of 
emotions, or emotional numbing, including in response to emotionally arousing 
situations (Orsillo, Theodore-Oklota, Luterek, & Plumb, 2007)  This instrument 
will be administered at the pre-treatment assessment visit.   
Sheehan Disability Scale (SDS).  The SDS is a 5-item measure that assesses 
disability and functional impact associated with symptoms (Leon, Shear, Portera, 

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& Klerman, 1992).  This instrument will be administered at the pre-treatment, 
post-treatment and 1-month follow-up assessment visits.   
Clinical Global Impressions (CGI).  The CGI is a 5-item, clinician-rated 
measure that provides a global assessment of severity, functioning, and 
improvement over the course of treatment (Kadouri, Corruble, & Falissard, 2007)  
This measure will be administered at the pre-treatment, post-treatment, and 1-
month follow-up assessment time-points. 
Columbia-Suicide Severity Rating Scale (C-SSRS).  The C-SSRS is a widely 
used standard assessment of lifetime and follow-up suicidality, including thoughts 
of intent, methods, plans, and preparatory efforts, as well as suicidal and self-
harm behaviors (Posner et al., 2011).  This instrument will be administered at the 
pre-treatment, post-treatment, and 1-month follow-up time-points. 
Treatment Process Measures 
Pre-session Self-Report Measures.  Prior to each session, participants will 
complete a number of self-report measures, which will be reviewed with the 
participant at the beginning of each session.  The pre-session measures are 
indicated in Table 1, and described in the sections above, and include: the PCL-
5, PTCI-9, and PHQ-9. 
Subject Units of Distress Scale (SUDS).  The SUDS is a simple visual 
analogue scale reflecting anticipated, peak, and/or current distress levels, rated 
from 0 = “No distress” to 100 = “Extreme distress.”  This scale is commonly used 
as part of standard PE to assess the level of emotional arousal, engagement, 
and response to in-session and between-session exposure practices (Wolpe, 
1973).   
Prolonged Exposure Therapist Questionnaire (PETQ).  Our group developed 
the PETQ, which is an 8-item Likert-type scale, as a means to capture therapists’ 
assessments of session-by-session trauma-memory engagement, recovery of 
significant details, meaning making, and change in trauma-related beliefs.  This 
instrument will be completed by study therapists immediately following each 
treatment visit that involves imaginal exposure and processing components (i.e., 
sessions 2-6).   
Remote Affective and Physiological Measures. 
As implemented in our ongoing VA study (PI: Wangelin), participants will undergo 
standardized trauma interview procedures at pre-treatment, post-treatment, and 
the 1-month follow-up that will be audio and video recorded.   This will involve 
capturing reactivity to (1) 1-min. standardized neutral imagery (e.g., describing 
and recounting a mundane morning routine); (2) a 5-min. standard trauma 
interview designed to elicit emotional, cognitive, and sensorial details related to 
the traumatic event; followed by (3) very brief, 1-min. imaginal “hot-spot” 
revisiting, in which participants will be guided in verbally recounting and vividly 
imagining the worst part of their index traumatic event.  Additional details 
regarding these procedures can be found in the appendix (see standard trauma 
interview form in the appendix).  Video and audio streams will be analyzed using 
open-source software to extract affective and physiological signals based solely 
on visual and acoustic properties of webcam footage.  The specific markers to be 
extracted are described in the following sections. 

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Remote photoplethysmography (rPPG).  We will apply state-of-the-art 
procedures for extracting high fidelity heart rate data from video (van der Kooij & 
Naber, 2019) acquired via commercial-grade webcams already in use within our 
clinic, and comparable to that used nationwide in the delivery of VA telemental 
health.  Video quality will be consistent across assessment sessions (1080p, 60 
frames per second). Default settings for video recordings will be used, and any 
automated corrections (e.g., dynamic adjustments for variations in brightness) 
will be turned off.  Open-source MATLAB-based software 
(https://github.com/marnixnaber/rPPG/ ) will be used to extract heart rate from 
video recordings.  This will involve a series of automated steps, as described by 
van der Kooij and Naber (2019), including: (a) spatiotemporal cropping; (b) facial 
detection and selection of target pixels on the skin surface; (c) averaging/filtering 
signals based on dynamic color variations; (d) independent component analysis; 
(e) fast Fourier transformations; (d) power spectra filtering; and (f) corrections for 
respiration and movement artifacts.  Previously validated parameters will be used 
to extract the final rPPG heart rate, which will be defined as the tallest power 
peak across components.  Heart rate variability will also be calculated, based on 
the root mean square of successive differences in beat-to-beat intervals 
(RMSSD).  Finally, in addition to heart rate indices, respiratory rate will be 
similarly derived from the rPPG signal using validated acquisition, processing, 
and analytic steps, including applying MATLAB-based algorithms for 
spatiotemporal filtering, motion correction, and signal pruning to produce 
contactless, high-quality respiratory rate signals (Chen et al., 2019). 
Facial emotion expressivity.  Whereas coding of emotional facial expressions 
by independent raters is a well-established practice in the affective sciences, 
advanced algorithms based on artificial intelligence can now be applied to visual 
signals from video to allow for automatic and continuous detection of emotional 
facial features, providing a more objective means of measuring expressivity in 
comparison to subjective and observer-based assessments (Samadiani, Huang, 
Cai, Luo, Chi, Xiang, & He, 2019).  Following a similar approach as with the 
rPPG data, MATLAB-based algorithms will be applied to the video recordings to 
extract continuous measures of affective valence, arousal, and intensity, and 
emotion classification based on empirically-derived facial features associated 
with each primary emotion (i.e., joy, sadness, fear, anger, and disgust), as well 
as affective displays associated with physical pain.   
Affective vocal features.  In addition to the metrics above that rely on visual 
features, affective vocal features will be extracted from auditory streams of the 
video recordings by applying established acquisition, processing and analytic 
pipelines, utilizing MATLAB-based scripts to automatically isolate the patient’s 
voice, and subsequently extract and quantify vocal prosodic and spectral 
features characteristic of emotional states (e.g., Gunawan, Alghifari & Kartiwi, 
2018).   
Treatment Procedures. 
Telehealth-delivered massed imaginal exposure therapy.  Within 1-week of 
completing the initial pretreatment assessment visit and eligibility determination, 
enrolled participants will receive a total of six 60-minute treatment sessions, with 
sessions 2-6 scheduled daily, following the manualized procedures developed for 
use by Zoellner et al., (2017), as previously implemented by Co-I Dr. Cobb.  This 

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protocol closely follows core elements of PE, which is a gold standard 
intervention widely disseminated throughout the VA.  In addition to in-session 
components, participants will also complete between-session assignments 
involving listening to the entire session recording for session 1, and listening to 
their imaginal exposures for sessions 2-6.  Additionally, the treatment provider 
will conduct a brief (~5-10 min.) nightly check-in with participants via Doxy.me, 
VVC-now, or another VA-approved videoconferencing or secure messaging 
platform.  More details regarding in-session components are provided in the 
following sections. 
Session 1 primarily consists of psychoeducation delivered in an interactive 
(rather than purely didactic) manner to promote understanding of participants’ 
trauma-related reactions, symptoms, and functional impairment.  A brief rationale 
for treatment is also provided in this initial visit to support understanding and 
engagement with subsequent exposure-based visits.   
Session 2 begins with a more detailed, but still brief rationale for treatment, 
followed by 30 to 40 min. of imaginal exposure and approximately 15 min. of 
discussion (i.e., emotional processing) aimed at promoting elaboration on 
thoughts and feelings associated with participants’ index trauma.   
Sessions 3-5 consist of ~30-40 min. of imaginal exposure, and ~15 min. of 
processing trauma-related thoughts and feelings.  As treatment progresses, 
participants’ will be encouraged to focus on “hot-spots”, reflecting the most 
distressing parts of their index trauma.   
Session 6 is the final treatment visit, including 30 min. of imaginal exposure, 15 
min. of processing, and 15 min. of reviewing treatment progress, promoting 
maintenance of treatment gains, discussing treatment termination, and planning 
follow-up assessments. 
The procedural flow is illustrated in Figure 1 below. 
 

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Figure 1. Study procedures.  Outcome assessments will take place at 
pre-treatment, and at 1-week, and 1-month after treatment.  At each 
assessment, remote photoplethysmography (rPPG) will be utilized to 
extract heart rate data from videos of a standard trauma-focused 
interview administered at pre-treatment, post- treatment, and 1-month 
follow-up, in addition to other video-based measures of affective 
reactivity, a clinical diagnostic interview, and self-report measures.   
Tolerability, acceptance, and perceived utility of the procedures based on 
the providers’ and participants’ self-reports will also be collected.  
Treatment process measures based on patient self-report will be 
collected before and just after each of 6-daily treatment sessions.  
Provider ratings of engagement and emotional processing will also be 
collected immediately following each treatment session that includes 
imaginal exposure and processing components (i.e., sessions 2-6).   
Participant Compensation 
For their time and effort, participants will be compensated a total of $100.00 for 
completion of the three assessment visits, including the 2-hour pre-treatment 
assessment and the 1 ½ hour post-treatment and 1-month follow-up 
assessments.  The rates below are based on standard participant compensation 
in our ongoing VA clinical trials and were selected to enhance generalizability of 
feasibility and acceptability findings to our routine treatment-seeking Veterans, 
with due consideration of the need to minimize coercion. 
Participant Compensation Schedule 
 
Completed Visit: 
Amount to be 
Paid: 
Pre-treatment Assessment Visit 
$25.00 
1-Week Post-treatment Assessment Visit 
$25.00 
1-Month Follow-up Assessment Visit 
$50.00 
All Study Visits (3) Completed (Total): 
$100.00 
 
10.0 Data Management  
Data Acquisition.  If (and only if) ultimately approved by the VA, we propose the 
use of VA Qualtrics, which is a secure, FedRAMP-authorized online data capture 
system that is widely used as a HIPPA-compliant web-based means to collect 
sensitive research data.  Moreover, if approved, in addition to remotely collecting 
validated self-report questionnaire data from participants using this platform, we 
also request leveraging Qualtrics’ functionality to integrate java script, which 
would enable us to directly capture audio and visual data from the participant’s 
side from their webcam and microphone.  This is an excellent alternative to our 
initially proposed procedures, which involve collecting streamed, then captured 
(i.e., on the clinician’s side) footage.  This is problematic due to significant 
temporal distortion and low sampling rate for screen-captured footage on 
currently deployed telehealth platforms approved by the VA (i.e., Teams, Webex, 
and VVC).  As mentioned, the use of Qualtrics will be entirely contingent on 
obtaining full MUSC IRB and VA R&D approval for our proposed use.  If 
ultimately not approved, we will continue to implement our procedures that 
involve capturing questionnaire data with hard copies, by mail.   

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Data Preparation.  Pre-processing of data as the study progresses will allow for 
more expedient dissemination of study findings.  As appropriate, pre-processing 
will follow standard best practices to ensure excellent data quality and security.  
Prior to analyses, data will be visually and statistically inspected for the presence 
of aberrant data points, which will be omitted prior to analyses.   
Analytical Plan.  Descriptive statistics will be reported for safety, feasibility, 
tolerability, and acceptability.  Linear mixed-effects models will be used to 
characterize trajectories of change in symptoms and impairment, while 
controlling for potential confounders, such as baseline severity. 
Following standard pre-processing steps, analyses will be conducted using 
generalized linear models, and will proceed in a bottom-up manner involving 
selection of the best fitting fixed and random growth terms, followed by adding 
predictors of interest.  Factors (e.g., sex) will be dichotomously coded, whereas 
all continuous predictors will be scaled and centered as a function of baseline 
values to allow for meaningful interpretation of effects as indicative of reliable 
change.   
Additionally, all models will control for baseline levels of the outcome to control 
for individual differences at pre-treatment in estimating effects.  Model refinement 
will be guided by theory, evaluating standard fit statistics (e.g. Log Likelihood, 
AIC, BIC, etc.) and whether modeling assumptions are sufficiently met. 
11.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
Safety will be monitored by reports of adverse events at all study visits 
throughout all phases of the project.  This will include formal assessment of 
psychiatric symptoms (including suicidality and homicidality) as well as invitation 
at each study visit to speak to a therapist regarding any suicidal or homicidal 
thoughts and a reminder about the Veterans’ Crisis Line.  Formal assessment of 
suicidality will be conducted using the C-SSRS, and suicidality will also be 
monitored throughout study participation based on item 9 on the PHQ-9.  Should 
a Veteran endorse suicidality on this question, or otherwise report to study staff 
any thoughts of wanting to hurt him/herself or others, the veteran will be fully 
evaluated for safety, and steps to ensure safety will be followed.  Suicidal or 
homicidal plan or intent will be immediately reported to the PI.  
All research participants will be assigned a numeric code (Subject ID) that is 
based on the chronological order in which they were enrolled in the study. This 
number accompanies all de-identified data. The participant’s identifying 
information and numeric code will be stored in the password-protected database 
on a protected VA virtual drive previously described. Password to participant data 
will be updated quarterly as an additional security measure.  All identifying 
information (e.g., signed consent forms and contact information) will be 
maintained separately from the rest of the study data collected. The Subject ID 
will not contain any identifiers or protected health information (PHI) as defined by 
HIPAA.  All data on separate VA data analysis computers (that are also 
password protected) are stripped of potential identifiers, with special attention 
paid to the problem of “cell size.”  VA research data will be retained according to 
RCS 10-1 and VA Information Security policies.   Moreover, if the proposed use 
of Qualtrics is ultimately approved, all procedures described above to de-identify 

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data will apply.  Specifically, data will only be connected to a numeric code (i.e., 
Subject ID, last name initial, and last four of SS#). 
Upon study completion, all links between identifiers and clinical research data will 
be deleted.  The process for de-identifying data will be completed by a qualified 
biostatistician with an extensive background in statistics, mathematics, clinical 
science, and knowledge of and experience with generally accepted statistical and 
scientific principles and methods for de-identification applying generally accepted 
principles and methods, as outlined in VHA DIRECTIVE 1605.01, Appendix A.  
In addition, for participants who express willingness to be contacted for future 
research opportunities on their informed consent document, we will retain their 
contact information (i.e., name, address, and phone number) in a repository 
consisting of a password-protected spreadsheet, with the password updated 
quarterly.  These data will likewise be stored on a secure VA server.   
Data and Safety Monitoring Plan (DSMP). The PI, Dr. McTeague will be in 
charge of (1) providing scientific oversight; (2) reviewing all adverse effects or 
complications related to the study; (3) monitoring enrollment; (4) reviewing 
summary reports relating to compliance with protocol requirements; and (5) 
providing advice on resource allocation. Dr. McTeague will meet every 6-months 
in-person and as necessary with the CoI-s as an internal Data Safety Monitoring 
Committee (DSMC) to review progress. The recommendations of the DSMC will 
be reviewed and the PI will take appropriate corrective actions as needed. At 
each meeting the DSMC will: 
• Review the research protocol and plans for data and safety monitoring. 
• Evaluate the progress of the study, including periodic assessments of 
data quality and timeliness, participant recruitment, enrollment, and 
retention, participant risk versus benefit, integrity of the intervention, and 
other factors that can affect study outcome. 
• Consider factors external to the study when interpreting the data, such 
as scientific developments that may impact the safety of study participants 
or the ethics of the study. 
• Make recommendations to the IRB for continuation or termination of the 
study. 
• Protect the confidentiality of study data and monitoring. 
DSMC reviews and reports will occur on a semi-annual basis and will be 
organized and prepared by the PI. Planned interim analysis will occur once 50% 
of the target study enrollment is reached (N = 13). 
On a daily basis, Dr. McTeague will be responsible for data and safety monitoring 
and will provide continuous, close data monitoring. Dr. McTeague will promptly 
report serious adverse events to the MUSC Institutional Review Board (IRB). A 
report of all non- serious adverse events will be provided to the IRB yearly. 
12.0 Withdrawal of Subjects (if applicable) 
If it is determined that it is not in the subject’s best interest to continue 
participating in the study, he or she will be withdrawn from the study without their 
consent. Examples of such circumstances include emergence of symptoms or 

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behavior that meet study exclusion criteria, consistent non-compliance with study 
assessment instructions, or if treatment of other acute health/mental health 
symptoms becomes a priority over study participation. In such cases, the PI will 
meet directly with the subject to explain the reasons for withdrawal from the 
study, and to assess whether any further action is required, including additional 
mental health intervention or modification of the current treatment plan. The 
treating therapist will be included in this discussion as appropriate.  
13.0 Risks to Subjects 
Clinical interviews and questionnaires administered include questions about 
exposure to stressors and other topics that might produce transitory distress in 
some individuals. There is also the potential for participants experiencing 
embarrassment or other negative consequences if some of the experiences were 
disclosed via a security breach, particularly if their identity were linked to their 
interview data.  These risks appear minimal given the protections in place to 
maintain confidentiality and to respond to participants who experience distress. 
We will use several procedures to protect against the risks that were previously 
identified. The first risk is that some participants might experience transitory 
distress when asked about stressor events in the interviews or during treatment. 
Based on our research teams’ previous experience in asking similar questions to 
more than 2,400 combat exposed veterans, we think that this risk is low if 
questions are phrased sensitively and interviewers are trained properly. 
Therefore, we will provide special training and supervision to the research 
interviewers and treatment providers. Only the best, most experienced clinicians 
will be used, many of whom will have had experience with other clinical and 
research interviews with trauma exposure populations, and are well-versed in 
each of the gold-standard treatments for PTSD.  Interviewers and treatment 
providers are supervised on a weekly basis to ensure they are conducting the 
study procedures effectively, appropriately, and with high fidelity to our 
established protocols.  
Study staff will report any potentially dangerous suicidal or homicidal ideation, or 
evidence of child abuse, to the appropriate individuals as required by law. The 
possibility of such reporting is included in the informed consent process. If the 
participant expresses a wish to talk to a team member, Dr. Lisa McTeague (PI of 
the current study proposal) or Dr. Bethany Wangelin (director, staff clinician on 
the PCT and co-I), both with extensive experience in the assessment and 
treatment of PTSD, will be notified by the interviewer.  Drs. McTeague and 
Wangelin are committed to being available via instant messaging, email, text, 
and phone during the time that the research interviewer is conducting interviews. 
Drs. McTeague or Wangelin will contact or greet the participant and determine 
whether any further action is required.  If it is decided that some type of mental 
health intervention is needed, or modification of the Veteran’s current treatment 
plan, arrangements will be made.   
Based on our prior experience, it is extremely unlikely that a participant will 
experience significant sustained distress.  These procedures for addressing 
participant distress are similar to those that have been successfully used in 
several prior studies directed by members of this research team. Specifically, 
with respect to assessment of suicide risk, all investigators complete VA training 

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on the recognition and management of suicide risk.  They will assess and 
document acute and chronic risk factors. Any individuals deemed to be at an 
elevated risk for suicide, will be reevaluated and treated as clinically indicated by 
Drs. McTeague (PI) and Wangelin (Co-I), and their clinical care team. 
We will follow all standard operating procedures for the conduct of secure 
videoconferencing for remote study participation and receipt of therapeutic 
services, as is approved and routinely implemented by the VA.  For example, 
with respect to ensuring participant safety, each study and treatment visit will 
commence with confirming the participants’ location, inquiring whether 
responsible others are available on-site in the event of an emergency, and 
procuring other local emergency contact information in the event that intervening 
is clinically required (e.g., for individuals expressing suicidal risk).   
As mentioned, some participants might experience embarrassment or other 
negative consequences if the confidentiality of their interview responses 
regarding sensitive topics was breached. Some of these topics involve 
victimization experiences and mental health problems. If confidentiality of this 
material were breached, the potential harm to participants is clear. Our research 
team has considerable experience conducting interviews on sensitive topics and 
has never had a breach of confidentiality. In addition to stressing the need for 
confidentiality in training and supervision, our research team has developed 
successful procedures to keep interview data confidential. The risk of loss of 
confidentiality is extremely small given the measures that we have in place. All 
information will be stored in locked files in a locked research area (i.e., behind 
two locks) specifically designated for research personnel. Computer data will only 
be stored on password-protected computers and using the VA virtual drives, with 
the exception of the potential use of Qualtrics for collecting data, as described 
above.  No names or identifying information will be used in publications that 
result from this research. Under no circumstances will identifying information be 
released to any outside party (beyond those immediately connected with the 
study) without written consent from the subject. 
14.0 Potential Benefits to Subjects or Others 
We believe that the potential risks to participants are minimal and are minimized 
further given the steps we will take to reduce and respond to participants’ 
distress and to maintain confidentiality.  Further, participants may benefit from 
receiving imaginal exposure, which is a core component of Prolonged Exposure 
(PE) therapy – a gold-standard evidence-based treatment for PTSD.  However, 
while our group’s prior work has suggested comparable efficacy of massed 
imaginal exposure relative to the full PE protocol (Zoellner et al., 2017; Sciarrino 
et al., 2020), it is unknown whether these effects will generalize to a telehealth 
modality, and thus these potential benefits cannot be guaranteed.  Should 
participants fail to respond, additional treatment will be offered. 
Benefits to others are potentially substantial.  If successful, this pilot study may 
provide support for developing alternative treatment schedules to afford flexibility 
and accommodate preferences, reduce burden on patients, providers, and clinic 
resources, and provide support for more developing more efficacious, efficient, 
and accessible treatments for PTSD. 

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