Contemporary Clinical Trials 91 (2020) 105990

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Contemporary Clinical Trials

journal homepage: www.elsevier.com/locate/conclintrial

The efficacy of written exposure therapy versus imaginal exposure delivered T

online for posttraumatic stress disorder: Design of a randomized controlled
trial in Veterans
⁎
Carmen P. McLeana,b, , Madeleine L. Millera, Richard Genglerc, Jason Hendersonc,
Denise M. Sloand,e
a
National Center for PTSD, Dissemination and Training Division, VA Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA 94025, USA
b
Stanford University, Department of Psychiatry and Behavioral Sciences, School of Medicine, 401 Quarry Road, Stanford, CA 94305, USA
c
Prevail Health Solutions, LLC, 105 W Chicago Ave #203, Chicago, IL 60642, USA
d
National Center for PTSD, Behavioral Science Division, VA Boston Healthcare System, 150 S Huntington Ave, Boston, MA 02130, USA
e
Boston University School of Medicine, 72 E Concord St, Boston, MA 02118, USA

A R T I C LE I N FO A B S T R A C T

Keywords: Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of ef-
Veteran behavioral health fective care to Veterans with posttraumatic stress disorder (PTSD). This paper describes the rationale for and
Posttraumatic stress disorder methods of a randomized controlled trial comparing the efficacy and efficiency of written exposure therapy
Written exposure versus imaginal exposure for PTSD delivered in a novel online and variable length format. Participants will be
Treatment mechanisms
300 Veterans seeking treatment for clinically significant symptoms of PTSD. Participants will be randomly as-
Web-treatment
signed to either written exposure or imaginal exposure via verbal recounting and will complete between 4 and 8
online therapy sessions facilitated by trained peer support specialists. Treatment is terminated before session 8 if
the PTSD symptom improvement criterion is met. Assessments will be conducted at baseline, post-treatment, and
at 3-month follow-up. The primary hypotheses are that written exposure therapy will be noninferior to imaginal
exposure with respect to treatment efficacy and efficiency. Secondary hypotheses relate to identifying and
comparing potential mediators of PTSD treatment outcome, including trauma-related cognitions and emotion
regulation.

1. Introduction with PTSD do not access these treatments. As many as 56–87% of

Posttraumatic stress disorder (PTSD) is an often chronic and debil-
itating condition characterized by intrusion symptoms, avoidance
symptoms, cognition and mood symptoms, and arousal symptoms.
PTSD affects an estimated 14% of Veterans returning from Iraq and
Afghanistan [45], and nearly 1 in 3 Veterans connected with VA care
[3], suffer from PTSD. Untreated PTSD is associated with numerous
comorbid psychiatric and medical disorders [2], significant functional
impairments [49,50], and higher health care utilization [35]. Although
effective evidence-based psychotherapies (EBP) exist, most Veterans
combat Veterans who experience psychological distress report that they
received no psychological help preceding deployment [20,22]. Barriers
to accessing traditional PTSD treatment include lack of available ser-
vices, distance from clinics, difficulty scheduling during work hours,
and stigma associated with mental health problems [33]. In addition,
given the high demand for mental health services among Veterans,
some facilities may be overburdened relative to staffing resources,
leading to long patient wait times that could discourage treatment
seeking [19].
Web-based treatments represent an innovative way to overcome

Abbreviations: DSM-5, Diagnostic and Statistical Manual of Mental Disorders, 5th Edition; DoD, U.S. Department of Defense; EBPs, evidence-based psychotherapies;
PTSD, posttraumatic stress disorder; U.S., United States of America; VA, U.S. Department of Veterans Affairs; RCT, randomized controlled trial; WET, written
exposure therapy; PCL-5, The PTSD Checklist for DSM-5; PE, Prolonged Exposure therapy; PHQ-9, Patient Health Questionnaire-9; RA, research assistant; LEC-5, Life
Events Checklist for DSM-5; CEQ, Credibility/Expectancy Questionnaire; WSAS, Work and Social Adjustment Scale; DERS-16, Difficulties in Emotional Regulation
Scale; PTCI-9, Posttraumatic Cognitions Inventory; MLM, multilevel modeling
⁎
Corresponding author at: Dissemination and Training Division, National Center for pTSD, VA Palo Alto HealthCare System, 795 Willow Road, Menlo Park, CA
94025, USA.
E-mail address: Carmen.McLean4@va.gov (C.P. McLean).

https://doi.org/10.1016/j.cct.2020.105990
Received 10 December 2019; Received in revised form 28 February 2020; Accepted 11 March 2020
Available online 14 March 2020
1551-7144/ © 2020 Elsevier Inc. All rights reserved.
C.P. McLean, et al.
these barriers by providing Veterans with a flexible treatment option
that can be accessed at a time and place of their choosing, and with
anonymity that may minimize stigma-related concerns. Meta-analyses
have found that web-treatments for PTSD are efficacious (see [38]);
however, none were developed from existing PTSD treatment protocols
with established efficacy (for an exception see, [30]) and most rely on
therapist facilitation, which minimizes cost-effectiveness and scal-
ability.
To address these limitations, this randomized controlled trial (RCT)
will compare two trauma-focused interventions, facilitated by trained
peer support specialists, and delivered through an online behavioral
health platform accessible to Veterans (VetsPrevail.org). Written ex-
posure therapy (WET; Sloan & Marx, 2019) is an evidence-based
trauma-focused treatment for PTSD that involves imaginal exposure
through repeated writing about a trauma memory in detail. WET is
recommended as a first line treatment [ [48]] and has been found ef-
ficacious [39,40] and noninferior to cognitive processing therapy
[42,44] in reducing PTSD symptoms. WET will be compared to ima-
ginal exposure conducted via repeated verbal recounting of the trauma
memory. This form of imaginal exposure is well-established for treating
PTSD both as a stand along approach (e.g., [46]), and as part of pro-
longed exposure therapy (PE) [48] and other trauma-focused inter-
ventions (e.g., [7,28]).
The goals of the study are to evaluate the efficacy and efficiency of
WET compared with imaginal exposure delivered online with peer
support specialist facilitation. As effective treatments are adapted for
new delivery formats, a better understanding of the mediators of PTSD
treatment outcome can inform how these modifications should be
made. Thus, this study will also evaluate negative trauma related cog-
nitions (e.g., [25]), emotion regulation [30], and exposure related
subjective distress (e.g., [54]) as potential mediators of PTSD change.
2. Design and methods
2.1. Aims and hypotheses
The first aim of this study is to investigate the relative efficacy of
online versions of written versus imaginal exposure in reducing PTSD
symptom severity. This is the first comparison of written exposure
therapy with imaginal exposure. Based on the comparably large effect
sizes for these treatments when delivered in-person (e.g., [42]) we
hypothesize imaginal exposure will be non-inferior to written exposure
recounting with respect to treatment efficacy, as measured by the
Posttraumatic Checklist for DSM-5 (PCL-5; [50]) given at pre-treat-
ment, mid-treatment, and 3-month follow up.
The second study aim is to examine the relative efficiency of written
versus imaginal exposure in reducing PTSD symptom severity. Using a
variable length study design, we will compare the rate of improvement
(i.e., the slope of symptom reduction) during treatment. The non-
inferiority hypothesis is that both conditions will yield the same
average amount of PTSD symptom reduction from one session to the
next session (i.e., noninferior efficiency).
The third aim of this study is to test potential underlying mechan-
isms of written and imaginal exposure therapy. Consistent with emo-
tional processing theory [59,60], results of numerous studies indicate
that changes in negative posttraumatic cognitions (e.g., “I'm in-
competent”; “The world is completely dangerous”; “No one can be
trusted”) mediate PTSD change during treatment (e.g., [25,29,30,58]).
Results of one recent study [30] suggest that certain emotional reg-
ulation strategies, namely catastrophizing, also mediate PTSD change,
particularly in exposure treatments. Based on these findings, we hy-
pothesize that trauma-related cognitions and emotion regulation will
mediate changes in PTSD outcomes over time, and we will explore
whether a different pattern of mediation is observed across treatment
conditions.
As an exploratory aim, we will test baseline measures predictors and
2
Contemporary Clinical Trials 91 (2020) 105990
moderators of PTSD outcomes including age, gender, depression,
trauma history, and initial PTSD severity. In addition, given mixed
findings on whether patterns of change in exposure-related distress are
associated with outcomes (see [1]), we will explore whether peak ex-
posure-related distress (sometimes referred to as emotional engage-
ment) and reduction in subjective distress across sessions are associated
with PTSD change during treatment.
2.2. Participants
Participants will be 300 men and women Veterans with clinically
significant self-reported symptoms of PTSD, defined as a total score of
≥31 [6]. Participants will be recruited through online advertisements
that link to the Vets Prevail website, where potential participants can
learn more about the study and can complete the two screening mea-
sures that determine eligibility for the study. The PCL-5 [51] will be
used to screen for clinically significant PTSD symptoms. The only ex-
clusion criterion is moderate risk for suicide, defined as a score of 3 or
higher on the Patient Health Questionnaire-9 (PHQ-9; [23]) suicide
item. Individuals with scores indicating moderate or high risk for sui-
cide will be excluded from the study. Participants that do not meet
these inclusion/exclusion criteria will be referred to other Vets Prevail
programs and provided crisis management resources as needed.
2.3. Procedures
This study was reviewed and approved by the Institutional Review
Board of Stanford University. Potential participants will be recruited
through online advertisements (e.g., Facebook ads) that connect to the
Vets Prevail website. Regular users of the Vets Prevail website will also
be recruited for the study as part of the website onboarding process.
Interested potential participants will complete the PCL-5 and the PHQ-9
to determine study eligibility. Eligible potential participants will be
invited to provide their contact information and the study research
assistant (RA) will then contact them to discuss the study and review
informed consent over the phone. Once informed consent is obtained, a
study RA will enroll the eligible participant using an online study
dashboard. Participants will be randomly assigned to one of two con-
ditions: written exposure or imaginal exposure, using block randomi-
zation. See Fig. 1 for an overview of the study design. Prior to the be-
ginning treatment, participants will be asked to complete a short
battery of self-report measures assessing for trauma exposure, emotion
regulation difficulties, functional impairment, and dysfunctional post-
traumatic cognitions. As part of informed consent, participants grant
permission for the two screening measures (PCL-5 and PHQ-9) to be
used as part of their pre-treatment data.
Participants then complete 4–8 sessions written or imaginal ex-
posure, depending on the random assignment, delivered through the
Vets Prevail website. Participants are encouraged to complete 2–3
sessions each week. Each session (referred to as levels on Vets Prevail)
is broken into multiple exercises for the participant to complete in a
specific order before they are able to move onto the next session (level).
Most sessions include the same components: completion of a short as-
sessment, chatting online with a peer support specialist, entering a pre-
exposure distress rating, completing a written or imaginal exposure
exercise, entering a post-exposure distress rating, and chatting online
with a peer support specialist. There is no between-session homework.
Self-report assessments are completed prior to starting treatment, mid-
treatment (session 3), post-treatment (two-weeks after the final ses-
sion), and 3-month follow up. Participants will also complete a cred-
ibility and expectancy measure after session 1 and, prior to sessions
4–7, participants will complete a four items version of the PCL-5. If the
participant scores ≤5 on this screen, which indicates minimal symp-
toms, they will be prompted to complete the full PCL-5 (minus the 4
items already completed) to verify their minimal symptom status. If the
full PCL-5 scores is ≤21, the participant will be notified that the
C.P. McLean, et al.
Fig. 1. Study Design Overview.
WET, Written Exposure Therapy; IE, Imaginal Exposure.
*Participants may terminate after sessions 4 through 8 depending on their PTSD
symptom reduction.
upcoming session will be their final session. The criterion for treatment
termination is empirically informed and similar to those used in other
variable length PTSD trials [16,37]. If a participant reaches session 8,
and has not achieved this criterion, they will terminate at that time (i.e.,
8 is the maximum number of sessions a participant will receive). Par-
ticipants will be compensated with electronic or physical gift cards to a
major US retailer for completing the pre-treatment assessment ($40),
the post-treatment assessment ($60), and the follow-up assessment
($60). Completion of each assessment will be tracked in the study
dashboard and monitored by the study RA, who will send out the
electronic or physical gift cards, accordingly.
The peer support specialists in this study are certified to the VA's
requirements and are persons with mental health conditions who are
currently in recovery. The peer support specialists guide and support
the participants through the treatment. This is facilitated by the Vets
Prevail online platform that allows them to engage the participants
through scripted and closely reviewed connections. The goals and in-
structions for each connection, or online chat, are defined for the peers
and presented to them within their dashboard. This allows the peers to
concentrate on the conversation with the participant, while still having
instructional messaging readily at hand. Another focus of the peers is to
identify those users who may be in crisis, either in danger of harming
themselves or harming others. Through a developed partnership with
the Veterans Crisis Line, the peers at Vets Prevail have the ability to
conduct warm hand-offs directly to the crisis line. This provides an
important safety net for the study participants given the lack of face-to-
face interaction.
2.4. Treatment conditions
2.4.1. Written exposure
Written Exposure Therapy [61] is an evidence-based treatment for
PTSD (VA/DoD, 2017) that is typically delivered in five, face-to-face
treatment sessions. During the first session, the therapist provides
psychoeducation about PTSD and the treatment rationale, followed by
instructions for writing about the traumatic experience. The therapist
reads scripted writing instructions and then has the client complete the
3
Contemporary Clinical Trials 91 (2020) 105990
30 min of writing without interference; the therapist alerts the client
when the 30 min is up and they should stop writing. Clients are in-
structed to write about their index (worst) trauma during each writing
session (same event at each session), providing as much detail as pos-
sible; participants are also instructed to include details on thoughts and
feelings they experienced during the event. Participants are instructed
to write about the experience as they “look back upon it now”. At the
conclusion of 30 min of writing, the therapist instructs the participant
to stop writing, and spends a short amount of time (i.e., ≤10 min)
inquiring about the participants' reaction to their writing session.
The written exposure condition in this study was modified in several
ways. Instead of a therapist, the protocol is delivered via an online
platform, with a peer support specialist providing instructions and
feedback before and after each writing session. Some of the tasks ty-
pically administered by the therapist, such as providing psychoeduca-
tion and collecting distress ratings on a 0–100 scale before and after the
narrative exposure, are automated into the online program. In addition,
instead of a set 5 sessions, the treatment length is variable, between 4
and 8 sessions. Consistent with in-person delivery, the first online ses-
sion takes approximately 60 min to complete, and the subsequent ses-
sions take approximately 40 min. All sessions include 30 min of writing.
The written narratives are saved to the participant's Vets Prevail
account and are accessible to the participant and the peer support
specialists, who is instructed to review the narrative from the prior
session in order to provide feedback to the participant before the next
writing exercise (consistent with standard WET procedure).
2.4.2. Imaginal exposure
Imaginal exposure involves verbally recounting the narrative of the
index trauma, typically with closed eyes to promote visualization and
engagement. It is a key component of a well-supported evidence-based
treatment for PTSD called PE [14], and it has also been found effica-
cious as a brief stand-alone intervention (). In this study, standard
imaginal exposure was implemented within the same protocol that is
described above, and the time to complete sessions is the same. The
only difference is that instead of writing for 30 min about the trauma,
participants are instructed to verbally recount the trauma narrative
with their eyes closed. Talk to text software is used to generate a written
account for the peer support specialist to review prior to the next ses-
sion.
2.5. Quality control
2.5.1. Training and supervision of peer support specialists
Peer Coaches are provided, trained, and supervised by Vets Prevail.
Peer Coaches are individuals who have already been through the Vets
Prevail program themselves, demonstrated that they are in recovery
from a mental health issue, completed a comprehensive training course
within the Vets Prevail platform, and completed a VA approved Peer
certification course. By requiring that Peer Coaches have used the
program and have dealt with a mental health issue, it is ensured that
the coaches have a personal experience with mental illness and can
share their own knowledge and experience with other users.
2.5.2. Assessment of fidelity
All Prevail Peer chats are reviewed for quality assurance by Peer
Admins. The Peer Admins ensure that Peer Coaches follow the Prevail
Protocols and that any adverse circumstances are appropriately iden-
tified and remediated in accordance with Prevail Crisis Protocols. If an
Admin deems that a chat was not done according to criteria, the chat is
marked “Disapproved” and is flagged down for action/remediation
from Prevail Peer Supervisors.
C.P. McLean, et al.
3. Measures
3.1. Background measures
3.1.1. Sociodemographic measure
This is a 14-item measure of demographic information such as
ethnicity, age, gender, and military service.
3.1.2. Life events checklist for DSM-5 (LEC-5)
The LEC-5 [51] is a 17-item self-report measure of exposure to
traumatic events. This measure is administered only at baseline.
3.1.3. Credibility/expectancy questionnaire (CEQ)
The CEQ [8] measures treatment expectancy and rationale cred-
ibility. This measure has demonstrated high internal consistency and
good test-retest reliability [8]. This measure is administered im-
mediately after session 1 and at post-treatment.
3.2. Outcome measures
3.2.1. Posttraumatic stress disorder checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report measure that assesses symptoms
of PTSD as defined by the DSM-5. The PCL-5 has been shown to have
high internal consistency (Cronbach's alpha 0.91–0.95; [56]) and strong
test–retest reliability [5,6]. The PCL-5 is administered at pre-, mid-, and
post-treatment, and 3-month follow-up. A 4-item version of the PCL-5
[36] is also given prior to sessions 4–7.
3.2.2. Patient health questionnaire (PHQ-9)
The PHQ-9 [23] is a 9-item self-report measure of depressive
symptoms. It has excellent internal reliability (0.86–0.89), and corre-
lates strongly with other measures of depression [23]. This measure is
administered at pre-, mid-, and post-treatment, and 3-month follow-up.
3.2.3. Work and social adjustment scale (WSAS)
The WSAS [27] is a 5-item self-report scale of functional impairment
that can be attributed to an identified problem. The WSAS has high
internal consistency (Cronbach's alpha = 0.74–0.94) and good test-
retest reliability (r = 0.73) [32]. This measure is administered at pre-,
mid-, and post-treatment, and 3-month follow-up.
3.3. Process measures
3.3.1. Difficulties in emotional regulation scale (DERS-16)
The DERS-16 [4] is a 16-item self-report measure assessing emotion
regulation difficulties. Responses are recorded on a Likert-scale that
ranges from 1 (almost never) to 5 (almost always). A higher score on the
DERS-16 indicates a greater level of emotion dysregulation. The DERS-
16 has good internal consistency (Cronbach's alpha = 0.92–0.95), and
test-retest reliability, and high construct and predictive validity [4].
This measure is administered at pre-, mid-, and post-treatment.
3.3.2. Posttraumatic cognitions inventory (PTCI-9)
The PTCI-9 [52,53] is a short version of the original 36-item PTCI
[13] that measures self-reported negative posttraumatic cognitions. The
PTCI-9 has been shown to be significantly correlated with measures of
PTSD, depression, and quality of life. The total scale and subscales have
shown high internal consistencies (Cronbach's alpha = 0.80–0.87) as
well as strong correlations with the PTCI in Veterans (rs = 0.90–0.96)
and civilians (rs = 0.91–0.96; [52,53]). The PTCI-9 is administered at
pre-, mid-, and post-treatment.
3.4. Data analytic plan
First, we will evaluate the noninferiority of the Written vs. Imaginal
exposure on PTSD outcomes (PCL-5). In noninferiority tests, the entire
4
Contemporary Clinical Trials 91 (2020) 105990
95% CI for the new treatment (μWritten) must be below the treatment
mean of the established treatment (μImaginal) plus the noninferiority
margin (Δ; [62]). To be conservative, we will employ one-half the
clinical change criterion as our Δ. In a study with a total N = 300,
Monson et al. [63] determined the clinically significant change cri-
terion on the PCL-IV to be 10. Thus, we estimate a noninferiority
margins of 5 points for the PCL-5 (1/2 the clinically significant change
criteria). A non-inferiority margin for the PCL-5 has yet to be estab-
lished but is expected to be available before the end of the study; the
margin used in the current trial will be updated as needed based on
these data. These noninferiority analyses will be performed at post-
treatment and at 3-month follow-up.
Next, we will evaluate the noninferiority of Written vs. Imaginal
exposure on treatment efficiency. Multilevel modeling (MLM) will be
used to calculate the average reduction in PTSD symptoms per treat-
ment session. MLM allows inclusion of all participants, regardless of
missing data or dropout, allows different numbers of assessments be-
tween participants, and is the recommended analysis for longitudinal
psychiatric data [64]. In this case, our “time” variable will be “session
number” (e.g., session 1–8). Thus, the regression coefficient represents
the average reduction in PTSD symptoms (on the PCL-5) per session.
Various models for the “growth” curve of PCL-5 over sessions will be
tested (linear, quadratic, logarithmic, piecewise), and the model that
best fits the data (based on Akaike information criterion [AIC] and
Bayesian information criterion [BIC] criteria) will be chosen. Treatment
condition will be modeled as a level-2 dummy variable predictor of
slope of improvement over sessions. Data from over 500 PE cases re-
lated to combat PTSD drawn from published and unpublished ongoing
efforts indicate Δ ranges from 1.1 to 1.25. Thus, we will conservatively
use Δ = 1.1 as the noninferiority margin for the present proposal (re-
quiring the 95% CI for the slope in Written exposure to be within 1.1 of
the rate for Imaginal exposure).
Hypotheses regarding mechanisms of change will be evaluated
using various methods. Longitudinal, multi-time point, cross-lagged
panel analysis and mediation analysis, following the general approach
of Hamaker et al. [65], will be used to investigate whether emotion
regulation (as measured by the DERS-16), negative cognitions (as
measured by the PTCI) and between-session extinction (as measured by
SUDS) mediate changes in PTSD symptoms as measured by the PCL-5.
4. Discussion
Web-based treatments have potential to offer EBP programs with
high fidelity and minimal cost while circumventing many of the major
logistical and stigma-related barriers to traditional mental health care.
This RCT will test the relative efficacy and efficiency of an established
EBP delivered through an innovative online platform. The study is re-
latively resource-intensive in that non-inferiority trials require a large
sample size compared to other designs and the novel online delivery
format necessitates an iterative program development phase. Key study
design decisions, described and justified below, were made to maximize
the impact of the findings on the development of scalable options for
PTSD care delivery.
Written exposure therapy is an evidence-based treatment that is
well-suited for online delivery. Delivered in person, written exposure
therapy has been found to significantly reduce PTSD severity (Sloan &
Marx, 2019) with large effect sizes similar to 10 sessions of PE. It has
also been found to be noninferior to 12 sessions of cognitive processing
therapy, with significantly lower dropout [42,44]. It is easily adapted to
online delivery because it is a highly structured program with
straightforward instructions. The therapist role is less involved relative
to other trauma-focused EBPs for PTSD and their instruction and
feedback is scripted, making it feasible for a trained peer support spe-
cialist to assume this role. Although typically delivered once-weekly, in
this study, participants will be encouraged to complete 2–3 sessions per
week, allowing them to complete the program in 2–4 weeks. Written
C.P. McLean, et al.
exposure therapy is well suited for frequent sessions because there is no
in-between session homework, unlike PE and most other cognitive be-
havioral therapies. Moreover, there is evidence that written exposure is
efficacious when delivered in a condensed format [41]. Shorter, more
condensed treatment formats are highly advantageous because they
minimize treatment drop out [12], maximize patient acceptability, and
accelerates PTSD recovery [10,15].
Given the large proportion of Veterans who do not access mental
health care [31], greater availability of EBPs is urgently needed.
However, our ability to expand traditional face-to-face services is lim-
ited by a shortage of mental health professionals [17]. Delivering
treatment online is a promising strategy to increase the reach of mental
health services while minimizing therapist time. Indeed, the majority of
online PTSD program (e.g., “Interapy”; [26]) are therapist-facilitated
(see [24]). In the current study, in contrast, peer support specialists are
used in place of therapists, making this model even more cost effective
and scalable. Task shifting from mental health specialists to trained lay
providers is an effective strategy to increase access to care [21]. The
peer support specialists in this study will interact with participants
using an online chat function and will follow detailed instructions and
scripts that mirror those followed by therapists administering the pro-
gram in person. Thus, this study provides an important test of online
EBP with significantly greater scalability potential than traditional face-
to-face treatment.
Another important feature of this study is the selection of a variable
length design. Given that this study compares two active interventions,
comparing the rate of clinical improvement (i.e., how quickly patients
recover) is critical to understanding the clinical efficiency of the pro-
grams. Treatment outcome research is increasingly moving away from
testing a pre-determined number of sessions because in practice,
therapists continue to provide care to patients until they have recovered
(i.e., meet some criterion for minimal symptoms) within a reasonable
upper limit number of sessions. Written exposure therapy has not been
evaluated in a variable length design, but it has been established as a 5-
session program based on work showing that three sessions was less
efficacious [40]. However, whether additional sessions are helpful for
some patients with PTSD is not known. Studies of a 10-session PE
protocol show that patients complete treatment with good outcomes
between 7 and 15 sessions [9,18,43,47,48,55,57]. Thus, the rate at
which patients recover from PTSD is variable, and studies that evaluate
this variability rather than ignore it, will help us to better understand
the relative clinical valuable of the study interventions. Given that this
is the first study of written exposure therapy delivered online and with
Veterans, we set the possible length of treatment between four and
eight sessions.
Imaginal exposure will be the comparator for written exposure in
this trial. As noted, imaginal exposure is a commonly used technique for
treating PTSD. This comparator will allow us to examine whether the
modality of exposure to the trauma memory (i.e., written versus verbal)
impacts overall treatment efficacy or efficiency, and potential media-
tors of change. Specifically, early work on emotional disclosure found
that relative to written expression of stressful events, verbal expression
of stressful events may arouse less negative affect but lead to greater
cognitive change [11,34]. While not conducted in PTSD samples, these
findings hint at possible differences in the therapeutic processes that
underlie written versus imaginal exposure. This study will explore the
associations between changes in trauma-related cognitions, emotional
regulation, exposure-related distress, and clinical outcomes. By better
understanding the mediators of change across these two forms of ex-
posure, we hope to gain insights that will lead to further treatment
improvements that enhance the efficacy and efficiency of PTSD treat-
ment.
5
Contemporary Clinical Trials 91 (2020) 105990
Acknowledgments
Funding
This material is the result of work supported with resources of the
National Center for PTSD and the use of facilities at the VA Palo Alto
Health Care System.
Disclaimer
The views expressed herein are solely those of the authors and do
not reflect an endorsement by or the official policy or position of the
Department of Veterans Affairs, or the U.S. Government.
Additional acknowledgments
We would like to thank Eric Neri, PhD for his statistical consultation
and review.
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