A Nonrandomized Trial of Prolonged Exposure and Cognitive Processing Therapy for Combat-Related Posttraumatic Stress Disorder in a Deployed Setting

Journal Pre-proof A Nonrandomized Trial of Prolonged Exposure and Cognitive Processing Therapy for Combat-Related Posttraumatic Stress Disorder in a Deployed Setting

Alan L. Peterson, Edna B. Foa, Patricia A. Resick, Timothy V. Hoyt, Casey L. Straud, Brian A. Moore, James V. Favret, Willie J. Hale, Brett T. Litz, Timothy E. Rogers, Jay M. Stone, Robert Villarreal, Christopher S. Woodson, Stacey B. YoungMcCaughan, Jim Mintz PII:

S0005-7894(20)30011-3

DOI:

https://doi.org/10.1016/j.beth.2020.01.003

Reference:

BETH 967

To appear in:

Behavior Therapy

Received date:

8 October 2019

Accepted date:

3 January 2020

Please cite this article as: A.L. Peterson, E.B. Foa, P.A. Resick, et al., A Nonrandomized Trial of Prolonged Exposure and Cognitive Processing Therapy for Combat-Related Posttraumatic Stress Disorder in a Deployed Setting, Behavior Therapy(2020), https://doi.org/10.1016/j.beth.2020.01.003

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© 2020 Published by Elsevier.

Journal Running head: PE AND CPT FOR PTSD IN A Pre-proof DEPLOYED SETTING

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A Nonrandomized Trial of Prolonged Exposure and Cognitive Processing Therapy for CombatRelated Posttraumatic Stress Disorder in a Deployed Setting

Alan L. Petersona,b,c,*, Edna B. Foad, Patricia A. Resicke, Timothy V. Hoytf, Casey L. Strauda,c, Brian A. Moorea,c, James V. Favretg, Willie J. Hale, PhDa,c, Brett T. Litzh,i, Timothy E. Rogersj,k, Jay M. Stoneg, Robert Villarreala, Christopher S. Woodsonl, Stacey B. Young-

Department of Psychiatry and Behavioral Sciences, University of Texas Health Science

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a

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McCaughana, Jim Mintz a,m, for the STRONG STAR Consortium

Center at San Antonio, San Antonio, TX, USA

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Research and Development Service, South Texas Veterans Health Care System, San

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Antonio, TX, USA

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d

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Department of Psychology, University of Texas at San Antonio, San Antonio, TX, USA Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA

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Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA f

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Defense Health Agency, Tacoma, WA, USA

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g

United States Air Force

Massachusetts Veterans Epidemiological Research and Information Center, VA Boston Healthcare System, Boston, MA, USA i

Departments of Psychiatry and Psychological & Brain Sciences, Boston University, Boston, MA, USA

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Center for Deployment Psychology, Uniformed Services University of the Health Sciences, Bethesda, MD, USA

JournalSETTING Pre-proof PE AND CPT FOR PTSD IN A DEPLOYED k

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Wilford Hall Ambulatory Surgical Center, Joint Base San Antonio-Lackland, San Antonio, TX, USA l

United States Army

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Department of Epidemiology and Biostatistics, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA

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*Corresponding author: Alan L. Peterson, PhD, Department of Psychiatry and Behavioral

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Sciences, University of Texas Health Science Center at San Antonio, 7550 Interstate Highway

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10 West, Suite 1325, San Antonio, TX 78229. E-mail: [email protected]

Author e-mail addresses: [email protected] (A. Peterson), [email protected] (E.

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Foa), [email protected] (P. Resick), [email protected] (T. Hoyt),

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[email protected] (C. Straud), [email protected], (B. Moore), [email protected] (J. Favret), [email protected] (W. Hale), [email protected] (B.

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Litz), [email protected] (T. Rogers), [email protected] (J. Stone),

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[email protected] (R. Villarreal), [email protected] (C. Woodson), [email protected] (S. Young-McCaughan), [email protected] (J. Mintz) Acknowledgments: The authors would like to thank Julie Collins and Joel Williams for their assistance in editing this manuscript. Funding: This work was supported by the Department of Defense through the U.S. Army Medical Research and Materiel Command, Congressionally Directed Medical Research Programs, Psychological Health and Traumatic Brain Injury Research Program award W81XWH-08-02-109 (Alan L. Peterson, Principal Investigator).

JournalSETTING Pre-proof PE AND CPT FOR PTSD IN A DEPLOYED

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Role of the funding source: The grant sponsor played no role in study design; the collection, analysis, and interpretation of data; the writing of this paper; or the decision to submit this paper for publication. Disclaimer: The views expressed herein are solely those of the authors and do not represent an endorsement by or the official policy or position of Brooke Army Medical Center, the U.S. Army Medical Department, the U.S. Army Office of the Surgeon General, the Department of the

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Army, the Department of the Air Force, the Department of Defense, the Department of Veterans

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Affairs, or the United States Government.

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Conflict of Interest Statement: The authors declare no conflicts of interest.

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Abstract For many decades, the U.S. military’s general operational guideline has been to limit the use of trauma-focused treatments for combat and operational stress reactions in military service members until they have returned from deployment. Recently, published clinical trials have documented that active duty military personnel with combat-related posttraumatic stress disorder (PTSD) can be treated effectively in garrison. However, there are limited data on the treatment

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of combat and operational stress reactions or combat-related PTSD during military deployments.

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This prospective, nonrandomized trial evaluated the treatment of active duty service members (N

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= 12) with combat and operational stress reactions or combat-related PTSD while deployed to

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Afghanistan or Iraq. Service members were treated by deployed military behavioral health providers using modified Prolonged Exposure (PE; n = 6) or modified Cognitive Processing

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Therapy (CPT; n = 6), with protocol modifications tailored to individual mission requirements.

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The PTSD Checklist – Military Version (PCL-M) total score was the primary outcome measure. Results indicated that both groups demonstrated clinically significant change in PTSD symptoms

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as indicated by a reduction of 10 points or greater on the PCL-M. Participants treated with

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modified PE had significant reductions in PTSD symptoms (t(1) = -3.83, p = .01; g = -1.32), with a mean reduction of 18.17 points on the PCL-M. Participants treated with modified CPT had a mean PCL-M reduction of 10.00 points, but these reductions were not statistically significant (t(1) = -1.49, p = .12; g = -0.51). These findings provide preliminary evidence that modified forms of PE and CPT can be implemented in deployed settings for the treatment of combat and operational stress reactions and combat-related PTSD. Keywords: combat and operational stress reactions, combat-related PTSD, Prolonged Exposure, Cognitive Processing Therapy, military deployments

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A Nonrandomized Trial of Prolonged Exposure and Cognitive Processing Therapy for CombatRelated Posttraumatic Stress Disorder in a Deployed Setting Introduction Since September 11, 2001, almost 3 million U.S. military personnel have deployed to support military conflicts in Afghanistan, Iraq, and surrounding locations (Wenger, O’Connell, & Cottrell, 2018). Recent research has estimated that about 23% of U.S. military veterans who

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have served in these conflicts meet criteria for posttraumatic stress disorder (PTSD; Fulton et al.,

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2015). The types of traumas experienced by deployed military personnel can be considerably

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different from the traumas experienced by civilians (Litz et al., 2018; Stein et al., 2012).

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Similarly, military personnel do not respond to first-line psychotherapies for PTSD to the same degree as civilians (Straud, Siev, Messer, & Zalta, 2019). Thus, the development, evaluation,

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and dissemination of evidence-based treatments for combat-related PTSD are imperative.

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The military mental health concept of operations or general guidelines for treating what was previously called “shell shock” was developed during World War I (see Jones & Wessely,

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2003). It was based on the PIE Model (Proximity, Immediacy, and Expectancy), which refers to

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treating psychiatric casualties (1) in the proximity of the battlefront, (2) immediately after the emergence of combat stress symptoms, and (3) with the expectancy that the service member will recover and return to the battlefield. The model for treating what is now called “combat and operational stress reactions,” or the various behavioral reactions a person may experience after exposure to stressful events related to military operations, has continued up to the present day with only minor revisions. The BICEPS (Brevity, Immediacy, Contact, Expectancy, Proximity, and Simplicity) Model is now used (Department of the Army, 2006, 2016). BICEPS refers to (1) the brevity of the treatment (i.e., limited number of sessions), (2) the immediacy of the initiation

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of treatment, (3) maintaining contact with the service member’s chain of command, (4) the expectancy that the service member will recover and return to the battlefield, (5) treatment occurring in the proximity of service member’s deployed unit, and (6) the simplicity of straightforward and uncomplicated methods to restore functioning. Although the BICEPS Model has good face validity, it does not recommend any specific evidence-based treatment interventions. Commonly used interventions include anger management, stress management,

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and positive thinking (Judkins & Bradley, 2017; Potter, Baker, Sanders, & Peterson, 2009).

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Thus, the primary emphasis of treatment in combat environments has been short-term

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interventions (1-4 sessions) and a goal of expeditious return to duty, primarily due to practical

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considerations and mission requirements (Department of the Army, 2006). Nonetheless, there are minimal empirical data to support the efficacy of either the PIE or BICEPS Models. Indeed,

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operational doctrine has stressed that “Combat Stress Control is not therapy…Psychotherapy is

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not done” in the deployed environment (Department of the Army, 2000, p. 54), and that diagnoses and treatment for PTSD “will not be used while the soldier is in the theater of

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operations” (Department of the Army, 1994, p. 76).

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Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT) are two first-line, evidence-based treatments for PTSD originally developed for the treatment of female sexual assault victims. PE and CPT are part of the recommended treatments listed in VA/DoD Clinical Practice Guideline for the Management of Posttraumatic Stress Disorder and Acute Stress Disorder (U.S. Department of Veterans Affairs [VA] & U.S. Department of Defense [DoD], 2017). Both PE and CPT have been part of extensive rollouts of evidence-based treatments for PTSD in the DoD and the VA (Borah et al., 2013; Karlin et al., 2010). Recent research has indicated that both treatments are effective at reducing combat-related PTSD in active duty

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military service members treated in garrison, or in nondeployed, home-duty locations (Cigrang et al., 2011; Cigrang et al., 2015; Cigrang et al., 2017; Foa et al., 2018; Resick et al., 2017; Resick et al., 2015). Preliminary findings suggest that evidence-based treatments for acute stress disorder and PTSD can be successfully adapted and delivered in deployed settings (Peterson, Straud, & Evans, 2019). Cigrang, Peterson, & Schobitz (2005) published a retrospective clinical case

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series (N = 3) in which an abbreviated version of PE was used to treat deployed service members

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with combat-related PTSD effectively. McLay, McBrien, Wiederhold, & Wiederhold (2010)

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found PE with or without virtual reality was effective across 10 retrospective clinical case reports

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of service members treated in Iraq. Finally, Pelton, Wangelin, and Tuerk (2015) demonstrated that PE supplemented with telehealth was effective for reducing trauma-related symptoms in a

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deployed service member. No studies have evaluated the use of CPT in deployed settings.

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To the best of our knowledge, there are no prospective studies that have evaluated any form of treatment for combat and operational stress reactions, acute stress disorder, or combat-

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related PTSD in active duty military personnel in deployed settings. Although individuals in

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civilian and military settings may present similar PTSD symptoms, military members in deployed settings are likely to be exposed to several successive traumatic events, but they are required to remain mission-ready, even if experiencing symptoms of PTSD. Thus, treatment should increase access to care, while decreasing stigma and accounting for operational needs. The purpose of this prospective nonrandomized trial was to evaluate the outcomes of routine clinical practice using modified PE and CPT for the treatment of combat-related PTSD in Iraq and Afghanistan, with protocol modifications tailored to mission requirements. It was hypothesized that service members could be safely and effectively treated with PE or CPT and

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would report significant reductions in PTSD symptoms as measured by the Posttraumatic Stress Disorder Checklist – Military Version (PCL-M; Weathers, Litz, Herman, Huska, & Keane, 1993). Material and Methods Participants Research participants were treatment-seeking active duty military personnel (N = 12)

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who reported combat operational stress reaction symptoms or PTSD symptoms after being

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exposed to a combat-related traumatic event while deployed to Iraq or Afghanistan between

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2009 and 2013. All participants voluntarily presented to the deployed behavioral health clinic

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through the regular referral process established at each of the five deployed locations. Prior to starting treatment, individuals were assessed for PTSD symptoms with a semi-structured clinical

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interview. Demographic characteristics of the sample are presented in Table 1. All participants

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were U.S. military personnel, the mean age was 28 years old, and the majority of the participants were U.S. Army (67%), male (83%), and enlisted personnel (83%).

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The inclusion criteria for the study included: (a) age 18 years or older; (b) U.S. military

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personnel including active duty, activated reserve, or National Guard personnel deployed to Iraq or Afghanistan; (c) exposure to one or more combat-related traumatic events during their deployment; (d) PCL-M score greater than or equal to 32 (Cigrang et al., 2011, 2015); (e) expressed interest in receiving treatment in the deployed location so that they could potentially remain in theater to complete their deployment; and (f) determination by service member’s deployed behavioral health provider to be a good candidate for PE or CPT (e.g., Eftekhari et al., 2013). Although there are no published guidelines for what makes a patient more suitable for exposure-based treatment, the latter criterion generally was based on the following: the patient

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not being in acute distress or crisis regarding the traumatic event despite endorsement of significant PTSD symptomatology; the patient’s assigned mission (i.e., military occupational specialty and current duty location) allowed for some kind of regular contact with the treating provider; current symptom endorsement and reason for seeking treatment directly related to trauma exposure, rather than acute stressors such as relationship or occupational problems; and due to either the severity or duration of the endorsed symptomatology, it was unlikely that

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symptoms would resolve without trauma-specific treatment. For example, several of the cases

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treated in the current study previously had deployed, and returning to the combat environment

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was a precipitating factor for the emergence of PTSD symptoms. The exclusion criteria included:

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(a) current diagnosis of another mental disorder considered more serious than acute stress disorder or PTSD requiring primary treatment or psychiatric aeromedical evacuation (e.g.,

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psychotic disorder, bipolar disorder, suicidal ideation with suicidal intent); and (b) current

health provider.

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diagnosis of alcohol or drug dependence based on a clinical interview by the treating mental

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The term “combat-related PTSD” was used in the present study to refer to PTSD

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symptoms that were related to exposure to one or more deployment-related traumatic events that were unique to the combat zone. Examples of such combat-related traumas include exposure to indirect fire (e.g., mortar or rocket attacks), severely injured combat casualties, human remains, and blast explosions (e.g., improvised explosive devices). Procedures The study used a nonrandomized design to measure within-subject changes in the PE and CPT groups. This design was used because a randomized trial design was deemed infeasible by military research oversight boards, and a prospective, nonrandomized design was considered to

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be a safe research design to be used during military deployments. Service members were assigned on a rolling admission basis to modified PE (n = 6) or modified CPT (n = 6) based on the clinical discretion of the deployed military behavioral health provider. Typical delivery of behavioral health services in the combat environment provides three typical options for treating patients who exhibit symptoms of PTSD (Department of the Army, 2006): (1) reassure the patient that his or her symptoms are “normal” for individuals serving in a

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combat zone and encourage them to continue with the mission; (2) provide brief supportive

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therapy but not address traumatic experiences directly; or (3) aeromedically evacuate the patient

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out of theater for their psychiatric condition. Psychotropic medications were an additional

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option, in some locations, when there was a prescribing provider. The current study provided an additional option for treatment through providing an evidence-based treatment such as PE or

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CPT (modified for mission requirements).

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Based on the Human Research Protection Plan (HRPP) in place at the time the study was conducted, the project was reviewed and approved by the DoD’s Joint Combat Casualty

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Research Team tasked to oversee and facilitate the conduct of research in the U. S. Central

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Command (USCENTCOM) area of responsibility as an assured institution (Dukes et al., 2015). Then the project was reviewed and approved by the Institutional Review Boards (IRBs) at Brooke Army Medical Center reviewing for the Multi-National Coalition – Iraq (MNC-I) and – Afghanistan (MNC-A) and The University of Texas Health Science Center at San Antonio. The U.S. Army Medical Research and Material Command Human Research Protection Office at Fort Detrick, Maryland also reviewed and approved the study. All participants were volunteers and completed informed consent before participation in the study.

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All behavioral health providers were trained in the standard treatment protocols for PE (Foa, Hembree, & Rothbaum, 2007) or CPT including the trauma account (Resick, Monson, & Chard, 2010) prior to their deployment through Department of Defense-funded PE and CPT training programs. Treatment anchored to a combat-related index trauma. Because the participants were treatment-seeking individuals seen as part of routine clinical practice in a deployed setting, the length of treatment varied across participants based on their individual

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needs and the constraints of the deployed locations.

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Therapists. The therapists were five active duty military clinical psychologists deployed

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to Iraq or Afghanistan. Three of the therapists were U.S. Air Force psychologists and two were

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U.S. Army psychologists. All therapists were trained in PE or CPT as part of the DoD rollout, which involved attendance at a 2- to 4-day workshop led by an approved PE or CPT trainer

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(Borah et al., 2013). The therapists were also required to complete human subjects research

principal investigator.

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training and other regulatory requirements before being approved to serve as a military site

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Prolonged Exposure. Prolonged Exposure (PE) is a trauma-focused, cognitive-

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behavioral therapy that involves four primary components: (1) psychoeducation about common reactions to trauma, (2) relaxed breathing, (3) in vivo (real world) exposure, and (4) imaginal exposure (Foa et al., 2007). Of the four components, in vivo exposure and imaginal exposure are considered to be the key interventions. The standard treatment protocol consists of 10-12 treatment sessions conducted once or twice weekly for 90 minutes. For the current study, deployed military providers were allowed to adapt the treatment protocol as needed to meet the clinical confines of their deployed location while maintaining the primary treatment components

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of PE (Peterson, Foa, & Riggs, 2019). The total number of modified PE sessions ranged from 3 to 10, and the mean number of sessions was 7.50 (See Table 1). Cognitive Processing Therapy. Cognitive Processing Therapy (CPT) is a traumafocused, cognitive therapy for PTSD in which patients learn the skills of recognizing and challenging dysfunctional beliefs and cognitions about the traumatic event, themselves, and the world (Resick et al., 2010). The standard CPT protocol is 12 weekly or bi-weekly sessions. As

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was the case for PE, deployed military providers were allowed to adapt the CPT treatment

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protocol as needed for military service members and to meet the clinical confines of their

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deployed location (Wachen et al., 2016). The total number of modified CPT sessions ranged

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from 3 to 11, and the mean number of sessions was 5.67 (See Table 1). Treatment Protocol Modifications. In contrast to non-deployed clinical settings,

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military combat and operational settings may prevent the scheduling of regular weekly treatment

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sessions. Thus, treatment protocol modifications are necessary in order to deliver evidenceinformed treatment in settings that may face barriers to care (see Marques et al., 2019). For

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example, previous reports have detailed modifications such as treatment provided by

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paraprofessionals or in hybrid telehealth models, to meet mission requirements (Hoyt et al., 2015). In the current study, the most common modifications to the treatment protocol involved the number of sessions and length of treatment. For example, previous reports have shown that service members enrolled in care in the deployed environment receive three sessions on average (Hoyt et al., 2015). With this in mind, the PE protocol typically would forego delivering a lengthy rationale for treatment or spending significant time on breathing retraining. Rather, a brief rationale would be followed by establishing a hierarchy for in-vivo exposure tasks and specific events for imaginal exposure. In place of weekly or biweekly sessions, treatment

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frequently was delivered in massed format on consecutive days (e.g., Foa et al., 2018), in order to meet patient availability between missions, and to address the potential for breaks of 2-3 weeks between treatment episodes. The length of sessions also may have been truncated to 30minutes, or extended to up to 3-hours, depending on the amount of session time available to the patient between operational commitments. Recording equipment typically also was not available in the deployed environment, which precluded audio recording of imaginal exposures. Thus,

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patients would be encouraged to repeat their trauma narrative to themselves between sessions

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rather than listening to a recording. Modifications to the CPT protocol were similar with regard

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to session length and timing, and often typically focused on CPT delivered without a written

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narrative (i.e., CPT-C). Delivery of CPT also emphasized the process of challenging questions and patterns of problematic thinking, and may not specifically address themes such as

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power/control, esteem, or intimacy, in order to deliver the treatment in fewer sessions.

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Treatment Termination and Return to Duty. For each case, the treatment protocol ended when the provider and patient mutually agreed that treatment goals (typically symptom

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reduction) had been met, when the patient and provider mutually agreed that treatment was not

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beneficial in addressing treatment goals, or when operational necessity required termination of the protocol (such as transfer to another base). Return to duty is the most common outcome of treatment in the deployed environment, regardless of condition (Hoyt et al., 2015). At treatment termination, if no duty limitations were required (e.g., weapons restriction, psychiatric aeromedical evacuation, restriction from convoy duties), then the patient was considered as returning to full, unrestricted duty. However, treatment non-response alone was not a sufficient reason for someone to not return to duty. Measures

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Posttraumatic Stress Disorder Checklist – Military Version (PCL-M). The PCL-M was the primary outcome measure for this study (Weathers et al., 1993). The PCL-M is a selfreport measure of PTSD and includes 17 items corresponding to the diagnostic criteria for PTSD according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; American Psychiatric Association, 2000). Each item is rated from 1 (no symptoms) to 5 (severe symptoms), resulting in a possible range of 17-85. A presumptive

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diagnosis can be determined by a combination of the total symptom severity score and

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“moderate” symptom ratings on each of the DSM-IV-TR criteria. Additionally, a change score of

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±10 is suggestive of a clinically meaningful change (Monson et al., 2008). Previous research has

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found the PCL to have good diagnostic specificity (.86), sensitivity (.94), test-retest reliability (r = .96), concurrent validity (r = .92), and internal consistency (α = .82 to .93; Blanchard, Jones-

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Alexander, Buckley, & Forneris, 1996; Creamer, Bell, & Failla, 2003; Forbes, Creamer, &

administered at each session.

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Biddle, 2001; Keen, Kutter, Niles, & Krinsley, 2008; Weathers et al., 1993). The PCL-M was

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Beck Depression Inventory – II (BDI-II). The BDI-II consists of 21 items that assess

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depressive symptoms. Each item is composed of four statements that reflect symptom severity. The statements are scaled from 0 (no disturbance) to 3 (maximal disturbance), resulting in a possible range of 0-63. The BDI-II has internal consistency of .91 and correlates strongly with other measures of depression (Beck, Ward, Mendelson, Mock, & Erbaugh, 1961). Scores on all items are summed to obtain a total severity score. Scores reflect minimal depressive symptoms (0-13), mild depressive symptoms (14-19), moderate depressive symptoms (20-28), or major depressive symptoms (29-63; Beck, Steer & Brown, 1996). The BDI-II was only administered at baseline and posttreatment.

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Theory and Data Analysis Drawing from the literature on the treatment of combat-related PTSD, it is reasonable to postulate that exposure-based interventions can be implemented in deployed military settings. Manualized versions of PE and CPT are effective in military environments in the United States (e.g., Foa et al., 2018; Resick et al., 2017; Resick et al., 2015), despite frequent disruptions for training exercises and other mission requirements that may require protocol adaptation (see Hoyt

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& Candy, 2011). In addition, abbreviated and modified versions of PE (e.g., four 30-minute PE

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sessions delivered in primary care settings) have also been demonstrated to be effective in non-

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deployed military settings (Cigrang et al., 2011; Cigrang et al., 2015; Cigrang et al., 2017).

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Principles of military psychology such as the PIE and BICEPS models suggest that psychological intervention should occur close to the point of injury in order to minimize mission

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impact and maintain occupational effectiveness (Department of the Army, 2016). Toward this

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end, initial case-based evaluations have suggested the potential utility of exposure-based treatment in deployed settings (e.g., Peterson, Straud et al., 2019). Indeed, a fundamental

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principle of exposure-based treatment is to increase a patient’s ability to remain in occupational

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settings that may otherwise cause symptoms of anxiety (Foa et al., 2007). However, deployed settings also necessitate treatment protocol modifications, which are in fact fairly common in a variety of settings and may still provide clinical benefit to patients even if not delivered under ideal conditions (Bruijniks, Franx, & Huibers, 2018). Thus, the current study provides an opportunity to evaluate the potential for systematic delivery of modified exposure-based treatments in deployed settings while tolerating the inherent limitations of naturalistic delivery of protocols tailored to mission requirements.

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The primary hypothesis was that service members treated with PE or CPT would have significantly reduced symptoms of PTSD at posttreatment as measured by the PCL-M. Changes in depression as measured by the BDI-II were also evaluated as a secondary outcome. Because participants were not randomized to treatment condition, participants were stratified by treatment (e.g., PE or CPT) and analyzed separately to address the primary hypothesis. Paired sample ttests were performed to explore pre-post changes in PTSD symptoms and depression symptoms

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for the modified PE group and the modified CPT group. Hedges’ g effect sizes were calculated

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to provide additional information regarding the magnitude of the change scores. It is known that

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Hedges’ g is recommended over Cohen’s d for small samples and that the same conventional

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interpretations for d can be applied to g (Ellis, 2010; Lakens, 2013). That is, Cohen (1988) suggested that effect size values of 0.5 can be considered a medium effect, effect size values of

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0.8 can be considered large, and effect size values of 1.0 or greater can be considered very large.

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Clinically significant change on the PCL-M was also used as a metric of significant change, with

Results

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(Monson et al., 2008).

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scores of 10 points or greater suggesting clinically significant changes in PTSD symptoms

Detailed treatment outcomes for PE and CPT are reported in Table 2. Prior to the primary analyses, the prevalence and symptom severity of PTSD and depression were examined at pretreatment in the PE and CPT groups. Overall, 83% of participants (n = 5/6) in the PE group endorsed symptoms indicative of a PTSD diagnosis using the combined PCL-M total symptom severity score and moderate or greater symptom ratings on each of the DSM-IV-TR criteria. Additionally, 67% of participants (n = 4/6) in the CPT group endorsed symptoms indicative of a PTSD diagnosis. The mean BDI-II total score for participants in the PE group was suggestive of

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moderate depression, while the mean BDI-II total score for participants in the CPT group was suggestive of mild depression. Individual depression scores ranged from minimal to major depression. Findings indicated those treated with PE demonstrated significant reductions (g = -1.32; p = .01) in PTSD symptoms on the PCL-M and moderate, albeit not significant, decreases (g = 0.59; p = .14) in depression symptoms (e.g., BDI-II). Individuals treated with CPT also

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demonstrated a robust pretreatment to posttreatment effect (g = -0.51) on the PCL-M. However,

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this change was not statistically significant (p = .12). Participants in the CPT group also

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demonstrated a moderate, albeit not significant, increase (g = 0.50, p = .21) in depressive

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symptoms.

Eleven of the participants (91.7%) reported reductions in PTSD symptoms on the PCL-

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M, and seven participants (58.3%) reported clinically significant reductions of symptoms on the

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PCL-M of 10 or more points (see Figure 1). One participant receiving CPT reported an increase in PTSD symptoms from pretreatment (PCL-M = 35) to posttreatment (PCL-M = 42) and

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dropped out after three treatment sessions. However, this 7-point increase in PTSD symptoms

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was not considered clinically meaningful using the 10-point PCL-M change criterion. No serious adverse events (e.g., suicide attempts, psychiatric hospitalizations, or psychiatric aeromedical evacuations out of the deployment theater) were reported in any of the participants. All participants were able to be returned to full deployment duties after the completion of treatment, including the one patient who had a slight increase in symptoms over the course of treatment. Discussion

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Deployed military behavioral health providers working in the combat theater frequently work with service members exposed to combat-related traumas. Providers conduct assessments to determine whether patients can be treated while deployed and returned to duty or whether they require psychiatric aeromedical evacuation out of theater (Baker et al., 2017; Peterson et al., 2018; Peterson, McCarthy, Busheme, Campise, & Baker 2011; Peterson, Shah, Lara-Ruiz, & Ritchie, 2019). The limited data on treating PTSD in theater make it difficult to know the

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difference between patients with combat-related PTSD who can be treated in theater versus those

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who need to be aeromedically evacuated. Psychiatric aeromedical evacuation out of the combat

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theater may be a career-ending event for many service members because they are at increased

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risk to be medically discharged from active duty (Peterson et al., 2018). Therefore, successfully treating combat-related PTSD during military deployments can help service members maintain

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fitness for duty and increase military operational readiness.

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The results of the first prospective study to date to evaluate the treatment of combatrelated PTSD in deployed U.S. military service members showed that modified PE and CPT can

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be implemented systematically in an active combat theater environment. The majority of

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participants (92%) reported reductions in PTSD symptoms on the PCL-M, almost 60% had clinically meaningful improvements, and PTSD diagnosis decreased by 25%, despite the fact that the treatments were almost always shorter than usual. This suggests that the standard PTSD treatment protocols developed for PE (Foa et al., 2007) and CPT (Resick et al., 2010) are robust treatment protocols capable of producing positive outcomes even when modified by military providers for use in the military combat theater. Only one participant in this study demonstrated worsening symptoms, although this increase was not clinically significant (PCL change greater than or equal to 10 points). This

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19

individual completed only three sessions of CPT and while self-reported PTSD symptoms increased, the patient and provider mutually terminated treatment and the service member returned to active duty. This increase in symptoms may potentially be explained by an initial, short-term symptom exacerbation that can occur in trauma-focused treatments. It is possible that symptoms would have reduced had the participant remained in treatment. Indeed, prior research has documented that continued treatment engagement generally results in significant symptom

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reductions by the end of treatment (Larsen, Wiltsey-Stirman, Smith, & Resick, 2016).

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The results are consistent with those from previous case reports of the treatment of PTSD

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among deployed service members (Cigrang et al., 2005; McLay et al., 2010; Pelton et al., 2015).

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The findings are also consistent with recent findings on the treatment of PTSD in military service members treated in garrison after returning from deployment (Cigrang et al., 2011; Cigrang et

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al., 2015; Cigrang et al., 2017; Foa et al., 2018; Resick et al., 2017; Resick et al., 2015). It is

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possible that these are two distinctly different patient populations—those who experience significant PTSD symptoms during deployment and seek treatment and those who successfully

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complete a deployment rotation and seek care after returning to their home station environment.

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The present findings suggest that evidence-based treatments are needed in both deployed and nondeployed locations, and the specific treatment protocol used may vary based on treatment setting. For example, the treatment protocol might include four to six modified PE or CPT sessions delivered on a daily basis for a service member sent for a brief admission in a combat stress facility in a deployed location. In other cases, treatment might start with one or two faceto-face treatment sessions at a remote combat outpost (COP) during a brief consultation visit by a traveling behavioral health provider from a larger forward operating base (FOB), with

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20

additional sessions conducted by telebehavioral health from the FOB to the COP after the provider returns to the FOB (Pelton et al., 2015). Additional research is needed on how frequently evidence-based protocols are implemented in deployed settings and how the modification of these protocols due to mission requirements may impact treatment outcomes. Future studies could improve on the current design by specifically measuring the degree of treatment fidelity and documenting protocol

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modifications. Relatedly, provider consultation could be furnished to front-line providers in

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order to ensure that modifications are protocol-compliant. Furthermore, future research on

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treatment preference among deployed service members may elucidate how these different patient

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populations seek and respond to care. The limited reductions in depression symptoms is in part consistent with other clinical trials of active duty military treated in garrison (Cigrang et al.,

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2011; Cigrang et al., 2015; Cigrang et al., 2017; Foa et al., 2018; Resick et al., 2017; Resick et

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al., 2015). Additional research is needed to better understand these findings, particularly with regard to depressive symptoms. Interestingly, both groups demonstrated a moderate change in

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depressive symptoms, but the effects were in opposite directions. The PE group demonstrated a

depression.

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moderate reduction in depression, while the CPT group demonstrated a moderate increase in

The present study has a number of limitations. Although this study is believed to be the largest prospective study to date of the treatment of PTSD during military deployments, the nonrandomized design, small sample size, and lack of a control group limit the generalization of the findings. With the lack of a control group, it is not possible to know whether symptom reduction was driven by treatment or natural recovery. The small sample size also prevented consideration of relevant moderator variables that may impact treatment outcomes (i.e., number

JournalSETTING Pre-proof PE AND CPT FOR PTSD IN A DEPLOYED

21

of sessions completed). Furthermore, the standard CPT and PE protocols were adapted to the realities of the deployed setting. The main adaptations were length of session (30 minutes to 3 hours) and the number of sessions. Despite these limitations, both treatment groups demonstrated clinically significant reductions in PTSD symptoms from pretreatment to posttreatment, and there was a medium to large treatment response among the two groups. The design of the present study also limited formal evaluation and difference testing

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between the two treatment groups. In particular, there was a statistically significant reduction in

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PTSD symptoms among PE participants that was not observed in the CPT group. While

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difference testing was not performed due to design and power, the trend of larger trauma

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symptom reductions in an exposure-based treatment versus a cognitive-based treatment is consistent with the largest randomized clinical trial to date (N = 90) on the treatment of civilians

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with acute stress disorder (Bryant et al., 2008). In the study by Bryant and colleagues (2008),

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participants received five weekly, 90-minute sessions of (a) a modified PE protocol including imaginal and in vivo exposure, (b) cognitive restructuring, or (c) a wait-list condition. The

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results indicated that fewer participants in the exposure group had PTSD (33%) than those in the

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cognitive restructuring (63%; OR = 2.52) or wait-list groups (77%; OR = 3.40). Although the present study did not evaluate the time between trauma exposure and the start of treatment in theater, PE and CPT were administered more promptly after trauma exposure than would typically be seen in the average military patient treated for PTSD in garrison after returning from a deployment. However, definitive conclusions about outcomes differences between PE and CPT cannot be drawn since decisions to enroll patients in each therapy were based on clinician judgment and severity of symptoms were not equivalent across the two conditions. Given the

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22

aforementioned limitations, future research should evaluate potential treatment-outcome differences between these two treatments in a larger sample of deployed service members. Additionally, a structured clinical diagnostic interview, such as the ClinicianAdministered PTSD Scale (Weathers, Ruscio, & Keane, 1999), was not used because it was not feasible in the deployed environment, and participants were not required to meet diagnostic criteria for PTSD. Instead, participants had to have experienced a combat-related trauma and to

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have a minimum total score of 32 on the PCL-M (Cigrang et al., 2011, 2015). The use of these

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inclusion criteria allowed deployed providers to address combat-trauma-related symptoms even

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if the patient did not meet formal diagnostic criteria for PTSD. This was helpful because

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military policy supports the use of the term “combat operational stress reaction” rather than acute stress disorder or PTSD during military deployments (Department of the Army, 2006, 2016).

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This term is used to help normalize combat stress reactions in the combat zone. Unfortunately,

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this can lead to confusion among deployed military behavioral health providers because there is not an operational definition of a combat operational stress reaction. Similarly, there are no

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(Peterson et al., 2019).

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evidence-based treatments that have been established for combat operational stress reactions

Conclusions

The results of the present study provide initial data to support the use of modified versions of PE and CPT for the treatment of combat-related PTSD—or what is often called combat and operational stress reactions—in deployed military personnel. There are a number of potential benefits of evidence-based treatments for delivery in the deployed combat theater. More service members may receive treatment, and there may be a decrease in the stigma of

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23

seeking care. If individuals are treated more quickly, it may result in decreased problems after returning from deployment. Additional research is needed, but conducting research in deployed operational combat locations is extremely challenging (Peterson, Straud, et al., 2019). The Joint Combat Casualty Research Team, which was established to facilitate U.S. military research in the combat theater, was disbanded with the official end of the U.S. military conflict in Iraq in 2010 and Afghanistan

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in 2014. At the present time, research in deployed U.S. military locations is no longer permitted.

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Therefore, the results of the current study, despite its methodological limitations, will need to be

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considered in future military guidelines on the treatment of combat operational stress reactions

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ur

na

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and combat-related PTSD in the military combat theater.

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Glossary Combat and operational stress reaction: The emotional, intellectual, physical, and/or behavioral reactions of a person exposed to stressful events in military operations. Combat outpost (COP): A COP is a term referring to any staging center smaller than a forward operating base (e.g., a patrol base or a secure, platoon-size bivouac area). Combat-related trauma: Any traumatic experience that occurs in the warzone

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Fitness for duty: Refers to an individual service member’s ability to perform the duties required

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of his “office, grade, rank, or rating.”

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Forward operating base (FOB): An airfield used to support tactical operations without establishing full support facilities.

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Garrison: This is a legacy term that refers to a service member’s primary duty location outside

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of a combat zone. This has traditionally referred to a military installation outside of a combat

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zone.

Psychiatric aeromedical evacuations: Refers to service members who require an aeromedical

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evacuation from the combat zone due to psychiatric concerns.

Abbreviations: BDI-II = Beck Depression Inventory – II; BICEPS = brevity, immediacy, contact, expectancy, proximity, and simplicity; COP = combat outpost; CPT = Cognitive Processing Therapy; DoD = U.S. Department of Defense; DSM-IV-TR = Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision; FOB = forward operating base; IRB = Institutional Review Board; PCL-M = PTSD Checklist – Military Version; PE = Prolonged Exposure therapy; PIE = proximity, immediacy, and expectancy; PTSD = posttraumatic stress disorder; U.S. = United States; VA = U.S. Department of Veterans Affairs.

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Beck, A. T., Steer, R. A., & Brown, G. K. (1996). Manual for the Beck Depression Inventory-II.

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Beck, A. T., Ward, C. H., Mendelson, M., Mock, J., & Erbaugh, J. (1961). An inventory for measuring depression. Archives of General Psychiatry, 4, 564-571. doi:10.1037/t00741-

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posttraumatic stress disorder in the Veterans Health Administration. Journal of Traumatic Stress, 23, 663-673. doi:10.1002/jts.20588 Keen, S. M., Kutter, C. J., Niles, B. L., & Krinsley, K. E. (2008). Psychometric properties of PTSD Checklist in sample of male veterans. Journal of Rehabilitation Research & Development, 45, 465-474. doi:10.1682/jrrd.2007.09.0138 Lakens D. (2013). Calculating and reporting effect sizes to facilitate cumulative science: A

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Marques, L., Valentine, S. E., Kaysen, D., Mackintosh, M., Dixon De Silva, L., Ahles, E. M. … Wiltsey-Stirman, S. (2019). Provider fidelity and modifications to cognitive processing therapy in a diverse community health clinic: Associations with clinical change. Journal of Consulting and Clinical Psychology, 87, 357-369. doi:10.1037/ccp0000384 McLay, R. N., McBrien, C., Wiederhold, M. D., & Wiederhold, B. K. (2010). Exposure therapy with and without virtual reality to treat PTSD while in the combat theater: A parallel case series. Cyberpsychology, Behavior, and Social Networking, 13, 37-42. doi:10.1089/cyber.2009.0346

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Peterson, A. L., Hale, W. J., Baker, M. T., Cigrang, J. A., Moore, B. A., Straud, C. L., … Mintz, J.; for the STRONG STAR Consortium. (2018). Psychiatric aeromedical evacuations of

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Freedom, and New Dawn. Military Medicine, 183, 11-12, e649-e658. doi:10.1093/milmed/usy188

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Peterson, A. L., McCarthy, K. R., Busheme, D. J., Campise, R. L., & Baker, M. T. (2011). The

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aeromedical evacuation. In E. C. Ritchie, J. C. Bradley, G. G. Grammer, R. D. Forsten, S. J. Cozza, D. M. Benedek, & B. J. Schneider (Eds.). Combat and operational mental health (pp. 191-207). San Antonio, TX: The Borden Institute. Peterson, A. L., Shah, D. V., Lara-Ruiz, J. M., & Ritchie, E. C. (2019), Aeromedical evacuation: Management of acute and stabilized patients. In W.W. Hurd & W. Beninati (Eds.), Aeromedical evacuation of psychiatric casualties (2nd ed), pp. 391-401. New York, NY: Springer. https://doi.org/10.1080/21635781.2018.1491908

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Peterson, A. L., Straud, C. L., & Evans, W. R. (2019). Treating combat-related posttraumatic stress disorder during military deployments: Importance, challenges, and special considerations. The Behavior Therapist, 42,127-131. Potter, A. R., Baker, M. T., Sanders, C. S., & Peterson, A. L. (2009). Combat-stress reactions during military deployments: Evaluation of the effectiveness of combat stress control

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Peterson, A. L.; on behalf of the STRONG STAR Consortium. (2015). A randomized clinical trial of group cognitive processing therapy compared with group present-centered therapy for PTSD among active duty military personnel. Journal of Consulting and Clinical Psychology, 83, 1058-1068. doi:10.1037/ccp0000016 Stein, N. R., Mills, M. A., Arditte, K., Mendoza, C., Borah, A. M., Resick, P. A., & Litz, B. T.; and the STRONG STAR Consortium. (2012). A scheme for categorizing traumatic military events. Behavior Modification, 36, 785-805. doi:10.1177/0145445512446945

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Straud, C. L., Siev, J., Messer, S., & Zalta, A. K. (2019). Examining military population and trauma type as moderators of treatment outcome for first-line psychotherapies for PTSD: A meta-analysis. Journal of Anxiety Disorders, 67, 103-122. doi: 10.1016/j.janxdis.2019.102133 U.S. Department of Veterans Affairs & U.S. Department of Defense. (2017). VA/DoD clinical practice guideline for the management of posttraumatic stress disorder and acute stress

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Practice, 23, 133-147. doi:10.1016/j.cbpra.2015.08.007 Weathers, F. W., Litz, B. T., Herman, D. S., Huska, J. A., & Keane, T. M. (1993, October). The

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Weathers, F. W., Ruscio, A. M., & Keane, T. M. (1999). Psychometric properties of nine scoring rules for the Clinician-Administered PTSD Scale (CAPS).Psychological Assessment, 11, 124-133. doi:10.1037//1040-3590.11.2.124 Wenger, J. W., O’Connell, C., & Cottrell, L. (2018). Examination of recent deployment experience across the services and components. Santa Monica, CA: RAND Corporation. Retrieved from https://www.rand.org/pubs/research_reports/RR1928.html

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Table 1 Demographic Characteristics of Participants (N = 12)

Demographic

Prolonged

Cognitive

Exposure

Processing Therapy

(n = 6)

(n = 6)

Total sample

characteristic

(N = 12)

10 (83%)

6 (100%)

4 (67%)

Married

7 (58%)

4 (67%)

3 (50%)

Parent

6 (50%)

3 (50%)

3 (50%)

(M = 27.0; SD = 5.1)

(M = 30.0; SD = 3.5)

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(M = 28.5; SD = 4.3)

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Age

Range = 26-35

Range = 19-35

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Range = 19-35

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Male gender

8 (67%)

4 (67%)

4 (67%)

Other

4 (33%)

2 (33%)

2 (33%)

1 (8%)

1 (17%)

0 (0%)

8 (67%)

3 (50%)

5 (83%)

3 (25%)

2 (33%)

1 (17%)

Army

8 (67%)

3 (50%)

5 (83%)

Air Force

1 (8%)

1 (17%)

0 (0%)

Coast Guard

2 (17%)

2 (33%)

0 (0%)

10 (83%)

4 (67%)

6 (100%)

Some college

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High school or less

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Education

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Caucasian

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Ethnicity

College graduate Branch of service*

Military grade Enlisted

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2 (17%)

2 (33%)

0 (0%)

1

5 (42%)

3 (50%)

2 (33%)

2

4 (33%)

2 (33%)

2 (33%)

3

2 (16%)

0.00

2 (33%)

Number of deployments*

Range = 3-10

Range = 3-11

(M = 6.60, SD = 3.0)

(M = 7.50, SD = 2.4)

(M = 5.67, SD = 3.4)

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sessions

Range = 3-11

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Number of treatment

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na

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Note. *The branch of service and number of deployments were each missing 1 response.

Journal Running head: PE AND CPT FOR PTSD IN A Pre-proof DEPLOYED SETTING

35

Table 2 Pretreatment to Posttreatment Changes in PTSD and Depression PCL-M

BDI-II

Within-Group Change

Within-Group Change

n Post

SD

56.6

16.3

46.6

13.4

5.67

7

1

7

1 -1.49

3

44

34

-10

3

35

42

3

69

5

48

Pt E

11

Pt F

9

0

7

3

14

11

-7

19

29

10

47

-1

6

10

4

73

32

-41

13

12

-1

71

63

-8

18

15

-3

re

8.34

7.6

g

0

na ur

62

59.0

13.7

40.8

7.50

0

4

G

7

Pt

8

PE

0.51

17.5

t/Δ

25

Pt D

14.0

SD

25

Pt C

-

Post

6 1.46 0.50

Pt B

SD

0

Pt A

Pre

ro

T

g

-p

CP

t/Δ

of

SD

lP

Pre

Jo

visits

17.6

-

-

22.6

10.8

13.6

9.5

-

3

1 3.83a

1.32

7

5

7

6 1.72 0.59

34

24

-10

9

4

-5

58

23

-35

35

5

-30

Pt

-

JournalSETTING Pre-proof PE AND CPT FOR PTSD IN A DEPLOYED

36

H Pt I

3

70

49

-21

31

20

-11

Pt J

8

68

49

-19

30

17

-13

9

69

68

-1

19

28

9

10

55

32

-23

12

8

-4

Pt K

re

-p

ro

of

Pt L

Note. PCL-M = Posttraumatic Stress Disorder Checklist – Military Version; BDI-II = Beck

lP

Depression Inventory-II; pre = pretreatment; post = posttreatment; t = paired sample t-test

na

statistic; Δ = individual pre-post change score; g = Hedges’ g; CPT = Cognitive Processing Therapy; Pt = patient; PE = Prolonged Exposure. denotes the paired sample t-test was statistically significant for designated group on the

ur

a

Jo

designated outcome; unmarked t-test statistics were not significant at p ≤ .05.

37

-p

ro

of

Journal Running head: PE AND CPT FOR PTSD IN A Pre-proof DEPLOYED SETTING

re

Figure 1. PTSD Checklist – Military Version (PCL-M) participant scores by visit and treatment

Jo

ur

na

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group. PE = Prolonged Exposure; CPT = Cognitive Processing Therapy.

JournalSETTING Pre-proof PE AND CPT FOR PTSD IN A DEPLOYED Highlights Few studies have evaluated trauma-focused treatments for PTSD during deployments



This study evaluated the use of PE and CPT for PTSD during a military deployment



Twelve deployed U.S. military service members were treated with PE or CPT



Both Treatments demonstrated clinically significant reductions in PTSD symptoms



Modified forms of PE and CPT can be effectively used in deployed settings

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

38

Figure 1