Study design comparing written exposure therapy to cognitive processing therapy for PTSD among military service members: A noninferiority trial

Denise M Sloan, Brian P Marx, Patricia A Resick, Stacey Young-McCaughan, Katherine A Dondanville, Jim Mintz, Brett T Litz, Alan L Peterson, STRONG STAR Consortium, Denise M Sloan, Brian P Marx, Patricia A Resick, Stacey Young-McCaughan, Katherine A Dondanville, Jim Mintz, Brett T Litz, Alan L Peterson, STRONG STAR Consortium

Abstract

Although there are a number of effective treatments for posttraumatic stress disorder (PTSD), there is a need to develop more efficient evidence-based PTSD treatments to address barriers to seeking and receiving treatment. Written exposure therapy (WET) is a potential alternative that is a 5-session treatment without any between-session assignments. WET has demonstrated efficacy, and low treatment dropout rates. However, prior studies with WET have primarily focused on civilian samples. Identifying efficient PTSD treatments for military service members is critical given the high prevalence of PTSD in this population. The current ongoing randomized clinical trial builds upon the existing literature by investigating whether WET is equally efficacious as Cognitive Processing Therapy (CPT) in a sample of 150 active duty military service members diagnosed with PTSD who are randomly assigned to either WET (n = 75) or CPT (n = 75). Participants are assessed at baseline and 10, 20, and 30 weeks after the first treatment session. The primary outcome measure is PTSD symptom severity assessed with the Clinician Administered PTSD Scale for DSM-5. Given the prevalence of PTSD and the aforementioned limitations of currently available first-line PTSD treatments, the identification of a brief, efficacious treatment that is associated with reduced patient dropout would represent a significant public health development.

Keywords: Clinical trial; Cognitive behavioral therapy; Posttraumatic stress disorder; Written exposure therapy.

Conflict of interest statement

Dr. Resick receives book royalties (Resick, Monson, & Chard 2016). Drs. Sloan and Marx receive book royalties (Sloan & Marx, 2019).

Figures

Fig. 1
Fig. 1
Planned participant flow. WET = Written Exposure Therapy; CPT = Cognitive Processing Therapy.

References

    1. Resick P.A., Monson C.M., Chard K.M. Guilford Press; New York: 2016. Cognitive Processing Therapy for PTSD: a Comprehensive Manual.
    1. Foa E.B., Hembree E., Rothbaum B.O. Oxford University Press; New York: 2007. Prolonged Exposure Therapy for PTSD: Emotional Processing of Traumatic Experiences Therapist Guide.
    1. Cusack K., Jonas D.E., Forneris C.A., Wines C., Sonis J., Middleton J.C., Feltner C. Psychological treatments for adults with posttraumatic stress disorder: a systematic review and meta-analysis. Clin. Psychol. Rev. 2016;43:128–141.
    1. Steenkamp M.M., Litz B.T., Hoge C.W., Marmar C.R. Psychotherapy for military-related PTSD: a review of randomized clinical trials. J. Am. Med. Assoc. 2015;314:489–500.
    1. Foa E.B., McLean C.P., Zang Y. Effect of prolonged exposure therapy delivered over 2 Weeks vs 8 Weeks vs present-centered therapy on PTSD symptom severity in military personnel: a randomized clinical trial. J. Am. Med. Assoc. 2018;319(4):354–364.
    1. Resick P.A., Wachen J.S., Dondanville K.A. Effect of group vs individual cognitive processing therapy in active-duty military seeking treatment for posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry. 2017;74(1):28–36.
    1. Resick P.A., Wachen J.S., Mintz J. A randomized clinical trial of group cognitive processing therapy compared with group present-centered therapy for PTSD among active duty military personnel. J. Consult. Clin. Psychol. 2015;83:1058–1068.
    1. Borah E.V., Wright E.C., Donahue D.A., Cedillos E.M., Riggs D.S., Isler W.C., Peterson A.L. Implementation outcomes of military provider training in cognitive processing therapy and prolonged exposure therapy for post-traumatic stress disorder. Mil. Med. 2013;178:939–944.
    1. Finley E.P., Garcia H.A., Ketchum N.S., McGeary D.D., McGeary C.A., Stirman S.W., Peterson A.L. Utilization of evidence-based psychotherapies in Veterans Affairs posttraumatic stress disorder outpatient clinics. Psychol. Serv. 2015:73–82.
    1. Wilk J.E., West J.C., Farifteh D.F., Herrell R.K., Rae D.S., Hoge C.W. Use of evidence-based treatment for posttraumatic stress disorder in Army behavioral healthcare. Psychiatry Interpers. Biol. Process. 2013;76:336–348.
    1. Sloan D.M., Marx B.P. American Psychological Press; Washington, DC: 2019. Written Exposure Therapy for PTSD: a Brief Treatment Approach for Mental Health Professionals.
    1. Sloan D.M., Marx B.P., Bovin M.J., Feinstein B.A., Gallagher M.W. Written exposure as an intervention for PTSD: a randomized clinical trial with motor vehicle accident survivors. Behav. Res. Ther. 2012;50:627–635.
    1. Sloan D.M., Lee D., Litwak S., Sawyer A.T., Marx B.P. Written exposure therapy for veterans diagnosed with PTSD: a pilot study. J. Trauma. Stress. 2013;26(6):776–779.
    1. Sloan D.M., Marx B.P., Lee D.J., Resick P.A. A brief exposure-based treatment vs cognitive processing therapy for posttraumatic stress disorder: a randomized noninferiority clinical trial. JAMA Psychiatry. 2018
    1. Thompson-Hollands J., Marx B.P., Lee D.J., Resick P.A., Sloan D.M. Long-term treatment gains of a brief exposure-based treatment for PTSD. Depress. Anxiety. 2018;35:985–991.
    1. US Department of Veterans Affairs and Department of Defense VA/DoD clinical practice guideline for the management of posttraumatic stress disorder and acute stress disorder. June 2017. Published.
    1. Weathers F.W., Blake D.D., Schnurr P.P., Kaloupek D.G., Marx B.P., Keane T.M. The clinician-administered PTSD scale for DSM-5 (CAPS-5). Instrument available from the National center for PTSD. 2013.
    1. Sheehan D.V., Lecrubier Y., Sheehan K.H., Amorim P., Janavs J., Weiller E. The Mini-International Neuropsychiatric Interview (MINI): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J. Clin. Psychiatry. 1998;59:22–33.
    1. Babor T.F., Higgins-Biddle J.C., Saunders J.B., Monteiro M.G. second ed. World Health Organization; Geneva, Switzerland: 2001. The Alcohol Use Disorders Identification Test: Guidelines for Use in Primary Care.
    1. Metalsky G.I., Joiner T.E. The hopelessness depression symptom questionnaire. Cogn. Ther. Res. 1997;21:359–384.
    1. Barnes J.B., Presseau C., Jordan A.H., Kline N.K., Young-McCaughan S., Keane T.M., Peterson A.L. The Consortium to Alleviate PTSD. Common data elements in the assessment of military-related PTSD research applied in the Consortium to Alleviate PTSD. Mil. Med. 2019;184:e218–e226.
    1. Marx B.P. Development and validation of a PTSD-related impairment scale. 2013. Retrieved from.
    1. Larsen D., Attkisson C., Hargreaves W., Nguyen T. Assessment of client/patient satisfaction: development of a general scale. Eval. Program Plann. 1979;2:197–207.
    1. Devilly G.J., Borkovec T.D. Psychometric properties of the credibility/expectancy questionnaire. J. Beh. Ther. Experiment Psychiat. 2000;31:73–86.
    1. Vogt D.S., Smith B.N., King L.A., King D.W., Knight J.A., Vasterling J.J. Deployment Risk and Resilience Inventory-2 (DRRI-2): an updated tool for assessing psychosocial risk and resilience factors among service members and veterans. J. Trauma. Stress. 2013;26:710–717.
    1. Ebbert J.O., Patten C.A., Schroeder D.R. The Fagerstrom test for nicotine dependence – smokeless tobacco (FTND-ST) Addict. Behav. 2006;31:1716–1721.
    1. Ferketich A.K., Wee A.G., Schultz J., Wewers M.E. A measure of nicotine dependence for smokeless tobacco users. Addict. Behav. 2007;9:1970–1975.
    1. Heatherton T.F., Kozlowski L.T., Frecker R.C., Fagerstrom K.O. The Fagerstrom test for nicotine dependence: a revision of the Fagerstrom tolerance questionnaire. Br. J. Addict. 1991;86:1119–1127.
    1. Spitzer R.L., Kroenke K., Williams J.B., Lowe B. A brief measure for assessing Generalized Anxiety Disorder: the GAD-7. Arch. Intern. Med. 2006;166:1092–1097.
    1. Schwab K.A., Baker G., Ivins B., Sluss-Tiller M., Lux W., Warden D. The Brief Traumatic Brain Injury Screen (BTBIS): investigating the validity of a self-report instrument for detecting traumatic brain injury (TBI) in troops returning from deployment in Afghanistan and Iraq. Neurology. 2006;66(5):A235. Sup. 2.
    1. Schwab K.A., Ivins B., Cramer G., Johnson W., Sluss-Tiller M., Kiley K. Screening for traumatic brain injury in troops returning from deployment in Afghanistan and Iraq: initial investigation of the usefulness of a short screening tool for traumatic brain injury. J. Head Trauma Rehabil. 2006;22:377–389.
    1. Morin C.M. The Guilford Press; New York: 1993. Insomnia: Psychological Assessment and Management.
    1. Weathers F.W., Blake D.D., Schnurr P.P., Kaloupek D.G., Marx B.P., Keane T.M. The life events checklist for DSM-5 (LEC-5). instrument available from the National center for PTSD. 2013.
    1. Kroenke K., Spitzer R.L., Williams J.B. The PHQ-9: validity of a brief depression severity measure. J. Gen. Intern. Med. 2001;16:606–613.
    1. Yu L., Buysse D.J., Germain A., Moul D.E., Stover A., Dodds N.E. Development of short forms from the PROMIS sleep disturbance and sleep-related impairment item banks. Behav. Sleep Med. 2011;10:6–24.
    1. Weathers F.W., Litz B.T., Keane T.M., Palmieri P.A., Marx B.P., Schnurr P.P. The PTSD checklist for DSM-5 (PCL-5). Scale available from the National center for PTSD. 2013.
    1. Sobell L.C., Agrawal S., Sobell M.B., Leo G.I., Young L.J., Cunningham J.A., Simco E.R. Comparison of a Quick drinking screen with the timeline followback for individuals with alcohol problems. J. Stud. Alcohol. 2003;64:858–861.
    1. Nock M.K., Holmberg E.B., Photos V.I., Michel B.D. Self-injurious thoughts and Behaviors interview: development, reliability, and validity in an adolescent sample. Psychol. Assess. 2007;19:309–317.
    1. Chung F., Yegneswaran B., Liao P., Chung S.A., Vairavanathan S., Islam S. STOP Questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008;108:812–921.
    1. Kazis L.E., Selim A., Rogers W., Ren X.S., Lee A., Miller D.R. Veterans RAND 12-Item Health Survey (VR-12): a white paper summary. 2008. Retrieved from.
    1. Tracey T.J., Kokotovic A.M. Factor structure of the working alliance inventory. Psychol. Assess. 1989;541:207–210.
    1. Sloan D.M., Marx B.P. A closer examination of the structured written disclosure procedure. J. Consult. Clin. Psychol. 2004;72:165–175.
    1. Sloan D.M., Marx B.P., Epstein E.M. Further examination of the exposure model underlying written emotional disclosure. J. Consult. Clin. Psychol. 2005;73:549–554.
    1. Sloan D.M., Marx B.P., Epstein E.M., Lexington J. Does altering the instructional set affect written disclosure outcome? Behav. Ther. 2007;38:155–168.
    1. Sloan D.M., Marx B.P., Greenberg E.M. A test of written emotional disclosure as an intervention for posttraumatic stress disorder. Behav. Res. Ther. 2011;49:299–304.
    1. Resick P.A., Galovski T.E., Uhlmansiek M.O.B., Scher C.D., Clum G.A., Young-Xu Y. A randomized clinical trial to dismantle components of cognitive processing therapy for posttraumatic stress disorder in female victims of interpersonal violence. J. Consult. Clin. Psychol. 2008;76(2):243–258.
    1. Foa E.B., Zoellner L.A., Feeny N.C., Hembree E.A., Alvarez-Conrad J. Does imaginal exposure exacerbate PTSD symptoms? J. Consult. Clin. Psychol. 2002;70:1022–1028.
    1. Little R.A. A test of missing completely at random for multivariate data with missing values. J. Amer Stat. Assoc. 1988. 1988;83(404):198–1202.
    1. Hirano K., Imbens G.W., Ridder G. Efficient estimation of average treatment effects using the estimated propensity score. Econometrica 2003. 2003;71:1161–1189.
    1. Little R. Selection and pattern-mixture models. In: Fitzmaurice G., Davidian M., Verbeke G., Molenberghs G., editors. Longitudinal Data Analysis. Chapman & Hall/CRC; Boca Raton, FL: 2009. pp. 409–432.
    1. Enders C.K. Guilford Press; New York: 2010. Models for Not Missing at Random Data. Applied Missing Data Analysis.
    1. Yuan Y. Sensitivity Analysis in Multiple Imputation for Missing Data. Rockville, MD: SAS Institute, Inc.
    1. Mallinckrodt C.H., Lin Q., Molenberghs M. A structured framework for assessing sensitivity to missing data assumptions in longitudinal clinical trials. Pharm Stat. 2012. 2012;12(1):1–6.
    1. Demirtas H., Schafer J.L. On the performance of random-coefficient pattern-mixture models for non-ignorable drop-out. Stat. Med. 2003;22:2553–2575.
    1. Therneau T.M., Grambsch P.M. Springer-Verlag.; New York: 2000. (Modeling Survival Data: Extending the Cox Model).
    1. Nobler M.S., Sackeim H.A., Moeller J.R., Prudic J., Petkova E., Waternaux C. Quantifying the speed of symptomatic improvement with electroconvulsive therapy: comparison of alternative statistical methods. Convuls. Ther. 1997;13(4) 208-21.
    1. Schnurr P.P., Friedman M.J., Foy D.W. Randomized trial of trauma-focused group therapy for posttraumatic stress disorder: results from a department of veterans affairs cooperative study. Arch. Gen. Psychiatr. 2003;60(5):481489.
    1. Cohen J. second ed. Erlbaum; Hillsdale, NJ: 1988. Statistical Power Analysis for the Behavioral Sciences.
    1. Hintze J. NCSS Statistical Software; Kaysville, UT: 2019. NCSS and PASS, Number Cruncher Statistical Systems.
    1. Markowitz J.C., Petkova E., Neria Y. Is exposure necessary? a randomized clinical trial of interpersonal psychotherapy for PTSD. Am. J. Psychiatry. 2015;172(5):430–440.
    1. Morland L.A., Mackintosh M.A., Rosen C.S. Telemedicine versus in-person delivery of cognitive processing therapy for women with posttraumatic stress disorder: a randomized noninferiority trial. Depress. Anxiety. 2015;32(11):811–820.
    1. Hoge C.W., Grossman S.H., Auchterlonie J.L., Riviere L.A., Milliken C.S., Wilk J.E. PTSD treatment for soldiers after combat deployment: low utilization of mental health care and reasons for dropout. Psychiatr. Serv. 2014;65(8):997–1004.
    1. Kehle-Forbes S.M., Meis L.A., Spoont M.R., PolusnyMA Treatment initiation and dropout from prolonged exposure and cognitive processing therapy in a VA outpatient clinic. Psychol Trauma. 2016;8(1):107–114.
    1. Cigrang J.A., Rauch S.A.M., Mintz J., Brundige A., Avila L., Bryan C.J. Treatment of active duty military with PTSD in primary care: a follow-up report. J. Anxiety Disord. 2015;36:110–114.
    1. Cigrang J.A., Rauch S.A., Mintz J., Brundige A.R., Mitchell J.A., Najera E. Moving effective treatment for posttraumatic stress disorder to primary care: a randomized controlled trial with active duty military. Fam. Syst. Health. 2017;35:450–462.
    1. Nacasch N., Huppert J.D., Yi-Jen S., Kivity Y., Dinshtein Y., Yeh R. Are 60-minute prolonged exposure sessions with 20-minute imaginal exposure to traumatic memories sufficient to successfully treat PTSD? A randomized noninferiority clinical trial. Behav. Ther. 2015;46:328–341.
    1. Galovski T.E., Blain L.M., Mott J.M., Elwood L., Houle T. Manualized therapy for PTSD: flexing the structure of cognitive processing therapy. J. Consult. Clin. Psychol. 2012;80:968–981.

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