Design of a randomized controlled trial examining the efficacy and biological mechanisms of web-prolonged exposure and present-centered therapy for PTSD among active-duty military personnel and veterans

Carmen P McLean; Sheila A M Rauch; Edna B Foa; Rebecca K Sripada; Hallie S Tannahill; Jim Mintz; Jeffrey Yarvis; Stacey Young-McCaughan; Katherine A Dondanville; Brittany N Hall-Clark; Brooke A Fina; Terence M Keane; Alan L Peterson; STRONG STAR Consortium and the Consortium to Alleviate PTSD

doi:10.1016/j.cct.2017.11.008

Design of a randomized controlled trial examining the efficacy and biological mechanisms of web-prolonged exposure and present-centered therapy for PTSD among active-duty military personnel and veterans

Contemp Clin Trials. 2018 Jan:64:41-48. doi: 10.1016/j.cct.2017.11.008. Epub 2017 Nov 8.

Authors

Affiliations

¹ Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 600N, Philadelphia, PA 19104, USA; Dissemination and Training Division, National Center for PTSD, VA Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA 94025, USA. Electronic address: mcleanca@pennmedicine.upenn.edu.
² Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, 12 Executive Park, 3rd Floor, Atlanta, GA 30329, USA; Mental Health Service Line, Atlanta VA Medical Center, 1670 Clairmont Road, Atlanta, GA 30033, USA. Electronic address: sheila.a.m.rauch@emory.edu.
³ Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 600N, Philadelphia, PA 19104, USA. Electronic address: foa@pennmedicine.upenn.edu.
⁴ VA Center for Clinical Management Research, 2215 Fuller Road, Ann Arbor, MI, 48105, USA; VA Ann Arbor Health Care System, 2215 Fuller Road, Ann Arbor, MI 48105, USA; Department of Psychiatry, University of Michigan, 4250 Plymouth Road, Ann Arbor, MI 48109, USA. Electronic address: rekaufma@med.umich.edu.
⁵ Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 600N, Philadelphia, PA 19104, USA. Electronic address: htannahill912@gmail.com.
⁶ Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, USA; Department of Epidemiology and Biostatistics, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, USA. Electronic address: mintz@uthscsa.edu.
⁷ Headquarters, Carl R. Darnall Army Medical Center, 36065 Santa Fe Avenue, Fort Hood, TX 76544, USA. Electronic address: jeffrey.s.yarvis.mil@mail.mil.
⁸ Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, USA. Electronic address: youngs1@uthscsa.edu.
⁹ Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, USA. Electronic address: dondanville@uthscsa.edu.
¹⁰ Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, USA. Electronic address: hallclark@uthscsa.edu.
¹¹ Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, USA. Electronic address: fina@uthscsa.edu.
¹² Behavioral Science Division, National Center for PTSD, VA Boston Healthcare System, 150 S. Hungtington Avenue, Boston, MA 02130, USA; Department of Psychiatry, Boston University School of Medicine, 72 East Concord Street, Boston, MA 02118, USA. Electronic address: terence.keane@va.gov.
¹³ Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, USA; Research and Development Service, South Texas Veterans Health Care System, 7400 Merton Minter, San Antonio, TX 78229, USA; Department of Psychology, University of Texas at San Antonio, 1 UTSA Circle, San Antonio, TX 78249, USA. Electronic address: petersona3@uthscsa.edu.

PMID: 29128649
DOI: 10.1016/j.cct.2017.11.008

Abstract

Improved accessibility of effective and efficient evidence-based treatments (EBTs) for military personnel suffering with posttraumatic stress disorder (PTSD) is an urgent need to meet the growing demand for timely care. In addition, a better understanding of the mechanism of action of behavioral therapy can inform the delivery of care to meet accessibility demands. Effective EBTs for PTSD are available, but logistical and stigma-related barriers to accessing behavioral healthcare can deter military personnel from receiving these treatments. Web-based treatments represent an innovative way to overcome these barriers. The efficacy of previously developed web-based treatments for PTSD appears promising; however, they were not developed based on treatment protocols with strong empirical support for their efficacy. No study to date has examined web-based treatment of PTSD using a well-established evidence-based treatment, nor delineated the biological mechanisms through which a web-based treatment exerts its effects. This paper describes the rationale and methods of a randomized controlled trial comparing the efficacy and potential biological mediators of 10 sessions of a web-version of Prolonged Exposure (PE), "Web-PE," delivered over 8weeks compared to 10 sessions of in-person Present-Centered Therapy (PCT) delivered over 8weeks by a therapist in 120 active duty military personnel and veterans with PTSD.

Keywords: Biomarkers; Military behavioral health; Posttraumatic stress disorder; Prolonged exposure; Treatment mechanisms; Web-treatment.

Publication types

Randomized Controlled Trial
Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

Adolescent
Adult
Aged
Female
Humans
Implosive Therapy / methods*
Internet*
Male
Middle Aged
Military Personnel*
Research Design
Stress Disorders, Post-Traumatic / therapy*
Telemedicine / methods
Veterans*
Young Adult