A Comparison of Web-Prolonged Exposure (Web-PE) and Present-Centered Therapy (PCT) for PTSD Among Active-Duty Military Personnel
Condition: Posttraumatic Stress Disorders; Combat Disorders
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Combat Disorders
Study type: Interventional

Summary: 
      The purpose of this randomized controlled trial is to compare the efficacy and potential
      biological mechanisms of action of 10 sessions of a web-version of Prolonged Exposure (PE),
      "Web-PE," delivered over 8-weeks to 10 sessions of Present Centered Treatment (PCT) delivered
      over 8-weeks by a therapist in 120 active duty military personnel with PTSD. Up to 170
      individuals will be consented to obtain data from 120 for analysis. Participants will be
      assessed at pre-treatment, mid-treatment, and 1-, 3- and 6-months after treatment completion.
    

Detailed description: 
      Background: It is urgent to make EBTs for military personnel readily accessible in order to
      meet the growing demand for effective and efficient treatment for PTSD in a timely manner.
      Effective EBTs for PTSD are available, but barriers to accessing care can deter military
      personnel from accessing care. Web-treatments represent an innovative way to overcome these
      barriers. The efficacy of previously developed web-treatments for PTSD appear promising,
      however, they are not based on treatment protocols with strong empirical support for their
      efficacy. Hence, it cannot be discerned whether the outcomes associated with existing
      web-treatments are due to the new intervention or to factors associated with the use of the
      Internet to deliver the treatment. No study to date has examined web-treatment of PTSD using
      a well-established treatment program. An important unanswered question is whether moving from
      the traditional, costly, access-limiting, therapist-delivered format of an effective
      treatment to a more accessible, cost-effective, web-format will impact treatment efficacy. In
      addition, based on evidence showing a link between neurosteroids and psychopathology and a
      role in PTSD treatment response, an add-on biomarkers study was funded that examines the role
      of candidate biomarkers [endogenous glucocorticoids and neurosteroids, i.e. cortisol,
      allopregnanolone (ALLO) and metabolites, and dehydroepiandrosterone (DHEA/DHEAS)] as: a)
      predictors of treatment response, and b) indices of therapeutic change during PTSD treatment.

      Objective/Hypotheses: To eliminate the confound inherent in changing simultaneously both the
      treatment program and the mode of delivery, the investigators propose to develop a
      web-version of PE, "Web-PE", and compare its efficacy to Present Centered Treatment (PCT), an
      active control comparison. The investigators hypothesize that Web-PE will be a more
      efficacious in reducing PTSD severity than PCT among military personnel returned from
      deployments in Afghanistan and Iraq at post-treatment and 3- and 6-months after treatment
      completion. In addition, the investigators expect that changes cortisol and neurosteriods
      will track symptom change.

      Specific Aims: The first aim is to develop a Web-PE program that will receive high ratings of
      ease of use, acceptability, comprehension of program content and functionality, and overall
      satisfaction by military personnel with PTSD symptoms and an advisory board of eight experts
      in PE and the treatment PTSD in the military. The second aim is to examine the efficacy of
      Web-PE by comparing it to therapist-delivered PCT on the following outcomes: 1) Change in
      PTSD severity and diagnostic status from pre- to post-treatment; 2) Change in symptoms of
      depression, anger, and other frequently co-occurring problems from pre- to post-treatment.
      The biological aims of the study include: 1) To identify specific neuroendocrine and
      neurosteroid changes that "track" Posttraumatic Stress Disorder (PTSD) symptom change over
      the course of effective treatment and 2) to determine the specificity of Prolonged Exposure
      (PE) -induced neuroendocrine/neurosteroid changes by directly comparing patterns of change
      during PE to those during Present Centered Therapy (PCT).

      Study Design: During Phase I (months 0-9), the investigators will develop and demonstrate the
      feasibility of the Web-PE program by piloting it with 10 military personnel with PTSD or
      subclinical PTSD and by members of the expert advisory board. During Phase II (months 9-36),
      the investigators will conduct an RCT comparing the efficacy of Web-PE with
      therapist-delivered PCT on measures of PTSD symptom severity and related psychopathology with
      160 OIF/OEF active duty military personnel with PTSD. Cortisol Awakening Response collected
      at home on the three mornings prior to the research sessions that occur at baseline, week 4,
      one and three months follow-up. Script driven imagery saliva collection for salivary cortisol
      in response to the general environment and specific trauma cues at baseline, week 4, and one
      and three months follow-up. Serum neurosteriods (allopregnanolone, pregnenolone,
      pregnanolone, androsterone, DHEA) at baseline, week 4 and 1 month follow-up of treatment.

      Relevance: Untreated PTSD becomes a chronic disorder, leaving military service-men and -women
      less effective or unable to perform their military duties, more likely to have comorbid
      mental and physical health problems as well as difficulties in daily functioning (Vasterling
      et al., 2007). The proposed Web-PE program can function as the first step in a step care
      model. As such it is expected to greatly facilitate the dissemination of EBT to those in need
      by capitalizing on the greater accessibility, cost-effectiveness, and anonymity that is
      afforded by Internet. Thus, the proposed study directly targets the MOM/JPC interest in
      research aim at developing and validating novel EBTs that exploit innovative telemedicine
      technologies. Because Web-PE could be accessed at home, the proposed study is also relevant
      to the MOM/ JPC interest in strategies to reduce the stigma associated with PTSD treatment.
      Integrating affective neuroscience methods into an RCT can make each study more informative,
      effective, and less expensive than two independent studies. Neurobiological studies of PTSD
      have linked specific candidate biomarkers [endogenous glucocorticoids and neurosteroids, i.e.
      cortisol, allopregnanolone (ALLO) and metabolites, and dehydroepiandrosterone (DHEA/DHEAS)]
      to PTSD severity and potentially to treatment response. Identifying the mechanisms involved
      in treatment response can assist in improving therapeutic techniques by targeting specific
      neurobiological processes involved.

      This study is affiliated with the South Texas Research Organizational Network Guiding Studies
      on Trauma and Resilience (STRONG STAR) (Consortium Director: Alan L. Peterson, Ph.D., ABPP,
      Professor, Behavioral Wellness Center for Clinical Trials, Department of Psychiatry-Mail Code
      7792, University of Texas Health Science Center at San Antonio (UTHSCSA), 7703 Floyd Curl
      Drive, San Antonio, TX 78229-3900). The Overall PIs for this study are Carmen P. McLean,
      Ph.D. of the Center for the Treatment and Study of Anxiety at the University of Pennsylvania
      and, for the biological measures portion of the study, Sheila Rauch, Ph.D., ABPP of Emory
      University. The PI for this study at the University of Texas Health Science Center at San
      Antonio (UTHSCSA) is Alan Peterson, Ph.D., ABPP, Department of Psychiatry, Division of
      Behavioral Medicine. The on-site PI is COL Jeffrey Yarvis, Ph.D.,Chief, Soldier Behavioral
      Health/Outpatient Psychiatry, Carl R. Darnall Army Medical Center, 36000 Darnall Loop, Fort
      Hood, TX, 76544. The study will be conducted at Fort Hood, Texas.
    

Intervention name(s): Web-PE Therapy; Therapist-Delivered Present-Centered Therapy
Intervention type(s): Other; Other
Intervention description(s): Ten 60-minute psychotherapy sessions over 8 weeks, focused on gradually confronting distressing trauma-related memories and reminders. Web-PE is an internet-based version of prolonged exposure (PE) for posttraumatic stress disorder (PTSD).; Ten 60-minute psychotherapy sessions over 8 weeks, focused on identifying and solving day-to-day problems as they are brought up by the participants. PCT is a manualized therapy that has been used as active control condition in several CBT studies. It provides a credible comparison therapy to control for nonspecific therapeutic factors so that observed effects of Web-PE can be attributed to its specific ingredients beyond the benefits of good therapy.
Other intervention name(s): Internet-based prolonged exposure; PCT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Combat; Psychological Treatment; Military; Psychotherapy; Trauma; Posttraumatic Stress; Posttraumatic Stress Disorder