An Open-Trial of Web-Prolonged Exposure (Web-PE) Among Active-Duty Military

Overview

It is urgent to make evidence-based treatments (EBTs) for military personnel readily accessible in order to meet the growing demand for effective and efficient treatment for posttraumatic stress disorder (PTSD) in a timely manner. Effective EBTs for PTSD are available, but barriers to accessing care can deter military personnel from receiving treatment. 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. No study to date has examined web-treatment of PTSD using a well-established treatment program. The purpose of this open trial is to examine the efficacy of 10 sessions of a web-version of Prolonged Exposure (PE), "Web-PE," delivered over 8-weeks in 40 active-duty military personnel and veterans with PTSD who deployed post 9-11. Up to 60 individuals will be consented to obtain data from 40 for analysis. Participants will be assessed at pre-treatment and 1- and 3-months after treatment completion.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 27, 2019

Interventions

  • Behavioral: Web-PE Therapy
    • 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).

Arms, Groups and Cohorts

  • Experimental: Web-PE
    • 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).

Clinical Trial Outcome Measures

Primary Measures

  • PTSD CheckList-5 (PCL-5)
    • Time Frame: Change from baseline to 1-month follow-up (post-treatment)
    • A 20-item self-report measure of PTSD symptoms as defined by the DSM-5. Higher scores indicate greater PTSD symptom severity.

Secondary Measures

  • Patient Health Questionnaire-9 (PHQ-9)
    • Time Frame: Change from baseline to 1-month follow-up (post-treatment)
    • A 9-item measure of the severity of depressive symptoms. Higher scores indicated greater depressive symptom severity.

Participating in This Clinical Trial

Inclusion Criteria

  • Active-duty military personnel and veterans who have deployed post 9/11 – Seeking treatment for PTSD – Significant PTSD symptoms as determined by a PCL-5 score greater than or equal to 31 – Has experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a period of recent military deployment – Able to speak and read English and access to an internet-connected computer – Indication that the participant plans to be able to participant in the study for the next three months following the first assessment Exclusion Criteria:

  • Diagnosis of bipolar disorder or psychotic disorder, as determined by participant self-report) – Current substance dependence, as determined by participant self-report) – Diagnosis of a moderate or severe traumatic brain injury, as determined by participant self-report) – Current suicidal ideation severe enough to warrant immediate attention, as determined by participant self-report) – Currently engaged in evidence-based treatment for PTSD (e.g. Prolonged Exposure Therapy or Cognitive Processing Therapy), as determined by participant self-report.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pennsylvania
  • Collaborator
    • University of Texas
  • Provider of Information About this Clinical Study
    • Principal Investigator: Carmen McLean, Adjunct Assistant Professor – University of Pennsylvania

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