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

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 Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder; Combat Disorders
• Intervention / Treatment: Behavioral: Web-PE Therapy

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Center for the Treatment and Study of Anxiety, University of Pennsylvania
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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).; Other Names: Internet-based prolonged exposure

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: University of Texas; VA Palo Alto Health Care System

Publications and helpful links

Helpful Links

• Study enrollment page
• STRONG STAR consortium

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): March 27, 2019
• Study Completion (Actual): February 14, 2020

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Posttraumatic Stress Disorder; Trauma; Military; Psychotherapy; Posttraumatic Stress; Combat; Psychological Treatment
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Combat Disorders
• Other Study ID Numbers: HSC20170600H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No