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.

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Key information

Conditions

Posttraumatic Stress Disorder Combat Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for the Treatment and Study of Anxiety, University of Pennsylvania, Philadelphia, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Web-PE Therapy

Behavioral

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

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

University of Texas
VA Palo Alto Health Care System

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2020
First posted: Nov 9, 2017
Registry last updated: Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed