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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337750
• Other study ID #: HSC20170600H
• Status: Completed
• Phase: N/A
• Start date: February 12, 2018
• Est. completion date: February 14, 2020

Study information

• Verified date: February 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 14, 2020
• Est. primary completion date: March 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Combat Disorders
• Disease
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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).

Locations

Country	Name	City	State
United States	Center for the Treatment and Study of Anxiety, University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	University of Texas, VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)

External Links

•   STRONG STAR consortium
•   Study enrollment page