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

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder; Combat Disorders
• Interventions: Behavioral: Web-PE Therapy

• Registration Number: NCT03337750
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-09
• Study Start: 2018-02-12
• Primary Completion: 2019-03-27
• Status Verified: 2020-02
• Study Completion: 2020-02-14
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Web-PE	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).

Primary Outcome Measures

Name	Time	Method
PTSD CheckList-5 (PCL-5)	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 Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9 (PHQ-9)	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.

Trial Locations

Locations (2)

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, United States