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

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT03337750

Collaborator

University of Texas (Other), VA Palo Alto Health Care System (U.S. Fed)

Enrollment

Locations

Arm

Actual Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder Combat Disorders	Behavioral: Web-PE Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 12, 2018

Actual Primary Completion Date :

Mar 27, 2019

Actual Study Completion Date :

Feb 14, 2020

Arms and Interventions

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

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

Other Names:

Internet-based prolonged exposure

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for the Treatment and Study of Anxiety, University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
2	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229