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

Primary Purpose

Posttraumatic Stress Disorder, Combat Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-PE Therapy
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Combat, Psychological Treatment, Military, Psychotherapy, Trauma, Posttraumatic Stress, Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Center for the Treatment and Study of Anxiety, University of Pennsylvania
  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Web-PE

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient Health Questionnaire-9 (PHQ-9)
A 9-item measure of the severity of depressive symptoms. Higher scores indicated greater depressive symptom severity.

Full Information

First Posted
November 3, 2017
Last Updated
February 18, 2020
Sponsor
University of Pennsylvania
Collaborators
University of Texas, VA Palo Alto Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT03337750
Brief Title
An Open-Trial of Web-Prolonged Exposure (Web-PE) Among Active-Duty Military
Official Title
An Open-Trial of Web-Prolonged Exposure (Web-PE) Among Active-Duty Military
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
February 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
University of Texas, VA Palo Alto Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Combat Disorders
Keywords
Combat, Psychological Treatment, Military, Psychotherapy, Trauma, Posttraumatic Stress, Posttraumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web-PE
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Web-PE Therapy
Other Intervention Name(s)
Internet-based prolonged exposure
Intervention Description
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 Measure Information:
Title
PTSD CheckList-5 (PCL-5)
Description
A 20-item self-report measure of PTSD symptoms as defined by the DSM-5. Higher scores indicate greater PTSD symptom severity.
Time Frame
Change from baseline to 1-month follow-up (post-treatment)
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
A 9-item measure of the severity of depressive symptoms. Higher scores indicated greater depressive symptom severity.
Time Frame
Change from baseline to 1-month follow-up (post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Center for the Treatment and Study of Anxiety, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Links:
URL
https://studypages.com/s/are-you-a-veteran-or-service-member-dealing-with-posttraumatic-stress-participate-in-a-web-based-treatment-study-357599/
Description
Study enrollment page
URL
https://tango.uthscsa.edu/strongstar/
Description
STRONG STAR consortium

Learn more about this trial

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

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