Clinical trial NCT03337750: 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
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Combat Disorders
Keywords: Combat
Psychological Treatment
Military
Psychotherapy
Trauma
Posttraumatic Stress
Posttraumatic Stress Disorder
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of Texas
name: VA Palo Alto Health Care System
First posted: 2017-11-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: PTSD CheckList-5 (PCL-5)
timeFrame: Change from baseline to 1-month follow-up (post-treatment)
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from baseline to 1-month follow-up (post-treatment)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for the Treatment and Study of Anxiety, University of Pennsylvania
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
References: