An Open-Trial of Web-Prolonged Exposure (Web-PE) Among Active-Duty Military
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- PTSD CheckList-5 (PCL-5)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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).
Intervention: Web-PE Therapy (Behavioral)
Outcomes
Primary Outcomes
PTSD CheckList-5 (PCL-5)
Time Frame: 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 Outcomes
- Patient Health Questionnaire-9 (PHQ-9)(Change from baseline to 1-month follow-up (post-treatment))
Investigators
Carmen McLean
Adjunct Assistant Professor
University of Pennsylvania