An interventional study of Web-PE Therapy in Posttraumatic Stress Disorder and Combat Disorders, sponsored by University of Pennsylvania. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-19.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's enrollment of 34 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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).
Also known as: Internet-based prolonged exposure
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.
Time frame: Change from baseline to 1-month follow-up (post-treatment)
Patient Health Questionnaire-9 (PHQ-9)
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)
Ran from Feb 2018 to primary completion in Mar 2019, 13 months.
Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 13 months is below that.
Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic →