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

Study Overview
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Brief Summary
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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.

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

Conditions
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Posttraumatic Stress Disorder, Combat Disorders

Intervention / Treatment
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* Behavioral: Web-PE Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-PE<br>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<br>* 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).<br>* Other names: Internet-based prolonged exposure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline to 1-month follow-up (post-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 (PHQ-9) | A 9-item measure of the severity of depressive symptoms. Higher scores indicated greater depressive symptom severity. | Change from baseline to 1-month follow-up (post-treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Combat, Psychological Treatment, Military, Psychotherapy, Trauma, Posttraumatic Stress, Posttraumatic Stress Disorder