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

NCT03337750 | Completed

• 1 other identifier: HSC20170600H
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Posttraumatic Stress Disorder; Combat Disorders

Keywords

Combat; Psychological Treatment; Military; Psychotherapy; Trauma; Posttraumatic Stress; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Health Questionnaire-9 (PHQ-9)

  Change from baseline to 1-month follow-up (post-treatment)

Study Arms (1)

Web-PE

EXPERIMENTAL

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

Interventions

Web-PE Therapy BEHAVIORAL

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

Web-PE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of Texas: collaborator
• VA Palo Alto Health Care System: collaborator

Study Sites (2)

Center for the Treatment and Study of Anxiety, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Links

• Study enrollment page
• STRONG STAR consortium

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Combat Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 9, 2017
• Study Start: February 12, 2018
• Primary Completion: March 27, 2019
• Study Completion: February 14, 2020
• Last Updated: February 19, 2020

Record last verified: 2020-02

Locations

US (2)