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

NCT ID: NCT03337750

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-12
• Study Completion Date: 2020-02-14

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Web-PE Therapy

Intervention Type: 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).

Interventions

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Internet-based prolonged exposure

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas

OTHER

Sponsor Role: collaborator

VA Palo Alto Health Care System

FED

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Carmen McLean

Adjunct Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Philadelphia, Pennsylvania, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Countries

United States

Related Links

https://studypages.com/s/are-you-a-veteran-or-service-member-dealing-with-posttraumatic-stress-participate-in-a-web-based-treatment-study-357599/

Study enrollment page

https://tango.uthscsa.edu/strongstar/

STRONG STAR consortium

Other Identifiers

HSC20170600H

Identifier Type: -

Identifier Source: org_study_id