Clinical Trial: A Comparison of Web-Prolonged Exposure (Web-PE) and Present-Centered Therapy (PCT) for PTSD Among Active-Duty Military Personnel
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title:
Brief Summary: The purpose of this randomized controlled trial is to compare the efficacy and potential biological mechanisms of action of 10 sessions of a web-version of Prolonged Exposure (PE), "Web-PE," delivered over 8-weeks to 10 sessions of Present Centered Treatment (PCT) delivered over 8-weeks by a therapist in 120 active duty military personnel with PTSD. Up to 170 individuals will be consented to obtain data from 120 for analysis. Participants will be assessed at pre-treatment, mid-treatment, and 1-, 3- and 6-months after treatment completion.
Detailed Summary:
Background: It is urgent to make EBTs for military personnel readily accessible in order to meet the growing demand for effective and efficient treatment for PTSD in a timely manner. Effective EBTs for PTSD are available, but barriers to accessing care can deter military personnel from accessing care. 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. Hence, it cannot be discerned whether the outcomes associated with existing web-treatments are due to the new intervention or to factors associated with the use of the Internet to deliver the treatment. No study to date has examined web-treatment of PTSD using a well-established treatment program. An important unanswered question is whether moving from the traditional, costly, access-limiting, therapist-delivered format of an effective treatment to a more accessible, cost-effective, web-format will impact treatment efficacy. In addition, based on evidence showing a link between neurosteroids and psychopathology and a role in PTSD treatment response, an add-on biomarkers study was funded that examines the role of candidate biomarkers [endogenous glucocorticoids and neurosteroids, i.e. cortisol, allopregnanolone (ALLO) and metabolites, and dehydroepiandrosterone (DHEA/DHEAS)] as: a) predictors of treatment response, and b) indices of therapeutic change during PTSD treatment.
Objective/Hypotheses: To eliminate the confound inherent in changing simultaneously both the treatment program and the mode of delivery, the investigators propose to develop a web-version of PE, "Web-PE", and compare its efficacy to Present Centered Treatment (PCT), an active control comparison. The investigators hypothesize that Web-PE will be a mor
Sponsor: University of Pennsylvania
Current Primary Outcome:
- To evaluate the efficacy of Web-PE relative to PCT in the reduction of PTSD severity (using the CAPS severity score). [ Time Frame: Three years ]
- To evaluate the efficacy of Web-PE relative to PCT in the reduction in associated psychopathology [ Time Frame: Three years ]Associated psychopathology: PTSD diagnosis and severity scores on measures of depression, general anxiety, anger, and PTSD-related cognitions
- To evaluate the efficacy of Web-PE relative to PCT in the change in associated biomarkers [ Time Frame: Three years ]i.e., Cortisol response to awakening, cortisol response to script-driven imagery, salivary and serum neurosteroids.
Original Primary Outcome: Same as current
Current Secondary Outcome: Composite ratings on the use of the Web-PE program [ Time Frame: Three years ]
Original Secondary Outcome: Same as current
Information By: University of Pennsylvania
Dates:
Date Received: July 24, 2015
Date Started: May 2016
Date Completion:
Last Updated: April 21, 2017
Last Verified: April 2017
