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A Comparison of Web-Prolonged Exposure (Web-PE) and Present-Centered Therapy (PCT) for PTSD Among Active-Duty Military Personnel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02556645
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : September 9, 2019
Sponsor:
Collaborators:
University of Texas
VA Palo Alto Health Care System
Information provided by (Responsible Party):
Carmen McLean, University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorders Combat Disorders Other: Web-PE Therapy Other: Therapist-Delivered Present-Centered Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: 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).
Other: 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).
Other Name: Internet-based prolonged exposure

Active Comparator: PCT
Ten 60-minute psychotherapy sessions over 8 weeks, focused on identifying and solving day-to-day problems as they are brought up by the participants. PCT is a manualized therapy that has been used as active control condition in several CBT studies.
Other: Therapist-Delivered Present-Centered Therapy
Ten 60-minute psychotherapy sessions over 8 weeks, focused on identifying and solving day-to-day problems as they are brought up by the participants. PCT is a manualized therapy that has been used as active control condition in several CBT studies. It provides a credible comparison therapy to control for nonspecific therapeutic factors so that observed effects of Web-PE can be attributed to its specific ingredients beyond the benefits of good therapy.
Other Name: PCT




Primary Outcome Measures :
  1. 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 ]
  2. 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

  3. 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.


Secondary Outcome Measures :
  1. Composite ratings on the use of the Web-PE program [ Time Frame: Three years ]
    Ratings of ease of use, acceptability, comprehension of program content and functionality, and overall satisfaction of the Web-PE program. Ratings made by military personnel with PTSD symptoms and an advisory board of eight experts in PE and the treatment PTSD in the military.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male and female active duty military personnel or veterans who have deployment since 9/11, ages 18-65 seeking treatment for PTSD. Veterans must be eligible for military medical care on Fort Hood.
  • Diagnosis of PTSD as determined by a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) clinical interview score ≥ 25. Person 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. The diagnosis of PTSD may be indexed to that event or to another Criterion A event.
  • Able to speak and read English
  • Indication that the participant plans to be in the area for the next five months following the first assessment

Exclusion Criteria:

  • Recent manic episode (past 12 months) or a psychotic disorder (as determined by the bipolar and psychosis sections of the MINI)
  • Current alcohol dependence (as determined by an a score of ≥ 4 on items #4-6 and a total score of ≥20 on the AUDIT)
  • Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
  • Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index-Suicidality Subscale and corroborated by a clinical risk assessment by a credentialed provider)
  • Other psychiatric disorders severe enough to warrant designation as the primary disorder
  • Recent course of PE within the past 12 months
  • Currently engaged in evidence-based treatment for PTSD (e.g. Prolonged Exposure Therapy or Cognitive Processing Therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556645


Locations
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United States, Georgia
Department of Psychiatry and Behavioral Sciences, Emory University
Atlanta, Georgia, United States, 30322
United States, Pennsylvania
Center for the Treatment and Study of Anxiety, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Carl R. Darnall Army Medical Center
Killeen, Texas, United States, 76544
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
University of Pennsylvania
University of Texas
VA Palo Alto Health Care System
Investigators
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Principal Investigator: Carmen McLean, Ph.D. University of Pennsylvania
Principal Investigator: Sheila Rauch, Ph.D. Emory University
Additional Information:
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Responsible Party: Carmen McLean, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02556645    
Other Study ID Numbers: W81XWH-14-1-0008
12012005 ( Other Identifier: Department of Defense )
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Keywords provided by Carmen McLean, University of Pennsylvania:
Combat
Psychological Treatment
Military
Psychotherapy
Trauma
Posttraumatic Stress
Posttraumatic Stress Disorder
Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Combat Disorders
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders