Posttraumatic Stress Disorders Clinical Trial
Verified date | September 2019 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 2019 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Department of Psychiatry and Behavioral Sciences, Emory University | Atlanta | Georgia |
United States | Carl R. Darnall Army Medical Center | Killeen | Texas |
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | University of Texas, VA Palo Alto Health Care System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the efficacy of Web-PE relative to PCT in the reduction of PTSD severity (using the CAPS severity score). | Three years | ||
Primary | To evaluate the efficacy of Web-PE relative to PCT in the reduction in associated psychopathology | Associated psychopathology: PTSD diagnosis and severity scores on measures of depression, general anxiety, anger, and PTSD-related cognitions | Three years | |
Primary | To evaluate the efficacy of Web-PE relative to PCT in the change in associated biomarkers | i.e., Cortisol response to awakening, cortisol response to script-driven imagery, salivary and serum neurosteroids. | Three years | |
Secondary | Composite ratings on the use of the Web-PE program | 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. | Three years |
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