Status:
COMPLETED
Stepped Enhancement of PTSD Services Using Primary Care (STEPS UP): A Randomized Effectiveness Trial
Lead Sponsor:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborating Sponsors:
United States Department of Defense
RAND
Conditions:
Posttraumatic Stress Disorder (PTSD)
Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The overall objective of this study is to test the effectiveness of a systems-level approach to primary care recognition and management of PTSD and depression in the military health system. More speci...
Detailed Description
Despite the significant prevalence of posttraumatic stress disorder (PTSD) and depression among veterans returning from Operations in Iraq and Afghanistan, less than half of service members who are re...
Eligibility Criteria
Inclusion
- Active duty status at the time of enrollment
- Positive PTSD screen (2 or more yes responses on PC-PTSD), per routine primary care screening.
- DSM-IV-TR criteria for A) PTSD using the PCL-C (i.e.., a "moderate" or greater severity level on 1 re-experiencing, 3 avoidance, and 2 hyperarousal symptoms) and/or B) Depression, using the PHQ-9 (i.e., endorsement of at least 5 of the 9 symptoms experienced "more than half the days" and at least one of those symptoms must include either "little interest or pleasure in doing things" or "feeling down, depressed or hopeless")
- Report of routine computer, Internet, and e-mail access
- Capacity to consent to participation and provide research informed consent using local IRB-approved form
Exclusion
- Treatment refractory PTSD or depression after participation in RESPECT-mil or specialty mental health treatment.
- Acute psychosis, psychotic episode, or psychotic disorder diagnosis by history within the past 2 years
- Bipolar I disorder by history or medical record review within last 2 years.
- Active substance dependence disorder in the past year by history within the past 12 months.
- Active suicidal ideation within the past 2 months by history.
- Patients on psychoactive medication, unless that medication dosing and administration has been stable and regular for at least 1 month.
- Acute or unstable physical illness.
- Anticipated deployment, demobilization, or separation during the next six months.
- Personnel who work in participating clinics.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
666 Patients enrolled
Trial Details
Trial ID
NCT01492348
Start Date
January 1 2012
End Date
February 1 2016
Last Update
March 14 2017
Active Locations (6)
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1
Evans Army Community Hospital
Fort Carson, Colorado, United States, 80913
2
Winn Army Community Hospital
Fort Stewart, Georgia, United States, 31409-5102
3
Blanchfield Army Community Hospital
Fort Campbell, Kentucky, United States, 42333
4
Womack Army Medical Center
Fort Bragg, North Carolina, United States, 28310