Improving PTSD Management in Primary Care
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- RAND
- Enrollment
- 404
- Locations
- 13
- Primary Endpoint
- PTSD Symptoms
Study Overview
Brief Summary
The purpose of this study is to conduct a randomized trial of a Post Traumatic Stress Disorder (PTSD) Care Management (PCM) program to detect, treat, and improve PTSD treatment processes and outcomes in patients seeking primary care from FQHCs and evaluate its effectiveness on improving the processes and outcomes of care for PTSD.
Detailed Description
Post-traumatic Stress Disorder (PTSD) is a common problem seen in primary care but the identification and management of PTSD is not routine and would benefit from new approaches. Efforts must overcome patient-, clinician-, and system-level barriers, such as patients' fear of stigma, clinician's time constraints for dealing with psychological issues, gaps in clinician treatment knowledge, and difficulty arranging for referrals to mental health specialists.
Unlike mood disorders such as depression, little is known about improving care for PTSD in primary care settings. However, previous experience for treating depression, as well as existing guidelines for addressing PTSD in primary care, provide evidence that effective interventions exist and that multi-faceted interventions are more effective than a single-component approaches.
In this project, the RAND Corporation, Clinical Directors Network Inc., Georgetown University Department of Psychiatry, and University of Washington will implement and evaluate a randomized controlled trial (RCT) of a PTSD Care Management (PCM) intervention to detect, treat, and improve PTSD treatment processes and health outcomes in patients seeking primary care from Federally Qualified Health Centers (FQHCs) in Northeastern USA.
The three specific aims are to:
- Evaluate the effectiveness of the PCM intervention compared to a minimally enhanced usual care (MEU) control in reducing PTSD and other mental health symptoms, and improving patients' health-related quality-of-life.
- Assess the success of the PCM intervention implementation and,
- Examine the direct costs of the PCM intervention compared to the TAU control treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Has a scheduled or walk-in appointment with a participating PCC
- •Speaks English of Spanish
- •Is between 18 and 65 years old
- •Expects to receive care in the CHC during the next year
Exclusion Criteria
- •Acutely ill and cannot participate in a discussion
- •Does not understand the information
Outcomes
Primary Outcomes
PTSD Symptoms
Time Frame: 12 months
same as baseline and 6 months
Secondary Outcomes
No secondary outcomes reported