Nurse-Led PTSD Treatment in Primary Care
Purpose
Purpose of the Study Post-traumatic stress disorder (PTSD) is a common and serious condition, but many people cannot get the help they need because there are not enough mental health specialists (like psychologists or psychiatrists) available. This study is testing a new program called NurseNET. The goal of NurseNET is to train nurses to provide a proven, short-term trauma treatment called Narrative Exposure Therapy (NET). Why This Study is Important Most people see their nurse or doctor for health concerns. Because nurses are highly trusted and already work on the front lines of healthcare, they may be in the best position to offer PTSD treatment quickly and conveniently. This study aims to see if nurse-led care can bridge the gap between patients and the treatment they deserve. What the Study Involves Researchers will enroll 100 participants who have symptoms of PTSD. Participants will work with a trained nurse in a primary care setting to complete the NurseNET program. The Treatment: The program consists of 4 to 6 sessions. During these sessions, the nurse helps the patient talk through their life story and process difficult memories in a safe, supportive way. What We Are Measuring: The research team will look at several factors to see if the program is successful: Effectiveness: Do PTSD symptoms improve after working with the nurse? Feasibility and Acceptability: Do patients and nurses find this type of care easy to use and helpful? Health Impact: Since PTSD is linked to heart health, the study will also look at whether the treatment improves things like blood pressure or physical activity levels. Goal of the Research By the end of this study, researchers hope to show that nurses can safely and effectively provide trauma care. If successful, this model could be used across the United States to make PTSD treatment much easier to access for everyone.
Condition
- Post Traumatic Stress Disorder PTSD
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- o PTSD + trauma exposure (PCL-5 score ≥28, plus trauma endorsed on LEC-5/CAPS) - Life-threatening CV event in the last 90 days (including myocardial infarction/heart attack, acute cerebrovascular accident/stroke, sudden cardiac arrest, acute decompensated heart failure, or life-threatening arrhythmia requiring cardioversion or defibrillation). - Primary care patient at Rush University Medical Center
Exclusion Criteria
- o Safety risk (documented suicidal ideation/need for acute psychiatric care) - NET conflict (actively receiving psychotherapy/PTSD treatment) - Cognitive/decisional non-capacity (University of California, San Diego Brief Assessment of Capacity to Consent [UBACC] ≤ 14.5)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
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Experimental NurseNET |
The NurseNET experimental arm involves training primary care nurses to deliver a condensed, 4 session version of Narrative Exposure Therapy (NET) to patients with PTSD symptoms. This task sharing approach integrates evidence-based trauma treatment directly into the primary care workflow to increase service access and improve select health outcomes. |
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Active Comparator Minimally-Enhanced Usual Care |
The minimally-enhanced usual care arm consists of provision of psychoeducational materials regarding trauma symptoms and available community resources, followed by referral to PTSD treatment. This arm serves as a rigorous control to account for the effects of time and general medical attention while identifying the specific clinical impact of the nurse-led Narrative Exposure Therapy intervention. |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Rush University Medical Center
Study Contact
Detailed Description
Background and Theoretical Framework This Type 2 Hybrid Implementation-Effectiveness Trial is designed to address the critical gap in posttraumatic stress disorder (PTSD) treatment for patients who have experienced co-occurring physical illness, namely cardiovascular (CV) events. Approximately one-third of CV event survivors develop PTSD, which serves as an independent risk factor for further CV morbidity and mortality. This study utilizes the Enduring Somatic Threat (EST) model, which posits that PTSD is driven by a persistent internal threat and can manifest as Fear-Related Behavioral Avoidance (FRBA). FRBA often leads to poor medication adherence and avoidance of necessary physical activities, creating a recursive cycle of poor health outcomes. The NurseNET Intervention The core of the experimental arm is Nurse-delivered Narrative Exposure Therapy (NurseNET), an evidence-based, four-session protocol integrated directly into the primary care (PC) setting. The treatment is delivered by specially trained nurses and follows a manualized structure: Session 1: Includes psychoeducation regarding medical trauma and the co-reconstruction of a "Lifeline", a chronological, autobiographical narrative of the patient's life events. Sessions 2-4: Focus on gradual imaginative exposure, where the nurse guides the patient to systematically process and extinguish trauma-related fear memories. Safety Component: Every session concludes with structured somatic relaxation or "grounding" exercises to help participants regulate emotional arousal. Study Design and Objectives Participants (N=100) are randomized 1:1 to either the NEST intervention or minimally-enhanced usual care (UC). The UC arm receives identical psychoeducation but is provided with external referrals for trauma treatment rather than co-located, nurse-led care. The trial aims to evaluate three primary domains: Effectiveness: Assessing changes in PTSD symptom severity (PCL-5) as the primary outcome, alongside secondary measures of depression (PHQ-9), anxiety (GAD-7), and CV-specific outcomes like blood pressure and medication adherence. Implementation: Using the Consolidated Framework for Implementation Research (CFIR) to identify contextual drivers and implementation outcomes (acceptability, feasibility, and fidelity) to develop a replicable blueprint for future large-scale integration. Cost-Effectiveness: Conducting a preliminary analysis of direct intervention costs and healthcare resource utilization (e.g., ED visits and hospitalizations) over 12 months. Safety and Monitoring To ensure participant safety, a Data Safety Monitoring Committee (DSMC) will conduct interim reviews when 25% and 50% of the target sample is reached. The study excludes individuals with acute safety risks, such as active suicidal ideation, and provides clinical consultation with psychiatry and psychology for managing acute distress if it arises during exposure sessions.
