A Hybrid Implementation-Effectiveness Trial of Nurse-Delivered Post-Traumatic Stress Disorder Treatment in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: NurseNET (Behavioral)
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.
干预措施: Referral to PTSD Treatment (Behavioral)
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5)
时间窗: Baseline, 3, 6, 12 months
20-item self-report scale that assesses the 20 DSM-5 PTSD symptoms; used to monitor symptom change/screen for probable PTSD diagnosis.
次要结局
- Medication Adherence Report Scale (MARS-5)(Baseline, 3, 6, 12 months)
- Self-Efficacy for Managing Chronic Conditions (PROMIS)(Baseline, 3, 6, 12 months)
- EuroQoL-5 Dimension (EQ-5D)(Baseline, 3, 6, 12 months)
- Blood Pressure(Baseline, 3, 6, 12 months)
- Acceptability of Intervention Measure (AIM)(3 months)
- Intervention Appropriateness Measure (IAM)(3 months)
- Feasibility of Intervention Measure (FIM)(3 months)
- Patient Health Questionnaire (PHQ-9)(Baseline, 3, 6, 12 months)
- Generalized Anxiety Disorder (GAD-7)(Baseline, 3, 6, 12 months)
- Somatic Symptoms Scale (SSS-8)(Baseline, 3, 6, 12 months)
研究者
Kirsten A. Dickins
Assistant Professor
Rush University Medical Center