Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:31 AM
Study NCT ID:
NCT07430657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nurse-Led PTSD Treatment in Primary Care
Sponsor:
Rush University Medical Center
Organization:
Study Overview
Official Title:
A Hybrid Implementation-Effectiveness Trial of Nurse-Delivered Post-Traumatic Stress Disorder Treatment in Primary Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: