Nurse-Led PTSD Treatment in Primary Care

Official title

A Hybrid Implementation-Effectiveness Trial of Nurse-Delivered Post-Traumatic Stress Disorder Treatment in Primary Care

Overview

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.

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.

Interventions

• Behavioral NurseNET
  NurseNET is a pragmatic clinical intervention designed to deliver evidence-based PTSD treatment within primary care workflows. It is distinguished from traditional Narrative Exposure Therapy (NET) and other primary care behavioral health interventions by the following four core elements: Nurse-Led Task Sharing. Unlike traditional models that rely on licensed mental health specialists (psychologists or social workers), NurseNET is delivered entirely by nurses. This leverages the existing nursing
• Behavioral Referral to PTSD Treatment
  Standard referral to PTSD treatment.

Primary outcome measures

• PTSD Checklist for DSM-5 (PCL-5) [Time frame: Baseline, 3, 6, 12 months]

Secondary outcome measures (10)

• Patient Health Questionnaire (PHQ-9) [Time frame: Baseline, 3, 6, 12 months]
• Generalized Anxiety Disorder (GAD-7) [Time frame: Baseline, 3, 6, 12 months]
• Somatic Symptoms Scale (SSS-8) [Time frame: Baseline, 3, 6, 12 months]
• Medication Adherence Report Scale (MARS-5) [Time frame: Baseline, 3, 6, 12 months]
• Self-Efficacy for Managing Chronic Conditions (PROMIS) [Time frame: Baseline, 3, 6, 12 months]
• EuroQoL-5 Dimension (EQ-5D) [Time frame: Baseline, 3, 6, 12 months]
• Blood Pressure [Time frame: Baseline, 3, 6, 12 months]
• Acceptability of Intervention Measure (AIM) [Time frame: 3 months]
• Intervention Appropriateness Measure (IAM) [Time frame: 3 months]
• Feasibility of Intervention Measure (FIM) [Time frame: 3 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Rush University Medical Center — Chicago
• Rush University Medical Center — Brookfield

Publications

• Dickins KA. Improving Traumatic Stress with Justice-Impacted Women and Women Experiencing Homelessness: A Pilot Study of Narrative Exposure Therapy. Issues Ment Health Nurs. 2024 Feb;45(2):121-141. doi: 10.1080/01612840.2023.2238091. Epub 2023 Aug 24. PMID 37616593
• Dickins KA, Houlihan MC, Neely S, Smith DL, Nowell H, Karnik N, Held P. Improving post-traumatic stress symptoms in homeless-experienced women using narrative exposure therapy: a single-arm, open pilot study. Eur J Psychotraumatol. 2026 Dec;17(1):2620215. doi: 10.1080/20008066.2026.2620215. Epub 2026 Feb 6. PMID 41645787

Identifiers

NCT: NCT07430657 · 25120501

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗