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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003130', 'term': 'Combat Disorders'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-18', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTSD Checklist for DSM-5 (PCL-5)', 'timeFrame': 'Baseline, 3, 6, 12 months', 'description': '20-item self-report scale that assesses the 20 DSM-5 PTSD symptoms; used to monitor symptom change/screen for probable PTSD diagnosis.'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Baseline, 3, 6, 12 months', 'description': '9-item tool used to screen, diagnose, and monitor the severity of depression/depressive symptoms based on DSM-IV(/V) criteria.'}, {'measure': 'Generalized Anxiety Disorder (GAD-7)', 'timeFrame': 'Baseline, 3, 6, 12 months', 'description': '7-item clinical scale for screening and measuring the severity of generalized anxiety disorder symptoms.'}, {'measure': 'Somatic Symptoms Scale (SSS-8)', 'timeFrame': 'Baseline, 3, 6, 12 months', 'description': '8-item self-report instrument used to assess the somatic symptom burden, focusing on physical manifestations of psychological distress.'}, {'measure': 'Medication Adherence Report Scale (MARS-5)', 'timeFrame': 'Baseline, 3, 6, 12 months', 'description': '5-item self-report scale used to identify non-adherent medication behaviors and beliefs about treatment.'}, {'measure': 'Self-Efficacy for Managing Chronic Conditions (PROMIS)', 'timeFrame': 'Baseline, 3, 6, 12 months', 'description': "4-item (short-form) instrument used to measure a patient's self-efficacy for managing chronic conditions, including symptoms and social tasks."}, {'measure': 'EuroQoL-5 Dimension (EQ-5D)', 'timeFrame': 'Baseline, 3, 6, 12 months', 'description': '5-item instrument for measuring health status and quality of life (mobility, self-care, activities, pain, anxiety/depression) used to calculate QALYs.'}, {'measure': 'Blood Pressure', 'timeFrame': 'Baseline, 3, 6, 12 months', 'description': 'Clinical assessment of systolic and diastolic pressure to evaluate the impact of trauma recovery on hypertension risk.'}, {'measure': 'Acceptability of Intervention Measure (AIM)', 'timeFrame': '3 months', 'description': '4-item measure used to assess the perception of whether a specific intervention is agreeable, palatable, or satisfactory to stakeholders.'}, {'measure': 'Intervention Appropriateness Measure (IAM)', 'timeFrame': '3 months', 'description': '4-item measure assessing the perceived fit or relevance of the intervention for a given setting or problem, such as referral-based care.'}, {'measure': 'Feasibility of Intervention Measure (FIM)', 'timeFrame': '3 months', 'description': '4-item measure assessing extent to which an intervention can be successfully carried out within a given setting, such as primary care clinics.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post traumatic stress disorder', 'primary care', 'nurse'], 'conditions': ['Post Traumatic Stress Disorder PTSD']}, 'referencesModule': {'references': [{'pmid': '37616593', 'type': 'BACKGROUND', 'citation': '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': '41645787', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nWhy 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.\n\nWhat 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.\n\nThe 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.\n\nWhat We Are Measuring: The research team will look at several factors to see if the program is successful:\n\nEffectiveness: Do PTSD symptoms improve after working with the nurse?\n\nFeasibility and Acceptability: Do patients and nurses find this type of care easy to use and helpful?\n\nHealth 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.\n\nGoal 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.', 'detailedDescription': '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.\n\nThe NurseNET Intervention\n\nThe 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:\n\nSession 1: Includes psychoeducation regarding medical trauma and the co-reconstruction of a "Lifeline", a chronological, autobiographical narrative of the patient\'s life events.\n\nSessions 2-4: Focus on gradual imaginative exposure, where the nurse guides the patient to systematically process and extinguish trauma-related fear memories.\n\nSafety Component: Every session concludes with structured somatic relaxation or "grounding" exercises to help participants regulate emotional arousal.\n\nStudy 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.\n\nThe trial aims to evaluate three primary domains:\n\nEffectiveness: 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.\n\nImplementation: 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.\n\nCost-Effectiveness: Conducting a preliminary analysis of direct intervention costs and healthcare resource utilization (e.g., ED visits and hospitalizations) over 12 months.\n\nSafety 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* o PTSD + trauma exposure (PCL-5 score ≥28, plus trauma endorsed on LEC-5/CAPS)\n\n * 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).\n * Primary care patient at Rush University Medical Center\n\nExclusion Criteria:\n\n* o Safety risk (documented suicidal ideation/need for acute psychiatric care)\n\n * NET conflict (actively receiving psychotherapy/PTSD treatment)\n * Cognitive/decisional non-capacity (University of California, San Diego Brief Assessment of Capacity to Consent \\[UBACC\\] ≤ 14.5)'}, 'identificationModule': {'nctId': 'NCT07430657', 'briefTitle': 'Nurse-Led PTSD Treatment in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'A Hybrid Implementation-Effectiveness Trial of Nurse-Delivered Post-Traumatic Stress Disorder Treatment in Primary Care', 'orgStudyIdInfo': {'id': '25120501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NurseNET', 'description': '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.', 'interventionNames': ['Behavioral: NurseNET']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Minimally-Enhanced Usual Care', 'description': '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.', 'interventionNames': ['Behavioral: Referral to PTSD Treatment']}], 'interventions': [{'name': 'NurseNET', 'type': 'BEHAVIORAL', 'description': '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:\n\nNurse-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 workforce to bypass specialist shortages and reduce the "referral cliff" associated with external mental health consultations.\n\nDose-Compressed Protocol. While standard NET often extends to 10 or more sessions, NurseNET utilizes a condensed 4-session format. This "minimum therapeutic dose" is specifically engineered for the high-throughput U.S. healthcare environment. We use a safety-net supervision framework and leverage the holistic nurse preparation in the context of co-located/integrated care', 'armGroupLabels': ['NurseNET']}, {'name': 'Referral to PTSD Treatment', 'type': 'BEHAVIORAL', 'description': 'Standard referral to PTSD treatment.', 'armGroupLabels': ['Minimally-Enhanced Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual Participant Data (IPD) will not be shared to ensure the maximum protection of participant privacy and confidentiality, which is paramount given the highly sensitive nature of the traumatic life events disclosed during Narrative Exposure Therapy. Due to the narrative nature of the intervention, the risk of deductive re-identification remains high even in de-identified datasets in this early, small sample pilot trial.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kirsten A. Dickins', 'investigatorAffiliation': 'Rush University Medical Center'}}}}