Post Traumatic Stress Disorder PTSDNCT07430657
Nurse-Led PTSD Treatment in Primary Care
A study testing NurseNET and Referral to PTSD Treatment in people with Post Traumatic Stress Disorder PTSD, run by Rush University Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder PTSD
- What is being tested?
- NurseNET and Referral to PTSD Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Mar 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Rush University Medical Center
Brookfield, Wisconsin, 53045
Kirsten Assistant Professor, PhD, FNP-C, 3129421442, kirsten_dickins@rush.edu
Sarah Senior Research Operations Manager, MA, LCPC, 3129421442
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Kirsten Dickins Assistant Professor, PhD, (312) 942-1442, kirsten_dickins@rush.edu
Sarah Pridgen, MA, LCPC, 312-563-0577, Sarah_Pridgen@rush.edu
About this study
Official title: A Hybrid Implementation-Effectiveness Trial of Nurse-Delivered Post-Traumatic Stress Disorder Treatment in Primary Care
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.
Read more
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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder PTSD
- Being tested
- NurseNET, Referral to PTSD Treatment
- Keywords
- post traumatic stress disorder, primary care, nurse
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NurseNETBehavioural
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 workforce to bypass specialist shortages and reduce the "referral cliff" associated with external mental health consultations.
Dose-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
Referral to PTSD TreatmentBehavioural
Standard referral to PTSD treatment.
| Study group | Role | What they receive |
|---|---|---|
| NurseNET | Experimental | 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. Receives: Behavioral: NurseNET |
| Minimally-Enhanced Usual Care | Active comparator | 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. Receives: Behavioral: Referral to PTSD Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-5 (PCL-5)
20-item self-report scale that assesses the 20 DSM-5 PTSD symptoms; used to monitor symptom change/screen for probable PTSD diagnosis.
Measured: Baseline, 3, 6, 12 months
Secondary outcomes (10)
Patient Health Questionnaire (PHQ-9)
9-item tool used to screen, diagnose, and monitor the severity of depression/depressive symptoms based on DSM-IV(/V) criteria.
Measured: Baseline, 3, 6, 12 months
Generalized Anxiety Disorder (GAD-7)
7-item clinical scale for screening and measuring the severity of generalized anxiety disorder symptoms.
Measured: Baseline, 3, 6, 12 months
Somatic Symptoms Scale (SSS-8)
8-item self-report instrument used to assess the somatic symptom burden, focusing on physical manifestations of psychological distress.
Measured: Baseline, 3, 6, 12 months
Medication Adherence Report Scale (MARS-5)
5-item self-report scale used to identify non-adherent medication behaviors and beliefs about treatment.
Measured: Baseline, 3, 6, 12 months
Self-Efficacy for Managing Chronic Conditions (PROMIS)
4-item (short-form) instrument used to measure a patient's self-efficacy for managing chronic conditions, including symptoms and social tasks.
Measured: Baseline, 3, 6, 12 months
EuroQoL-5 Dimension (EQ-5D)
5-item instrument for measuring health status and quality of life (mobility, self-care, activities, pain, anxiety/depression) used to calculate QALYs.
Measured: Baseline, 3, 6, 12 months
Blood Pressure
Clinical assessment of systolic and diastolic pressure to evaluate the impact of trauma recovery on hypertension risk.
Measured: Baseline, 3, 6, 12 months
Acceptability of Intervention Measure (AIM)
4-item measure used to assess the perception of whether a specific intervention is agreeable, palatable, or satisfactory to stakeholders.
Measured: 3 months
Intervention Appropriateness Measure (IAM)
4-item measure assessing the perceived fit or relevance of the intervention for a given setting or problem, such as referral-based care.
Measured: 3 months
Feasibility of Intervention Measure (FIM)
4-item measure assessing extent to which an intervention can be successfully carried out within a given setting, such as primary care clinics.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start30 Mar 2026
- Primary completionJun 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress Disorder PTSDStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsten A. Dickins, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430657
- Sponsor's protocol ID
- 25120501
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 37616593Dickins 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.
PubMed 41645787
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Implementation-Effectiveness Trial of Nurse-Delivered Post-Traumatic Stress Disorder Treatment in Primary Care
- ClinicalTrials.gov ID
- NCT07430657
- Acronym / sponsor ID
- 25120501
- Conditions
- Post Traumatic Stress Disorder PTSD
- Keywords
- post traumatic stress disorder, primary care, nurse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NurseNET | Experimental | Behavioral: NurseNETThe 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. |
| Minimally-Enhanced Usual Care | Active comparator | Behavioral: Referral to PTSD TreatmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- o PTSD + trauma exposure (PCL-5 score ≥28, plus trauma endorsed on LEC-5/CAPS)
Key exclusion criteria (3 listed)
- o Safety risk (documented suicidal ideation/need for acute psychiatric care)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NurseNETNurseNET 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 workforce to bypass specialist shortages and reduce the "referral cliff" associated with external mental health consultations. Dose-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 | Behavioural | NurseNET |
| Referral to PTSD TreatmentStandard referral to PTSD treatment. | Behavioural | Minimally-Enhanced Usual Care |
Primary outcome
PTSD Checklist for DSM-5 (PCL-5)
Time frame: 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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 37616593Dickins 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.
- Background: PubMed 41645787Dickins 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NurseNET and Referral to PTSD Treatment in people with Post Traumatic Stress Disorder PTSD, run by Rush University Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL-5) (time frame: Baseline, 3, 6, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07430657, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.