The Effect of Early Intervention on the Incidence of Posttraumatic Stress Disorder After Intensive Care Hospitalization Due to Sepsis

In recent years, the survival rate among intensive care patients has improved due to advancements in diagnosing severe infections and the use of broad-spectrum antibiotics. However, many survivors face long-term complications, known as Post-Intensive Care Syndrome (PICS), including physical, cognitive, and psychological impairments such as post-traumatic stress disorder (PTSD), anxiety, and depression. Approximately 9-27% of ICU survivors develop these symptoms, particularly those hospitalized due to sepsis. Common risk factors include traumatic hospital experiences, delirium, and extended mechanical ventilation. Despite the prevalence of these issues, most medical centers lack structured models for screening and early intervention, highlighting the need for evaluations of early intervention strategies to support at-risk patients post-discharge and improve their quality of life.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; ICU; PTSD - Post Traumatic Stress Disorder
• Intervention / Treatment: Other: Psychiatric interview

Detailed Description

In recent years, there has been a significant increase in the survival rate of patients hospitalized in intensive care, due in part to improved capabilities in diagnosing and treating severe infections and sepsis, the use of broad-spectrum antibiotics, and the development of advanced life-support technologies. However, alongside this rise in survival, it has become evident that many patients continue to suffer from long-term complications following their discharge from intensive care. This phenomenon is described in the literature as Post-Intensive Care Syndrome (PICS) and encompasses physical, cognitive, and psychological impairments that develop or persist after an intensive care stay.

Among the prominent psychological consequences following an intensive care unit (ICU) stay is post-traumatic stress disorder (PTSD), alongside symptoms of anxiety and depression. Various studies indicate that a significant proportion (9-27%) of ICU survivors develop post-traumatic symptoms; while these may appear during the hospital stay itself, they sometimes develop or worsen after discharge. Potential risk factors for the development of these symptoms include traumatic experiences during the hospital stay, delirium, prolonged mechanical ventilation, exposure to certain medications, and the severity of the underlying illness.

Patients hospitalized in the ICU due to sepsis constitute a particularly high-risk population for developing these symptoms, given the severity of the illness, the duration of the hospital stay, and exposure to numerous invasive procedures. Beyond the psychological impact, post-traumatic symptoms can significantly affect patients' quality of life, daily functioning, and recovery process following hospital discharge.

Despite the prevalence of this phenomenon, most medical centers currently lack a structured model for screening and early intervention among patients discharged from the ICU. Most research in this field focuses on identifying the phenomenon or describing its risk factors, whereas data regarding the efficacy of early interventions to prevent PTSD following ICU hospitalization remain limited.

In light of this, there is a need to evaluate the feasibility of an early intervention model for patients discharged from the intensive care unit following hospitalization for sepsis. Such an intervention could help identify at-risk patients early, reduce the severity of psychological symptoms, and improve their quality of life after hospital discharge.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Leshin Carmel, MD; Phone Number: +972525253037; Email: danielles@bmc.gov.il
• Study Contact Backup: Name: Pnina Nir; Email: pninan@bmc.gov.il

Study Locations

• Israel
  • Ashkelon, Israel
    • Recruiting
    • Barzilai Medical Center
    • Contact: Daniel Leshin-Carmel, MD; Phone Number: +972525253037; Email: danielles@bmc.gov.il
    • Contact: pnina nir, study coordinator; Email: pninan@bmc.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Discharged from ICU due to sepsis
• Age over 18 years old

Exclusion Criteria:

• Age under 18 years old
• Lack of consent
• Dementia/ mental retardation or any other condition due to which the patient cannot fill the questionnaires or participate in the psychiatric interview.
• A cute psychosis or other psychiatric condition nesiccating psychiatric treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early psychiatric intervention; Interventional arm. Early intervention after discharge from ICU.	Other: Psychiatric interview; Psychiatric interview for 45 minutes
No Intervention: No intervention; Observational arm. No intervention after discharge from ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD risk according to PCL-5	Post Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5). The PCL-5 is widely used in clinical and research settings to screen for PTSD, assess symptom severity, and monitor treatment progress over time. Total scores can range from 0 to 80, with higher scores indicating greater PTSD symptom severity. In addition to a raw score being presented, a mean score is also computed, which is the subscale score divided by the number of items within that subscale. The average score can help determine elevated symptom clusters when comparing each of the four subscales. These scores range between 0 to 4, where higher scores represent higher severity.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression risk	Patient Health Questionnaire-9 is a validated, 9-question tool to assess for the degree of depression present in an individual. The total score ranges from 0 to 27. The higher the score is the more severe the depression is.	30 days
General well being	This questionnaire is designed to measure general well-being, including negative well-being, energy and positive well-being. The Well-Being Questionnaire (W-BQ) was first developed in the early 1980s as a 22-item measure. The range is from 0 to 110, the higher the score the better is the general well being.	30 days

Collaborators and Investigators

• Sponsor: Barzilai Medical Center
• Investigators: Principal Investigator: daniel Leshin Carmel, MD, Barzilai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; ICU; SEPSIS; EARLY INTERVENTION
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Stress Disorders, Traumatic; Pathological Conditions, Signs and Symptoms; Sepsis; Stress Disorders, Post-Traumatic; Combat Disorders
• Other Study ID Numbers: 0041-26-BRZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No