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

NCT07707765 | Recruiting

• 1 other identifier: 0041-26-BRZ
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PTSD - Post Traumatic Stress Disorder; Sepsis; ICU

Keywords

PTSD; SEPSIS; ICU; EARLY INTERVENTION

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Depression risk

  30 days

• General well being

  30 days

Study Arms (2)

Early psychiatric intervention

EXPERIMENTAL

Interventional arm. Early intervention after discharge from ICU.

Other: Psychiatric interview

No intervention

NO INTERVENTION

Observational arm. No intervention after discharge from ICU.

Interventions

Psychiatric interview OTHER

Psychiatric interview for 45 minutes

Early psychiatric intervention

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barzilai Medical Center: lead

Study Sites (1)

Barzilai Medical Center

Ashkelon, Israel

RECRUITING

MeSH Terms

Conditions

Combat Disorders; Sepsis; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• daniel Leshin Carmel, MD

  Barzilai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Leshin Carmel, MD

CONTACT

+972525253037; danielles@bmc.gov.il

Pnina Nir

CONTACT

pninan@bmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of infection control and prevention

Model Details: This is a prospective, single-center study comparing the incidence of post-traumatic stress disorder (PTSD) in patients discharged from the intensive care unit following hospitalization for sepsis, contrasting early intervention with no intervention. As this is a pilot study assessing the feasibility of early intervention, a maximum of 60 participants will be recruited and randomly assigned to one of two groups: intervention or control.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)