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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorBarzilai Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Discharged from ICU due to sepsis

Age over 18 years old

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psychiatric interview

    Other intervention

    Psychiatric interview for 45 minutes

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Early psychiatric interventionExperimental treatment 1 intervention
Group B: No interventionNo intervention 0 interventions

Trial outcomes

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.

Time frame
30 days

Secondary outcomes

1

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.

Time frame
30 days
2

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.

Time frame
30 days

Other outcomes

Sponsors and contacts

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