A study to evaluate if hydrocortisone helps reduce symptoms of post-traumatic stress disorder in patients after exposure to a traumatic event.

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What is this study about?

This study focuses on Posttraumatic Stress Disorder, a mental health condition that can develop after experiencing or witnessing a traumatic event. The purpose of the study is to investigate whether the medication hydrocortisone can reduce the severity of symptoms compared to a placebo.

Participants in the study will be given either hydrocortisone in the form of an oral tablet or a placebo. Following the initial administration of the medication, participants will be monitored over a period of time. This involves completing various questionnaires to report on their experiences and symptoms, as well as providing samples such as saliva. Additionally, some participants may use wearable devices to track their heart rate and heart rate variability, which refers to the variation in time between each heartbeat.

Who Can Join the Study?

  • You must be between 18 and 65 years old.
  • You can be of any gender.
  • You must be able to speak and understand Dutch well.
  • You must have visited the Emergency Department (ED), which is the part of the hospital used for immediate medical care, following a single event.
  • This event must have involved an injury caused by an accident, physical violence, sexual violence, or another exceptional situation.
  • You must be experiencing symptoms of Posttraumatic Stress Disorder (PTSD), which is a mental health condition that can develop after experiencing or witnessing a terrifying event.

Who Cannot Join the Study?

  • You are unable to provide informed consent, which means you cannot give your formal and voluntary permission to participate in the study after understanding all the details.
  • You are not allowed to take hydrocortisone, which is a type of medicine used to manage certain body functions.
  • A doctor determines through an anamnesis, which is a detailed medical history interview, that you have mental health conditions that would make participating unsafe or inappropriate.
  • You face practical exclusion criteria, such as not having regular or reliable access to a telephone or the internet.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
Diakonessenhuis Stichting Utrecht The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
Aliuhyije Unl Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
01.01.2026

Trial locations

Investigated drugs:

Hydrocortisone is a type of steroid medication used in this study to see if it can help reduce symptoms of post-traumatic stress disorder (PTSD) following a traumatic event.

Investigated diseases:

Posttraumatic Stress Disorder – This condition develops after an individual experiences or witnesses a distressing or shocking event. It is characterized by intrusive memories or flashbacks related to the event. People may also experience intense emotional distress or physical reactions when reminded of the trauma. Avoidance of certain places, people, or thoughts associated with the event is common. Additionally, changes in mood, sleep patterns, or negative thoughts about oneself can occur. These symptoms can persist over a long period of time.

Trial ID:
2025-523350-13-02
Protocol code:
SHIELD
Trial Phase:
Therapeutic exploratory (Phase II)

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