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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>initial intake</b>

    A saliva sample is collected during the intake process.

    Various questionnaires regarding personal background, life experiences, and sleep patterns are completed.

    A wearable device is used to measure heart rate and heart rate variability, which are measures of how the heart responds to different situations.

  2. Step 2

    <b>medication administration</b>

    An oral medication is provided. this is either hydrocortisone (a type of steroid) at a dose of 30 mg or a placebo, which is a pill that looks identical to the medication but contains no active substance.

  3. Step 3

    <b>follow-up assessments</b>

    Symptom severity for posttraumatic stress disorder (ptsd), a condition that can occur after a distressing event, is reported through self-reporting questionnaires at the following intervals: 2 weeks, 1 month, 6 weeks, 3 months, 6 months, and 12 months after the medication is taken.

    At the 3-month mark, a clinician evaluates the severity of ptsd symptoms using a standardized clinical interview tool.

    Additional questionnaires assessing various health and well-being factors are completed at each follow-up interval from 2 weeks to 12 months.

Who can join the trial?

6 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

  • Hydrocortisone Hualan

    This medication is taken orally in the form of a tablet. It is a well-established steroid used widely in medicine to manage various inflammatory and stress-related conditions. In the body, it works by mimicking a natural hormone produced by the adrenal glands, which helps regulate how the body responds to stress and reduces swelling or immune system overactivity at a cellular level. It is classified as a corticosteroid.

  • Placebo

    This is an inactive pill that is designed to look exactly like the real medication being tested. It contains no active medicinal ingredients and is used in clinical studies to provide a baseline for comparison. It has no pharmacological effect on the body and is used solely to ensure that the results of the study are due to the actual medicine rather than the patient's expectations.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523350-13-02Protocol codeSHIELDEstimated enrolment196 patientsSponsorAmsterdam UMC

sourced from the EU Clinical Trials Register and site verification

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