AuthorisedTherapeutic exploratory (Phase II)Interventional

SHIELD – Swift Hydrocortisone Intervention after trauma exposure

The SHIELD study is investigating whether a medication containing 10mg of hydrocortisone can help people who have recently been through a traumatic experience. The main goal is to see if taking this medicine soon after the event can prevent or reduce the severity of Post-Traumatic Stress Disorder (PTSD) symptoms over three months. Participants will either receive the hydrocortisone tablets or a dummy pill (placebo) that looks exactly the same. Researchers will regularly check on their well-being, including PTSD symptoms, and collect information like heart rate, sleep patterns, and saliva samples. This is a Phase II study, meaning it's an early step to explore if the treatment works and is safe before larger trials.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Amsterdam UMC Stichting

Enrolment target

196

Start

17 Mar 2026

Posttraumatic Stress Disorder (PTSD)

What is this study about?

The SHIELD study is looking at a new way to help people who have recently experienced a very upsetting or frightening event, also known as trauma. When someone goes through trauma, they can sometimes develop Post-Traumatic Stress Disorder, or PTSD. This can involve flashbacks, nightmares, anxiety, and trouble with daily life.

This study wants to find out if giving a small dose of a medicine called hydrocortisone shortly after a traumatic event can stop PTSD from developing, or make its symptoms less severe. Hydrocortisone is a type of steroid, and researchers believe it might help the body cope better with the stress of trauma. Participants will either receive the active hydrocortisone medicine or a 'dummy' pill (called a placebo) that won't have any medicine in it, but will look identical.

The main thing the researchers will be watching for is how severe any PTSD symptoms are three months after the treatment, using a standard way to measure them. They will also look at whether people are diagnosed with PTSD at that time, and track symptoms, mood, and sleep over a whole year. This information will help them understand if hydrocortisone could be a helpful early treatment for trauma.

Key takeaways

The SHIELD study explores if an early dose of hydrocortisone helps after trauma.
It aims to prevent or reduce PTSD symptoms.
Participants will receive either hydrocortisone or a dummy pill.
The study involves regular check-ups and questionnaires over a year.
It's an early-stage study to understand effectiveness and safety.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is open to adults aged 18 years and older. There is no upper age limit for taking part. Both men and women are welcome to participate in the study.

To be considered for the study, you would need to have experienced a recent traumatic event that the researchers are focusing on. Exact details about the specific type of trauma will be explained by the study team.

There might be other specific health conditions or medications you are taking that could prevent you from joining. The study team will discuss all of these details with you to see if the study is a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently experienced a traumatic event?
Are you able to attend follow-up appointments for up to a year?
Are you willing to potentially take a study medication or a placebo?
Are you comfortable filling out questionnaires about your well-being?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the SHIELD study, you'll be randomly assigned to either receive the hydrocortisone tablets or a matching dummy pill (placebo). You won't know which one you're taking, and neither will the study team, to ensure fair results. You'll take the medication for a short period after the traumatic event.

Over the course of a year, you'll have several check-ups with the study team. These visits will likely involve filling out questionnaires about your feelings, sleep, and overall well-being. They might also ask to collect a saliva sample or for you to wear a device that tracks your heart rate. The first few follow-ups will be more frequent – at 2 weeks, 1 month, 6 weeks, and 3 months. After that, you'll have check-ups at 6 months and 12 months. This allows the researchers to carefully monitor any changes over time and understand the long-term effects.

Potential risks and benefits

Taking part in this study may or may not directly benefit you. The hydrocortisone treatment being studied is still in its early stages of research, so it's not yet known if it will help reduce PTSD symptoms. There's also a chance you could receive the placebo, which has no active medicine. Like all medications, hydrocortisone can have side effects, and the study team will fully explain any known risks to you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care, and your decision will be respected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is PTSD?

PTSD, or Post-Traumatic Stress Disorder, is a condition that can develop after someone experiences a very frightening, shocking, or dangerous event. Symptoms can include nightmares, flashbacks, and feeling on edge.

What is hydrocortisone?

Hydrocortisone is a type of steroid hormone that our bodies naturally produce. It helps control stress, inflammation, and many other body functions. In this study, a low dose is being tested to see if it helps with trauma.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks exactly like the real medicine but contains no active ingredients. It's used in studies to compare the effects of the actual medicine against no treatment.

How long will the study last?

If you take part, your involvement in the study will last for about 12 months in total, with several check-ups during that time.

Will I know if I'm getting the real medicine?

No, you won't know if you're receiving the hydrocortisone or the placebo. This is to make sure the study results are as unbiased as possible.