Project details

Summary

What is the study about?

Many people who experience psychosis have experienced distressing life events both in childhood and adulthood.

At the moment, talking therapy focused on managing the impact of trauma is recommended to help with these problems (called ‘trauma-focused’ therapy). Small studies have shown that this type of therapy is safe and can be helpful for people who also have problems such as voices, visions and sensations, or have worries about being unsafe or persecuted.

The STAR Trial is a large clinical trial led by King’s College London and hosted locally by researchers at C-TRU and the GMMH Psychosis Research Unit.

The STAR trial will follow this therapy approach on a larger scale. It will include 300 people, across 5 NHS areas in England. The first 16 months after we begin recruitment will be a pilot study, to make sure that the recruitment, the therapy and the assessments are going as planned. The trial aims to find out whether this therapy can help people feel better on a range of problems. If the therapy is found to be helpful, we will aim to make it more widely available on the NHS.

What are you trying to find out?

STAR is evaluating whether a talking therapy called trauma-focused cognitive behavioural therapy for psychosis (TF-CBTp) could help people with psychosis who also experience distressing symptoms of post-traumatic stress disorder (e.g. flashbacks, distressing and vivid memories of traumatic life events, feeling numb and ‘unreal’).

These post-traumatic symptoms are common in people with psychosis, but unfortunately they are often neglected by services. If eligible for the trial, participants will have a 50% chance of receiving nine months of therapy, as well as the opportunity to take part in additional paid studies exploring the impact of this intervention in more detail (for example using neuroimaging methods).

What did taking part involve?

This study is no longer looking for new participants but is still ongoing.

The therapy involves weekly sessions with a trained therapist for around 6 months, and then monthly sessions for 3 more months.

To test whether the therapy is helpful, half of the people taking part will receive the therapy in addition to their usual care and half will continue with their usual care only. This is decided randomly by a computer, with a 50/50 chance, like flipping a coin. We will then compare how the two study groups get on over a period of 2 years.

Participants met with a Research Worker at the beginning of the study and then after 4, 9 and 24 months to answer some questions about how you are currently doing. Each meeting will last between 2-2.5 hours. We also kept in touch by phone every 3 months between months 9 and 24.

Who was it for?

This study is no longer looking for new participants but is still ongoing.

People who:

• Are over the age of 18;
• Have experienced stressful or traumatic events (at least 1 month ago), which have had a lasting impact. This could include a difficult hospital admission or the events leading up to it;
• Have problems such as hearing, seeing or feeling things other people can’t, or have worries about being unsafe or persecuted, or other unshared or distressing beliefs;
• Have not had trauma-focused therapy in the last 3 months.

Why is it important? 

We hope that people receiving the therapy will find it helpful, although this cannot be guaranteed. The information may help us to support other people with similar problems. If trauma-focused therapy is shown to work, then we will aim to make it more widely available in NHS services in the future.

How can I find out more?

You can also find out more information on the project website here.

This study is no longer looking for new participants but is still ongoing. 

However, if you have questions for the research team, click the button below to email the research team:

Email the research team