CompletedInterventional

Mindfulness for paranoia

This study is for people who experience paranoia (persecutory delusions) as part of schizophrenia. It's investigating if a specific type of group therapy, called mindfulness, can help improve their well-being. Mindfulness involves learning meditation techniques. Researchers want to see if this 10-week therapy can reduce feelings of distress and depression, improve overall mental health, and help people on their journey to recovery. Participants will either receive the mindfulness therapy alongside their usual medical care, or just their usual medical care. The study will compare how people in both groups feel over time. This will help understand if mindfulness therapy is truly helpful, who benefits most, and if it's a good use of NHS resources.

At a glance

Status

Completed

Sponsor

University of Southampton

Enrolment target

144

Start

01 Sep 2024

Estimated completion

01 Mar 2026

Paranoia

What is this study about?

Many people living with schizophrenia sometimes experience intense feelings of paranoia, known as persecutory delusions. This means they might feel strongly that others are trying to harm them, which can be very upsetting and lead to depression. Talking therapies that include mindfulness, a type of meditation practice focused on the present moment, are being explored as ways to help with mental health challenges.

Previous small studies have shown promising results, suggesting that mindfulness could be helpful for people experiencing these paranoid thoughts. For example, in an earlier study, most people who tried mindfulness therapy completed it, and many reported feeling less depressed afterward. These encouraging findings inspired a larger study, called a clinical trial, to thoroughly investigate if this therapy can indeed help people with schizophrenia and paranoia.

This new study aims to recruit 144 individuals. Half of them will receive the 10-week group mindfulness therapy in addition to their regular medical care, while the other half will continue with their usual care only. Participants will fill out questionnaires at different times to help researchers understand if the mindfulness therapy makes a difference. The goal is to see if it reduces distress and depression, improves mental well-being, and helps people move forward in their recovery. It will also help the NHS understand if this therapy is valuable.

Key takeaways

This study investigates mindfulness therapy for paranoia in schizophrenia.
It aims to reduce distress, depression, and improve mental well-being.
Participants will either get mindfulness therapy plus usual care, or usual care alone.
It's a randomized study, so you might not get the therapy.
There are few expected downsides, and your regular care continues.
The study helps understand if this therapy is truly beneficial for the NHS.

Who may be eligible?

This study is looking for adults aged 18 and over who have a diagnosis of schizophrenia (or are receiving early help for psychosis) and are currently experiencing distressing paranoid thoughts.

You should also be able to understand what the study involves and agree to take part freely. Your healthcare team will confirm if your paranoid thoughts are related to your diagnosis.

However, you won't be able to join if your symptoms have a clear physical cause that isn't related to schizophrenia, if you have a learning disability, or if there's a significant risk of you harming others. Your doctor will help determine if you fit these criteria.

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?
Do you have a diagnosis of schizophrenia or are you getting early help for psychosis?
Are you currently experiencing distressing paranoid thoughts?
Can you understand the study information and agree to take part yourself?
Do you have a learning disability? (If yes, you can't join.)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first complete some questionnaires. Following this, a secure online system will randomly decide whether you will receive a 10-week group mindfulness therapy alongside your regular medical care, or if you will continue with your regular care only. It's like flipping a coin – you'll have an equal chance of being in either group.

The group mindfulness therapy involves weekly sessions over 10 weeks. All participants, whether they receive the therapy or not, will be asked to fill out the same questionnaires at three points: at the very beginning of the study, again after the therapy period (around 10 weeks later), and then once more at a follow-up point to see how you are doing further down the line.

The study is expected to run from March 2024 to March 2027.

Potential risks and benefits

Since this is the first comprehensive study of mindfulness therapy for this specific group, we don't yet know for certain if it will be more helpful than standard care alone. However, previous small studies have shown promising results that suggest it might reduce depression. There are very few expected downsides to taking part, but we will carefully monitor everyone throughout the study for any concerns. It's important to know that talking about difficult thoughts and feelings in therapy can sometimes be challenging, but this is a normal part of the process, and the therapists are highly skilled and experienced in supporting you through this. You are free to withdraw from the study at any time, for any reason, without your medical care being affected.

Locations (3)

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

Hampshire and Isle of Wight Healthcare NHS Foundation Trust
City only
Southampton, England
Greater Manchester Mental Health NHS Foundation Trust
City only
Manchester, England
Pennine Care NHS Foundation Trust
City only
Ashton-under-lyne, England

Common questions

What is mindfulness?

Mindfulness is a type of meditation practice where you learn to focus on the present moment, kindly observing your thoughts and feelings without judgment.

Will I have to stop my usual medicines or treatments?

No, you will continue with your regular medical care throughout the study, whether you receive the mindfulness therapy or not.

How long will I be in the study?

The study involves filling out questionnaires at the start, after about 10 weeks, and then at a follow-up date. The mindfulness therapy itself lasts for 10 weeks if you are in that group.

Will I definitely get the mindfulness therapy?

No, because it's a 'randomised' study, you have a 50/50 chance of being in the group that receives the mindfulness therapy or the group that continues with usual care only.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR), a major research funder in the UK.

How to find out more

Lyn Ellett

l.a.ellett@soton.ac.uk +44 2380 599599 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.