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Be Part of Research - Trial Details - Feeling Safer: a guided online programme for the treatment of severe paranoia

Feeling Safer: a guided online programme for the treatment of severe paranoia

Medical Conditions

Psychosis with a current persecutory delusion


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Persecutory delusions (inaccurate beliefs that others intend to harm you) (e.g. “MI5 and the police are trying to torture me” “My neighbours are out to get me and are spreading nasty gossip”) are very common in severe mental health disorders such as schizophrenia. People withdraw from everyday life. This seriously affects their mental and physical health.
Existing treatments often don’t work well enough. In the UK 150,000 NHS patients experience these distressing thoughts despite treatment. This is why the Feeling Safe programme has been developed. It is the outcome of 15 years of research and clinical practice. Feeling Safe was recently tested in a clinical trial with 130 patients with persistent persecutory delusions. The treatment was delivered by clinical psychologists over 20 sessions. Half of people achieved large benefits. Another quarter made moderate gains. These results provide great cause for optimism in the treatment of delusions.
The challenge now is to make Feeling Safe widely available. So, the study team have created a 6-month guided online version that users can access whenever they choose via smartphone/computer/or tablet. A range of mental health workers can support the delivery of the treatment over 6 months (both remotely and face-to-face). Six face-to-face sessions will be reserved for a key task: going out with patients into everyday situations to relearn safety. The new programme is called Feeling Safer.
By providing Feeling Safe in an accessible version for use across the NHS, the aim is to achieve substantially improved outcomes for the large number of people with persecutory delusions who have not responded sufficiently to current treatment. The study team now wish to assess the effectiveness of Feeling Safer. There is an initial cohort study of Feeling Safer, and then the main clinical trial that this trial registration confirms.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

25 Nov 2024 31 Jan 2026

Publications

2025 Protocol article in https://pubmed.ncbi.nlm.nih.gov/40480660/ (added 09/06/2025)

What does the study involve?
Participants will complete a set of questionnaires at baseline. Participants will then be randomly allocated to one of four groups. Three groups will receive Feeling Safer supported by either a peer support worker, graduate mental health worker, or CBT therapist, in addition to their usual care. The fourth group will continue to receive their usual care. All groups will then complete another set of questionnaires after 3, 6 and 9 months. Whether a person has Feeling Safer will be randomly decided by a computer (rather like flipping a coin).

What are the possible risks and benefits of participating?
The study team hope that using Feeling Safer will help people feel safer, happier, and to be more active. The research aims to find out whether this is the case. The study team do not anticipate any major risks from taking part. People can stop using the Feeling Safer programme if they wish. If the assessments are experienced as upsetting then it is possible to reduce the number of these or stop.

Where is the study run from?
University of Oxford (UK)

When is the study starting and how long is it expected to run for?
August 2023 to May 2027

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK) (NIHR PGfAR NIHR204013)

Who is the main contact?
1. Prof. Daniel Freeman, daniel.freeman@psy.ox.ac.uk
2. Dr Laina Rosebrock, laina.rosebrock@psy.ox.ac.uk


Patients (aged 16 years or older) with persecutory delusions in the context of a diagnosis of psychosis attending NHS mental health services.

You can take part if:



You may not be able to take part if:


1. A primary diagnosis of another mental health condition (e.g. substance use disorder) that would be the first clinical priority to treat2. Current engagement in any other intensive individual psychological therapy or a significant change in medication.3. In forensic settings or Psychiatric Intensive Care Unit (PICU)4. Command of spoken English inadequate for engaging in the therapy5. Significant learning difficulties that would prevent the completion of assessments or the therapy6. A participant may also not enter the trial if there is another factor (for example, current active suicidal plans that need to the focus of intervention), which, in the judgement of the investigator, would preclude the participant from providing informed consent or from safely engaging with the trial procedures


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Central and North West London NHS Foundation Trust
    Trust Headquarters 350 Euston Road Regents PLACE
    London
    NW1 3AX
  • Greater Manchester Mental Health NHS Foundation Trust
    Prestwich Hospital Bury New Road Prestwich
    Manchester
    M25 3BL
  • Avon and Wiltshire Mental Health Partnership NHS Trust
    Bath NHS House Newbridge Hill
    Bath
    BA1 3QE
  • Northamptonshire Healthcare NHS Foundation Trust
    St Marys Hospital 77 London Road
    Kettering
    NN15 7PW
  • Pennine Care NHS Trust
    225 Old Street
    Ashton-under-lyne
    OL6 7SR
  • Oxford Health NHS Foundation Trust
    Warneford Hospital Warneford Lane Headington
    Oxford
    OX3 7JH
  • Berkshire Healthcare NHS Trust Headquarters
    Skimped Hill Lane
    Bracknell
    RG12 1LH
  • Tees, Esk & Wear Valley NHS Trust
    West Park Hospital Edward Pease Way
    Darlington
    DL2 2TS
  • Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
    St. Nicholas Hospital Jubilee Road Gosforth
    Newcastle upon Tyne
    NE3 3XT
  • Coventry and Warwickshire Partnership NHS Trust
    Wayside House Wilsons Lane
    Coventry
    CV6 6NY

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.


The study is sponsored by University of Oxford and funded by National Institute for Health and Care Research.




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Read full details for Trial ID: ISRCTN93974770

Or CPMS 57021

Last updated 09 June 2025

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