Feeling Safer
Research type
Research Study
Full title
Feeling Safer: A Cohort Study and a Randomised Controlled Trial of a Guided Online Programme for the Treatment of Persecutory Delusions
IRAS ID
330744
Contact name
Daniel Freeman
Contact email
Sponsor organisation
University of Oxford Research Governance, Ethics and Assurance
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
Background:
Persecutory delusions (inaccurate beliefs that others intend to harm you) are very common in mental health conditions such as schizophrenia.
Existing treatments often don’t work well enough. This is why we developed the Feeling Safe programme. We recently tested Feeling Safe 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.
The challenge now is to make Feeling Safe widely available. So, we have created a six-month guided online version. A range of mental health workers can support the delivery of the treatment. The new programme is called Feeling Safer.
Aim:
By providing Feeling Safe in an accessible version, we aim to achieve substantially improved outcomes for the large number of people with persecutory delusions who have not responded sufficiently to current treatment. We now wish to assess the effectiveness of Feeling Safer.
Methods:
The project has four elements:
1. Initial clinical testing. 15 patients with persecutory delusions will receive Feeling Safer. They will be assessed before and after completing the intervention. If there is evidence of improvement in the delusions then we will proceed to the full clinical trial.
2. Full clinical trial. Feeling Safer will be tested in a multi-centre randomised controlled trial. 484 patients with persecutory delusions will be randomised to one of four conditions: Feeling Safer (added to standard care) supported by peer support workers, or graduate mental health workers, or CBT therapists, or standard care.
3. In-depth interviews. We will also interview a smaller number of patients, Feeling Safer deliverers, and other mental health staff to learn more about the therapy and how it may be used in the NHS.
4. Cost-effectiveness. We will analyse the cost-effectiveness of using Feeling Safer.
REC name
London - Harrow Research Ethics Committee
REC reference
23/LO/0951
Date of REC Opinion
24 Nov 2023
REC opinion
Favourable Opinion