Psychological support for fears about other people
Research type
Research Study
Full title
Psychological support for fears about other people: A comparison of the Feeling Safe Programme to befriending.
IRAS ID
186095
Contact name
Daniel Freeman
Contact email
Sponsor organisation
Buckinghamshire NHS Trust
Duration of Study in the UK
4 years, 9 months, 1 days
Research summary
Persecutory delusions (strong unfounded fears that others intend harm) occur in over 70% of patients with schizophrenia. This major psychotic experience is a key treatment target, but many patients do not respond adequately to current treatments. A much more efficacious, easily useable psychological intervention for persecutory delusions is required.
The applicant has developed a theoretical model of persecutory delusions. At the core of the delusion is a belief of being unsafe, developed in the context of genetic and environmental risk, that is maintained by disrupted sleep, worrying, negative beliefs about the self, reasoning biases, and avoidance of others. The delusion diminishes if maintaining factors are reduced and the patient is then enabled to relearn that they are safe. The applicant and colleagues have developed and evaluated brief intervention modules each targeting a maintaining factor. These modules need to be tested together as a full treatment.
The target is recovery in persistent delusions for 50% of patients. The key question asked is: Does the new treatment (called the Feeling Safe Programme) lead to greater recovery in persecutory delusions, psychological well-being, and activity levels compared to befriending (i.e. controlling for the time spent with a therapist)?The study is a randomised controlled trial for 150 patients who have persecutory delusions despite previous treatment i.e. the group most at need. Patients will be randomised to The Feeling Safe Programme or befriending (both provided over six months). Medication prescription will continue as usual. Assessments, by a rater blind to allocation, will be conducted at 0, 6 (post treatment), and 12 months. All main analyses will be intention-to-treat. A small number of qualitative interviews will also be carried out to determine views of the intervention and implementation.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0508
Date of REC Opinion
28 Sep 2015
REC opinion
Further Information Favourable Opinion