Persecutory delusions are very common in severe mental health disorders such as schizophrenia. Existing treatments often do not work well enough. We developed a face-to-face theory-driven psychological intervention, called Feeling Safe, that produces very large reductions in persistent persecutory delusions. The challenge now is to make Feeling Safe widely available. So, we developed a 6-month supported online version, called Feeling Safer. The aim is an intervention that patients can easily access and use, reduces persecutory delusions and can be supported by a range of mental health professionals in less contact time than face-to-face therapy. Initial proof of concept testing of Feeling Safer was very encouraging. In a randomised controlled trial, we now plan to test whether Feeling Safer is efficacious for patients and can be successfully delivered by any of three different mental health staff groups (peer-support workers, graduate psychologists and cognitive behavioural therapy (CBT) therapists). We will also test whether Feeling Safer works equally across gender, age, ethnicity and cognitive functioning (moderation) and whether Feeling Safer works via the targeted psychological processes (mediation).
The study design is a multicentre, single-blind (outcome assessor), parallel, four-arm randomised controlled trial; 484 patients with persistent persecutory delusions will be randomised to one of the four conditions (1:1:1:1): Feeling Safer (added to treatment as usual (TAU)) supported by peer-support workers, or Feeling Safer (added to TAU) supported by graduate mental health workers including assistant psychologists, or Feeling Safer (added to TAU) supported by CBT therapists or TAU. Feeling Safer will be provided for 6 months with a staff member. Assessments will be conducted at 0, 3, 6 and 9 months by research assistants blind to group allocation. The primary outcome is severity of persecutory delusions at 6 months rated with the Psychotic Symptoms Rating Scale—Delusions. The secondary outcomes are other psychiatric symptoms (depression, anxiety, insomnia, agoraphobia and paranoia), psychological well-being, recovery, activity and health-related quality of life. Analysis will be conducted under a treatment policy strategy following the intention-to-treat principle, incorporating data from all participants including those who do not complete treatment. Moderation and mediation will be tested. A within-trial cost-effectiveness analysis will be conducted of Feeling Safer compared with TAU.
The trial has received ethical approval from the NHS Health Research Authority (23/LO/0951). Informed consent will be obtained from all participants. A key output will be an open-access publication in a peer-reviewed journal reporting on the clinical effectiveness of a high-quality supported online programme for the treatment of persecutory delusions that has the potential to be used at scale in mental health services.
To estimate the prevalence of dementia and mild cognitive impairment (MCI) in the older prisoner population in England and Wales and to establish risk of harm to self and others, activity of daily living needs and social networks of prisoners with likely MCI and dementia.
We screened 869 older prisoners (aged 50 years and older) using the Montreal Cognitive Assessment (MoCA). Participants testing positive on the MoCA (≤23) were interviewed using the Addenbrooke’s Cognitive Examination, Third Revision (ACE-III) and a range of standardised assessments were used to assess risks of externalised violence and of self-harm; activities of daily living needs; mental health needs; history and symptoms of brain injury (if applicable) and social networks.
The sample was drawn randomly from women’s prisons (n=10) and a representative range of adult men’s prisons (n=11) across England and Wales.
Participants were aged 50 or over and resident in one of the participating prison establishments on the study’s census day.
ACE-III.
We recruited 596 men and 273 women prisoners. Across the whole sample of older prisoners, the prevalence of dementia was 7.0% (95% CI 5.5%, 8.9%) (when weighted for sex and age), with the highest prevalence found among prisoners aged 70 years and older at 11.8% (95% CI 8.0%, 17.1%). The prevalence of dementia for men was 7.0% (95% CI 5.2%, 9.4%) and for women was 6.0% (95% CI 3.8%, 9.5%). Only two individuals (3%) who screened positively on the MoCA had a diagnosis of dementia in their prison healthcare notes, suggesting current under-recognition. The prevalence of MCI was 0.8% (95% CI 0.4% to 1.7%, weighted by age). Of those who screened positively on the MoCA, 32 (46%) participants had a high or very high risk of harm to self or others, and 70 (35%) had no friends with whom they could talk to about private matters or to call on for help (n=35, 50%).
Approximately 1020 older adults living in prison have symptoms of likely dementia, and service provision for this group is inadequate.