Evidence map›Paper›PMID 40480660›Full record

ArticleBMJ open2025

Efficacy of a 6-month supported online programme (Feeling Safer) for the treatment of persecutory delusions: protocol for a randomised controlled trial.

Daniel Freeman, Richard Emsley, Laina Rosebrock, Anthony Morrison, Kate Chapman, Stephanie Common, Robert Dudley, Louise Isham, Thomas Kabir, Alex Kenny and 7 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Daniel FreemanDepartment of Experimental Psychology, University of Oxford, Oxford, UK daniel.freeman@psych.ox.ac.uk.ORCID http://orcid.org/0000-0002-2541-2197
Richard EmsleyDepartment of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Laina RosebrockDepartment of Experimental Psychology, University of Oxford, Oxford, UK.
Anthony MorrisonThe Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.
Kate ChapmanAvon and Wiltshire Mental Health Partnership NHS Trust, Bristol, UK.
Stephanie CommonTees, Esk and Wear Valleys NHS Foundation Trust, Stockton on Tees, UK.
Robert DudleyCumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle, UK.
Louise IshamDepartment of Experimental Psychology, University of Oxford, Oxford, UK.
Thomas KabirDepartment of Experimental Psychology, University of Oxford, Oxford, UK.
Alex KennyMcPin Foundation, London, UK.
Jason FreemanDepartment of Experimental Psychology, University of Oxford, Oxford, UK.
Ariane BeckleyDepartment of Experimental Psychology, University of Oxford, Oxford, UK.
Verity WestgateDepartment of Experimental Psychology, University of Oxford, Oxford, UK.
Natalie RouseDepartment of Experimental Psychology, University of Oxford, Oxford, UK.
José LealHealth Economics Research Centre, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Megan McGovernDepartment of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Felicity WaiteDepartment of Experimental Psychology, University of Oxford, Oxford, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPersecutory 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). METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: ISRCTN93974770.

Indexed as

Cognitive Behavioral TherapyDelusionsSchizophreniaAdultFemaleHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicSingle-Blind MethodTreatment OutcomeAdult psychiatryDigital TechnologyMENTAL HEALTHRandomized Controlled TrialSchizophrenia & psychotic disorders

Identifiers

PMID40480660
PMCPMC12161337

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.