STOP- Successful Treatment of Paranoia

• Research type

  Research Study

• Full title

  STOP- Successful Treatment Of Paranoia: Replacing harmful paranoid thoughts with better alternatives

• IRAS ID

  303876

• Contact name

  Jenny Yiend

• Contact email

  jenny.yiend@kcl.ac.uk

• Sponsor organisation

  King's College London

• ISRCTN Number

  ISRCTN17754650

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  3 years, 0 months, 0 days

• Research summary

  Psychosis is one of the most disabling mental health condition, associated with distress and impairment in work, family and social functioning. Many people with psychosis continue to have paranoid beliefs, despite the best treatments available.

  STOP is a mobile app self-administered psychological procedure that has been developed by combining basic research on biases in paranoia with established intervention techniques and builds on promising feasibility study data, IRAS ID 187338.

  Participants read stories on a computer screen, complete missing words and answer a question about each story in a way that encourages more helpful beliefs about themselves and others. STOP encourages people to develop alternative ways of interpreting paranoid thoughts (i.e. “someone is watching me”), leading participants to change their understanding of what these situations might mean.

  Preliminary research shows that, after one session, people with paranoia display a range of helpful effects, including significant belief change, and less distress in ambiguous social situations. Feasibility testing over 6 sessions showed the currently proposed RCT to be feasible and suggested belief change and reduced symptoms. The present 3 arm RCT will randomise patients to 6 or 12 sessions of STOP or an active control, in addition to usual treatment. Patients will be assessed at baseline, 6, 12, 18 and 24 weeks post randomisation on a range of outcome measures including paranoia symptom change, belief change, and user-endorsed measures of recovery. 273 participants will be randomised across two study sites, London and Bath.

  The overall aim is to test whether STOP could be an effective treatment for paranoia and identify an optimum dose (number of sessions). If efficacious STOP would have a number of potential advantages over other approaches, including, minimal effort to complete, no homework, no therapist, and accessibility.

  Lay summary of study results: A total of 274 people took part in the STOP trial, and they had a range of different mental health difficulties. They were split into three groups: 92 people used the STOP app for 6 weeks, 90 used it for 12 weeks, and 92 were in the control group. By the 24-week check-in, 85% of participants had completed the main follow-up. Most people engaged with the treatment as planned (85%). Minor adverse events were similar across all groups, and the 13 serious adverse events (2 in the control group, 7 in the 6-week group, and 4 in the 12-week group) were not caused by the app. People using the app for 12 weeks showed the biggest improvement in symptoms, with some improvement also seen in the 6-week group, compared to the control. A full report of the main results will be available on the STOP website (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.stoptrial.co.uk%2F&data=05%7C02%7Cstanmore.rec%40hra.nhs.uk%7C3458e52916a44a23221f08ddc47cf048%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638882763077222198%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=aaCUo3Yv1q8p8%2Fj9LMk59NP9Jv3o5YVe7kprUUtgJuM%3D&reserved=0) as a peer-reviewed open access paper.
  Has the registry been updated to include summary results?: Yes
  If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fdoi.org%252F10.1186%252FISRCTN17754650%2FNBTI%2F3be_AQ%2FAQ%2Fe30be387-956d-43e4-80d0-2758043dd830%2F3%2FdCgOJJGJCj&data=05%7C02%7Cstanmore.rec%40hra.nhs.uk%7C3458e52916a44a23221f08ddc47cf048%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638882763077242985%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=UNVUdtypNkXfgAcDRs%2BdA5tUPyzXdUv97g5qNUGY39w%3D&reserved=0
  If no – why not?:
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: Yes. Preparation of manuscript drafts for peer-reviewed scientific journals are under review by co-authors. The Chief Investigator is attending one international and one UK conference in 2025 to disseminate study results. Once available, all study publications will be available via the STOP trial website via open access links.
  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Pending
  If yes, describe and/or provide URLs to materials shared and how they were shared:
  If pending, date when feedback is expected: 28/02/2026
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: Yes
  If yes, describe or provide URLs to how it has been shared: Yes. Fully anonymised main outcome data has been deposited with the UK Data Archive here: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Freshare.ukdataservice.ac.uk%252F857941%252F.%2FNBTI%2F3be_AQ%2FAQ%2Fe30be387-956d-43e4-80d0-2758043dd830%2F4%2FdVyjD2fhQx&data=05%7C02%7Cstanmore.rec%40hra.nhs.uk%7C3458e52916a44a23221f08ddc47cf048%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638882763077265260%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=YE3aGAw3lshcnhzLXBuAJ8rzkHCKqaLwrUyNJ1m3Adg%3D&reserved=0 Please note this link is under embargo until 31 Dec 2025
  If no, explain why sharing hasn't been enabled:
  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL:
  If no, explain why: Not applicable. No tissue samples were collected for this trial.
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• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  21/LO/0896

• Date of REC Opinion

  14 Jan 2022

• REC opinion

  Further Information Favourable Opinion