STOP- Successful Treatment Of Paranoia: Replacing harmful paranoid thoughts with better alternatives
Lead Research Organisation:
King's College London
Department Name: Psychosis Studies
Abstract
Paranoia is linked to several mental health conditions, including psychosis and leads to distress and impairment in work, family and social functioning. Recent advances in thinking suggest that treatments might be more effective if they focus on one particular symptom at a time and try to treat that rather than trying to treat the whole disorder in one go. This study proposes to develop and test a mobile app version of a new therapy for paranoia called CBM-pa. CBM-pa is a self-administered psychological therapy that has been developed by combining basic research on biases in paranoia with established techniques that can change these biases. CBM-pa is computerised and involves reading text that could be interpreted in a paranoid way (such as the stare of a stranger which could reflect harmful intentions). The therapy encourages readers to make the alternative interpretation (such as the stare reflecting harmless curiosity) by using word tasks and questions. A six-session version has been developed and a feasibility study has been completed with promising results. In year 1 of this study we will develop CBM-pa into a more accessible and engaging 12- session app for mobile phones, called STOP: Successful Treatment of Paranoia, by adding 6 newly created sessions. In years 2-4 we will give patients STOP alongside their usual treatment and compare this with a control condition where patients simply read text in the mobile app instead. The study uses a randomised controlled design and patients are recruited from two different UK sites. Participants will receive either 6 or 12 sessions of STOP and we will measure clinical symptoms immediately and at 3 and 6 months later. These treatment data will be compared with data from similar people who take part in a control condition (reading text in the app) and are assessed at the same times. The data will show us whether there are any beneficial effects of STOP and, if so, how long they last. We will also measure in more detail exactly how many sessions produce enough symptom reduction to be clinically useful.
Technical Summary
Paranoia is associated with a range of mental health conditions, including psychosis. The lifetime rate of psychotic disorders is 3.5%. Psychosis is one of the most disabling mental health conditions, associated with distress and impairment in work, family and social functioning. Recent advances favour targeted interventions, focussing on specific symptoms or mechanisms.This study proposes to develop and test the efficacy of an app version (STOP) of a novel intervetion for paranoia (CBM-pa). CBM-pa is a self-administered psychological procedure that has been developed by combining basic research on biases in paranoia with established CBM techniques. CBM-pa is computerised and involves reading text inviting paranoid interpretations, but then generating responses reflecting an alternative, non-paranoid interpretation. A six session version has been developed and a feasibility study has been completed with promising results. In this proposal (year 1) we will develop CBM-pa into a more accessible and engaging 12 session 'STOP' app for mobile phones, adding 6 newly created sessions. We will then (years 2-4) deliver STOP in addition to treatment as usual and compare it with a text reading control condition, conducting app-based outcome assessments after every session. As suggested in previous feedback, we now propose a 2 arm dose-finding study using a randomised controlled design conducted across two sites. Retrospective time series analysis will establish the minimum number of sessions required to achieve clinically significant reduction of paranoid symptoms. To add value at minimal cost, and to provide data required by potential investors, we will include a 3 and 6 month follow up to assess long term efficacy of 12 sessions. This design will establish both the minimum immediately effective dose of STOP plus the long term efficacy of 12 sessions when this promising intervention is delivered in a form suitable for widespread patient/public use.
Publications
Lam CLM
(2021)
Anxiety mediates the relationship between interpretation bias and paranoia in patients with persistent persecutory beliefs.
in Anxiety, stress, and coping
Shani R
(2021)
Personalized cognitive training: Protocol for individual-level meta-analysis implementing machine learning methods.
in Journal of psychiatric research
Yiend, J.
(2022)
STOP user guide - patients
Yiend, J.
(2022)
STOP user guide - researchers
Title | STOP Graphics, animations, and audio |
Description | The STOP therapy and active control condition comprises 12 x 40-item therapy sessions or control sessions. Each item is a short 3 line scenario which is illustrated with either static or animated (series of static images or GIF) pictures. These pictures have been individually created to reflect the unique content of every item. There are A proportion of the items are additionally augmented with audio to match the content of the scenario. In addition 4 illustrated trivia are interspersed among every session, to give 96 (12 x 4 x 2) trivia pieces. |
Type Of Art | Artwork |
Year Produced | 2021 |
Impact | Enhancement and improved engagement in content of therapy/ control |
Description | AdVERse evenTs (AVERT Project) Guideline Development Group. |
Geographic Reach | National |
Policy Influence Type | Participation in a guidance/advisory committee |
Description | Digital Mental Health Interventions: Design, Efficacy, Personalisation and Implementation |
Geographic Reach | Europe |
Policy Influence Type | Influenced training of practitioners or researchers |
Impact | Publicized the clinical trial to mental healthcare professionals working within the field by presenting a symposium on digital mental health and including the STOP trial at this international conference. |
URL | http://online.eabct2023.org/hibrit/index.asp?p=bilimsel-program&islem=sorgula |
Description | MHRA/NICE (Wellcome Trust funded) project exploring effective regulation and evaluation of digital mental health technology, the MHRA are hosting two virtual roundtable discussions specific to digital mental health technologies. Roundtable One - Professional Focus - Tuesday 16th January 12 - 1:30pm. |
Geographic Reach | National |
Policy Influence Type | Contribution to a national consultation/review |
Impact | MHRA/NICE (Wellcome Trust funded) project exploring effective regulation and evaluation of digital mental health technology,. New national guidelines will be produced as part of this consultation exercise. |
URL | https://www.gov.uk/government/news/mental-health-funding-of-18m-welcomed-by-mhra-and-nice-to-explore... |
Description | STOP - Successful Treatment of Paranoia: Replacing harmful paranoid thoughts with better alternatives |
Geographic Reach | National |
Policy Influence Type | Influenced training of practitioners or researchers |
Impact | Publicized the clinical trial to mental healthcare professionals working within the field by presenting the planned study at a national event. Fialho, C., Maleviti, Aglaia., Hsu, C. W., Hampshire, C., Stahl, D., Mouchlianitis, E., Peters, E., Vamvakas, G., Keppens, J., Jacobsen, P., McGuire, P., Taher, R., Shergill, S., North, T., Ricci, T., Kabir, T., & Yiend, J. (2022, July 20-23). STOP - Successful Treatment of Paranoia: Replacing harmful paranoid thoughts with better alternatives [Open paper symposium]. British Association for Behavioural & Cognitive Psychotherapies, London, UK. |
URL | https://babcp2022.org/symposia/ |
Description | Agile Workforce Support |
Amount | £9,000 (GBP) |
Organisation | UK Clinical Research Network (UKCRN) |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 05/2023 |
End | 03/2024 |
Description | CRN Contingency Fund |
Amount | £19,590 (GBP) |
Organisation | UK Clinical Research Network (UKCRN) |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 08/2023 |
End | 03/2024 |
Description | Commerical Development Fund |
Amount | £45,040 (GBP) |
Funding ID | 1122436 |
Organisation | King's College London |
Sector | Academic/University |
Country | United Kingdom |
Start | 03/2023 |
End | 09/2023 |
Description | Digital Therapies Theme |
Amount | £43,000,000 (GBP) |
Funding ID | NIHR203318 |
Organisation | Kings BRC |
Sector | Academic/University |
Country | United Kingdom |
Start | 12/2022 |
End | 11/2027 |
Title | Health Machine STOP study interface |
Description | Clinical trial platform and integrated database to host, deliver and collect trial data direct from the mobile app. Includes registration of patients, randomisation, scheduling of sessions, collection of some trial outcome data, safety alerts, tracking of patient flow through the trial. |
Type Of Material | Database/Collection of data |
Year Produced | 2022 |
Provided To Others? | No |
Impact | Core component to deliver the clinical trial on the mobile app. |
URL | https://app.healthmachine.io/admin/login?locale=en |
Title | MACRO database for STOP clinical trial |
Description | CTU designed and hosted database of clinical trial data |
Type Of Material | Database/Collection of data |
Year Produced | 2022 |
Provided To Others? | No |
Impact | Database will house paper CRF data entries for all participants, and safety data. |
URL | https://ctu.co.uk/ |
Description | Dr Charlotte Hall and team |
Organisation | NIHR MindTech MedTech Co-operative |
Country | United Kingdom |
Sector | Public |
PI Contribution | 1. Collaborating to write an academic process/ methodology paper on the development of the Adverse events monitoring procedures that have been developed as part of the current grant. 2. Joining Nottingham University's NIHR-funded focus group work to develop expert guidance on the identification and classification of adverse event in mental health trials. |
Collaborator Contribution | 1. Commented on draft publication reporting a systematic review of digital mental health intervention (DMHI) safety. 2. Invited to join a forthcoming (October 2023) symposium organised by us on DMHI. 3. Joining our consensus study that seeks to evaluate clinician and user attitudes towards digital mental health safety |
Impact | None as yet |
Start Year | 2023 |
Description | Dr Melvyn Zhang |
Organisation | Nanyang Technological University |
Country | Singapore |
Sector | Academic/University |
PI Contribution | Organising an academic symposium |
Collaborator Contribution | Applying for international funding for collaborative work in global digital mental health |
Impact | None as yet |
Start Year | 2023 |
Description | KIng's 20 Accelerator - Spin Out Cohort (Entrepreneurship Institute) |
Organisation | King's College London |
Department | King's Commercialisation Institute |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Participating in all the activities and networking events laid on for the Accelerator participants to accelerate the impact of their work from concept to commercialisation. |
Collaborator Contribution | Schedule of weekly bootcamps & workshops to educate emerging innovators and entrepreneurs from within academia Dedicated Digital Health pathway covering topics of specific relevance to these products Physical bookable office space located in central London for networking and events Experts in residence for free consultation Lookbook portfolio to showcase ventures to VCs and Angel investors |
Impact | Discussions with would be investors for future support. |
Start Year | 2022 |
Description | McPin |
Organisation | McPin Foundation |
Country | United Kingdom |
Sector | Charity/Non Profit |
PI Contribution | Briefing on the proposed study design and content, including therapy. Receiving and acting upon feedback provided. |
Collaborator Contribution | Recruiting service users to an advisory panel; attending regular meetings; holding bespoke workshops as required |
Impact | Therapeutic and control content for the clinical trial - McPIn have provided feedback on content throughout the development process. Study materials - McPin have provided feedback on user facing documentation for the trial |
Start Year | 2021 |
Title | STOP logo iteration 2 |
Description | Previous logo evaluated by King's IP and licensing and reviewed by Commercialisation Committee for suitability for trademark registration. Team advised to change it by incorporating the orange stop sign within the "O" of "STOP" and removing the descriptor "Successful Treatment of Paranoia" which does not add anything. This increased the distinctive character of the mark as a whole and made it easier for to argue against an alleged likelihood of confusion with other "STOP" marks, should this be required. Formal screening search was conducted by King's IP and confirmed the risk of infringing third party marks in the UK with the new version is currently low. Team advised to use the TM symbol alongside the revised STOP logo. |
IP Reference | |
Protection | Trade Mark |
Year Protection Granted | 2022 |
Licensed | No |
Impact | Use of TM alongside the logo asserts that the STOP logo mark is exclusive to King's and acts as a deterrent to competitors |
Title | STOP (successful treatment of paranoia) mobile app |
Description | STOP (Successful Treatment of Paranoia) is a 12 session mobile therapeutic app intended to reduce symptoms of paranoia and the distress associated with these, in vulnerable adults. Final release of the app occurred in February 2022. Funded directly from the present grant (STOP- Successful Treatment Of Paranoia: Replacing harmful paranoid thoughts with better alternatives MRC Reference: MR/V027484/1) |
Type | Therapeutic Intervention - Medical Devices |
Current Stage Of Development | Early clinical assessment |
Year Development Stage Completed | 2022 |
Development Status | Under active development/distribution |
Impact | none as yet. The app will be used in the clinical trial supported by the current grant. |
Title | STOP therapy and control item content |
Description | 1) Therapy content: 240 items of therapeutic text, each item comprising an individual 3 line story with an associated word completion and question. Items arranged in an evidence based hierarchy, graded for paranoia severity and strength of belief challenge (operationalised through use of specific adverbs - e.g. think, assume, know) 2) As above but containing control content |
Type | Therapeutic Intervention - Psychological/Behavioural |
Current Stage Of Development | Early clinical assessment |
Year Development Stage Completed | 2022 |
Development Status | Under active development/distribution |
Impact | therapy is currently under evaluation |
Title | STOP mobile app - technical and functional documentation |
Description | STOP mobile app platform and technical specification to support the trial |
Type Of Technology | Webtool/Application |
Year Produced | 2022 |
Impact | The therapy and control conditions are available for use in the trial |
Description | STOP Spring Newsletter |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Study newsletter created with the McPin Foundation for dissemination of conference activity, recruitment progress and to motivate existing nationwide sites recruiting to the trial and to update STOP trial participants and other interested parties. |
Year(s) Of Engagement Activity | 2023,2024 |
URL | https://www.stoptrial.co.uk/_files/ugd/42e8b2_ca006bb578444801be4f7222e35220d4.pdf |
Description | STOP Video |
Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Study participants or study members |
Results and Impact | The STOP video illustrates the STOP therapy and shows what will be involved in taking part in the trial |
Year(s) Of Engagement Activity | 2021 |
URL | https://drive.google.com/file/d/11OBtU-35jTLXCWn0-YuCbMJLTZMUlRi9/view |
Description | STOP study Website |
Form Of Engagement Activity | Engagement focused website, blog or social media channel |
Part Of Official Scheme? | No |
Geographic Reach | Regional |
Primary Audience | Study participants or study members |
Results and Impact | Study website created and launched to promote launch of the STOP trial, facilitate recruitment of sites, patients, and clinicians and inform the wider academic community about the trial. |
Year(s) Of Engagement Activity | 2021,2022 |
URL | https://wix.to/1oewsS4? |
Description | Science Media Centre (Tom Sheldon) |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Media (as a channel to the public) |
Results and Impact | Expert reaction provided in response to NICE's announcement that 8 digitally enabled therapies to treat depression and anxiety in adults conditionally recommended [WEDNESDAY 1 MARCH 2023] 2 relevant URLs: https://www.bmj.com/content/380/bmj.p495 |
Year(s) Of Engagement Activity | 2023 |
URL | https://www.mirror.co.uk/news/uk-news/robots-treat-40000-depression-patients-29345698 |