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Transdiagnostic App-Based Cognitive Bias Modification Intervention for Paranoia (Successful Treatment of Paranoia; STOP): Protocol for a Mixed Methods Process Evaluation Embedded in a Randomized Controlled Trial.

Λεπτομέρειες βιβλιογραφικής εγγραφής
Τίτλος: Transdiagnostic App-Based Cognitive Bias Modification Intervention for Paranoia (Successful Treatment of Paranoia; STOP): Protocol for a Mixed Methods Process Evaluation Embedded in a Randomized Controlled Trial.
Συγγραφείς: Hampshire C; Department of Psychology, University of Bath, Bath, United Kingdom., Dack C; Department of Psychology, University of Bath, Bath, United Kingdom., Eid L; Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom., Fialho C; Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom., Kenny A; McPin Foundation, London, England, United Kingdom., Scott H; Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom., Taher R; Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom., Taylor T; Department of Psychology, University of Bath, Bath, United Kingdom., Yiend J; Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom., Jacobsen P; Department of Psychology, University of Bath, Bath, United Kingdom.
Πηγή: JMIR research protocols [JMIR Res Protoc] 2025 Dec 22; Vol. 14, pp. e81167. Date of Electronic Publication: 2025 Dec 22.
Τύπος έκδοσης: Journal Article; Clinical Trial Protocol; Research Support, Non-U.S. Gov't
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: JMIR Publications Country of Publication: Canada NLM ID: 101599504 Publication Model: Electronic Cited Medium: Internet ISSN: 1929-0748 (Electronic) Linking ISSN: 19290748 NLM ISO Abbreviation: JMIR Res Protoc Subsets: MEDLINE
Imprint Name(s): Original Publication: Toronto : JMIR Publications
Ιατρικοί όροι (MeSH): Paranoid Disorders*/therapy , Paranoid Disorders*/psychology , Cognitive Behavioral Therapy*/methods , Mobile Applications*, Humans ; Randomized Controlled Trials as Topic ; Adult ; England
Περίληψη: Background: Paranoia (unfounded concerns that other people are deliberately trying to harm you) can be a distressing experience that impacts day-to-day functioning for many people. Digitally delivered interventions are a promising mode of treatment that can increase access to support and reach populations underserved by current provision. One such intervention is the Successful Treatment of Paranoia (STOP) intervention, which is a transdiagnostic self-administered smartphone app for paranoia that was evaluated in England for efficacy in a large, multisite randomized controlled trial. Although there is growing evidence regarding how STOP may work, little is known about the factors that influence its implementation during or after a trial. Understanding these factors is critical for supporting the future adoption of STOP and may inform the implementation of other digital mental health interventions.
Objective: This paper aims to describe the protocol for a process evaluation that will explore intervention implementation to understand how much, by whom, and under what circumstances STOP was used in a trial context and what factors might influence future implementation in routine practice.
Methods: We will conduct a mixed methods process evaluation informed by guidance published by the Medical Research Council in the United Kingdom and embedded in the main STOP efficacy randomized controlled trial, with the aim of understanding who agreed to try STOP, how they used STOP, and users' and health care professionals' views on factors that will affect future implementation, including barriers and facilitators. Process evaluation participants will include three samples: (1) STOP trial participants (randomized participants and nonrandomized referrals who agreed to try STOP), (2) individuals experiencing paranoia who participated in the Adult Psychiatric Morbidity Survey in England, and (3) health care professionals in England. We will use mixed methods data collected in the STOP trial (demographics, app use, recruitment data, and qualitative data exploring intervention acceptability from the perspectives of users and health care professionals) and demographic data from another paranoia population collected in the Adult Psychiatric Morbidity Survey.
Results: The STOP trial was completed in December 2024, having recruited 274 participants. The process evaluation received funding in winter 2023. As of December 2025, data analysis for process evaluation studies 2 and 3 is ongoing following preregistration in July 2025. Results are expected to be completed and submitted for publication by February 2027.
Conclusions: Findings from this process evaluation will help develop an evidence-based understanding of implementing STOP, including identifying suitable implementation strategies for posttrial delivery both inside and outside mental health services. Our findings will inform future iterations and the upscaling of STOP and may inform implementation of other self-administered digital mental health interventions.
Trial Registration: International Standard Registered Clinical/Social Study Number ISRCTN17754650; https://www.isrctn.com/ISRCTN17754650.
International Registered Report Identifier (irrid): DERR1-10.2196/81167.
(©Chloe Hampshire, Charlotte Dack, Laura Eid, Carolina Fialho, Alexandra Kenny, Hannah Scott, Rayan Taher, Theresa Taylor, Jenny Yiend, Pamela Jacobsen. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 22.12.2025.)
References: BMC Psychiatry. 2023 Aug 17;23(1):597. (PMID: 37592231)
JMIR Ment Health. 2025 Jan 20;12:e65246. (PMID: 39832352)
JMIR Res Protoc. 2025 Dec 22;14:e81167. (PMID: 41427643)
Front Psychiatry. 2019 May 10;10:344. (PMID: 31133906)
Implement Sci. 2022 Oct 29;17(1):75. (PMID: 36309746)
Internet Interv. 2023 Sep 28;34:100677. (PMID: 37808416)
Psychol Psychother. 2022 Sep;95(3):680-700. (PMID: 35445520)
Psychol Med. 2020 Apr;50(5):771-780. (PMID: 30947766)
Qual Health Res. 2018 Apr;28(5):824-831. (PMID: 29424274)
Clin Psychol Psychother. 2024 Jul-Aug;31(4):e3019. (PMID: 38940680)
Front Psychiatry. 2024 Sep 03;15:1382726. (PMID: 39290300)
J Adolesc. 2025 Apr;97(3):871-878. (PMID: 39748522)
BMC Public Health. 2024 Feb 2;24(1):348. (PMID: 38308213)
JMIR Ment Health. 2024 May 8;11:e57155. (PMID: 38717799)
Br J Psychiatry. 2005 May;186:427-35. (PMID: 15863749)
Psychol Med. 2011 May;41(5):923-36. (PMID: 20735884)
Trials. 2024 Dec 2;25(1):806. (PMID: 39623444)
Schizophr Res. 2024 Sep;271:206-219. (PMID: 39047309)
BMJ. 2015 Mar 19;350:h1258. (PMID: 25791983)
J Med Internet Res. 2019 Oct 24;21(10):e14366. (PMID: 31651400)
BMC Public Health. 2025 Jul 14;25(1):2450. (PMID: 40660205)
Schizophr Bull. 1987;13(2):261-76. (PMID: 3616518)
JMIR Hum Factors. 2023 Dec 8;10:e45453. (PMID: 38064256)
World Psychiatry. 2025 Jun;24(2):156-174. (PMID: 40371757)
Br J Psychiatry. 2013 Jun;202:419-27. (PMID: 23661767)
BMJ Ment Health. 2024 Dec 3;27(1):. (PMID: 39631828)
JMIR Hum Factors. 2025 Aug 7;12:e70181. (PMID: 40773747)
Lancet Psychiatry. 2016 Jul;3(7):685-92. (PMID: 27371990)
BMJ. 2021 Sep 30;374:n2061. (PMID: 34593508)
BMJ Open. 2022 Jan 31;12(1):e053945. (PMID: 35105631)
Psychol Med. 2023 Jul;53(10):4614-4626. (PMID: 35699135)
Curr Treat Options Psychiatry. 2023 Sep;10(3):119-135. (PMID: 38390026)
J Clin Epidemiol. 2012 Oct;65(10):1041-51. (PMID: 22910536)
BMC Med. 2016 Jun 24;14(1):96. (PMID: 27342217)
JMIR Res Protoc. 2021 Dec 7;10(12):e34591. (PMID: 34806990)
Actas Esp Psiquiatr. 2025 Mar;53(2):379-421. (PMID: 40071361)
Grant Information: MR/V027484/1 Medical Research Council (MRC)
Contributed Indexing: Keywords: digital mental health; implementation; implementation science; paranoia; process evaluation; randomized controlled trial; smartphone intervention
Molecular Sequence: ISRCTN ISRCTN17754650
Entry Date(s): Date Created: 20251222 Date Completed: 20251222 Latest Revision: 20260821
Update Code: 20260821
PubMed Central ID: PMC12770924
DOI: 10.2196/81167
PMID: 41427643
Βάση Δεδομένων: MEDLINE
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  Data: Transdiagnostic App-Based Cognitive Bias Modification Intervention for Paranoia (Successful Treatment of Paranoia; STOP): Protocol for a Mixed Methods Process Evaluation Embedded in a Randomized Controlled Trial.
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  Data: Background: Paranoia (unfounded concerns that other people are deliberately trying to harm you) can be a distressing experience that impacts day-to-day functioning for many people. Digitally delivered interventions are a promising mode of treatment that can increase access to support and reach populations underserved by current provision. One such intervention is the Successful Treatment of Paranoia (STOP) intervention, which is a transdiagnostic self-administered smartphone app for paranoia that was evaluated in England for efficacy in a large, multisite randomized controlled trial. Although there is growing evidence regarding how STOP may work, little is known about the factors that influence its implementation during or after a trial. Understanding these factors is critical for supporting the future adoption of STOP and may inform the implementation of other digital mental health interventions.<br />Objective: This paper aims to describe the protocol for a process evaluation that will explore intervention implementation to understand how much, by whom, and under what circumstances STOP was used in a trial context and what factors might influence future implementation in routine practice.<br />Methods: We will conduct a mixed methods process evaluation informed by guidance published by the Medical Research Council in the United Kingdom and embedded in the main STOP efficacy randomized controlled trial, with the aim of understanding who agreed to try STOP, how they used STOP, and users' and health care professionals' views on factors that will affect future implementation, including barriers and facilitators. Process evaluation participants will include three samples: (1) STOP trial participants (randomized participants and nonrandomized referrals who agreed to try STOP), (2) individuals experiencing paranoia who participated in the Adult Psychiatric Morbidity Survey in England, and (3) health care professionals in England. We will use mixed methods data collected in the STOP trial (demographics, app use, recruitment data, and qualitative data exploring intervention acceptability from the perspectives of users and health care professionals) and demographic data from another paranoia population collected in the Adult Psychiatric Morbidity Survey.<br />Results: The STOP trial was completed in December 2024, having recruited 274 participants. The process evaluation received funding in winter 2023. As of December 2025, data analysis for process evaluation studies 2 and 3 is ongoing following preregistration in July 2025. Results are expected to be completed and submitted for publication by February 2027.<br />Conclusions: Findings from this process evaluation will help develop an evidence-based understanding of implementing STOP, including identifying suitable implementation strategies for posttrial delivery both inside and outside mental health services. Our findings will inform future iterations and the upscaling of STOP and may inform implementation of other self-administered digital mental health interventions.<br />Trial Registration: International Standard Registered Clinical/Social Study Number ISRCTN17754650; https://www.isrctn.com/ISRCTN17754650.<br />International Registered Report Identifier (irrid): DERR1-10.2196/81167.<br /> (©Chloe Hampshire, Charlotte Dack, Laura Eid, Carolina Fialho, Alexandra Kenny, Hannah Scott, Rayan Taher, Theresa Taylor, Jenny Yiend, Pamela Jacobsen. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 22.12.2025.)
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  Data: BMC Psychiatry. 2023 Aug 17;23(1):597. (PMID: <searchLink fieldCode="PM" term="%2237592231%22">37592231)</searchLink><br />JMIR Ment Health. 2025 Jan 20;12:e65246. (PMID: <searchLink fieldCode="PM" term="%2239832352%22">39832352)</searchLink><br />JMIR Res Protoc. 2025 Dec 22;14:e81167. (PMID: <searchLink fieldCode="PM" term="%2241427643%22">41427643)</searchLink><br />Front Psychiatry. 2019 May 10;10:344. (PMID: <searchLink fieldCode="PM" term="%2231133906%22">31133906)</searchLink><br />Implement Sci. 2022 Oct 29;17(1):75. (PMID: <searchLink fieldCode="PM" term="%2236309746%22">36309746)</searchLink><br />Internet Interv. 2023 Sep 28;34:100677. (PMID: <searchLink fieldCode="PM" term="%2237808416%22">37808416)</searchLink><br />Psychol Psychother. 2022 Sep;95(3):680-700. (PMID: <searchLink fieldCode="PM" term="%2235445520%22">35445520)</searchLink><br />Psychol Med. 2020 Apr;50(5):771-780. (PMID: <searchLink fieldCode="PM" term="%2230947766%22">30947766)</searchLink><br />Qual Health Res. 2018 Apr;28(5):824-831. (PMID: <searchLink fieldCode="PM" term="%2229424274%22">29424274)</searchLink><br />Clin Psychol Psychother. 2024 Jul-Aug;31(4):e3019. (PMID: <searchLink fieldCode="PM" term="%2238940680%22">38940680)</searchLink><br />Front Psychiatry. 2024 Sep 03;15:1382726. (PMID: <searchLink fieldCode="PM" term="%2239290300%22">39290300)</searchLink><br />J Adolesc. 2025 Apr;97(3):871-878. (PMID: <searchLink fieldCode="PM" term="%2239748522%22">39748522)</searchLink><br />BMC Public Health. 2024 Feb 2;24(1):348. (PMID: <searchLink fieldCode="PM" term="%2238308213%22">38308213)</searchLink><br />JMIR Ment Health. 2024 May 8;11:e57155. (PMID: <searchLink fieldCode="PM" term="%2238717799%22">38717799)</searchLink><br />Br J Psychiatry. 2005 May;186:427-35. (PMID: <searchLink fieldCode="PM" term="%2215863749%22">15863749)</searchLink><br />Psychol Med. 2011 May;41(5):923-36. (PMID: <searchLink fieldCode="PM" term="%2220735884%22">20735884)</searchLink><br />Trials. 2024 Dec 2;25(1):806. (PMID: <searchLink fieldCode="PM" term="%2239623444%22">39623444)</searchLink><br />Schizophr Res. 2024 Sep;271:206-219. (PMID: <searchLink fieldCode="PM" term="%2239047309%22">39047309)</searchLink><br />BMJ. 2015 Mar 19;350:h1258. (PMID: <searchLink fieldCode="PM" term="%2225791983%22">25791983)</searchLink><br />J Med Internet Res. 2019 Oct 24;21(10):e14366. (PMID: <searchLink fieldCode="PM" term="%2231651400%22">31651400)</searchLink><br />BMC Public Health. 2025 Jul 14;25(1):2450. (PMID: <searchLink fieldCode="PM" term="%2240660205%22">40660205)</searchLink><br />Schizophr Bull. 1987;13(2):261-76. (PMID: <searchLink fieldCode="PM" term="%223616518%22">3616518)</searchLink><br />JMIR Hum Factors. 2023 Dec 8;10:e45453. (PMID: <searchLink fieldCode="PM" term="%2238064256%22">38064256)</searchLink><br />World Psychiatry. 2025 Jun;24(2):156-174. (PMID: <searchLink fieldCode="PM" term="%2240371757%22">40371757)</searchLink><br />Br J Psychiatry. 2013 Jun;202:419-27. (PMID: <searchLink fieldCode="PM" term="%2223661767%22">23661767)</searchLink><br />BMJ Ment Health. 2024 Dec 3;27(1):. (PMID: <searchLink fieldCode="PM" term="%2239631828%22">39631828)</searchLink><br />JMIR Hum Factors. 2025 Aug 7;12:e70181. (PMID: <searchLink fieldCode="PM" term="%2240773747%22">40773747)</searchLink><br />Lancet Psychiatry. 2016 Jul;3(7):685-92. (PMID: <searchLink fieldCode="PM" term="%2227371990%22">27371990)</searchLink><br />BMJ. 2021 Sep 30;374:n2061. (PMID: <searchLink fieldCode="PM" term="%2234593508%22">34593508)</searchLink><br />BMJ Open. 2022 Jan 31;12(1):e053945. (PMID: <searchLink fieldCode="PM" term="%2235105631%22">35105631)</searchLink><br />Psychol Med. 2023 Jul;53(10):4614-4626. (PMID: <searchLink fieldCode="PM" term="%2235699135%22">35699135)</searchLink><br />Curr Treat Options Psychiatry. 2023 Sep;10(3):119-135. (PMID: <searchLink fieldCode="PM" term="%2238390026%22">38390026)</searchLink><br />J Clin Epidemiol. 2012 Oct;65(10):1041-51. (PMID: <searchLink fieldCode="PM" term="%2222910536%22">22910536)</searchLink><br />BMC Med. 2016 Jun 24;14(1):96. (PMID: <searchLink fieldCode="PM" term="%2227342217%22">27342217)</searchLink><br />JMIR Res Protoc. 2021 Dec 7;10(12):e34591. (PMID: <searchLink fieldCode="PM" term="%2234806990%22">34806990)</searchLink><br />Actas Esp Psiquiatr. 2025 Mar;53(2):379-421. (PMID: <searchLink fieldCode="PM" term="%2240071361%22">40071361)</searchLink>
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            – Type: issn-electronic
              Value: 1929-0748
          Numbering:
            – Type: volume
              Value: 14
          Titles:
            – TitleFull: JMIR research protocols
              Type: main
ResultId 1