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

Sep 29, 2026

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Paranoia involves unfounded beliefs that others intend to harm you and can disrupt daily functioning. Digitally delivered treatments may expand access, and the Successful Treatment of Paranoia (STOP) smartphone app has been tested for efficacy in England. While evidence exists for how STOP might work, key implementation factors during and after trials remain unclear. This paper outlines a mixed methods process evaluation protocol to quantify usage, identify who used STOP and under what circumstances, and determine barriers and facilitators for future routine adoption.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages13

Reading Time33 min

AccessFree to download

Abstract

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JMIR RESEARCH PROTOCOLS Hampshire et al Protocol 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 | Chloe Hampshire 1, MSc; Charlotte Dack 1, PhD; Laura Eid2, DClinPsy; Carolina Fialho2, MSc; Alexandra Kenny3, BA; Hannah Scott2, PhD; Rayan Taher2, MSc; Theresa Taylor 1, DClinPsy; Jenny Yiend2, PhD; Pamela Jacobsen 1, DClinPsy, PhD | | --- | | 1Department of Psychology, University of Bath, Bath, United Kingdom
2Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, United Kingdom 3McPin Foundation, London, England, United Kingdom
Corresponding Author:
Pamela Jacobsen, DClinPsy, PhD Department of Psychology
University of Bath Claverton Down Bath, BA2 7AY United Kingdom Phone: 44 1225 385091
[Email:](Email: pcj25@bath.ac.uk)[ ](Email: pcj25@bath.ac.uk)[pcj25@bath.ac.uk](Email: pcj25@bath.ac.uk)
Abstract | 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. [https://www.researchprotocols.org/2025/1/e81167](https://www.researchprotocols.org/2025/1/e81167) XSL• FO RenderX JMIR Res Protoc 2025 | vol. 14 | e81167 | p. 1 (page number not for citation purposes) Conclusions: Findings from this process evaluation will help develop an evidence-base

FAQs

What is the STOP intervention and why is a process evaluation needed?

STOP is a transdiagnostic, self-administered smartphone app for paranoia. A process evaluation is needed because, although efficacy is established, implementation factors affecting how STOP is used during and after trials are not well understood.

Who will participate in the mixed methods process evaluation?

The evaluation includes three samples: STOP trial participants (randomized participants and nonrandomized referrals who agreed to try STOP), individuals from England experiencing paranoia who took part in the Adult Psychiatric Morbidity Survey, and health care professionals in England.

What outcomes are expected from the process evaluation?

The study aims to clarify intervention implementation by examining who used STOP, how it was used, and which barriers and facilitators influence future adoption, producing evidence-based implementation guidance for posttrial delivery.

Sep 29, 2026

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