Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context

Rayan Taher¹, Palak Bhanushali¹, Stephanie Allan², Mario Alvarez-Jimenez^{3

4}, Heather Bolton⁵, Laura Dennison⁶, Brian E Wallace⁷, Heather D Hadjistavropoulos⁸, Charlotte L Hall⁹, Amy Hardy¹, Alasdair L Henry¹⁰, Sam Lane¹¹, Tess Maguire⁶, Adam Moreton¹², Talar R Moukhtarian¹³, Elvira Perez Vallejos⁹, Sukhi Shergill^{1

14}, Daniel Stahl¹⁵, Graham R Thew^{16

17}, Ladislav Timulak¹⁸, David van den Berg¹⁹, Noemi Viganò¹¹, Ben Wensley Stock²⁰, Katherine S Young^{11

21}, Jenny Yiend¹

Affiliations

¹ Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
² Institute of Health and Wellbeing, University of Glasgow, UK.
³ Centre for Youth Mental Health, University of Melbourne, Australia.
⁴ Orygen, Parkville, Australia.
⁵ Unmind, London, UK.
⁶ School of Psychology, University of Southampton, UK.
⁷ Calmsie, Warsaw, Poland.
⁸ Department of Psychology, University of Regina, Canada.
⁹ NIHR MindTech-MedTech Co-operative, NIHR Nottingham Biomedical Research Centre, School of Medicine, Institute of Mental Health, University of Nottingham, UK.
¹⁰ Big Health Ltd, London, UK.
¹¹ SilverCloud by Amwell, Boston, USA.
¹² ORCHA, Daresbury, UK.
¹³ Mental Health and Wellbeing Unit, Warwick Medical School, University of Warwick, UK.
¹⁴ Kent and Medway Medical School, Canterbury, UK.
¹⁵ Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
¹⁶ Department of Experimental Psychology, University of Oxford, UK.
¹⁷ Oxford Health NHS Foundation Trust, Oxford, UK.
¹⁸ School of Psychology, Trinity College Dublin, Ireland.
¹⁹ Department of Clinical Psychology, VU University and Amsterdam Public Health Research, Amsterdam, Netherlands.
²⁰ University of Oxford Medical Sciences Division, University of Oxford, UK.
²¹ Social Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.

PMID: 38828683
PMCID: PMC11363077
DOI: 10.1192/bjo.2024.713

Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context

Rayan Taher et al. BJPsych Open. 2024.

. 2024 Jun 3;10(4):e126.

doi: 10.1192/bjo.2024.713.

Authors

Affiliations

¹ Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
² Institute of Health and Wellbeing, University of Glasgow, UK.
³ Centre for Youth Mental Health, University of Melbourne, Australia.
⁴ Orygen, Parkville, Australia.
⁵ Unmind, London, UK.
⁶ School of Psychology, University of Southampton, UK.
⁷ Calmsie, Warsaw, Poland.
⁸ Department of Psychology, University of Regina, Canada.
⁹ NIHR MindTech-MedTech Co-operative, NIHR Nottingham Biomedical Research Centre, School of Medicine, Institute of Mental Health, University of Nottingham, UK.
¹⁰ Big Health Ltd, London, UK.
¹¹ SilverCloud by Amwell, Boston, USA.
¹² ORCHA, Daresbury, UK.
¹³ Mental Health and Wellbeing Unit, Warwick Medical School, University of Warwick, UK.
¹⁴ Kent and Medway Medical School, Canterbury, UK.
¹⁵ Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
¹⁶ Department of Experimental Psychology, University of Oxford, UK.
¹⁷ Oxford Health NHS Foundation Trust, Oxford, UK.
¹⁸ School of Psychology, Trinity College Dublin, Ireland.
¹⁹ Department of Clinical Psychology, VU University and Amsterdam Public Health Research, Amsterdam, Netherlands.
²⁰ University of Oxford Medical Sciences Division, University of Oxford, UK.
²¹ Social Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.

PMID: 38828683
PMCID: PMC11363077
DOI: 10.1192/bjo.2024.713

Abstract

Background: Digital Mental Health Interventions (DMHIs) that meet the definition of a medical device are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The MHRA uses procedures that were originally developed for pharmaceuticals to assess the safety of DMHIs. There is recognition that this may not be ideal, as is evident by an ongoing consultation for reform led by the MHRA and the National Institute for Health and Care Excellence.

Aims: The aim of this study was to generate an experts' consensus on how the medical regulatory method used for assessing safety could best be adapted for DMHIs.

Method: An online Delphi study containing three rounds was conducted with an international panel of 20 experts with experience/knowledge in the field of UK digital mental health.

Results: Sixty-four items were generated, of which 41 achieved consensus (64%). Consensus emerged around ten recommendations, falling into five main themes: Enhancing the quality of adverse events data in DMHIs; Re-defining serious adverse events for DMHIs; Reassessing short-term symptom deterioration in psychological interventions as a therapeutic risk; Maximising the benefit of the Yellow Card Scheme; and Developing a harmonised approach for assessing the safety of psychological interventions in general.

Conclusion: The implementation of the recommendations provided by this consensus could improve the assessment of safety of DMHIs, making them more effective in detecting and mitigating risk.

Keywords: Digital mental health interventions; MHRA; consensus; mental health; safety.

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Conflict of interest statement

None of the authors have any interests to declare, except A.L.H. who reports being employed by Big Health Ltd and is a shareholder in the company.

Figures

**Fig. 1**
A screenshot of the guide used to assist participants in round 3.

See this image and copyright information in PMC

References

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1. Medicines and Healthcare Products Regulatory Agency. Notify the MHRA about a Clinical Investigation for a Medical Device. UK Government, 2014. (https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-f...).

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Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context

Affiliations

Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

LinkOut - more resources

Full Text Sources

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