Abstract
Background: Evidence suggests that digital mental health interventions (DMHIs) for common mental health conditions are effective. However, digital interventions, such as face-to-face therapies, pose risks to patients. A safe intervention is considered one in which the measured benefits outweigh the identified and mitigated risks.
Objective: This study aims to review the literature to assess how DMHIs assess safety, what risks are reported, and how they are mitigated in both the research and postmarket phases and building on existing recommendations for assessing, reporting, and mitigating safety in the DMHI and standardizing practice. Methods: PsycINFO, Embase, and MEDLINE databases were searched for studies that addressed the safety of DMHIs. The inclusion criteria were any study that addressed the safety of a clinical DMHI, even if not as a main outcome, in an adult population, and in English. As the outcome data were mainly qualitative in nature, a meta-analysis was not possible, and qualitative analysis was used to collate the results. Quantitative results were synthesized in the form of tables and percentages. To illustrate the use of a single common safety metric across studies, we calculated odds ratios and CIs, wherever possible.
Results: Overall, 23 studies were included in this review. Although many of the included studies assessed safety by actively collecting adverse event (AE) data, over one-third (8/23, 35%) did not assess or collect any safety data. The methods and frequency of safety data collection varied widely, and very few studies have performed formal statistical analyses. The main treatment-related reported AE was symptom deterioration. The main method used to mitigate risk was exclusion of high-risk groups. A secondary web-based search found that 6 DMHIs were available for users or patients to use (postmarket phase), all of which used indications and contraindications to mitigate risk, although there was no evidence of ongoing safety review.
Conclusions: The findings of this review show the need for a standardized classification of AEs, a standardized method for assessing AEs to statically analyze AE data, and evidence-based practices for mitigating risk in DMHIs, both in the research and postmarket phases. This review produced 7 specific, measurable, and achievable recommendations with the potential to have an immediate impact on the field, which were implemented across ongoing and future research. Improving the quality of DMHI safety data will allow meaningful assessment of the safety of DMHIs and confidence in whether the benefits of a new DMHI outweigh its risks.
| Original language | English |
|---|---|
| Article number | e47433 |
| Journal | JMIR mental health |
| Volume | 10 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 9 Oct 2023 |
Bibliographical note
Funding Information:The authors thank Dr Charlotte Hall and Dr Aislinn Gómez Bergin from the National Institute for Health and Care Research (NIHR) MindTech MedTech Co-operative and the University of Nottingham Biomedical Research Centre for their comments on an earlier draft of this manuscript. This work was supported by the Medical Research Council Biomedical Catalyst: Developmental Pathway Funding Scheme (DPFS), MRC Reference: MR/V027484/1. The authors would also like to express their gratitude to the NIHR Biomedical Research Centre hosted in South London and Maudsley National Health Service (NHS) Foundation Trust in partnership with King’s College London. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, Department of Health and Social Care, the Economic and Social Research Council, or King’s College London. Finally, the authors gratefully acknowledge the contributions made to this work by the STOP study Lived Experience Panel, supported by Dr Thomas Kabir and the McPin Foundation.
ASJC Scopus subject areas
- Psychiatry and Mental health
