TY - JOUR AU - Taher, Rayan AU - Hsu, Che-Wei AU - Hampshire, Chloe AU - Fialho, Carolina AU - Heaysman, Clare AU - Stahl, Daniel AU - Shergill, Sukhi AU - Yiend, Jenny PY - 2023 DA - 2023/10/9 TI - The Safety of Digital Mental Health Interventions: Systematic Review and Recommendations JO - JMIR Ment Health SP - e47433 VL - 10 KW - digital KW - digital therapeutics KW - mental health KW - psychological KW - safety KW - risk KW - negative effects KW - harm KW - adverse event KW - risk mitigation KW - mobile phone AB - 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. Trial Registration: PROSPERO CRD42022333181; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=333181 SN - 2368-7959 UR - https://mental.jmir.org/2023/1/e47433 UR - https://doi.org/10.2196/47433 UR - http://www.ncbi.nlm.nih.gov/pubmed/37812471 DO - 10.2196/47433 ID - info:doi/10.2196/47433 ER -