JMIR Publications

ABSTRACT

Background:

Evidence suggests that Digital Mental Health Interventions (DMHIs) for common mental health conditions can be effective. However, these digital interventions, like face-to-face therapies, pose risks to patients.

Objective:

Review the literature to assess how DMHIs are assessing safety, what risks are reported, and how they are mitigated both in research and post-market. To build on existing recommendations for assessing, reporting, and mitigating safety in DMHI and standardizing practice.

Methods:

Psycinfo, EMBASE, and Medline were searched for studies that address 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. Results were synthesized in the form of tables and percentages. We calculated odds ratios and confidence intervals, wherever published data permitted, to illustrate the use of a single common safety metric across studies.

Results:

Twenty-three studies were included in this review. While many of the included studies assessed safety by actively collecting adverse events data, over one third did not assess or collect any safety data. The methods and frequency of safety data collection varied widely and very few studies performed any formal statistical analyses. The main treatment-related reported adverse event was deterioration in symptoms. The main method used to mitigate risk was exclusion of high-risk groups. A secondary online search found that six DMHIs were available for users/patients to use (post-market), all of which used indications and contraindications for use to mitigate risk although there was no evidence of ongoing safety review.

Conclusions:

This review produced seven specific, measurable and achievable recommendations with the potential to bring immediate impact to the field, were they to be implemented across ongoing and future research. Beyond this, the review highlighted a pressing need for consensus-building research to standardize practice across a number of areas, including measurement, classification, analysis, interpretation and post-market refresh of safety. Improving the quality of DMHI safety data will allow meaningful assessment of the safety of DMHIs and confidence about whether the benefits of a new DMHI outweigh its risks. Clinical Trial: PROSPERO CRD42022333181.