Adverse Events of Mood Monitoring and Ambulatory Assessment in Depression and Bipolar Disorder: Systematic Review and Meta-Analysis.

Background: Mood monitoring and ambulatory assessment offer improvements in measuring mood and behavior for mental health research and clinical practice. However, concerns about adverse effects and usability may hinder their implementation. Objective: This systematic review and meta-analysis assessed the prevalence of adverse events, barriers and facilitators to use, and suggestions for improvement in quantitative mood monitoring studies involving people with depression and bipolar disorder. Methods: We conducted a systematic review and meta-analysis of 77 quantitative studies that used mood monitoring or ambulatory assessment in depression and bipolar disorder, assessing adverse events, barriers and facilitators to use, and suggestions for improvement. Adverse events data were pooled to identify prevalence. Results: Of the 77 studies, 15 (19%) reported adverse events, and 20 (26%) reported usability issues. Pooled prevalence of adverse events was 0.04 (95% CI 0.03-0.06; P<.001). Specific adverse effects included increased burden or stress (0.04, 95% CI 0.02-0.07; P<.001), mood worsening (0.02, 95% CI 0.01-0.02; P=.001), self-harm (0.05, 95% CI-0.02 to 0.10; P=.007), and hospitalization (0.06, 95% CI 0.04-0.09; P=.26). The top facilitators were perceived helpfulness and ease of use, the top barriers included technical challenges and the time-consuming nature of the interventions, and the top suggested improvement was personalization. Conclusions: A small number of mood monitoring or ambulatory assessment users experienced negative psychological effects; however, we were unable to infer causality. Due to the severe underreporting of adverse events as well as heterogeneity and publication bias in the included studies, there was limited certainty in the prevalence, duration, and severity of these adverse events. More systematic monitoring of adverse events is needed to optimize safety and usability. Many mood monitoring protocols may require additional development to decrease adverse events and improve acceptability.