Accepted for/Published in: JMIR Mental Health
Date Submitted: Jun 23, 2025
Date Accepted: Oct 1, 2025
Adverse events of mood monitoring and ambulatory assessment in depression and bipolar disorder: a systematic review and meta-analysis
ABSTRACT
Background:
Mood monitoring and ambulatory assessment offers improvements in measuring mood and behaviour for mental health research and clinical practice. However, concerns about adverse effects and usability may hinder its implementation.
Objective:
This systematic review and meta-analysis assessed the prevalence of adverse events, barriers to use, facilitators to use and suggestions for improvement in quantitative mood monitoring studies in people with depression and bipolar disorder.
Methods:
We conducted a systematic review and meta-analysis (PROSPERO: CRD42023396473) of 77 quantitative studies using mood monitoring/ambulatory assessment in depression and bipolar disorder, assessing adverse events, barriers and facilitators to use, and suggestions for improvement. Adverse events data was pooled to identify prevalence.
Results:
Of 77 studies, 15 reported adverse events and 20 reported usability issues. Pooled prevalence (95%CI, P-value) of adverse events was 0.04 (0.03, 0.06; p <0.001). Specific adverse effects (95%CI, P-value) included increased burden/stress (0.04 (0.02, 0.07; p <0.001)), mood worsening (0.02 (: 0.01, 0.02; p=0.001)), self-harm (0.05 (-0.02, 0.10; p= 0.007)) and hospitalisation (0.06 (0.04, 0.09; p= 0.259)). The top two facilitators were perceived helpfulness and ease of use; top barriers included technical issues challenges and time-consuming; the top suggested improvement was personalisation.
Conclusions:
A small number of mood monitoring/ambulatory assessment users experience negative psychological effects, however we were unable to infer causality. Due to the severe under-reporting of adverse events, heterogeneity and publication bias in mood monitoring/ambulatory studies there was limited certainty in prevalence, duration and severity of these adverse events. More systematic monitoring of adverse events is needed to optimise safety and usability. Many mood monitoring protocols may require additional development to decrease adverse events and improve acceptability.
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