National Institute for Health and Care Research

The Recording of Adverse Events from Psychological Treatments in Clinical Trials: Evidence from a Review of NIHR-Funded Trials

Duggan et al. (2014) examine how adverse events and potential harms are identified and reported in clinical trials of psychological interventions.

The authors reviewed NIHR-funded clinical trials and found that adverse events were rarely reported in studies evaluating psychological treatments, despite growing recognition that such interventions can sometimes cause harm. They argue that existing adverse event frameworks were largely developed for drug trials and may be poorly suited to capturing harms specific to psychological therapies. The paper proposes a broader conceptualisation of harm, including sustained deterioration, increased symptoms, dependency, or negative impacts on relationships and functioning. Overall, the review highlights the need for more systematic monitoring and reporting of adverse events in psychological treatment research.

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