Consensus statement on defining and measuring negative effects of Internet interventions

• Prior research of face-to-face treatment suggests that 5–10% of all patients experience negative effects in terms of deterioration, but other types of negative effects have been proposed to exist as well.
• There is insufficient knowledge concerning the occurrence and characteristics of negative effects in Internet interventions.
• Negative effects should be examined across treatment conditions in order to examine what types of negative effects exist, as well as to facilitate an analysis of causality.
• A uniform classification of negative effects is proposed to ease monitoring procedures and the process of reporting the results in scientific journals.
• Quantitative and qualitative measures are proposed in order to detect both deterioration and subjective experiences of negative effects during treatment.

Internet interventions have great potential for alleviating emotional distress, promoting mental health, and enhancing well-being. Numerous clinical trials have demonstrated their efficacy for a number of psychiatric conditions, and interventions delivered via the Internet will likely become a common alternative to face-to-face treatment. Meanwhile, research has paid little attention to the negative effects associated with treatment, warranting further investigation of the possibility that some patients might deteriorate or encounter adverse events despite receiving best available care. Evidence from research of face-to-face treatment suggests that negative effects afflict 5–10% of all patients undergoing treatment in terms of deterioration. However, there is currently a lack of consensus on how to define and measure negative effects in psychotherapy research in general, leaving researchers without practical guidelines for monitoring and reporting negative effects in clinical trials. The current paper therefore seeks to provide recommendations that could promote the study of negative effects in Internet interventions with the aim of increasing the knowledge of its occurrence and characteristics. Ten leading experts in the field of Internet interventions were invited to participate and share their perspective on how to explore negative effects, using the Delphi technique to facilitate a dialog and reach an agreement. The authors discuss the importance of conducting research on negative effects in order to further the understanding of its incidence and different features. Suggestions on how to classify and measure negative effects in Internet interventions are proposed, involving methods from both quantitative and qualitative research. Potential mechanisms underlying negative effects are also discussed, differentiating common factors shared with face-to-face treatments from those unique to treatments delivered via the Internet. The authors conclude that negative effects are to be expected and need to be acknowledged to a greater extent, advising researchers to systematically probe for negative effects whenever conducting clinical trials involving Internet interventions, as well as to share their findings in scientific journals.