Defining and Assessing Adverse Events and Harmful Effects in Psychotherapy Study Protocols: A Systematic Review

The assessment of safety data has become a standard across many clinical interventions. The aim of this systematic review is to investigate the extent to which harm is addressed within psychotherapy study protocols. The review includes study protocols of randomized controlled trials published between 2004 and 2017 investigating the effects of psychotherapy in adult patients with affective disorders, phobia, anxiety, obsessive-compulsive disorder, posttraumatic stress disorder, and/or personality disorders. We conducted a systematic search in the CENTRAL, Medline, PsycINFO, and Web of Science databases as well as in relevant journals. In total, 115 study protocols were included, examining 168 psychotherapy and 85 control conditions. These protocols differed considerably in the way they conceptualized harm: 77 explicitly addressed harm, 62 considered serious adverse events, and 39 considered adverse events. Although serious adverse events were defined somewhat consistently, adverse events were not. Our results imply that clinical researchers do not apply standardized approaches with regard to harm concepts, assessment, and management. To gather data on frequencies of harmful effects, we argue a higher degree of standardization would be useful. Feasible recommendations are provided based on examples of good practice from the reviewed study protocols. Clinical Impact StatementQuestion: How are potential adverse events (AEs) and harmful effects dealt with in published psychotherapy study protocols? This review specifically aimed at (a) identifying common terms and definitions of harm in psychotherapy, (b) reviewing common practices for assessing harm, (c) determining whether assessment practices have changed over time or differed between bona fide and non-bona fide treatments, and (d) examining strategies for harm management. Findings: The analysis of 115 study protocols showed that the extent to which harm is considered varied greatly. AE and serious adverse event (SAE) were found to be the most commonly implemented concepts. AE definitions in particular differed in some relevant aspects. Adopting the medically influenced SAE definition sometimes raises the question of significance and meaning for the psychotherapy context. At least in some aspects, harm consideration increased in recent years. Although there was little consensus with regard to harm assessment and management, we provide a collection of promising approaches and suggestions for future standards.