Reporting of harms in randomized controlled trials of psychological interventions for mental and behavioral disorders: A review of current practice
"A total of 132 eligible trials were identified. Only 28 trials (21%) included information that indicated any monitoring of harms on patient level. Four (3%) of these trials provided a description of adverse events as well as the methods used for collecting these data. Five of the trials (4%) reported adverse events but did not give complete information about the method. An additional four reports (3%) briefly stated that no adverse events occurred, whereas 15 trials (11%) only provided information on deterioration or indicated monitoring of deterioration."
Mostly harmless? Clinical practice guidelines need further consideration of psychotherapy adverse effects
"Randomised controlled trial evidence on psychotherapy adverse effects is limited. This is problematic because clinicians must balance the benefits of treatment against the harms, and clinical decisions become skewed without data on adverse effects. We suggest that clinical practice guidelines should be more guarded about recommending psychotherapy and add consensus statements on adverse effects for informed consent and clinical decision-making."
2843 – The problem of side effects in psychotherapy: adverse treatment reactions or unwanted events
"The side effects of drugs are deemed so important that their pubblication are strictly regulated by national health agency. But no one agency requires such warnings connected to other mental health treatment including Psychotherapy. In contrast to all pharmacotherapy studies in groups of patients, there is precious little information about the safety of psychotherapeutic interventions, which are also, in some patients and in some instances, associated with adverse events that need to be noted."
Adverse events in psychotherapy randomized controlled trials: A systematic review
"Because the AE recording approaches of the individual studies differed substantially, results could only be compared to a limited extent. Consistent with other findings, this review demonstrates that AEs can be expected to affect more than one in ten participants. Serious AEs occurred more than in one in 21 participants in psychotherapy RCTs.[/url]
Adverse Events of Psychological Interventions: Definitions, Assessment, Current State of the Research and Implications for Research and Clinical Practice
"But while in other fields of health care the safety of interventions is studied alongside effectiveness, adverse events (AEs) have only recently been assessed in clinical studies of psychological interventions."
"Measures of AEs and SAEs as well as more nuanced descriptions of dropout should be included in all clinical studies of psychological interventions. If this happens, we might learn that psychological interventions differ with respect to AEs, SAEs and acceptability. As many psychological interventions are about equally effective, they might one day be chosen based on differences in their safety profile rather than their differential effectiveness."
Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review.
"Our results imply that clinical researchers do not apply standardized approaches with regard to harm concepts, assessment, and management."
Negative Effects of Psychological Treatments: An Exploratory Factor Analysis of the Negative Effects Questionnaire for Monitoring and Reporting Adverse and Unwanted Events
"In comparison to pharmacological research, studies involving psychological treatments seldom report the possibility of negative effects [14]. A recent review showed that only one-fifth of a large number of randomized controlled trials mentioned the occurrence of harm [15]."
