Adverse events in psychotherapy randomized controlled trials: A systematic review.

Objective: Although evidence for benefits of psychotherapy is substantial, less is known about potential harm. Therefore, we systematically summarized randomized controlled trials (RCTs) to compile evidence-based data on the frequency and characteristics of adverse events (AEs) of psychotherapy. Method: This systematic review of result publications is based on a review of harm consideration in psychotherapy study protocols. Results: On the basis of 115 study protocols, 85 RCTs with 126 psychotherapy and 61 control conditions were eligible for inclusion. The sample consisted of 14,420 participants with the most common mental disorders. Harmful events, e.g., AEs, number of individuals with symptom deterioration, were explicitly reported in 60% of the studies. Conceptualization, recording, and reporting of AEs were heterogeneous. For most reported AEs, the association to study treatment remained unclear. Conclusions: 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. To allow a balanced risk/benefit evaluation of psychotherapy, systematic harm monitoring and reporting should become standard in psychotherapy RCTs.

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. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Adverse effects of psychotherapy: protocol for a systematic review and meta-analysis.

BACKGROUND: While it is well known that psychotherapy is efficacious in the treatment of mental disorders, much less is known about the adverse effects of psychotherapeutic interventions. The aim of this systematic review is to examine the definition, frequency, nature, and severity of adverse effects occurring parallel to or following psychotherapeutic treatment and to compare it against control groups. METHODS: All registered randomised controlled trials published since 2004 (publication year of harm-reporting extension of the CONSORT statement) with adult patients fulfilling clinical criteria of defined mental disorders, which compare individual or group psychotherapy against a control group, will be included. First, a search through international trial registers as well as a search in literature databases (e.g. MEDLINE) and in relevant journals (e.g. Trials) for study protocols will be conducted to identify eligible trials. In a second step, we will search for respective publications of the results of the eligible studies. Publications will be retrieved and screened for eligibility. Two previously trained, independent raters will extract the data in duplicate. Reporting of adverse effects will be descriptively analysed regarding frequency, heterogeneity, and longitudinal course. We will further compare the adverse effects of psychotherapeutic interventions against various control groups. For each categorical outcome, we will calculate relative risks (RR) together with 95% confidence intervals. For continuous outcomes, standardised mean differences (Hedges' g) with a 95% confidence interval will be computed. Between-study heterogeneity will be tested with the Q statistic and quantified using I2. DISCUSSION: Preselecting studies with regard to randomised controlled trials might induce bias due to dropout before the beginning of treatment or end of treatment. However, we will thoroughly assess the negative effects of randomisation, e.g. reasons for non-randomisation, if reported. Even if delayed adverse effects might be overlooked in randomised controlled trials, these are the only sources of causal evidence. SYSTEMATIC REVIEW REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews 2017: CRD42017055507 (17 January 2017).

The Efficacy of Body-Oriented Yoga in Mental Disorders­A Systematic Review and Meta-Analysis

BACKGROUND: The efficacy of body-oriented yoga in the treatment of mental disorders has been investigated in numerous studies. This article is a systematic review and meta-analysis of the relevant publications. METHODS: All studies in which the efficacy of hatha-yoga, i.e., body-oriented yoga with asanas and pranayama, was studied in adult patients suffering from a mental disorder (as diagnosed by ICD or DSM criteria) were included in the analysis. The primary endpoint was disorder-specific symptom severity. The publications were identified by a systematic search in the PubMed, Web of Science, PsycINFO and ProQuest databases, supplemented by a search with the Google Scholar search engine and a manual search in the reference lists of meta-analyses and primary studies, as well as in specialized journals. RESULTS: 25 studies with a total of 1339 patients were included in the analysis. A large and significant effect of yoga was seen with respect to the primary endpoint (symptom severity) (Hedges' g = 0.91; 95% confidence interval [0.55; 1.28]; number needed to treat [NNT]: 2.03), with substantial heterogeneity (I2 = 69.8%) compared to untreated control groups. Small but significant effects of yoga were also seen in comparison with attention control (g = 0.39; [0.04; 0.73]; NNT: 4.55) and physical exercise (g = 0.30; [0.01; 0.59]; NNT: 5.75); no difference in efficacy was found between yoga and standard psychotherapy (g = 0.08; [-0.24; 0,40]; NNT: 21.89). In view of the relatively high risk of bias, these findings should be interpreted with caution. CONCLUSION: Body-oriented yoga with asanas and pranayama as central components is a promising complementary treatment for mental disorders and should be investigated in further high-quality studies.