Adverse Events of Psychological Interventions: Definitions, Assessment, Current State of the Research and Implications for Research and Clinical Practice.

BACKGROUND: The effectiveness of psychological interventions is undisputed. 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. This critical review summarizes the definition, assessment and current research status of AEs of psychological interventions. SUMMARY: AEs are defined as any untoward event or unfavorable change that occurs in the course of a psychological intervention. AEs that are caused by the intervention can be classified into side effects of correctly applied treatment, malpractice (i.e., incorrectly applied treatment) and unethical conduct (e.g., sexual abuse). Ideally, they are assessed by independent raters or alternatively by self-report questionnaires that should also cover serious adverse events (SAEs, e.g., suicide attempts or self-injurious behaviors). About 1 to 2 in 3 patients report at least 1 AE and results of meta-analyses suggest that treatments might differ in frequency and/or severity of AE and in treatment acceptability (measured as dropout rates). KEY MESSAGES: 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. Ideally, reducing AEs might also lead to more effective interventions.

App-Based Addiction Prevention at German Vocational Schools: Implementation and Reach for a Cluster-Randomized Controlled Trial.

This article examines the implementation, participation rates, and potential determinants of participation in the digital addiction prevention program "ready4life." A two-arm cluster-randomized trial recruited German vocational students via class-based strategies. Intervention group received 16 weeks of in-app coaching; the control group received health behavior information, with coaching offered after 12 months. Potential determinants of participation were analyzed based on class and individual characteristics. Out of 525 contacted schools, 35 participated, enrolling 376 classes. Implementation during the pandemic required flexible adjustments, with 49.7% of introductions conducted in person, 43.1% digitally via online streaming, and 7.2% received a video link via email. Despite challenges, 72.3% of the vocational students downloaded the app, and 46.7% gave informed consent. Participation rates were highest among (associate) professionals, vocational grammar school classes, classes introduced by females, younger individuals, members of the project team, and classes introduced face-to-face. Female gender, lower social competencies, lifetime cannabis use, higher problematic internet use, and higher perceived stress were associated with higher individual participation. The study highlights the importance of proactive outreach and personalized interventions for addiction prevention programs in vocational schools. While reached students aligned with the aims of the app, tailored recruitment strategies could enhance engagement among under-represented groups. The trial was registered in the German Clinical Trials Register (DRKS): DRKS00022328; registration date 09.10.2020.

Does childhood emotional abuse moderate the effect of cognitive behavioral analysis system of psychotherapy versus meta-cognitive therapy in depression? A propensity score analysis on an observational study.

Background Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and Metacognitive Therapy (MCT) are effective for depression. CBASP might offer most benefit in patients reporting childhood emotional abuse (CEA). This needs to be confirmed in real-world settings and in comparisons with depression-specific psychotherapies. This study examines the moderating influence of CEA on the effectiveness of CBASP versus MCT. Methods In this observational study, we recruited patients treated with either CBASP or MCT in an intensive day treatment program for depression. CEA was assessed using the Childhood Trauma Questionnaire (CTQ). Patients reported symptoms weekly using the Quick Inventory of Depressive Symptoms (QIDS-SR). Mixed model analysis was run on the Intention to Treat dataset (ITT) using propensity matching to overcome baseline imbalances. Results A total of 141 patients were included in the analysis (MCT n = 78, CBASP n = 63). CEA moderated the treatment effect (time x CEA x treatment: ß = 0.03, SE = 0.01, p = 0.014). Post-hoc analyses revealed that CBASP was more effective than MCT in patients without CEA (time x treatment: ß = -0.01, SE = 0.007, p = .045). The difference between CBASP and MCT was not statistically significant for patients with CEA (ß = 0.015, SE = 0.008, p = .11). Limitations Because of non-random treatment allocation the differences between CBASP and MCT can be due to unobserved baseline imbalances. Conclusions Our findings suggest that in patients reporting CEA, CBASP might not offer additional benefits above other depression-specific psychotherapies. Public Health Significance Statements This study shows that, on average, individuals with depression benefit equally from CBASP and MCT under the conditions of routine practice. Yet, CBASP was more effective than MCT for those without childhood emotional abuse. If childhood emotional abuse was present, CBASP and MCT were equally effective.

Investigating Care Dependency and Its Relation to Outcome (ICARE): Results From a Naturalistic Study of an Intensive Day Treatment Program for Depression.

Background: This study explores the association of experienced dependency in psychotherapy as measured with the CDQ (Care Dependency Questionnaire) and treatment outcome in depression. Furthermore, the course of care dependency and differences in the CDQ scores depending on the received type of treatment, MCT (metacognitive therapy), or CBASP (cognitive behavioral analysis system of psychotherapy), were investigated. Methods: The study follows a prospective, parallel group observational design. Patients suffering from depression received an 8-week intensive day clinic program, which was either CBASP or MCT. The treatment decision was made by clinicians based on the presented symptomatology and with regard to the patients' preferences. The patients reported depressive symptoms with the QIDS-SR16 (Quick Inventory of Depressive Symptomatology) and levels of experienced care dependency with the German version of the CDQ on a weekly basis. Mixed-model analyses were run to account for the repeated-measures design. Results: One hundred patients were included in the analyses. Results indicate that higher levels of care dependency might predict a less favorable outcome of depressive symptomatology. Levels of care dependency as well as depressive symptoms decreased significantly over the course of treatment. There was no significant between-group difference in care dependency between the two treatment groups. Conclusion: The results suggest that care dependency might be associated with a worse treatment outcome in depressed patients. In general, care dependency seems to be a dynamic construct, as it is changing over time, while the levels of care dependency seem to be independent from the received type of treatment. Future research should continue investigating the mechanisms of care dependency in a randomized controlled design. Clinical Trial Registration: https://www.drks.de/drks_web/, identifier: DRKS00023779.

Change in Interpersonal and Metacognitive Skills During Treatment With Cognitive Behavioral Analysis System of Psychotherapy and Metacognitive Therapy: Results From an Observational Study.

Background: Interpersonal skills deficits and dysfunctional metacognitive beliefs have been implicated in the etiology and maintenance of depression. This study aimed to investigate the association between changes in these skills deficits and change in depressive symptoms over the course of treatment with Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and Metacognitive Therapy (MCT). Methods: In this prospective, parallel group observational study, data was collected at baseline and after 8 weeks of an intensive day clinic psychotherapy program. Based on a shared decision between patients and clinicians, patients received either CBASP or MCT. Ninety patients were included in the analyses (CBASP: age M = 38.7, 40.5% female, MCT: age M = 44.7, 43.3% female). Interpersonal deficits were assessed with the short-form of the Luebeck Questionnaire for Recording Preoperational Thinking (LQPT-SF) and the Impact Message Inventory (IMI-R). Metacognitive beliefs were assessed with the Metacognition Questionnaire-30 (MCQ-30). The Quick Inventory of Depressive Symptomatology (QIDS-SR16) was utilized to assess depressive symptoms. A regression analysis was conducted to assess variables associated with outcome. ANCOVAs were utilized to investigate whether improvement in skills deficits is dependent on type of treatment received. Results: Improvements in preoperational thinking and increases in friendly-dominant behavior were associated with change in depressive symptoms. There was no association between reductions in dysfunctional metacognitive beliefs and a decrease in depressive symptoms. While both treatment groups showed significant improvements in interpersonal and metacognitive skills, there was no significant between-group difference in the change scores for either of these skills. Conclusion: Our findings suggest that changes in interpersonal skills seem to be of particular relevance in the treatment of depression. These results have to be replicated in a randomized-controlled design before firm conclusions can be drawn.