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Negative effects of psychotherapy (NEP) include side effects, malpractice, and unethical behavior. Its setting-specific frequencies and predictors are mostly unknown. The two presented studies aim to investigate NEP and its predictors systematically across different treatment settings. In study 1, N = 197 patients of a German outpatient center were recruited, on average, 3.76 years after the termination of psychotherapy. In study 2, data from N = 118 patients of two German inpatient clinics were collected at admission ( t 0 ), discharge ( t 1 ), and 9-month follow-up ( t 2 ). All participants evaluated the negative effects of their previous out- or inpatient psychotherapy with the Inventory for the Balanced Assessment of Negative Effects in Psychotherapy and a priori hypothesized predictors. At least one side effect was reported by 37.3% of inpatients ( t 2 ) and 15.2% of outpatients. At least one case of malpractice and unethical behavior was reported by 28.8% of inpatients ( t 2 ) and 7.1% of outpatients. Inpatients reported significantly more side effects ( U = 14347, z = 4.70, p < 0.001, r = 0.26) and malpractice and unethical behavior ( U = 14168, z = 5.21, p < 0.001, r = 0.29) than outpatients. Rates of severe malpractice in the form of breaking confidentiality and physical and sexual abuse were less than 1% in both settings. Predictors of side effects were prior experience with psychotherapy and current interpersonal difficulties in the outpatient setting and higher motivation for psychotherapy ( t 0 ) in the inpatient setting. Predictors of malpractice and unethical behavior were younger age in the outpatient setting and poor therapeutic alliance, prior negative experience with malpractice and unethical behavior, and higher outcome expectations in the inpatient setting. NEP are common in both, in- and outpatient settings. Inpatients are at higher risk for the NEP than outpatients. To safeguard patients’ wellbeing, the systematic assessment and distinction of side effects and malpractice and unethical behavior should gain more attention in research and clinical practice.

Background Informed consent is a legal and ethical prerequisite for psychotherapy. However, in clinical practice, consistent strategies to obtain informed consent are scarce. Inconsistencies exist regarding the overall validity of informed consent for psychotherapy as well as the disclosure of potential mechanisms and negative effects, the latter posing a moral dilemma between patient autonomy and nonmaleficence. Objective This protocol describes a randomized controlled web-based trial aiming to investigate the efficacy of a one-session optimized informed consent consultation. Methods The optimized informed consent consultation was developed to provide information on the setting, efficacy, mechanisms, and negative effects via expectation management and shared decision-making techniques. A total of 122 participants with an indication for psychotherapy will be recruited. Participants will take part in a baseline assessment, including a structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) disorders. Eligible participants will be randomly assigned either to a control group receiving an information brochure about psychotherapy as treatment as usual (n=61) or to an intervention group receiving treatment as usual and the optimized informed consent consultation (n=61). Potential treatment effects will be measured after the treatment via interview and patient self-report and at 2 weeks and 3 months follow-up via web-based questionnaires. Treatment expectation is the primary outcome. Secondary outcomes include the capacity to consent, decisional conflict, autonomous treatment motivation, adherence intention, and side-effect expectations. Results This trial received a positive ethics vote by the local ethics committee of the Center for Psychosocial Medicine, University-Medical Center Hamburg-Eppendorf, Hamburg, Germany on April 1, 2021, and was prospectively registered on June 17, 2021. The first participant was enrolled in the study on August 5, 2021. We expect to complete data collection in December 2022. After data analysis within the first quarter of 2023, the results will be submitted for publication in peer-reviewed journals in summer 2023. Conclusions If effective, the optimized informed consent consultation might not only constitute an innovative clinical tool to meet the ethical and legal obligations of informed consent but also strengthen the contributing factors of psychotherapy outcome, while minimizing nocebo effects and fostering shared decision-making. Trial Registration PsychArchives; http://dx.doi.org/10.23668/psycharchives.4929 International Registered Report Identifier (IRRID) DERR1-10.2196/39843

Objective This study aimed to assess clinicians' attitudes and their current clinical practices regarding informed consent for psychotherapy. Method A convenience sample of N = 530 clinicians in Germany (n = 418 licensed psychotherapists and n = 112 postgraduate psychotherapy trainees) took part in an online survey. Results Most clinicians (84%) reported obtaining informed consent for psychotherapy in their daily routine. However, many psychotherapists felt unsure about satisfactorily fulfilling the legal (63%) and ethical obligations (52%). The two most frequently reported components of information disclosure related to explaining the terms and conditions of psychotherapy (96%) and the psychotherapeutic approach (91%). Providing information about mechanisms of psychotherapy (33%) and the role of expectations (30%) were least practiced. One in five psychotherapists reported not informing clients about potential risks and side effects. A considerable proportion reported concern about inducing anxiety in patients by disclosing information about risks and side effects (52%). Conclusions Although obtaining informed consent for psychotherapy seems to be the rule rather than the exception in clinical practice, the quality of its implementation in terms of legal, ethical and clinical demands remains questionable. Training psychotherapists in providing comprehensive informed consent enables informed decision‐making and might have a positive influence on treatment expectations and outcomes.

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