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Zusammenfassung Ziel der Studie Colitis ulcerosa (CU) und Reizdarmsyndrom (RDS) gehen mit hoher somatischer Symptombelastung, reduzierter Lebensqualität und psychischen Beschwerden einher. Die subjektive Belastung, der Wunsch vieler Betroffener und die Beteiligung psychischer Prozesse an der Wahrnehmung der Symptomatik begründen die Entwicklung psychosozialer Unterstützungsangebote. Ziel dieser Machbarkeitsstudie war es, Bedarf, inhaltlichen Fokus und Machbarkeit eines solchen Angebots zu evaluieren. Betroffene mit CU und RDS wurden parallel eingeschlossen, um krankheitsspezifische und krankheitsübergreifende Aspekte für psychosoziale Interventionen zu identifizieren. Methodik Erwachsene Menschen mit CU oder RDS wurden telefonisch mithilfe eines standardisierten Interviewleitfadens befragt. Mittels numerischer Analogskalen sowie offener Fragen wurden Belastungen durch und Umgang mit der Erkrankung, krankheitsbezogene Erwartungen und Krankheitsangst, Zufriedenheit mit der Versorgung, Unterstützungs- und Informationsbedarf sowie Präferenzen hinsichtlich eines Unterstützungsprogramms erfragt. Deskriptive Kennzahlen zu quantitativen Variablen und diagnosespezifische Gruppenvergleiche wurden berechnet. Die Antworten zu den offenen Fragen wurden nah an den Aussagen der Teilnehmenden zusammengefasst und ausgezählt. Ergebnisse n=35 Personen (CU: n=15; RDS: n=20) nahmen teil (Alter: m=40,8, SD=14,6; 71% weibl.). Betroffene beider Erkrankungen zeigten ein mittleres Belastungsniveau, wobei jenes von Personen mit RDS signifikant höher war. Beide Gruppen berichteten über relevante krankheitsbezogene Ängste, wobei die Einschränkung durch diese bei RDS-Betroffenen höher war. Krankheitsbezogene Erwartungen unterschieden sich nicht zwischen den Gruppen. Patient:innen mit RDS zeigten eine geringe Zufriedenheit mit der Versorgung und fühlten sich schlechter über ihre Erkrankung informiert als Betroffene von CU. Beide Gruppen gaben eine hohe Wahrscheinlichkeit an, an einem psychologischen Unterstützungsprogramm teilzunehmen und benannten krankheitsbezogene Erwartungen und Krankheitsangst als wichtige Bestandteile eines solchen. Diskussion Die Ergebnisse bestätigen den erhöhten Bedarf und das Interesse an psychosozialer Unterstützung sowie die Relevanz krankheitsbezogener Erwartungen und Krankheitsangst bei beiden Erkrankungen. Unterschiede in Symptomwahrnehmung und Bewertung der Versorgung weisen auf die Notwendigkeit krankheitsspezifischer Elemente in psychosozialen Unterstützungsangeboten hin. Schlussfolgerung Die Ergebnisse zeigen den hohen Bedarf an psychosozialer Unterstützung von Menschen mit CU und RDS und liefern Hinweise auf die Machbarkeit eines psychosozialen Therapieprogramms.

ZusammenfassungErwartungseffekte bei Antidepressiva wurden in zahlreichen randomisierten Studien und Metaanalysen nachgewiesen. In den Placebogruppen zeigten sich sowohl relevante Verbesserungen der depressiven Erkrankungen (Ansprechraten: Placebo 40 % vs. Verum 50 %) als auch belastende Nebenwirkungen im Sinne von Noceboeffekten. Diese Befunde unterstreichen den Einfluss individueller Erwartungshaltungen auf die Wirksamkeit und Verträglichkeit von Antidepressiva und legen nahe, dass diese auch beim Absetzen relevant sind. Das Absetzen von Antidepressiva kann mit belastenden Beschwerden wie Schwindel, Schlaflosigkeit und Reizbarkeit verbunden sein. Diese sog. Absetzsymptome sind in der Mehrzahl der Fälle mild und klingen nach wenigen Tagen bis Wochen wieder ab. Sind Patient:innen allerdings nicht auf solche möglichen Beschwerden vorbereitet, kann deren Auftreten Ängste vor einem Rückfall oder einer Abhängigkeit auslösen. Insbesondere, wenn das Absetzen ohne ärztliche und psychologische Begleitung stattfindet, können Absetzsymptome leicht mit dem Wiederauftreten einer Depression verwechselt werden. In der aktuellen Versorgungspraxis finden sich zunehmend Berichte zu missglückten Absetzversuchen und entsprechend negativen Erwartungen an das Absetzen. Erwartungen lassen sich vornehmlich in der Interaktion mit Behandelnden und über die Patient:innen-Information verändern. Dieser Beitrag diskutiert therapeutische Strategien zum Umgang mit Absetzsymptomen mit dem Ziel, Erwartungen, angepasst an individuelle Vorerfahrungen, zu optimieren. Um realistische Erwartungen zu erarbeiten und den Absetzprozess durch eine therapeutische Begleitung positiv zu beeinflussen, können Strategien wie Psychoedukation, Framing, die Aufklärung über Placebo- und Noceboeffekte sowie die Erarbeitung von Coping-Strategien eingesetzt werden.

IntroductionOverall, 20%–30% of women with endometriosis report endometriosis-related disability after successful laparoscopy. This indicates a potential impact of psychological factors, such as expectations, on treatment outcomes. It is already known that expectations determine treatment outcomes in various health conditions, such as cardiologic or gynaecology. Therefore, we investigate the impact of expectations and other psychological factors on patients’ course of treatment outcomes after laparoscopy.Methods and analysisA longitudinal mixed-methods study with N=300 women treated at a specialised centre of surgical endoscopy and endometriosis will be conducted with one preoperative and eight postoperative assessments of endometriosis-related disability and a priori specified predictors such as expectations.Additionally, two subsamples (each ~n=30) will be either interviewed about their endometriosis-related disability, expectations, and experiences of laparoscopy before and after surgery or asked once per day for 30 consecutive days using ambulatory assessments. Quantitative data will be analysed using multilevel modelling for longitudinal data. Structural content analysis will be used for qualitative data.DiscussionTo optimise treatment for women with endometriosis, it is essential to understand how treatment expectations and other psychological and medical factors influence treatment outcomes after laparoscopy.Ethics and disseminationThe Ethics Committee of the Psychotherapeutenkammer Hamburg, Germany, gave ethical approval (ROXWELL-2021-HH, 25 June 2021).Trial registration numberClinicalTrials.gov Registry (NCT05019612).

The project to be preregistered is part of the cooperative research unit “Mechanisms of change in dynamic social interactions” of the University of Hamburg (Institute of Psychology, Department of Informatics, UKE), Medical School Hamburg (Department of Psychology), and the Helmut-Schmidt-University/University of the Federal Armed Forces, Hamburg (Department of Clinical Psychology). This interdisciplinary research unit is funded by the Hamburg Senate (LFF-FV 79-2019) and consists of different working groups in the fields of psychology and informatics in Hamburg. Within the framework of the research collaboration, video recordings of social situations will be analyzed in the associated subprojects and new (automated) recording methods of dynamic social contexts will be jointly developed. The primary goal of the cooperative research unit is to incorporate Lewin's premise of person-environment interaction in five closely linked and coordinated subprojects. The aim is to advance knowledge of person-environment interaction by accounting for temporal changes (infancy, adolescence, adults) and clinical situations. Current techniques in computer science will be incorporated as a promising approach to measure the complexities of conduct and change processes in dynamic social environments. To investigate such dynamic social interaction mechanisms, the cooperative research unit will address specific but interlinked psychological sub-questions with the to be preregistered project focusing on dynamics of social interaction in psychotherapy. A central element of psychotherapy is the dyadic social interaction between therapist and patient. The intermittent coupling of the nonverbal behavioral patterns of both interaction partners is referred to as nonverbal or motion synchrony (Koole & Tschacher, 2016). Significant correlations between motion synchrony and relevant psychotherapeutic process and outcome measures, such as therapeutic relationship (Koole & Tschacher, 2016; Ramseyer & Tschacher, 2011) and the probability of patient-side discontinuation (Paulick et al., 2018), have already been demonstrated in previous studies. The aim of the present research project is to examine possible influences of the nonverbal aspects of social interaction on the therapeutic relationship, therapy motivation, and treatment expectation using different types of interaction partners in virtual information sessions about psychotherapy. Two different types of interaction partners will be examined: a human therapist interaction partner represented by a study psychologist and an avatar therapist, which is implemented by a zoom filter controlled by a study psychologist but with limited social interaction cues regarding gesticulation or Duchenne smiling. The information sessions are manualized, conducted by trained psychologists (bachelor level) and conducted with the aid of structured information cards. Content, duration and level of patient involvement in the information sessions are kept constant to the highest possible degree. Outcomes are the subjectively experienced (self-report) and objectively-measured (motion synchrony) indicators of the therapeutic relationship in relation to their interaction partner condition as well as the motivation for therapy and therapy-related expectation in relation to pre- and post-assessment. Findings of the present research project will provide important insights into the social mechanisms for modulating therapeutic relationship, motivation, and expectation. A total of 150 people from the German population (general population) who are interested in psychotherapy, are at least 18 years old, and are currently not undergoing psychotherapeutic treatment, will be included in the study. Subjects will be primarily recruited via social networks and cooperating research projects. For quantitative data analyses, a mixed multivariate analysis of variance (repeated-measures MANOVA) with a within-subject factor “time” (measurement points: pre- vs. post-assessment) and a between-subject factor “group” (type of interaction partner: human therapist vs. avatar therapist condition) will be conducted. Further statistical analyses will be additionally applied for group comparisons at single measurement points (e.g., independent-samples t-Test). It is hypothesized that subjects in the human therapist condition compared to those in the avatar therapist condition a) achieve higher values on both subjectively experienced and objectively-measured indicators of “therapeutic relationship” and b) achieve a higher increase in “therapy-related motivation” and “therapy-related expectation” between the measurement points and after the virtual information session about psychotherapy (intervention). Appropriate measures of effect size will be additionally reported.

Placebo- und Noceboeffekte haben uber individuelle Erwartungen und Vorerfahrungen von Patient:innen einen direkten Einfluss auf die Wirksamkeit und Vertraglichkeit von Behandlungen. Erwartungseffekte in der Krebsbehandlung wurden in Studien fur Symptome wie chronische Erschopfung, Schmerzen oder Ubelkeit und Erbrechen nachgewiesen. Erwartungen werden masgeblich in den Interaktionen mit Behandelnden und uber die Patient:inneninformation generiert. Die informierte Aufklarung eignet sich besonders als Ansatzpunkt, um realistische und positive Erwartungen an die Behandlung zu erarbeiten. Hierbei kommen Strategien wie das „framing“, die Aufklarung uber Placebo- und Noceboeffekte und die Erarbeitung von Copingstrategien zum Umgang mit Nebenwirkungen zum Einsatz. Wenn es gelingt, Erwartungen angepasst an individuelle Vorerfahren zu optimieren, konnen positive Behandlungseffekte uber den Placeboeffekt zusatzlich verstarkt werden. Auf der anderen Seite lassen sich Noceboeffekte minimieren, um die Belastung durch Nebenwirkungen zu verringern und die Behandlungsadharenz zu steigern.

This study aimed to assess clinicians' attitudes and their current clinical practices regarding informed consent for psychotherapy.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.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%).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.

Background Adverse events of chemotherapy may be caused by pharmacodynamics or psychological factors such as negative expectations, which constitute nocebo effects. In a randomized controlled trial, we examined whether educating patients about the nocebo effect is efficacious in reducing the intensity of self-reported adverse events. Methods In this proof-of-concept study, N = 100 outpatients (mean age: 60.2 years, 65% male, 54% UICC tumour stage IV) starting first-line, de novo chemotherapy for gastrointestinal cancers were randomized 1:1 to a nocebo education (n = 49) or an attention control group (n = 51). Our primary outcome was patient-rated intensity of four chemotherapy-specific and three non-specific adverse events (rated on 11-point Likert scales) at 10-days and 12-weeks after the first course of chemotherapy. Secondary outcomes included perceived control of adverse events and tendency to misattribute symptoms. Results General linear models indicated that intensity of adverse events differed at 12-weeks after the first course of chemotherapy (mean difference: 4.04, 95% CI [0.72, 7.36], p = .02, d = 0.48), with lower levels in the nocebo education group. This was attributable to less non-specific adverse events (mean difference: 0.39, 95% CI [0.04, 0.73], p = .03, d = 0.44) and a trend towards less specific adverse events in the nocebo education group (mean difference: 0.36, 95% CI [− 0.02, 0.74], p = .07, d = 0.37). We found no difference in adverse events at 10-days follow-up, perceived control of adverse events, or tendency to misattribute non-specific symptoms to the chemotherapy. Conclusions This study provides first proof-of-concept evidence for the efficacy of a brief information session in preventing adverse events of chemotherapy. However, results regarding patient-reported outcomes cannot rule out response biases. Informing patients about the nocebo effect may be an innovative and clinically feasible intervention for reducing the burden of adverse events. Trial registration Retrospectively registered on March 27, 2018 to the German Clinical Trial Register (ID: DRKS00009501).

IntroductionUlcerative colitis (UC) and irritable bowel syndrome (IBS) are distressing chronic diseases associated with abdominal pain and altered bowel habits of unknown aetiology. Results from previous studies indicate that, across both diseases, increased levels of illness-related anxiety and dysfunctional symptom expectations contribute to symptom persistence. Thus, comparing both disorders with regard to common and disease-specific factors in the persistence and modification of gastrointestinal symptoms seems justified. Our primary hypothesis is that persistent gastrointestinal symptoms in UC and IBS can be improved by modifying dysfunctional symptom expectations and illness-related anxiety using expectation management strategies.Methods and analysisTo assess the extent to which persistent somatic symptoms are modifiable in adult patients with UC and IBS, we will conduct an observer-blinded, three-arm randomised controlled trial. A total of 117 patients with UC and 117 patients with IBS will be randomised into three groups of equal size: targeted expectation management aiming to reduce illness-related anxiety and dysfunctional symptom expectations in addition to standard care (SC, intervention 1), non-specific supportive treatment in addition to SC (intervention 2) or SC only (control). Both active intervention groups will comprise three individual online consultation sessions and a booster session after 3 months. The primary outcome is baseline to postinterventional change in gastrointestinal symptom severity.Ethics and disseminationThe study was approved by the Ethics Committee of the Hamburg Medical Association (2020-10198-BO-ff). The study will shed light onto the efficacy and mechanisms of action of a targeted expectation management intervention for persistent gastrointestinal symptoms in patients with UC and IBS. Furthermore, the detailed analysis of the complex biopsychosocial mechanisms will allow the further advancement of aetiological models and according evidence-based intervention strategies.Trial registration numberISRCTN30800023.

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

ImportanceUptake of vaccination against COVID-19 is strongly affected by concerns about adverse effects. Research on nocebo effects suggests that these concerns can amplify symptom burden.ObjectiveTo investigate whether positive and negative expectations prior to COVID-19 vaccination are associated with systemic adverse effects.Design, Setting, and ParticipantsThis prospective cohort study analyzed the association of expected benefits and risks of vaccination, adverse effects at first vaccination, and observed adverse effects in close contacts with severity of systemic adverse effects among adults receiving a second dose of messenger RNA (mRNA)–based vaccines between August 16 and 28, 2021. A total of 7771 individuals receiving the second dose at a state vaccination center in Hamburg, Germany, were invited to participate; of these, 5370 did not respond, 535 provided incomplete information, and 188 were excluded retrospectively. The mobile application m-Path was used for data collection.Main Outcomes and MeasuresPrimary outcome was a composite severity index of systemic adverse effects in 12 symptom areas measured once daily with an electronic symptom diary over 7 consecutive days. Data were analyzed by mixed-effects multivariable ordered logistic regression adjusted for prevaccine symptom levels and observation times.ResultsA total of 10 447 observations from 1678 individuals receiving vaccinations (BNT162b2 [Pfizer BioNTech] in 1297 [77.3%] and mRNA-1273 [Moderna] in 381 [22.7%]) were collected. The participants’ median age was 34 (IQR, 27-44) years, and 862 (51.4%) were women. The risk for more severe adverse effects was higher for persons expecting a lower benefit of vaccination (odds ratio [OR] for higher expectations, 0.72 [95% CI, 0.63-0.83]; P P P P = .004), and if the vaccine mRNA-1273 was given rather than BNT162b2 (OR, 2.45 [95% CI, 2.01-2.99]; P Conclusions and RelevanceIn this cohort study, several nocebo effects occurred in the first week after COVID-19 vaccination. The severity of systemic adverse effects was associated not only with vaccine-specific reactogenicity but also more negative prior experiences with adverse effects from the first COVID-19 vaccination, more negative expectations regarding vaccination, and tendency to catastrophize instead of normalize benign bodily sensations. Clinician-patient interactions and public vaccine campaigns may both benefit from these insights by optimizing and contextualizing information provided about COVID-19 vaccines.

Open-label (honestly prescribed) placebos are an ethical way to evoke placebo effects in patients. As part of a mixed-methods study, we conducted in-depth interviews with eight menopausal women who underwent and benefitted from open-label placebo treatment in a randomized-controlled trial of hot flushes. Data were analyzed using Interpretative Phenomenological Analysis. We found that the women had low expectations about the placebo treatment yet endorsed what they referred to as “hope” and openness to “see what happens”. Recording hot flushes via the symptom diary was viewed as a valuable opportunity for self-examination and appraising outcomes. Receiving relief from the placebo treatment empowered women and enhanced their sense of control and agency. In summary, participants’ initial openness towards placebos, their hopes to get better, monitoring symptoms closely, and taking the initiative to address symptoms were components of a positive open-label placebo experience.

Objectives A recent trial comparing Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and supportive psychotherapy in chronic depression found CBASP to be more effective in treating depressive symptoms. We aimed to evaluate adverse events that occurred during this trial. Materials and method A randomized trial of chronically depressed outpatients was performed. The treatment included 32 sessions of CBASP or supportive psychotherapy. Therapists asked patients about adverse events and their intensity in each session using a standardized checklist. We analyzed the mean number of (severe) adverse events per patient up to Session 32 with gamma frailty recurrent event models. Results Two hundred and sixty patients were included in the analyses (66% female, mean age 45 years). Patients in the supportive psychotherapy group reported less severe adverse events in general, and less severe adverse events related to personal life and to occupational life than patients in the CBASP group. Less adverse events related to suicidal thoughts were reported in the CBASP compared with the supportive psychotherapy group. Conclusions Differences in the adverse events profile may be explained by the treatment elements. Adverse events related to personal and occupational life for example might be considered a necessary and expected yet temporary adverse treatment outcome of an effective CBASP treatment.

ObjectivesDuring serious illness, open communication with caregivers can ensure high-quality care. Without end-of-life communication, caregivers may become surrogates and decision-makers without knowing the patient’s preferences. However, expectations and fears may influence the initiation of communication. The present study investigates differences between palliative patients with cancer and caregivers regarding expectations of end-of-life communication, end-of-life fears and experiences with end-of-life communication.DesignA cross-sectional study using a semi-structured interview and a paper-based questionnaireSettingUniversity Hospital in Germany.Participants151 participants: 85 palliative cancer patients (mean age: 62.8 years, 65.9% male) and 66 caregivers (mean age: 56.3 years, 28.8% male).Primary and secondary outcome measuresExpectations, end-of-life fears and experiences of end-of-life discussions.ResultsPatients and caregivers wish for the patient to be self-determined. In general, participants reported more positive than negative expectations of end-of-life discussions. Importantly, concerns about emotionally burdening other person was rated much higher in an informal context than a professional context (F(1,149)=316 958, pp²=0.680), even though the emotional relief was expected to be higher (F(1,149)=46.115, pp²=0.236). Caregivers reported more fears about the last period of life and more fears about end-of-life discussions than palliative patients, whereas palliative patients tended to avoid the topics of death and dying to a greater extent.ConclusionsThere seems to exist a ‘self-other’ asymmetry: palliative patients and their caregivers expect substantial personal relief when openly talking about end-of-life issues, but also expect the other person to be burdened by such communication. Professionals repeatedly need to initiate end-of-life communication.

Negative effects of psychotherapy include side effects, malpractice, and unethical behavior. Its' setting-specific frequencies and predictors are mostly unknown. The aim of the two presented studies is 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 termination of psychotherapy. In study 2, data from N=118 patients of two German inpatient clinics were collected at admission (t0), discharge (t1), and 9-months follow-up (t2). All participants evaluated negative effects of their previous out-or inpatient psychotherapy and a priori hypothesized predictors. Inpatients reported significantly more side effects (U = 14347, z = 4.70 p < .001, r = 0.26) and malpractice and unethical behavior (U = 14168, z = 5.21, p < .001, r = 0.29) than outpatients. At least one side effect was reported by 37.3% of inpatients (t2) and 15.2% of outpatients. Frequently reported side effects were "experiencing more downs since the end of my therapy" by inpatients (t2; 16.1%) and "having trouble finding insurance or being worried about applying for new insurance" by outpatients (4.6%). At least one case of malpractice and unethical behavior was reported by 28.8% of inpatients (t2) and 7.1% of outpatients. Frequently reported cases were "being hurt by what the therapist said to me" by inpatients (t2; 20.3%) and "feeling forced to do things I did not want to do (e.g. confrontations, role plays)" by outpatients (4.1%). Rates of severe malpractice in form of breaking confidentiality, physical and sexual abuse were less than 1% in both settings. Predictors of side effects were prior experience with psychotherapy and current interpersonal difficulties. Predictors of malpractice and unethical behavior were a poor therapeutic alliance and prior negative experience with malpractice and unethical behavior. Negative effects of psychotherapy are common in both, in-and outpatient settings. Inpatients are at higher risk for negative effects of psychotherapy than outpatients. In order 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 Medication side effects are strongly determined by non-pharmacological, nocebo mechanisms, particularly patients’ expectations. Optimizing expectations could minimize side effect burden. This study evaluated whether brief psychological expectation management training (EXPECT) optimizes medication-related expectations in women starting adjuvant endocrine therapy (AET) for breast cancer. Method In a multisite randomized controlled design, 197 women were randomized to EXPECT, supportive therapy (SUPPORT), or treatment as usual (TAU). The three-session cognitive-behavioral EXPECT employs psychoeducation, guided imagery, and side effect management training. Outcomes were necessity-concern beliefs about AET, expected side effects, expected coping ability, treatment control expectations, and adherence intention. Results Both interventions were well accepted and feasible. Patients’ necessity-concern beliefs were optimized in EXPECT compared to both TAU and SUPPORT, d = .41, p < .001; d = .40, p < .001. Expected coping ability and treatment control expectations were optimized compared to TAU, d = .35, p = .02; d = .42, p < 001, but not to SUPPORT. Adherence intention was optimized compared to SUPPORT, d = .29, p = .02, but not to TAU. Expected side effects did not change significantly. Conclusion Expectation management effectively and partly specifically (compared to SUPPORT) modified medication-related expectations in women starting AET. Given the influence of expectations on long-term treatment outcome, psychological interventions like EXPECT might provide potential pathways to reduce side effect burden and improve quality of life during medication intake.

ZusammenfassungEin Problem in der Befassung mit Nebenwirkungen von Psychotherapie besteht darin, dass es bislang keine allgemein anerkannte Definition von Nebenwirkungen gibt. Nicht einmal die Unterscheidung zwischen Haupt- und Nebenwirkungen ist immer eindeutig. Für die Erfassung und Einordnung von Psychotherapie-Nebenwirkungen sind mehrere wissenschaftliche und therapeutische Urteile erforderlich. Als Erstes ist zu prüfen, welche Ereignisse potentiell relevant sein könnten. Ein Ereignis definiert sich methodisch über die zeitliche Kontingenz zur Therapie. Als Zweites muss definiert werden, ob es sich um ein unerwünschtes oder ein erwünschtes Ereignis handelt. Unerwünscht ist alles, was problematisch wäre, wenn es auch anders ginge. Als Drittes muss ein kausaler Zusammenhang mit dem Therapieprozess wahrscheinlich gemacht werden. Als Viertes muss beurteilt werden, ob die Therapie fachgerecht war oder ob ein Kunstfehler oder sonstiges inadäquates Therapeutenverhalten vorlag. Eine Nebenwirkung ist als eine unerwünschte Folge einer korrekten Therapie zu defineren. Die Frage der Relevanz von Nebenwirkungen ist mit Blick auf die Schwere und Nachhaltigkeit zu beurteilen.

Despite growing awareness of occasional adverse effects of psychological treatments, only a few instruments cover side effects and other unwanted effects of psychotherapy. For the present study, the Positive and Negative Effects of Psychotherapy Scale (PANEPS) was evaluated in a population of individuals with depression who had completed at least one course of face-to-face psychotherapy. A total of 135 individuals with a current or previous depressive episode as verified by a diagnostic interview filled out the online version of the PANEPS, which is designed to capture both positive and adverse events. Factor analysis yielded four dimensions: positive effects, side effects, malpractice, and unethical conduct. Internal consistency of the individual subscales was satisfactory to excellent (Cronbach's α: 0.72 and 0.92). Positive effects were reported by virtually all patients (95.6%). At the same time, approximately half of the sample noted at least one adverse event (52.6%). Among these, side effects (38.5%) and malpractice (26.7%) were significantly more prevalent than unethical conduct (8.1%). As expected, positive effects were negatively correlated with adverse events. Our results challenge the common clinical assumption that some degree of destabilization is necessary for symptom improvement. The survey was conducted anonymously, and the sample underwent diagnostic verification. The results indicate a need for improved treatment guidelines and mechanisms to monitor treatment.

ZusammenfassungPsychotherapie bei Kinder- und Jugendlichen wirkt, jedoch können auch unerwünschte Effekte auftreten. Im Kinder- und Jugendbereich ist dieses wichtige Thema bisher vernachlässigt worden, obwohl gerade Kinder und Jugendliche eines besonderen Schutzes bedürfen. Durch Therapie verursachte unerwünschte Effekte der Psychotherapie sind im Kinder- und Jugendbereich bisher nicht systematisch untersucht worden und eine entsprechende Konzeptualisierung fehlt. Ziel des vorliegenden Artikels ist es, aktuelle Klassifikationen zu unerwünschten Effekten von Psychotherapie bei Erwachsenen hinsichtlich der Übertragbarkeit auf das Kindes- und Jugendalter zu prüfen und die Besonderheiten in diesem Bereich herauszuarbeiten. Des Weiteren wird die Adaptation des Inventars zur Erfassung negativer Effekte für das Kindes- und Jugendalter vorgestellt (Kinder-INEP) 1. Abschließend werden Maßnahmen zur Aufklärung und Vermeidung von unerwünschten, negativen Effekten in der Kinder- und Jugendlichenpsychotherapie aufgezeigt.

Zusammenfassung Hintergrund Die Positive and Negative Effects of Psychotherapy Scale (PANEPS), ein Selbstauskunftsfragebogen für Patienten zur Erfassung von positiven Effekten (PE) und unerwünschten Ereignissen (UE) während der letzten Psychotherapie (PT), wurde erstmalig bei einer Patientenstichprobe mit Depression eingesetzt. Der Fragebogen wurde auf seine Anwendbarkeit hin überprüft und lieferte erste empirische Ergebnisse zu PE und UE einer PT bei dieser Patientengruppe. Methode Im Rahmen einer Onlinebefragung füllten 135 Personen mit einer aktuellen oder früheren depressiven Störung die 43 Items der PANEPS aus, welche UE in Nebenwirkungen (NW), Kunstfehler (KF) und unethisches Fehlverhalten (UF) unterteilt. Zusätzlich wurden soziodemografische Angaben (Alter, Geschlecht, Beziehungsstatus) sowie Details zu psychotherapeutischer Vorerfahrung und der zuletzt wahrgenommenen PT erfasst. Die PANEPS wurde mittels Hauptkomponentenanalyse mit Varimax-Rotation geprüft und überarbeitet. Ergebnisse Eine 4-Faktoren-Lösung wurde ermittelt, welche die zuvor definierten Skalen (PE, NW, KF, UF) abbildet und eine weitere Reduktion der PANEPS ermöglicht. Die finale Version der PANEPS, wies eine zufriedenstellende bis exzellente interne Konsistenz auf (Cronbach’s α=0,72–0,92). Von den Befragten gaben 95,6% mind. einen PE (Range=0–5, MW=3,3, SD=1,4) an und 52,6% mind. ein UE (Range=0–14, MW=1,8, SD=2,9). Es gaben 38,5% mind. eine NW (Range=0–6, MW=0,7, SD=1,3), 26,7% mind. einen KF (Range=0–10, MW=0,9, SD=1,9) und 8,1% mind. ein UF (Range=0–4, MW=0,1, SD=0,5) an. PE korrelierten negativ mit KF, aber nicht mit NW und UF. Zudem bestehen Zusammenhänge zwischen Patientenmerkmalen und dem Auftreten von GE und UE. Diskussion Etwas mehr als die Hälfte der Befragten bestätigte mind. ein UE im PANEPS, wobei besonders die Zustimmung zu mind. einem KF oder UF unerwartet hoch ausfielen. Insbesondere die aktuelle Symptombelastung (PHQ-9) scheint für die Zustimmung zu PE und UE einer PT relevant zu sein. Der negative Zusammenhang zwischen PE und KF unterstreicht die Wichtigkeit leitliniengerechter Behandlung für den Erfolg von Psychotherapie. Schlussfolgerung Nebenwirkungen von PT sind auch bei Patienten mit Depressionen zu erwarten und sollten regelhaft erfasst werden.

Purpose To identify modifiable factors predictive of long-term adherence to adjuvant endocrine therapy (AET). Methods As part of a 2-year cohort study in primary care (n = 116), we investigated whether initial treatment expectations predict adherence at 24 months after controlling for demographic, medical, and psychosocial variables. Treatment expectations were measured as necessity–concern beliefs, expected side-effect severity, and expected coping with side effects. Their stability over time and differences of trajectories between the adherent and nonadherent group were examined. Results Nonadherence at 24 months was 14.7% (n = 17). Side-effect severity at 3 months [OR 0.25, 95% CI (0.08, 0.81), p = 0.02] and necessity–concern beliefs [OR 2.03, 95% CI (1.11, 3.72), p = 0.02] were the sole predictors of adherence. Necessity–concern beliefs remained stable over 2 years, whereas expected side-effect severity (p = 0.01, η p 2 = 0.07) and expected coping with side effects became less optimistic over time (p η p 2 = 0.19), the latter particularly among nonadherers (p η p 2 = 0.10). Conclusions Patients’ initial necessity–concern beliefs about the AET and early severity of side effects affect long-term adherence. Expecting poor management of side effects may also facilitate nonadherence. We suggest that discussing benefits, addressing concerns of AET, and providing side-effect coping strategies could constitute a feasible and promising option to improve adherence in clinical practice.

To provide an overview of a selection of largely neglected psychological risk factors for nonadherence, and to offer new approaches to improve medication adherence.Current adherence research and intervention programs focus on a few risk factors for nonadherence, such as complexity of the drug regimen. In addition, other important risk factors of nonadherence are neglected or insufficiently addressed. There is good evidence for the significant role of the quality of the patient-healthcare provider relationship. Other risk factors like the individual history of nonadherence, the lack of acceptance of having a treatable disorder, fear of side-effects, comorbid depression, and cognitive impairment have been broadly neglected in adherence programs, although they offer a powerful key to improve adherence-oriented interventions.Current research on determinants of nonadherence has focused on a few risk factors, while neglecting crucial psychological predictors of nonadherence. The personalized consideration of a multiplicity of risk factors offers a new basis for the development and evaluation of interventions to better promote adherence.

Background Males receive more aggressive care near death. End-of-life (EOL) conversations can protect from aggressive care near death and support more consistent EOL care. Therefore, information about gender effects on engagement in and realization of EOL conversations are needed. Methods In a cross-sectional study 186 cancer patients from an university and rehab hospital were asked about their preferences for EOL discussions using a semi-structured interview, focusing on a) the importance of six different EOL issues (medical and nursing care, organizational, emotional, social and spiritual/religious aspects), b) the desired time point, c) mode of discussion initiation. Results The importance of EOL topics differ significantly by issue (p=.002, η2=.02) and gender (p Conclusion Because of distinct gender differences for engagement in and realization of EOL conversations a gender sensitive approach is recommended. Independent of gender, the tendency of patients to talk late about EOL issues should be considered to reduce the risk of delayed or neglected EOL conversations. Therefore, a two-step approach of end-of-life conversations is suggested.

Background Beneficial effects of placebos are high in double-blind hot flush trials. Studies in various conditions suggest that honestly prescribed placebos may elicit symptom improvement. Objective To determine whether open label placebo (OLP) treatment is efficacious in alleviating hot flushes among peri- and postmenopausal women. Methods/design In this assessor-blinded, randomized-controlled trial, n = 100 women experiencing five or more daily hot flushes of at least moderate severity and bothersomeness are assigned 1:1 to a 4-week OLP treatment or no treatment. To explore the duration and maintenance of placebo effects, the OLP group is randomized a second time to either discontinue or continue the OLP treatment for another 4 weeks. All participants receive a briefing about placebo effects and study visits at baseline, post-treatment (4 weeks), and follow-up (8 weeks, OLP group only). Qualitative interviews about subjective experiences with the OLP treatment are conducted. Primary outcomes are differences between the OLP and the no-treatment group in the hot flush composite score (frequency × severity), and bothersomeness of hot flushes as assessed with the Hot Flush Rating Scale at post-treatment. Secondary outcomes include hot flush frequency, health-related quality of life, global improvement, and the number of responders at post-treatment. Data are analyzed by fitting (generalized) linear mixed models. An exploratory analysis of maintenance and duration is performed including follow-up data. Discussion This trial will contribute to the evaluation of OLP treatments in clinical practice and further our understanding about the magnitude of placebo effects in hot flush treatments. Trial registration Clinicaltrials.gov, NCT03838523. Retrospectively registered on February 12th, 2019. The first patient was enrolled on October 10th, 2018.

Einleitung: Obwohl Biofeedback zur Behandlung von Kopfschmerz vom Spannungstyp und Migrane als wirksam gilt, ist die Integration des Verfahrens in das ambulante Gesundheitssystem luckenhaft. Ziele dieser randomisiert kontrollierten Pilotstudie waren die Testung der Durchfuhrbarkeit und Implementierbarkeit einer Biofeedbackkompaktbehandlung bei chronifiziertem Kopfschmerz in der ambulanten Versorgung, die Abschatzung der Behandlungseffekte mittels standardisierter Effektstarken, sowie die Prufung des Einflusses von Erwartungen auf die Behandlungsergebnisse. Methoden: In der Pilotstudie wurden die Patienten (N=18) gemas der Kriterien der International Headache Society diagnostiziert und anschliesend randomisiert. Die Patienten erhielten 8–11 Biofeedbacksitzungen (je nach Indikation: Elektromyografiebiofeedback, Vasokonstriktions-/Vasodilatationstraining oder eine Kombination). Die Erhebungen fanden vor und nach der Biofeedbackbehandlung mittels Fragebogen statt. Hedges’ g wurde fur Veranderungen der Behandlungserwartungen und des Sitzungserfolgs (Patienten und Therapeuten), der kopfschmerzspezifischen Selbstwirksamkeitserwartung (Fragebogen zu Kopfschmerzmanagement und Selbstwirksamkeit-Kurzform), der Kopfschmerzparameter (Pain Disability Index, Fragebogen zur Erfassung der Schmerzverarbeitung) und der komorbiden Beanspruchung (Hospital Anxiety and Depression Scale) ermittelt. Fur die Zusammenhange der Veranderungen wurden Pearson-Korrelationen berechnet. Ergebnisse: Die Effektstarken der meisten Erwartungen und der Bewaltigung waren hoch (g=0,94–1,45). Ubungsbereitschaft und Beeintrachtigung im Alltag verbesserten sich moderat (g=0,40–0,51). Die Zusammenhange zwischen Patientenerwartungen mit Beeintrachtigung und mit Bewaltigung waren moderat (r=−0,42 – 0,41). Es bestand eine moderat negative Korrelation zwischen Sitzungserfolg, eingeschatzt durch die Patienten und Depressivitat (r=−0,33). Diskussion und Schlussfolgerung: Die Biofeedbackkompaktbehandlung war ambulant gut durchfuhrbar, implementierbar und zeigte erste Hinweise auf eine gute Wirksamkeit. Aufgrund der Zusammenhange zwischen den durch Patienten und Therapeuten eingeschatzten Erwartungen und dem Behandlungsergebnis erscheint die Erhebung von Erwartungen indiziert.

Objectives To investigate adverse event (AE) reporting practices in a systematic review of randomized controlled trials for persistent depressive disorder (PDD). Study Design and Setting A systematic electronic database search was conducted up to October 2014 to identify randomized controlled trials investigating pharmacologic, psychotherapeutic, and combined treatments for PDD in adults. We calculated the number and percentage of studies that reported predefined AE information. All calculations were carried out including all studies and stratified for study type (pharmacologic, psychotherapeutic, and mixed) and publication year [before and after the publication of the Consolidated Standards of Reporting Trials (CONSORT) extension for harms in 2004], respectively. Results Sixty studies, reported in 126 publications, were included. Across all studies, reporting of AE information was insufficient. Substantial differences between studies that investigated different treatments emerged. Most pharmacologic studies (39/42) and mixed studies (7/9) reported any AE information, although the amount of information varied and the reported methods to assess and analyze AEs were heterogeneous. We found no substantial change in reporting practices after the publication of the CONSORT extension. Psychotherapeutic studies, although almost entirely published after the CONSORT extension, largely neglected reporting of any AE information (1/9). Conclusions There is a strong need to improve the current practice of assessing, analyzing, and reporting AEs, especially for psychotherapeutic studies.

Objectives Patients' negative treatment expectations can lead to nocebo-related side effects and non-initiation of treatment. This study aims to identify correlates of treatment expectations in patients with breast cancer before the start of endocrine therapy. Methods Expectations were assessed in a cross-sectional sample of 166 patients with breast cancer after receiving treatment information. Side effect expectations (one item) and treatment necessity–concern balance (Beliefs about Medicines Questionnaire) were assessed. Correlates were analyzed using regression analyses. The structure of treatment expectations was investigated using a network analysis. Results About 25% of patients expressed negative expectations. Higher side effect expectations were associated with lower treatment efficacy expectations (s = −0.20, p = 0.01), higher medication overuse beliefs (s = 0.17, p = 0.01), and a negative treatment appraisal before study treatment information (s = −0.17, p = 0.02). A negative necessity–concern balance was associated with lower treatment efficacy expectations (s = 0.36, p

ObjectivePatients’ expectations—as a central mechanism of placebo and nocebo effects—are an important predictor of health outcomes. However, the lack of a way to assess expectations across different settings restricts progress in understanding the role of expectations and to quantify their importance in medical and psychological treatments. The aim of this study was to develop a theory-based, generic, multidimensional measure assessing patient expectations of medical and psychological treatments.DesignThe Treatment Expectation Questionnaire (TEX-Q) was developed based on the integrative model of expectations and a systematic literature review of treatment expectation scales. After creating a comprehensive item pool, the scale was further refined by use of expert ratings and patient interviews.SettingPatients were recruited in primary care at two hospitals in Hamburg, Germany.Participants13 scientific experts participated in the expert survey. 11 patients waiting for psychological or surgical treatments participated in the qualitative interviews.ResultsThe 2×2×2 multidimensional structure of the TEX-Q assesses two expectation constructs (probabilistic vs value-based) across two outcome domains with two valences (direct benefits and adverse events, broader positive and negative impact), plus process and behavioural control expectations. We examined 583 items from 38 scales identified in the systematic review and developed 78 initial items. Content validity was then rated by experts according to item fit and comprehensibility. The best 53 items were further evaluated for comprehensibility, acceptability, phrasing preference and understanding by interviewing patients prior to treatment using the ‘think aloud’ technique. This resulted in a first 35-item version of the TEX-Q.ConclusionsThe TEX-Q is a generic, multidimensional measure to assess patient expectations of medical and psychological treatments and allows comparison of the impact of multidimensional expectations across different conditions. The final TEX-Q will be available after psychometric validation.

Depression and anxiety are highly prevalent among people with epilepsy (PwE) but often remain unrecognized and treated inadequately. Effective psychosocial treatments such as cognitive behavioral therapy (CBT) are rarely available to most PwE, which is one reason electronically delivered CBT (eCBT) is regarded as promising. This study examined an eCBT intervention, termed Emyna, that was tailored to suit the needs of PwE. It includes CBT-related content on depression, stress and anxiety, seizure triggers and auras, and lifestyle habits. The trial examined the efficacy of Emyna in reducing symptoms of depression (primary outcome) and anxiety as well as improving quality of life.Participants (N = 200) with epilepsy, a diagnosis of a depressive disorder, and at least moderate depressive symptoms were randomized to Emyna or care as usual. At baseline and after 3, 6, and 9 months, participants were invited to complete online questionnaires. The primary outcome was improvement of depressive symptoms at 3 months.Relative to the control group, intervention group participants experienced significantly greater improvements in depression, anxiety, stress, social-occupational impairment, and epilepsy-related quality of life, in both intention-to-treat (ITT) and per-protocol analyses. In ITT analyses, effects of medium magnitude were observed, as measured by the Patient Health Questionnaire-9 items (Cohen d = 0.54, 95% confidence interval [CI] = 0.25-0.82, P 0.001) and the Neurological Disorders Depression Inventory for Epilepsy (d = 0.51, 95% CI = 0.23-0.79, P 0.01). At 3 months, intervention group participants also reported fewer illness-related days off work and fewer days hospitalized over the preceding months, compared to control group participants (P ≤ 0.05), whereas no such differences were present at baseline (P 0.30).These findings showed that Emyna, used adjunctively to usual care, could help improve mental health, social-occupational functioning, and quality of life among PwE. The program provides an additional treatment option that could produce clinically relevant symptom reductions and reduce key cost drivers (ie, hospitalization rates and illness-related inability to work).

Neben zahlreichen positiven Effekten berichten Patienten regelmasig auch negative Effekte psychotherapeutischer Interventionen. Am haufigsten werden dabei negative Veranderungen der Gedanken- und Gefuhlswelt, Partnerschaftsprobleme, Angst vor Stigmatisierung und Schwierigkeiten mit Versicherungen genannt (Ladwig, Rief & Nestoriuc 2014). Angesichts der Pravalenzraten von 1–22% scheint es notwendig, mogliche negative Therapiefolgen routinemasig zu ­erfassen – um Auftreten und Verlauf moglicher Belastungen zu ­klaren, und um zu untersuchen, inwieweit es sich um vermeidbare oder ­unvermeidbare Risiken handelt.

Objective The study investigates the association between somatosensory amplification and the reporting of side effects. It establishes a German version of the Somatosensory Amplification Scale and examines its psychometric properties in a representative sample of the German population. Methods Sample size was 2.469, with 51% taking any medication. Participants answered the Somatosensory Amplification Scale, Generic Assessment of Side Effects Scale, and indicated whether they were taking any medication and the type of medication. Correlational analysis and binary logistic regression were performed. Results When examining a subsample reporting both medication intake and general bodily symptoms, participants higher in somatosensory amplification rated more of their general bodily symptoms as medication-attributed side effects. However, somatosensory amplification scores were not associated with the intake of any type of medication. In the overall sample, higher somatosensory amplification scores were associated with an increased report of bodily symptoms. Additionally, participants with higher somatosensory amplification reported intake of a greater number of different medications. The psychometric properties of the translated scale were good, and previously established associations of somatosensory amplification with demographic variables (age, sex) were replicated. Conclusion Results suggest a possible attributional bias concomitant to somatosensory amplification which in turn may increase the reporting of side effects after medication intake.

Preterm birth and survival rates of very low birth-weight (VLBW:1.500g) infants have increased. Although new parents are frequently affected by depressive symptoms, little is known about prevalence, risk, and predictors of parental postpartum depression (PPD) following VLBW birth. Furthermore, most studies assessing PPD in parents of preterm children relied on self-report only.As part of the HaFEn cohort-study, data from the index groups of parents with VLBW infants and the control group of parents with term infants were cross-sectionally analysed. Families were recruited at the three largest centres of perinatal medical care in Hamburg, Germany. PPD was evaluated one month postpartum using standardized questionnaires and clinical interviews. Socioeconomic status, social support, risks during pregnancy, and psychiatric lifetime diagnoses were also assessed. A multiple random coefficient model was used to examine predictors of PPD in both parents simultaneously.230 mothers and 173 fathers were included. Depending on the measure, the risk of being postnatally depressed was 4 to 18 times higher in mothers and 3 to 9 times higher in fathers from the index group. The most relevant risk factor for PPD was the birth of a VLBW infant, followed by female sex, lifetime psychiatric disorder, and low social support.Results presented here, are based on cross sectional data. Therefore no temporal relationships can be established.Our findings highlight the importance of early screening for PPD in both parents of VLBW infants. Factors contributing to developing depression should also be considered in neonatal care.

Objective It is almost a matter of fact for both clinicians and patients that pharmacological agents exert wanted as well as unwanted effects. In contrast, unwanted events of psychotherapy have long been neglected. Method The present study investigated the frequency and correlates of wanted and unwanted effects of psychotherapy in 85 participants with obsessive–compulsive disorder (OCD). The study was performed anonymously over the Internet in order to reduce response biases. Results Most patients showed ambivalent appraisals: 95% named at least one wanted effect, whereas 93% named at least one adverse treatment reaction (i.e., side-effect) and 89% indicated at least one instance of (subjective) malpractice. Complaints about unethical behavior were named by 14% of the participants. Wanted and unwanted effects were negatively correlated. Prevalent side-effects included development of new symptoms in 29% of the participants, for example, in the course of exposure treatment. Conclusions Our findings corroborate prior reports that adverse effects in psychotherapy are common, even if treatment is successful. Results refute a “no pain no gain” view: adverse events negatively impact outcome. Findings await confirmation in well-characterized in- and outpatient samples.

Hintergrund: Erwartungen können den tatsächlichen Verlauf einer medizinischen Behandlung beeinflussen - im positiven wie im negativen Sinne (Placebo- bzw. Nocebo-Effekt). Anhand zweier Fallberichte wird eine psychologische Kurzzeitintervention vorgestellt, die für Patientinnen mit Brustkrebs zu Beginn der Antihormontherapie konzipiert wurde («Antihormonelle Therapie erfolgreich meistern», ATEM). Den inhaltlichen Schwerpunkt bildet die Optimierung individueller behandlungsrelevanter Erwartungen mit dem Ziel, die Belastung durch Nebenwirkungen während der Medikamenteneinnahme zu verringern und die Lebensqualität zu verbessern. Falldarstellungen: Zwei Patientinnen, die im Rahmen einer randomisierten kontrollierten Studie am ATEM-Präventionsprogramm teilnahmen, werden vorgestellt. Die Kurzzeitintervention, die eine patientenzentrierte Aufklärung zu Nocebo-Effekten, Ressourcenaktivierung und Stärkung der Selbstwirksamkeitserwartungen im Umgang mit individuell befürchteten Symptomen umfasst, wurde qualitativ und quantitativ ausgewertet. Erhoben wurden die Behandlungserwartungen vor und nach der Intervention sowie die tatsächliche Nebenwirkungsbelastung und Lebensqualität vor Beginn der Antihormontherapie und im Follow-up nach 3 und 6 Monaten. Beide Patientinnen berichteten, von dem Programm profitiert zu haben, wobei sich unterschiedliche Schlüsselinterventionen zeigten. Bei beiden Patientinnen verbesserten sich die behandlungsrelevanten Erwartungen, verringerte sich die Nebenwirkungsbelastung und steigerte sich die Lebensqualität. Schlussfolgerung: Die psychologische Unterstützung zum Umgang mit befürchteten Nebenwirkungen erwies sich in beiden Fällen als geeignet, um die Belastung durch Krebsbehandlungen zu reduzieren. Die Optimierung von Behandlungserwartungen könnte einen wertvollen Beitrag zur Verbesserung der Versorgung von Patientinnen mit Brustkrebs leisten.

The main objective of this study was a detailed comparison of the level of anxiety about surgery and anesthesia. Other objectives included the assessment of the prevalence and intensity of preoperative anxiety.This cross-sectional single-center survey used the validated Amsterdam anxiety and information scale (APAIS) and a modified numeric rating scale (mNRS) to assess preoperative anxiety, anxiety about surgery and anxiety about anesthesia. Prevalences and intensities of anxieties were predominantly analyzed descriptively.3200 patients were enrolled and 3087 (57% females) were analyzed. 92.6% reported preoperative anxiety according to APAIS scores. The average total APAIS anxiety score (APAIS-A-T) was 9.9 (SD 3.6). 40.5% reported high anxiety (defined as APAIS-A-T 10). Mean anxiety about surgery (APAIS-A-Su) was higher than mean anxiety about anesthesia (APAIS-A-An): 5.5 (SD 2.1) vs. 4.3 (SD 1.9), p 0.0001. Accordingly, more patients were substantially more afraid (score difference 2) of surgery (642, 20.8%, 95% CI 19.4-22.3) than of anesthesia (48, 1.6%, 95% CI 1.2-2.1).Preoperative anxiety is still very common among adult patients scheduled to undergo an elective procedure. Therefore, it should be evaluated routinely. Anxiety about surgery and anxiety about anesthesia differ in many patients. For this reason, anxiety about surgery and anxiety about anesthesia should be assessed separately. This would allow providing a more individualized support of patients to cope with their anxiety and could require particular attention by the surgeon or the anesthetist.

Preterm births rates of infants with very low birth weight (VLBW 1500 g) are increasing. Prematurity poses several risks for emotional child development, e.g., internalizing symptoms. Our understanding of this condition in young children is limited, for at preschool age, symptoms have mostly been assessed from the mother's perspective only.As part of the longitudinal HaFEn cohort-study in Hamburg, Germany, we measured the level of internalizing symptoms in VLBW and term preschoolers as well as predictors from four informants' perspectives: mother, father, teacher, and child. A multilevel model was constructed to examine predictors of internalizing symptoms. n = 104 VLBW and n = 79 term children were included.From both their parents' perspective, children with VLBW had a significantly higher level of internalizing symptoms. From the teacher's and child's own perspectives, there were no significant mean group differences. In the multilevel analyses, the results were different regarding the four perspectives. VLBW did not predict internalizing symptoms. From mother's perspective, her own postpartum psychological distress, and from father's perspective, his postpartum and current psychological distress predicted a higher level of internalizing symptoms in their offspring. From teacher's perspective, socio-economic status predicted internalizing symptoms.The sample size was relatively small. Exclusion criteria and drop out of families could have created some selection bias.Our findings point to the importance of early identification of parental postpartum psychological distress given the potential for later internalizing symptoms in their children or the perception of their offspring as vulnerable and symptomatic, which may also impact the child's development.

Background The quality of decision-making in multidisciplinary team meetings (MDTMs) depends on the quality of information presented and the quality of team processes. Few studies have examined these factors using a standardized approach. The aim of this study was to objectively document the processes involved in decision-making in MDTMs, document the outcomes in terms of whether a treatment recommendation was given (none vs. singular vs. multiple), and to identify factors related to type of treatment recommendation. Methods An adaptation of the observer rating scale Multidisciplinary Tumor Board Metric for the Observation of Decision-Making (MDT-MODe) was used to assess the quality of the presented information and team processes in MDTMs. Data was analyzed using descriptive statistics and mixed logistic regression analysis. Results N = 249 cases were observed in N = 29 MDTMs. While cancer-specific medical information was judged to be of high quality, psychosocial information and information regarding patient views were considered to be of low quality. In 25% of the cases no, in 64% one, and in 10% more than one treatment recommendations were given (1% missing data). Giving no treatment recommendation was associated with duration of case discussion, duration of the MDTM session, quality of case history, quality of radiological information, and specialization of the MDTM. Higher levels of medical and treatment uncertainty during discussions were found to be associated with a higher probability for more than one treatment recommendation. Conclusions The quality of different aspects of information was observed to differ greatly. In general, we did not find MDTMs to be in line with the principles of patient-centered care. Recommendation outcome varied substantially between different specializations of MDTMs. The quality of certain information was associated with the recommendation outcome. Uncertainty during discussions was related to more than one recommendation being considered. Time constraints were found to play an important role. Some of those aspects seem modifiable, which offers possibilities for the reorganization of MDTMs. Electronic supplementary material The online version of this article (10.1186/s12885-017-3768-5) contains supplementary material, which is available to authorized users.

Blood volume pulse biofeedback represents an effective non-pharmacological treatment for migraine. However, the underlying mechanisms of blood volume pulse biofeedback are still unclear. This study investigated the influence of vividness of imagination, private body consciousness, perfectionism, and general self-efficacy on physiological (blood volume pulse amplitude) and psychological (session performance rated by participants and by trainers) success. Changes in skin conductance and skin temperature indicating habituation to training context were examined. Forty-five healthy male participants were randomized to four sessions of vasoconstriction training or vasodilatation training. Hierarchical linear models were estimated. Results showed significant changes of session performance rated by participants (UC = 0.62, p

Objective The SSS–8 is a brief questionnaire for the assessment of somatic symptom burden. This study examines its sensitivity to change and the minimal clinically important difference (MCID) in patients with mental disorders. Method 55 outpatients with mental disorders completed the SSS-8 and measures of anxiety, depression, and disability before and after receiving treatment. Effect sizes and correlations between the change scores were calculated. The MCID was estimated using a one standard error of measurement threshold and the change in disability as an external criterion. Results There was a medium decline in somatic symptom burden for the complete sample (n = 55, d z = 0.53) and a large decline in a subgroup with very high somatic symptom burden at baseline (n = 11, d z = 0.94). Decreases in somatic symptom burden were associated with decreases in anxiety (r = 0.68, p Conclusion The SSS-8 is sensitive to change. A 3-point decrease reflects a clinically important improvement. Due to its brevity and sound psychometric properties, the SSS-8 is useful for monitoring somatic symptom burden.

Objective Adherence to adjuvant endocrine therapy in women with breast cancer is low, and patients are not informed sufficiently. This study analyzes the effects of a structured treatment information on patients' satisfaction, knowledge, and adherence. Methods An interventional single cohort study of postoperative women with estrogen-receptor-positive breast cancer was conducted to study the effects of enhanced information about endocrine therapy given additionally to clinical routine information. Knowledge and satisfaction with additional information given 1–3 weeks after surgery were assessed before and after informing patients; adherence and knowledge were measured 3 months after start of treatment. Results A total of 137 patients were analyzed before and after provision of enhanced treatment information as well as 3 months after start of endocrine therapy. Enhanced information increased satisfaction with information and knowledge. The percentage of patients who knew their estrogen receptor status increased from 50% to 93%. At 3 months follow-up, 60% still had correct knowledge. Patients who learned their receptor status were older, and those who forgot had lower cognitive abilities and lower educational level. Patients with higher satisfaction, better learning, and comprehension directly after enhanced information showed better adherence at 3 months follow-up. Conclusion Patients, especially older ones, can benefit from enhanced treatment information given additionally to routine care. Enhanced information about mode of action and potential side effects of endocrine therapy when included into clinical routine might foster patient autonomy and prevent early disruptions in adherence. Copyright © 2014 John Wiley & Sons, Ltd.

Objective: A cancer diagnosis affects patients’ quality of life (QOL) as well as their pursuit of life goals. However, numerous studies have shown surprisingly stable QOL measures in cancer patients over time. We propose that life goal adjustment can act as the missing link in explaining this response shift. Thus, the aim of this study was to examine associations between life goal adjustment and patients’ QOL at baseline and over the course of 20 months. Methods: Eighty-six cancer patients were recruited during rehabilitation and reassessed at followup 20 months later. Life goals were measured using the Life Goals Questionnaire and analyzed in relation to global QOL as assessed with the World Health Organization Quality of Life Questionnaire – Short Form. Results: The overall attainment of life goals was associated with QOL. Moreover, over a period of 20 months, perceived QOL and goal attainment remained stable, whereas importance of life goals decreased. Lesser importance and improved goal attainment were predictors of increases in QOL. Conclusions: Results suggest that downgrading unattainable goals and making more progress in accomplishing attainable goals may be possible mechanisms of response shift as an adaption to illness. Thus, integrating life goal adjustment into rehabilitation services for cancer patients seems to be worthwhile to enhance an adaptive self-regulation and QOL. Copyright © 2014 John Wiley & Sons, Ltd.

Hintergrund: Negative Effekte von Psychotherapie sind bis heute wenig systematisch untersucht. Diese Studie stellt die Konstruktion eines Selbstbeurteilungsverfahrens zur Erfassung negativer Effekte von Psychotherapie vor. Patienten und Methoden: Ein Itempool zur breiten Erfassung möglicher erlebter negativer Veränderungen durch Psychotherapie in den Bereichen intrapersonelle Veränderungen, Partnerschaft, Freunde und Familie, Arbeitsplatz, therapeutisches Fehlverhalten und Stigmatisierung wurde über Literaturrecherchen und Expertenbefragungen generiert. Items wurden bipolar formuliert, um ein negatives Priming zu verhindern. Zusätzlich wurde die jeweilige Attribution der Veränderung auf die Psychotherapie oder andere externe Ursachen erfragt. Im Zeitraum von November 2010 bis Februar 2011 nahmen 195 ehemalige Psychotherapiepatienten (74,9% weiblich; Alter M = 38,4 Jahre; SD = 11,8) an einer Onlineuntersuchung teil, bei der auch die Rahmenbedingungen der Psychotherapie erfragt wurden. Ergebnisse: Von 195 Befragten gaben 93,8% (n = 183) an, negative Effekte durch ihre Psychotherapie erlebt zu haben. Die höchsten Raten erlebter negativer Effekte ergaben sich in den Bereichen intrapersonelle Veränderungen (15,8%), Stigmatisierung (14,9%) und Partnerschaft (12,0%). Schwerwiegendes therapeutisches Fehlverhalten wie sexuelle Belästigung (2,6%) oder körperliche Gewalt (1%) durch den Therapeuten hatten eine geringe Prävalenz. Anhand von Itemanalysen sowie inhaltlichen Kriterien wurde das Inventar zur Erfassung negativer Effekte von Psychotherapie (INEP) mit 21 Items erstellt (α = 0,86). Diskussion: Ein Großteil der negativen Veränderungen trat innerhalb des therapeutischen Settings auf (z.B. verletzende Aussagen des Therapeuten, Phasen der Niedergeschlagenheit). Zudem wurden mehr negative Effekte genannt, wenn die therapeutische Beziehung als negativ beschrieben wurde. Schlussfolgerung: Negative Effekte von Psychotherapien sind feststellbar und können mittels Patientenbefragungen und einer systematischen Analyse, via INEP erfasst werden. Die Analyse des Instruments in weiteren klinischen Subpopulationen ist notwendig.

Despite various ups and downs in the history of psycho-oncology, it’s more and more developing to an evidence-based intervention that is a necessary prerequisite of a competent cancer treatment center. Various psychosocial factors have been identified that contribute to the development, course, and prognosis of cancer, such as life stress, social network, or comorbid depression. Psycho-oncology offers training programs for physicians how to minimize distress in the “breaking bad news” situation, but full intervention programs how to cope with life stress, how to cope with comorbid pain and fatigue are also available. Latest developments offer interventions to reduce the burden that is associated with medical side effects of oncologic treatments. In addition to the medical treatments, psycho-oncologic interventions are crucial to optimize quality of life of cancer patients. Finally, psychosocial interventions how to deal with end-of-life issues are also developing, but need further evaluation.

Background We aimed to investigate placebo and nocebo reactions in randomized controlled trials (RCT) of pharmacological treatments for persistent depressive disorder (PDD). Methods We conducted a systematic electronic search and included RCTs investigating antidepressants for the treatment of PDD. Outcomes were the number of patients experiencing response and remission in placebo arms (=placebo reaction). Additional outcomes were the incidence of patients experiencing adverse events and related discontinuations in placebo arms (=nocebo reaction). A priori defined effect modifiers were analyzed using a series of meta-regression analyses. Results Twenty-three trials were included in the analyses. We found a pooled placebo response rate of 31% and a placebo remission rate of 22%. The pooled adverse event rate and related discontinuations were 57% and 4%, respectively. All placebo arm outcomes were positively associated with the corresponding medication arm outcomes. Placebo response rate was associated with a greater proportion of patients with early onset depression, a smaller chance to receive placebo and a larger sample size. The adverse event rate in placebo arms was associated with a greater proportion of patients with early onset depression, a smaller proportion of females and a more recent publication. Conclusions Pooled placebo and nocebo reaction rates in PDD were comparable to those in episodic depression. The identified effect modifiers should be considered to assess unbiased effects in RCTs, to influence placebo and nocebo reactions in practice. Limitations Limitations result from the methodology applied, the fact that we conducted only univariate analyses, and the number and quality of included trials.

Background This study aims to determine the role of patient expectations as potentially modifiable factor of side-effects, quality of life, and adherence to endocrine treatment of breast cancer. Patients and methods A 2-year prospective clinical cohort study was conducted in routine primary care with postoperative patients with hormone-receptor-positive breast cancer, scheduled to start adjuvant endocrine treatment. Structured patient-reported assessments of side-effects, side-effect expectations, quality of life, and adherence took place during the first week post-surgery and after 3 and 24 months of endocrine treatment. Results Of 111 enrolled patients, at 3 and 24 months, 107 and 88 patients, respectively, were assessed. After 2 years of endocrine treatment, patients reported high rates of side-effects (arthralgia: 71.3%, weight gain: 53.4%, hot flashes: 46.5%), including symptoms not directly attributable to the medication (breathing problems: 28.1%, dizziness: 25.6%). Pre-treatment expectations significantly predicted patient-reported long-term side-effects and quality of life in multivariate models controlling for relevant medical and psychological variables. Relative risk of side-effects after 2 years of endocrine treatment was higher in patients with high negative expectations at baseline than in those with low negative expectations (RR = 1.833, CI 95%, 1.032–3.256). A significant interaction confirmed this expectation effect to be particularly evident in patients with high side-effects at 3 months. Furthermore, baseline expectations were associated with adherence at 24 months (r = -0.25, P = 0.006). Conclusions Expectations are a genuine factor of clinical outcome from endocrine treatment for breast cancer. Negative expectations increase the risk of treatment-specific side-effects, nocebo side-effects, and non-adherence. Yet, controlled studies are needed to analyze potential causal relationships. Optimizing individual expectations might be a promising strategy to improve side-effect burden, quality of life, and adherence during longer-term drug intake. Trial registration ClinicalTrials.gov Identifier: NCT02088710.

This comprehensive review provides an overview about placebo and nocebo phenomena in antidepressant trials. Improvements in the placebo groups may partly be explained through methodological issues such as natural course of depression and regression to the mean, but also fundamentally reflect investigators' and participants' expectations. A meta-analysis by our group of 96 randomized placebo-controlled trials showed large placebo responses to antidepressant medication. Moderator analyses revealed substantially larger placebo responses in observer ratings compared with self-report. Effect sizes in observer ratings showed strong increase with publication year while this effect was not found for patients' self-ratings. This reflects the strong influence of investigators' expectations. The analysis of ‘nocebo effects’, e.g. adverse effects in placebo groups of antidepressant trials also confirms the impact of expectations: nocebo symptoms reflected the typical side-effect patterns expected in the drug group, with higher symptoms rates in the placebo groups of tricyclic antidepressant trials compared with placebo groups of trials testing selective serotonin reuptake inhibitors. While the placebo response seems to be similar for women and men, gender differences were found for nocebo rates. In the conclusion, we discuss potential implications for clinical trial designs and argue for interventions aimed at optimizing positive expectations of treatment benefit while minimizing the impact of adverse effects.

Purpose Side effects in clinical trials are frequently assessed in an unstructured fashion, using ascertainment strategies with unclear quality criteria. To improve the assessment and interpretation of general side effects, a structured approach is presented and validated (General Assessment of Side Effects, GASE). Base rates and reference data of the general population as well as quality criteria of this new side effect ascertainment method are provided. Methods We developed a screener assessing the most common subjective side effects of clinical trials (according to FDA statistics and others). The screener was evaluated in a general population survey including 2512 participants, 1276 of them taking drugs. Results We present reference data of the general population that help to interpret and compare future results of clinical trials assessing general side effects. Highest scores for side effects were reported from users of psychopharmacological drugs, medium scores of people taking antihypertensives, and lower scores of people taking lipid-lowering drugs, pain killers, and antidiabetics. If people take multiple drugs, more side effects are reported compared to single-class drugs. This confirms GASE's validity to assess side effects. Conclusion We suggest that a structured, patient-based approach to assess general side effects could improve the detection of drug-induced side effects. The problem of clinical studies being underpowered to detect side effects could be reduced by using more reliable approaches. Our plea is for side effect ascertainment with sophisticated approaches for expected side effects, systematic screening for general side effects, and open question methods for spontaneous reports. Copyright © 2010 John Wiley & Sons, Ltd.