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Introduction Somatic symptom disorder (SSD) is a distressing mental disorder characterised by the presence of at least one persistent somatic symptom and a significant psychological burden due to the symptom(s), as well as excessive thoughts, feelings or behaviours related to them or associated health concerns. The primary aim of our study is to deepen the understanding of risk factors and mechanisms for somatic symptom persistence. Specifically, we will investigate the role of patients’ expectations and somatic comorbidity regarding symptom persistence.Methods and analysis In a prospective 12-month cohort study, n=240 patients with SSD will be recruited from the outpatient clinics of the Department of Psychosomatic Medicine and Psychotherapy at the University Medical Center Hamburg-Eppendorf. The roles of two hypothesised predictors (ie, expectations and comorbidity) will be analysed together with known predisposing and maintaining factors of persistent somatic symptoms. The study entails macrolevel and microlevel assessments to investigate symptom severity over different timespans. Assessments at the macrolevel take place at baseline, 6 and 12 months. At the microlevel, a 10-day ecological momentary assessment study will be implemented to elucidate patients’ dynamic experience with somatic symptoms in their natural environments. In order to elicit possible framing effects on the 10-day course of symptom severity, participants are randomised to either a positive or a negative expectation framing group. Cross-lagged panel models will be used to analyse data at the macrolevel. At the microlevel, multivariate latent growth curve models will be conducted to relate temporal changes in predictor and outcome variables to one another.Ethics and dissemination The study was approved by the Ethics Committee of the Medical Associations Hamburg, Germany (2020-10197-BO-ff). The results will enable us to draw conclusions regarding the role of expectations for future targeted treatment options and regarding the utility of somatic comorbidity as a potential diagnostic specifier of SSD. Dissemination of our results will be achieved through scientific publications, and lay summaries for study participants, patient advocacy groups and the general public.Trial registration number ISRCTN36251388.

Background Treatment expectations influence clinical outcomes in various physical and psychological conditions; however, no studies have explored their role in endometriosis treatment. It is necessary to understand how these expectations can be measured to study treatment expectations and their effects in clinical practice. This study aimed to psychometrically analyze and compare different treatment expectation measurements and describe treatment expectations in women with suspected endometriosis. Method Analysis of cross-sectional baseline data of a mixed-method clinical observational study of N=699 patients undergoing laparoscopy in Germany. Descriptives, bivariate associations, convergent and discriminant validity of four expectation measurements (Treatment Expectation Questionnaire (TEX-Q); Generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE); numerical rating scales (NRS) assessing improvement and worsening of endometriosis symptoms, expected Pain Disability Index (PDI); range: 0 to 10) were estimated. A cluster analysis was performed on the three GEEE items. Results Most participants expected high improvement (M=6.68 to 7.20, SD=1.90 to 2.09) and low worsening (M=1.09 to 2.52, SD=1.80 to 2.25) of disability from laparoscopy. Participants who expected greater worsening expected more side effects (r=.31 to .60, p

Abstract Background Antidepressant discontinuation is associated with a broad range of adverse effects. Debilitating discontinuation symptoms can impede the discontinuation process and contribute to unnecessary long-term use of antidepressants. Antidepressant trials reveal large placebo effects, indicating a potential use of open-label placebo (OLP) treatment to facilitate the discontinuation process. We aim to determine the effect of OLP treatment in reducing antidepressant discontinuation symptoms using a series of N-of-1 trials. Methods A series of randomized, single-blinded N-of-1 trials will be conducted in 20 patients with fully remitted DSM-V major depressive disorder, experiencing moderate to severe discontinuation symptoms following antidepressant discontinuation. Each N-of-1 trial consists of two cycles, each comprising two-week alternating periods of OLP treatment and of no treatment in a random order, for a total of eight weeks. Our primary outcome will be self-reported discontinuation symptoms rated twice daily via the smartphone application ‘StudyU’. Secondary outcomes include expectations about discontinuation symptoms and (depressed) mood. Statistical analyses will be based on a Bayesian multi-level random effects model, reporting posterior estimates of the overall and individual treatment effects. Discussion Results of this trial will provide insight into the clinical application of OLP in treating antidepressant discontinuation symptoms, potentially offering a new cost-effective therapeutic tool. This trial will also determine the feasibility and applicability of a series of N-of-1 trials in a clinical discontinuation trial. Trial registration ClinicalTrials.gov: NCT05051995, first registered September 20, 2021.

Abstract Background Antidepressants are established as an evidence-based, guideline-recommended treatment for Major Depressive Disorder. Prescriptions have markedly increased in past decades, with a specific surge in maintenance prescribing. Patients often remain on antidepressants longer than clinically necessary. When attempting to stop, many patients experience adverse discontinuation symptoms. Discontinuation symptoms can be debilitating and hinder successful discontinuation. While discontinuation symptoms can result from pharmacological effects, evidence on nocebo-induced side effects of antidepressant use suggests that patients' expectations may also influence occurrence. Methods To disentangle pharmacological and expectation effects in antidepressant discontinuation, patients with fully remitted Major Depressive Disorder who fulfill German guideline recommendations to discontinue will either remain on or discontinue their antidepressant. Participants' expectations will be manipulated by varying verbal instructions using an open-hidden paradigm. Within the open trial arms, participants will receive full information about treatment, i.e., high expectation. Within the hidden trial arms, participants will be informed about a 50% chance of discontinuing versus remaining on their antidepressant, i.e., moderate expectation. A total of N = 196 participants will be randomly assigned to either of the four experimental groups: open discontinuation (OD; n = 49), hidden discontinuation (HD; n = 49), open continuation (OC; n = 49), or hidden continuation (HC; n = 49). Discontinuation symptom load during the 13-week experimental phase will be our primary outcome measure. Secondary outcome measures include discontinuation symptom load during the subsequent 39-week clinical observation phase, recurrence during the 13-week experimental period, recurrence over the course of the complete 52-week trial evaluated in a time-to-event analysis, and stress, anxiety, and participants’ attentional and emotional processing at 13 weeks post-baseline. Blood and saliva samples will be taken as objective markers of antidepressant blood serum level and stress. Optional rsfMRI measurements will be scheduled. Discussion Until today, no study has explored the interplay of pharmacological effects and patients’ expectations during antidepressant discontinuation. Disentangling their effects has important implications for understanding mechanisms underlying adverse discontinuation symptoms. Results can inform strategies to manage discontinuation symptoms and optimize expectations in order to help patients and physicians discontinue antidepressants more safely and effectively. Trial registration ClinicalTrials.gov (NCT05191277), January 13, 2022.

Abstract Background The legal and ethical guidelines of psychological professional associations stipulate that informed consent by patients is an essential prerequisite for psychotherapy. Despite this awareness of the importance of informed consent, there is little empirical evidence on what psychotherapists’ attitudes towards informed consent are and how informed consent is implemented in psychotherapeutic practice. Methods 155 psychotherapists in Switzerland completed an online survey assessing their attitudes regarding informed consent. Results Among the surveyed psychotherapists, there was a high consensus on important information that should be communicated to patients in the context of informed consent. Almost all psychotherapists rated confidentiality and its exemptions (95%) and self-determined decision-making (97%) as important. The importance to disclose information regarding fees and the empirical effectiveness of the provided treatment, were both seen as important by more than 80% of participants. The disclosure of personal information about the therapist was rated as important by 60%. Other aspects, which are not direct components of informed consent but rather overarching goals, were also evaluated rather homogeneously: self-determined decision making of the patient was rated as important by almost all of the surveyed psychotherapists (97%). The following components were also judged as important by a majority of the participants: promotion of hope (80%) and discussion of treatment goals (93%). Most psychotherapists described the implementation of informed consent as an ongoing process, rather than a one-time event during the first session of therapy. Therapists’ age, postgraduate training, treated patient group, and setting influenced attitudes towards informed consent. Conclusions The present study shows that informed consent is perceived by psychotherapists as both a challenge and a resource. The implementation of informed consent in psychotherapy requires further research from a clinical and ethical perspective.

Introduction Overall, 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 analysis A 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.Discussion To 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 dissemination The Ethics Committee of the Psychotherapeutenkammer Hamburg, Germany, gave ethical approval (ROXWELL-2021-HH, 25 June 2021).Trial registration number ClinicalTrials.gov Registry (NCT05019612).

BackgroundPatients' expectations, as a central mechanism behind placebo and nocebo effects, are an important predictor of health outcomes. Yet, theoretically based generic assessment tools allowing for an integrated understanding of expectations across conditions and treatments are lacking. Based on the preliminary 35-item version, this study reports the development and validation of the Treatment Expectation Questionnaire (TEX-Q), a generic, multidimensional self-report scale measuring patients' expectations of medical and psychological treatments.MethodsThe TEX-Q was developed in a validation sample of n = 251 patients undergoing different treatments using exploratory factor analyses and item analyses, as well as analysis of convergent and divergent validity. Confirmatory factor analysis was conducted in an independent sample of n = 303 patients undergoing cancer treatment. Two-weeks test-retest reliability was assessed in n = 28 psychosomatic outpatients.ResultsFactor analyses revealed six theoretically founded stable subscales. The TEX-Q assesses expectations of treatment benefit, positive impact, adverse events, negative impact, process and behavioural control with a total of 15 items. Results for the subscales and the sum score indicated good internal consistency (α = .71-.92), moderate to high test-retest reliability (r = .39-.76) as well as good convergent validity with regard to other expectation measures (r = .42-.58) and divergent validity with regard to measures of generalized expectations (r < .32) and psychopathology (r < .28).ConclusionsWhile further validation is needed, the results suggest that the TEX-Q is a valid and reliable scale for the generic, multidimensional assessment of patients' treatment expectations. The TEX-Q overcomes constraints of ad-hoc and disease-specific scales, while allowing to compare the impact of different expectation constructs across conditions and treatments.

BackgroundInformed 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. ObjectiveThis protocol describes a randomized controlled web-based trial aiming to investigate the efficacy of a one-session optimized informed consent consultation. MethodsThe 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. ResultsThis 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. ConclusionsIf 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 RegistrationPsychArchives; http://dx.doi.org/10.23668/psycharchives.4929 International Registered Report Identifier (IRRID)DERR1-10.2196/39843

Abstract Although awareness of side effects over the course of psychotherapy is growing, side effects are still not always reported. The purpose of the present study was to examine side effects in a randomized controlled trial comparing Metacognitive Training for Depression (D-MCT) and a cognitive remediation training in patients with depression. 84 patients were randomized to receive either D-MCT or cognitive remediation training (MyBrainTraining) for 8 weeks. Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ). D-MCT and MyBrainTraining did not differ significantly in the number of side effects. At post assessment, 50% of the D-MCT group and 59% of the MyBrainTraining group reported at least one side effect in the SIAN. The most frequently reported side effect was disappointment in subjective benefit of study treatment. At follow-up, 52% reported at least one side effect related to MyBrainTraining, while 34% reported at least one side effect related to the D-MCT in the NEQ. The most frequently reported side effects fell into the categories of “symptoms” and “quality”. Our NEQ version was missing one item due to a technical error. Also, allegiance effects should be considered. The sample size resulted in low statistical power. The relatively tolerable number of side effects suggests D-MCT and MyBrainTraining are safe and well-received treatment options for people with depression. Future studies should also measure negative effects to corroborate our results.

Objectives During 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.Design A cross-sectional study using a semi-structured interview and a paper-based questionnaireSetting University Hospital in Germany.Participants 151 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 measures Expectations, end-of-life fears and experiences of end-of-life discussions.Results Patients 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, p

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.

Abstract 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.

Relevance: Understanding patients’ informational needs and adapting drug-related information are the prerequisites for a contextualized informed consent. Current information practices might rather harm by inducing nocebo effects.Objective: To investigate whether informing about the nocebo effect using a short information sheet affects patients’ need for information about antidepressants.Methods: A total of 97 patients taking recently prescribed antidepressants (≤4 months intake) were recruited over the internet and randomized to receiving either a one-page written information about the nocebo effect or a control text about the history of antidepressants. After experimental manipulation, informational needs about the side effects and mechanisms of antidepressants were assessed with 3 and 7 items on categorical and 5-point Likert scales. Group differences in informational needs were calculated with Chi-square tests and ANOVAs.Results: Patients received antidepressants for depression (84.5%) and/or anxiety disorders (42.3%). Three participants (6.0%) of the nocebo group reported previous knowledge of the nocebo effect. After the experimental manipulation, participants in the nocebo group reported a reduced desire for receiving full side effect information [X(4,97)2 = 12.714, Cramer’s V = 0.362, p = 0.013] and agreed more frequently to the usefulness of withholding information about possible side effects [X(4,97)2 = 14.878, Cramer’s V = 0.392, p = 0.005]. Furthermore, they desired more information about the mechanisms of antidepressants (F = 6.373, p = 0.013, partial η2 = 0.063) and, specifically, non-pharmacological mechanisms, such as the role of positive expectations (F = 16.857, p < 0.001, partial η2 = 0.151).Conclusions: Learning about the nocebo effect can alter patients’ informational needs toward desiring less information about the potential side effects of antidepressants and more information about general mechanisms, such as expectations. The beneficial effects of including nocebo information into contextualized informed consent should be studied clinically concerning more functional information-seeking behavior, which may ultimately lead to improved treatment outcomes, such as better adherence and reduced side effect burden.

Objective Patients’ 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.Design The 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.Setting Patients were recruited in primary care at two hospitals in Hamburg, Germany.Participants 13 scientific experts participated in the expert survey. 11 patients waiting for psychological or surgical treatments participated in the qualitative interviews.Results The 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.Conclusions The 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.

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 (t0), discharge (t1), and 9-month follow-up (t2). 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 (t2) and 15.2% of outpatients. At least one case of malpractice and unethical behavior was reported by 28.8% of inpatients (t2) 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 (t0) 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.

Objectives We aimed to develop a digital intervention to support antidepressant discontinuation in UK primary care that is scalable, accessible, safe and feasible. In this paper, we describe the development using a theory, evidence and person-based approach.Design Intervention development using a theory, evidence and person-based approach.Setting Primary Care in the South of England.Participants Fifteen participants with a range of antidepressant experience took part in ‘think aloud’ interviews for intervention optimisation.Intervention Our digital intervention prototype (called ‘ADvisor’) was developed on the basis of a planning phase consisting of qualitative and quantitative reviews, an in-depth qualitative study, the development of guiding principles and a theory-based behavioural analysis. Our optimisation phase consisted of ‘think aloud’ interviews where the intervention was iteratively refined.Results The qualitative systematic review and in-depth qualitative study highlighted the centrality of fear of depression relapse as a key barrier to discontinuation. The quantitative systematic review showed that psychologically informed approaches such as cognitive–behavioural therapy were associated with greater rates of discontinuation than simple advice to reduce. Following a behavioural diagnosis based on the behaviour change wheel, social cognitive theory provided a theoretical basis for the intervention. The intervention was optimised on the basis of think aloud interviews, where participants suggested they like the flexibility of the system and found it reassuring. Changes were made to the tone of the material and the structure was adjusted based on this qualitative feedback.Conclusions ‘ADvisor’ is a theory, evidence and person-based digital intervention designed to support antidepressant discontinuation. The intervention was perceived as helpful and reassuring in optimisation interviews. Trials are now needed to determine the feasibility, clinical and cost-effectiveness of this approach.

[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.

Abstract Background Patients undergoing chemotherapy are highly burdened by side effects. These may be caused by the pharmacodynamics of the drug or be driven by psychological factors such as negative expectations or pre-conditioning, which reflect nocebo effects. As such, negative pre-treatment expectations or prior experiences might exacerbate the burden of chemotherapy side effects. Educating patients about this nocebo effect has been put forward as a potential strategy to optimize patients’ pre-treatment expectations. In this study, we evaluate whether a briefing about the nocebo effect is efficacious in reducing side effects. Methods In this exploratory study, a total number of n = 100 outpatients with newly diagnosed gastrointestinal cancers are randomized 1:1 to an information session about the nocebo effect (nocebo-education) or an attention control group (ACG) with matching interaction time. Assessments take place before the intervention (T1 pre), post-intervention (T1 post), and 10 days (T2) and 12 weeks (T3) after the initial chemotherapy. The primary outcomes are the patient-rated number and intensity of side effects at 10-days and at 12-weeks follow-up. Secondary outcomes include coping with side effects, tendency to misattribute symptoms, compliance intention, attitude towards the chemotherapy, co-medication to treat side effects and the clinician-rated severity of toxicity. Further analyses are conducted to investigate whether a potential beneficial effect is mediated by a change of expectations before and after the intervention. Discussion Informing patients about the nocebo effect might be an innovative and feasible intervention to reduce the burden of side effects and strengthen patients’ perceived control over adverse symptoms. Trial registration The trial is registered at the German Clinical Trials Register (ID: DRKS00009501; retrospectively registered on March 27, 2018). The first patient was enrolled on September 29, 2015.

Abstract 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.

Relevance: Informing patients about potential adverse events as part of the informed consent may facilitate the development of nocebo-driven drug adverse events (nocebo side effects).Objective: To investigate whether informing about the nocebo effect using a short information sheet can reduce nocebo side effects.Methods: A total of N = 44 participants with weekly headaches for at least 6 months were recruited using the cover story of a clinical trial for a headache medicine. In reality, all participants took a placebo pill and were randomized to the nocebo information group or the standard leaflet group. Participants were instructed to read the bogus medication leaflet entailing side effects information shortly before pill intake. The nocebo group additionally received an explanation about the nocebo effect as part of the leaflet. Questionnaires were completed at baseline, 2 min, and 4 days after the pill intake. We conducted general linear models with bootstrap sampling. Baseline symptoms were included as a covariate.Results: Most participants (70.5%) reported nocebo side effects at 2 min. Participants who received the nocebo information (n = 24) reported less nocebo symptoms than the control group (n = 20) (estimated difference: 3.3, BCa 95% CI [1.14; 5.15], p = 0.01, Cohen’s d = 0.59). Baseline symptoms, perceived sensitivity to medicine, and side effect expectations each moderated the group effect (estimated difference in slope: 0.47, BCa 95% CI [0.19; 0.73], p = 0.001, d = 0.75; 1.07 [0.27; 1.61], p = 0.006, d = 0.73; 1.57 [0.38; 2.76], p = 0.02, d = 0.58). No group differences were found at 4-day follow-up. After revealing the actual aim of the study, 86% of the participants evaluated the nocebo information to be helpful in general.Conclusions: Results provide the first evidence that informing about the nocebo effect can reduce nocebo side effects.

BACKGROUND:Providing patient information is a central aspect of patient-centered care. Fulfilling personal information needs has positive effects on several health-related outcomes. Measurement instruments help to identify individual information needs in an effective way. The present study gives an overview of existing information needs measures and further evaluates the quality of their psychometric properties and their psychometric studies. METHODS:We conducted a systematic search on psychometric studies of measures that assess information needs in PubMed and Embase. Furthermore, we carried out a secondary search with reference and citation tracking of the included articles. Title, abstracts and full texts were screened by two independent reviewers for eligibility. We extracted data on content of the measures, validation samples and psychometric properties. In addition we rated the methodological quality with the COSMIN checklist and the quality of psychometric properties with the criteria of Terwee and colleagues. RESULTS:24 studies on 21 measures were included. Most instruments assessed information needs of patients with cancer or cardiac diseases. The majority of the instruments were in English language and from western countries. Most studies included information on internal consistency and content validity. The ratings showed mixed results with clear deficiencies in the methodological quality of most studies. DISCUSSION:This is the first systematic review that summarized the existing evidence on measures on patient information needs using two instruments for a systematic quality assessment. The results show a need for more psychometric studies on existing measures. In addition, reporting on psychometric studies needs to be improved to be able to evaluate the reliability of the psychometric properties. Furthermore, we were not able to identify any measures on information needs for some frequent chronic diseases. Other methods to elicit information needs (e.g. open-ended interviews, question prompt sheets) could be considered as alternatives if sound measures are missing.

While substantial placebo and nocebo effects have been documented in antidepressant clinical trials, physicians' awareness of the nonspecific effects in routine antidepressant treatment remains unclear. The study investigated physicians' beliefs and explanatory models regarding the desired effects and undesired side effects of antidepressants, with specific emphasis on nonspecific effects accounted for by placebo and nocebo mechanisms.An online survey was conducted among 87 physicians (40.2% psychiatrists, 25.3% neurologists, 24.1% general practitioners, 12.6% internists, 21.8% other). The survey assessed the physician's beliefs in antidepressant effectiveness, as well as 6 explanatory models regarding antidepressant effectiveness and 8 explanatory models for the occurrence of side effects.Most physicians (89.7%) believed in the effectiveness of antidepressants while acknowledging a considerable role of the placebo effect by attributing around 40% of the total effects to nonspecific factors. For both antidepressant effectiveness and the occurrence of side effects, pharmacological effects were rated as most important (93.1% and 80.5% agreement), but physicians also attributed a substantial role to the patients' expectations (63.2% and 58.6%) and experiences (60.9% and 56.3%). Concerning the physician's own role in promoting nonspecific effects in antidepressant effectiveness, highest endorsements were found for the quality of the physician-patient-relationship (58.6%) and own expectations (41.4%). When asked about side effects, fewer participants agreed that informing the patient about known side effects (25.2%) or the physicians' expectations themselves (17.2%) could induce side effects.Physicians, when prescribing antidepressants, are generally open towards nonspecific treatment mechanisms. However, they consider their own influence as less important than the patient's side, especially when it comes to the explanation of unwanted side effects. Awareness of the possible beneficial as well as malicious role of nonspecific mechanisms should be fostered as the first step towards optimizing antidepressant treatment by promoting placebo while avoiding nocebo effects.

We aimed to compare the safety of antidepressants for the treatment of persistent depressive disorder (PDD) with each other and with placebo. We conducted a systematic electronic search and included randomized controlled trials that investigated antidepressants for the treatment of PDD in adults. Outcomes were the incidence of experiencing any adverse event, specific adverse events and related treatment discontinuations. We analyzed the data using traditional and network meta-analyses. Thirty-four studies that comprised 4,769 patients and examined 20 individual agents in nine substance classes were included. Almost all analyzed substance classes were associated with higher discontinuation rates than placebo including tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), antipsychotics, and the serotonin antagonist and reuptake inhibitor (SARI) trazodone. The odds of experiencing any adverse event were significantly higher for TCAs and serotonin noradrenaline reuptake inhibitors (SNRIs) compared to placebo. Pairwise comparisons among the substance classes revealed that more patients receiving TCAs or SNRIs experienced any adverse event and that more patients receiving TCAs or the SARI trazodone discontinued treatment. The complementary treatment with acetyl-l-carnitine showed lower rates of experiencing any adverse event and related discontinuations than all other comparators. TCAs were primarily associated with (anti-)cholinergic and sedating adverse events. SSRIs primarily showed gastrointestinal adverse events. Patients treated with the antipsychotic amisulpride were more likely to manifest weight gain and endocrine adverse events. The comparative evidence for further agents was insufficient or lacking. The identified safety differences may be used to inform the selection among the antidepressants.

BACKGROUND: Adherence to medication is low in specific populations who need chronic medication. However, adherence to medication is also of interest in a more general fashion, independent of specific populations or side effects of particular drugs. If clinicians and researchers expect patients to show close to full adherence, it is relevant to know how likely the achievement of this goal is. Population based rates can provide an estimate of efforts needed to achieve near complete adherence in patient populations. The objective of the study was to collect normative data for medication nonadherence in the general population. METHODS AND FINDINGS: We assessed 2,512 persons (a representative sample of German population). Adherence was measured by Rief Adherence Index. We also assessed current medication intake and side effects. We found that at least 33% of Germans repeatedly fail to follow their doctor's recommendations regarding pharmacological treatments and only 25% of Germans describe themselves as fully adherent. Nonadherence to medication occurs more often in younger patients with higher socioeconomic status taking short-term medications than in older patients with chronic conditions. Experience with medication side effects was the most prominent predictor of nonadherence. CONCLUSIONS: The major strengths of our study are a representative sample and a novel approach to assess adherence. Nonadherece seems to be commonplace in the general population. Therefore adherence cannot be expected per se but needs special efforts on behalf of prescribers and public health initiatives. Nonadherence to medication should not only be considered as a drug-specific behaviour problem, but as a behaviour pattern that is independent of the prescribed medication.