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It is not only crucial to provide patients with information, but also to communicate this information in a way to enable patient participation in health decisions. Experimental studies investigating the association between the communication style of health professionals and patients' health decisions are rare, which limits causal conclusions. This study investigated the effect of a doctor's patient-centered communication style on the likelihood to take a medication.Healthy women (N = 120) were randomly allocated to one of three groups. They either received a medical consultation characterized by a patient-centered communication style (PC group) or by a doctor-centered communication style (DC group) or they received no consultation at all (control group). All participants were told that the study would investigate the effects of a 'concentration-enhancing medication'. Voluntary intake of the medication (a placebo pill) served as behavioral outcome. Participants' self-rated intention to take the medication was measured at three assessment points. Data were analyzed using a Chi-square-test and a mixed analysis of covariance.In each group, 40 participants were analyzed. Following the consultation, groups did not differ regarding the behavioral outcome, but participants' intention to take the medication was higher in the PC group compared with the control group.Our results indicate that patient-centered communication has a beneficial influence on participants' intention to take medication. Future studies should investigate the role of communication in individuals with health conditions that require a specified treatment plan and taking medication over the long-term.

Background: Open-label placebo (OLP) treatment seems to be effective in several medical conditions but has not yet been investigated in insomnia. Furthermore, it needs to be evaluated whether providing a plausible treatment rationale is essential to obtain OLP effects., Methods: In two consecutive nights, the sleep of patients with primary insomnia (n = 45) was assessed via subjective and objective measures. Before the second night, they received a single OLP pill that was randomly provided either with a treatment rationale (OLP+) or without (OLP-). When (M)ANOVAs did not reveal differential effects between the two OLP groups, the OLP+ group was compared post-hoc to a formerly assessed no pill control sample (NPC; n = 23)., Results: Neither the MANOVAs nor the ANOVAs revealed significant interaction effects of treatment group and assessment night. The OLP+ condition was superior neither to OLP- nor to NPC in improving the patients' sleep., Discussion: Our findings do neither confirm the general efficacy of OLP in primary insomnia nor differential effects depending on the treatment rationale. Possible explanations lie in the dosing scheme (i.e., single OLP application), the provision of the OLP rationale by video and the experimental instead of therapeutic character of our investigation. Trials with larger samples and longer-term OLP treatment in insomnia are needed. Providing the rationale face-to-face and in a clinical setting might be additionally beneficial., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Adverse events in clinical drug trials are often poorly assessed and reported. The absence of baseline assessment and structured symptom lists, as well as the fact that most drug trials are industry-sponsored are common sources of bias. In addition, adverse events are usually assessed in patient samples, which can bias results because of the misattribution of symptoms that are part of the illness to medication intake. We aimed to identify amitriptyline's placebo- and baseline-controlled side effects by examining a sample of healthy adults, using structured assessments via a symptom list. Forty healthy individuals were randomized equally to either a group taking 50 mg amitriptyline on four consecutive days or to a placebo control group. Complaints were assessed via the Generic Assessment of Side Effects Scale prior to and after four days of medication intake. Frequency of complaints and their intensity were compared after medication intake between the two groups while controlling for complaints at baseline. The amitriptyline group's participants reported having suffered from "dry mouth," "dizziness," "subjective blood circulation-associated problems," and "constipation" significantly more often. When taking into account the complaint's intensity, the amitriptyline group also reported higher intensities for "dry mouth," "dizziness," and "subjective blood circulation-associated problems." Our results emphasize the importance of a structured and well-controlled harm assessment. Future drug trials should report the placebo- and baseline-controlled side effects with a clear causal relationship to the intake of the drug under investigation, in addition to the frequency of complaints and their odds ratios. (PsycINFO Database Record, ((c) 2018 APA, all rights reserved).)

Studies examining the rates of negative effects of psychotherapy are rare and the reported rates differ widely. To be able to calculate adequate benefit-cost ratios in conjunction with different samples and settings, we need a deeper understanding of these effects. We therefore investigated whether different treatment settings would reveal varying rates and kinds of negative effects by recruiting patients from a psychiatric (n=93) and a psychosomatic rehabilitation (n=63) hospital. Negative effects of psychotherapy were assessed with the Inventory for the Assessment of Negative Effects of Psychotherapy post-treatment. To investigate whether patients' pre-treatment expectations have an influence on reported negative effects, patients filled in the Patient Questionnaire on Therapy Expectation and Evaluation prior to treatment begin. Patients from the psychiatric hospital reported an average 1.41 negative effects, with 58.7% reporting at least one negative effect. Those from the psychosomatic hospital reported 0.76 negative effects on average, with 45.2% of patients reporting at least one negative effect. The differences between these samples are significant. The two samples' top three reported types of negative effects are that patients had experienced more downs during or just before the end of the therapy, that patients had difficulty making important decisions without the therapist, and that patients were concerned that colleagues or friends might find out about the therapy. A regression analysis revealed that the clinical setting (psychosomatic rehabilitation hospital vs. psychiatric hospital) and expectations in the form of hope of improvement were significant predictors for negative effects of psychotherapy. Our study highlights the need to examine the negative effects of psychotherapy in different settings and samples to better evaluate the benefit-cost ratios of treatments for different patient groups. It also shows that we need guidelines for assessing and reporting negative effects., (Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.)

Background: Side effects play a key role in patients' failure to take antidepressants. There is evidence that verbal suggestions and informed consent elicit expectations that can in turn trigger the occurrence of side effects. Prior experience or learning mechanisms are also assumed to contribute to the development of side effects, although their role has not been thoroughly investigated. In this study, we examined whether an antidepressant's side effects can be learned via Pavlovian conditioning., Methods: Participants (n = 39) were randomly allocated to one of two groups and were exposed to a classical conditioning procedure. During acquisition, 19 participants received amitriptyline and 20 participants received a placebo pill. Pills were taken for four nights together with a novel-tasting drink. After a washout phase, both groups received a placebo pill together with the novel-tasting drink (evocation). Side effects were assessed via the Generic Assessment of Side Effects Scale prior to acquisition (baseline), after acquisition, and after evocation. A score of antidepressant-specific side effects was calculated., Results: Participants taking amitriptyline reported significantly more antidepressant-specific side effects after acquisition compared to both baseline and the placebo group. After evocation, participants who underwent the conditioning procedure with amitriptyline reported significantly more antidepressant-specific side effects than those who never received amitriptyline, even though both groups received a placebo., Conclusions: Our results indicate that antidepressant side effects can be learned using a conditioning paradigm and evoked via a placebo pill when applied with the same contextual factors as the verum., Competing Interests: Compliance with ethical standards Funding The study was prepared in the context of the FOR1328 research unit on placebo and nocebo mechanisms and was partially supported by a grant from the German Research Foundation (Deutsche Forschungsgemeinschaft (DFG), RI 574/22–1). Conflict of interest The authors Julia Rheker, Alexander Winkler, Bettina K. Doering, and Winfried Rief have no conflicts of interest including any financial, personal, or other relationships with other people or organizations to declare that could inappropriately influence, or be perceived to influence, the present work. However, Bettina K. Doering has received honoraria from Biologische Heilmittel Heel for presentations on stress reactions. Winfried Rief has received honoraria from Biologische Heilmittel Heel, Berlin Chemie, and Bayer for presentations on placebo effects.

Clinical trials in sleep disorders report substantial improvement in symptoms in their placebo groups. Behavioral conditioning is one of the underlying mechanisms of the placebo response. However, we do not know whether, and if so, the extent to which sleep architecture is influenced by behavioral conditioning, similarly to other physiological responses (i.e., those in the immune system). We therefore applied a conditioning paradigm to 39 healthy adults pairing a novel-tasting drink (conditioned stimulus, CS) with the REM sleep suppressing tricyclic antidepressant amitriptyline as unconditioned stimulus during the acquisition phase. Subsequent sole presentation of the CS (together with a placebo pill) in an evocation night led to significantly more REM sleep in the amitriptyline group. Instead of the expected REM sleep suppression in the evocation night, we observed more REM sleep, indicating a rebound that interferes with the conditioned response., (© 2016 Society for Psychophysiological Research.)