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Background Prolonged grief is a disorder (PGD) characterized by severe and disabling grief reactions for an extended period of time after the loss of a significant person. ICD-11 and DSM-5-TR differ substantially in individual criteria. Objective Estimation of the respective prevalence of PGDICD-11 and PGDDSM-5-TR and the frequency with which single symptoms of prolonged grief occur in the general population. Methods Out of a representative sample of the German general population (N=2498), n = 914 reported a significant loss and prolonged grief symptoms based on the extended version of the self-reported Prolonged Grief Disorder-13+9 (PG13+9). Sociodemographic and loss-related characteristics were collected. Results The probable prevalence of PGDICD-11 was 1.5% and that of PGDDSM-5-TR was 1.2% in the general sample. Among bereaved persons (n=914), the prevalence of developing PGDICD-11 was 4.2% and that of PGDDSM-5-TR was 3.3%. Diagnostic agreement between the two criteria-sets was very high and did not increase after heightening the accessory symptom threshold for PGDICD-11. Difficulties accepting the loss was the most frequent single symptom (14-25%) and grief-related impairment was common (10-16%). Over 60% of participants with a probable PGD diagnosis utilized health care services. Limitations Results are based on self-reported data. The PG13+9 was not designed to assess grief symptoms according to ICD-11 and DSM-5-TR diagnostic criteria. Conclusions Prolonged grief according to ICD-11 and DSM-5-TR is a notable disorder in the general population. Among bereaved persons, single symptoms of prolonged grief are relatively frequent and cause substantial degrees of impairment.

The COVID-19 outbreak has raised questions about how vulnerable groups experience the pandemic. Research that focuses on the view of individuals with pre-existing mental health conditions is still limited, and so are cross-country comparative surveys. We gathered our sample of qualitative data during the first lockdown after governmental measures against the spread of the SARS-CoV-2 virus came into force in Austria, Czechia, Germany, and Slovakia. A total of n = 1690 psychotherapists from four middle European countries answered the question of how the COVID-19 pandemic was addressed in sessions by their patients during the early stage of unprecedented public health conditions. We employed a descriptive qualitative methodology to determine themes following levels of the social-ecological model (SEM) regarding how the COVID-19 pandemic affected patients. At the public policy level, stressful environmental conditions concerned the governmental mitigation efforts. At the level of community/society, reported key themes were employment, restricted access to educational and health facilities, socioeconomic consequences, and the pandemic itself. Key themes at the interpersonal level regarded forced proximity, the possibility of infection of loved ones, childcare, and homeschooling. Key themes at the individual level were the possibility of contracting COVID-19, having to stay at home/isolation, and a changing environment. Within the SEM framework, adaptive and maladaptive responses to these stressors were reported, with more similarities than differences between the countries. A quantification of word stems showed that the maladaptive reactions predominated.

Background Meta-analyses demonstrate that placebo effects play an important role in antidepressant treatment. Expectations seem to constitute a highly relevant placebo mechanism in this context. This study investigated whether an expectation manipulation combined with the intake of an active placebo could reduce acute sadness in depressed participants following a sadness-inducing mood manipulation. Methods Women who suffered from a major depressive episode (N = 94) were randomly allocated to the drug expectation group (expectation to receive a fast-operating antidepressant), the placebo expectation group (expectation to receive a placebo) or the no treatment group (no expectation, no placebo). The drug expectation and the placebo expectation group received a placebo. All participants watched a sadness-inducing film. Sadness was assessed at baseline, after randomization and after placebo intake and mood induction. Data were analyzed by a 3 × 3 analysis of variance. Results There were significant between-group differences in sadness change from the baseline after mood induction. While sadness increased in the no treatment group, it did not change in the placebo expectation group. In the drug expectation group, sadness even decreased. Limitations Only a single medication intake was simulated. Effects on acute sadness do not allow inferences about depression symptoms. Conclusion This experimental study found a placebo effect on sadness in clinically depressed participants. The effects were even larger than expected. Future research must investigate placebo effects on depression symptoms as well as long-term placebo intake.

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.

Prolonged grief disorder (PGD), characterized by severe, persistent and disabling grief, is newly included in the International Classification of Diseases 11 (ICD-11). Receiving a PGD diagnosis could lead to stigmatizing public reactions (i.e. public stigma), yet research on this topic is limited. Additionally, while there is evidence that experiencing suicide bereavement causes public stigma, no studies to date have investigated the interaction between PGD and cause of death on public stigma. To fill these knowledge gaps, this experimental study tested if a PGD diagnosis (vs. no diagnosis) and experiencing suicide bereavement (vs. homicide and natural loss) cause public stigma. Three hundred and seventeen adults from the general population were randomly assigned to read one of 6 different vignettes of a person with and without PGD who had lost a spouse through a suicide, homicide or a stroke. After reading a vignette, negative attributions, emotional reactions, and desire for social distance were assessed. Notably, only persons with PGD were attributed relatively more negative characteristics, and elicited more anger, anxiety and pro-social emotions, and a larger preferred social distance in participants. This study supports the claim that PGD causes public stigma, but nuances claims that suicide bereavement induces public stigma.

After acquired brain injury (ABI) many patients suffer from persistent cognitive and emotional disturbances. The aim of this study was to investigate the treatment outcome of an integrated intervention, combining neuropsychological and cognitive behavioural therapy (nCBT), against waitlist (WL) in outpatients with ABI. Individuals seeking outpatient treatment for cognitive and emotional problems after ABI were randomly allocated to nCBT (

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.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).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.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.

Psychotherapists around the world are facing an unprecedented situation with the outbreak of the novel coronavirus disease (COVID-19). To combat the rapid spread of the virus, direct contact with others has to be avoided when possible. Therefore, remote psychotherapy provides a valuable option to continue mental health care during the COVID-19 pandemic. The present study investigated the fear of psychotherapists to become infected with COVID-19 during psychotherapy in personal contact and assessed how the provision of psychotherapy changed due to the COVID-19 situation and whether there were differences with regard to country and gender. Psychotherapists from three European countries: Czech Republic (CZ, n = 112), Germany (DE, n = 130) and Slovakia (SK, n = 96), with on average 77.8% female participants, completed an online survey. Participants rated the fear of COVID-19 infection during face-to-face psychotherapy and reported the number of patients treated on average per week (in personal contact, via telephone, via internet) during the COVID-19 situation as well as (retrospectively) in the months before. Fear of COVID-19 infection was highest in SK and lowest in DE (p &lt, 0.001) and was higher in female compared to male psychotherapists (p = 0.021). In all countries, the number of patients treated on average per week in personal contact decreased (p &lt, 0.001) and remote psychotherapies increased (p &lt, 0.001), with more patients being treated via internet than via telephone during the COVID-19 situation (p &lt, 0.001). Furthermore, female psychotherapists treated less patients in personal contact (p = 0.036), while they treated more patients via telephone than their male colleagues (p = 0.015). Overall, the total number of patients treated did not differ during COVID-19 from the months before (p = 0.133) and psychotherapy in personal contact remained the most common treatment modality. Results imply that the supply of mental health care could be maintained during COVID-19 and that changes in the provision of psychotherapy vary among countries and gender.

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.

Purpose of review There is increasing recognition that a minority of bereaved persons experiences persistent and disabling grief symptoms, also termed complicated grief. We review currently proposed criteria for complicated grief in the Diagnostic and Statistical Manual of Mental Disorders (DSM 5) and the International Statistical Classification of Diseases and Related Health Problems (ICD-11), highlight controversies with regard to establishing complicated grief as a psychiatric disorder, summarize recent complicated grief treatment research within a cognitive behavioral treatment framework, and establish a novel and systematic research agenda for complicated grief treatment. Recent findings Clinicians should be wary of overdiagnosis and misdiagnosis of complicated grief. Recent changes to definitions of complicated grief may threaten generalizability and clinical application of research findings. Universal treatment, treatment for at-risk groups and preventive complicated grief treatment appear ineffective. Although medication is often prescribed to bereaved persons, evidence for its effectiveness is equivocal. Face-to-face and internet-based cognitive behavioral therapy techniques appear most effective in targeting complicated grief. However, little is known about what, how, and for whom treatment works best. Summary In light of these findings, we recommend systematic investigation of: what works best in complicated grief treatment, by conducting well designed, stepped effectiveness trials and treatment component dismantling studies; how it works, by conducting investigations on therapeutic theories and examining mediators of therapeutic change; and for whom it works, by examining potential moderators of treatment effects.

The questionnaire study aimed to evaluate the relative contribution of body awareness, subjective symptoms, and anxiety to the construct of somatosensory amplification in both healthy controls ( n = 475) and patients visiting their general practitioner ( n = 236). Regression analysis explained 52.0 percent of total variance of the somatosensory amplification scale scores. Body awareness was the most influential predictor ( β = 0.489, p

‘Cyberchondria’ describes a pattern of researching health information online motivated by distress or anxiety about health, which becomes excessive and in turn increases distress. The Cyberchondria Severity Scale (CSS) assesses this construct. The aims of the present study were to validate a German version of the CSS and to propose a short form. The CSS was translated and posted online. Inclusion criteria were fulfilled by n = 500 participants (age 29.1 ± 10.4 years, 73.6 % women). Item analyses, an exploratory factor analysis and correlations with health anxiety, somatic symptoms, health-care utilization and depression were calculated. A brief version with 15 items was developed (CSS-15) and validated in a second sample (n = 292; age 24.2 ± 4.1 years, 76.4 % women). The internal consistency of the CSS was α = .93 and its split-half reliability α = .95. The mean item-total correlation was r itc = .51, the mean inter-item correlation r = .29 and the mean item difficulty p i = .36. The principal component analysis extracted five factors. The CSS score correlated highly with health anxiety and moderately with somatic symptoms and health-care utilization. The CSS-15 still had an internal consistency of α = .82 and the confirmatory factor analysis confirmed the five factors. The correlation coefficients with health-related measures were unaffected. The German version of the CSS possesses very good psychometric characteristics, which were preserved in a short version. The factorial structure was replicated. The correlations with health anxiety and depression for both scales underscore their validity and clinical relevance.

Body focus is often considered an undesirable characteristic from medical point of view as it amplifies symptoms and leads to higher levels of health anxiety. However, it is connected to mindfulness, well-being and the sense of self in psychotherapy. The current study aimed to investigate the contribution of various body focus related constructs to acute and chronic generation and maintenance of medically unexplained symptoms (MUS). Thirty-six individuals with idiopathic environmental intolerance to electromagnetic fields (IEI-EMF) and 36 controls were asked to complete questionnaires assessing negative affect, worries about harmful effects of EMFs, health anxiety (HA), body awareness, and somatosensory amplification (SSA), and to report experienced symptoms evoked by a sham magnetic field. Body awareness, HA, SSA, and EMF-related worries showed good discriminative power between individuals with IEI-EMF and controls. Considering all variables together, SSA was the best predictor of IEI-EMF. In the believed presence of a MF, people with IEI-EMF showed higher levels of anxiety and reported more symptoms than controls. In the IEI-EMF group, actual symptom reports were predicted by HA and state anxiety, while a reverse relationship between symptom reports and HA was found in the control group. Our findings show that SSA is a particularly important contributor to IEI-EMF, probably because it is the most comprehensive factor in its aetiology. IEI-EMF is associated with both a fear-related monitoring of bodily symptoms and a non-evaluative body focus. The identification of dispositional body focus may be relevant for the management of MUS.

Objectives: COVID-19 has led to changes in the provision in mental health services. The current study investigated influencing factors on: (i) the comparability of psychotherapy via internet/telephone with psychotherapy in face-to-face contact as well as (ii) the actual experience with psychotherapy via internet/telephone compared to respective prior expectations in CBT therapists. Methods: A quantitative cross-sectional study was conducted in the form of an online survey. The research samples, registered cognitive-behavioral therapy (CBT) psychotherapists in Austria and Germany, were contacted by e-mail. Results: One hundred and ninety CBT therapists were analyzed in this study. The total number of patients treated via telephone/internet is a decisive factor for the subjective evaluation of the comparability of psychotherapy via telephone/internet and psychotherapy in personal contact. This factor also influences the extent (positive/negative) of the assessment of the actual experience with psychotherapy via internet/telephone compared to previous expectations. Neither age nor gender were associated with comparability of psychotherapy via internet/telephone with psychotherapy in face-to-face contact or the actual experience with psychotherapy via internet/telephone compared to respective prior expectations. Conclusions: Implications of the results are that attitudes towards remote psychotherapy might be increased in CBT therapists when they treat more patients remotely and experiences with remote psychotherapies should be included in psychotherapy training.

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

Informing patients about treatment side effects increases the occurrence and intensity of side effects. Since the obligatory informed consent procedure in drug treatments requires transparency and nocebo research suggests that the informed consent of a drug leads to an increased occurrence of the mentioned side effects, the aim of this proof of concept study was to determine the effect of two different framings of informed consent on the occurrence, intensity, and perceived threat of side effects. Healthy male participants (n = 80) were randomized to one of two framing groups. The positive framing group was informed that the common side effect dizziness was a sign that the drug had started to work, while the neutral framing group was told that dizziness is an unpleasant but well-known side effect. Side effects were measured after the administration of metoprolol, an antihypertensive agent. Post hoc moderator analyses investigated the effect of pre-existing negative beliefs about the general harm of medication on the framing manipulation. Metoprolol-specific drug-attributed side effects were rated significantly less threatening in the positive framing group. The between-group effect size (Cohen’s d) was small (d = 0.38, p = 0.049). Exploratory post hoc moderator analyses suggest that participants who believed that medication is a source of harmful effects benefited from positive framing, compared to neutral framing of drug-attributed side effects. Positive framing was partially effective in decreasing specific side effect measures, particularly among participants with a tendency to believe that medicine is harmful. Informed consent procedures should therefore be personalized, focusing on patients with negative treatment beliefs.

Placebo research has shown that patients' expectations are among the strongest predictors of treatment outcome regarding various medical conditions. Therefore, interventions focusing on the change of such expectations might be most effective. This could be of relevance not only for outcome expectations but also for disease-specific, problem-specific, and treatment-specific expectations. A theoretical model is introduced to illustrate the conditions for expectation change and persistence. Strategies for patients regarding how to devalue learning effects in expectation violation situations are exemplified, and ways to optimize expectation-violating effects are highlighted. Data from a large randomized controlled trial serve as a practical example and demonstrate the effect of a presurgery optimization of expectations in patients scheduled for heart surgery (coronary artery bypass grafting). Disability scores that were obtained 6 months postsurgery confirmed that patients who participated in preoperative psychological interventions, which aimed at optimizing expectations, demonstrate the best outcome after heart surgery. Practical aspects of the intervention are presented, and suggestions on implementing these procedures to optimize outcome in medical interventions are discussed. Psychotherapy is conceptualized as an intervention that should target expectation violation of disorder- and treatment-specific expectations.

Side effects consist of drug-specific and non-specific symptoms. Both components are based on bodily sensations that a person perceives after taking a drug and subsequently attributes to the drug. We suggest that somatosensory amplification (SSA) may explain a proportion of inter-individual differences in reports of side effects that cannot be accounted for by drug-specific safety profiles. This hypothesis was investigated in hypertensive patients starting a new pharmacotherapy. This longitudinal study included 50 patients (66 % women, aged 55 ± 14 years) with a diagnosis of primary hypertension. Patients completed the Somatosensory Amplification Scale (SSAS), started to take their new medication, and recorded side effects on a daily basis for 4 weeks. After controlling for age, gender, number of pills taken, and previous personal and family experiences with medication side effects in the regression analyses, SSAS scores remained a significant predictor of reported side effects over the entire study period (weeks 1 and 2: β = .621, p

Hip fractures are common in elderly people. Despite great progress in surgical care, the outcome of patients with hip fracture remains disappointing. This study determined four prognostic factors (lower ASA score, higher pre-fracture EQ-5D index, higher MMSE score, and female gender) to predict 1-year survival in patients with hip fracture. This study determined the prognostic factors for 1-year survival in patients with hip fracture. Based on these predictors, a scoring system was developed for use upon patients’ admission to the hospital. Hip fracture patients, aged ≥60 years, were prospectively enrolled. Upon admission, patients’ sociodemographic data, type of fracture, American Society of Anesthesiologists (ASA) score, health-related quality of life scores (EQ-5D index) and Mini-Mental State Examination (MMSE) scores were recorded, among other parameters. Correlational analysis was performed on all potential variables to identify relevant predictor variables of 1-year survival. Univariate regression analysis was performed on all selected variables, followed by a multivariate analysis for variables that were significant in the univariate analysis. The final score was developed by converting the β-coefficients of each variable from the multivariate analysis into a scoring system. For 391 hip fracture patients, complete data were available at the time of the 1-year follow-up. In multivariate regression analysis, independent predictors of 1-year survival were lower ASA score, higher pre-fracture EQ-5D index, higher MMSE score, and female gender. The different variables were weighted according to their β-coefficient to build the prognostic score, which ranged from 0 to 10 points. The ROC curve for 1-year mortality after hip fracture showed an area under the curve of 0.74 (R 2 = 0.272; 95 % CI 0.68–0.79; p

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.

Background Dysfunctional expectations are considered to be core features of mental disorders and, in particular, major depression. The aim of the present study was to integrate two important types of expectations into the cognitive model of depression: situation-specific dysfunctional expectations (SDE) and dispositional optimism (DO). It was hypothesized that the influence of both DO and intermediate beliefs (IB) on depressive symptoms would be mediated via SDE. Methods We examined 95 individuals (age M = 40.7, 68.1% female) with a diagnosed major depressive disorder from two inpatient clinics and one outpatient clinic. Measurements used in the study included the Depressive Expectations Scale, Dysfunctional Attitudes Scale, Life Orientation Test Revised, and Beck's Depression Inventory-II. Relationships between the constructs were analyzed using path-analytic models with bias-corrected bootstrapping confidence intervals. Results Results indicate that the effect of IB on depressive symptoms was fully mediated via SDE, while the effect of DO on depressive symptoms was partly mediated via SDE. IB and DO moderately correlated with each other. Limitations Due to the cross-sectional design of the study, it is not possible to draw unambiguous conclusions regarding the causality of the suggested relationships. Conclusions The present study stresses the crucial role of dysfunctional expectations for major depression. Moreover, it reveals that SDEs as expectations with a high level of situational specificity may pose an important link between global cognitions and depressive symptoms. Given this situational specificity, SDEs are amenable to disconfirmation through behavioral experiments and may therefore be a promising target for cognitive-behavioral interventions.

Hypertension is often treated pharmacologically, yet adherence is poor. Beliefs about antihypertensive medicine, i.e., the necessity-concern framework (NCF), are valuable for explaining adherence. Therefore, a model structure is transferred from hypercholesterolemia to hypertension, assuming a mediating role of the NCF.Patients with hypertension (n=273) were surveyed online about demographics, health- and treatment-related factors, control beliefs, necessity and concern beliefs about their medication, and adherence. The data were analyzed using structural equation modeling (SEM).Necessity was positively (β=0.26, p=0.009) and concern was negatively (β=-0.51, p=0.020) associated with adherence. The NCF mediated the influence of background variables on adherence. Necessity was associated with comorbidity (β=-0.36, p0.001), treatment time (β=0.19, p=0.004), emotionally supportive doctor-patient communication (β=0.12, p=0.045), side effects (β=0.16, p=0.013), personal control (β=-0.13, p=0.022), and treatment control (β=0.29, p0.001). Concern was associated with side effects (β=0.38, p0.001) and beliefs about medicine in general being harmful (β=0.61, p0.001). The model fit was acceptable (RMSEA=0.61).The transferred adherence model with the necessity-concern framework as a mediating factor was confirmed in hypertension, explaining more variance than previous approaches (23%).A personalized, emotionally supportive doctor-patient communication could be key to addressing beliefs about medicine and therefore to increasing adherence.

Although insomnia is a frequent health complaint that is often treated with drugs, little is known about differences in treatment efficacy of various drug classes on objective versus subjective outcome measures.Our aim was to compare treatment efficacy of classical benzodiazepines, benzodiazepine receptor agonists (zopiclone, zolpidem and zaleplon), antidepressants (including low-dose doxepin), neuropeptides, progesterone receptor antagonists, hormones, melatonin receptor agonists, antihistamines, antiepileptics, and narcotics addressing primary insomnia.We conducted a comprehensive literature search (up to 5 April 2013) using PubMed, Cochrane Clinical Trials, PQDT OPEN, OpenGREY, ISI Web of Knowledge, PsycINFO, PSYNDEX, and the WHO International Clinical Trials Registry Platform.Only polysomnographic, parallel-group, randomized controlled drug trials were included; eligibility was determined by two independent authors.We used a random effects model, based on 31 studies reporting 80 treatment conditions, covering 3,820 participants.Effect size estimates for the total sample of pooled drug classes suggest that there is a small-to-moderate, significant, and robust effect for objective outcomes (sleep onset latency g = -0.36, total sleep time g = 0.27) and subjective outcomes (sleep onset latency g = -0.24, total sleep time g = 0.21). Results indicate higher effect sizes for benzodiazepine receptor agonists and classical benzodiazepines compared with antidepressants (including low-dose doxepin) and for classical benzodiazepines compared with benzodiazepine receptor agonists. Benzodiazepine receptor agonists demonstrated higher effect sizes for objective outcomes.Data on drug safety were not analyzed.Future studies should use objective and subjective assessment. Focusing on efficacy, clinicians should favor benzodiazepine receptor agonists and classical benzodiazepines over antidepressants (including low-dose doxepin) for primary insomnia treatment, but the additional consideration of different side effect profiles can lead to alternative treatment decisions.

Acquired brain injury (ABI) confronts patients with sudden and possibly permanent functional impairments which disrupt or block the attainment of important life goals and reduce subjective well-being (SWB). This longitudinal study aimed at investigating changes in the importance and the attainability of communion and agency life goals and their impact on SWB. Self-report measures of life goals, functional status and SWB were assessed in 42 patients during acute rehabilitation two months following ABI (baseline) and reassessed 19 months following discharge (follow up). Results indicate a significant longitudinal decrease of the general attainability of life goals and of the present success in achieving communal and agentic life goals. Life goal importance remained stable. After controlling for baseline SWB and follow up functional status the attainability of communal life goals significantly predicted SWB at follow up whereas agentic life goals failed to predict SWB. The present findings show long-term deterioration of life goal attainability. They highlight that more emphasis should be given to realistic attainability attributions during rehabilitation processes. Moreover, the results stress the need for outpatient treatment to promote disengagement from unobtainable life goals and to offer means for the engagement in alternative life goals in order to maintain or regain SWB.

Hypertension is often treated pharmacologically. Since there is evidence that the cardiovascular system is sensitive to placebo mechanisms, our aim was to conduct an effect size analysis of placebo groups in double-blinded randomized controlled parallel-group drug trials using beta-blockers to treat hypertensive patients. A comprehensive literature search via PubMed, PsycINFO, PSYNDEX, PQDT OPEN, OpenGREY, ISI Web of Knowledge, and the WHO International Clinical Trials Registry Platform provided the basis of our meta-analysis. Effect sizes were estimated using a random-effects model based on 23 studies covering a total of 11,067 participants. Main outcomes were systolic blood pressure (sBP) and diastolic blood pressure (dBP). Blood pressure was lowered in placebo groups with significant and robust effect sizes (Hedges' g). The estimates for sBP (-0.27, P .001) and dBP (-0.49, P .001) can be interpreted as small to moderate. The placebo response accounted for 34% of the drug response for sBP and 47% of the drug response for dBP. Our moderator analyses indicated that a higher study quality and more study site visits were marginally associated with a higher placebo response. In light of these strong placebo responses, placebo mechanisms need to be considered in order to improve antihypertensive treatment.

Objectives Dysfunctional expectations are considered to be core features of various mental disorders. The aim of the study was to develop the Depressive Expectations Scale (DES) as a depression-specific measure for the assessment of dysfunctional expectations. Whereas previous research primarily focused on general cognitions and attitudes, the DES assesses 25 future-directed expectations (originally 75 items) which are situation-specific and falsifiable. Design and methods To evaluate the psychometric properties of the DES, the scale was completed by 175 participants with and without severe depressive symptoms in an online survey. Participants additionally completed the Patient Health Questionnaire modules for depression (PHQ-9) and anxiety (GAD-7). People experiencing depressive symptoms were informed about the study with the help of self-help organizations. Results Reliability analyses indicated excellent internal consistency of the scale. An exploratory factor analyses revealed four factors: social rejection, social support, mood regulation, and ability to perform. The DES sum score strongly correlated with the severity of depressive symptoms. The DES sum score also significantly correlated with symptoms of generalized anxiety. Conclusion The DES was shown to have excellent reliability; validity analyses were promising. As the DES items are situation-specific and falsifiable, they can be tested by the individual using behavioural experiments and may therefore facilitate cognitive restructuring. Thus, a structured assessment of patients’ expectation with help of the DES can provide a basis for interventions within cognitive–behavioural treatment of depression. Practitioner points Assessing situation-specific expectations in patients experiencing depressive symptoms can provide a basis for the conduction of behavioural experiments to test patients’ expectations. For the use of behavioural experiments, therapists should choose those dysfunctional expectations which a patient strongly agrees on. To modify patients’ expectations, they should be exposed to situations where the discrepancy between patients’ expectations and actual situational outcomes can be maximized. The Depressive Expectations Scale can be completed repeatedly to monitor a patient's progress within cognitive–behavioural treatment.

Purpose of review Acquired brain injury (ABI) does not only result in physical and cognitive impairments, but may also entail behavioral-emotional difficulties and mental disorders. Although neuropsychological approaches target the rehabilitation of cognitive deficits, the treatment of emotional and behavioral sequelae has received less consideration. This review argues for the integration of cognitive-behavioral approaches into the rehabilitation process and examines respective recent research. Recent findings Cognitive-behavioral interventions have been investigated in the treatment of behavioral disturbances and mental disorders after ABI. They have also been targeted at supporting adaptive coping with chronic injury-related impairments. Problem-solving approaches of cognitive behavioral therapy may work as meta-models or framework for the rehabilitative process. Unfortunately, most studies reviewed employed methodologically weak designs, which limit convincing conclusions. Still, positive intervention effects have been demonstrated concerning specific outcome measures. Whether these changes also translate into increased psychosocial functioning or quality of life remains unclear. Summary Methodologically sound evidence for cognitive-behavioral interventions after ABI is limited, but preliminary results support the effectiveness of these interventions in the treatment of behavioral disorders and emotional disturbances after ABI. Integrating neuropsychological and cognitive-behavioral approaches may therefore prove beneficial to the rehabilitation process.

Sequelae of acquired brain injury (ABI) require adjustment processes in which survivors must strive to regain subjective well-being (SWB) in the face of chronic impairment. The current study investigates whether the self-concept of achievement mediates this process. Thirty-five post-acute patients with ABI were assessed neuropsychologically for performance in memory, attention, concept formation and reasoning. Data concerning subjective complaints in applied cognition, self-concept, and SWB were collected. Patients rated their self-concept more negatively compared to a normative sample. Effects of subjective complaints in applied cognition on SWB were mediated by the self-concept of achievement. Contrary to expectations, objective cognitive deficits demonstrated no independent significant relationship to self-concept of achievement or SWB in multiple regression modelling when subjective complaints in applied cognition were considered simultaneously. The findings highlight the necessity of considering patients' subjective complaints and self-concepts to improve rehabilitative progress. Potential implications for neuropsychological rehabilitation are discussed.

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.

Background Several studies indicate that patients’ presurgical expectations can influence postsurgical health outcome. Purpose To estimate the potential for clinical exploitation of this association, a meta-analysis of prospective studies which assess the association between patients’ presurgical expectations and postsurgical quality of life is applied to accumulate the overall effect. Methods We searched the databases MEDLINE, CENTRAL, and PsychINFO for English- and German-language articles published from 1980 until December 2013. Additionally, manual searches of bibliographies of retrieved articles and relevant reviews were conducted. Prospective studies measuring presurgical expectations and postsurgical quality of life in patients aging 18–65 were selected. Correlations between presurgical expectations and postsurgical quality of life were extracted or provided by the authors. Results The search yielded 21 prospective studies (including 2611 patients undergoing surgery) with a follow-up period ranging from 1 week to 13 years. The pooled correlations were 0.369 (95 % confidence interval (CI), 0.264 to 0.466; P for heterogeneity

Aims The objective of this study was to assess the efficacy profile of Nx4 (Neurexan ®) in an acute experimental stress setting. An acute stress reaction is a biopsychological condition arising in response to an event that is individually regarded as emotionally stressful. Medications can mitigate stress perception and stress reactions, but may also have side effects. Materials and methods Sixty-four healthy male and female volunteers participated in this prospective two-arm two-site study following an explorative randomized placebo-controlled double-blind study design. Participants took six tablets of either Nx4 or placebo during a time period of 2.5 h before exposure to an acute psychological stressor (Trier Social Stress Test), and were subsequently monitored for 1.5 h. Subjective stress ratings as well as cardiovascular and neuroendocrine parameters were analyzed before and after stress exposure. Key findings All changes in primary and secondary efficacy parameters corresponded well with the experimental acute stress setting. Nx4 did not affect subjective stress ratings but significantly diminished stress-induced increases in salivary cortisol and plasma adrenaline. Nx4 was as safe as placebo and very well tolerated. Significance The results suggest an attenuated neuroendocrine stress response in healthy volunteers induced by Nx4. However, further investigations are needed to confirm these observations as well as to better understand why some parameters were affected while others were not. Future investigations should be extended to chronically stressed individuals with a greater disposition to experience stress in everyday life. ClinicalTrials.gov Identifier: NCT01703819

Salivary alpha-Amylase activity (sAA) and plasma noradrenaline (NA) concentrations are often considered to be surrogate markers of sympathetic activation in response to stress. However, despite accumulating evidence for a close association between sAA and noradrenaline and other indicators of sympathetic activity, reliability and generality of this relation remains unclear. We employed the Trier Social Stress Test (TSST) in order to directly compare the responses in sAA and NA to psychological stress in healthy volunteers (n = 23). The TSST significantly increased sAA and NA plasma levels with no significant differences in females and males. However, when subjects were divided according to their NA responses into low versus high responders, both groups did not significantly differ in their sAA before, during or after stress exposure. These data suggest that in response to acute psychological stress both plasma NA levels and sAA reflect sympathetic activity, however seemed to increase independently from each other. Copyright: OA gold

Medicine 96(37), e7820 (2017). doi:10.1097/MD.0000000000007820, Published by Lippincott Williams & Wilkins, Baltimore, Md.

The knowledge and systematic application of the placebo effect remains limited, although its importance to the treatment of various medical conditions has increasingly been recognized. A possible application of the placebo effect to pharmacotherapy is seen in conditioning processes that aim at a placebo-controlled dose reduction of drugs while maintaining the efficacy of the medical treatment. The pairing of a placebo and a pharmacological agent may achieve satisfactory treatment outcomes in combination with a lower dose of medication. This procedure includes classic and instrumental conditioning processes that involve both conscious and non-conscious information processing. Although recent studies have gathered preliminary evidence for the efficacy of placebo-controlled dose reduction (e.g. in psoriasis and attention deficit hyperactivity disorder [ADHD]), they have also illustrated the difficulties that are inherent to this approach. We critically review previous approaches and discuss designs for clinical trials that seem appropriate to the investigation of conditioned placebo effects in pharmacotherapy.

Sequelae of acquired brain injury endanger the realisation of important life-goals. Discrepancies arise between the importance attached to a goal and the success in realising it. This study investigates goal discrepancies and their influence on patients' subjective well-being (SWB) in different rehabilitation stages. Life-goals, SWB and daily functioning were assessed in 130 neurological inpatients and 42 outpatients by self-report questionnaires. Both patient groups reported greater discrepancies between importance and success of life-goals than a normative sample of healthy controls. In multiple regression modelling, goal discrepancy predicted SWB in the inpatient sample even when controlling for the influence of ABI-related functional limitations. Of significant influence were the discrepancies in the domains of intimacy and achievement. In the respective analysis of the outpatient sample, goal discrepancy was not a significant predictor of SWB when accounting for functional limitations. A post-hoc analysis examined the inter-relation between functional limitations and goal discrepancy. Functional limitations influenced the ratings of successful goal realisation, yet they had less impact on the importance attached to a goal. The findings highlight the importance of patients' life-goals for successful neuropsychological rehabilitation. They indicate a need for further research considering goal adjustment processes in the face of chronic functional impairment.

Objective: To identify subjective importance, attainability and success of life goals and their predictive value for subjective well-being in patients with acquired brain injury. Design: Cross-sectional, descriptive. Setting: Two inpatient neurological rehabilitation centres. Participants: Patients with non-progressive neurological disorders. Interventions: Survey using questionnaires. Measures: Life goal characteristics were assessed using a life goal questionnaire (GOALS). Subjective well-being (composite score) was measured using the Center of the Epidemic Studies Depression Scale (CES-D), the Positive and Negative Affect Schedule (PANAS) and the Satisfaction With Life Scale (SWLS). Results: Fifty-nine patients participated in the study. The most important life goals are intimacy (4.59/5), achievement (3.96/5) and altruism (3.89/5). The intimacy goals are considered most attainable (4.19/5) and patients feel most successful in this domain (3.98/5). Two important predictions of the personal goal model of subjective well-being could be confirmed. First, goal attainability moderates the relation between goal importance and goal success. Second, the influence of goal importance on subjective well-being is mediated by experienced success. The most powerful predictors for subjective well-being are success in the achievement domain (β = 0.404) and discrepancy between importance and success in the intimacy domain (β = —0.276). Conclusions: The subjective well-being of neurological patients depends not only on the appraised importance of life goals but also on their attainability and success.

OA hybrid Emerging evidence indicates that treatment context profoundly affects psychopharmacological interventions. We review the evidence for the interaction between drug application and the context in which the drug is given both in human and animal research. We found evidence for this interaction in the placebo response in clinical trials, in our evolving knowledge of pharmacological and environmental effects on neural plasticity, and in animal studies analyzing environmental influences on psychotropic drug effects. Experimental placebo research has revealed neurobiological trajectories of mechanisms such as patients’ treatment expectations and prior treatment experiences. Animal research confirmed that “enriched environments” support positive drug effects, while unfavorable environments (low sensory stimulation, low rates of social contacts) can even reverse the intended treatment outcome. Finally we provide recommendations for context conditions under which psychotropic drugs should be applied. Drug action should be steered by positive expectations, physical activity, and helpful social and physical environmental stimulation. Future drug trials should focus on fully controlling and optimizing such drug × environment interactions to improve trial sensitivity and treatment outcome.