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

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

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.

Ulcerative colitis (UC) and irritable bowel syndrome (IBS) are associated with high somatic symptom burden, reduced quality of life, and increased psychological distress. The subjective burden, the wish of many patients, and the involvement of psychological processes in symptom perception justify the development of psychosocial support services. We aimed to evaluate need, content and feasibility of such an offer. We included patients with both UC and RDS in order to identify disease-specific and trans-diagnostic aspects for psychosocial interventions.We conducted telephone interviews with adult patients with UC or IBS using a standardized interview guide. We used numerical rating scales and open-ended questions to assess burden of and coping with the disease, disease-related expectations and anxiety, satisfaction with care, support and information needs, and preferences regarding support programs. We calculated descriptive metrics for quantitative variables as well as diagnosis-specific group comparisons. The answers to the open questions were summarised and counted in close accordance with the participants' statements.The results confirm an increased need for psychosocial support and the relevance of disease-related expectations and anxiety for both diseases. Differences in symptom perception and care satisfaction indicate the importance of disease-specific elements in psychosocial therapy programs.The results demonstrate the high need for psychosocial support of patients with UC and IBS and indicate the feasibility of a psychosocial therapy program.Colitis ulcerosa (CU) und Reizdarmsyndrom (RDS) gehen mit hoher somatischer Symptombelastung, reduzierter Lebensqualität und psychischen Beschwerden einher. Die subjektive Belastung, der Wunsch vieler Betroffener und die Beteiligung psychischer Prozesse an der Wahrnehmung der Symptomatik begründen die Entwicklung psychosozialer Unterstützungsangebote. Ziel dieser Machbarkeitsstudie war es, Bedarf, inhaltlichen Fokus und Machbarkeit eines solchen Angebots zu evaluieren. Betroffene mit CU und RDS wurden parallel eingeschlossen, um krankheitsspezifische und krankheitsübergreifende Aspekte für psychosoziale Interventionen zu identifizieren.Erwachsene Menschen mit CU oder RDS wurden telefonisch mithilfe eines standardisierten Interviewleitfadens befragt. Mittels numerischer Analogskalen sowie offener Fragen wurden Belastungen durch und Umgang mit der Erkrankung, krankheitsbezogene Erwartungen und Krankheitsangst, Zufriedenheit mit der Versorgung, Unterstützungs- und Informationsbedarf sowie Präferenzen hinsichtlich eines Unterstützungsprogramms erfragt. Deskriptive Kennzahlen zu quantitativen Variablen und diagnosespezifische Gruppenvergleiche wurden berechnet. Die Antworten zu den offenen Fragen wurden nah an den Aussagen der Teilnehmenden zusammengefasst und ausgezählt. ERGEBNISSE:innen mit RDS zeigten eine geringe Zufriedenheit mit der Versorgung und fühlten sich schlechter über ihre Erkrankung informiert als Betroffene von CU. Beide Gruppen gaben eine hohe Wahrscheinlichkeit an, an einem psychologischen Unterstützungsprogramm teilzunehmen und benannten krankheitsbezogene Erwartungen und Krankheitsangst als wichtige Bestandteile eines solchen.Die Ergebnisse bestätigen den erhöhten Bedarf und das Interesse an psychosozialer Unterstützung sowie die Relevanz krankheitsbezogener Erwartungen und Krankheitsangst bei beiden Erkrankungen. Unterschiede in Symptomwahrnehmung und Bewertung der Versorgung weisen auf die Notwendigkeit krankheitsspezifischer Elemente in psychosozialen Unterstützungsangeboten hin.Die Ergebnisse zeigen den hohen Bedarf an psychosozialer Unterstützung von Menschen mit CU und RDS und liefern Hinweise auf die Machbarkeit eines psychosozialen Therapieprogramms.

This study investigated the efficacy of an open-label placebo (OLP) treatment for menopausal hot flushes. Women with at least five moderate or severe hot flushes per day were allocated to receive four weeks of OLP for twice a day or no-treatment. Intention-to-treat analyses included n = 100 women. In comparison to no-treatment, OLP reduced the log-transformed hot flush composite score (frequency × intensity) (mean difference in change: − 0.32, 95% CI [− 0.43; − 0.21], p d = 0.86), hot flush frequency (− 1.12 [− 1.81; − 0.43], p = 0.02, Cohen’s d = 0.51), and improved overall menopause-related quality of life (− 2.53 [− 4.17; − 0.89], p = 0.02, Cohen’s d = 0.49). Twelve (24%) (vs. three [6%]) patients had 50% lesser hot flushes. Problem rating of hot flushes and subdomains of quality of life did not improve. After four weeks, the OLP group was further divided via randomization to continue or discontinue the treatment. Benefits were maintained at week 8 (log-transformed score: − 0.04 [− 0.06; 0.14], p = 0.45). There was no difference between taking placebos for 8 or 4 weeks (log-transformed score: 0.04 [− 0.17; 0.25], p = 0.73). Results indicate that open-label placebos may be an effective, safe alternative for menopausal hot flushes.

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.

Purpose Patients with advanced cancer often receive suboptimal end-of-life (EOL) care. Particularly males with advanced cancer are more likely to receive EOL care that is more aggressive, even if death is imminent. Critical factors determining EOL care are EOL conversations or advance care planning. However, information about gender-related factors influencing EOL conversations is lacking. Therefore, the current study investigates gender differences concerning the content, the desired time point, and the mode of initiation of EOL conversations in cancer patients. Methods In a cross-sectional study, 186 female and male cancer patients were asked about their preferences for EOL discussions using a semi-structured interview, focusing on (a) the importance of six different topics (medical and nursing care, organizational, emotional, social, and spiritual/religious aspects), (b) the desired time point, and (c) the mode of discussion initiation. Results The importance of EOL topics differs significantly regarding issue (p = 0.002, η2 = 0.02) and gender (p η2 = 0.11). Males wish to avoid the engagement in discussions about death and dying particularly if they are anxious about their end-of-life period. They wish to be addressed regarding the “hard facts” nursing and medical care only. In contrast, females prefer to speak more about “soft facts” and to be addressed about each EOL topic. Independent of gender, the majority of patients prefer to talk rather late: when the disease is getting worse (58%), at the end of their therapy, or when loosing self-sufficiency (27.5%). Conclusion The tendency of patients to talk late about EOL issues increases the risk of delayed or missed EOL conversations, which may be due to a knowledge gap regarding the possibility of disease-associated incapability. Furthermore, there are significant gender differences influencing the access to EOL conversations. Therefore, for daily clinical routine, we suggest an early two-step, gender-sensitive approach to end-of-life conversations.

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

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

ObjectivesWe 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.DesignIntervention development using a theory, evidence and person-based approach.SettingPrimary Care in the South of England.ParticipantsFifteen participants with a range of antidepressant experience took part in ‘think aloud’ interviews for intervention optimisation.InterventionOur 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.ResultsThe 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.

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

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

Children and adolescents with major depressive disorder (MDD) appear to be more responsive to placebo than adults in randomized placebo-controlled trials (RCTs) of second and newer generation antidepressants (SNG-AD). Previous meta-analyses obtained conflicting results regarding modifiers. We aimed to conduct a meta-analytical evaluation of placebo response rates based on both clinician-rating and self-rating scales. Based on the most recent and comprehensive study on adult data, we tested whether the placebo response rates in children and adolescents with MDD also increase with study duration and number of study sites. We searched systematically for published RCTs of SNG-AD in children and/or adolescents (last update: September 2017) in public domain electronic databases and additionally for documented studies in clinical trial databases. The log-transformed odds of placebo response were meta-analytically analyzed. The primary and secondary outcomes were placebo response rates at the end of treatment based on clinician-rating and self-rating scales, respectively. To examine the impact of study duration and number of study sites on placebo response rates, we performed simple meta-regression analyses. We selected other potential modifiers of placebo response based on significance in at least one previous pediatric meta-analysis and on theoretical considerations to perform explorative analyses. We applied sensitivity analyses with placebo response rates closest to week 8 to compare our data with those reported for adults. We identified 24 placebo-controlled trials (2229 patients in the placebo arms). The clinician-rated placebo response rates ranged from 22 to 62% with a pooled response rate of 45% (95% CI 41–50%). The number of study sites was a significant modifier in the simple meta-regression analysis [odds ratio (OR) 1.01, 95% CI 1.01–1.02, p = 0.0003, k = 24) with more study sites linked to a higher placebo response. Study duration was not significantly associated with the placebo response rate. The explorative simple analyses revealed that publication year may be an additional modifier. However, in the explorative multivariable analysis including the number of study sites and the publication year only the number of study sites reached a p value ≤ 0.05. The self-rated placebo response rates ranged from 1 to 68% with a pooled response rate of 26% (95% CI 10–54%) (k = 6; n = 396). This meta-analysis confirms a high pooled placebo response rate in children and adolescents based on clinician ratings, which exceeds that observed in the most recent meta-analysis of placebo effects in adults (36%; 95% CI 35–37%) published in 2016. However, and similar to findings in adults, the pooled response rates based on self-ratings were substantially lower. In accordance with previous meta-analyses, we corroborated the number of study sites as significant modifier. In comparison to the recent adult meta-analysis, the substantially lower number of pediatric studies entails a reduced power to detect modifiers. Future studies should provide more precise and homogenous information to support discovery of potential modifiers and consider no-treatment—if ethically permissible—to allow differentiation between placebo and spontaneous remission rates. If these differ, practicing clinicians should facilitate placebo effects as an addition to the verum effect to maximize benefits. Further research is required to explain the discrepant response rates between clinician and self-ratings. Electronic supplementary material The online version of this article (10.1007/s00787-018-1244-7) contains supplementary material, which is available to authorized users.

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.

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

Psychotherapy in children and adolescents is effective, but unwanted effects can occur. Until now, psychotherapy research has neglected this important topic, although children and youths are in need of special protection. Unwanted effects caused by therapy are not systematically investigated and a corresponding conceptualization is missing. The aim of this article is to investigate whether the current classifications of unwanted effects of psychotherapy in adults are applicable to children and adolescents and to identify distinctive features. Furthermore, the adaptation of the Inventory for the Assessment of Negative Effects of Psychotherapy for children and adolescents (Children-INEP) is presented. Finally, steps for the information and prevention of unwanted, and negative effects of psychotherapy in children and adolescents are pointed out.Psychotherapie bei Kinder- und Jugendlichen wirkt, jedoch können auch unerwünschte Effekte auftreten. Im Kinder- und Jugendbereich ist dieses wichtige Thema bisher vernachlässigt worden, obwohl gerade Kinder und Jugendliche eines besonderen Schutzes bedürfen. Durch Therapie verursachte unerwünschte Effekte der Psychotherapie sind im Kinder- und Jugendbereich bisher nicht systematisch untersucht worden und eine entsprechende Konzeptualisierung fehlt. Ziel des vorliegenden Artikels ist es, aktuelle Klassifikationen zu unerwünschten Effekten von Psychotherapie bei Erwachsenen hinsichtlich der Übertragbarkeit auf das Kindes- und Jugendalter zu prüfen und die Besonderheiten in diesem Bereich herauszuarbeiten. Des Weiteren wird die Adaptation des Inventars zur Erfassung negativer Effekte für das Kindes- und Jugendalter vorgestellt (Kinder-INEP) 1. Abschließend werden Maßnahmen zur Aufklärung und Vermeidung von unerwünschten, negativen Effekten in der Kinder- und Jugendlichenpsychotherapie aufgezeigt.

The Positive and Negative Effects of Psychotherapy Scale (PANEPS), a self report questionnaire to measure positive effects (PE) and unwanted events (UE) during the last psychotherapy (PT), was applied for the first time within a sample of patients with depression. The questionnaires applicability was tested and delivered first empirical results about PE and UE of a PT within this population.The 43 items of the PANEPS were completed during an online survey by 135 persons with a current or previous depressive disorder. UE were further divided into side effects (SE), malpractice (MP) and unethical misconduct (UM). In addition, sociodemographic information (age, sex, state of relationship), details about previous psychotherapeutic treatment and the last therapy were collected. The PANEPS was tested and revised using a principal components analysis with varimax rotation.A four-factor solution was determined, reflecting the previously defined scales (PE, SE, MP, UM) and allowed for further reduction of the PANEPS. The final version of the PANEPS showed satisfactory to excellent internal consistency withOver half of the participants in our study confirmed presence of at least one UE as measured with the PANEPS, with unexpected high approval of at least one MP or UM. Especially the current symptomatology (PHQ-9) seems to be relevant for the approval of PE and UE of a PT. The negative association between PE and MP underlines the importance of guideline-oriented treatment for successful psychotherapy.Side effects of psychotherapy are common in patients with depression and should be measured regularly.DieIm Rahmen einer Onlinebefragung füllten 135 Personen mit einer aktuellen oder früheren depressiven Störung die 43 Items der PANEPS aus, welche UE inEine 4-Faktoren-Lösung wurde ermittelt, welche die zuvor definierten Skalen (PE, NW, KF, UF) abbildet und eine weitere Reduktion der PANEPS ermöglicht. Die finale Version der PANEPS, wies eine zufriedenstellende bis exzellente interne Konsistenz auf (Etwas mehr als die Hälfte der Befragten bestätigte mind. ein UE im PANEPS, wobei besonders die Zustimmung zu mind. einem KF oder UF unerwartet hoch ausfielen. Insbesondere die aktuelle Symptombelastung (PHQ-9) scheint für die Zustimmung zu PE und UE einer PT relevant zu sein. Der negative Zusammenhang zwischen PE und KF unterstreicht die Wichtigkeit leitliniengerechter Behandlung für den Erfolg von Psychotherapie.Nebenwirkungen von PT sind auch bei Patienten mit Depressionen zu erwarten und sollten regelhaft erfasst werden.

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

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

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

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

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

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

Drug side effects place a considerable burden on health care systems, clinicians and patients. For example, the annual costs associated with adverse drug-related events in the US rose from $76.6 billion to over $177.4 billion between 1995 and 2000 1. Side effects are generally defined as an action of a drug other than the one for which it is being used. They do not only include drug or drug-use induced adverse effects, but also side effects brought about by patient, treatment or doctor-related factors, such as beliefs and expectations. Most studies have focused on the incidence of relatively infrequent but medically serious adverse events, morbidity and mortality 2. However, the majority of side effects are non-serious and non-specific symptoms that are not clearly attributable to the pharmacologic action of a drug. Depending on the method of ascertainment and the patient population, they comprise 62% to 89% of all patient-reported adverse effects 3, 4. Non-specific symptoms that the patient perceives to be medication-related are frightening and distressing to patients, decrease quality of life 5, cause non-adherence 6, 7 and add to the cost of treatment. Such side effects are even seen in patients taking placebo rather than active drugs 8,9. Understanding the determinants of non-specific side effects would be particularly useful in managing patients with chronic diseases, as it may provide guidance in deciding whether to discontinue or adjust the dose of a medication and/or treat the symptom with another agent if the medication is viewed as medically essential. Side effects to placebo (the nocebo phenomenon) are widely reported. In randomized controlled trials of arthritis therapy, the incidence and type of many side effects are similar in patients taking active drugs compared to those taking placebo 10, 11. In addition, there is a clinical impression that some patients are more likely to report and suffer from bothersome effects than others. This suggests that patient characteristics along with disease and medication variables affect side effect reporting 12. Side effect reporting has been associated with patient’s expectations, prior experiences with medication, gender, age, anxiety, and depression 3, 8, 13. One reliable measure of patient’s positive and negative expectations regarding their medications is the Beliefs about Medicines Questionnaire (BMQ) 14. This questionnaire assesses an individual’s perceptions of medicines prescribed for them on the basis of how they judge their personal need for the medication (Necessity beliefs) relative to their concerns about potential risks (Concerns). In studies across a range of illnesses including asthma, diabetes, cancer 15, depression 16, 17, HIV/Aids 18, 19 and rheumatoid arthritis (RA) 20, 21, medication beliefs are more strongly associated with adherence than socio-demographic or clinical factors, with low adherence related to doubts about personal needs and concerns about side effects. Specific concerns include commonly-held beliefs about the potential dangers of regular medication use like dependence or accumulated long-term effects 14, 22, they are prevalent even among patients who have not experienced side effects from medicines 19. However, little is known about the direct relationship of medication beliefs and side effects. We hypothesized that patients with negative beliefs about their medications would report more side effects, and that the predictive value of those beliefs persists after taking into account objective measures of disease severity and the medication regimen. Furthermore we hypothesized that pre-existing beliefs about medicines would influence subsequent side effect reporting, as opposed to prior experience with side effects from arthritis medication generating negative beliefs about those medicines. A further aim was to determine whether beliefs about medicines have a specific effect on side effects when patients start with a newly prescribed drug. It was hypothesized that RA patients with heightened specific concerns about arthritis medications would experience more bothersome symptoms that they view to be caused by the new medication 23. We believe this to be the first investigation of the nature, direction and course of these relationships in RA patients. Understanding these factors can inform clinical practice. If negative beliefs precede increased side effects reporting, needless termination or adjustment of dose, or additional medications to mitigate these nocebo effects might be averted.

Both preterm delivery and survival rates of very low birth weight (VLBW:1500 g) infants are increasing. To date, the focus on studies about postpartum mental health after preterm birth has been on depression and on women. There is a paucity of research regarding prevalence, risks, and predictors of postpartum anxiety in parents after VLBW birth.Parents with VLBW infants and parents with term infants were recruited into the longitudinal HaFEn-study at the three largest centers of perinatal care in Hamburg, Germany. State anxiety was assessed with the State-Trait-Anxiety Inventory and anxiety and adjustment disorders with a clinical interview one month postpartum. Psychiatric lifetime diagnoses, social support, trait anxiety, stress during birth, socioeconomic status, risks during pregnancy, and mode of delivery were also evaluated. To examine predictors of postpartum state anxiety in both parents simultaneously a multiple random coefficient model was used.230 mothers and 173 fathers were included. The risk for minor/major anxiety symptoms and adjustment disorders was higher in parents with VLBW infants compared to the term group. The risk for anxiety disorders was not higher in parents with VLBW infants. The most important predictors for postpartum state anxiety were high trait anxiety, the birth of a VLBW infant, high stress during birth, and low social support.Data reported here are cross-sectional. Thus, temporal relationships cannot be established.Our results emphasize the importance of early screening for postpartum anxiety in both parents with VLBW infants.

Patients' negative treatment expectations can lead to nocebo-related side effects and non-initiation of treatment. This study aims to identify correlates of treatment expectations in patients with breast cancer before the start of endocrine therapy.Expectations were assessed in a cross-sectional sample of 166 patients with breast cancer after receiving treatment information. Side effect expectations (one item) and treatment necessity-concern balance (Beliefs about Medicines Questionnaire) were assessed. Correlates were analyzed using regression analyses. The structure of treatment expectations was investigated using a network analysis.About 25% of patients expressed negative expectations. Higher side effect expectations were associated with lower treatment efficacy expectations (ß = -0.20, p = 0.01), higher medication overuse beliefs (ß = 0.17, p = 0.01), and a negative treatment appraisal before study treatment information (ß = -0.17, p = 0.02). A negative necessity-concern balance was associated with lower treatment efficacy expectations (ß = 0.36, p 0.001), lower adherence intention (ß = 0.21, p 0.001), and no knowledge of tumor's receptor status (ß = 0.21, p 0.001); furthermore, it was associated with higher medication harmfulness beliefs (ß = -0.16, p = 0.02), negative treatment pre-appraisal (ß = 0.15, p = 0.01), higher somatosensory amplification (ß = -0.14, p = 0.02), and higher education (ß = -0.12, p = 0.02). The most important network node was the concern that endocrine therapy disrupts life.Negative treatment expectations before treatment start are mainly associated with psychological variables. These results are relevant for patient education in clinical settings. To improve expectations, clinicians might emphasize treatment efficacy and discuss general and specific medication concerns. Improving treatment knowledge could also be beneficial. Copyright © 2016 John WileySons, Ltd.

Background Only a minority of people suffering from depression receive adequate treatment. Psychological Online Interventions (POIs) could help bridge existing treatment gaps and augment the effectiveness of current treatments. Apart from effectiveness, user acceptance of POIs must be achieved if such interventions are to be broadly implemented in existing health-care. Valid measurement tools examining attitudes towards POIs are lacking. Therefore, we examined the dimensionality of attitudes towards POIs, developed a novel questionnaire, the Attitudes towards Psychological Online Interventions Questionnaire (APOI), and gathered data to examine its reliability. Methods We recruited a sample of 1004 adults with mild to moderate depressive symptoms from a range of sources. We constructed a set of 35 items based on literature review as well as expert and patient queries. The initial items were subjected to an exploratory factor analysis (EFA) in a randomly selected subsample. A final set of 16 items was subjected to a confirmatory factor analysis (CFA) to cross-validate the factor structure in a separate subsample. Results The EFA revealed four dimensions: “Scepticism and Perception of Risks”, “Confidence in Effectiveness”, “Technologization Threat” and “Anonymity Benefits”. The model fit in the CFA was excellent relating to all applied indices (χ2=105.816, p=.651; SRMR=.042; RMSEA=.013; CFI=.994) and the APOI total scale showed acceptable to good internal consistency. Conclusions Further research with the APOI might facilitate the development and dissemination of POIs and, ultimately, help improve the quality of care for people experiencing depressive symptoms.

Objective This study aims to develop and validate a German version of French and colleagues’ Headache Management Self-efficacy Scale and to construct an abbreviated form for use in behavioral headache research. Furthermore, the contribution of headache-specific self-efficacy to pain-related disability in German chronic headache sufferers was examined. Background Headache-specific self-efficacy refers to an individuals’ confidence that they can engage in behaviors to either prevent headache episodes or to manage headache-related pain and disability. Self-efficacy beliefs have been shown repeatedly to be positively associated with psychological well-being, effective coping, and enhanced treatment outcomes. Methods A cross-sectional sample of 304 individuals diagnosed with either migraine, chronic tension-type headache, or a combination of 2 or more headache disorders completed the German Headache Management Self-efficacy Scale and questionnaires assessing headache activity, pain-related coping, general self-efficacy, depression, and anxiety. Responsiveness of the scale was analyzed in a longitudinal subsample of 32 inpatients undergoing headache treatment. Finally, a short form was constructed and evaluated regarding psychometric properties. Results The German Headache Management Self-efficacy Scale showed good reliability (Cronbach's α = 0.87) as did the 6-item short form (Cronbach's α = 0.72). In the longitudinal sample, both versions showed a good ability to change over time (SRM= 0.52-1.16). Chronic headache patients with higher levels of self-efficacy reported lower levels of disability (r = −0.26 to −0.31). Multiple regression analyses revealed headache intensity and headache-specific self-efficacy as strongest predictors of headache-related disability (βself-efficacy = −0.21, βintensity = 0.26). Conclusions Both the 25-item version and the 6-item version appear to be valid, reliable measures of self-efficacy beliefs. These scales will allow clinicians to identify headache sufferers with low levels of headache-specific self-efficacy with the goal of enhancing this expectancy for improvement. The new short form can help accomplish this goal without adding significantly to the burden of the self-report assessment batteries used in clinical settings.

Objective Informing patients about medical treatments and their possible side effects is ethically and legally obligatory but may trigger negative expectations and nocebo-related side effects. This pilot study aims to investigate the effect of different informed consent procedures on treatment expectations for adjuvant breast cancer treatments (Study 1: endocrine therapy; Study 2: chemotherapy). Method Using an experimental 2-factorial design, healthy women were informed about endocrine therapy (n = 60) or chemotherapy (n = 64) within a hypothetical scenario. Information was framed with or without treatment benefit information and delivered in a personalized or standardized interaction. Primary outcomes were necessity-concern beliefs about the treatment and side-effect expectations, secondary outcomes were decisional conflicts. Results In Study 1, side-effect expectations (η²p= .08) and decisional conflicts (η²p = .07) were lower when framed treatment information was given. Providing personalized information resulted in more functional necessity-concern beliefs (η²p = .06) and lower decisional conflicts (η²p = .07). Personalizing and framing of information resulted in more functional necessity-concern beliefs (η²p = .10) and lower decisional conflicts. In Study 2, necessity-concern beliefs were more functional with framing (η²p = .06). Participants in the personalized groups reported lower decisional conflicts (η²p = .06). No differences in side-effect expectations were revealed. Conclusions This is the first study to provide evidence for optimized treatment expectations through altered informed consent strategies. The results emphasize that framing and personalizing informed consent can positively influence treatment expectations and reduce decisional conflicts. However, generalizations are impaired by the study's pilot character. The potential to prevent nocebo responses in clinical practice should be analyzed. (PsycINFO Database Record

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

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

Panic attacks, the cardinal symptom of panic disorder (PD), are characterized by intense physiological reactions including accelerated heart activity. Although cortical processes are thought to trigger and potentiate panic attacks, it is unknown whether individuals with PD have a general tendency to show elevated cortico–cardiac interactions, which could predispose them for brain-driven modulations of heart activity during panic. Consistent with this hypothesis, serotonin, a highly relevant neurotransmitter for panic and PD presumably affects the cortical control of the heart. The current study thus aimed to test whether PD and serotonin reuptake inhibitor (SRI) intake are related to cortico–cardiac interactions in the absence of acute panic. Human participants with PD (N=22), major depression (MD, clinical control group, N=21) or no psychiatric diagnosis (healthy control group, N=23) performed a gambling task. To measure cortico–cardiac coupling, the within-subject covariation of single-trial EEG after feedback presentation and subsequent changes in heart period was determined. As in prior studies, there was a significant time-lagged covariation of EEG and heart activity indicating that trial-by-trial fluctuations of feedback-evoked EEG amplitude determined how much heart activity accelerated seconds later. Importantly, this covariation pattern was significantly potentiated in PD vs control participants. Moreover, concurrent SRI intake further augmented brain–heart covariation in individuals with PD and MD. The present findings demonstrate that PD and serotonin are associated with altered brain–heart interactions in a non-panic situation. Future work should clarify whether brain–heart coupling has a causal role in PD, for example by facilitating panic attacks.

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.

Objective To assess and compare the benefits of 3 psychosocial treatments for rheumatoid arthritis (RA). Methods RA patients were randomized to cognitive-behavior therapy (CBT), relaxation response training (RR), or arthritis education (AE). All treatment was conducted in groups. Follow-up occurred immediately after treatment and 6 and 12 months later. Pain, other RA symptoms, role impairment, and psychological distress were assessed with standardized self-report questionnaires. Arthritis severity and activity were assessed with a joint examination, erythrocyte sedimentation rate, grip strength, and walking time. An intent-to-treat analytic strategy was employed. Linear regression was used to establish treatment effect on pain and other RA symptoms, while adjusting for sociodemographic and clinical variables. Results One hundred sixty-eight patients were randomized. Pain improved significantly at 12 months in the RR and AE groups and showed a nonsignificant positive trend with CBT. Other RA symptoms improved significantly with CBT and AE and showed a nonsignificant trend with RR. There were no significant differences in the outcomes across the 3 treatment groups. When the results for all 3 groups were aggregated, significant benefits were found for pain, other RA symptoms, self-care activities, and social activities. Effect sizes ranged between 0.26 and 0.35. Conclusions These 3 psychosocial treatments were beneficial, with treatment effect sizes in the small to moderate range. The effects appeared immediately after treatment and were generally sustained at long-term follow-up. These benefits were achieved over and above those resulting from medical management. These treatments constitute an effective augmentation to standard medical therapy for RA patients.

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

Background Although Axis I hypochondriasis is closely related to certain personality characteristics, the nature and extent of personality dysfunction in these patients still needs clarification. This study assessed the prevalence of personality disorders observed in hypochondriacal patients, described the types and comorbidity of personality disorders, and compared the psychological distress of patients with and without the most common comorbid personality disorder. Method One hundred fifteen patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for hypochondriasis completed self-administered assessments, including the Personality Diagnostic Questionnaire-4+ (PDQ-4+), the Hopkins Symptom Checklist-90-Revised (SCL-90-R), the Whiteley Index, and the Somatic Symptom Inventory. These data were taken from a study conducted between September 1997 and November 2001. Results Eighty-eight patients (76.5%) had 1 or more personality disorders, whereas 27 patients (23.5%) had no personality disorders. Fifty-one patients (44.3%) had more than 3 personality disorders. The most common personality disorder in the hypochondriacal patients was obsessive-compulsive personality disorder (OCPD; 55.7%), followed by avoidant personality disorder (40.9%). The comorbidity of OCPD and avoidant personality disorder was 53.1% (34 of 64 patients with OCPD). The total PDQ-4+ score of the 64 patients with OCPD was significantly higher than that of the 51 patients without OCPD. On the SCL-90-R, the 64 patients with OCPD showed significantly higher scores on all of 3 global indices and 7 of 10 primary symptom dimensions (paranoid ideation, depression, anxiety, phobic anxiety, obsessive-compulsive, interpersonal sensitivity, and psychoticism) on the SCL-90-R compared to the 51 patients without OCPD. Conclusions The high prevalence of personality disorders, particularly OCPD, among patients with hypochondriasis suggests that consideration of personality features is important in assessment and therapeutic interventions for hypochondriasis.

Background Adjuvant endocrine therapy can improve disease-free survival and time before recurrence in breast cancer patients. However, it is associated with considerable side effects that negatively affect patients’ quality of life and cause non-adherence. The recently demonstrated effect of individual expectations on side-effect development (nocebo effect) suggests that psychological factors play a role in the prevention of side effects. The aim of this study is to evaluate cognitive-behavioral side-effect prevention training (SEPT) for breast cancer patients. This article describes the study protocol and applied research methods. Methods/Design In a randomized controlled trial, 184 female breast cancer patients are assigned to receive either SEPT, standard medical care or a manualized supportive therapy at the start of adjuvant endocrine treatment. SEPT consists of three sessions of cognitive-behavioral training including psychoeducation to provide a realistic view of endocrine therapy, imagination-training to integrate positive aspects of medication into daily life, and side-effect management to enhance expectations about coping ability. Side effects three months after the start of endocrine therapy serve as primary outcomes. Secondary outcomes include quality of life, coping ability and patients’ medication adherence. Patients’ expectations (i.e., expectations about side effects, coping ability, treatment and illness) are analyzed as mediators. Discussion The optimization of expectations might be a potential pathway in health care to improve patients’ quality of life during long-term medication intake. The results will provide implications for a possible integration of evidence-based prevention training into clinical practice. Trial registration ClinicalTrials.gov, (NCT01741883).

Depression is common among persons with epilepsy (PwE), affecting roughly one in three individuals, and its presence is associated with personal suffering, impaired quality of life, and worse prognosis. Despite the availability of effective treatments, depression is often overlooked and treated inadequately in PwE, in part because of assumed concerns over drug interactions or proconvulsant effects of antidepressants. Internet-administered psychological interventions might complement antidepressant medication or psychotherapy, and preliminary evidence suggests that they can be effective. However, no trial has yet examined whether an Internet intervention designed to meet the needs of PwE can achieve sustained reductions in depression and related symptoms, such as anxiety, when offered as adjunct to treatment as usual. This randomized controlled trial will include 200 participants with epilepsy and a current depressive disorder, along with currently at least moderately elevated depression (Patient Health Questionnaire (PHQ-9) sum score of at least 10). Patients will be recruited via epilepsy treatment centers and other sources, including Internet forums, newspaper articles, flyers, posters, and media articles or advertisements, in German-speaking countries. Main inclusion criteria are: self-reported diagnosis of epilepsy and a depressive disorder, as assessed with a phone-administered structured diagnostic interview, none or stable antidepressant medication, no current psychotherapy, no other major psychiatric disorder, no acute suicidality. Participants will be randomly assigned to either (1) a care-as-usual/waitlist (CAU/WL) control group, in which they receive CAU and are given access to the Internet intervention after 3 months (that is, a CAU/WL control group), or (2) a treatment group that may also use CAU and in addition immediately receives six-month access to the novel, Internet-administered intervention. The primary outcome measure is the PHQ-9, collected at three months post-baseline; secondary measures include self-reported anxiety, work and social adjustment, epilepsy symptoms (including seizure frequency and severity), medication adherence, potential negative treatment effects and health-related quality of life. Measurements are collected online at pre-treatment (T0), three months (T1), six months (T2), and nine months (T3). Results of this trial are expected to extend the body of knowledge with regard to effective and efficient treatment options for PwE who experience elevated depression and anxiety. ClinicalTrials.gov: NCT02791724 . Registered 01 June 2016.

Background Anaesthesia and surgery provoke preoperative anxiety and stress. Patients try to regain control of their emotions by using coping efforts. Coping may be more effective if supported by specific strategies or external utilities. This study is the first to analyse coping strategies in a large population of patients with high preoperative anxiety. Methods We assessed preoperative anxiety and coping preferences in a consecutive sample of 3087 surgical patients using validated scales (Amsterdam Preoperative Anxiety and Information Scale/Visual Analogue Scale). In the subsample of patients with high preoperative anxiety, patients’ dispositional coping style was determined and patients’ coping efforts were studied by having patients rate their agreement with 9 different coping efforts on a four point Likert scale. Statistical analysis included correlational analysis between dispositional coping styles, coping efforts and other variables such as sociodemographic data. Statistical significance was considered for p < 0.05. Results The final analysis included 1205 patients with high preoperative anxiety. According to the initial self-assessment, about two thirds of the patients believed that information would help them to cope with their anxiety (“monitors”); the remainder declined further education/information and reported self-distraction to be most helpful to cope with anxiety (“blunters”). There was no significant difference between these two groups in anxiety scores. Educational conversation was the coping effort rated highest in monitors whereas calming conversation was the coping effort rated highest in blunters. Coping follows no demographic rules but is influenced by the level of education. Anxiolytic Medication showed no reliable correlation to monitoring and blunting disposition. Both groups showed an exactly identical agreement with this coping effort. Demand for medical anxiolysis, blunting or the desire for more conversation may indicate increased anxiety. The use of the internet was independent of the anxiety level and the demand of information. Conclusion Conversation with medical staff proved to be the most popular coping strategy. Acknowledgment of the division between information-seeking and blunting-like personalities is central to supporting the patient’s individual coping efforts. Internet access may be the easiest way to support coping today. Electronic supplementary material The online version of this article (doi:10.1186/s12913-016-1492-5) contains supplementary material, which is available to authorized users.