Nestoriuc, Yvonne

Background: Many patients with depressive disorders use antidepressants longer than clinically indicated. Long-term use is associated with high individual and societal costs. Patients often perceive antidepressant discontinuation as challenging. Aim: To understand patients’ expectations towards discontinuation, document their experiences with long-term use and discontinuation, and identify factors that can help or hinder discontinuation. Design and Setting: Qualitative study using semi-structured interviews via telephone with adult patients in Germany. Method: Thirty-two patients with remitted Major Depressive Disorder and long-term antidepressant use were interviewed. We analysed transcripts with content analysis aided by MaxQDA to derive thematic categories. Results: Patients expected to eliminate side effects or regain independence following discontinuation. Such positive expectations were perceived as facilitators and motivated patients’ discontinuation wish. However, patients also had negative expectations such as recurrence or discontinuation symptoms. Patients’ negative expectations were often fuelled by negative experiences, persisted despite a wish to stop antidepressants, and hindered discontinuation. Most patients perceived antidepressants as effective, but experienced side effects and further hassles. Patients felt inadequately informed about treatment duration and methods for discontinuation. Further barriers and facilitators included a stable environment, availability of support, and treatment information. Conclusion: Patients prefer to discontinue antidepressants within structured frameworks that provide information and support. Identified facilitators and barriers may help optimise appropriate use and discontinuation of antidepressants in routine practice. The utility of functional expectations and specification of individualised approaches to minimise dysfunctional expectations, adapted to patients’ previous experiences, appear to be especially important.

Psoriasis is a highly debilitating chronic inflammatory disease. Increased understanding of its pathophysiology has enabled development of targeted treatments such as biologics. Several medical treatments have been shown to be influenced by patients’ experiences and expectations. However, only little is known about patients’ experiences with and expectations towards biologics. Our objectives were to identify patients’ treatment experiences and treatment expectations and assess their trajectories over the course of treatment with the IL-17A inhibitor secukinumab. Moreover, we aimed to document effects of psoriasis, factors that influence symptomatology, and prior treatment experiences. Patients and Methods We conducted semi-structured interviews with n = 24 patients with moderate-to-severe plaque psoriasis and employed a qualitative content analysis to derive thematic and evaluative codes. Findings were validated via peer debriefings with experienced dermatologists. Results Patients reported burdensome physical and psychological psoriasis symptoms and identified factors that can improve or worsen symptomatology, including stress and self-efficacy. Prior treatment experiences were mostly negative. Past barriers to effective treatment included time constraints or limited access. Concerning secukinumab, patients initially expected complete to partial remission of symptoms and occurrence or absence of side effects. Closer inspection of expectations and experiences revealed three trajectories. For most patients, initial expectations were met and future expectations remained unchanged. For the other patients, however, the experience did not match their initial expectation. One group then adapted their future expectations according to their experience, while the other group did not. Conclusion To our knowledge, this is the first qualitative study to assess expectations towards treatment effectiveness and side effects, their trajectories, and interplay with experiences among psoriasis patients. Our findings highlight the value of further research on the subject in order to optimize care for psoriasis patients and to learn more about the trajectories and influence of treatment expectations in general.

Background Informed consent is an ethical prerequisite for psychotherapy. There are no routinely used standardized strategies for obtaining informed consent. A new optimized informed consent consultation (OIC) strengthened treatment‐relevant aspects. It remains unclear which factors influence the OIC efficacy regarding clinical and decision‐related outcomes. Methods N = 122 adults were included in a randomized controlled online trial. Participants received an information brochure on psychotherapy (TAU; n = 61) or OIC + TAU (n = 61). The main and interaction effects of group allocation, therapeutic alliance, prior knowledge about psychotherapy and treatment motivation on treatment expectations, decisional conflict and capacity to consent were tested. Floodlight analyses were conducted for significant interactions. Results Large interaction effects were shown between treatment motivation and group allocation on treatment expectations (β = −0.53) and between prior knowledge and group assignment on capacity to consent (β = 0.68). The interaction between treatment motivation and group allocation was significant up to a motivation score of 5.54 (range: 1–7). The interaction between prior knowledge and group assignment was significant up to a knowledge score of 14.38 (range: 5–20). Conclusion Moderator analyses indicated varying efficacy degrees for the OIC regarding decisional outcomes and expectation. Especially patients with little treatment motivation or low prior knowledge benefited from optimized information about the efficacy and possible side effects of psychotherapy. Trial Registration: PsychArchives (https://doi.org/10.23668/psycharchives.4929): 17.06.2021

Background: Treatment expectations influence clinical outcomes in various physical and psychological conditions; however, no studies have explored their role in endometriosis treatment. It is necessary to understand how these expectations can be measured to study treatment expectations and their effects in clinical practice. This study aimed to psychometrically analyze and compare different treatment expectation measurements and describe treatment expectations in women with suspected endometriosis. Method: Analysis of cross-sectional baseline data of a mixed-method clinical observational study of N=699 patients undergoing laparoscopy in Germany. Descriptives, bivariate associations, convergent and discriminant validity of four expectation measurements (Treatment Expectation Questionnaire (TEX-Q); Generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE); numerical rating scales (NRS) assessing improvement and worsening of endometriosis symptoms, expected Pain Disability Index (PDI); range: 0 to 10) were estimated. A cluster analysis was performed on the three GEEE items. Results: Most participants expected high improvement (M=6.68 to 7.20, SD=1.90 to 2.09) and low worsening (M=1.09 to 2.52, SD=1.80 to 2.25) of disability from laparoscopy. Participants who expected greater worsening expected more side effects (r=.31 to .60, p<.001). Associations between the positive and negative expectation dimensions, including side effects, were small to non-significant (r =|.24| to .00, p<.001 to.978). Four distinct clusters, described as’positive’, ‘no pain, no gain’, ‘diminished’, and ‘uniform’ were found, with a total PVE of 62.2%. Conclusions: Women with suspected endometriosis reported positive expectations concerning laparoscopy, but wide ranges indicated interindividual differences. Treatment expectations seem to be a multidimensional construct in this patient group. The investigated measurements did not correlate to the extent that they measured exactly the same construct. The selection of measurements should be carefully considered and adapted for the study purposes. Clusters provide initial indications for individualized interventions that target expectation manipulation. Trial Registration Number: ID NCT05019612 (ClinicalTrials.gov)

Die Aufklärung und informierte Einwilligung stellen eine rechtliche und ethische Voraussetzung für eine Psychotherapie dar. Wir befragten daher 530 psychotherapeutisch Praktizierende in Deutschland zu ihren Einstellungen und zur praktischen Umsetzung der Aufklärung mit informierter Einwilligung für Psychotherapie. Für die meisten Behandelnden (84%) war das Einholen einer informierten Behandlungseinwilligung alltägliche Routine. Viele Psychotherapeut*innen fühlten sich unsicher, ob sie die rechtlichen (63%) und ethischen Verpflichtungen (52%) zufriedenstellend erfüllen. Vier von fünf Behandelnden (80%) gaben an, Patient*innen auch über mögliche Risiken zu informieren. Viele Befragte (52%) befürchteten allerdings, durch diese Informationen Ängste bei Patient*innen auszulösen. Obwohl die informierte Einwilligung für Psychotherapie in der klinischen Praxis eher die Regel als die Ausnahme zu sein scheint, bleibt die Umsetzungsqualität im Hinblick auf die rechtlichen, ethischen und klinischen Anforderungen fraglich.

Background Patients' capacity to consent to treatment (CCT) is a prerequisite for ethically sound informed consent in psychotherapy. The MacArthur Competence Assessment Tool for Treatment (MacCAT‐T) is a reliable instrument for assessing CCT. A German version was adapted to the psychotherapeutical context (MacCAT‐PT) to investigate its reliability and possible influences of age, education and prior experience with psychotherapy on CCT in a mixed clinical sample. Methods N = 108 patients with indication for psychotherapy were recruited. The MacCAT‐PT was administered by trained psychologists, took 20 min on average and was rated by the administering psychologist and an independent rater. Reliability statistics were investigated and regression analyses were conducted on MacCAT‐PT scores and sociodemographic variables. Results Sufficient to moderate inter‐rater reliability (ICC = 0.80) and internal consistency (α = 0.80) were found for the total sum score of the MacCAT‐PT and its scales, Understanding (ICC = 0.79, α = 0.77), Reasoning (ICC = 0.57, α = 0.65) and Making a Choice (ICC = 0.57). Appreciation featured an unacceptable inter‐rater reliability (ICC = −0.01). Regression analyses indicated no significant effects. Conclusion These findings suggest that the MacCAT‐PT is a reliable tool for assessing patients' overall CCT in psychotherapy. Psychometric properties of three scales were of good quality, while Appreciation needs to be reanalysed in patient samples with lower motivation for psychotherapy or limited CCT. The CCT may be suggested to be independent of age, education and prior experience. Future research should provide analyses focusing on structural and clinical validity in multiple clinical samples.

Objective: The objective of this research was to determine the efficacy and safety of an optimized informed consent (OIC) consultation for psychotherapy. Method: We performed a randomized controlled superiority online trial involving 2 weeks of treatment and 3 months of follow-up. One hundred twenty-two adults with mental disorders confirmed by structured interview currently neither in out- nor inpatient psychotherapy (mean age: 32, gender identity: 51.6% female, 1.6% diverse), were randomized. Participants received an information brochure about psychotherapy for self-study (treatment as usual [TAU]; n = 61) or TAU plus a one-session OIC utilizing expectation management, contextualization, framing, and shared decision making (n = 61). The primary outcome was treatment expectations at 2-week follow-up. Results: At 2-week follow-up, participants receiving OIC showed more positive treatment expectations compared to those receiving TAU only (mean difference: 0.70, 95% CI [0.36, 1.04]) with a medium effect size (d = 0.73). Likewise, OIC positively influenced motivation (d = 0.74) and adherence intention (d = 0.46). OIC entailed large effects on reduction of decisional conflict (d = 0.91) and increase of knowledge (d = 0.93). Participants receiving OIC showed higher capacity to consent to treatment (d = 0.63) and higher satisfaction with received information (d = 1.34) compared to TAU. No statistically significant group differences resulted for expected adverse effects of psychotherapy. Results were maintained at 3-month follow-up. Data sets for n = 10 cases (8.2%) were missing (postassessment n = 4, 2-week n = 6, 3-month follow-up n = 8). Conclusions: Explaining to patients how psychotherapy works via a short consultation was effective in strengthening treatment expectations and decision making in a nonharmful way. Further trials clarifying whether this effectively translates to better treatment outcomes are required.

Background Growing evidence suggests that in addition to pathophysiological, there are psychological risk factors involved in the development of Long COVID. Illness-related anxiety and dysfunctional symptom expectations seem to contribute to symptom persistence. Aims With regard to the development of effective therapies, our primary aim is to investigate whether symptoms of Long COVID can be improved by a targeted modification of illness-related anxiety and dysfunctional symptom expectations. Second, we aim to identify additional psychosocial risk factors that contribute to the persistence of Long COVID, and compare them with risk factors for symptom persistence in other clinical conditions. Method We will conduct an observer-blinded, three-arm, randomised controlled trial. A total of 258 patients with Long COVID will be randomised into three groups of equal size: targeted expectation management in addition to treatment as usual (TAU), non-specific supportive treatment plus TAU, or TAU only. Both active intervention groups will comprise three individual online video consultation sessions and a booster session after 3 months. The primary outcome is baseline to post-interventional change in overall somatic symptom severity. Conclusions The study will shed light onto the action mechanisms of a targeted expectation management intervention for Long COVID, which, if proven effective, can be used stand-alone or in the context of broader therapeutic approaches. Further, the study will enable a better understanding of symptom persistence in Long COVID by identifying additional psychological risk factors.

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

This chapter reviews evidence for placebo and nocebo effects in depression, including their mechanisms of action. The authors then consider how these effects could be used clinically. Meta-analyses indicate that antidepressants provide only marginal benefits over placebos, which suggests that placebos could benefit patients nearly as much as antidepressants do, but without medication side effects. Open-label placebos are a promising avenue for evoking these effects. It is also presented evidence for expectancy as an important mechanism underlying placebo and nocebo effects. It is discussed how expectancies regarding treatment efficacy and side effects could be manipulated to reduce side effects and improve clinical outcomes. In particular, the authors discuss how communication strategies such as contextualizing informed consent and framing treatment information can optimize treatment expectations, improve clinical outcomes, and reduce nocebo-related side effects. Finally, implications that such expectancy manipulations might have for clinical trial design are covered.