openHSU – Research Showcase

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  • Publication
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    Study protocol: combined N-of-1 trials to assess open-label placebo treatment for antidepressant discontinuation symptoms [FAB-study]
    (2023-10)
    Konigorski, Stefan
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    Meißner, Carina
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    Fadai, Tahmine
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    Warren, Claire V.
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    Falkenberg, Irina
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    Kircher, Tilo
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    Nestoriuc, Yvonne 
    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.
  • Publication
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    Disentangling pharmacological and expectation effects in antidepressant discontinuation among patients with fully remitted major depressive disorder
    (2023-06-21)
    Meißner, Carina
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    Warren, Claire
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    Fadai, Tahmine
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    Zapf, Antonia
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    Lezius, Susanne
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    Ozga, Ann-Kathrin
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    Falkenberg, Irina
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    Kircher, Tilo
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    Nestoriuc, Yvonne 
    Background Antidepressants are established as an evidence-based, guideline-recommended treatment for Major Depressive Disorder. Prescriptions have markedly increased in past decades, with a specific surge in maintenance prescribing. Patients often remain on antidepressants longer than clinically necessary. When attempting to stop, many patients experience adverse discontinuation symptoms. Discontinuation symptoms can be debilitating and hinder successful discontinuation. While discontinuation symptoms can result from pharmacological effects, evidence on nocebo-induced side effects of antidepressant use suggests that patients' expectations may also influence occurrence. Methods To disentangle pharmacological and expectation effects in antidepressant discontinuation, patients with fully remitted Major Depressive Disorder who fulfill German guideline recommendations to discontinue will either remain on or discontinue their antidepressant. Participants' expectations will be manipulated by varying verbal instructions using an open-hidden paradigm. Within the open trial arms, participants will receive full information about treatment, i.e., high expectation. Within the hidden trial arms, participants will be informed about a 50% chance of discontinuing versus remaining on their antidepressant, i.e., moderate expectation. A total of N = 196 participants will be randomly assigned to either of the four experimental groups: open discontinuation (OD; n = 49), hidden discontinuation (HD; n = 49), open continuation (OC; n = 49), or hidden continuation (HC; n = 49). Discontinuation symptom load during the 13-week experimental phase will be our primary outcome measure. Secondary outcome measures include discontinuation symptom load during the subsequent 39-week clinical observation phase, recurrence during the 13-week experimental period, recurrence over the course of the complete 52-week trial evaluated in a time-to-event analysis, and stress, anxiety, and participants’ attentional and emotional processing at 13 weeks post-baseline. Blood and saliva samples will be taken as objective markers of antidepressant blood serum level and stress. Optional rsfMRI measurements will be scheduled. Discussion Until today, no study has explored the interplay of pharmacological effects and patients’ expectations during antidepressant discontinuation. Disentangling their effects has important implications for understanding mechanisms underlying adverse discontinuation symptoms. Results can inform strategies to manage discontinuation symptoms and optimize expectations in order to help patients and physicians discontinue antidepressants more safely and effectively. Trial registration ClinicalTrials.gov (NCT05191277), January 13, 2022.
  • Publication
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    Can nocebo information and empathy alleviate symptoms in advanced cancer?
    (2023-03-23)
    Meijers, Maartje
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    Stouthard, Jacqueline
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    Evers, Andrea
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    Das, Enny
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    Plum, Nicole
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    Drooger, Elrike
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    Jansen, Sophie
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    Francke, Anneka
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    Van der Wall, Elsken
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    Nestoriuc, Yvonne 
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    Dusseldorp, Elise
    Introduction To alleviate anti-cancer treatment burden in advanced breast cancer, patient-clinician communication strategies based on nocebo-effect mechanisms are promising. We assessed distinct/combined effects on psychological outcomes (e.g. anxiety; main outcome) and side-effect expectations of i) nocebo information about the (non)pharmacological origin of side effects, and ii) clinician-expressed empathy through reassurance of continuing support. Furthermore, we explored whether information and empathy effects on side-effect expectations were mediated by decreased anxiety. Methods In a two-by-two experimental video-vignette design, 160 cancer patients/survivors and healthy women watched one of four videos differing in level of nocebo information (+/-) and empathy (+/-). Regression and mediation analysis were used to determine effects of information/empathy and explore anxiety’s mediating role. Results Anxiety was not influenced by empathy or information (Stai-state: p=.295; p=.390, VAS p=.399; p=.823). Information improved (specific) side-effect coping expectations (p<.01). Empathy improved side-effect intensity expectations (p<.01=specific; p<.05=non-specific/partial) and specific side-effect probability expectations(p<.01), and increased satisfaction, trust, and self-efficacy (p<.001). No mediating effects were found of anxiety on expectations. Conclusion Mainly empathy, but also nocebo information improved psychological outcomes and – mainly specific – side-effect expectations. Exploring the power of these communication elements in clinical practice is essential to diminish the anti-cancer treatment burden in advanced breast cancer.
  • Publication
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    Expectations and prior experiences associated with adverse effects of COVID-19 vaccination
    (2023-03-27)
    Schäfer, Ingmar
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    Oltrogge, Jan Hendrik
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    Nestoriuc, Yvonne 
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    Warren, Claire V.
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    Brassen, Stefanie
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    Blattner, Maximilian
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    Lühmann, Dagmar
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    Tinnermann, Alexandra
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    Scherer, Martin
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    Büchel, Christian
    Importance Uptake of vaccination against COVID-19 is strongly affected by concerns about adverse effects. Research on nocebo effects suggests that these concerns can amplify symptom burden. Objective To investigate whether positive and negative expectations prior to COVID-19 vaccination are associated with systemic adverse effects. Design, Setting, and Participants This prospective cohort study analyzed the association of expected benefits and risks of vaccination, adverse effects at first vaccination, and observed adverse effects in close contacts with severity of systemic adverse effects among adults receiving a second dose of messenger RNA (mRNA)–based vaccines between August 16 and 28, 2021. A total of 7771 individuals receiving the second dose at a state vaccination center in Hamburg, Germany, were invited to participate; of these, 5370 did not respond, 535 provided incomplete information, and 188 were excluded retrospectively. The mobile application m-Path was used for data collection. Main Outcomes and Measures Primary outcome was a composite severity index of systemic adverse effects in 12 symptom areas measured once daily with an electronic symptom diary over 7 consecutive days. Data were analyzed by mixed-effects multivariable ordered logistic regression adjusted for prevaccine symptom levels and observation times. Results A total of 10 447 observations from 1678 individuals receiving vaccinations (BNT162b2 [Pfizer BioNTech] in 1297 [77.3%] and mRNA-1273 [Moderna] in 381 [22.7%]) were collected. The participants’ median age was 34 (IQR, 27-44) years, and 862 (51.4%) were women. The risk for more severe adverse effects was higher for persons expecting a lower benefit of vaccination (odds ratio [OR] for higher expectations, 0.72 [95% CI, 0.63-0.83]; P &lt; .001), expecting higher adverse effects of vaccination (OR, 1.39 [95% CI, 1.23-1.58]; P &lt; .001), having experienced higher symptom burden at the first vaccination (OR, 1.60 [95% CI, 1.42-1.82]; P &lt; .001), scoring higher on the Somatosensory Amplification Scale (OR, 1.21 [95% CI, 1.06-1.38]; P = .004), and if the vaccine mRNA-1273 was given rather than BNT162b2 (OR, 2.45 [95% CI, 2.01-2.99]; P &lt; .001). No associations were seen for observed experiences. Conclusions and Relevance In this cohort study, several nocebo effects occurred in the first week after COVID-19 vaccination. The severity of systemic adverse effects was associated not only with vaccine-specific reactogenicity but also more negative prior experiences with adverse effects from the first COVID-19 vaccination, more negative expectations regarding vaccination, and tendency to catastrophize instead of normalize benign bodily sensations. Clinician-patient interactions and public vaccine campaigns may both benefit from these insights by optimizing and contextualizing information provided about COVID-19 vaccines.
  • Publication
    Unknown
    The treatment expectation questionnaire (TEX-Q)
    (2023-01-23)
    Shedden-Mora, Meike C.
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    Alberts, Jannis
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    Petrie, Keith J.
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    Laferton, Johannes A. C.
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    Blanckenburg, Pia von
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    Kohlmann, Sebstian
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    Nestoriuc, Yvonne 
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    Löwe, Bernd
    Background Patients’ expectations, as a central mechanism behind placebo and nocebo effects, are an important predictor of health outcomes. Yet, theoretically based generic assessment tools allowing for an integrated understanding of expectations across conditions and treatments are lacking. Based on the preliminary 35-item version, this study reports the development and validation of the Treatment Expectation Questionnaire (TEX-Q), a generic, multidimensional self-report scale measuring patients’ expectations of medical and psychological treatments. Methods The TEX-Q was developed in a validation sample of n = 251 patients undergoing different treatments using exploratory factor analyses and item analyses, as well as analysis of convergent and divergent validity. Confirmatory factor analysis was conducted in an independent sample of n = 303 patients undergoing cancer treatment. Two-weeks test-retest reliability was assessed in n = 28 psychosomatic outpatients. Results Factor analyses revealed six theoretically founded stable subscales. The TEX-Q assesses expectations of treatment benefit, positive impact, adverse events, negative impact, process and behavioural control with a total of 15 items. Results for the subscales and the sum score indicated good internal consistency (α = .71-.92), moderate to high test-retest reliability (r = .39-.76) as well as good convergent validity with regard to other expectation measures (r = .42-.58) and divergent validity with regard to measures of generalized expectations (r < .32) and psychopathology (r < .28). Conclusions While further validation is needed, the results suggest that the TEX-Q is a valid and reliable scale for the generic, multidimensional assessment of patients’ treatment expectations. The TEX-Q overcomes constraints of ad-hoc and disease-specific scales, while allowing to compare the impact of different expectation constructs across conditions and treatments.
  • Publication
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    Do expectations determine postoperative disability in women with endometriosis?
    (2023-01-04) ;
    Meyrose, Ann-Katrin 
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    Buchweitz, Olaf
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    Nestoriuc, Yvonne 
    Introduction Overall, 20%–30% of women with endometriosis report endometriosis-related disability after successful laparoscopy. This indicates a potential impact of psychological factors, such as expectations, on treatment outcomes. It is already known that expectations determine treatment outcomes in various health conditions, such as cardiologic or gynaecology. Therefore, we investigate the impact of expectations and other psychological factors on patients’ course of treatment outcomes after laparoscopy. Methods and analysis A longitudinal mixed-methods study with N=300 women treated at a specialised centre of surgical endoscopy and endometriosis will be conducted with one preoperative and eight postoperative assessments of endometriosis-related disability and a priori specified predictors such as expectations. Additionally, two subsamples (each ~n=30) will be either interviewed about their endometriosis-related disability, expectations, and experiences of laparoscopy before and after surgery or asked once per day for 30 consecutive days using ambulatory assessments. Quantitative data will be analysed using multilevel modelling for longitudinal data. Structural content analysis will be used for qualitative data. Discussion To optimise treatment for women with endometriosis, it is essential to understand how treatment expectations and other psychological and medical factors influence treatment outcomes after laparoscopy. Ethics and dissemination The Ethics Committee of the Psychotherapeutenkammer Hamburg, Germany, gave ethical approval (ROXWELL-2021-HH, 25 June 2021). Trial registration number ClinicalTrials.gov Registry (NCT05019612).
  • Publication
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    (WIP) Social interaction dynamics in a simulated virtual consultation about psychotherapy
    (2023-04)
    Melchiors, Leslie-Maryse
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    Nestoriuc, Yvonne 
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    Steinicke, Frank
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    Riehle, Marcel
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    Joshi, Nidhi
    Background A central element of psychotherapy is the dyadic social interaction between therapist and patient. The intermittent coupling of nonverbal behavioral patterns of both interaction partners is referred to as nonverbal or motion synchrony. Motion synchrony significantly correlates with relevant psychotherapeutic process and outcome measures, such as therapeutic relationship and the probability of patient-side discontinuation. At the same time, the education of patients is crucial for an informed decision about psychotherapeutic treatment. In a simulated virtual educational consultation about psychotherapy, the impact of nonverbal social interaction on therapy-related motivation and expectations will be examined. Methods Educational consultation sessions will be conducted with N = 150 participants from the German population who are interested in psychotherapy. Consultations are performed via video call by either a psychologist or an avatar, i.e. a virtual embodied representation of a person. Video data will be analyzed using Motion Energy Analysis to assess motion synchrony. T-tests and a RM-MANOVA with a within-subject factor “time” (pre- vs. post-measurement) and a between-subject factor “group” (psychologist vs. avatar condition) will be conducted. Findings It is hypothesized that subjects in the psychologist condition compared to those in the avatar condition: 1) experience higher values for therapeutic relationship (both self-rated and objectively by motion synchrony) and 2) report a greater increase in therapy-related motivation and expectation from pre- to post-measurement. Discussion The results of the Motion Energy Analysis of the virtual dyadic interaction will provide important insights into the social mechanisms for modulating motivation and expectation and options for fostering the therapeutic relationship.
  • Publication
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    So gelingt die Aufklärung über Psychotherapie
    (DPtV Deutsche Psychotherapeuten Vereinigung, 2023-12)
    Leonie Gerke
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    Meyrose, Ann-Katrin 
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    Nestoriuc, Yvonne 
    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.
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    Inventar zur balancierten Erfassung negativer Effekte von Psychotherapie (INEP)
    (Medizinisch Wissenschaftliche Verlagsgesellschaft, 2022-03-16)
    Gerke, Leonie
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    Rief, Winfried
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    Nestoriuc, Yvonne 
  • Publication
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    Aus- und Weiterbildung von Psychotherapeut:innen
    (Medizinisch Wissenschaftliche Verlagsgesellschaft, 2022-03-16)
    Scholten, Saskia
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    Brakemeier, Eva-Lotta
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    Nestoriuc, Yvonne