openHSU – Research Showcase

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  • Publication
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  • Publication
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    Capacity to consent to psychotherapy
    (2023-11-22) ; ;
    Gerke, Leonie
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    Trachsel, Manuel
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    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.
  • Publication
    Metadata only
    Optimizing treatment expectations and decision making through informed consent for psychotherapy
    (2023-11-16)
    Gerke, Leonie
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    ; ;
    Liebherz, Sarah
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    Reininger, Klaus Michael
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    Kriston, Levente
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    Trachsel, Manuel
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    Härter, Martin
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    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.
  • Publication
    Metadata only
    Psychological risk factors for Long COVID and their modification
    (Cambridge Univ. Press, 2023-11-03)
    Engelmann, Petra
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    Büchel, Christian
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    Frommhold, Jördis
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    Klose, Hans F. E.
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    Lohse, Ansgar W.
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    Maehder, Kerstin
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    Scherer, Martin
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    Suling, Anna
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    Toussaint, Anne
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    Weigel, Angelika
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    Zapf, Antonia
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    Löwe, Bernd
    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.
  • Publication
    Unknown
    Placebo and nocebo effects in depression
    (2023-10)
    Rief, Winfried
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    Kelley, John M.
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    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.
  • Publication
    Metadata only
    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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    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
    Metadata only
    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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    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
    Metadata only
    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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    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
    Metadata only
    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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    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.