Now showing 1 - 10 of 16
  • Publication
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    What helps, what hinders antidepressant discontinuation? Qualitative analysis of patients’ experiences and expectations
    (Royal College of General Practitioners, 2024-06-27)
    Meißner, Carina
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    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.
  • Publication
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    “I was almost in disbelief” - qualitative analysis of experiences and expectations among psoriasis patients undergoing biologic treatment with secukinumab
    (Dove Medical Press Ltd, 2024-06-24)
    Hölsken, Stephanie
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    Benthin, Carina
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    Krefting, Frederik
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    Mühlhaus, Senta
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    Schedlowski, Manfred
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    Sondermann, Wiebke
    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.
  • Publication
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    Informed consent for psychotherapy: the moderating role of therapeutic alliance, prior knowledge and autonomous motivation on decision‐making and treatment expectation
    (Wiley, 2024-04-11) ; ;
    Gerke, Leonie
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    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
  • Publication
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    Assessment of treatment expectations in women with suspected endometriosis: A psychometric analysis
    (F1000 Research Ltd., 2024-03-11) ;
    Basedow, Lukas A.
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    Buchweitz, Olaf
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    Rief, Winfried
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    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)
  • Publication
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    “Let’s see what happens:”—Women’s experiences of open-label placebo treatment for menopausal hot flushes in a randomized controlled trial
    (2022-11-04)
    Pan, Yiqi
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    Frank, Miriam L.
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    Kaptchuk, Ted J.
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    Abdelbasset, Walid Kamal
    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.
  • Publication
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    Optimized informed consent for psychotherapy: protocol for a randomized controlled trial
    (JMIR Publications Inc., 2022-09-30)
    Gerke, Leonie
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    Trachsel, Manuel
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    Härter, Martin
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    Background Informed consent is a legal and ethical prerequisite for psychotherapy. However, in clinical practice, consistent strategies to obtain informed consent are scarce. Inconsistencies exist regarding the overall validity of informed consent for psychotherapy as well as the disclosure of potential mechanisms and negative effects, the latter posing a moral dilemma between patient autonomy and nonmaleficence. Objective This protocol describes a randomized controlled web-based trial aiming to investigate the efficacy of a one-session optimized informed consent consultation. Methods The optimized informed consent consultation was developed to provide information on the setting, efficacy, mechanisms, and negative effects via expectation management and shared decision-making techniques. A total of 122 participants with an indication for psychotherapy will be recruited. Participants will take part in a baseline assessment, including a structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) disorders. Eligible participants will be randomly assigned either to a control group receiving an information brochure about psychotherapy as treatment as usual (n=61) or to an intervention group receiving treatment as usual and the optimized informed consent consultation (n=61). Potential treatment effects will be measured after the treatment via interview and patient self-report and at 2 weeks and 3 months follow-up via web-based questionnaires. Treatment expectation is the primary outcome. Secondary outcomes include the capacity to consent, decisional conflict, autonomous treatment motivation, adherence intention, and side-effect expectations. Results This trial received a positive ethics vote by the local ethics committee of the Center for Psychosocial Medicine, University-Medical Center Hamburg-Eppendorf, Hamburg, Germany on April 1, 2021, and was prospectively registered on June 17, 2021. The first participant was enrolled in the study on August 5, 2021. We expect to complete data collection in December 2022. After data analysis within the first quarter of 2023, the results will be submitted for publication in peer-reviewed journals in summer 2023. Conclusions If effective, the optimized informed consent consultation might not only constitute an innovative clinical tool to meet the ethical and legal obligations of informed consent but also strengthen the contributing factors of psychotherapy outcome, while minimizing nocebo effects and fostering shared decision-making. Trial Registration PsychArchives; http://dx.doi.org/10.23668/psycharchives.4929 International Registered Report Identifier (IRRID) DERR1-10.2196/39843
  • Publication
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    Informed consent for psychotherapy: Ethical illusion or clinical reality? A survey about psychotherapists' attitudes and practices in Germany
    (2022-09-30)
    Gerke, Leonie
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    Meyrose, Ann‐Katrin
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    Objective This study aimed to assess clinicians' attitudes and their current clinical practices regarding informed consent for psychotherapy. Method A convenience sample of N = 530 clinicians in Germany (n = 418 licensed psychotherapists and n = 112 postgraduate psychotherapy trainees) took part in an online survey. Results Most clinicians (84%) reported obtaining informed consent for psychotherapy in their daily routine. However, many psychotherapists felt unsure about satisfactorily fulfilling the legal (63%) and ethical obligations (52%). The two most frequently reported components of information disclosure related to explaining the terms and conditions of psychotherapy (96%) and the psychotherapeutic approach (91%). Providing information about mechanisms of psychotherapy (33%) and the role of expectations (30%) were least practiced. One in five psychotherapists reported not informing clients about potential risks and side effects. A considerable proportion reported concern about inducing anxiety in patients by disclosing information about risks and side effects (52%). Conclusions Although obtaining informed consent for psychotherapy seems to be the rule rather than the exception in clinical practice, the quality of its implementation in terms of legal, ethical and clinical demands remains questionable. Training psychotherapists in providing comprehensive informed consent enables informed decision‐making and might have a positive influence on treatment expectations and outcomes.
  • Publication
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    Possible alleviation of symptoms and side effects through clinicians’ nocebo information and empathy in an experimental video vignette study
    (2022-09-27)
    Meijers, M. C.
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    Stouthard, J.
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    Evers, A. W. M.
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    Das, E.
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    Drooger, H. J.
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    Jansen, S. J. A. J.
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    Francke, A. L.
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    Plum, N.
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    van der Wall, E.
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    Dusseldorp, E.
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    van Vliet, L. M.
    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 (1) nocebo information about the (non)pharmacological origin of side effects, and (2) 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. 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. Anxiety was not influenced by empathy or information (Stai-state: p = 0.295; p = 0.390, VAS p = 0.399; p = 0.823). Information improved (specific) side-effect coping expectations (p < 0.01). Empathy improved side-effect intensity expectations (p < 0.01 = specific; p < 0.05 = non-specific/partial) and specific side-effect probability expectations (p < 0.01), and increased satisfaction, trust, and self-efficacy (p < 0.001). No mediating effects were found of anxiety on expectations. 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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    Preventing adverse events of chemotherapy for gastrointestinal cancer by educating patients about the nocebo effect: a randomized-controlled trial
    (Springer Nature, 2022-09-23)
    Michnevich, T.
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    Pan, Y.
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    Hendi, A.
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    Oechsle, K.
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    Stein, A.
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    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).
  • Publication
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    Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: study protocol for a three-arm randomised controlled trial (SOMA.GUT-RCT)
    (BMJ Publishing Group, 2022-06-14)
    Löwe, Bernd
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    Andresen, Viola
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    Vettorazzi, Eik
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    Zapf, Antonia
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    Hübener, Sina
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    Maehder, Kerstin
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    Peters, Luisa
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    Lohse, Ansgar W
    Introduction Ulcerative colitis (UC) and irritable bowel syndrome (IBS) are distressing chronic diseases associated with abdominal pain and altered bowel habits of unknown aetiology. Results from previous studies indicate that, across both diseases, increased levels of illness-related anxiety and dysfunctional symptom expectations contribute to symptom persistence. Thus, comparing both disorders with regard to common and disease-specific factors in the persistence and modification of gastrointestinal symptoms seems justified. Our primary hypothesis is that persistent gastrointestinal symptoms in UC and IBS can be improved by modifying dysfunctional symptom expectations and illness-related anxiety using expectation management strategies. Methods and analysis To assess the extent to which persistent somatic symptoms are modifiable in adult patients with UC and IBS, we will conduct an observer-blinded, three-arm randomised controlled trial. A total of 117 patients with UC and 117 patients with IBS will be randomised into three groups of equal size: targeted expectation management aiming to reduce illness-related anxiety and dysfunctional symptom expectations in addition to standard care (SC, intervention 1), non-specific supportive treatment in addition to SC (intervention 2) or SC only (control). Both active intervention groups will comprise three individual online consultation sessions and a booster session after 3 months. The primary outcome is baseline to postinterventional change in gastrointestinal symptom severity. Ethics and dissemination The study was approved by the Ethics Committee of the Hamburg Medical Association (2020-10198-BO-ff). The study will shed light onto the efficacy and mechanisms of action of a targeted expectation management intervention for persistent gastrointestinal symptoms in patients with UC and IBS. Furthermore, the detailed analysis of the complex biopsychosocial mechanisms will allow the further advancement of aetiological models and according evidence-based intervention strategies. Trial registration number ISRCTN30800023.