Inpatient's, therapist's and staff's expectations regarding treatment and their effects on placebo response in the psychiatric ward - results from an add-on oxytocin RCT.
Uri Nitzan, A Grossman-Girron, O Sedoff, H Maoz, O Arad, E Tilbor, C Dror, D Tzur Bitan
{"title":"Inpatient's, therapist's and staff's expectations regarding treatment and their effects on placebo response in the psychiatric ward - results from an add-on oxytocin RCT.","authors":"Uri Nitzan, A Grossman-Girron, O Sedoff, H Maoz, O Arad, E Tilbor, C Dror, D Tzur Bitan","doi":"10.1007/s00213-024-06593-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>Patient's and therapist's expectations are considered an important factor influencing placebo response in experimental and therapeutic settings. Nevertheless, the placebo effects of common neurological facilitators that promote treatment efficacy have not been explored. In the present study we examined the estimations of patients, therapists, and staff members, regarding their treatment type and assessed their influence on the facilitating effects of oxytocin.</p><p><strong>Methods: </strong>Patients (N = 87) were randomized and double-blindly allocated to receive either oxytocin or placebo, twice daily for a period of four weeks, as part of a larger randomized, double-blind, placebo-controlled trial. Patient's, therapist's and staff's expectations were assessed based on their estimation of treatment type (agent or placebo). Multilevel modeling and univariate and multivariate regression analysis were performed to assess the effects of patient's, therapist's, and staff's estimations on treatment outcome beyond the effects of treatment type.</p><p><strong>Results: </strong>Staff's, therapist's, and patient's estimations were significantly associated with treatment outcomes. Nevertheless, only therapist's and patient's estimations significantly predicted improvement beyond actual administration, with therapist's and patient's estimations associated with improvement in trait anxiety (STAI-T, B=-1.80, p < .05, and B=-2.02, p < .05, respectively); therapist's estimations were associated with improvement in general distress (OQ-45, B=-3.71, p < .05), and patient's estimations were associated with symptom relief (HSCL-11, B=-0.13, p < .05). Overall, patient's estimations had a higher relative contribution to treatment success, with standardized coefficients across scales ranging from - 0.06 to -0.26.</p><p><strong>Conclusions: </strong>The neurobiological factors that promote treatment success are also influenced by patient's and therapist's expectations. Future studies should consider these effects when examining their impact in inpatient settings.</p>","PeriodicalId":20783,"journal":{"name":"Psychopharmacology","volume":null,"pages":null},"PeriodicalIF":3.5000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11339156/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Psychopharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00213-024-06593-x","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/25 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"NEUROSCIENCES","Score":null,"Total":0}
引用次数: 0
Abstract
Objectives: Patient's and therapist's expectations are considered an important factor influencing placebo response in experimental and therapeutic settings. Nevertheless, the placebo effects of common neurological facilitators that promote treatment efficacy have not been explored. In the present study we examined the estimations of patients, therapists, and staff members, regarding their treatment type and assessed their influence on the facilitating effects of oxytocin.
Methods: Patients (N = 87) were randomized and double-blindly allocated to receive either oxytocin or placebo, twice daily for a period of four weeks, as part of a larger randomized, double-blind, placebo-controlled trial. Patient's, therapist's and staff's expectations were assessed based on their estimation of treatment type (agent or placebo). Multilevel modeling and univariate and multivariate regression analysis were performed to assess the effects of patient's, therapist's, and staff's estimations on treatment outcome beyond the effects of treatment type.
Results: Staff's, therapist's, and patient's estimations were significantly associated with treatment outcomes. Nevertheless, only therapist's and patient's estimations significantly predicted improvement beyond actual administration, with therapist's and patient's estimations associated with improvement in trait anxiety (STAI-T, B=-1.80, p < .05, and B=-2.02, p < .05, respectively); therapist's estimations were associated with improvement in general distress (OQ-45, B=-3.71, p < .05), and patient's estimations were associated with symptom relief (HSCL-11, B=-0.13, p < .05). Overall, patient's estimations had a higher relative contribution to treatment success, with standardized coefficients across scales ranging from - 0.06 to -0.26.
Conclusions: The neurobiological factors that promote treatment success are also influenced by patient's and therapist's expectations. Future studies should consider these effects when examining their impact in inpatient settings.
期刊介绍:
Official Journal of the European Behavioural Pharmacology Society (EBPS)
Psychopharmacology is an international journal that covers the broad topic of elucidating mechanisms by which drugs affect behavior. The scope of the journal encompasses the following fields:
Human Psychopharmacology: Experimental
This section includes manuscripts describing the effects of drugs on mood, behavior, cognition and physiology in humans. The journal encourages submissions that involve brain imaging, genetics, neuroendocrinology, and developmental topics. Usually manuscripts in this section describe studies conducted under controlled conditions, but occasionally descriptive or observational studies are also considered.
Human Psychopharmacology: Clinical and Translational
This section comprises studies addressing the broad intersection of drugs and psychiatric illness. This includes not only clinical trials and studies of drug usage and metabolism, drug surveillance, and pharmacoepidemiology, but also work utilizing the entire range of clinically relevant methodologies, including neuroimaging, pharmacogenetics, cognitive science, biomarkers, and others. Work directed toward the translation of preclinical to clinical knowledge is especially encouraged. The key feature of submissions to this section is that they involve a focus on clinical aspects.
Preclinical psychopharmacology: Behavioral and Neural
This section considers reports on the effects of compounds with defined chemical structures on any aspect of behavior, in particular when correlated with neurochemical effects, in species other than humans. Manuscripts containing neuroscientific techniques in combination with behavior are welcome. We encourage reports of studies that provide insight into the mechanisms of drug action, at the behavioral and molecular levels.
Preclinical Psychopharmacology: Translational
This section considers manuscripts that enhance the confidence in a central mechanism that could be of therapeutic value for psychiatric or neurological patients, using disease-relevant preclinical models and tests, or that report on preclinical manipulations and challenges that have the potential to be translated to the clinic. Studies aiming at the refinement of preclinical models based upon clinical findings (back-translation) will also be considered. The journal particularly encourages submissions that integrate measures of target tissue exposure, activity on the molecular target and/or modulation of the targeted biochemical pathways.
Preclinical Psychopharmacology: Molecular, Genetic and Epigenetic
This section focuses on the molecular and cellular actions of neuropharmacological agents / drugs, and the identification / validation of drug targets affecting the CNS in health and disease. We particularly encourage studies that provide insight into the mechanisms of drug action at the molecular level. Manuscripts containing evidence for genetic or epigenetic effects on neurochemistry or behavior are welcome.