Placebo effects in mental health disorders: protocol for an umbrella review
Introduction Given the high prevalence of mental health disorders and their significant socioeconomic burden, there is a need to develop improved treatments, and to evaluate them through placebo-controlled trials. However, the magnitude of the placebo response in randomised controlled trials to test...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/11/e073946.full |
| _version_ | 1797429032345665536 |
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| author | Marco Solmi Christoph U Correll Catherine M Hill Samuele Cortese David S Baldwin Samuel R Chamberlain Jay Amin Ruihua Hou Oliver D Howes Nathan TM Huneke Matthew Garner Julia MA Sinclair |
| author_facet | Marco Solmi Christoph U Correll Catherine M Hill Samuele Cortese David S Baldwin Samuel R Chamberlain Jay Amin Ruihua Hou Oliver D Howes Nathan TM Huneke Matthew Garner Julia MA Sinclair |
| author_sort | Marco Solmi |
| collection | DOAJ |
| description | Introduction Given the high prevalence of mental health disorders and their significant socioeconomic burden, there is a need to develop improved treatments, and to evaluate them through placebo-controlled trials. However, the magnitude of the placebo response in randomised controlled trials to test medications may be substantial, affecting their interpretation. Therefore, improved understanding of the patient, trial and mental disorder factors that influence placebo responses would inform clinical trial design to better detect active treatment effects. There is a growing literature exploring the placebo response within specific mental health disorders, but no overarching synthesis of this research has been produced to date. We present a protocol for an umbrella review of systematic reviews and/or meta-analyses in which we aim to understand the effect size and potential predictors of placebo response within, and across, mental health disorders.Methods and analysis We will systematically search databases (Medline, PsycINFO, EMBASE+EMBASE Classic, Web of Knowledge) for systematic reviews and/or meta-analyses that report placebo effect size in clinical trials in patients with mental health disorders (initial search date 23 October 2022). Screening of abstracts and full texts will be done in pairs. We will extract data to qualitatively examine how placebo effect size varies across mental health disorders. We also plan to qualitatively summarise predictors of increased placebo response identified either quantitatively (eg, through meta-regression) or qualitatively. Risk of bias will be assessed using the AMSTAR-2 tool. We aim to not only summarise the current literature but also to identify gaps in knowledge and generate further hypotheses.Ethics and dissemination We do not believe there are any specific ethical considerations relevant to this study. We will publish the results in a peer-reviewed journal. |
| first_indexed | 2024-03-09T09:07:20Z |
| format | Article |
| id | doaj.art-a9d178034fed4dfa9095d0d8843cef12 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-09T09:07:20Z |
| publishDate | 2023-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-a9d178034fed4dfa9095d0d8843cef122023-12-02T10:05:08ZengBMJ Publishing GroupBMJ Open2044-60552023-11-01131110.1136/bmjopen-2023-073946Placebo effects in mental health disorders: protocol for an umbrella reviewMarco Solmi0Christoph U Correll1Catherine M Hill2Samuele Cortese3David S Baldwin4Samuel R Chamberlain5Jay Amin6Ruihua Hou7Oliver D Howes8Nathan TM Huneke9Matthew Garner10Julia MA Sinclair11Centre for Innovation in Mental Health, School of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UKPsychiatry, The Zucker Hillside Hospital, Glen Oaks, New York, USAClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UKClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UKClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UKClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UKClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UKClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UKDepartment of Psychosis Studies, King`s College London Institute of Psychiatry Psychology and Neuroscience, London, UKClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UKClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UKClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UKIntroduction Given the high prevalence of mental health disorders and their significant socioeconomic burden, there is a need to develop improved treatments, and to evaluate them through placebo-controlled trials. However, the magnitude of the placebo response in randomised controlled trials to test medications may be substantial, affecting their interpretation. Therefore, improved understanding of the patient, trial and mental disorder factors that influence placebo responses would inform clinical trial design to better detect active treatment effects. There is a growing literature exploring the placebo response within specific mental health disorders, but no overarching synthesis of this research has been produced to date. We present a protocol for an umbrella review of systematic reviews and/or meta-analyses in which we aim to understand the effect size and potential predictors of placebo response within, and across, mental health disorders.Methods and analysis We will systematically search databases (Medline, PsycINFO, EMBASE+EMBASE Classic, Web of Knowledge) for systematic reviews and/or meta-analyses that report placebo effect size in clinical trials in patients with mental health disorders (initial search date 23 October 2022). Screening of abstracts and full texts will be done in pairs. We will extract data to qualitatively examine how placebo effect size varies across mental health disorders. We also plan to qualitatively summarise predictors of increased placebo response identified either quantitatively (eg, through meta-regression) or qualitatively. Risk of bias will be assessed using the AMSTAR-2 tool. We aim to not only summarise the current literature but also to identify gaps in knowledge and generate further hypotheses.Ethics and dissemination We do not believe there are any specific ethical considerations relevant to this study. We will publish the results in a peer-reviewed journal.https://bmjopen.bmj.com/content/13/11/e073946.full |
| spellingShingle | Marco Solmi Christoph U Correll Catherine M Hill Samuele Cortese David S Baldwin Samuel R Chamberlain Jay Amin Ruihua Hou Oliver D Howes Nathan TM Huneke Matthew Garner Julia MA Sinclair Placebo effects in mental health disorders: protocol for an umbrella review BMJ Open |
| title | Placebo effects in mental health disorders: protocol for an umbrella review |
| title_full | Placebo effects in mental health disorders: protocol for an umbrella review |
| title_fullStr | Placebo effects in mental health disorders: protocol for an umbrella review |
| title_full_unstemmed | Placebo effects in mental health disorders: protocol for an umbrella review |
| title_short | Placebo effects in mental health disorders: protocol for an umbrella review |
| title_sort | placebo effects in mental health disorders protocol for an umbrella review |
| url | https://bmjopen.bmj.com/content/13/11/e073946.full |
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