Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers' experiences in a placebo-controlled trial of duloxetine.
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| Title: | Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers' experiences in a placebo-controlled trial of duloxetine. |
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| Authors: | Kwakye, Isaac N., Garner, Matthew, Baldwin, David S., Bamford, Susan, Pinkney, Verity, Bishop, Felicity L. |
| Source: | Human Psychopharmacology: Clinical & Experimental. Jul2016, Vol. 31 Issue 4, p332-340. 9p. |
| Subjects: | Duloxetine, Psychiatric drugs, Mental depression, Therapeutics, Generalized anxiety disorder, Placebos |
| Abstract: | Objective The objective of this study was to develop an in-depth understanding of healthy volunteers' experiences of mental health trials. Methods A qualitative study was nested within a healthy volunteer placebo-controlled trial of duloxetine, a psychotropic drug used for treating patients with major depression and generalized anxiety disorder. Eight participants were interviewed, and data were analyzed using interpretative phenomenological analysis. Results Interviewees described volunteering for the trial because they were interested in research, wanted the monetary incentive, wanted to help researchers, and wanted to be part of something. On entering the trial, participants considered the possible risks and described feeling anxious, excited, and determined; they had some clear expectations and some loosely held hopes about what would happen. During the trial, participants were curious about whether they were taking duloxetine or placebo, self-monitored their bodies' reactions, and guessed which treatment they received. On being un-blinded to treatment allocation after completing the trial, some participants' guesses were confirmed, but others were surprised, and a few were disappointed. Conclusions Small changes to advertising/consent materials to reflect volunteers' motivations could improve recruitment rates to similar trials; 'active' placebos might be particularly useful for maintaining blinding in healthy volunteer trials; and sensitive procedures are needed for un-blinding participants to treatment allocation. Copyright © 2016 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR] |
| Copyright of Human Psychopharmacology: Clinical & Experimental is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
| FullText | Links: – Type: pdflink Text: Availability: 0 |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 116620141 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers' experiences in a placebo-controlled trial of duloxetine. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Kwakye%2C+Isaac+N%2E%22">Kwakye, Isaac N.</searchLink><br /><searchLink fieldCode="AR" term="%22Garner%2C+Matthew%22">Garner, Matthew</searchLink><br /><searchLink fieldCode="AR" term="%22Baldwin%2C+David+S%2E%22">Baldwin, David S.</searchLink><br /><searchLink fieldCode="AR" term="%22Bamford%2C+Susan%22">Bamford, Susan</searchLink><br /><searchLink fieldCode="AR" term="%22Pinkney%2C+Verity%22">Pinkney, Verity</searchLink><br /><searchLink fieldCode="AR" term="%22Bishop%2C+Felicity+L%2E%22">Bishop, Felicity L.</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Human+Psychopharmacology%3A+Clinical+%26+Experimental%22">Human Psychopharmacology: Clinical & Experimental</searchLink>. Jul2016, Vol. 31 Issue 4, p332-340. 9p. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Duloxetine%22">Duloxetine</searchLink><br /><searchLink fieldCode="DE" term="%22Psychiatric+drugs%22">Psychiatric drugs</searchLink><br /><searchLink fieldCode="DE" term="%22Mental+depression%22">Mental depression</searchLink><br /><searchLink fieldCode="DE" term="%22Therapeutics%22">Therapeutics</searchLink><br /><searchLink fieldCode="DE" term="%22Generalized+anxiety+disorder%22">Generalized anxiety disorder</searchLink><br /><searchLink fieldCode="DE" term="%22Placebos%22">Placebos</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Objective The objective of this study was to develop an in-depth understanding of healthy volunteers' experiences of mental health trials. Methods A qualitative study was nested within a healthy volunteer placebo-controlled trial of duloxetine, a psychotropic drug used for treating patients with major depression and generalized anxiety disorder. Eight participants were interviewed, and data were analyzed using interpretative phenomenological analysis. Results Interviewees described volunteering for the trial because they were interested in research, wanted the monetary incentive, wanted to help researchers, and wanted to be part of something. On entering the trial, participants considered the possible risks and described feeling anxious, excited, and determined; they had some clear expectations and some loosely held hopes about what would happen. During the trial, participants were curious about whether they were taking duloxetine or placebo, self-monitored their bodies' reactions, and guessed which treatment they received. On being un-blinded to treatment allocation after completing the trial, some participants' guesses were confirmed, but others were surprised, and a few were disappointed. Conclusions Small changes to advertising/consent materials to reflect volunteers' motivations could improve recruitment rates to similar trials; 'active' placebos might be particularly useful for maintaining blinding in healthy volunteer trials; and sensitive procedures are needed for un-blinding participants to treatment allocation. Copyright © 2016 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Human Psychopharmacology: Clinical & Experimental is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=116620141 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1002/hup.2543 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 9 StartPage: 332 Subjects: – SubjectFull: Duloxetine Type: general – SubjectFull: Psychiatric drugs Type: general – SubjectFull: Mental depression Type: general – SubjectFull: Therapeutics Type: general – SubjectFull: Generalized anxiety disorder Type: general – SubjectFull: Placebos Type: general Titles: – TitleFull: Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers' experiences in a placebo-controlled trial of duloxetine. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Kwakye, Isaac N. – PersonEntity: Name: NameFull: Garner, Matthew – PersonEntity: Name: NameFull: Baldwin, David S. – PersonEntity: Name: NameFull: Bamford, Susan – PersonEntity: Name: NameFull: Pinkney, Verity – PersonEntity: Name: NameFull: Bishop, Felicity L. IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 07 Text: Jul2016 Type: published Y: 2016 Identifiers: – Type: issn-print Value: 08856222 Numbering: – Type: volume Value: 31 – Type: issue Value: 4 Titles: – TitleFull: Human Psychopharmacology: Clinical & Experimental Type: main |
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