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Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers’ experiences in a placebo-controlled trial of duloxetine

Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers’ experiences in a placebo-controlled trial of duloxetine
Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers’ experiences in a placebo-controlled trial of duloxetine
Objectives: 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 analysed 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.
0885-6222
1-29
Kwakye, Isaac N
28094e96-e210-47d1-b605-60c30634c299
Garner, Matthew
3221c5b3-b951-4fec-b456-ec449e4ce072
Baldwin, David S.
1beaa192-0ef1-4914-897a-3a49fc2ed15e
Bamford, Susan
9b57bccd-485f-4d05-aa46-62687293e97a
Pinkney, Verity
d75fe138-8bc5-4344-b6b0-4da2e6891923
Bishop, Felicity L.
1f5429c5-325f-4ac4-aae3-6ba85d079928
Kwakye, Isaac N
28094e96-e210-47d1-b605-60c30634c299
Garner, Matthew
3221c5b3-b951-4fec-b456-ec449e4ce072
Baldwin, David S.
1beaa192-0ef1-4914-897a-3a49fc2ed15e
Bamford, Susan
9b57bccd-485f-4d05-aa46-62687293e97a
Pinkney, Verity
d75fe138-8bc5-4344-b6b0-4da2e6891923
Bishop, Felicity L.
1f5429c5-325f-4ac4-aae3-6ba85d079928

Kwakye, Isaac N, Garner, Matthew, Baldwin, David S., Bamford, Susan, Pinkney, Verity and Bishop, Felicity L. (2016) Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers’ experiences in a placebo-controlled trial of duloxetine. Human Psychopharmacology Clinical and Experimental, 1-29. (In Press)

Record type: Article

Abstract

Objectives: 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 analysed 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.

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Accepted/In Press date: 18 May 2016
Organisations: Faculty of Medicine, Psychology

Identifiers

Local EPrints ID: 395253
URI: http://eprints.soton.ac.uk/id/eprint/395253
ISSN: 0885-6222
PURE UUID: fa5056cc-1b34-4d04-ba1e-2485ba8cd568
ORCID for David S. Baldwin: ORCID iD orcid.org/0000-0003-3343-0907
ORCID for Felicity L. Bishop: ORCID iD orcid.org/0000-0002-8737-6662

Catalogue record

Date deposited: 26 May 2016 09:27
Last modified: 18 Feb 2021 17:00

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Contributors

Author: Isaac N Kwakye
Author: Matthew Garner
Author: Susan Bamford
Author: Verity Pinkney

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