Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000735954
Ethics application status
Approved
Date submitted
4/06/2020
Date registered
14/07/2020
Date last updated
23/04/2021
Date data sharing statement initially provided
14/07/2020
Date results information initially provided
23/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of different types of medicine information on side effect reporting
Scientific title
The effect of different types of medicine information on side effects attributed to a placebo tablet
Secondary ID [1] 301437 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General medication use 317739 0
Condition category
Condition code
Public Health 315809 315809 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nocebo information: Participants randomised to this group will be shown a 4-minute animated video that explains how the nocebo effect occurs. Participants will be informed that when we are told about medicine side effects, we come to expect side effects and are more aware of our natural symptoms causing us to mistakenly attribute them to the medication. The video will be delivered on a computer before participants take a placebo tablet, during a 45-minute study session at the University of Auckland. The video will be delivered once and individually to each participant in this group. To ensure the researcher remains blinded to participant group allocation, they will not be in the room when participants watch the video.
Intervention code [1] 317751 0
Behaviour
Comparator / control treatment
The study has two control groups.
Media information: participants randomised to this group will be shown a real 4-minute television news item that discusses patient and healthcare providers' concerns about the efficacy and side effects of a new generic medicine.
Control information: participants randomised to this group will be shown a 4-minute animated TED Talk video that describes, in a general way, how medicines work in the body.

For both these groups, the video will be delivered on a computer before participants take a placebo tablet, during a 45-minute study session at the University of Auckland. The video will be delivered once and individually to each participant in these groups. To ensure the researcher remains blinded to participant group allocation, they will not be in the room when participants watch the video.
Control group
Active

Outcomes
Primary outcome [1] 324018 0
Self-reported side effects measured using a list of 50 symptoms.
Timepoint [1] 324018 0
20 minutes after taking the placebo tablet and 48 hours after the study session.
Primary outcome [2] 324207 0
Side effect attribution score measure using the Side Effect Attribution Scale (MacKrill et al).
Timepoint [2] 324207 0
20 minutes after taking the tablet and 48 hours after the study session.
Secondary outcome [1] 383556 0
Change in self-reported mood measured using the PANAS (Watson, Clark, & Tellegen, 1988)
Timepoint [1] 383556 0
Baseline, 20 minutes after taking placebo tablet, and 48 hours after the study session.
Secondary outcome [2] 383557 0
Change in reaction time measured using an online choice reaction task (Deary-Liewald task) powered by PsyToolkit.
Timepoint [2] 383557 0
Baseline and 20 minutes after taking placebo tablet.
Secondary outcome [3] 384019 0
Change in self-reported anxiety measured with the STAI-6 (Marteau & Bekker, 1992)
Timepoint [3] 384019 0
Baseline, 20 minutes after taking placebo tablet, and 48 hours after the study session.

Eligibility
Key inclusion criteria
Participants must be 18 years of age or older, able to read and write in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are taking any prescription medications, if they have epilepsy, diabetes, any liver or kidney disorders, or any heart problems.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Online survey software Qualtrics will randomly allocate participants to one of the three information groups. The researcher will not be in the room when this happens and will not know which video the participant watched.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A previous study examining the effect a nocebo explanation had on symptom reporting following a negative news item found a large effect size of n2 = 0.20 (Crichton & Petrie, 2015). Using this effect size, an alpha level of .05 and power level of .08, it is estimated that a sample size of 64 is required to find a difference between the groups in side effect reporting. However, as this study has three groups and to factor in participants lost to follow-up, it is estimated that a minimum of 90 participants will be needed.

Analysis of Covariance (ANCOVA) controlling for the number of symptoms reported at baseline will be conducted to assess the number of side effects reported by the three groups at the end of the study session and 48-hours later. Repeated-measures ANOVAs will be used to assess changes between study groups in anxiety and mood, at baseline, end of session and 48 hour follow-up. Repeated-measures ANOVAs will be used to assess changes between study groups in reaction time at baseline and end of session.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/07/2020
Actual
14/07/2020
Date of last participant enrolment
Anticipated
Actual
30/09/2020
Date of last data collection
Anticipated
Actual
2/10/2020
Sample size
Target
90
Accrual to date
Final
116
Recruitment outside Australia
Country [1] 22652 0
New Zealand
State/province [1] 22652 0
Auckland

Funding & Sponsors
Funding source category [1] 305875 0
University
Name [1] 305875 0
University of Auckland
Country [1] 305875 0
New Zealand
Primary sponsor type
Individual
Name
Professor Keith Petrie
Address
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
22-30 Park Avenue, Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 306325 0
Individual
Name [1] 306325 0
Kate MacKrill
Address [1] 306325 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
22-30 Park Avenue, Grafton
Auckland 1023
Country [1] 306325 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306135 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 306135 0
The University of Auckland
49 Symonds Street
Private Bag 92019
Auckland 1010
New Zealand
Ethics committee country [1] 306135 0
New Zealand
Date submitted for ethics approval [1] 306135 0
Approval date [1] 306135 0
20/02/2020
Ethics approval number [1] 306135 0

Summary
Brief summary
The aim of this study is to investigate the effect of different types of medicine information on side effect reporting. It is hypothesised that people who receive an explanation of the nocebo effect will report fewer side effects and have improved mood compared to those who watch a negative news item about a medicine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102830 0
Prof Keith Petrie
Address 102830 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
Country 102830 0
New Zealand
Phone 102830 0
+64 9 923 6564
Fax 102830 0
Email 102830 0
[email protected]
Contact person for public queries
Name 102831 0
Prof Keith Petrie
Address 102831 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
Country 102831 0
New Zealand
Phone 102831 0
+64 9 923 6564
Fax 102831 0
Email 102831 0
[email protected]
Contact person for scientific queries
Name 102832 0
Prof Keith Petrie
Address 102832 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
Country 102832 0
New Zealand
Phone 102832 0
+64 9 923 6564
Fax 102832 0
Email 102832 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIncreasing and dampening the nocebo response following medicine-taking: A randomised controlled trial.2021https://dx.doi.org/10.1016/j.jpsychores.2021.110630
N.B. These documents automatically identified may not have been verified by the study sponsor.