Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000722897p
Ethics application status
Submitted, not yet approved
Date submitted
24/05/2021
Date registered
9/06/2021
Date last updated
9/06/2021
Date data sharing statement initially provided
9/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of a brief mindset intervention on side effect reporting and experience of the COVID-19 vaccination
Scientific title
The efficacy of a brief mindset intervention on side effect reporting and experience of the COVID-19 vaccination
Secondary ID [1] 304297 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vaccination response 322027 0
COVID-19
 322185 0
Condition category
Condition code
Inflammatory and Immune System 319757 319757 0 0
Other inflammatory or immune system disorders
Infection 319915 319915 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to alter how people view potential COVID-19 vaccination side effects through the use of a brief mindset intervention that frames symptoms as positive signals that the body is responding to the COVID-19 vaccination. Recent research has shown that changing patient mindsets can positively impact both the meaning and experience of side effects. Participants will be randomized to view a specifically made brief 5 minute video on an electronic tablet about the meaning of COVID-19 side effects and how they are often positive signals that the vaccine is bolstering the immune system or receive the standard information. This will be administered in the 30- minute wait period post their first COVID-19 vaccination. Side effects will be assessed at the end of the waiting period following the first vaccine and three days later. We will also assess side effects following the second vaccination in both groups. We hypothesise that this mindset intervention will decrease side effect reporting and improve the experience of any side effects experienced, resulting in less distress for the individual.
Intervention code [1] 320633 0
Prevention
Intervention code [2] 320751 0
Behaviour
Comparator / control treatment
The control group will not be given the intervention video, but respond to the same measures. the information they will be responding about is the standard information as received by medical professionals on the day of their vaccination. There is no specifically designed standard information for this group, more so a TAU approach.
Control group
Active

Outcomes
Primary outcome [1] 327619 0
Side effect reporting - measured through the SEAS (Mackrill et al., 2020).
Timepoint [1] 327619 0
Immediately after the COVID-19 vaccine
3 days after the first dose
3 days after the second dose
Secondary outcome [1] 395949 0
Side effect experience - as measured through study specific questions placed after the SEAS.
Timepoint [1] 395949 0
immediately after the COVID-19 vaccination
3 days after the first dose
3 days after the second dose
Secondary outcome [2] 396421 0
Perceived sensitivity to vaccines - as measured by the brief 4-item Perceived Sensitivity to Vaccination Scale (Horne et al., 2013)
Timepoint [2] 396421 0
Immediately after the first vaccine
Secondary outcome [3] 396422 0
Perceived attitudes to vaccines - The brief Vaccination Attitudes Examination Scale (VAX) (Martin & Petrie, 2017)
Timepoint [3] 396422 0
Immediately after the first vaccine
Secondary outcome [4] 396423 0

Past vaccination behavior
- Participants will be asked how many flu (influenza) vaccinations they have received over the past five years via a study specific question on a questionnaire
Timepoint [4] 396423 0
Immediately after the first vaccine
Secondary outcome [5] 396424 0
COVID-19 mindset evaluation - Five study-designed questions assessing the individuals’ mindset, beliefs, and feelings surrounding the COVID-19 vaccination will be asked.
Timepoint [5] 396424 0
Immediately after the first vaccination
Secondary outcome [6] 396425 0
Intent to vaccinate in future - Participants will be asked via a study specific questionnaire about their intention to recommend the vaccine to family and friends, their intentions to be vaccinated against COVID-19 and other illnesses in the future.

Timepoint [6] 396425 0
Three day follow-up after first and second vaccination dose

Eligibility
Key inclusion criteria
Eligible for the COVID-19 vaccine
Have an active email address
18+ years old
English speaking
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-English speaking (as cannot give informed consent)
No email (as cannot send follow-up questionnaires)
Under 18 years old

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/07/2021
Actual
Date of last participant enrolment
Anticipated
30/07/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
660
Accrual to date
Final
Recruitment outside Australia
Country [1] 23718 0
New Zealand
State/province [1] 23718 0
Auckland

Funding & Sponsors
Funding source category [1] 308673 0
University
Name [1] 308673 0
University of Auckland
Country [1] 308673 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Psychological Medicine, University of Auckland
85 Park Road, Grafton, Auckland, 1023
Country
New Zealand
Secondary sponsor category [1] 309663 0
None
Name [1] 309663 0
Address [1] 309663 0
Country [1] 309663 0
Other collaborator category [1] 281801 0
University
Name [1] 281801 0
Stanford University
Address [1] 281801 0
Department of Psychology, Stanford University, Palo Alto
450 Serra Mall, Stanford, CA 94305, USA
Country [1] 281801 0
United States of America

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308596 0
Health and Disability Ethics Commitee
Ethics committee address [1] 308596 0
Ethics committee country [1] 308596 0
New Zealand
Date submitted for ethics approval [1] 308596 0
26/05/2021
Approval date [1] 308596 0
Ethics approval number [1] 308596 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111270 0
Prof Keith Petrie
Address 111270 0
Department of Psychological Medicine
University of Auckland
85 Park Road
Grafton, 1023
Auckland NZ
Country 111270 0
New Zealand
Phone 111270 0
+64 211117222
Fax 111270 0
Email 111270 0
[email protected]
Contact person for public queries
Name 111271 0
Keith Petrie
Address 111271 0
Department of Psychological Medicine
University of Auckland
85 Park Road
Grafton, 1023
Auckland NZ
Country 111271 0
New Zealand
Phone 111271 0
+64 211117222
Fax 111271 0
Email 111271 0
[email protected]
Contact person for scientific queries
Name 111272 0
Keith Petrie
Address 111272 0
Department of Psychological Medicine
University of Auckland
85 Park Road
Grafton, 1023
Auckland NZ
Country 111272 0
New Zealand
Phone 111272 0
+64 211117222
Fax 111272 0
Email 111272 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
Data will not be shared and only be accessible by the research team for analyses purposes.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11743Study protocol    382053-(Uploaded-24-05-2021-11-24-09)-Study-related document.docx
11744Informed consent form    382053-(Uploaded-24-05-2021-11-24-24)-Study-related document.docx



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseChanging Mindsets About Side Effects of the COVID-19 Vaccination: A Randomized Controlled Trial.2023https://dx.doi.org/10.1093/abm/kaad020
N.B. These documents automatically identified may not have been verified by the study sponsor.