BeliefsNCT05085613

Does Framing and Humor Improve the Effectiveness of Messages About COVID-19 Vaccine

A study testing Corrective message framing and humor in people with Beliefs, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 99 years
Conditions the study is for: Beliefs
What is being tested?: Corrective message framing and humor
Type of treatment: Vaccines, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 31 Oct 2021to 31 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Are 21 years of age or older.
Have not participated in the cognitive interview.
Have not yet received a COVID vaccine.
Are registered with MTurk in the United States.
Have completed >= 5,000 HIITs within the MTurk system
Have a HIIT approval rating of >= 97%
Rate their agreement with the following statement as less than or equal to 50 out of 100: "To what extent do you agree with the following: "The FDA only authorizes COVID vaccines that are safe and effective."

Who cannot join

Are younger than 21 years of age
Participated in the cognitive interviews
Have already received a COVID vaccine.
Are not registered with MTurk in the US
Have completed < 5,000 HIITS
Have a HIIT approval rating of <97%
Rate their agreement with the following statement as greater than 50 out of 100: "To what extent do you agree with the following: "The FDA only authorizes COVID vaccines that are safe and effective."

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: A Randomized Controlled Trial Testing the Efficacy of Humor and Framing in Messaging to Correct Misperceptions About COVID-19 Vaccines

This study seeks to assess the efficacy of educational messages to correct misperceptions. People hold a number of misperceptions that are relevant to public health, including misperceptions regarding COVID vaccines. Some people incorrectly think the COVID vaccines authorized by FDA are not safe or effective. These misperceptions can reduce adherence to public health recommendations and result in continued spread of COVID. This study will test if humor and different types of framing increase the efficacy of messages to correct misperceptions about FDA's authorized coronavirus vaccine safety and effectiveness. The frames tested will include: framing the vaccine as a way to boost economic recovery and framing the vaccine as a way to increase freedom to choose how to behave. The addition of humor will also be tested. Message efficacy will be measured via improved accuracy of beliefs after being exposed to the message. In other words, participants will be asked how safe and effective FDA authorized COVID vaccines are before seeing a message, then they will see a message about why the COVID vaccines are safe and effective, and then they will again be asked how safe and effective they think the vaccines are. This study will also assess the accuracy of inferential beliefs. This will be accomplished by asking participants questions about other vaccines that either are or are not authorized by FDA. If participants have understood the messages and updated their mental models of how FDA evaluates vaccines, they should be able to infer if other vaccines are safe and effective based on their FDA authorization status.

Hypotheses

H1: Participants who are exposed to A.) a message with humor, B.) a message with an economic recovery fame, or C.) a message with a freedom frame will be more likely to increase their agreement with the statement that the FDA will only authorize coronavirus vaccines that are safe and effective after message exposure than participants exposed to the control condition.

H2: Participants who are exposed to A.) a message with humor, B.) a message with an economic recovery fame, or C.) a message with a freedom frame will agree more strongly with the statement that the FDA approved flu vaccine is safe and effective after message exposure than participants exposed to the control condition.

H3. Participants who are exposed to A.) a message with humor, B.) a message with an economic recovery fame, or C.) a message with a freedom frame will agree more strongly with the statement that the ResVax vaccine, which was not approved by the FDA for the treatment of RSV, is a safe and effective after message exposure than participants exposed to the control condition.

H4. Participants who are exposed to A.) a message with humor, B.) a message with an economic recovery fame, or C.) a message with a freedom frame will be more likely to increase behavioral intentions to get an FDA authorized COVID vaccine after message exposure than participants exposed to the control condition.

Conditions: Beliefs
Being tested: Corrective message framing and humor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Corrective message framing and humorBehavioural
The main content of the messages will be the same. Experimental conditions (arms 2-4) will additionally include consequent framing as a result of getting vaccinated (e.g. economic recovery for arm 2 and freedom for arm 3) and humor for arm 4. Participants will be randomized to view one of the four messages.

Study groups in NCT05085613
Study group	Role	What they receive
Vaccine Corrective Control	Active comparator	A message that explains why people are hesitant to accept the FDA authorized COVID vaccines are safe and effective and how the vaccines are evaluated as safe and effective by FDA. Receives: Behavioral: Corrective message framing and humor
Vaccine corrective with economic recovery framing	Experimental	The content of the control message with the addition of the text, "If everyone gets vaccinated, we can keep schools, stores, and other businesses open so more Americans can keep working and supporting their families." The message will also include a picture of an "open for business" sign. Receives: Behavioral: Corrective message framing and humor
Vaccine corrective with freedom framing	Experimental	The content of the control message with the addition of the text, "Everyone getting vaccinated is the key to freedom! A vaccine can give us the freedom to hang out with friends, shop, and worship together again safely." The message will also include a picture of an American flag. Receives: Behavioral: Corrective message framing and humor
Vaccine corrective with humor	Experimental	The content of the control message with the addition of the text, "Unfortunately, everyone getting vaccinated means leaving the house again." The message will include a meme of a cat being pulled/rescued from a window with text boxes labeling the cat as "People at home working in sweatpants" and the rescuer as "COVID Vaccines." Receives: Behavioral: Corrective message framing and humor

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Accuracy of the Belief That FDA Authorized COVID-19 Vaccines Are Safe and Effective
Assessed by change in response to the question To what extent do you agree or disagree with the following statement: The FDA has only authorized COVID vaccines that are safe and effective; with response options on a continuous scale from 0 "I do not agree at all" to 100, "I completely agree."
Measured: Baseline and up to 5 minutes after receiving the corrective message
Accuracy of Inferential Belief That the FDA Authorized Flu Vaccine is Safe and Effective
Assessed by response to the question To what extent do you agree with the following: The FDA authorized flu vaccine is safe and effective.; with response options on a continuous scale from 0 "I do not agree at all" to 100, "I completely agree."
Measured: Up to 5 minutes after receiving the corrective message
Accuracy of Inferential Belief That RexVax is Safe and Effective
Assessed by response to the question, The FDA recommended more testing of ResVax and did NOT authorize the vaccine because it did not prevent enough RSV infections.
To what extent do you agree with the following: ResVax is safe and effective; with response options on a continuous scale from 0 "I do not agree at all" to 100, "I completely agree."
Measured: Up to 5 minutes after receiving the corrective message
Change in Intention to Get a COVID-19 Vaccine
Assessed by change in response to the statement: I plan on getting an FDA authorized coronavirus vaccine; with response options on a continuous scale from 0 "I do not agree at all" to 100, "I completely agree."
Measured: Baseline and up to 5 minutes after receiving the corrective message

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 202131 Mar 2022

First posted20 Oct 2021
Study start31 Oct 2021
Primary completion30 Jan 2022
Study completion31 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BeliefsStudies of the same condition, open and under way.
More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Model Description: Participants will be randomized to view one of four messages. The control message explains why people are hesitant to accept the FDA authorized COVID vaccines are safe and effective and how they are evaluated. Arm 2 additionally includes consequent framing regarding economic recovery (e.g. "If everyone gets vaccinated, we can keep schools, stores, and other businesses open so more Americans can keep working and supporting their families." With a picture of an "open for business" sign), arm 3 includes consequent framing regarding freedom to behave as one chooses (e.g. "Everyone getting vaccinated is the key to freedom! A vaccine can give us the freedom to hang out with friends, shop, and worship together again safely." With a picture of an American flag), and arm 4 includes humor (e.g. "Unfortunately, everyone getting vaccinated means leaving the house again.").
Masking: Single blind
Who is masked: Participant
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05085613
Sponsor's protocol ID: 00015120B
Status last verified: Jul 2023
First submitted: 1 Oct 2021
Last updated: 21 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Upon request, deidentified participant data collected during the study may be shared. Upon request, we may also share the study protocol, survey, and informed consent form. Data will be made available upon request beginning 3 months following publication of the final article from this study, with no end date. Data will be made available for analyses deemed appropriate by the study PI. Proposals should be directed to mmoran22@jhu.edu. Data requestors will need to sign a data access agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial Testing the Efficacy of Humor and Framing in Messaging to Correct Misperceptions About COVID-19 Vaccines
ClinicalTrials.gov ID: NCT05085613
Acronym / sponsor ID: 00015120B
Conditions: Beliefs
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
Study start: 31 Oct 2021 (actual)
Primary completion: 30 Jan 2022 (actual)
Study completion: 31 Mar 2022 (actual)
First posted: 20 Oct 2021 (actual)
Results: Posted 21 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Hypotheses

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4
Model description: Model Description: Participants will be randomized to view one of four messages. The control message explains why people are hesitant to accept the FDA authorized COVID vaccines are safe and effective and how they are evaluated. Arm 2 additionally includes consequent framing regarding economic recovery (e.g. "If everyone gets vaccinated, we can keep schools, stores, and other businesses open so more Americans can keep working and supporting their families." With a picture of an "open for business" sign), arm 3 includes consequent framing regarding freedom to behave as one chooses (e.g. "Everyone getting vaccinated is the key to freedom! A vaccine can give us the freedom to hang out with friends, shop, and worship together again safely." With a picture of an American flag), and arm 4 includes humor (e.g. "Unfortunately, everyone getting vaccinated means leaving the house again.").

Arm	Type	Receives
Vaccine Corrective Control	Active comparator	Behavioral: Corrective message framing and humorA message that explains why people are hesitant to accept the FDA authorized COVID vaccines are safe and effective and how the vaccines are evaluated as safe and effective by FDA.
Vaccine corrective with economic recovery framing	Experimental	Behavioral: Corrective message framing and humorThe content of the control message with the addition of the text, "If everyone gets vaccinated, we can keep schools, stores, and other businesses open so more Americans can keep working and supporting their families." The message will also include a picture of an "open for business" sign.
Vaccine corrective with freedom framing	Experimental	Behavioral: Corrective message framing and humorThe content of the control message with the addition of the text, "Everyone getting vaccinated is the key to freedom! A vaccine can give us the freedom to hang out with friends, shop, and worship together again safely." The message will also include a picture of an American flag.
Vaccine corrective with humor	Experimental	Behavioral: Corrective message framing and humorThe content of the control message with the addition of the text, "Unfortunately, everyone getting vaccinated means leaving the house again." The message will include a meme of a cat being pulled/rescued from a window with text boxes labeling the cat as "People at home working in sweatpants" and the rescuer as "COVID Vaccines."

Who may qualify

Ages: 21 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Are 21 years of age or older.
Have not participated in the cognitive interview.
Have not yet received a COVID vaccine.
Are registered with MTurk in the United States.
Have completed >= 5,000 HIITs within the MTurk system

Key exclusion criteria (7 listed)

Are younger than 21 years of age
Participated in the cognitive interviews
Have already received a COVID vaccine.
Are not registered with MTurk in the US
Have completed < 5,000 HIITS

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Corrective message framing and humorThe main content of the messages will be the same. Experimental conditions (arms 2-4) will additionally include consequent framing as a result of getting vaccinated (e.g. economic recovery for arm 2 and freedom for arm 3) and humor for arm 4. Participants will be randomized to view one of the four messages.	Behavioural	Vaccine Corrective Control, Vaccine corrective with economic recovery framing, Vaccine corrective with freedom framing, Vaccine corrective with humor

Primary outcome

Change in Accuracy of the Belief That FDA Authorized COVID-19 Vaccines Are Safe and Effective
Time frame: Baseline and up to 5 minutes after receiving the corrective message
Assessed by change in response to the question To what extent do you agree or disagree with the following statement: The FDA has only authorized COVID vaccines that are safe and effective; with response options on a continuous scale from 0 "I do not agree at all" to 100, "I completely agree."
Accuracy of Inferential Belief That the FDA Authorized Flu Vaccine is Safe and Effective
Time frame: Up to 5 minutes after receiving the corrective message
Assessed by response to the question To what extent do you agree with the following: The FDA authorized flu vaccine is safe and effective.; with response options on a continuous scale from 0 "I do not agree at all" to 100, "I completely agree."
Accuracy of Inferential Belief That RexVax is Safe and Effective
Time frame: Up to 5 minutes after receiving the corrective message
Assessed by response to the question, The FDA recommended more testing of ResVax and did NOT authorize the vaccine because it did not prevent enough RSV infections. To what extent do you agree with the following: ResVax is safe and effective; with response options on a continuous scale from 0 "I do not agree at all" to 100, "I completely agree."
Change in Intention to Get a COVID-19 Vaccine
Time frame: Baseline and up to 5 minutes after receiving the corrective message
Assessed by change in response to the statement: I plan on getting an FDA authorized coronavirus vaccine; with response options on a continuous scale from 0 "I do not agree at all" to 100, "I completely agree."

Results and safety

Results posted to the registry on 21 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vaccine Corrective Control	27	27
Vaccine Corrective With Economic Recovery Framing	27	27
Vaccine Corrective With Freedom Framing	24	24
Vaccine Corrective With Humor	22	22

Primary outcome: Change in Accuracy of the Belief That FDA Authorized COVID-19 Vaccines Are Safe and Effective

Time frame: Baseline and up to 5 minutes after receiving the corrective message. Mean (Standard Deviation). Unit: score on a 0-100 scale

Measure	Vaccine Corrective Control n = 27	Vaccine Corrective With Economic Recovery Framing n = 27	Vaccine Corrective With Freedom Framing n = 24	Vaccine Corrective With Humor n = 22
Value	20.1 (23.8)	22.8 (24.0)	24.2 (26.9)	22.7 (24.1)

Vaccine Corrective Control vs Vaccine Corrective With Economic Recovery Framing: Mean Difference (Final Values): .6279928 (95% CI -9.463627 to 10.71961), p = 0.998, ANCOVA
Vaccine Corrective Control vs Vaccine Corrective With Freedom Framing: Mean Difference (Final Values): 4.044194 (95% CI -6.416608 to 14.505), p = 0.725, ANCOVA
Vaccine Corrective Control vs Vaccine Corrective With Humor: Mean Difference (Final Values): -1.53656 (95% CI -12.25295 to 9.179834), p = 0.980, ANCOVA

Primary outcome: Accuracy of Inferential Belief That the FDA Authorized Flu Vaccine is Safe and Effective

Time frame: Up to 5 minutes after receiving the corrective message. Mean (Standard Deviation). Unit: score on a 0-100 scale

Measure	Vaccine Corrective Control n = 27	Vaccine Corrective With Economic Recovery Framing n = 27	Vaccine Corrective With Freedom Framing n = 24	Vaccine Corrective With Humor n = 22
Value	37.074074 (33.546668)	44.666667 (31.619128)	49.583333 (35.808569)	50.954545 (35.18993)

Vaccine Corrective Control vs Vaccine Corrective With Economic Recovery Framing: Mean Difference (Final Values): 7.002255 (95% CI -14.39448 to 28.39899), p = 0.813, ANCOVA
Vaccine Corrective Control vs Vaccine Corrective With Freedom Framing: Mean Difference (Final Values): 15.12214 (95% CI -6.938055 to 37.18234), p = 0.268, ANCOVA
Vaccine Corrective Control vs Vaccine Corrective With Humor: Mean Difference (Final Values): 14.4032 (95% CI -8.218891 to 37.0253), p = 0.330, ANCOVA

Primary outcome: Accuracy of Inferential Belief That RexVax is Safe and Effective

Time frame: Up to 5 minutes after receiving the corrective message. Mean (Standard Deviation). Unit: units on a scale

Measure	Vaccine Corrective Control n = 27	Vaccine Corrective With Economic Recovery Framing n = 27	Vaccine Corrective With Freedom Framing n = 24	Vaccine Corrective With Humor n = 22
Value	14.923077 (20.853629)	14.24 (23.502269)	12.47619 (17.28473)	23.863636 (28.782097)

Vaccine Corrective Control vs Vaccine Corrective With Economic Recovery Framing: Mean Difference (Final Values): -1.457003 (95% CI -16.98852 to 14.07451), p = 0.994, ANCOVA
Vaccine Corrective Control vs Vaccine Corrective With Freedom Framing: Mean Difference (Final Values): -1.097586 (95% CI -17.34491 to 15.14973), p = 0.998, ANCOVA
Vaccine Corrective Control vs Vaccine Corrective With Humor: Mean Difference (Final Values): 8.926191 (95% CI -7.110771 to 24.96315), p = 0.447, ANCOVA

Primary outcome: Change in Intention to Get a COVID-19 Vaccine

Time frame: Baseline and up to 5 minutes after receiving the corrective message. Mean (Standard Deviation). Unit: score on a 0-100 scale

Measure	Vaccine Corrective Control n = 27	Vaccine Corrective With Economic Recovery Framing n = 27	Vaccine Corrective With Freedom Framing n = 24	Vaccine Corrective With Humor n = 22
Value	15.925926 (24.935187)	9.4814815 (16.032108)	9.625 (21.906546)	12.863636 (20.2797)

Vaccine Corrective Control vs Vaccine Corrective With Economic Recovery Framing: Mean Difference (Final Values): -4.154612 (95% CI -8.985328 to .6761041), p = 0.113, ANCOVA
Vaccine Corrective Control vs Vaccine Corrective With Freedom Framing: Mean Difference (Final Values): -2.685896 (95% CI -7.66090 to 2.289114), p = 0.473, ANCOVA
Vaccine Corrective Control vs Vaccine Corrective With Humor: Mean Difference (Final Values): -6.469932 (95% CI -11.58151 to -1.358358), p = 0.008, ANCOVA

Adverse events

Time frame: up to 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vaccine Corrective Control	0 of 27 (0%)	0 of 27 (0%)	0 of 27
Vaccine Corrective With Economic Recovery Framing	0 of 27 (0%)	0 of 27 (0%)	0 of 27
Vaccine Corrective With Freedom Framing	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Vaccine Corrective With Humor	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Limitations and caveats (from the sponsor): Limitations include the ANCOVAs being underpowered. Failure to reject the null offers limited value because there's not strong support for lack of effect. Beliefs were also measured on a continuous scales, which can detect even small effects.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Upon request, deidentified participant data collected during the study may be shared. Upon request, we may also share the study protocol, survey, and informed consent form. Data will be made available upon request beginning 3 months following publication of the final article from this study, with no end date. Data will be made available for analyses deemed appropriate by the study PI. Proposals should be directed to mmoran22@jhu.edu. Data requestors will need to sign a data access agreement.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Meghan Moran, PhD principal investigator

Johns Hopkins Bloomberg School of Public Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Corrective message framing and humor in people with Beliefs, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Accuracy of the Belief That FDA Authorized COVID-19 Vaccines Are Safe and Effective (time frame: Baseline and up to 5 minutes after receiving the corrective message). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05085613.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.