Brief Digital Intervention to Increase COVID-19 Vaccination Among Individuals With Anxiety or Depression
NCT ID: NCT06119854
Last Updated: 2025-09-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1419 participants
INTERVENTIONAL
2024-04-15
2024-11-15
Brief Summary
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The investigators aim to determine the effectiveness of two different brief digital intervention strategies compared with conventional public health messaging for increasing vaccine uptake in undervaccinated adults with and without anxiety or depressive symptoms. Attitudinal inoculation is a brief, scalable strategy that leverages the power of narrative, values, and emotion to strengthen resistance to mis/disinformation and reduce hesitancy. Though this approach has been shown to decrease COVID-19 vaccine hesitancy among US adults, the extent to which this approach increases COVID-19 vaccination remains unknown. Cognitive-behavioral therapy (CBT) is an evidence-based intervention for anxiety and depression. However, the efficacy of incorporating CBT-informed messaging in a vaccine promotion intervention has not been tested. The investigators hypothesize that both attitudinal inoculation and CBT-style communication will be more effective than conventional public health messaging to increase COVID-19 vaccination. The investigators also hypothesize that the CBT-informed intervention will be more effective than the attitudinal inoculation intervention for increasing COVID-19 vaccination among participants with symptoms of anxiety or depression.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Attitudinal inoculation intervention
Participants randomized to this arm will view a brief video addressing one anti-vaccine "meta-narrative" or issue (e.g., concerns about the vaccine not working) most salient to the entire CHASING COVID study population (per recent historical data) and focused on bolstering resistance to mis/disinformation.
Attitudinal inoculation
A brief video focused on bolstering resistance to mis/disinformation about the COVID vaccine. Participants will receive two messages via text or email (1 and 3 days after the inoculation intervention). These messages will include reminders to get vaccinated.
Cognitive behavioral therapy-informed intervention
Participants randomized to this arm will view a brief video using a CBT-informed approach and focused on addressing barriers to vaccination, with no inoculation messaging.
Cognitive-behavioral therapy-informed intervention
A brief video using a CBT-informed approach and focused on addressing barriers to COVID-19 vaccination. Participants will receive two messages via text or email (1 and 3 days after the inoculation intervention). These messages will include reminders to get vaccinated.
Conventional public health messaging
Participants randomized to this arm will view a brief video conveying conventional public health messaging adapted from a review of public health public service announcements, with no inoculation or CBT-informed messaging.
Conventional public health messaging
A brief video conveying conventional public health messaging adapted from a review of public health public service announcements with no inoculation messaging. Participants will receive two messages via text or email (1 and 3 days after the inoculation intervention). These messages will include reminders to get vaccinated.
Interventions
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Attitudinal inoculation
A brief video focused on bolstering resistance to mis/disinformation about the COVID vaccine. Participants will receive two messages via text or email (1 and 3 days after the inoculation intervention). These messages will include reminders to get vaccinated.
Cognitive-behavioral therapy-informed intervention
A brief video using a CBT-informed approach and focused on addressing barriers to COVID-19 vaccination. Participants will receive two messages via text or email (1 and 3 days after the inoculation intervention). These messages will include reminders to get vaccinated.
Conventional public health messaging
A brief video conveying conventional public health messaging adapted from a review of public health public service announcements with no inoculation messaging. Participants will receive two messages via text or email (1 and 3 days after the inoculation intervention). These messages will include reminders to get vaccinated.
Eligibility Criteria
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Inclusion Criteria
* Last COVID-19 vaccine dose prior to September 11, 2023
* Current residence in the US or a US territory
* Comprehension of written English
Exclusion Criteria
* Had a SARS-CoV-2 infection in the past 3 months
18 Years
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
National Institute of Mental Health (NIMH)
NIH
City University of New York, School of Public Health
OTHER
Responsible Party
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Denis Nash
Professor
Principal Investigators
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Denis Nash, PhD
Role: PRINCIPAL_INVESTIGATOR
CUNY Institute for Implementation Science in Population Health
Locations
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CUNY Graduate School of Public Health & Health Policy
New York, New York, United States
Countries
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References
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Piltch-Loeb R, Su M, Hughes B, Testa M, Goldberg B, Braddock K, Miller-Idriss C, Maturo V, Savoia E. Testing the Efficacy of Attitudinal Inoculation Videos to Enhance COVID-19 Vaccine Acceptance: Quasi-Experimental Intervention Trial. JMIR Public Health Surveill. 2022 Jun 20;8(6):e34615. doi: 10.2196/34615.
Robertson MM, Kulkarni SG, Rane M, Kochhar S, Berry A, Chang M, Mirzayi C, You W, Maroko A, Zimba R, Westmoreland D, Grov C, Parcesepe AM, Waldron L, Nash D; CHASING COVID Cohort Study Team. Cohort profile: a national, community-based prospective cohort study of SARS-CoV-2 pandemic outcomes in the USA-the CHASING COVID Cohort study. BMJ Open. 2021 Sep 21;11(9):e048778. doi: 10.1136/bmjopen-2021-048778.
Parcesepe AM, Robertson M, Berry A, Maroko A, Zimba R, Grov C, Westmoreland D, Kulkarni S, Rane M, Salgado-You W, Mirzayi C, Waldron L, Nash D. The relationship between anxiety, health, and potential stressors among adults in the United States during the COVID-19 pandemic. medRxiv [Preprint]. 2020 Nov 4:2020.10.30.20221440. doi: 10.1101/2020.10.30.20221440.
Piltch-Loeb R, Shen Y, Fleary S, Robertson M, Nunez Sahr J, Penrose K, Sanborn J, Yadav S, Srivastava A, Nash D, Parcesepe A. Testing Theory-Enhanced Messaging to Promote COVID-19 Vaccination Among Adults: Randomized Controlled Trial. J Med Internet Res. 2025 Oct 7;27:e79228. doi: 10.2196/79228.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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