Brief Digital Intervention to Increase COVID-19 Vaccination Among Individuals With Anxiety or Depression

The COVID-19 pandemic has led to a mis/disinformation ecosystem that promotes divergent views of vaccine efficacy, as well as the legitimacy of science and medicine. Individuals are confronted with vaccine-related information from a multitude of sources, posing a challenge to identifying inaccurate information. COVID-19 vaccine uptake is lower among people with anxiety and depression than in the general population, due in part to higher levels of vaccine hesitancy. The prevalence of anxiety and depressive symptoms among US adults increased significantly during the COVID pandemic and has remained elevated. Interventions capable of mitigating the impact of vaccine hesitancy and mis/disinformation among undervaccinated people with anxiety or depression are therefore an urgent priority. Emerging evidence suggests that reasons for vaccine hesitancy and the impact of conventional vaccination messaging differ between those with and without mental health symptoms. There may also be added challenges overcoming logistical barriers to vaccination for people with anxiety or depressive symptoms.

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.

Study Overview

• Status: Completed
• Conditions: Depression; COVID-19; Anxiety; Vaccine Hesitancy; Misinformation
• Intervention / Treatment: Behavioral: Attitudinal inoculation; Behavioral: Cognitive-behavioral therapy-informed intervention; Behavioral: Conventional public health messaging

Detailed Description

The project will recruit undervaccinated participants with and without symptoms of anxiety or depression from the CHASING COVID Cohort, a large and geographically diverse community-based US cohort, to tailor and test the effectiveness of two brief digital interventions to increase vaccine uptake among adults with anxiety or depressive symptoms. The investigators will assign undervaccinated cohort participants, with and without symptoms of anxiety or depression, to: 1) an attitudinal inoculation intervention; 2), a CBT-informed intervention; or 3) a conventional public health messaging intervention without attitudinal inoculation or CBT-informed content. The investigators will examine the outcome of COVID-19 vaccination at 4 weeks post-intervention, conducting intent-to-treat comparisons between arms.

• Study Type: Interventional
• Enrollment (Actual): 1419
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • CUNY Graduate School of Public Health & Health Policy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Recently engaged in the CHASING COVID Cohort study (i.e., started ≥ 1 survey since December 7, 2022)
• 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:

• No dose of a COVID-19 vaccine
• Had a SARS-CoV-2 infection in the past 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Receipt of COVID Vaccine Dose by 4 Weeks Post-intervention	Following our theoretical premise that our intervention will impact the uptake of COVID-19 vaccination, the investigators define our primary outcome as self-reported receipt of a COVID vaccine dose in the 4 weeks post-intervention. Risk ratios will be used to estimate and compare the proportion of participants in each arm who achieved the outcome. The investigators will adjust for differences in measured pre-baseline variables to address potential imbalances and conduct a mediation analysis to better understand the intervention's mechanisms of action.	4 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Classified as Vaccine Willing	The investigators will estimate vaccine hesitancy at baseline, immediately post-intervention, 4 weeks post-intervention, and at 6 months post-intervention. People who indicate that they are "not willing" to get a vaccine dose will be defined as vaccine resistant, people who indicate that they are "somewhat willing" will be described as vaccine hesitant, and people who report that they are "very willing" or who report having received a vaccine dose will be classified as vaccine willing. Risk ratios will be used to estimate and compare the proportion of participants in each arm who are either vaccine resistant or vaccine hesitant to those who are vaccine willing at each time point. The investigators will adjust for differences in measured pre-baseline variables to address potential imbalances.	4 weeks post-intervention
Self-reported Receipt of a COVID Vaccine Dose by 6 Months Post-intervention	The investigators define our outcome as self-reported receipt of a COVID vaccine dose in the 6 months post-intervention. Risk ratios will be used to estimate and compare the proportion of participants in each arm who achieved the outcome. The investigators will adjust for differences in measured pre-baseline variables to address potential imbalances and conduct a mediation analysis to attempt to better understand the intervention's mechanisms of action.	6 months post-intervention
Vaccine Willingness Post-intervention	The investigators will estimate vaccine hesitancy at baseline, immediately post-intervention, 4 weeks post-intervention, and at 6 months post-intervention. People who indicate that they are "not willing" to get a vaccine dose will be defined as vaccine resistant, people who indicate that they are "somewhat willing" will be described as vaccine hesitant, and people who report that they are "very willing" or who report having received a vaccine dose will be classified as vaccine willing. Risk ratios will be used to estimate and compare the proportion of participants in each arm who are either vaccine resistant or vaccine hesitant to those who are vaccine willing at each time point. The investigators will adjust for differences in measured pre-baseline variables to address potential imbalances.	6-months post-intervention
Vaccine Willingness Post-intervention	The investigators will estimate vaccine hesitancy at baseline, immediately post-intervention, 4 weeks post-intervention, and at 6 months post-intervention. People who indicate that they are "not willing" to get a vaccine dose will be defined as vaccine resistant, people who indicate that they are "somewhat willing" will be described as vaccine hesitant, and people who report that they are "very willing" or who report having received a vaccine dose will be classified as vaccine willing. Risk ratios will be used to estimate and compare the proportion of participants in each arm who are either vaccine resistant or vaccine hesitant to those who are vaccine willing at each time point. The investigators will adjust for differences in measured pre-baseline variables to address potential imbalances.	immediately post-intervention

Collaborators and Investigators

• Sponsor: City University of New York, School of Public Health
• Collaborators: National Institute of Mental Health (NIMH); University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Denis Nash, PhD, CUNY Institute for Implementation Science in Population Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): June 13, 2024
• Study Completion (Actual): November 15, 2024

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Anxiety; COVID-19; Vaccination
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Behavior; Treatment Adherence and Compliance; Health Behavior; Treatment Refusal; Vaccination Refusal; COVID-19; Anxiety Disorders; Depression; Communication; Vaccination Hesitancy
• Other Study ID Numbers: RF1MH132360 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: CUNY Institute for Implementation Science in Population Health staff are available to assist externa researchers who may have further specific data questions or uses.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No