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Completed

NCT Number: NCT06119854

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.

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Key information

Conditions

Misinformation Anxiety Anxiety Disorders Behavior Behavioral Symptoms COVID-19 Communication Coronaviridae Infections Coronavirus Infections Depression Health Behavior Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Treatment Adherence and Compliance Treatment Refusal Vaccination Hesitancy Vaccination Refusal Vaccine Hesitancy Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CUNY Graduate School of Public Health & Health Policy

New York, 10027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Attitudinal inoculation

Behavioral

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

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Self-reported Receipt of COVID Vaccine Dose by 4 Weeks Post-intervention

    Time frame: 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.

Secondary outcomes

  1. Participants Classified as Vaccine Willing

    Time frame: 4 weeks 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.

  2. Self-reported Receipt of a COVID Vaccine Dose by 6 Months Post-intervention

    Time frame: 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.

  3. Vaccine Willingness Post-intervention

    Time frame: 6-months 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.

  4. Vaccine Willingness Post-intervention

    Time frame: immediately 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.

Sponsors and collaborators

Lead sponsor

City University of New York, School of Public Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of North Carolina, Chapel Hill

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2023
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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