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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Misinformation, Vaccine Hesitancy, Anxiety, Depression, COVID-19

Intervention / Treatment
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* Behavioral: Attitudinal inoculation
* Behavioral: Cognitive-behavioral therapy-informed intervention
* Behavioral: Conventional public health messaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Actively engaged in the CHASING COVID Cohort study (i.e., completed >1 survey or specimen collection since January 1, 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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. Participants will be randomly assigned to one of the three intervention arms at a ratio of 1:1:1. Each arm will also be stratified 1:1 by presence or absence of anxiety or depression symptoms. Masking of participants to study arm assignment is not feasible due to the nature of the interventions. However, data collection analysts, study staff, and investigators will be masked to study arm assignments until analyses are complete.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Attitudinal inoculation intervention<br>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<br>* A brief video focused on bolstering resistance to mis/disinformation about the COVID vaccine. Participants will receive two text messages (1 and 3 days after the inoculation intervention). These text messages will include reminders to get vaccinated.<br>|
| Experimental: Cognitive behavioral therapy-informed intervention<br>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<br>* A brief video using a CBT-informed approach and focused on addressing barriers to COVID-19 vaccination. Participants will receive two text messages (1 and 3 days after the inoculation intervention). These text messages will include reminders to get vaccinated.<br>|
| Active Comparator: Conventional public health messaging<br>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<br>* 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 text messages (1 and 3 days after the inoculation intervention). These text messages will include reminders to get vaccinated.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| Vaccine hesitancy 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, 4 weeks post-intervention, and 6 months 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Depression, Vaccination, COVID-19