Anxiety, COVID-19, Depression, Misinformation, Vaccine Hesitancy
Conditions
Keywords
Anxiety, Depression, Vaccination, COVID-19
Brief summary
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
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.
Interventions
BEHAVIORALAttitudinal 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.
BEHAVIORALCognitive-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.
BEHAVIORALConventional 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.
Sponsors
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
City University of New York, School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Receipt of COVID Vaccine Dose by 4 Weeks Post-intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Participants Classified as Vaccine Willing | 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. |
| Self-reported Receipt of a COVID Vaccine Dose by 6 Months Post-intervention | 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. |
| Vaccine Willingness Post-intervention | 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. |
Countries
United States
Participant flow
Pre-assignment details
Overall, 2,411 CHASING COVID Cohort participants were invited, and 1,419 (59%) were eligible and randomized to the intervention. After completing the 4-week survey, 16 participants were removed from the sample based on data quality protocols, leaving an analytic sample of 1403 participants. Randomization resulted in 469 individuals in CBT-kernels arm, 466 in the Inoculation arm, and 468 in the Standard public health messaging arm
Participants by arm
| Arm | Count |
|---|---|
| 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. | 466 |
| 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. | 469 |
| 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. | 468 |
| Total | 1,403 |
Baseline characteristics
| Characteristic | Cognitive Behavioral Therapy-informed Intervention | Conventional Public Health Messaging | Attitudinal Inoculation Intervention | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 53 Participants | 53 Participants | 51 Participants | 157 Participants |
| Age, Categorical Between 18 and 65 years | 416 Participants | 415 Participants | 415 Participants | 1246 Participants |
| Number of COVID-19 vaccine doses as of Dec 2023 | 3.00 vaccine doses | 3.00 vaccine doses | 3.00 vaccine doses | 3.00 vaccine doses |
| Race/Ethnicity, Customized Race/Ethnicity Asian/American Indian/Pacific (non-Hispanic) | 34 Participants | 40 Participants | 46 Participants | 120 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black (non-Hispanic) | 49 Participants | 42 Participants | 60 Participants | 151 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 84 Participants | 84 Participants | 78 Participants | 246 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other/unknown | 14 Participants | 16 Participants | 14 Participants | 44 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White (non-Hispanic) | 288 Participants | 286 Participants | 268 Participants | 842 Participants |
| Region of Enrollment United States MidWest | 76 Participants | 84 Participants | 72 Participants | 232 Participants |
| Region of Enrollment United States NorthEast | 127 Participants | 134 Participants | 113 Participants | 374 Participants |
| Region of Enrollment United States Other | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States South | 163 Participants | 135 Participants | 167 Participants | 465 Participants |
| Region of Enrollment United States West | 102 Participants | 114 Participants | 113 Participants | 329 Participants |
| Sex/Gender, Customized Gender : Female | 270 Participants | 254 Participants | 263 Participants | 787 Participants |
| Sex/Gender, Customized Gender : Male | 192 Participants | 199 Participants | 183 Participants | 574 Participants |
| Sex/Gender, Customized Gender : Non-binary | 7 Participants | 15 Participants | 20 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 466 | 0 / 469 | 0 / 468 |
| other Total, other adverse events | 0 / 466 | 0 / 469 | 0 / 468 |
| serious Total, serious adverse events | 0 / 466 | 0 / 469 | 0 / 468 |
Outcome results
Primary
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.
Time frame: 4 weeks post-intervention
Population: Overall, 2,411 CHASING COVID Cohort participants were invited, and 1,419 (59%) were eligible and randomized to the intervention. After completing the 4-week survey, 16 participants were removed from the sample based on data quality protocols, leaving an analytic sample of 1403 participants.~Randomization resulted in 469 individuals in CBT-kernels arm, 466 in the Inoculation arm, and 468 in the Standard public health messaging arm (Figure 1).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Attitudinal Inoculation Intervention | Self-reported Receipt of COVID Vaccine Dose by 4 Weeks Post-intervention | Received vaccine | 4 Participants |
| Attitudinal Inoculation Intervention | Self-reported Receipt of COVID Vaccine Dose by 4 Weeks Post-intervention | Did not receive vaccine | 462 Participants |
| Cognitive Behavioral Therapy-informed Intervention | Self-reported Receipt of COVID Vaccine Dose by 4 Weeks Post-intervention | Received vaccine | 7 Participants |
| Cognitive Behavioral Therapy-informed Intervention | Self-reported Receipt of COVID Vaccine Dose by 4 Weeks Post-intervention | Did not receive vaccine | 462 Participants |
| Conventional Public Health Messaging | Self-reported Receipt of COVID Vaccine Dose by 4 Weeks Post-intervention | Received vaccine | 6 Participants |
| Conventional Public Health Messaging | Self-reported Receipt of COVID Vaccine Dose by 4 Weeks Post-intervention | Did not receive vaccine | 462 Participants |
95% CI: [0.406, 3.59]
95% CI: [-0.013, 0.018]
95% CI: [0.194, 2.436]
95% CI: [-0.018, 0.01]
Secondary
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.
Time frame: 4 weeks post-intervention
Population: Of the 1,403 participants analyzed at baseline, 59 participants were lost to follow up (20 in CBT arm, 21 in inoculation arm, and 18 in standard arm)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Attitudinal Inoculation Intervention | Participants Classified as Vaccine Willing | 168 Participants |
| Cognitive Behavioral Therapy-informed Intervention | Participants Classified as Vaccine Willing | 138 Participants |
| Conventional Public Health Messaging | Participants Classified as Vaccine Willing | 139 Participants |
95% CI: [0.785, 1.253]
95% CI: [-0.063, 0.058]
95% CI: [0.981, 1.534]
95% CI: [0.008, 0.133]
Secondary
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.
Time frame: 6 months post-intervention
Population: Of the 1,403 participants analyzed, 74 were lost to follow up by month 6 (25 in CBT arm, 23 in inoculation arm, and 26 in standard arm)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Attitudinal Inoculation Intervention | Self-reported Receipt of a COVID Vaccine Dose by 6 Months Post-intervention | 72 Participants |
| Cognitive Behavioral Therapy-informed Intervention | Self-reported Receipt of a COVID Vaccine Dose by 6 Months Post-intervention | 61 Participants |
| Conventional Public Health Messaging | Self-reported Receipt of a COVID Vaccine Dose by 6 Months Post-intervention | 57 Participants |
95% CI: [0.74, 1.527]
95% CI: [-0.037, 0.053]
95% CI: [0.892, 1.784]
95% CI: [-0.013, 0.08]
Secondary
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.
Time frame: 6-months post-intervention
Population: Of the 1,403 participants analyzed at baseline, 76 participants were lost to follow up by month 6 (26 in CBT arm, 23 in inoculation arm, and 27 in standard arm)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Attitudinal Inoculation Intervention | Vaccine Willingness Post-intervention | 202 Participants |
| Cognitive Behavioral Therapy-informed Intervention | Vaccine Willingness Post-intervention | 172 Participants |
| Conventional Public Health Messaging | Vaccine Willingness Post-intervention | 152 Participants |
95% CI: [0.911, 1.406]
95% CI: [-0.019, 0.109]
95% CI: [1.074, 1.631]
95% CI: [0.045, 0.176]
Secondary
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.
Time frame: immediately post-intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Attitudinal Inoculation Intervention | Vaccine Willingness Post-intervention | 153 Participants |
| Cognitive Behavioral Therapy-informed Intervention | Vaccine Willingness Post-intervention | 133 Participants |
| Conventional Public Health Messaging | Vaccine Willingness Post-intervention | 141 Participants |