An interventional study of Attitudinal inoculation and Cognitive-behavioral therapy-informed intervention in Misinformation, Vaccine Hesitancy and Anxiety, sponsored by City University of New York, School of Public Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by City University of New York, School of Public Health · Not applicable, Interventional, and Health services research
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.
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.
183 studies on the registry are indexed under Communication; 87 are open to participants now.
This study's enrollment of 1,419 is above the median of 171 across 158 interventional studies indexed under Communication.
Browse Communication studies →City University of New York, School of Public Health is the lead sponsor of 14 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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 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.
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.
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.
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
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
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
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
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
| Milestone | Attitudinal Inoculation Intervention | Cognitive Behavioral Therapy-informed Intervention | Conventional Public Health Messaging |
|---|---|---|---|
| Started | 472 | 473 | 474 |
| Completed | 466 | 469 | 468 |
| Not completed | 6 | 4 | 6 |
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.
| Participants | Attitudinal Inoculation Intervention | Cognitive Behavioral Therapy-informed Intervention | Conventional Public Health Messaging |
|---|---|---|---|
| Received vaccine | 4 | 7 | 6 |
| Did not receive vaccine | 462 | 462 | 462 |
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.
| Participants | Attitudinal Inoculation Intervention | Cognitive Behavioral Therapy-informed Intervention | Conventional Public Health Messaging |
|---|---|---|---|
| Participants Classified as Vaccine Willing | 168 | 138 | 139 |
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.
| Participants | Attitudinal Inoculation Intervention | Cognitive Behavioral Therapy-informed Intervention | Conventional Public Health Messaging |
|---|---|---|---|
| Self-reported Receipt of a COVID Vaccine Dose by 6 Months Post-intervention | 72 | 61 | 57 |
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.
| Participants | Attitudinal Inoculation Intervention | Cognitive Behavioral Therapy-informed Intervention | Conventional Public Health Messaging |
|---|---|---|---|
| Vaccine Willingness Post-intervention | 202 | 172 | 152 |
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.
| Participants | Attitudinal Inoculation Intervention | Cognitive Behavioral Therapy-informed Intervention | Conventional Public Health Messaging |
|---|---|---|---|
| Vaccine Willingness Post-intervention | 153 | 133 | 141 |
Collected over Adverse events were collected for 6 months after the intervention.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Attitudinal Inoculation Intervention | 0/466 (0%) | 0/466 (0%) | 0/466 (0%) |
| Cognitive Behavioral Therapy-informed Intervention | 0/469 (0%) | 0/469 (0%) | 0/469 (0%) |
| Conventional Public Health Messaging | 0/468 (0%) | 0/468 (0%) | 0/468 (0%) |
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).
| Age, Categorical(Participants) | Attitudinal Inoculation Intervention | Cognitive Behavioral Therapy-informed Intervention | Conventional Public Health Messaging | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 415 | 416 | 415 | 1246 |
| >=65 years | 51 | 53 | 53 | 157 |
| Sex/Gender, Customized(Participants) | Attitudinal Inoculation Intervention | Cognitive Behavioral Therapy-informed Intervention | Conventional Public Health Messaging | Total |
|---|---|---|---|---|
| Gender : Male | 183 | 192 | 199 | 574 |
| Gender : Female | 263 | 270 | 254 | 787 |
| Gender : Non-binary | 20 | 7 | 15 | 42 |
| Race/Ethnicity, Customized(Participants) | Attitudinal Inoculation Intervention | Cognitive Behavioral Therapy-informed Intervention | Conventional Public Health Messaging | Total |
|---|---|---|---|---|
| Race/Ethnicity — Hispanic | 78 | 84 | 84 | 246 |
| Race/Ethnicity — White (non-Hispanic) | 268 | 288 | 286 | 842 |
| Race/Ethnicity — Black (non-Hispanic) | 60 | 49 | 42 | 151 |
| Race/Ethnicity — Asian/American Indian/Pacific (non-Hispanic) | 46 | 34 | 40 | 120 |
| Race/Ethnicity — Other/unknown | 14 | 14 | 16 | 44 |
| Region of Enrollment(Participants) | Attitudinal Inoculation Intervention | Cognitive Behavioral Therapy-informed Intervention | Conventional Public Health Messaging | Total |
|---|---|---|---|---|
| United States — MidWest | 72 | 76 | 84 | 232 |
| United States — NorthEast | 113 | 127 | 134 | 374 |
| United States — South | 167 | 163 | 135 | 465 |
| United States — Other | 1 | 1 | 1 | 3 |
| United States — West | 113 | 102 | 114 | 329 |
| Number of COVID-19 vaccine doses as of Dec 2023(vaccine doses) | Attitudinal Inoculation Intervention | Cognitive Behavioral Therapy-informed Intervention | Conventional Public Health Messaging | Total |
|---|---|---|---|---|
| Median | 3.00 (2.00 to 4.00) | 3.00 (2.00 to 4.00) | 3.00 (2.00 to 4.00) | 3.00 (2.00 to 4.00) |
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City University of New York, School of Public Health