Last reviewed · How we verify

NCT06119854

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

Completed NA Results posted Last updated 11 September 2025
What this trial tests

NA trial testing Attitudinal inoculation in Misinformation in 1,419 participants. Completed in 15 November 2024.

Timeline
15 April 2024
Primary endpoint
13 June 2024
15 November 2024

Quick facts

Lead sponsorCity University of New York, School of Public Health
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment1,419
Start date15 April 2024
Primary completion13 June 2024
Estimated completion15 November 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

City University of New York, School of Public Health

Who can join

18 and older, any sex, with Misinformation or Vaccine Hesitancy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

GroupValue95% CI
Attitudinal Inoculation Intervention4
Cognitive Behavioral Therapy-informed Intervention7
Conventional Public Health Messaging6
Attitudinal Inoculation Intervention462
Cognitive Behavioral Therapy-informed Intervention462
Conventional Public Health Messaging462
Participants Classified as Vaccine Willing Secondary · 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 va

GroupValue95% CI
Attitudinal Inoculation Intervention168
Cognitive Behavioral Therapy-informed Intervention138
Conventional Public Health Messaging139
Self-reported Receipt of a COVID Vaccine Dose by 6 Months Post-intervention Secondary · 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.

GroupValue95% CI
Attitudinal Inoculation Intervention72
Cognitive Behavioral Therapy-informed Intervention61
Conventional Public Health Messaging57
Vaccine Willingness Post-intervention Secondary · 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 va

GroupValue95% CI
Attitudinal Inoculation Intervention202
Cognitive Behavioral Therapy-informed Intervention172
Conventional Public Health Messaging152
Vaccine Willingness Post-intervention Secondary · 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 va

GroupValue95% CI
Attitudinal Inoculation Intervention153
Cognitive Behavioral Therapy-informed Intervention133
Conventional Public Health Messaging141

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Testing Theory-Enhanced Messaging to Promote COVID-19 Vaccination Among Adults: Randomized Controlled Trial.
    Piltch-Loeb R, Shen Y, Fleary S, Robertson M, et al · · 2025 · PMID 41057045 · DOI 10.2196/79228

Verify or expand the search:

Other recruiting trials for Misinformation

Currently open trials in the same condition.

Other City University of New York, School of Public Health trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06119854.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing