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N/A N=1,419 Randomized Health Services Research

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

Misinformation · Vaccine Hesitancy · Anxiety · Depression · COVID-19

Enrolled (actual)
1,419
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Self-reported Receipt of COVID Vaccine Dose by 4 Weeks Post-intervention — 4; 7; 6; 462 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Attitudinal inoculation (Behavioral); Cognitive-behavioral therapy-informed intervention (Behavioral); Conventional public health messaging (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
City University of New York, School of Public Health
Primary completion
Jun 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Self-reported Receipt of COVID Vaccine Dose by 4 Weeks Post-intervention
4; 7; 6; 462; 462; 462
SECONDARY
Participants Classified as Vaccine Willing
168; 138; 139
SECONDARY
Self-reported Receipt of a COVID Vaccine Dose by 6 Months Post-intervention
72; 61; 57
SECONDARY
Vaccine Willingness Post-intervention
153; 133; 141
SECONDARY
Vaccine Willingness Post-intervention
153; 133; 141

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06119854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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