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临床试验/NCT06119854
NCT06119854已完成不适用

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

City University of New York, School of Public Health1 个研究点 分布在 1 个国家目标入组 1,419 人开始时间: 2024年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,419
试验地点
1
主要终点
Self-reported Receipt of COVID Vaccine Dose by 4 Weeks Post-intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • No dose of a COVID-19 vaccine
  • Had a SARS-CoV-2 infection in the past 3 months

结局指标

主要结局

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

时间窗: 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.

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

时间窗: 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.

次要结局

  • Participants Classified as Vaccine Willing(4 weeks post-intervention)
  • Self-reported Receipt of a COVID Vaccine Dose by 6 Months Post-intervention(6 months post-intervention)
  • Vaccine Willingness Post-intervention(immediately post-intervention)
  • Participants Classified as Vaccine Willing(4 weeks post-intervention)
  • Self-reported Receipt of a COVID Vaccine Dose by 6 Months Post-intervention(6 months post-intervention)
  • Vaccine Willingness Post-intervention(immediately post-intervention)

研究者

发起方
City University of New York, School of Public Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Denis Nash

Professor

City University of New York, School of Public Health

研究点 (1)

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