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

Sponsor
City University of New York, School of Public Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06119854
Collaborator
University of North Carolina, Chapel Hill (Other)
1,500
3
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Attitudinal inoculation
  • Behavioral: Cognitive-behavioral therapy-informed intervention
  • Behavioral: Conventional public health messaging
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Brief Digital Intervention to Increase COVID-19 Vaccination Among Individuals With Anxiety or Depression
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: Attitudinal inoculation
A brief video focused on bolstering resistance to mis/disinformation about the COVID vaccine. Participants will receive two text messages (1 and 3 days after the inoculation intervention). These text messages will include reminders to get vaccinated.

Experimental: 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.

Behavioral: 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 text messages (1 and 3 days after the inoculation intervention). These text messages will include reminders to get vaccinated.

Active Comparator: 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.

Behavioral: 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 text messages (1 and 3 days after the inoculation intervention). These text messages will include reminders to get vaccinated.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Vaccine hesitancy post-intervention [immediately post-intervention, 4 weeks post-intervention, and 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Actively engaged in the CHASING COVID Cohort study (i.e., completed >1 survey or specimen collection since January 1, 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • City University of New York, School of Public Health
  • University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Denis Nash, PhD, CUNY Institute for Implementation Science in Population Health

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Denis Nash, Professor, City University of New York, School of Public Health
ClinicalTrials.gov Identifier:
NCT06119854
Other Study ID Numbers:
  • RF1MH132360
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Denis Nash, Professor, City University of New York, School of Public Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023