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

NCT ID: NCT06119854

Last Updated: 2025-09-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1419 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2024-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Misinformation Vaccine Hesitancy Anxiety Depression COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Attitudinal inoculation

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Cognitive-behavioral therapy-informed intervention

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Conventional public health messaging

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Attitudinal inoculation

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.

Intervention Type 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 messages via text or email (1 and 3 days after the inoculation intervention). These messages will include reminders to get vaccinated.

Intervention Type 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 messages via text or email (1 and 3 days after the inoculation intervention). These messages will include reminders to get vaccinated.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

City University of New York, School of Public Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Denis Nash

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Denis Nash, PhD

Role: PRINCIPAL_INVESTIGATOR

CUNY Institute for Implementation Science in Population Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CUNY Graduate School of Public Health & Health Policy

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Piltch-Loeb R, Su M, Hughes B, Testa M, Goldberg B, Braddock K, Miller-Idriss C, Maturo V, Savoia E. Testing the Efficacy of Attitudinal Inoculation Videos to Enhance COVID-19 Vaccine Acceptance: Quasi-Experimental Intervention Trial. JMIR Public Health Surveill. 2022 Jun 20;8(6):e34615. doi: 10.2196/34615.

Reference Type BACKGROUND
PMID: 35483050 (View on PubMed)

Robertson MM, Kulkarni SG, Rane M, Kochhar S, Berry A, Chang M, Mirzayi C, You W, Maroko A, Zimba R, Westmoreland D, Grov C, Parcesepe AM, Waldron L, Nash D; CHASING COVID Cohort Study Team. Cohort profile: a national, community-based prospective cohort study of SARS-CoV-2 pandemic outcomes in the USA-the CHASING COVID Cohort study. BMJ Open. 2021 Sep 21;11(9):e048778. doi: 10.1136/bmjopen-2021-048778.

Reference Type BACKGROUND
PMID: 34548354 (View on PubMed)

Parcesepe AM, Robertson M, Berry A, Maroko A, Zimba R, Grov C, Westmoreland D, Kulkarni S, Rane M, Salgado-You W, Mirzayi C, Waldron L, Nash D. The relationship between anxiety, health, and potential stressors among adults in the United States during the COVID-19 pandemic. medRxiv [Preprint]. 2020 Nov 4:2020.10.30.20221440. doi: 10.1101/2020.10.30.20221440.

Reference Type BACKGROUND
PMID: 33173880 (View on PubMed)

Piltch-Loeb R, Shen Y, Fleary S, Robertson M, Nunez Sahr J, Penrose K, Sanborn J, Yadav S, Srivastava A, Nash D, Parcesepe A. Testing Theory-Enhanced Messaging to Promote COVID-19 Vaccination Among Adults: Randomized Controlled Trial. J Med Internet Res. 2025 Oct 7;27:e79228. doi: 10.2196/79228.

Reference Type DERIVED
PMID: 41057045 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RF1MH132360

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RF1MH132360

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The PredictPlusPrevent Study
NCT06351800 NOT_YET_RECRUITING NA