Trial Outcomes & Findings for Brief Digital Intervention to Increase COVID-19 Vaccination Among Individuals With Anxiety or Depression (NCT NCT06119854)

NCT ID: NCT06119854

Last Updated: 2025-09-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

1419 participants

Primary outcome timeframe

4 weeks post-intervention

Results posted on

2025-09-11

Participant Flow

Overall, 2,411 CHASING COVID Cohort participants were invited, and 1,419 (59%) were eligible and randomized to the intervention. After completing the 4-week survey, 16 participants were removed from the sample based on data quality protocols, leaving an analytic sample of 1403 participants. Randomization resulted in 469 individuals in CBT-kernels arm, 466 in the Inoculation arm, and 468 in the Standard public health messaging arm

Participant milestones

Participant milestones
Measure	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. 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.	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. 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.	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. 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.
Overall Study STARTED	472	473	474
Overall Study COMPLETED	466	469	468
Overall Study NOT COMPLETED	6	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Attitudinal Inoculation Intervention n=466 Participants 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. 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.	Cognitive Behavioral Therapy-informed Intervention n=469 Participants 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. 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.	Conventional Public Health Messaging n=468 Participants 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. 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.	Total n=1403 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	415 Participants n=5 Participants	416 Participants n=7 Participants	415 Participants n=5 Participants	1246 Participants n=4 Participants
Age, Categorical >=65 years	51 Participants n=5 Participants	53 Participants n=7 Participants	53 Participants n=5 Participants	157 Participants n=4 Participants
Sex/Gender, Customized Gender : Male	183 Participants n=5 Participants	192 Participants n=7 Participants	199 Participants n=5 Participants	574 Participants n=4 Participants
Sex/Gender, Customized Gender : Female	263 Participants n=5 Participants	270 Participants n=7 Participants	254 Participants n=5 Participants	787 Participants n=4 Participants
Sex/Gender, Customized Gender : Non-binary	20 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants	42 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	78 Participants n=5 Participants	84 Participants n=7 Participants	84 Participants n=5 Participants	246 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · White (non-Hispanic)	268 Participants n=5 Participants	288 Participants n=7 Participants	286 Participants n=5 Participants	842 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black (non-Hispanic)	60 Participants n=5 Participants	49 Participants n=7 Participants	42 Participants n=5 Participants	151 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian/American Indian/Pacific (non-Hispanic)	46 Participants n=5 Participants	34 Participants n=7 Participants	40 Participants n=5 Participants	120 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other/unknown	14 Participants n=5 Participants	14 Participants n=7 Participants	16 Participants n=5 Participants	44 Participants n=4 Participants
Region of Enrollment United States · MidWest	72 Participants n=5 Participants	76 Participants n=7 Participants	84 Participants n=5 Participants	232 Participants n=4 Participants
Region of Enrollment United States · NorthEast	113 Participants n=5 Participants	127 Participants n=7 Participants	134 Participants n=5 Participants	374 Participants n=4 Participants
Region of Enrollment United States · South	167 Participants n=5 Participants	163 Participants n=7 Participants	135 Participants n=5 Participants	465 Participants n=4 Participants
Region of Enrollment United States · Other	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment United States · West	113 Participants n=5 Participants	102 Participants n=7 Participants	114 Participants n=5 Participants	329 Participants n=4 Participants
Number of COVID-19 vaccine doses as of Dec 2023	3.00 vaccine doses n=5 Participants	3.00 vaccine doses n=7 Participants	3.00 vaccine doses n=5 Participants	3.00 vaccine doses n=4 Participants

PRIMARY outcome

Timeframe: 4 weeks post-intervention

Population: Overall, 2,411 CHASING COVID Cohort participants were invited, and 1,419 (59%) were eligible and randomized to the intervention. After completing the 4-week survey, 16 participants were removed from the sample based on data quality protocols, leaving an analytic sample of 1403 participants. Randomization resulted in 469 individuals in CBT-kernels arm, 466 in the Inoculation arm, and 468 in the Standard public health messaging arm (Figure 1).

Outcome measures

Outcome measures
Measure	Attitudinal Inoculation Intervention n=466 Participants 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. 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.	Cognitive Behavioral Therapy-informed Intervention n=469 Participants 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. 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.	Conventional Public Health Messaging n=468 Participants 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. 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.
Self-reported Receipt of COVID Vaccine Dose by 4 Weeks Post-intervention Received vaccine	4 Participants	7 Participants	6 Participants
Self-reported Receipt of COVID Vaccine Dose by 4 Weeks Post-intervention Did not receive vaccine	462 Participants	462 Participants	462 Participants

SECONDARY outcome

Timeframe: 4 weeks post-intervention

Population: Of the 1,403 participants analyzed at baseline, 59 participants were lost to follow up (20 in CBT arm, 21 in inoculation arm, and 18 in standard arm)

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.

Outcome measures

Outcome measures
Measure	Attitudinal Inoculation Intervention n=445 Participants 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. 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.	Cognitive Behavioral Therapy-informed Intervention n=449 Participants 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. 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.	Conventional Public Health Messaging n=450 Participants 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. 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.
Participants Classified as Vaccine Willing	168 Participants	138 Participants	139 Participants

SECONDARY outcome

Timeframe: 6 months post-intervention

Population: Of the 1,403 participants analyzed, 74 were lost to follow up by month 6 (25 in CBT arm, 23 in inoculation arm, and 26 in standard arm)

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.

Outcome measures

Outcome measures
Measure	Attitudinal Inoculation Intervention n=443 Participants 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. 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.	Cognitive Behavioral Therapy-informed Intervention n=444 Participants 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. 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.	Conventional Public Health Messaging n=411 Participants 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. 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.
Self-reported Receipt of a COVID Vaccine Dose by 6 Months Post-intervention	72 Participants	61 Participants	57 Participants

SECONDARY outcome

Timeframe: 6-months post-intervention

Population: Of the 1,403 participants analyzed at baseline, 76 participants were lost to follow up by month 6 (26 in CBT arm, 23 in inoculation arm, and 27 in standard arm)

Outcome measures

Outcome measures
Measure	Attitudinal Inoculation Intervention n=443 Participants 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. 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.	Cognitive Behavioral Therapy-informed Intervention n=443 Participants 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. 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.	Conventional Public Health Messaging n=441 Participants 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. 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.
Vaccine Willingness Post-intervention	202 Participants	172 Participants	152 Participants

SECONDARY outcome

Timeframe: immediately post-intervention

Outcome measures

Outcome measures
Measure	Attitudinal Inoculation Intervention n=466 Participants 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. 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.	Cognitive Behavioral Therapy-informed Intervention n=469 Participants 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. 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.	Conventional Public Health Messaging n=468 Participants 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. 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.
Vaccine Willingness Post-intervention	153 Participants	133 Participants	141 Participants

Adverse Events

Attitudinal Inoculation Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cognitive Behavioral Therapy-informed Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Public Health Messaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Denis Nash

CityUNYSPH

Phone: 3473316554

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place