Trial results for a brief digital intervention study aimed at increasing COVID-19 vaccination among individuals with anxiety or depression were posted on ClinicalTrials.gov on 2025-09-11, with the Attitudinal Inoculation Intervention group showing 72 participants receiving a vaccine dose by 6 months post-intervention.
Background
The COVID-19 pandemic significantly increased the prevalence of anxiety and depressive symptoms among US adults, contributing to a complex mis/disinformation landscape around vaccines. Individuals with anxiety and depression have demonstrated lower COVID-19 vaccine uptake compared to the general population, partly due to higher levels of vaccine hesitancy. This challenge highlights the need for targeted interventions that address specific psychological barriers and misinformation to improve vaccination rates in these vulnerable groups.
Trial design
This completed study, identified as Phase NA, enrolled 1419 participants. The trial focused on individuals experiencing Misinformation, Vaccine Hesitancy, Anxiety, Depression, and COVID-19. The study evaluated three intervention approaches: an Attitudinal Inoculation Intervention, a Cognitive Behavioral Therapy-informed Intervention, and Conventional Public Health Messaging. The primary aim was to assess the impact of these brief digital interventions on COVID-19 vaccination rates and vaccine willingness.
Key results
The trial measured self-reported receipt of a COVID-19 vaccine dose at 4 weeks and 6 months post-intervention, as well as participants classified as vaccine willing:
- For self-reported receipt of a COVID vaccine dose by 4 weeks post-intervention:
- 4 out of 462 participants in the Attitudinal Inoculation Intervention group.
- 7 out of 462 participants in the Cognitive Behavioral Therapy-informed Intervention group.
- 6 out of 462 participants in the Conventional Public Health Messaging group.
- For participants classified as vaccine willing:
- 168 participants in the Attitudinal Inoculation Intervention group.
- 138 participants in the Cognitive Behavioral Therapy-informed Intervention group.
- 139 participants in the Conventional Public Health Messaging group.
- For self-reported receipt of a COVID vaccine dose by 6 months post-intervention:
- 72 participants in the Attitudinal Inoculation Intervention group.
- 61 participants in the Cognitive Behavioral Therapy-informed Intervention group.
- 57 participants in the Conventional Public Health Messaging group.
Further analyses provided risk ratios and risk differences comparing intervention groups:
- A Risk Ratio (RR) of 1.207 (95.0% CI: 0.406 to 3.59) was reported.
- A Risk Difference (RD) of 0.003 (95.0% CI: -0.013 to 0.018) was reported.
- A Risk Ratio (RR) of 0.687 (95.0% CI: 0.194 to 2.436) was reported.
- A Risk Difference (RD) of -0.004 (95.0% CI: -0.018 to 0.01) was reported.
- A Risk Ratio (RR) of 0.992 (95.0% CI: 0.785 to 1.253) was reported.
- A Risk Difference (RD) of -0.003 (95.0% CI: -0.063 to 0.058) was reported.
What this means
The results suggest a modest impact of the digital interventions on COVID-19 vaccination uptake among individuals with anxiety or depression. While a small number of participants across all groups reported receiving a vaccine dose by 4 weeks and 6 months post-intervention, the overall percentages remain low relative to the group sizes. The Attitudinal Inoculation Intervention group showed the highest number of vaccinated participants at 6 months. The reported risk ratios and risk differences, accompanied by wide 95% confidence intervals, indicate variability in the observed effects and suggest that the interventions did not lead to a substantial, statistically precise increase in vaccination rates or willingness. These findings highlight the persistent challenges in addressing vaccine hesitancy within this population, even with targeted digital strategies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06119854, titled "Brief Digital Intervention to Increase COVID-19 Vaccination Among Individuals With Anxiety or Depression", were posted on 2025-09-11 on clinicaltrials.gov.