Changing Mindsets About Side Effects of the COVID-19 Vaccination: A Randomized Controlled Trial.

BACKGROUND: Side-effect concerns are a major barrier to vaccination against COVID-19 and other diseases. Identifying cost- and time-efficient interventions to improve vaccine experience and reduce vaccine hesitancy-without withholding information about side effects-is critical. PURPOSE: Determine whether a brief symptom as positive signals mindset intervention can improve vaccine experience and reduce vaccine hesitancy after the COVID-19 vaccination. METHODS: English-speaking adults (18+) were recruited during the 15-min wait period after receiving their second dose of the Pfizer COVID-19 vaccination and were randomly allocated to the symptom as positive signals mindset condition or the treatment as usual control. Participants in the mindset intervention viewed a 3:43-min video explaining how the body responds to vaccinations and how common side effects such as fatigue, sore arm, and fever are signs that the vaccination is helping the body boost immunity. The control group received standard vaccination center information. RESULTS: Mindset participants (N = 260) versus controls (N = 268) reported significantly less worry about symptoms at day 3 [t(506)=2.60, p=.01, d=0.23], fewer symptoms immediately following the vaccine [t(484)=2.75, p=.006, d=0.24], and increased intentions to vaccinate against viruses like COVID-19 in the future [t(514)=-2.57, p=.01, d=0.22]. No significant differences for side-effect frequency at day 3, coping, or impact. CONCLUSIONS: This study supports the use of a brief video aimed at reframing symptoms as positive signals to reduce worry and increase future vaccine intentions. CLINICAL TRIAL INFORMATION: Australian New Zealand Clinical Trials Registry: ACTRN12621000722897p.

Side-effect concerns are a major barrier to vaccination against COVID-19 and other diseases. Therefore, the purpose of this study was to determine whether a brief symptom as positive signals mindset intervention could improve vaccine experience and reduce vaccine hesitancy after the COVID-19 vaccination. Participants were recruited during the 15-min wait period after receiving their second dose of the Pfizer COVID-19 vaccination and were randomly allocated to a treatment as usual control condition or to a mindset intervention condition which entailed watching a 3:43-min video explaining how the body responds to vaccinations and how common side effects such as fatigue, sore arm, and fever are signs that the vaccination is helping the body boost immunity. Compared with participants in the control condition, participants in the mindset intervention condition reported significantly less worry about symptoms at day 3, fewer symptoms immediately following the vaccine and increased intentions to vaccinate against viruses like COVID-19 in the future. No significant differences emerged for side-effect frequency at day 3, coping, or impact. These finding provide initial support for cost- and time-efficient interventions to improve vaccine experience and reduce vaccine hesitancy without withholding information about side effects.

Increasing and dampening the nocebo response following medicine-taking: A randomised controlled trial.

OBJECTIVE: The nocebo effect is the adverse effects of treatment that cannot be attributed to a medicine. We investigated if we could increase or decrease nocebo responding following medicine taking. A nocebo explanation to reduce side effects was compared with a negative medication news item designed to increase side effects and a control condition. METHODS: 108 healthy participants enrolled in a between-subjects study purportedly testing the effect of lamotrigine (actually placebo) on mood and cognition. Participants were randomised to watch either a video explaining the nocebo effect; a negative media item on lamotrigine, or control video prior to receiving the tablet. Side effects were assessed at 45-min and 48-h. RESULTS: The negative media group reported significantly more side effects (M = 0.78, SD = 1.53) than the control group (M = 0.46, SD = 1.80, p = .035) at the end of session and a greater proportion of the negative media group (33%) reported at least one side effect compared to the nocebo explanation (11%) and control group (11%, p = .020). The nocebo explanation group reported significantly fewer side effects (M = 0.38, SD = 1.16) than the control group (M = 1.37, SD = 2.98, p = .038) at the 48-h follow-up. CONCLUSION: Explaining the nocebo effect may be a beneficial addition to standard medicine information for reducing side effect reporting. Negative media coverage about a drug is likely to generate increased side effects. Future research should examine the benefit of nocebo explanation in patients starting new medicines.