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.

Medicine plus mindset: A mixed-methods evaluation of a novel mindset-focused training for primary care teams.

OBJECTIVES: Patient mindsets influence health outcomes; yet trainings focused on care teams' understanding, recognizing, and shaping patient mindsets do not exist. This paper aims to describe and evaluate initial reception of the "Medicine Plus Mindset" training program. METHODS: Clinicians and staff at five primary care clinics (N = 186) in the San Francisco Bay Area received the Medicine Plus Mindset Training. The Medicine Plus Mindset training consists of a two-hour training program plus a one-hour follow-up session including: (a) evidence to help care teams understand patients' mindsets' influence on treatment; (b) a framework to support care teams in identifying specific patient mindsets; and (c) strategies to shape patient mindsets. RESULTS: We used a common model (Kirkpatrick) to evaluate the training based on participants' reaction, learnings, and behavior. Reaction: Participants rated the training as highly useful and enjoyable. Learnings: The training increased the perceived importance of mindsets in healthcare and improved self-reported efficacy of using mindsets in practice. Behavior: The training increased reported frequency of shaping patient mindsets. CONCLUSIONS: Development of this training and the study's results introduce a promising and feasible approach for integrating mindset into clinical practice. Practice Implications Mindset training can add a valuable dimension to clinical care and should be integrated into training and clinical practice.

Making sense of a pandemic: Mindsets influence emotions, behaviors, health, and wellbeing during the COVID-19 pandemic.

RATIONALE: As the SARS-COV-2 virus spread across the world in the early months of 2020, people sought to make sense of the complex and rapidly evolving situation by adopting mindsets about what the pandemic was and what it meant for their lives. OBJECTIVE: We aimed to measure the mindsets of American adults over the first six months of the COVID-19 pandemic to understand their relative stability over time and their relationship with emotions, behaviors, experiences, and wellbeing. METHODS: American adults (N = 5,365) were recruited in early March of 2020 to participate in a longitudinal survey with follow-up surveys at 6-weeks and 6-months. Three mindsets that people formed about the COVID-19 pandemic were measured: 'the pandemic is a catastrophe', 'the pandemic is manageable' and 'the pandemic can be an opportunity'. RESULTS: In line with our pre-registered hypotheses, these mindsets were associated with a unique and largely self-fulfilling pattern of emotions (positive, negative), behaviors (healthy, unhealthy, and compliance with CDC guidelines), experiences (growth/connection, isolation/meaninglessness) and wellbeing (physical health, mental health, quality of life). Moreover, mindsets formed in the first week of the pandemic were associated with quality of life 6 months later, an effect that was mediated by emotions and health behaviors. CONCLUSION: The mindsets that people adopted about the COVID-19 pandemic - that it is 'a catastrophe', 'manageable', or 'an opportunity' may explain some of the heterogeneity in the lived experiences of Americans through their self-fulfilling impact on peoples' emotions, health behaviors, and wellbeing.

Changing mindsets about side effects.

Given research showing that the very act of communicating side effects can increase their likelihood, how can providers inform patients about side effects while upholding their oath to do no unnecessary harm? An emerging approach provides a potential solution: truthfully describe certain minor side effects as a sign the treatment is active and working in the body. This approach focuses on instilling adaptive mindsets about the meaning of side effects while still keeping patients informed. This article describes existing research suggesting that this approach can be helpful in improving experience and outcomes in treatments for pain, hypertension and allergy. Compared with control groups given a standard, empathetic message about side effects, patients who were informed that side effects are a sign treatment is working were less anxious about side effects and rated them as less threatening and intense. A longitudinal, randomised controlled trial of this approach in patients receiving oral immunotherapy for food allergies found that describing side effects as a sign treatment was working reduced the rate at which patients contacted providers with concerns about side effects and led to greater increases in a biomarker of allergic tolerance from pretreatment to post-treatment (peanut-specific blood IgG4). In unveiling this approach, this article also raises important issues regarding which treatments and symptoms this approach should be applied to. Finally, we outline questions future research should address to further understand and leverage this approach.

Qualitative Evaluations of mHealth Interventions: Current Gaps and Future Directions.

Psycho-social factors are often addressed in behavioral health studies. While the purpose of many mHealth interventions is to facilitate behavior change, the focus is more prominently on the functionality and usability of the technology and less on the psycho-social factors that contribute to behavior change. Here we aim to identify the extent to which mHealth interventions for patient self- management address psychological factors. By understanding users' motivations, facilitators, and mindsets, we can better tailor mHealth interventions to promote behavior change.

When Your Doctor "Gets It" and "Gets You": The Critical Role of Competence and Warmth in the Patient-Provider Interaction.

Background: Research demonstrates that the placebo effect can influence the effectiveness of medical treatments and accounts for a significant proportion of healing in many conditions. However, providers may differ in the degree to which they consciously or unconsciously leverage the forces that produce placebo effects in clinical practice. Some studies suggest that the manner in which providers interact with patients shapes the magnitude of placebo effects, but this research has yet to distill the specific dimensions of patient-provider interactions that are most likely to influence placebo response and the mechanisms through which aspects of patient-provider interactions impact placebo response. Methods: We offer a simplifying and unifying framework in which interactions that boost placebo response can be dissected into two key dimensions: patients' perceptions of competence, or whether a doctor "gets it" (i.e., displays of efficiency, knowledge, and skill), and patients' perceptions of warmth, or whether a doctor "gets me" (i.e., displays of personal engagement, connection, and care for the patient). Results: First, we discuss how this framework builds on past research in psychology on social perception of competence and warmth and in medical literature on models of effective medical care, patient satisfaction, and patient-provider interactions. Then we consider possible mechanisms through which competence and warmth may affect the placebo response in healthcare. Finally, we share original data from patients and providers highlighting how this framework applies to healthcare. Both patient and provider data illustrate actionable ways providers can demonstrate competence and warmth to patients. Discussion: We conclude with recommendations for how researchers and practitioners alike can more systematically consider the role of provider competence and warmth in patient-provider interactions to deepen our understanding of placebo effects and, ultimately, enable providers to boost placebo effects alongside active medications (i.e., with known medical ingredients) and treatment in clinical care.

The role of patient beliefs in open-label placebo effects.

OBJECTIVE: Recent research on open-label placebos, or placebos administered without deception or concealment, suggests that they can be effective in a variety of conditions. The current research sought to unpack the mechanisms underlying the treatment efficacy of open-label placebos. METHOD: A health care provider induced an allergic reaction in 148 participants via a histamine skin prick test. Participants were then exposed to 1 of 4 conditions additively leveraging various mechanisms of open-label placebo treatments: a supportive patient-provider relationship, a medical ritual, positive expectations, and a rationale about the power of placebos. RESULTS: There were no main effects of condition on allergic responses. However, participant beliefs about placebos moderated the effect of open-label placebo treatment condition on physiological allergic reactions: the condition including all 4 components of open-label placebos (a supportive patient-provider relationship, a medical ritual, positive expectations, and a rationale about the power of placebos) significantly reduced physiological allergic reaction among participants with a strong belief in placebos compared with participants in the control group. CONCLUSION: Participants' beliefs about placebos interact with information from the provider to reduce physiological allergic reactions in response to an open-label placebo treatment. This study underscores the importance of measuring and understanding how participants' beliefs influence outcomes of treatment, and furthers our understanding of when and how open-label placebo treatments work. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Changing Patient Mindsets about Non-Life-Threatening Symptoms During Oral Immunotherapy: A Randomized Clinical Trial.

BACKGROUND: Oral immunotherapy (OIT) can lead to desensitization to food allergens, but patients can experience treatment-related symptoms of allergic reactions that cause anxiety and treatment dropout. Interventions to improve OIT for patients are needed. OBJECTIVE: To determine whether fostering the mindset that non-life-threatening symptoms during OIT can signal desensitization improves treatment experience and outcomes. METHODS: In a randomized, blinded, controlled phase II study, 50 children/adolescents (28% girls, aged 7-17 years, M = 10.82, standard deviation = 3.01) completed 6-month OIT for peanut allergies. Patients and their parent(s) had monthly clinic visits at the Sean N. Parker Center for Allergy and Asthma Research between January 5, 2017, and August 3, 2017. All families received identical symptom management training. In a 1:1 approach, 24 patients and their families were informed that non-life-threatening symptoms during OIT were unfortunate side effects of treatment, and 26 patients and their families were informed that non-life-threatening symptoms could signal desensitization. Families participated in activities to reinforce these symptom mindsets. RESULTS: Compared with families informed that symptoms are side effects, families informed that symptoms can signal desensitization were less anxious (B = -0.46, 95% confidence interval [CI]: -0.76 to -0.16; P = .003), less likely to contact staff about symptoms (5/24 [9.4%] vs 27/154 [17.5%] instances; P = .036), experienced fewer non-life-threatening symptoms as doses increased (BInteraction = -0.54, 95% CI: -0.83 to -0.27; P < .001), less likely to skip/reduce doses (1/26 [4%] vs 5/24 [21%] patients; P = .065), and showed a greater increase in patient peanut-specific blood IgG4 levels (BInteraction = 0.76, 95% CI: 0.36 to 1.17; P < .001). CONCLUSIONS: Fostering the mindset that symptoms can signal desensitization improves OIT experience and outcomes. Changing how providers inform patients about non-life-threatening symptoms is a promising avenue for improving treatment.