ABSTRACT
BACKGROUND: Mindfulness meditation is a form of mind-body intervention that has increasing scientific support for its ability to reduce age-related declines in cognitive functioning, improve affective health, and strengthen the neural circuitry supporting improved cognitive and affective health. However, the majority of existent studies have been pilot investigations with small sample sizes, limited follow-up data, and a lack of attention to expectancy effects. Here, we present the study design of a Phase I/II, efficacy trial-HealthyAgers trial-that examines the benefits of a manualized mindfulness-based stress reduction program in improving attentional control and reducing mind-wandering in older adults. METHODS: One hundred fifty older adults (ages 65-85 years) will be randomized into one of two groups: an eight-week mindfulness program or an eight-week, placebo-controlled, lifestyle education program. Behavioral and neuroimaging assessments are conducted before and after the training. Participants are then invited to booster sessions once every three months for a period of 12 months with post-intervention follow-up assessments conducted at 6-months and 12-months. The primary outcomes for the study are behavioral measures of attentional control and mind-wandering. Additional, secondary outcomes include network strength in an a priori defined neuromarker of attentional control, fluid and everyday cognition, emotion regulation strategy use, and markers of inflammation. DISCUSSION: This study will establish the efficacy of a group-based, low-cost mind-body intervention for the inter-related facets of attentional control and mind-wandering in older adults. Strengths of this study include a well-designed, placebo-controlled comparison group, use of web/mobile application to track study adherence, and longitudinal follow-up. TRIAL REGISTRATION: Clinicaltrials.gov (# NCT03626532 ). Registered August 4, 2018.
Subject(s)
Attention , Mindfulness , Stress, Psychological , Aged , Aged, 80 and over , Attention/physiology , Clinical Trials, Phase I as Topic , Clinical Trials, Phase II as Topic , Humans , Mindfulness/methods , Randomized Controlled Trials as Topic , Research Design , Stress, Psychological/prevention & control , Stress, Psychological/psychologySubject(s)
COVID-19 , Heuristics , Cognition , Decision Making , Humans , Risk Assessment , SARS-CoV-2ABSTRACT
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine candidates are being evaluated, with the goal of conferring immunity on the highest percentage of people who receive the vaccine as possible. It is noteworthy that vaccine efficacy depends not only on the vaccine but also on characteristics of the vaccinated. Over the past 30 years, a series of studies has documented the impact of psychological factors on the immune system's vaccine response. Robust evidence has demonstrated that stress, depression, loneliness, and poor health behaviors can impair the immune system's response to vaccines, and this effect may be greatest in vulnerable groups such as the elderly. Psychological factors are also implicated in the prevalence and severity of vaccine-related side effects. These findings have generalized across many vaccine types and therefore may be relevant to the SARS-CoV-2 vaccine. In this review, we discuss these psychological and behavioral risk factors for poor vaccine responses, their relevance to the COVID-19 pandemic, as well as targeted psychological and behavioral interventions to boost vaccine efficacy and reduce side effects. Recent data suggest these psychological and behavioral risk factors are highly prevalent during the COVID-19 pandemic, but intervention research suggests that psychological and behavioral interventions can increase vaccine efficacy.