The SCD‐Well randomized controlled trial: Effects of a mindfulness‐based intervention versus health education on mental health in patients with subjective cognitive decline (SCD)

Abstract

IntroductionSubjectively experienced cognitive decline in older adults is an indicator of increased risk for dementia and is also associated with increased levels of anxiety symptoms. As anxiety is itself emerging as a risk factor for cognitive decline and dementia, the primary question of the present study is whether an 8-week mindfulness-based intervention can significantly reduce anxiety symptoms in patients with subjective cognitive decline (SCD). The secondary questions pertain to whether such changes extend to other domains of psychological, social, and biological functioning (including cognition, self-regulation, lifestyle, well-being and quality of life, sleep, and selected blood-based biomarkers) associated with mental health, older age, and risk for dementia.MethodsSCD-Well is a multicenter, observer-blinded, randomized, controlled, superiority trial, which is part of the Horizon 2020 European Union-funded “Medit-Ageing” project. SCD-Well compares an 8-week mindfulness- and compassion-based intervention specifically adapted for older adults with SCD with a validated 8-week health education program. Participants were recruited from memory clinics in four European sites (Cologne, Germany; London, United Kingdom; Barcelona, Spain; and Lyon, France) and randomized with a 1:1 allocation, stratified by site.ResultsThe primary outcome, change in anxiety symptoms, and secondary outcomes reflecting psychological, cognitive, social, and biological functioning are assessed at baseline, postintervention, and 4 months after the end of the intervention.DiscussionThe study will provide evidence on whether a mindfulness-based intervention can effect changes in anxiety and other risk factors for cognitive decline and dementia in older adults with SCD and will inform the establishment of intervention strategies targeted at improving mental health in older adults.

The impact of meditation on healthy ageing — the current state of knowledge and a roadmap to future directions

“…The inclusion of active control groups is particularly important, as older adults are particularly responsive to the effects of social activity [56], and mindfulness based interventions are often not superior to active control groups when it comes to psychological health and well-being [41,57]. Furthermore, it will be important for future studies to reduce risks in biases that may for instance stem from not blinding composed of three studies with older adults: i) the Age-Well observational study, a cross-sectional study comparing expert meditators to non meditators [58], ii) the Age-Well clinical trial, a longitudinal study in which an 18-month meditation intervention is compared to an active control group (English training) and a passive control group [59], and iii) the SCD-Well clinical trial [60], a longitudinal study in which participants with subjective cognitive decline, a known risk factor for dementia [61], are assigned to a 2-month meditation intervention (with 4-month follow-up) or a health education intervention [23,62]. To reduce the risk of bias, the longitudinal studies are clinical randomized controlled trials in which experimenters are blinded to the condition of the participants and in which data analyses of the primary endpoints are analysed externally.…”

Repetitive Negative Thinking is associated with Subjective Cognitive Decline in older adults: a cross-sectional study

“…Speci cally, higher levels of RNT were related to lower levels of selfperceived cognition and a higher likelihood of memory complaints. This association between RNT and SCD is particularly compelling because RNT has been theoretically and empirically linked with dementia risk (8,26) and because no previous study had explicitly examined this relationship. SCD is a relatively newly de ned clinical presentation with heterogeneous underlying aetiologies and requires more research to allow clearer predictions of its clinical trajectories.…”

“…Relatedly, recent theory and research discusses the potential bene ts of meditation for (brain) health and cognition in ageing and for repetitive negative thinking in the context of a longer-term commitment to a regular meditation practice (36,55,56). Shorter-term meditation-based interventions tend to focus primarily on affective outcomes such as anxiety and depressive symptoms (8), which have been shown to be reduced by relatively brief meditation retreats (57).…”

“…Given the lack of effective interventions for curing or treating dementia, increasing importance has been given to dementia prevention (7). This shift in research orientation has led to a growing interest in (i) re ning risk factor pro les for dementia and early presentations of potential dementia (e.g., SCD, mild cognitive impairment) (1,7), and (ii) developing preventative intervention approaches (8)(9)(10)(11). Alongside well-established cardiovascular risk factors such as hypertension, obesity, physical inactivity, and smoking (7,13), psychological risk factors, such as depression and anxiety, are emerging as promising intervention targets (14)(15)(16).…”

Repetitive Negative Thinking is associated with Subjective Cognitive Decline in older adults: a cross-sectional study

“…Given the lack of effective interventions for curing or treating dementia, increasing importance has been given to dementia prevention (7). This shift in research orientation has led to a growing interest in (i) refining risk factor profiles for dementia and early presentations of potential dementia (e.g., SCD, mild cognitive impairment) (1, 7), and (ii) developing preventative intervention approaches (8)(9)(10)(11). Alongside well-established cardiovascular risk factors such as hypertension, obesity, physical inactivity, and smoking (7,13), psychological risk factors, such as depression and anxiety, are emerging as promising intervention targets (14)(15)(16).…”