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)
Authors: Marchant Natalie L. , Barnhofer Thorsten , Klimecki Olga M. , Poisnel Géraldine , Lutz Antoine , Arenaza‐Urquijo Eider , Collette Fabienne , Wirth Miranka , Schild Ann‐Katrin , Coll‐Padrós Nina , Reyrolle Leslie , Horney Deborah , Krolak‐Salmon Pierre , Molinuevo José Luis , Walker Zuzana , Maillard Aline , Frison Eric , Jessen Frank , Chételat Gael ,   SCD‐WELL Medit‐Ageing Research Group, Ashton Nicholas , Allais Florence , Asselineau Julien , Bachelet Romain , Belleoud Viviane , Benson Clara , Bosch Beatriz , Botton Maelle , Casanova Maria Pilar , Chocat Anne , Delphin Floriane , Demnitz‐King Harriet , Egret Stéphanie , Gonneaud Julie , Hye Abdul , Philippe Agathe Joret , La Joie Renaud , Leon Maria , Meiberth Dix , Milz Ester , Mueller Hendrik , Mueller Theresa , Ourry Valentin , Ramirez Alfredo , Rauchs Géraldine , Reyrolle Leslie , Richert Laura , Salinero Ana , Salmon Eric , Sannemann Lena , Satgunasingam Yamna , Schlosser Marco , Schwimmer Christine , Steinhauser Hilde , Tomadesso Clémence , Vivien Denis , Vuilleumier Patrik , Wallet Cédrick , Whitfield Tim , Wingrove Janet 
Published: December 2018

AbstractIntroductionSubjectively 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.