Effects of a mindfulness-based intervention versus health self-management on subclinical anxiety in older adults with subjective cognitive decline: the SCD-Well randomized superiority trial

Abstract

Introduction: Older adults experiencing subjective cognitive decline (SCD) have a heightened risk of developing dementia and frequently experience subclinical anxiety, which is itself associated with dementia risk. Objective: To understand whether subclinical anxiety symptoms in SCD can be reduced through behavioral interventions. Methods: SCD-Well is a randomized controlled trial designed to determine whether an 8-week mindfulness-based intervention (caring mindfulness-based approach for seniors; CMBAS) is superior to a structurally matched health self-management program (HSMP) in reducing subclinical anxiety. Participants were recruited from memory clinics at 4 European sites. The primary outcome was change in anxiety symptoms (trait subscale of the State-Trait Anxiety Inventory; trait-STAI) from pre- to postintervention. Secondary outcomes included a change in state anxiety and depression symptoms postintervention and 6 months postrandomization (follow-up). Results: One hundred forty-seven participants (mean [SD] age: 72.7 [6.9] years; 64.6% women; CMBAS, n = 73; HSMP, n = 74) were included in the intention-to-treat analysis. There was no difference in trait-STAI between groups postintervention (adjusted change difference: -1.25 points; 95% CI -4.76 to 2.25) or at follow-up (adjusted change difference: -0.43 points; 95% CI -2.92 to 2.07). Trait-STAI decreased postintervention in both groups (CMBAS: -3.43 points; 95% CI -5.27 to -1.59; HSMP: -2.29 points; 95% CI -4.14 to -0.44) and reductions were maintained at follow-up. No between-group differences were observed for change in state anxiety or depression symptoms. Conclusions: A time-limited mindfulness intervention is not superior to health self-management in reducing subclinical anxiety symptoms in SCD. The sustained reduction observed across both groups suggests that subclinical anxiety symptoms in SCD are modifiable. ClinicalTrials.gov identifier: NCT03005652. ; SCD-Well was sponsored by the Institut National de la Santé et de la Recherche Médicale (Inserm). The SCD-Well RCT is part of the Medit-Ageing project funded through the European Union in Horizon 2020 program related to the call PHC22 Promoting Mental Well-Being in the Ageing Population and under grant agreement No. 667696. N.L.M. was supported by a Senior Fellowship from the Alzheimer's Society (AS-SF-15b-002). The funders had no role in the study design, data acquisition, data analysis, data interpretation, or writing.