Dataset Information

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: Introduction:Subjectively 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. Methods:SCD-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. Results:The 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. Discussion:The 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.

SUBMITTER: Marchant NL

PROVIDER: S-EPMC6296291 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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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).

Marchant Natalie L NL Barnhofer Thorsten T Klimecki Olga M OM Poisnel Géraldine G Lutz Antoine A Arenaza-Urquijo Eider E Collette Fabienne F Wirth Miranka M Schild Ann-Katrin AK Coll-Padrós Nina N Reyrolle Leslie L Horney Deborah D Krolak-Salmon Pierre P Molinuevo José Luis JL Walker Zuzana Z Maillard Aline A Frison Eric E Jessen Frank F Chételat Gael G

Alzheimer's & dementia (New York, N. Y.) 20181214

<h4>Introduction</h4>Subjectively 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 ...[more]

PMID: 30581979

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Project description:BackgroundOlder individuals with subjective cognitive decline (SCD) perceive that their cognition has declined but do not show objective impairment on neuropsychological tests. Individuals with SCD are at elevated risk of objective cognitive decline and incident dementia. Non-pharmacological interventions (including mindfulness-based and health self-management approaches) are a potential strategy to maintain or improve cognition in SCD, which may ultimately reduce dementia risk.MethodsThis study utilized data from the SCD-Well randomized controlled trial. One hundred forty-seven older adults with SCD (MAge = 72.7 years; 64% female) were recruited from memory clinics in four European countries and randomized to one of two group-based, 8-week interventions: a Caring Mindfulness-based Approach for Seniors (CMBAS) or a health self-management program (HSMP). Participants were assessed at baseline, post-intervention (week 8), and at 6-month follow-up (week 24) using a range of cognitive tests. From these tests, three composites were derived-an "abridged" Preclinical Alzheimer's Cognitive Composite 5 (PACC5Abridged), an attention composite, and an executive function composite. Both per-protocol and intention-to-treat analyses were performed. Linear mixed models evaluated the change in outcomes between and within arms and adjusted for covariates and cognitive retest effects. Sensitivity models repeated the per-protocol analyses for participants who attended ≥ 4 intervention sessions.ResultsAcross all cognitive composites, there were no significant time-by-trial arm interactions and no measurable cognitive retest effects; sensitivity analyses supported these results. Improvements, however, were observed within both trial arms on the PACC5Abridged from baseline to follow-up (Δ [95% confidence interval]: CMBAS = 0.34 [0.19, 0.48]; HSMP = 0.30 [0.15, 0.44]). There was weaker evidence of an improvement in attention but no effects on executive function.ConclusionsTwo non-pharmacological interventions conferred small, non-differing improvements to a global cognitive composite sensitive to amyloid-beta-related decline. There was weaker evidence of an effect on attention, and no evidence of an effect on executive function. Importantly, observed improvements were maintained beyond the end of the interventions. Improving cognition is an important step toward dementia prevention, and future research is needed to delineate the mechanisms of action of these interventions and to utilize clinical endpoints (i.e., progression to mild cognitive impairment or dementia).Trial registrationClinicalTrials.gov, NCT03005652.

Project description:BackgroundSince SCD (plus) was standardized, little is known about its demographic characteristics and its outcomes of neuropsychological assessments, including the SCD questionnaire 9 (SCD-Q9).ObjectiveTo characterize SCD (plus) by comparing the neuropsychological features among its subgroups and with normal controls (NC). Also, to explore its demographics and to understand the relation of the chief complaints and the scores of SCD-Q9.MethodsMultistage stratified cluster random sampling was conducted to select participants. As a result, 84 NC and 517 SCD (plus) were included. SCD (plus) was further classified into several subgroups (SCD-C: concerned cognitive decline; SCD-F: complaints about SCD within the past five years; SCD-P: feeling performance being not as good as their peers; SCD+: presented> 3 of SCD (plus) features; SCD-: presented ? 3 of SCD (plus) features (see the diagnostic criteria for the details)) and between-group comparisons of neuropsychological scores were conducted. Point-biserial correlation and binary logistic regression analyses were performed to investigate the demographic characteristics of its subgroups. Finally, Spearman correlation was used to better understand the relation of SCD (plus) to SCD-Q9.Results(1) Scores of AVLT-LR (AVLT-LR: Auditory Verbal Learning Test-Long Delayed Recall) and MoCA-B (MoCA: Montreal Cognitive Assessment-Basic) were lower in the SCD-P group than those in the NC group, and the SCD+ group scored lower in the MoCA-B and CDT(CDT: Clock Drawing Test) than the SCD- group. (2) Females were more concerned than male participants. Individuals with lower education level felt that their cognitive performance were worse than their peers. Also, younger people might express concerns more than the more elderly. People who had complaints of SCD-P might be more likely to report SCD-C, but less likely to report SCD-F. (3) Positive correlations were found between the chief complaints of SCD (plus) and some items of SCD-Q9.ConclusionsSCD (plus) may be related to demographic factors. Individuals with SCD (plus) already exhibited cognitive impairment, which can be detected by SCD-Q9.

Project description:BackgroundPrimary care is often the first point of contact when community-dwelling older adults experience subjective cognitive decline (SCD) or mild cognitive impairment (MCI). Living with SCD or MCI can be life-altering, resulting in low mood and increased anxiety, further exacerbating cognitive decline. However, there is scant literature on interventions that interprofessional primary care providers can provide to support those living with SCD or MCI. Practicing mindfulness-based stress reduction (MBSR) in an interprofessional primary care setting may support emotional health and well-being for those with cognitive decline, but it has not been studied in an interprofessional primary care context.ObjectivesThis study's primary aim was to determine the feasibility of, and perceived benefits to and satisfaction with, a 9-Week MBSR program delivered in a team-based primary care setting. The secondary aim was to examine the acceptability of using technology (computer tablet and App Insight Timer®) for program delivery and home practice.MethodsA convergent mixed-methods, single-blind pilot randomized controlled trial (RCT) study design was used. A quantitative strand was used to evaluate the feasibility of the MBSR program. The qualitative strand used a focus group with older adult participants with SCD or MCI. Individual semi-structured interviews with occupational therapists who are qualified-MBSR teachers were conducted to explore the acceptability of using computer tablets for program delivery and home practice.Results27 participants were randomized (14 MBSR; 13 Control) with retention rates of 64.3% (9/14 completed ≥6 sessions), true adherence rates of 50% (7/14 met ≥19.5 hrs of home practice), 21.4% attrition rates, and 100% post-intervention follow-up. No participants who used computer tablets at the beginning of the intervention switched to low technology. Older adult participants found the use of computer tablets in the MBSR course acceptable and appreciated the portability of the tablets.ConclusionsBased on the lower-than-expected rates of recruitment, retention, and adherence, our study, as designed, did not meet the feasibility benchmarks that were set. However, with minor modifications to the design, including changing how participants who drop-out are analyzed, extending recruitment, and adding multiple sites, this intervention would be well suited to further study using a full-scale RCT. However, we found that embedding MBSR in an interprofessional primary care setting was feasible in practice and qualitative data highlighted the satisfaction and perceived benefits based on the intervention. The use of technology was acceptable and portable, as participants utilized their computer tablets consistently until the study's end. Our study showed that older adults living with SCD or MCI were highly receptive to learning how to use technology, and future group intervention programs in interprofessional primary care settings may also incorporate tablet use.Trial registrationThis study was reviewed and approved by the Research Ethics Board in Toronto, Ontario, Canada (REB# 2017-0056-E); Queen's University (REB# 6026418) in Kingston, Ontario, Canada, and Clinicaltrials.gov (08/03/2019; NCT03867474).

Project description:IntroductionAlzheimer's disease patients are reported to have higher survival rate compared to patients with vascular dementia or dementia with Lewy bodies. There is a paucity of studies investigating survival including persons with cognitive decline and dementia of various aetiologies.ObjectivesWe aimed to compare survival for patients with subjective cognitive decline, mild cognitive impairment, Alzheimer's disease, vascular dementia, mixed Alzheimer's/vascular dementia, dementia with Lewy bodies/Parkinson's disease, and other dementias compared to the general Norwegian population, taking into account the role of gender, cognitive function, function in everyday activities, comorbidity and education.MethodsPatients (N = 4682), ≥65 years, in the The Norwegian register of persons assessed for cognitive symptoms (NorCog) during 2009-2017 were followed for mortality in the National Registry until January 2018. Flexible parametric survival models were applied to estimate relative survival, life expectancy and years of life lost for diagnostic groups compared with the general population.ResultsPatients with vascular dementia or dementia with Lewy bodies/Parkinson's had the shortest survival, followed by mixed dementia, Alzheimer's disease, unspecified dementia, mild cognitive impairment and subjective cognitive decline. At age 70 years, men with vascular dementia or dementia with Lewy bodies/Parkinson's had life expectancy of 4.7 years, which corresponded to 10.3 years of life lost compared to the general population. Years of life lost for other diagnoses were 10.0 years for mixed dementia, 9.2 years for Alzheimer's disease, 9.3 years for other dementias, 5.2 years for mild cognitive impairment and 2.2 years for subjective cognitive decline. Corresponding years of life lost in women were: 12.7 years, 10.5 years, 9.8 years, 10.6 years, 7.8 years, and 2.6 years. Poor relative survival among dementia patients was associated with male gender, comorbidity, low cognitive function, and low function in activities of daily living.ConclusionsCompared with the general population, patients with subjective cognitive decline had no significant loss in life expectancy, while patients with mild cognitive impairment and all dementia subtypes had large losses, especially those with a diagnosis of vascular dementia or dementia with Lewy bodies/Parkinson's.

Project description:IntroductionSubjects exhibiting subjective cognitive decline (SCD) are at an increased risk for mild cognitive impairment and dementia. Given the delay between risk exposure and disease onset, SCD individuals are increasingly considered a good target population for cost-effective lifestyle-based Alzheimer's disease prevention trials.MethodsThe PENSA study is a randomized, double-blind, controlled clinical trial that aims to evaluate the efficacy of a personalized multimodal intervention in lifestyle (diet counseling, physical activity, cognitive training, and social engagement) combined with the use of epigallocatechin gallate (EGCG) over 12 months, in slowing down cognitive decline and improving brain connectivity. The study population includes 200 individuals meeting SCD criteria and carrying the apolipoprotein E ε4 allele, who will be randomized into four treatment arms (multimodal intervention + EGCG/placebo, or lifestyle recommendations + EGCG/placebo). The primary efficacy outcome is change in the composite score for cognitive performance measured with the Alzheimer's Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS-PACC-like) adding to the original version the Interference score from the Stroop Color and Word Test and the Five Digit Test. Secondary efficacy outcomes are (1) change in functional magnetic resonance imaging (fMRI) and structural neuronal connectivity (structural MRI) and (2) the safety assessment of the EGCG compound. This study is framed within the WW-FINGERS consortium.DiscussionThe use of new technologies (i.e., mobile ecological momentary assessments [EMAs], activity tracker) in the PENSA study allows the collection of continuous data on lifestyle behaviors (diet and physical activity) and mood, enabling a personalized design as well as an intensive follow-up of participants. These data will be used to give feedback to participants about their own performance along the intervention, promoting their involvement and adherence. The results of the study may aid researchers on the design of future clinical trials involving preventive lifestyle multicomponent interventions.

Dataset Information

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).

Publications

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).

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