Award Title: Further EvAluation of SCD-WELL: mindfulness THERapy for older adults (FEATHER)
Funder: Dunhill Medical Trust

Abstract: Background
It is increasingly recognized that most neuropathological processes start years before the onset of dementia. It is important to target intervention in the earliest stages when neurodegeneration is limited. There is evidence that subjective cognitive decline (SCD) is associated with increased risk for future cognitive decline. (1) Persons with SCD also experience increased depressive symptoms, which have been shown to increase dementia risk in the general population. (2)

Objectives
Our main objective is to evaluate the effects of an 8-week Caring Mindfulness-Based Approach for Seniors (CMBAS) compared to a health education programme (HEP) on depressive symptoms in older adults with SCD. 

Our secondary objective will be to improve our understanding of the relationship between SCD and depressive symptoms. We would first seek to replicate the previous finding of an association between SCD and depressive symptoms, and then seek to explain this association via statistical mediation. Further objectives will be to investigate whether CMBAS improves cognition in areas most sensitive to dementia.

Methods
We will utilize data collected during the SCD-WELL trial, a pan-European randomized study of CMBAS versus HEP in 160 older adults with SCD. Data are being collected at baseline (pre-intervention), week-8 (post-intervention) and week-24 (follow-up). Standardized measures are collected by blinded raters, and include Geriatric Depression Scale (GDS) (3); Cognitive Difficulties Scale (measures subjective cognitive complaints) (4); World Health Organisation Quality of Life (5); Physical Activity Scale (6); Big-Five Inventory (Personality) (7); Loneliness Scale (8); Pittsburgh Sleep Quality Index (9); Psychological Well-being (10); and an extensive range of cognitive measures. These include the Mattis Dementia Rating Scale-2 (11); Rey Verbal Auditory Learning Test (12); Trail Making Tests (13); verbal fluency (14); Stroop (15); and WAIS Coding/Matrix Reasoning/Vocabulary (16).

Statistical analysis
The CMBAS and HEP groups will be compared on baseline demographic, cognitive and medical variables in order to describe the sample and identify covariates needing to be adjusted for. The analysis will follow Intention-to-Treat. The change on the primary outcome, Geriatric Depression Scale, will be compared between CMBAS and HEP at weeks 8 and 24 using ANCOVA. Characteristics of responders and non-responders will be evaluated using baseline variables.

Impact
An intervention that reduces the incidence of dementia and depressive symptoms would have enormous societal, personal and economic value. CMBAS, if successful, could be promoted as a non-pharmacological therapy that could have a major positive effect on the mental health and quality of life of older patients.

Lay Abstract: Background
Results from clinical trials for dementia have been disappointing. One explanation is that most treatments have been tested in patients with a diagnosis of dementia when the brain is already damaged. People experiencing mild memory problems who still perform well on memory tests are more likely to develop dementia. This condition is called subjective cognitive decline (SCD). People with SCD frequently experience depression, and depression is also a risk factor for dementia.

Objectives
Our main objective is to evaluate if people with SCD who take part in an 8-week mindfulness therapy have a greater reduction in their symptoms of depression compared to those taking a health education course.

Our secondary objective will be to improve our understanding of the relationship between SCD and symptoms of depression by looking at factors linking the two. Further objectives will be to investigate whether mindfulness therapy improves memory and thinking skills affected by dementia.

Methods
We will use data collected for a European clinical trial called 'SCD-WELL' taking place in France, Germany, Spain and the UK. SCD-WELL is comparing the beneficial effects of a mindfulness therapy to those of a health education course in 160 adults with SCD. The main study (ongoing, already funded) is looking at the effect of the groups on participants' anxiety, but this Fellowship proposal will explore many other outcomes which are also relevant to people with SCD.

Participants are asked to fill in a number of questionnaires and are given tests that measure thinking and memory before the start of the groups, at 8-weeks (when the groups have concluded) and 4 months later. The questionnaires and memory tests will collect information about depressive symptoms, subjective cognitive complaints, quality of life, physical activity, personality traits, loneliness, quality of sleep, and wellbeing.

Statistical analysis
We will compare the two groups to see whether symptoms of depression change more in the group receiving mindfulness therapy relative to those receiving the health education course. We will compare the two groups to see whether mindfulness therapy has a relatively greater effect on memory and thinking skills.

Impact
An intervention that reduces the occurrence of dementia and symptoms of depression would have enormous societal, personal and economic value. Mindfulness-based therapy, if successful, could be a promising therapy to reduce the risk of dementia and also to have a major positive effect on the mental health and quality of life of older adults.

Research Activity Codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health Categories: NEUROLOGICAL;MENTAL HEALTH