SCD-WELL
Research type
Research Study
Full title
A multicentre randomised superiority study to compare the effects of an 8-week mindfulness-based intervention versus health education programme on mental health and wellbeing in individuals with Subjective Cognitive Decline
IRAS ID
213008
Contact name
Natalie Marchant
Contact email
Sponsor organisation
Institut National de la Sante et de la Recherch Medicale (INSERM) PRC
Clinicaltrials.gov Identifier
213008, IRAS
Duration of Study in the UK
1 years, 11 months, 25 days
Research summary
The European Commission has funded the SCD-WELL trial to investigate the effects of a behavioural intervention to reduce anxiety in individuals with Subjective Cognitive Decline (SCD).
People have SCD feel that their thinking and/or memory have declined however they score within the normal range on tests for dementia. These individuals with SCD are at increased risk of developing dementia and are more likely to have symptoms of stress, anxiety and depression, which further increase the risk of dementia.
Some factors however appear to have a relatively protective effect against dementia and declines in thinking abilities. This project is based on the premise that mental training to control stress and regulate emotions delivered through a mindfulness intervention, or cognitive stimulation delivered though a health education course, should reduce negative symptoms and improve cognition, wellbeing and mental health of people with SCD. Both interventions follow a manual, are group-based, include at-home activities, and are 8 weeks in duration. They are each led by trained facilitators.
160 older-adults clinically judged to have SCD will be recruited to the study from memory clinics at four European sites: London, UK; Cologne, Germany; Barcelona, Spain; Lyon, France where they will have sought help for their memory. They will randomly be assigned to either the mindfulness training or health education intervention. Behavioural assessments and blood draws will take place at baseline, after the intervention, and at follow-up (16 weeks after the end of the intervention). Because the interventions have the potential to affect many areas of life we will also examine changes in psycho-affective symptoms (including depression, worry, mindfulness), social functioning (including loneliness), lifestyle, wellbeing and quality of life, sleep quality, wellbeing of spouses/friends/siblings, cognition (including memory and attention), and blood-based biological markers after the intervention and at follow-up.
REC name
London - Queen Square Research Ethics Committee
REC reference
17/LO/0056
Date of REC Opinion
3 Mar 2017
REC opinion
Further Information Favourable Opinion