Effects Of An 8-Weeks Mindfulness-based Intervention In Individuals With Subjective Cognitive Decline

Summary

The European Commission Horizon 2020 programme has funded the SCD-WELL trial to investigate the efficacy of mindfulness-based training to reduce anxiety in individuals with Subjective Cognitive Decline (SCD), in comparison to an active comparison condition.

It is increasingly recognized that most neuropathological processes start years before the onset of clinical Alzheimer's disease (AD). Hence, there is a growing urgency to target individuals in the earliest stages for intervention when neurodegeneration is still limited. Individuals clinically judged to have SCD, defined by subjectively experienced cognitive decline but normal performance on cognitive tests, are at increased risk for future cognitive decline and AD. These individuals with SCD currently have no established treatment options. Symptoms of anxiety have high prevalence in this population, and evidence from recent longitudinal research links anxiety with significantly accelerated cognitive decline in at risk individuals. Effectively reducing anxiety in this population may therefore not only relieve participants from burdensome symptoms, but may also slow cognitive decline and delay or prevent the onset of AD.

The investigators chose to study the efficacy of a mindfulness-based intervention to reduce anxiety in this population because this type of intervention has been shown to reduce anxiety in a number of populations, including in older adults. Further, accumulating evidence indicates that intensive mindfulness training effectively down-regulates a number of other adverse psychological and biological risk factors for AD, such as stress, depression, insomnia, feelings of loneliness and social exclusion, and cardiovascular risk factors. These findings are relevant to AD because approximately a third of AD cases worldwide might be attributable to potentially modifiable risk factors. In spite of the increased use of mindfulness-based interventions to treat clinical symptoms, these trials often suffer from the lack of an adequate comparison condition and lack of follow up to know whether initial benefits are maintained.

Conditions

• Cognitive Dysfunction

Interventions

BEHAVIORAL

Mindfulness weekly courses for 8 weeks

The mindfulness intervention combines intensive training in mindfulness and compassion meditations, light movement and yoga activities, and psycho-educational components to promote nonjudgmental awareness of present moment experiences.

BEHAVIORAL

Health education weekly courses for 8 weeks

The health education intervention is group-based programme has been developed and validated in an SCD population. Each session of the course covers different subjects, which include self-management, problem-solving, sleep, stress, exercise, managing medicines and memory, communicating with healthcare professionals, eating, and planning for the future.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France

  lead OTHER_GOV

Principal Investigators

• Frank Jessen · Director of the Clinic for Psychiatry and Psychotherapy at University Hospital Cologne

• Natalie Marchant · Division of Psychiatry, University College London

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-04-21

Primary Completion

2018-09-18

Completion

2018-09-18

Countries

• France
• Germany
• Spain
• United Kingdom

Study Locations