Cognitive Dysfunction Clinical Trial
— SCD-WELLOfficial title:
A Multicenter Randomized Superiority Study To Compare The Effects Of An 8-Weeks Mindfulness-based Intervention Versus Health Education Programme On Mental Health And Wellbeing In Individuals With Subjective Cognitive Decline
Verified date | February 2021 |
Source | Institut National de la Santé Et de la Recherche Médicale, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 168 |
Est. completion date | September 18, 2018 |
Est. primary completion date | September 18, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - Aged = 60 years - Meet the research criteria proposed by the international SCD-I working group for studies in SCD - Performance within the normal range on standardised cognitive tests according to agreed study-specific standards to rule out mild cognitive impairment (MCI) and dementia - Either referred to the memory clinic by a physician or who are self-referrals because of memory concerns (assessed by a positive response to the question 'Are you worried about your memory?') - Ability to provide informed consent in accordance with International Conference on Harmonization of Good Clinical Practice (GCP/ICH) guidelines and local regulations - State that they are available for the trial duration Exclusion Criteria: - Presence of a major neurological or psychiatric disorder (including generalised anxiety, major depressive disorder, or an addiction to alcohol or drugs) according to ICD-10 and/or DSM 5 criteria - Under legal guardianship or incapacitation - History of cerebral disease (vascular, degenerative, physical malformation, tumor, or head trauma with loss of consciousness for more than an hour) which interferes with the aims of the study protocol - Presence of a chronic disease or acute unstable illness (respiratory, cardiovascular, digestive, renal, metabolic, hematologic, endocrine or infectious) which interferes with the aims of the study protocol - Current or recent medication that may interfere with cognitive action (psychotropic, systemic corticosteroid, anti-Parkinson's, or analgesic drugs). The interfering nature of the different treatments will be at the discretion of the investigating doctor. - Have regularly or intensively practiced meditation or comparable practices (yoga, Qi Gong, Alexander technique) - more than one day per week for more than six months consecutively over the last 10 years, - intensively (internship or retreat > five consecutive days) over the past 10 years, - more than 25 days of retreats (cumulatively) prior to the last 10 years. |
Country | Name | City | State |
---|---|---|---|
France | The Clinical Research Memory Centre of Lyon (CMRR), department of the University Hospitals of Lyon - Hospices Civils de Lyon (HCL) | Lyon | |
Germany | The Department of Psychiatry at University of Cologne (UKK) | Cologne | |
Spain | The Consorci Institut D'Investigacions Biomediques August Pi i Sunyer (IDIBAPS) | Barcelona | |
United Kingdom | The Division of Psychiatry at University College London (UCL). | London | England |
Lead Sponsor | Collaborator |
---|---|
Institut National de la Santé Et de la Recherche Médicale, France |
France, Germany, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Difference in partner perceptions of participant mindfulness measured by Five-Facet Mindfulness Questionnaire (FFMQ-15, range 15-75, higher scores indicate greater mindfulness) | Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant. | a) from baseline to the end of the 8-week intervention and b) from baseline to 24 weeks. | |
Other | Difference in partner perceptions of participant compassion towards others measured by Compassionate Love Scale (Range 21-147, higher scores indicate greater compassion) | Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant. | a) from baseline to the end of the 8-week intervention and b) from baseline to 24 weeks. | |
Other | Difference in partner perceptions of participant depression measured by the Geriatric Depression Scale (range 0-15, higher scores indicate greater depressive symptoms) | Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant. | a) from baseline to the end of the 8-week intervention and b) from baseline to 24 weeks. | |
Other | Difference in partner perceptions of participant anxiety measured by trait subscale of the state-trait anxiety inventory (trait-STAI, range 20-80, higher scores indicate greater anxiety symptoms) | Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant. | a) from baseline to the end of the 8-week intervention and b) from baseline to 24 weeks. | |
Other | Difference in partner perceptions of participant prosocialness measured by Prosocialness scale (range 16-80, higher scores indicate greater prosocialness) | Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant. | a) from baseline to the end of the 8-week intervention and b) from baseline to 24 weeks. | |
Primary | Mean change in anxiety after the intervention | (measured by the trait-STAI) | Between baseline and the end of the 8-week interventions | |
Secondary | Mean change in anxiety from baseline to 24 weeks | measured by the trait-STAI | From baseline and 24 weeks | |
Secondary | Change in depression by the Geriatric Depression Scale (GDS) | depression (Geriatric Depression Scale) : Range 0-15, higher scores indicate greater depressive symptoms. | a) from baseline to the end of the 8-week intervention b) from baseline to 24 weeks. | |
Secondary | Change in behavioural measures of compassion measured by the Self Compassion and Compassionate Love Scale questionnaires | Self Compassion: Range 12-60, higher scores indicate greater compassion. Compassionate Love Scale: Range 21-147, higher scores indicate greater compassion. | a) from baseline to the end of the 8-week intervention b) from baseline to 24 weeks. | |
Secondary | Change in cognitive function assessed by a composite score derived from neuropsychological tests. | The composite score will correspond to the mean of z-scores calculated from relevant test scores from the Mattis Dementia Rating Scale-2 (DRS-2), Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding, Rey Auditory Verbal Learning Test (RAVLT), Category Fluency (Animals). Higher z-scores correspond to better cognitive performance. | a) from baseline to the end of the 8-week intervention b) from baseline to 24 weeks. | |
Secondary | Subjective measures of sleep collected via the Pittsburg Sleep Quality Index questionnaire | collected via the Pittsburg Sleep Quality Index questionnaire: Range 0-21, higher scores indicate better sleep quality | a) from baseline to the end of the 8-week intervention b) from baseline to 24 weeks. | |
Secondary | Change in lifestyle as assessed by The Physical Activity Scale for the Elderly questionnaire | assessed by The Physical Activity Scale for the Elderly questionnaire: Range 0-873, higher scores indicate more physical activity | a) from baseline to the end of the 8-week intervention b) from baseline to 24 weeks. | |
Secondary | Change in quality of life assessed by the world health organization quality of life - brief questionnaire | WHOQOL-bref: Range 21-147, higher scores indicate better quality of life. | a) from baseline to the end of the 8-week intervention b) from baseline to 24 weeks. | |
Secondary | Mean change in blood-based biological markers of stress and Alzheimer's disease assessed by DNA methylation patterns and quantities of proteins - neurofilament light and tau | assessed by DNA methylation patterns and quantities of proteins - neurofilament light and tau | a) from baseline to the end of the 8-week interventions and b) from baseline to 24 weeks. |
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