Clinical trial NCT02286791: Mindful Awareness Program for the Prevention of Dementia: A Randomized Controlled Trial
Official title: Mindful Awareness Program for the Prevention of Dementia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Prevention of dementia
Mindful awareness program
Mild cognitive impairment
Mindfulness
Elderly
Cognitive decline
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 55
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to determine whether regular Mindful Awareness Program (MAP) may reverse cognitive impairment and/or prevent further cognitive decline among older adults. 60 elderly with mild cognitive impairment (MCI) were randomized to participate in either the MAP or the Health Education Program (HEP). Sessions will be conducted weekly for 12 weeks, and monthly for 6 months. Participants would be assessed at 3 time-points: at the start, at 3-months and at 9-months.

It was hypothesized that as compared to HEP participants, MAP participants will (1) have improved functional connectivity, (2) have a decreased risk in cognitive decline and (3) report higher psychological well-being.

Detailed description: Participants Study participants are community-dwelling elderly.

Assessments Demographic data will be collected at the start. Psychological tests for depression and anxiety and neuropsychological tests of cognitive functioning will be done at the start, at 3-months and at 9-months, the end of the study. A urine sample will be collected at the start and at the end of the study; blood, fecal and saliva samples will be collected at all three time points. Participants will also undergo a brain neuro-imaging scan at the start of the study and at the 3-months interval.

Intervention Sessions This is an intervention study with a control group design. The strength of this design is its experimental nature with randomization. The control group is the health education program participants.

In the Mindful Awareness Program, all 30 participants will be seen in a group format once a week for 40 minutes for 12 weeks, followed by once a month for 40 minutes for 6 months. The intervention is modelled on similar groups teaching mindfulness meditation to the elderly. The sessions will be led by an experienced instructor who has conducted pilot studies on the use of mindful awareness practice techniques with the elderly.

Participants shall be required to practice these techniques at home daily and will be asked to keep a log of their practice.

For the Health Education Program, all 30 participants will be seen in a group format once a week for 40 minutes for 12 weeks, followed by once a month for 40 minutes for 6 months. Each weekly session will cover a healthy living topic related to maintaining and improving cognitive function. The monthly sessions will review the topics covered with a discussion of how participants have implemented the imparted knowledge to their daily lives. The sessions will be led by an experienced instructor who has conducted similar teaching sessions to the elderly.

Participants will be provided with hand-outs at each session, and there will be discussions to encourage them to practice what is being taught in their daily lives.

Eligibility criteria: Inclusion Criteria:

1. an elderly person between the age of 60 and 85 living in the community and fulfill the operational criteria/definition of MCI:

   1. At least one age-education adjusted neuropsychological test Z score \< -1.5
   2. Do not meet DSM-IV criteria for dementia syndrome
   3. Memory / Cognitive complaint, preferably corroborated by a reliable informant
   4. Intact Activities of Daily Living.
2. function independently
3. do not suffer from dementia,
4. able to travel on their own to the data collection site and participate in the MAP or HEP

Exclusion Criteria:

1. Those who do not meet the above inclusion criteria (ie. Do not have a MCI diagnosis),
2. Those with Dementia or Normal Ageing
3. Have a neurological condition (e.g., epilepsy, Parkinson's Disease),
4. Have a major psychiatric condition (e.g., major depressive disorder)
5. Suffer from a terminal illness (e.g., cancer).
6. Have significant visual or hearing impairment, or
7. Marked upper and lower limb motor difficulties, which may affect their ability to participate in the study.
8. Are in another interventional study at the same time

Primary outcomes:
measure: Change from baseline Mini-Mental State Examination (MMSE) at 3 months and 9 months
timeFrame: baseline, 3-months, 9-months
measure: Change from baseline Clinical Dementia Rating (CDR ) at 3 months and 9 months
timeFrame: baseline, 3-months, 9-months
measure: Change from baseline Rey Auditory Verbal Learning Test (RAVLT) at 3 months and 9 months
timeFrame: baseline, 3-months, 9-months
measure: Change from baseline Digit Span Task at 3 months and 9 months
timeFrame: baseline, 3-months, 9-months
measure: Change from baseline Colour Trails Tests (CTT) at 3 months and 9 months
timeFrame: baseline, 3-months, 9-months
measure: Change from baseline Block Design at 3 months and 9 months
timeFrame: baseline, 3-months, 9-months
measure: Change from baseline Semantic Verbal Fluency (Animals) at 3 months and 9 months
timeFrame: baseline, 3-months, 9-months
measure: Change from baseline fMRI scan at 3 months
timeFrame: baseline, 3-months
measure: Change from baseline Biomarkers: blood sample at 3 months and 9 months
timeFrame: baseline, 3-months, 9-months
measure: Change from baseline Biomarkers: urine sample at 9 months
timeFrame: baseline, 9-months
measure: Change from baseline Biomarker - fecal sample at 3 months and 9 months
timeFrame: baseline,3 months, 9 months
measure: Change from baseline Biomarker - saliva sample at 3 months and 9 months
timeFrame: baseline,3 months, 9 months
Secondary outcomes:
measure: Change from baseline Basic Health Screen at 3 months and 9 months
timeFrame: baseline, 3-months, 9-months
measure: Change from baseline Activities of daily Living (ADL) at 3 months and 9 months
timeFrame: baseline, 3-months, 9-months
measure: Change from baseline Instrumental Activities of Daily Living (IADL) at 3 months and 9 months
timeFrame: baseline, 3-months, 9-months
measure: Change from baseline Geriatric Depression Scale (GDS) at 3 months and 9 months
timeFrame: baseline, 3-months, 9-months
measure: Change from baseline Geriatric Anxiety Inventory (GAI) at 3 months and 9 months
timeFrame: baseline, 3-months, 9-months
Other outcomes:
measure: Demographic questionnaire
timeFrame: Baseline
Locations:
city: Singapore
country: Singapore
facility: Training and Research Academy
Study officials:
affiliation: National University of Singapore
name: Rathi Mahendran, Ph.D
role: PRINCIPAL_INVESTIGATOR
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