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Completed

NCT Number: NCT02286791

Mindful Awareness Program for the Prevention of Dementia: A Randomized Controlled Trial

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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Training and Research Academy

Singapore, 648886

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • an elderly person between the age of 60 and 85 living in the community and fulfill the operational criteria/definition of MCI:
  • At least one age-education adjusted neuropsychological test Z score < -1.5
  • Do not meet DSM-IV criteria for dementia syndrome
  • Memory / Cognitive complaint, preferably corroborated by a reliable informant
  • Intact Activities of Daily Living.
  • function independently
  • do not suffer from dementia,
  • able to travel on their own to the data collection site and participate in the MAP or HEP

Exclusion criteria

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

Treatment and study plan

Mindful Awareness Program

Behavioral

For Mindful Awareness Program, 40-minutes weekly sessions for 12 weeks, followed by 40-minutes monthly for 6 months. The mindful awareness practice techniques to be taught to the elderly include: (1) mindfulness of the senses practice; (2) the body scan practice; (3) walking meditation practice; (4) 'movement nature meant' practice; and (5) visuo-motor limb tasks

Other names: MAP

Health Education Program

Behavioral

For the Health Education Program, weekly sessions of 40 minutes for 12 weeks, followed by monthly sessions of 40 minutes for 6 months.

Week 1: Diabetes Mellitus Week 2: Hypertension Week 3: Home Safety Week 4: Medications Week 5: Diet Week 6: Depression Week 7: Dementia Week 8: Anxiety Week 9: Sleep Week 10: Exercise Week 11: Coping with bereavement Week 12: Social support

Other names: HEP

Primary outcomes

  1. Change from baseline Mini-Mental State Examination (MMSE) at 3 months and 9 months

    Time frame: baseline, 3-months, 9-months

    Mini-Mental State Examination (MMSE) is a brief 30-point questionnaire administered by health care professionals to screen for cognitive impairment. The score ranges from 0 to 30; the higher the score, the less impaired is the participant's cognitive function.

  2. Change from baseline Clinical Dementia Rating (CDR ) at 3 months and 9 months

    Time frame: baseline, 3-months, 9-months

    Clinical Dementia Rating (CDR ) is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care.

  3. Change from baseline Rey Auditory Verbal Learning Test (RAVLT) at 3 months and 9 months

    Time frame: baseline, 3-months, 9-months

    Rey Auditory Verbal Learning Test (RAVLT) evaluates declarative verbal learning and memory.

  4. Change from baseline Digit Span Task at 3 months and 9 months

    Time frame: baseline, 3-months, 9-months

    Digit Span Task, which consists of a Digit Span Forward (DSF) and a Digit Span Backward (DSB) task is used to assess attention and verbal working memory.

  5. Change from baseline Colour Trails Tests (CTT) at 3 months and 9 months

    Time frame: baseline, 3-months, 9-months

    Colour Trails Tests (CTT) 1 and 2 assesses sustained attention and sequencing.

  6. Change from baseline Block Design at 3 months and 9 months

    Time frame: baseline, 3-months, 9-months

    Block Design is a subtest that is administered as part of several of the Wechsler Intelligence tests, and it primarily measures visual-spatial and organizational processing abilities, as well as non-verbal problem-solving skills.

  7. Change from baseline Semantic Verbal Fluency (Animals) at 3 months and 9 months

    Time frame: baseline, 3-months, 9-months

    Semantic Verbal Fluency (Animals) taps lexical knowledge and semantic memory organization.

  8. Change from baseline fMRI scan at 3 months

    Time frame: baseline, 3-months

    Functional Magnetic Resonance Imaging (fMRI) will be employed to examine changes in functional connectivity. Images will be acquired on a 3T Siemens scanner using a standard Siemens whole head coil. All subjects will undergo the task-free fMRI scan after being instructed only to remain awake with their eyes closed. White Matter Diffiusion Tractography Imaging (DTI) will be utilized to identify anatomical connections between functionally correlated regions . The MRI Brain Scan is non-invasive and does not involve the use of Contrast; duration of each scan is approximately one hour.

  9. Change from baseline Biomarkers: blood sample at 3 months and 9 months

    Time frame: baseline, 3-months, 9-months

    5 ml of blood will be collected using plasma tubes with indomethacin (15uM final conc) and BHT (20ul of 2mM) will be added prior to freezing (-80 Degree Celsius) to preserve the sample and prevent artifacts (at baseline, 3 months, 9 months).

    3 ml of blood will be collected using tubes with no coagulant (at baseline, 3 months and 9 months).

    5 ml of blood will be collected using Tempus Blood RNA tubes and will be stored in a refrigerator at approximately 4 Degree Celsius (at baseline and 9 months).

    Blood sample would be analysed for cytokine levels; chromosomal studies and terminal telomere restriction fragment length.

  10. Change from baseline Biomarkers: urine sample at 9 months

    Time frame: baseline, 9-months

    15 ml sample of urine will be collected and frozen as quickly as possible. Urine sample would be analysed for oxidative biomarkers.

  11. Change from baseline Biomarker - fecal sample at 3 months and 9 months

    Time frame: baseline,3 months, 9 months

    A fecal sample will also be collected in a tube with RNALater and microbeads. These can be kept at 40C till processing. Fecal sample would be analysed for bacteria.

  12. Change from baseline Biomarker - saliva sample at 3 months and 9 months

    Time frame: baseline,3 months, 9 months

    Saliva will be collected in a test-tube by having participants continuously spit into a 50ml centrifuge tube for 5 minutes. Saliva sample would be analysed for salivary cortisol analysis, DNA extraction and sequencing for stress biomarkers (cytokines).

Secondary outcomes

  1. Change from baseline Basic Health Screen at 3 months and 9 months

    Time frame: baseline, 3-months, 9-months

    the Blood pressure, Pulse rate, Height and Weight will be measured.

  2. Change from baseline Activities of daily Living (ADL) at 3 months and 9 months

    Time frame: baseline, 3-months, 9-months

    Activities of daily Living (ADL) is a questionnaire to screen for functional assessment.

  3. Change from baseline Instrumental Activities of Daily Living (IADL) at 3 months and 9 months

    Time frame: baseline, 3-months, 9-months

    Instrumental Activities of Daily Living (IADL) is a questionnaire to screen for functional assessment.

  4. Change from baseline Geriatric Depression Scale (GDS) at 3 months and 9 months

    Time frame: baseline, 3-months, 9-months

    Psychological well-being will be assessed using the Geriatric Depression Scale. Subjects with high scores will not be enrolled into the study and will be informed of the scores and advised to see a doctor at a polyclinic or their family physician with a referral letter prepared for this purpose.

  5. Change from baseline Geriatric Anxiety Inventory (GAI) at 3 months and 9 months

    Time frame: baseline, 3-months, 9-months

    Psychological well-being will be assessed using the Geriatric Anxiety Inventory (GAI). Subjects with high scores will not be enrolled into the study and will be informed of the scores and advised to see a doctor at a polyclinic or their family physician with a referral letter prepared for this purpose.

Other outcomes

  1. Demographic questionnaire

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Acronym: MAPRCT

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 10, 2014
Registry last updated
Aug 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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