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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02286791
Recruitment Status : Completed
First Posted : November 10, 2014
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
Rathi Mahendran, National University, Singapore

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.


Condition or disease Intervention/treatment Phase
Dementia Behavioral: Mindful Awareness Program Behavioral: Health Education Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mindful Awareness Program for the Prevention of Dementia: A Randomized Controlled Trial
Study Start Date : September 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Mindful Awareness Program
18 sessions of mindful awareness program teaching the elderly mindful awareness practice techniques
Behavioral: Mindful Awareness Program
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 Name: MAP

Active Comparator: Health Education Program
18 sessions of health education program focusing on healthy living topics
Behavioral: Health Education Program

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 Name: HEP




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Demographic questionnaire [ Time Frame: Baseline ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286791


Locations
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Singapore
Training and Research Academy
Singapore, Singapore, 648886
Sponsors and Collaborators
National University, Singapore
Investigators
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Principal Investigator: Rathi Mahendran, Ph.D National University, Singapore
Publications:
Mcbee, L. (2008) Mindfulness-based elder care. New York: Springer.
Schmidt, M. (1996). Rey auditory verbal learning test: A handbook. Los Angeles: Western Psychological Services.
Ardila, A., Ostrosky-Solís, F, & Bernal,B. (2006). Cognitive testing toward the future: The example of Semantic Verbal Fluency (ANIMALS), International Journal of Psychology, 41(5), 324-332

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Responsible Party: Rathi Mahendran, Senior Consultant Psychiatrist, National University, Singapore
ClinicalTrials.gov Identifier: NCT02286791    
Other Study ID Numbers: B-14-110
First Posted: November 10, 2014    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015
Keywords provided by Rathi Mahendran, National University, Singapore:
Prevention of dementia
Mindful awareness program
Mild cognitive impairment
Mindfulness
Elderly
Cognitive decline
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders