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

N

National University of Singapore

Status

Completed

Conditions

Dementia

Treatments

Behavioral: Health Education Program
Behavioral: Mindful Awareness Program

Study type

Interventional

Funder types

Other

Identifiers

NCT02286791
B-14-110

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

60 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

55 participants in 2 patient groups

Mindful Awareness Program
Experimental group
Description:
18 sessions of mindful awareness program teaching the elderly mindful awareness practice techniques
Treatment:
Behavioral: Mindful Awareness Program
Health Education Program
Active Comparator group
Description:
18 sessions of health education program focusing on healthy living topics
Treatment:
Behavioral: Health Education Program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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