Dementia Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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