The purpose of this study is to test whether a tailored mindfulness program, called the Mindful Awareness Practice (MAP) or a Health Education Program (HEP) can reduce stress and improve memory, mood, and well-being in older adults with Mild Cognitive Impairment (MCI) and elevated stress.
The purpose of this study is to test whether a tailored mindfulness program, called the Mindful Awareness Practice (MAP) or a Health Education Program (HEP) can reduce stress and improve memory, mood, and well-being in older adults with Mild Cognitive Impairment (MCI) and elevated stress. If you agree to participate in this study, your participation may last about 6 months, including 12 weeks of weekly sessions and 3 virtual/remotevisits (baseline, 3 months, 6 months). You will be randomly assigned (like flipping a coin) to MAP mindfulness program or Health Education Program (HEP). Both programs involve 12 weeks of weekly 1-hour virtual sessions (recordings + some live Microsoft Teams). You will have 3 virtual/remote visits via phone or Microsoft Teams for cognitive testing, questionnaires, and to guide your self-collection of blood (finger-stick dried blood spot) and saliva samples. We will mail you the necessary collection kits in advance There are risks to you for participating in this study. In this study, there is a very small risk that you may feel a little tired, frustrated or stressed especially during activities that involve thinking or answering questions; emotional discomfort during mindfulness activities; minor risks from finger stick dried blood spot collection, similar to checking blood sugar, which may include brief pain, mild bruising, or, very rarely, infection at the fingertip; and very small chance of loss of privacy of data despite strong safeguards. These risks are rare and we will do our best to prevent this from happening. You may benefit from taking part in this study. Based on experience with mindful awareness program/health education program in patients with similar conditions, researchers believe it may be of benefit to people with your condition or it may be as good as standard therapy with fewer side effects. You may feel less stressed and have improved memory and mood. Even if you do not benefit directly, knowledge gained may help future programs to prevent Alzheimer's disease and related dementias. However, because individuals respond differently to interventions, no one can know in advance if it will be helpful for you.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
30
Mindful Awareness Practice (MAP), a MBSR format-tailored to mild cognitive impairment (MCI)
Fidelity
Rating of instructors will be done via 1) participant ratings using a softcopy delivery assessment form11 and 2) mindfulness-based interventions teaching assessment criteria scale13 to be filled up by the PI and co-I Krueger, viewing recordings of intervention sessions and comparing them against the a priori-designed intervention manuals.
Time frame: From enrollment to the end of treatment at 12 weeks
Study Feasibility, including recruitment adherence and retention
Recruitment = number of participants who consented to participate/number of potential participants who responded to recruitment/screened; Accrual \& randomization = number of participants consented \& passed eligibility criteria; goals: n=15 by recruitment month 3, n=25 by month 4.5, n=30 by month 5 or 6 (higher n at the beginning and tapering towards the end). Adherence = 1) the number of sessions attended at intervention 3-month \& 6-month/total number of sessions offered (reasons for absence will also be noted for descriptive analyses and for informing future trial11), 2) the average number of minutes of: a. sessions attended and b. assigned homework completed by intervention 3-month \& 6-month. Retention = 1) (of participants) the number of participants assessed at 3-month \& 6-month /total number of participants randomized at baseline; 2) (of outcome measures) number of participants completed a specific outcome measure at 3-month \& 6-month /total number of participants measured
Time frame: From enrollment to the end of treatment at 12 weeks
Safety, indicated by number of adverse events
The number of adverse events directly related to the delivery/receipt of the intervention10-12.
Time frame: From enrollment to the end of treatment at 12 weeks
Acceptability (quantitative)
12-item adapted questionnaire used in a previous NIH-funded RCT14.The questions assess satisfaction with the intervention and perception of benefits conferred by the intervention11,15, such as: "Overall, how satisfied were participant with the MAP/HEP intervention?" "Did (\& if so, how did) the intervention improve participant memory?" Similar to the original questionnaire11, each question has four options, i.e., "not at all", "a little", "some", and "a great deal". Acceptability will be based on the aggregate percentage of participants answering "some" and "a great deal", ranging from 0-100%.
Ted Ng
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From enrollment to the end of treatment at12 weeks
Acceptability (qualitative)
Measuring Acceptability (qualitative)
Time frame: From enrollment to the end of treatment at 12 weeks
Cognitive Outcomes
Boston story recall tests (attention, memory), Digit span forward \& backward (memory, executive function), Category fluency (Fruits/Vegetables) (language), and 10-item MMSE (global cognition). Global Cognition Composite Score will be calculated based on the sum of z-scores of all tests. All tests are validated.
Time frame: From enrollment to the end of treatment at12 weeks
Depressive & anxiety symptoms
10-item CES-D and a 7-item Geriatric Anxiety Index (GAI).16 They are valid and have high reliability (α= 0.80 to 0.86 for CES-D and α= 0.85 to 0.92 for GAI).
Time frame: From enrollment to the end of treatment at12 weeks
Mindfulness
* Trait mindfulness: 15-item Five-facet Mindfulness Questionnaire (α=0.67 to 0.92) * State Mindfulness: 9-item Multidimensional State Mindfulness Questionnaire (MSMQ)(α=0.65-0.83)10617, (α=0.65-0.83 contingent on the facet/subscale).18
Time frame: From enrollment to the end of treatment at12 weeks
Perceived stress
10-item Perceived Stress Scale,19 an assessment of one's global appraisal of stress. The PSS has established validity and reliability (α=0.82).19
Time frame: From enrollment to the end of treatment at12 weeks
Social (dis) connections
10-item UCLA Loneliness Scale; 7-item Positive Relations with Others sub-scale from the 42-item Ryff's Psychological Well-being Scale
Time frame: From enrollment to the end of treatment at 12 weeks
Stress-related biomarker (Salivary cortisol)
Measuring Stress-related biomarker (Salivary cortisol)
Time frame: From enrollment to the end of treatment at 12 weeks
Dried blood spot (DBS) inflammatory and Alzheimer's disease (AD) biomarkers
Stress-related biomarker (Salivary cortisol) Dried blood spot (DBS) inflammatory and Alzheimer's disease (AD) biomarkers
Time frame: From enrollment to the end of treatment at 12 weeks