About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
MCI participant: Community-dwelling, ≥65 years old, and diagnosed with MCI within the past 12 months, consented to participate in the trial, and have Wi-Fi access; Diagnosed with chronic stress-related conditions based on ICD-10 codes. No prior experience in mindfulness or other mind-body practices (e.g., yoga, Qi Gong, and Tai Chi) within the past year for >10 minutes per day28.
Ability to speak and read English
Ability to provide informed consent
Disqualifiers
Diagnosed major psychiatric disorder, e.g., psychosis, bipolar disorder, and schizophrenia.Those with depression and anxiety will not be excluded, as they may be the prime targets for such an intervention and to avoid floor effects on measures that we suspected with our previous trial.
Trial design
Parallel
Treatments tested in this trial
Mindful Awareness Practice (MAP)
BehavioralMindful Awareness Practice (MAP), a MBSR format-tailored to mild cognitive impairment (MCI)
Treatment groups
Trial outcomes
Primary outcomes
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.
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
Safety, indicated by number of adverse events
The number of adverse events directly related to the delivery/receipt of the intervention10-12.
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%.
Secondary outcomes
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.
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).
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
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
Locations
Sponsors and contacts
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