(MAP) Pilot Randomized Controlled Trial for Older Adults With Mild Cognitive Impairment and Elevated Stress

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorRush University Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Mindful Awareness Practice (MAP)

    Behavioral

    Mindful Awareness Practice (MAP), a MBSR format-tailored to mild cognitive impairment (MCI)

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Mindful Awareness Practice (MAP)Experimental treatment 1 intervention
Group B: Health Education Program (HEP)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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%.

Time frame
From enrollment to the end of treatment at12 weeks

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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