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

Mindful Awareness Practice (MAP) Pilot Randomized Controlled Trial for Older Adults With Mild Cognitive Impairment 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mild Cognitive Impairment (MCI); Stress (Psychology)
• Intervention / Treatment: Behavioral: Mindful Awareness Practice (MAP)

Detailed Description

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
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ted Ng, PhD; Phone Number: 6029078883; Email: kheng_s_ng@rush.edu
• Study Contact Backup: Name: Ted Ng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

If taking medications with significant cholinergic, anticholinergic effects, anti-depressants, corticosteroid, or non-steroidal anti-inflammatory drug (NSAID), stabilized dose for ≥6 months.

• Ability to speak and read English
• Ability to provide informed consent

Exclusion Criteria:

• 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.

Diagnosed major neurological disorders, e.g., large vessel stroke, brain tumor, and severe brain injury.

Diagnosed terminal illness, including cancer, requiring palliative care, and organ failure, including hepatic or renal failure.

Sensory impairment, e.g., visual/hearing impairment impacting abilities to participate in the study.

Participating in other intervention(s) concurrently, either a research study or for self-interest (e.g., lifelong learning programs).which may improve memory for >2 days/week, 30 minutes a session in the past 3 months. After a wash-out period of ≥6 months, potential participants will be allowed to join this present study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindful Awareness Practice (MAP)	Behavioral: Mindful Awareness Practice (MAP); Mindful Awareness Practice (MAP), a MBSR format-tailored to mild cognitive impairment (MCI)
Active Comparator: Health Education Program (HEP)	Behavioral: Mindful Awareness Practice (MAP); Mindful Awareness Practice (MAP), a MBSR format-tailored to mild cognitive impairment (MCI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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%.	From enrollment to the end of treatment at12 weeks
Acceptability (qualitative)	Measuring Acceptability (qualitative)	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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	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	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	From enrollment to the end of treatment at 12 weeks
Stress-related biomarker (Salivary cortisol)	Measuring Stress-related biomarker (Salivary cortisol)	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	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Ted Ng, PhD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: mindfulness; stress; MCI
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 25093005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No