Mild Cognitive Impairment (MCI)CohnMAP-RCTNCT07389655
(MAP) Pilot Randomized Controlled Trial for Older Adults With Mild Cognitive Impairment and Elevated Stress
A study testing Mindful Awareness Practice (MAP) in people with Mild Cognitive Impairment (MCI) and Stress (Psychology), run by Rush University Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Stress (Psychology)
- What is being tested?
- Mindful Awareness Practice (MAP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ted Ng contact
About this study
Official title: 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.
Read the 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.
- Being tested
- Mindful Awareness Practice (MAP)
- Keywords
- mindfulness; stress; MCI
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Awareness Practice (MAP)Behavioural
Mindful Awareness Practice (MAP), a MBSR format-tailored to mild cognitive impairment (MCI)
| Study group | Role | What they receive |
|---|---|---|
| Mindful Awareness Practice (MAP) | Experimental | Mindful Awareness Practice (MAP) Receives: Behavioral: Mindful Awareness Practice (MAP) |
| Health Education Program (HEP) | Active comparator | Health Education Program (HEP) Receives: Behavioral: Mindful Awareness Practice (MAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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%.
Measured: From enrollment to the end of treatment at12 weeks
Acceptability (qualitative)
Measuring Acceptability (qualitative)
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (7)
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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: From enrollment to the end of treatment at 12 weeks
Stress-related biomarker (Salivary cortisol)
Measuring Stress-related biomarker (Salivary cortisol)
Measured: 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
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ted K.S. Ng, Rush University Medical Center
- Investigators
- Ted Ng, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389655
- Sponsor's protocol ID
- 25093005
- Acronym
- CohnMAP-RCT
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Awareness Practice (MAP) Pilot Randomized Controlled Trial for Older Adults With Mild Cognitive Impairment and Elevated Stress
- ClinicalTrials.gov ID
- NCT07389655
- Acronym / sponsor ID
- CohnMAP-RCT / 25093005
- Keywords
- mindfulness; stress; MCI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Awareness Practice (MAP) | Experimental | Behavioral: Mindful Awareness Practice (MAP)Mindful Awareness Practice (MAP) |
| Health Education Program (HEP) | Active comparator | Behavioral: Mindful Awareness Practice (MAP)Health Education Program (HEP) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Awareness Practice (MAP)Mindful Awareness Practice (MAP), a MBSR format-tailored to mild cognitive impairment (MCI) | Behavioural | Health Education Program (HEP), Mindful Awareness Practice (MAP) |
Primary outcome
Fidelity
Time frame: From enrollment to the end of treatment at 12 weeks
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
Time frame: From enrollment to the end of treatment at 12 weeks
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
Time frame: From enrollment to the end of treatment at 12 weeks
The number of adverse events directly related to the delivery/receipt of the intervention10-12.
Acceptability (quantitative)
Time frame: From enrollment to the end of treatment at12 weeks
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%.
Acceptability (qualitative)
Time frame: From enrollment to the end of treatment at 12 weeks
Measuring Acceptability (qualitative)
7 secondary outcomes
Cognitive Outcomes
Time frame: From enrollment to the end of treatment at12 weeks
Depressive & anxiety symptoms
Time frame: From enrollment to the end of treatment at12 weeks
Mindfulness
Time frame: From enrollment to the end of treatment at12 weeks
Perceived stress
Time frame: From enrollment to the end of treatment at12 weeks
Social (dis) connections
Time frame: From enrollment to the end of treatment at 12 weeks
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
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ted Ng contact
Ted Ng, PhD principal investigator
Rush University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Awareness Practice (MAP) in people with Mild Cognitive Impairment (MCI) and Stress (Psychology), run by Rush University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ted Ng, PhD (6029078883, kheng_s_ng@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.