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

NCT07389655 | Not Yet Recruiting

• 1 other identifier: 25093005
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stress (Psychology); Mild Cognitive Impairment (MCI)

Keywords

mindfulness; stress; MCI

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Cognitive Outcomes

  From enrollment to the end of treatment at12 weeks

• Depressive & anxiety symptoms

  From enrollment to the end of treatment at12 weeks

• Mindfulness

  From enrollment to the end of treatment at12 weeks

• Perceived stress

  From enrollment to the end of treatment at12 weeks

• Social (dis) connections

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Mindful Awareness Practice (MAP)

EXPERIMENTAL

Mindful Awareness Practice (MAP)

Behavioral: Mindful Awareness Practice (MAP)

Health Education Program (HEP)

ACTIVE COMPARATOR

Health Education Program (HEP)

Behavioral: Mindful Awareness Practice (MAP)

Interventions

Mindful Awareness Practice (MAP) BEHAVIORAL

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

Health Education Program (HEP); Mindful Awareness Practice (MAP)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ted Ng, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ted Ng, PhD

CONTACT

6029078883; kheng_s_ng@rush.edu

Ted Ng

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share