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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Fidelity [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Study Feasibility, including recruitment adherence and retention [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Safety, indicated by number of adverse events [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Acceptability (quantitative) [Срок оценки: From enrollment to the end of treatment at12 weeks]
• Acceptability (qualitative) [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (7)

• Cognitive Outcomes [Срок оценки: From enrollment to the end of treatment at12 weeks]
• Depressive & anxiety symptoms [Срок оценки: From enrollment to the end of treatment at12 weeks]
• Mindfulness [Срок оценки: From enrollment to the end of treatment at12 weeks]
• Perceived stress [Срок оценки: From enrollment to the end of treatment at12 weeks]
• Social (dis) connections [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Stress-related biomarker (Salivary cortisol) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Dried blood spot (DBS) inflammatory and Alzheimer's disease (AD) biomarkers [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07389655 · 25093005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗