NCT05431192 · The Miriam Hospital
Mind Your Heart-II
(MYH-II)
What this study is about
This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.
View original scientific description
This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.
Interventions
BEHAVIORAL
Mindfulness Training + Enhanced Usual Care
Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks. MT involves training in the following (1) Awareness of breath; (2) Body scan; (3) Directing attention to simple activities of daily life; (4) Becoming aware of own thoughts and emotions; (5) "Open awareness" - a technique by which the participant is invited to direct his/her attention to any event arising in their field of experience at a given moment. In addition, participants will practice mindfulness techniques for 20 minutes daily on their own with the guidance of a digitally recorded, standardized guided mindfulness practice.
OTHER
Enhanced Usual Care
Usual care will be enhanced in BOTH conditions with printed education materials provided to all participants using publicly available materials (the "Healthier Living with Heart Failure" guide available at the AHA Heart Failure Resource Center).66 The guide is organized in 7 chapters containing information on topics such as understanding HF, making healthy lifestyle changes, managing HF symptoms, taking medications, and living well with HF. Printed materials will be mailed weekly to all participants during the first 8 weeks of the study.
Primary outcome measures
Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery.
Time frame: Baseline, 3 months, 9 months
The NIH Toolbox is comprised of seven cognitive tests, of which two measure crystallized cognitive ability (i.e., vocabulary and reading) and five tests measure fluid cognitive functioning (i.e., working memory, memory, speed of processing, and executive function). The fluid cognition composite score is obtained by averaging the normalized scores of the Fluid Cognition measures. Higher scores indicate higher levels of functioning. A score \~ 100 indicates average fluid cognitive ability compared with others nationally. Scores \~115 suggest above-average ability, while scores \~130 suggest superior ability. Conversely, a score in the range of 85 suggests below-average ability, and a score \~ 70 or below suggests significant impairment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age \> 18 years old
- A documented diagnosis of HF
- Access to a telephone
- Mild cognitive impairment (MoCA score \< = 26)
- Ability to understand and speak English or Spanish
Exclusion criteria
- Unwillingness/inability to provide informed consent
- Reversible causes of HF (e.g., takotsubo syndrome; myocarditis)
- Severe hearing impairment not allowing phone delivery
- Suicidal ideation or plan
- Current (at least once a month) mind/body practice
- Planning to move out of the area during the study period
- Severe cognitive impairment (MoCA scores \< 15)
- New York Heart Association (NYHA) class IV heart failure or clinically unstable
- Ongoing psychiatric or neurologic conditions
- Current enrollment in another study
Where
- Providence, Rhode Island
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 19, 2026 · Source of record for eligibility and locations