Mind Your Heart-II

NCT05431192 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2026-03-19

No results posted yet for this study

Summary

This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.

Conditions

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.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH
  • The Miriam Hospital

    lead OTHER

Principal Investigators

  • Elena Salmoirago-Blotcher, MD, PhD · Cardiovascular Institute, The Miriam Hospital, Brown University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05431192 on ClinicalTrials.gov