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Mindfulness Training

Mindfulness Training for Heart Failure (MYH-II Trial)

N/A
Recruiting
Led By Elena Salmoirago-Blotcher, MD, PhD
Research Sponsored by The Miriam Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years old
A documented diagnosis of HF
Must not have
Suicidal ideation or plan
New York Heart Association (NYHA) class IV heart failure or clinically unstable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 9 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study if mindfulness training can help improve self-care among heart failure patients with cognitive impairment.

Who is the study for?
This trial is for adults over 18 with heart failure and mild cognitive issues who can speak English or Spanish. They must have a phone and not be planning to move during the study. People with severe mental health issues, enrolled in another study, or with very poor hearing or severe heart failure aren't eligible.
What is being tested?
The trial examines if mindfulness training plus enhanced usual care helps patients manage their heart conditions better than just enhanced usual care alone. Participants will either receive this new combination of treatments or continue with their regular care.
What are the potential side effects?
Mindfulness training is generally safe but may include temporary feelings of discomfort when dealing with emotions, fatigue from practice sessions, and potential frustration if no immediate improvement in self-care is noticed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I have been diagnosed with heart failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had thoughts of harming myself.
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My heart condition is very severe or unstable.
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My heart failure is not caused by conditions like takotsubo or myocarditis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery.
Secondary study objectives
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)levels.
Change in average 6-min walk test (6MWT) distance.
Change in average Depression subscale score on the Hospital Anxiety and Depression Scale (HADS).
+4 more
Other study objectives
HF hospital readmissions

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Mindful Training + Enhanced Usual CareExperimental Treatment1 Intervention
Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks.
Group II: Enhanced Usual Care aloneExperimental Treatment1 Intervention
Usual care.

Find a Location

Who is running the clinical trial?

The Miriam HospitalLead Sponsor
244 Previous Clinical Trials
37,702 Total Patients Enrolled
3 Trials studying Heart Failure
80 Patients Enrolled for Heart Failure
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,156 Total Patients Enrolled
43 Trials studying Heart Failure
213,304 Patients Enrolled for Heart Failure
Elena Salmoirago-Blotcher, MD, PhDPrincipal InvestigatorCardiovascular Institute, The Miriam Hospital, Brown University
3 Previous Clinical Trials
189 Total Patients Enrolled

Media Library

Mindfulness Training (Mindfulness Training) Clinical Trial Eligibility Overview. Trial Name: NCT05431192 — N/A
Heart Failure Research Study Groups: Enhanced Usual Care alone, Mindful Training + Enhanced Usual Care
Heart Failure Clinical Trial 2023: Mindfulness Training Highlights & Side Effects. Trial Name: NCT05431192 — N/A
Mindfulness Training (Mindfulness Training) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05431192 — N/A
~88 spots leftby Dec 2026
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