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Telephone-based mindfulness training to reduce stress in women with myocardial infarction: Rationale and design of a multicenter randomized controlled trial.

ABSTRACT: BACKGROUND:Elevated stress is associated with adverse cardiovascular disease outcomes and accounts in part for the poorer recovery experienced by women compared with men after myocardial infarction (MI). Psychosocial interventions improve outcomes overall but are less effective for women than for men with MI, suggesting the need for different approaches. Mindfulness-based cognitive therapy (MBCT) is an evidence-based intervention that targets key psychosocial vulnerabilities in women including rumination (i.e., repetitive negative thinking) and low social support. This article describes the rationale and design of a multicenter randomized controlled trial to test the effects of telephone-delivered MBCT (MBCT-T) in women with MI. METHODS:We plan to randomize 144 women reporting elevated perceived stress at least two months after MI to MBCT-T or enhanced usual care (EUC), which each involve eight weekly telephone sessions. Perceived stress and a set of patient-centered health outcomes and potential mediators will be assessed before and after the 8-week telephone programs and at 6-month follow-up. We will test the hypothesis that MBCT-T will be associated with greater 6-month improvements in perceived stress (primary outcome), disease-specific health status, quality of life, depression and anxiety symptoms, and actigraphy-based sleep quality (secondary outcomes) compared with EUC. Changes in mindfulness, rumination and perceived social support will be evaluated as potential mediators in exploratory analyses. CONCLUSIONS:If found to be effective, this innovative, scalable intervention may be a promising secondary prevention strategy for women with MI experiencing elevated perceived stress.

SUBMITTER: Spruill TM

PROVIDER: S-EPMC7432959 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Telephone-based mindfulness training to reduce stress in women with myocardial infarction: Rationale and design of a multicenter randomized controlled trial.

Spruill Tanya M TM Reynolds Harmony R HR Dickson Victoria Vaughan VV Shallcross Amanda J AJ Visvanathan Pallavi D PD Park Chorong C Kalinowski Jolaade J Zhong Hua H Berger Jeffrey S JS Hochman Judith S JS Fishman Glenn I GI Ogedegbe Gbenga G

American heart journal 20180421

<h4>Background</h4>Elevated stress is associated with adverse cardiovascular disease outcomes and accounts in part for the poorer recovery experienced by women compared with men after myocardial infarction (MI). Psychosocial interventions improve outcomes overall but are less effective for women than for men with MI, suggesting the need for different approaches. Mindfulness-based cognitive therapy (MBCT) is an evidence-based intervention that targets key psychosocial vulnerabilities in women inc ...[more]

PMID: 29864732

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Project description:BackgroundSolid organ transplant recipients must take immune suppressive medications that have side effects, cause complications, and lead to distressing symptoms that reduce health-related quality of life (QOL). Mindfulness meditation has been shown to reduce these symptoms in other patient populations, and it is unlikely to interfere with the immune suppressive medication regimen.PurposeThis article describes the design and rationale of a clinical trial to determine whether training in mindfulness meditation can reduce depression, anxiety and insomnia after transplantation, and summarizes baseline characteristics of the participants.MethodsTransplant recipients were randomized in equal numbers to one of three arms: a Mindfulness-based Stress Reduction (MBSR) program consisting of 8 weeks of group instruction, home practice and telephone monitoring; a time and attention control Health Education program; or a waitlist arm. After serving 6 months as waitlist controls, these participants were re-randomized to MBSR or Health Education. Evaluations were obtained at baseline (prior to the active interventions), 8 weeks, 6 months, and 1 year (after randomization to MBSR or Health Education only). The primary analysis will compare composite symptom scores between MBSR and Health Education, initially or after serving in the waitlist. Subsequent analyses will compare these two groups on depression, anxiety, and insomnia symptom scales and secondary outcomes of health-related QOL, actigraphy, and health care utilization. A separate analysis, using only data collected before re-randomization, will compare short-term outcomes between the waitlist and active treatment arms.ResultsOne hundred fifty recipients were randomized and 72% of waitlist participants (31/43) were recycled to an active intervention after 6 months. Patient characteristics were balanced across trial arms after initial and secondary randomizations.LimitationsTransplant recipients are a very select population. Their adherence to the intervention and willingness to serve as waitlist controls prior to re-randomization may be atypical. Participants were not blinded to treatment and primary outcomes are self-reports.ConclusionThe innovative design used in the trial enabled the waitlist group to directly contribute to the number in the primary analysis of active arms, and to also serve as an internal validation test. The trial may be a useful model for trials involving very small target populations.

Project description:BackgroundOver the past 20 years, the development of regional ST-elevation myocardial infarction (STEMI) care systems has led to remarkable progress in achieving timely coronary reperfusion with attendant improvement in clinical outcomes, including survival. Despite this progress, contemporary STEMI care does not consistently meet the national guideline-recommended goals, which offers an opportunity for further improvement in STEMI outcomes. The lack of single, comprehensive, national STEMI registry complicates our ability to improve STEMI outcomes in particular for high-risk STEMI subsets such as cardiac arrest (CA) and/or cardiogenic shock (CS).ObjectivesTo address this need, the Midwest STEMI Consortium (MSC) was created as a collaboration of 4 large, regional STEMI care systems to provide a comprehensive, multicenter, and prospective STEMI registry without any exclusionary criteria.MethodsThe MSC is a collaboration of 4 large, regional STEMI care systems: Iowa Heart Center in Des Moines, IA; Minneapolis Heart Institute Foundation in Minneapolis, MN; Prairie Heart Institute in Springfield, IL; and The Christ Hospital in Cincinnati, OH. Each has similar standardized STEMI protocol and together include 6 percutaneous coronary intervention (PCI)-capable hospitals and over 100 non-PCI-capable hospitals. Each center had a prospective database that was transferred to a data coordinating center to create the multicenter database. The comprehensive database includes traditional risk factors, cardiovascular history, medications, time to treatment data, detailed angiographic characteristics, and short- and long-term clinical outcomes up to 5-year for myocardial infarction, stroke, and cardiovascular and all-cause mortality. Ten-year mortality rates were assessed by using national death index.ResultsCurrently, the comprehensive database (03/2003-01/2020) includes 14,911 consecutive STEMI patients with mean age of 62.3 ± 13.6 years, female gender (29%), and left anterior descending artery as the culprit vessel (34%). High risk features included: Age >75 years (19%), left ventricular ejection fraction <35% (15%), CA (10%), and CS (8%).ConclusionThis collaboration of 4 large, regional STEMI care systems with broad entry criteria including high-risk STEMI subsets such as CA and/or CS provides a unique platform to conduct clinical research studies to optimize STEMI care.

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Dataset Information

Telephone-based mindfulness training to reduce stress in women with myocardial infarction: Rationale and design of a multicenter randomized controlled trial.

Publications

Telephone-based mindfulness training to reduce stress in women with myocardial infarction: Rationale and design of a multicenter randomized controlled trial.

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