Adapted MBCT for Acute Coronary Syndrome

Phase-Based Estimates
1
Effectiveness
1
Safety
Mongan Institute: Health Policy Research Center, Boston, MA
Acute Coronary Syndrome+3 More
Adapted MBCT - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Acute Coronary Syndrome

Study Summary

This study is evaluating whether mindfulness based cognitive therapy may help improve the lives of individuals with chronic pain.

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Eligible Conditions

  • Acute Coronary Syndrome
  • Syndrome
  • Depression
  • Cardiovascular Diseases

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Adapted MBCT will improve 8 primary outcomes and 15 secondary outcomes in patients with Acute Coronary Syndrome. Measurement will happen over the course of 6 months.

6 months
Assessment of Survivor Concerns (ASC)
Blood spot acceptability: blood spot collection ease and comfort
Blood spot feasibility: rate of adequate blood spot sample completion
Cognitive and Affective Mindfulness Scale- Revised (CAMS-R)
Current Experiences Scale (CES)
Eligibility feasibility: percent of participants determined eligible
Experiences Questionnaire (EQ)
Hospital Anxiety and Depression Scale (HADS)
Interpersonal Reactivity Index (IRI)
MBCT and control group acceptability: ratings of intervention satisfaction
MBCT intervention and control group feasibility: percent of participants adherent to their assigned treatment group
Medical Outcomes Study - Specific Adherence Scale (MOS-SAS)
Mindfulness Based Cognitive Therapy-Adherence Scale
One item from the Short Form-12 (SF-12)
PROMIS- Physical Function (PROMIS-PF)
Patient Health Questionnaire-9 (PHQ-9)
Recruitment feasibility: percent of participants recruited and enrolled
Self-Other Four Immeasurables (SOFI)
The Multidimensional Assessment of Interoceptive Awareness (MAIA)
The Positive and Negative Affect Schedule-Positive Affect (PANAS-PA)
Videoconferencing acceptability: ratings of videoconferencing satisfaction
Videoconferencing feasibility: number and type of videoconferencing difficulties
Whole dried blood spots

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

No Control Group
Virtual Health Enhancement Control

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Adapted MBCT is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Virtual Health Enhancement Control
Behavioral
Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes).
Virtual MBCT Intervention
Behavioral
Participants will participate in 8 weekly virtual group sessions of MBCT. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Who is running the study

Principal Investigator
C. L.
Prof. Christina Luberto, Assistant Professor, Department of Psychiatry, Harvard Medical School; Staff Psychologist, Massachusetts General Hospital
Massachusetts General Hospital

Closest Location

Mongan Institute: Health Policy Research Center - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
This study provides a lifetime estimate of the number of ambulatory care visits (ACSs) for a cohort of individuals with a specific medical record and/or patient confirmation. show original
Current elevated depression symptoms (PHQ-9 greater than or equal to 5)
Age 35-85 years
Access to high-speed internet

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can acute coronary syndrome be cured?

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Most patients with non-ST-segment-elevation acute coronary syndrome who receive thrombolysis benefit within 2 weeks of the onset of symptoms and meet the definitions of myocardial infarction.

Unverified Answer

How many people get acute coronary syndrome a year in the United States?

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ACS are common. Most people of all ages experience them, and their frequency is increasing. In many cases, the symptoms are subtle and not noticed by the health care provider until significant coronary plaque rupture and/or thrombosis has occurred. ACS management and patient care in this setting can be challenging and a high level of expertise is highly recommended.

Unverified Answer

What are the signs of acute coronary syndrome?

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The majority of patients display transient ST elevation abnormalities consistent with acute coronary syndrome. However, a significant number of patients with ST elevation have no significant coronary artery stenosis. ST elevation may be a marker of other subclinical cardiac conditions such as transient ischaemic attack or stable ischaemic heart disease. Recent findings a large proportion (21%) of patients had transient ischaemic attacks. Furthermore, the majority had atherothrombotic events prior to their clinical presentation.

Unverified Answer

What are common treatments for acute coronary syndrome?

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A large percentage of patients had acute coronary syndrome, and coronary artery bypass surgery was the most common treatment. In severe cases, open heart surgery were utilized. Coronary arteries were most commonly targeted during percutaneous coronary intervention. Targeted therapeutic therapies for acute coronary syndrome have also become increasingly common.

Unverified Answer

What is acute coronary syndrome?

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The vast majority of patients with non-ST-elevation myocardial infarction have chest pain rather than an acute coronary syndrome. The diagnosis of ACS based on symptoms alone seems to be unreliable. For instance, the sensitivity of chest pain for ACS at a primary care level is very low. An adequate investigation is recommended for all patients with non-ST-elevation myocardial infarction to prevent underdiagnosis.

Unverified Answer

What causes acute coronary syndrome?

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It is not clear what causes acute coronary syndrome in all patients presenting to the emergency department with new-onset chest pain, left bundle-branch block, or positive Troponin. In most patients, there is a combination of risk factors.

Unverified Answer

Does adapted mbct improve quality of life for those with acute coronary syndrome?

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This is the first randomized, controlled trial of adapted mbct for A* ACS patients, and results are promising. Although the study lacked in statistical power, these results indicate that adaptation to self-management interventions such as mbct for A* ACS patients can have improved outcomes for patients and provide some support for implementing additional adaptation to existing patient education programs for patients with ACS.

Unverified Answer

What are the common side effects of adapted mbct?

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Adapted MBCT has a relatively high rate of side effects, and in some cases serious side effects have occurred. We think that some adaptations in the protocols may help. One problem is that there is no consensus over the definition of a side effect and the most effective means of preventing them as well. For example, we think that some patients may wish for an enlarged prostate which is not an appropriate adaptation if it is considered a serious side effect.

Unverified Answer

What does adapted mbct usually treat?

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There are several factors relating to age, sex, and location that affect treatment decisions in patients hospitalized with an uncomplicated acute myocardial infarction being treated with standard medication and protocol. These factors have been shown to be helpful in determining the optimal timing of invasive procedures. The data showed that more patients may benefit from an early invasive approach than from a conservative medical treatment. These considerations should be considered in deciding when to do an invasive exam.

Unverified Answer

Is adapted mbct typically used in combination with any other treatments?

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This is the first study where a large number of patients have been evaluated for their treatment choice after mbct, and it highlights the utility of adapted treatment in combination with other therapies. However, it also shows that many patients with a high-risk profile are not being offered mbct in primary PCI, perhaps a result of the complexity of choosing the correct treatment for their circumstances. This finding needs to be considered in our practice.

Unverified Answer

How does adapted mbct work?

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Treatment with Adapted MBCT is associated with a significant reduction on hospital readmission in patients with CABG/AADK. Findings from a recent study highlights the important role of adapted mbct in reducing readmissions after CABG/AADK.

Unverified Answer

What is adapted mbct?

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In [the hospital in which we conduct the research(s)], we found that [adapted mbct] is not uncommon in patients with a myocardial infarction. When a patient is transferred to cardiology-related wards on a Wednesday, mbct may be [used] at [the next appointment] and [the patient will] be [attempted to return to their [previous workplace]].

Unverified Answer
See if you qualify for this trial
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