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New treatment option for Cardiovascular Diseases
Official title HARP Mindfulness Study
ClinicalTrials.gov ID: NCT05841784
What this study is testing
- What it's testing
- This study was designed using the Multiphase Optimization Strategy (MOST) framework to determine whether two supplemental components increase the efficacy of a mindfulness-based cognitive therapy program delivered via telephone (MBCT-T) for psychological distress. Specifically, this study will test mindfulness booster sessions to follow a standard 8-week MBCT-T intervention, as well as website support in patients with heart disease and/or heart disease risk factors.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients meeting one of the following criteria:
- Has a diagnosis of ischemic heart disease (ICD-10 codes I20 - I25) with no cardiac hospitalizations in the past 6 months
- Has cardiovascular disease risk factors without meeting a diagnosis of ischemic heart disease or having a cardiovascular disease event (heart attack...
- Patients meeting one or more of the following criteria at baseline:
- Elevated stress (PSS-10 score ≥15)
You likely can't join if
- Active suicidal ideation
- History of, or current diagnosis of, psychosis
- Significant cognitive impairment (noted in the EHR or evident during screening)
- Significant hearing loss
- Current participation in another behavioral clinical trial
- Has received the MBCT-T intervention in a previous clinical trial.
See the full eligibility criteria
- Patients meeting one of the following criteria:
- Has a diagnosis of ischemic heart disease (ICD-10 codes I20 - I25) with no cardiac hospitalizations in the past 6 months
- Has cardiovascular disease risk factors without meeting a diagnosis of ischemic heart disease or having a cardiovascular disease event (heart attack, stroke, heart failure, and/or unstable angina). Cardiovascular...
- Patients meeting one or more of the following criteria at baseline:
- Elevated stress (PSS-10 score ≥15)
- Mild to moderate depressive symptoms (PHQ-9 score between 5-14)
- Mild or greater anxiety (GAD-7 score ≥5)
- Willing to provide informed consent and comply with all aspects of the protocol
- Able to read and communicate in English
- Active suicidal ideation
- History of, or current diagnosis of, psychosis
- Significant cognitive impairment (noted in the EHR or evident during screening)
- Significant hearing loss
- Current participation in another behavioral clinical trial
- Has received the MBCT-T intervention in a previous clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.