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HARP Mindfulness Study

HARP Mindfulness Study

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

Inclusion 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 disease risk factors include hypertensive diseases (ICD-10 codes I10 - I11, I15 - I16), diabetes (E8 - E13), and/or hyperlipidemia (E78.0 - E78.5, E78.9)
  • 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

Exclusion Criteria:

  • 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.

Study details
    Cardiovascular Diseases

NCT05841784

NYU Langone Health

13 May 2026

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