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NCT05841784NARecruiting

HARP Mindfulness Study

NYU Langone Health

Start Date

5/15/2025

Completion Date

12/31/2026

Summary

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

BEHAVIORAL

MBCT-T

BEHAVIORAL

Booster Mindfulness Sessions

BEHAVIORAL

Website Support

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Conditions

Cardiovascular Diseases

Locations

NYU Langone Health

New York, New York 10016

United States