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Clinical trial Recruiting at 1 site Interventional Ages 18 and up

HARP Mindfulness program for people with heart disease or heart disease risk factors

Official title: NYU HARP Telephone-Based Mindfulness Program

Run by NYU Langone Health · NCT05841784 · Data updated 2026-11-12

This trial will test whether adding brief mindfulness booster sessions and a supportive website to an 8-week telephone mindfulness-based cognitive therapy helps reduce stress, anxiety, and mild-to-moderate depressive symptoms in people with heart disease or cardiovascular risk factors.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment160 (estimated)
SponsorNYU Langone Health
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedMay 15, 2025
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedApril 17, 2026
Trial IDNCT05841784 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with ischemic heart disease or cardiovascular risk factors who have elevated stress (PSS-10 ≥15), mild-to-moderate depressive symptoms (PHQ-9 5–14), or mild-or-greater anxiety (GAD-7 ≥5), who can read and communicate in English and provide informed consent, are the intended participants.

Probably not a fit

People with active suicidal ideation, other exclusionary psychiatric conditions, recent unstable cardiac events, or who cannot participate via telephone or access the website are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses the Multiphase Optimization Strategy (MOST) framework to determine whether two supplemental components—mindfulness booster sessions after an 8-week telephone-delivered mindfulness-based cognitive therapy (MBCT-T) and a supportive website—increase the program's effect on psychological distress. Participants are patients with ischemic heart disease or cardiovascular risk factors who also have elevated stress, mild-to-moderate depressive symptoms, or mild-or-greater anxiety. The core MBCT-T program is delivered by phone, and the supplemental components are provided remotely to test scalable enhancements. The design compares combinations of the supplemental components to identify which configuration best improves symptoms and can be feasibly implemented.

Why it matters

Potential benefit: If successful, this approach could provide a scalable, remote way to reduce stress, anxiety, and mild-to-moderate depression in people with heart disease or risk factors, potentially improving quality of life and adherence to cardiac care.

How similar studies have gone: Mindfulness-based interventions including MBCT have shown benefits for depression, anxiety, and stress in general populations and some cardiac cohorts, but telephone delivery with post-course boosters and website support is less extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • NYU Langone Health
    New York, New York, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.