HARP Mindfulness program for people with heart disease or heart disease risk factors
NYU HARP Telephone-Based Mindfulness Program
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05841784 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Tanya Spruill, PhD — NYU Langone Health
- Study coordinator: Tanya Spruill
- Email: Tanya.Spruill@nyulangone.org
- Phone: 646-501-3429
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.