RecruitingNot ApplicableNCT05841784

HARP Mindfulness Study

NYU HARP Telephone-Based Mindfulness Program

Sponsor

NYU Langone Health

Enrollment

160 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases

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

Min Age: 18 Years

Inclusion Criteria9

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 Criteria6

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.

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Interventions

BEHAVIORALMBCT-T

MBCT-T is an 8-week group-based program that combines training in mindfulness and cognitive-behavioral therapy to reduce psychological distress and negative emotions. Each weekly 1-hour session will consist of a check-in, discussion, teaching, mindfulness or cognitive behavioral practice or exercise, inquiry by the facilitator, and summary of the at-home practice.

BEHAVIORALBooster Mindfulness Sessions

Following the standard 8-week MBCT-T program, participants in certain arms will receive monthly MBCT-T booster sessions for 4 months of follow up. Each booster session will be 1 hour long. The sessions will include a concise review and summary of the main MBCT-T sessions.

BEHAVIORALWebsite Support

Participants in certain arms will receive continuous intervention support via the use of an online study website. The website will provide quick access to intervention materials and support to encourage participants to complete the at-home practice and apply the content of the MBCT-T program to real life situations.