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
Conditions
Cardiovascular Diseases
Locations
NYU Langone Health
New York, New York 10016
United States