HARP Mindfulness Study
Recruiting now · Not applicable
Conditions studied: Cardiovascular Diseases
In brief
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.
Key facts
- Study ID
- NCT05841784
- Run by
- NYU Langone Health
- People needed
- 160
- Starts
- 2025-05-15
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-04-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- NYU Langone Health — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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