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Recruiting Not applicable NCT05841784

HARP Mindfulness Study

No applicable phase (e.g. observational)
Conditions: Cardiovascular Diseases

Sponsor: NYU Langone Health

trial.available_in: БГ
Overview
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.
Who can participate
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
MBCT-T
BEHAVIORAL
Booster Mindfulness Sessions
BEHAVIORAL
Website Support
BEHAVIORAL
Locations 1
United States (1)
NYU Langone Health
New York , New York
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.05.2025
Completion date
31.12.2026
Registry ID
NCT05841784
Source
clinicaltrials.gov
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