| NCT ID | NCT05841784 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Cardiovascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2025-05-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Tanya Spruill, PhD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT05841784 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05841784 currently recruiting?
Yes, NCT05841784 is actively recruiting participants. Contact the research team at Tanya.Spruill@nyulangone.org for enrollment information.
Where is the NCT05841784 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05841784 clinical trial?
NCT05841784 is sponsored by NYU Langone Health. The principal investigator is Tanya Spruill, PhD at NYU Langone Health. The trial plans to enroll 160 participants.