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Recruiting NCT05841784

HARP Mindfulness Study

No phase Interventional Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MBCT-T, Booster Mindfulness Sessions, Website Support.
Who it may be relevant to
Registry conditions: Cardiovascular Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

NYU HARP Telephone-Based Mindfulness Program

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.

Interventions

  • Behavioral MBCT-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.
  • Behavioral Booster 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.
  • Behavioral Website 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.

Primary outcome measures

  • Composite Score of 3 Questionnaires: Perceived Stress Scale 10-item Version (PSS-10); Patient Health Questionnaire 9-Item Version (PHQ-9); and Generalized Anxiety Disorder Questionnaire 7-Item Version (GAD-7) at Baseline [Time frame: Baseline]
  • Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Post-Intervention [Time frame: Month 2]
  • Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Follow-Up [Time frame: Month 6]
Secondary outcome measures (12)
  • PSS-10 Score at Baseline [Time frame: Baseline]
  • PSS-10 Score at Post-Intervention [Time frame: Month 2]
  • PSS-10 Score at Follow-Up [Time frame: Month 6]
  • PHQ-9 Score at Baseline [Time frame: Baseline]
  • PHQ-9 Score at Post-Intervention [Time frame: Month 2]
  • PHQ-9 Score at Follow-Up [Time frame: Month 6]
  • GAD-7 Score at Baseline [Time frame: Baseline]
  • GAD-7 Score at Post-Intervention [Time frame: Month 2]
  • GAD-7 Score at Follow-Up [Time frame: Month 6]
  • Sleep-Quality Score at Baseline [Time frame: Baseline]
  • Sleep-Quality Score at Post-Intervention [Time frame: Month 2]
  • Sleep-Quality Score at Follow-Up [Time frame: Month 6]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT05841784 · 22-01609

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗