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Mindfulness-Based Cognitive Therapy for Heart Disease
N/A
Waitlist Available
Led By Tanya Spruill, PhD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights
Study Summary
This trial tests if adding two components to an 8-week MBCT-T program can help reduce psychological distress in people with heart disease or risk factors.
Who is the study for?
This trial is for English-speaking individuals with heart disease or risk factors like high blood pressure, diabetes, or high cholesterol. They should have mild to moderate depression and/or anxiety but no recent hospitalizations for heart issues. Participants must not be in other behavioral trials, have significant cognitive impairments, hearing loss, psychosis, suicidal thoughts, or previous MBCT-T treatment.Check my eligibility
What is being tested?
The study tests if adding booster mindfulness sessions and website support can improve the effectiveness of a telephone-based mindfulness program (MBCT-T) for those experiencing psychological distress due to heart disease or its risk factors.See study design
What are the potential side effects?
As this is a non-drug intervention focusing on mindfulness therapy via phone and online support tools, side effects may include emotional discomfort during self-reflection exercises but are generally considered low-risk compared to medication treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Follow-Up
Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Post-Intervention
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
Secondary outcome measures
Average Sleep Duration at Baseline
Average Sleep Duration at Follow-Up
Average Sleep Duration at Post-Intervention
+18 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: MBCT-T + Website Support + Booster Mindfulness SessionsExperimental Treatment3 Interventions
Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to both booster sessions and website support.
Group II: MBCT-T + Website SupportExperimental Treatment2 Interventions
Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to website support.
Group III: MBCT-T + Booster Mindfulness SessionsExperimental Treatment2 Interventions
Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to booster mindfulness sessions.
Group IV: MBCT-T (Reference)Active Control1 Intervention
Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MBCT-T
2018
N/A
~110
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,601 Total Patients Enrolled
American Heart AssociationOTHER
324 Previous Clinical Trials
4,933,618 Total Patients Enrolled
Tanya Spruill, PhDPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently having thoughts about harming myself.I have risk factors for heart disease but haven't had a heart attack, stroke, or heart failure.I have significant hearing loss.I have participated in a clinical trial for MBCT-T before.I have been diagnosed with heart disease but haven't been hospitalized for it in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: MBCT-T (Reference)
- Group 2: MBCT-T + Booster Mindfulness Sessions
- Group 3: MBCT-T + Website Support
- Group 4: MBCT-T + Website Support + Booster Mindfulness Sessions
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment open for this research project?
"As noted on the clinicaltrials.gov database, this experiment is not presently recruiting participants. The study was initially published on June 1st of 2023 and last updated April 24th of 2023; however, there are 420 other studies in progress looking for volunteers right now."
Answered by AI
What are the primary goals of this trial?
"The principal objective of this clinical trial is the composite evaluation of three questionnaires (PSS-10, PHQ-9, and GAD-7) post intervention over a baseline period. Secondary goals include assessing PSS-10 scores at post treatment and follow up as well as PHQ-9 scores at baseline. Each survey has its own rating scale ranging from 0 to 4 or 0 to 3 respectively; higher numbers suggest heightened levels of stress/depressive symptoms."
Answered by AI
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